Document:

QuickLinks
 -- Click here to rapidly navigate through this document

 

 
 

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 & Ca, 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 20th 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. 

2

 

        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. 

3

 

        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 

4

 

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 

5

 

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. 

6

 

 

        (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. 

7

 

        (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. 

8

 

        (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 

9

 

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"): 

	Milestone Event
 
	 	Milestone Payment

(in U.S. Dollars)

	Receipt of written confirmation from the FDA following a pre-NDA meeting with the FDA that it will accept the NDA submission for the BIA 2-093 Product [**] prior to filing an NDA for Adjunctive Use in Adult Partial
Epileptic Seizures	 	$	[**]
	

Written acceptance by the FDA of an NDA file for the BIA 2-093 Product for Adjunctive Use in Adult Partial Epileptic Seizures	
 	
$	

[**]
	

FDA approval of the BIA 2-093 Product for Adjunctive Use in Adult Partial Epileptic Seizures	
 	
$	

[**]
	

FDA approval of a Licensed Product for any and each additional indication (other than Adult and Pediatric Adjunct Partial Epileptic Seizures), for either adult or pediatric use, including without limitation the following indications:
[**]. 	
 	
$	

[**]
	

FDA grant of six months pediatric exclusivity for the BIA 2-093 Product for Adjunctive use in Partial Epileptic Seizures	
 	
$	

[**]

        (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. 

10

 

        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. 

11

 

  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 (where all
Parties can hear and be heard). In addition, the JSC may be polled through electronic mail or correspondence. The JSC will meet within [**] of the Effective Date and at least
[**] every calendar year thereafter, where the first [**] such meetings will be in person for all of the JSC members. The JSC will meet on such dates,
and at such places and times or in such manner, as the members of the JSC will agree from time to time. Meetings of the JSC that are held in person will alternate between the offices of BIAL and
SEPRACOR, or at such other place as the Parties may agree. The Party hosting the meeting will be responsible for recording minutes of the meeting in writing. Such minutes will be circulated to the
Parties promptly following the meeting for review, comment and written approval. 

        5.5    Decision-making:    The JSC may make decisions with respect to any subject matter within the JSC's functions as
described above. Except as expressly provided in this Agreement, all decisions which are to be made by the JSC will be made by unanimous vote or written consent, with each Party having one vote in all
decisions. The JSC will use reasonable best efforts to resolve the matters within its roles and functions or otherwise referred to it. 

        5.6    Right to Decide:    If, with respect to a decision that is to be made by the JSC pursuant to
Section 5.3, the JSC cannot reach consensus within [**] after it has met (whether in person or by telephone or video conference) and attempted to reach such consensus or
the Parties cannot reach consensus on whether the JSC has decision-making authority under Section 5.3 regarding a matter within [**] after such matter was first raised
by either Party, the dispute in question will be referred to 

12

 

the
Chief Executive Officer ("CEO") of BIAL and the CEO of SEPRACOR for resolution. The CEO's will use reasonable efforts to resolve the matter referred to them. If the CEO's cannot resolve the matter
within [**], then the matter will be decided: 

        (i)    by
the CEO of BIAL in good faith, giving appropriate consideration to the reasonable business and scientific concerns of SEPRACOR, for all matters relating to the
disputes mentioned in Sections [**]. 

        (ii)   by
the CEO of SEPRACOR in good faith, giving appropriate consideration to the reasonable business and scientific concerns of BIAL, for all matters specifically
mentioned in Sections [**]. 

        (iii)  For
the avoidance of doubt, neither the CEO of BIAL nor the CEO of SEPRACOR will have decision making authority with respect to [**]. 

        (iv)  To
the extent additional responsibilities are imposed on the JSC pursuant to Section 5.3 (xii), the Parties will mutually agree which CEO will have the right to
decide any matter encompassed by that responsibility in the event that neither the JSC nor the CEO's can reach an agreement regarding that dispute. 

        (v)   Notwithstanding
anything to the contrary contained herein or this Section 5.6, neither Party's CEO will have decision making authority over any dispute explicit
reserved for arbitration pursuant to Section 16.1. 

        Neither
Party will exercise its right to finally resolve a dispute in accordance with this Section 5.6 in a manner that (a) excuses such Party from any of its obligations
specifically enumerated under this Agreement, or (b) requires the other Party to make payments or other commitments in excess of those specifically set forth herein. Notwithstanding this
Section 5.6, any dispute regarding the interpretation of this Agreement or any alleged breach of this Agreement will be resolved in accordance with the terms of Section 16.1. 

        5.7    Alliance Managers:    Promptly after the Effective Date, each Party will appoint an individual to act as the
alliance manager for such Party (the "Alliance Manager"). Each Alliance Manager who is not otherwise a member of the JSC will thereafter be permitted to attend meetings of the JSC. The Alliance
Managers will be the primary contact for the Parties regarding the activities contemplated by this Agreement and will facilitate all such activities hereunder. Each Party may replace its Alliance
Manager with an alternative representative at any time with prior written notice to the other Party. The Alliance Managers will not, in any manner, take over the role of the JSC and will not have any
rights, powers or discretion except as expressly granted to the Alliance Managers hereunder. In no event will the Alliance Managers have any power to modify or amend this Agreement. The Parties agree
that the Alliance Managers will meet in July of each year so that the Parties can discuss any issues, including without limitation [**]. 

ARTICLE 6  

DEVELOPMENT OF THE LICENSED PRODUCTS

IN THE FIELD AND TERRITORY  

        6.1    Responsibility:    Except as otherwise provided for in this Agreement, SEPRACOR will be responsible for,
[**], the development of the Licensed Products for use, offer for sale and sale, marketing, commercialization, importation, and distribution within the Field and Territory,
including primary responsibility for all efforts required to obtain the Approvals for the use of Licensed Products within the Field and Territory. 

13

 

        6.2    Development Activity:    SEPRACOR will use Commercially Reasonable Efforts to conduct,
[**] (except as set forth in Section 6.4(c)), the development of the Licensed Products in accordance with the development plans for the Licensed Products within the
Field and Territory (the "Development Plan") including, but not limited to any preclinical, clinical, or post-marketing studies (the "Development Studies") set forth in any such
Development Plan, provided that such development efforts are consistent with [**]. SEPRACOR will use Commercially Reasonable Efforts to complete the Development Studies as soon
as reasonably practicable. For the avoidance of doubt, SEPRACOR does not commit to complete such Development Studies within any given period of time or to obtain any positive results. 

        6.3    Development Plans:    

        (a)   Within
the period of [**] after receiving the FDA minutes from a Pre-NDA meeting with respect to the BIA 2-093 Product,
SEPRACOR will provide BIAL with a copy of the Three (3) Year Strategic Development Plan for 2008-2010. 

        (b)   SEPRACOR
will also submit a draft Annual Development Plan to BIAL by [**] of each calendar year (the first being due by
[**] for calendar year 2009) and a revised Three (3) Year Strategic Development Plan by [**] of each calendar year (the first being due by
[**] for calendar years 2009-2011) for BIAL's review and comment. Development Plans will at a minimum and without limitation include a reasonable
description of the following: 

        [**] 

        (c)   BIAL
will review and comment upon each Annual Development Plan and each revised Three (3) Year Strategic Development Plan within [**] of
receipt thereof. If BIAL fails to provide SEPRACOR with specific comments within the respective timeframe, the Annual Development Plan or the Three (3) Year Strategic Development Plan, as the
case may be, will be deemed accepted by BIAL. SEPRACOR will consider in good faith all comments by BIAL to the Development Plan. BIAL [**] any Annual Development Plan, revised
Three (3) Year Strategic Development Plan (other than the portion of such plans regarding (a) regulatory activities (subject to Section 6.6(b)), and (b) publication plans
for the Licensed Products in the Territory), or a Developmental Study (including its protocol) [**], including without limitation the development, regulatory approval,
marketing, sale and commercialization thereof. In the event of a dispute between the Parties as to whether there is a reasonable likelihood that an Annual Development Plan, revised Three
(3) Year Strategic Development Plan (other than the portion of such plans regarding (a) regulatory activities (subject to Section 6.6(b)), and (b) publication plans for the
Licensed Products in the Territory), or a Development Study [**] the dispute will be submitted to the JSC and will be decided in accordance with the mechanism set forth in
Sections 5.5 [**]. 

        (d)   SEPRACOR
will submit any amendments to the Annual Development Plans or the Three (3) Year Strategic Development Plans for BIAL's review and comment
within the period mentioned in Section 6.3 (c) and under the terms of the said Section 6.3(c). 

        (e)   If
not previously submitted for BIAL's review and comment as part of an Annual Development Plan, SEPRACOR will submit any additional proposed Development
Study, including the final draft protocol thereof, for review and comment by BIAL within the period and under the terms mentioned in Section 6.3(c). 

        (f)    Before
issuing final study reports on any Development Study, a first draft report must be sent to BIAL for review and comment within the period of
[**]. 

        (g)   In
addition to BIAL's rights under this Section 6.3, SEPRACOR will consider in good faith any comments provided by BIAL within the applicable time
periods in relation to any Annual 

14

 

Development
Plan, revised Three (3) Year Strategic Development Plan, Development Study, and draft protocol for any such Development Study or draft report. 

        (h)   SEPRACOR
will regularly through the JSC and promptly upon BIAL's written request, keep BIAL fully informed of the status of any Development Study. BIAL has the right to
appoint one or more monitors to observe SEPRACOR's development activities related to the Licensed Product. 

        6.4    Ongoing and Supplemental Studies:    

        (a)   BIAL
will use Commercially Reasonable Efforts to conduct, [**], the studies listed in  Exhibit D (the "BIAL Studies"). All decisions regarding such studies, including the corresponding protocols (the
"BIAL Protocols"),
[**], provided that (i) BIAL will consider in good faith any comments provided by SEPRACOR in relation to any BIAL Study or draft BIAL Protocol and (ii) BIAL will
regularly through the JSC and promptly upon SEPRACOR's written request, keep SEPRACOR fully informed of the status of any BIAL Study. SEPRACOR has the right to appoint one or more monitors to observe
the BIAL Studies. All data and information resulting from such BIAL Studies and Controlled by BIAL will be promptly shared with SEPRACOR and will be considered BIAL Know-How. BIAL will use
Commercially Reasonable Efforts to complete the BIAL Studies as soon as reasonably practicable. For the avoidance of doubt, BIAL does not commit to complete such BIAL Studies within any given period
of time or to obtain any positive results. 

        (b)   BIAL
will provide SEPRACOR with any amendments to the BIAL Protocols for review and comment within [**] of its receipt thereof. Before issuing
final study reports on any BIAL Studies, a first draft report must be sent to SEPRACOR for review and comment within the period of [**], and BIAL will consider in good faith
any comments in relation thereto. 

        (c)   The
Parties [**] conducting any studies required by the FDA to obtain the Approval of the BIA 2-093 Product for Adult Adjunct Partial
Epileptic Seizures in the United States of America, provided that (i) SEPRACOR will be responsible for conducting such studies and (ii) prior to initiating any such study the Parties
[**]. Once approved, [**]. The Parties acknowledge that the [**]. 

        (d)   Except
as provided for in Sections 6.4(a) and 6.4(c), [**] of all other studies necessary or useful for the Approval of the BIA
2-093 Product and/or Licensed Products within the Field and the Territory, as well as for any marketing or post-Approval studies. 

        6.5    CMC Program:    BIAL or a BIAL Affiliate is responsible for performing (itself or through one or more contract
manufacturers) and will bear the expenses of the CMC Program for the BIA 2-093 Product. BIAL or a BIAL Affiliate will also be responsible for performing (itself or through one or more
contract manufacturers) and will bear the expenses of the CMC Program for a Licensed Product other than the BIA 2-093 Product in the event that BIAL decides to
be the supplier (directly or through a BIAL Affiliate) of such Licensed Product to SEPRACOR. If BIAL decides not to be the supplier of such Licensed Product to SEPRACOR, SEPRACOR will be responsible
for performing (itself or through one or more contract manufacturers) and will bear the expenses of the CMC Program for such Licensed Product. 

        6.6    INDs/NDAs:    

        (a)   Except
in the event that the licenses granted by BIAL to SEPRACOR under Sections 2.1 and 2.3 [**], SEPRACOR is responsible for the filing
of and will own any and all INDs, NDAs and other regulatory filings for the Licensed Products within the Field and Territory, provided that BIAL will be responsible for maintaining and keeping the BIA
2-093 IND in good standing until it is transferred to SEPRACOR in accordance with Section 2.7. 

15

 

        (i)    BIAL
will have the right to use and refer to all INDs, Approvals, NDAs and regulatory filings for the Licensed Products within the Field and the Territory and all
Know-How submitted in support thereof, 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 (ii) subject to Section 2.2(a), for the sole purpose of conducting permitted development activities within the
Territory. 

        (ii)   SEPRACOR
will use Commercially Reasonable Efforts to submit an NDA for the BIA 2-093 Product for Adult Adjunct Partial Epileptic Seizures as soon as
reasonably practicable but no later than [**] following the preparation, final compilation and quality control review of all the necessary data, summaries, and administrative
sections required to permit a NDA filing. SEPRACOR does not guarantee acceptance or approval by the FDA (or Canadian equivalent) of any IND, NDA or other regulatory filings. 

        (b)   SEPRACOR
will provide BIAL with a proposed draft of (a) the initial label to be submitted to the FDA for review and approval for each Licensed Product, and
(b) the initial draft of any modifications to a Licensed Product label to be submitted to the FDA for review and approval, solely to the extent regarding any new indications.
[**]. 

        (c)   In
addition to Section 6.6(b), SEPRACOR will provide BIAL with a draft of all proposed regulatory filings and will consider in good faith any comments by BIAL
within [**]
upon receipt of such draft. If BIAL fails to provide SEPRACOR with specific comments within such timeframe, the NDA or other regulatory filing will be deemed acceptable by BIAL.
[**] and SEPRACOR will not amend the proposed NDA or regulatory filing in the manner requested by BIAL, the dispute will be submitted to the JSC and will be decided in
accordance with the mechanism set forth in Sections 5.5 and [**], except as otherwise provided in Section [**]. 

        (d)   To
the extent that providing a copy of a draft regulatory filing pursuant to Section 6.6(c) is not practicable, SEPRACOR will give access thereof to BIAL and
provide BIAL with [**] written notice prior to the date such draft may be accessed by BIAL. Notwithstanding the foregoing, BIAL will have the right, to the extent reasonably
practicable, to request copies of portions of such draft regulatory filings. 

        (e)   Notwithstanding
Section 6.6(a), BIAL will have the right to participate in any meetings, interactions, or communications ("Interactions") with the FDA or other
regulatory authorities in the Territory to the extent that such Interactions relate to the DMF. BIAL may [**], in other Interactions with the FDA or other regulatory
authorities in the Territory. Prior to any such Interactions, SEPRACOR will provide BIAL with a draft of any communication, agenda and/or notice of any planned interaction and will consider in good
faith any comments provided by BIAL within the period of [**] upon receipt of the said draft by BIAL. 

        (f)    Neither
Party warrants to the other Party that any Approvals will be obtained within the Field or Territory. The Parties agree that any and all costs and expenses
incurred by SEPRACOR or BIAL in connection thereto are not refundable under any circumstances and are not creditable against the transfer prices and/or royalties due under Article 4 or any
other payments due by SEPRACOR under this Agreement or the Supply Agreement. 

        (g)   Except
as otherwise provided in Section 14.5(b), upon the termination or expiration of the Term of this Agreement, all right, title, and interest in any and all
regulatory filings and authorizations issued thereunder, including without limitation the Approvals, the IND and the NDA and its Canadian equivalents, will be assigned to BIAL. 

16

 

        6.7    Drug Master File:    Notwithstanding Section 6.6(a), BIAL will be responsible for filing and
maintaining, directly or through a Third Party appointed by BIAL, the Drug Master File ("DMF") relating to the manufacture of the BIA 2-093 active pharmaceutical ingredient, to the extent
that (i) the Parties agree that DMF submission is preferable to incorporation of the DMF information in the applicable NDA and (ii) BIAL has obtained from its Third Party suppliers the
right to file and maintain such DMF. In such an event, BIAL will file and maintain such DMF in its own name and/or in the
name of its relevant suppliers and will permit SEPRACOR to cross-reference the open portion of such DMF in its regulatory filings for Licensed Products in the Territory. For the avoidance of doubt,
regulatory authorities in the Territory will have the right to access the entire DMF, including the closed portion. 

        6.8    SEPRACOR Know-How:    SEPRACOR will, as soon as reasonably practicable and promptly upon
BIAL's written request, provide BIAL with a copy of all SEPRACOR Know-How created during the Term of this Agreement. SEPRACOR grants to BIAL a fully paid-up,
royalty-free, perpetual, exclusive license (even to SEPRACOR), with the right to grant sublicenses to BIAL's Affiliates, Third Party licensees and distributors in any country outside the
Territory, under any SEPRACOR Know-How to the extent necessary to allow BIAL, its Affiliates, Third Party licensees and distributors to use, make, have made, import, develop, register,
market, offer for sale, sell, and commercialize Licensed Products or similar products outside the Territory. Subject to Section 2.2(a), SEPRACOR also grants to BIAL a fully paid-up,
royalty-free, perpetual, non-exclusive license, with the right to grant sublicenses to BIAL's Affiliates and Third Party licensees, under any SEPRACOR Know-How to
the extent necessary to allow BIAL and its sublicensees to develop Licensed Products or similar products within the Territory for use outside of the Territory. To the extent that SEPRACOR
licenses-in know-how during the Term, which would not be encompassed by the term "SEPRACOR Know-How" because prior authorization by and/or an additional payment to
the licensor of such know-how is required before it can be disclosed and sublicensed to BIAL. SEPRACOR will use Commercially Reasonable Efforts to obtain such rights for BIAL, provided
that BIAL agrees, in writing, to: (i) comply with any terms that may apply to such disclosure/sublicensing; (ii) pay [**]; and (iii) pay
[**]. SEPRACOR will use Commercially Reasonable Efforts to obtain reasonable terms when negotiating BIAL's sublicense. 

17

 

  ARTICLE 7  

COMMERCIALIZATION OF THE LICENSED PRODUCTS

IN THE FIELD AND TERRITORY  

        7.1    Commercialization:    SEPRACOR will use Commercially Reasonable Efforts to market and sell the BIA
2-093 Product within the Field and Territory and will initiate commercialization of the BIA 2-093 Product in the United States within [**] after
receiving FDA Approval, provided however that failure to launch the BIA 2-093 Product within such [**] period will not be considered a breach of this Agreement if
such failure was caused by circumstances beyond the reasonable control of SEPRACOR including, but not limited to, BIAL's failure to meet timeframes hereunder or inability to supply the
BIA 2-093 Product in accordance with the terms of the Supply Agreement. Notwithstanding anything in this Agreement to the contrary, the decision whether or not to pursue the development
and/or launch of Licensed Products in addition to the BIA 2-093 Product, and the timing of such launch, will be at SEPRACOR's sole discretion. 

        7.2    Responsibility:    Except as otherwise expressly provided for in this Agreement, SEPRACOR is solely responsible
for commercializing the Licensed Products within the Territory. Notwithstanding anything in this Agreement to the contrary, the decision whether or not to launch the Licensed Products in Canada and
the timing of such launch will be at SEPRACOR's sole discretion. 

        7.3    Commercialization Plans:    

        (a)   Within
the period of [**] after the Effective Date, SEPRACOR will designate an employee to work with BIAL on the preparation of a Strategic
Commercialization Plan to be used as an interim plan until the adoption of the first Annual Commercialization Plan in accordance with this Section 7.3(a). A draft annual commercialization plan
will be provided to BIAL no later than [**] of each calendar year for the following calendar year (the first being due by [**] for calendar year 2009)
for review and comment by BIAL (each, an "Annual Commercialization Plan"). Notwithstanding the foregoing, SEPRACOR will use
Commercially Reasonable Efforts to provide the Annual Commercialization Plan to BIAL by [**] of each year. Annual Commercialization Plans will at a minimum and without
limitation include a reasonable description of the following: 

        [**].

        For
clarity, Commercialization Plans will not include sales force incentives and budgets. 

        (b)   SEPRACOR
will consider in good faith any comments by BIAL in relation to the draft Annual Commercialization Plan that are provided to SEPRACOR within
[**] of BIAL's receipt thereof. If BIAL fails to provide SEPRACOR specific comments within the respective timeframes, the draft Annual Commercialization Plan
will be deemed acceptable to BIAL. 

        (c)   SEPRACOR
will provide BIAL with [**]. 

        (d)   SEPRACOR
will provide BIAL with any material amendments to the Annual Commercialization Plans for review and comment by BIAL and will consider in good faith any comments
provided by BIAL within [**] of receipt thereof. 

        7.4    Minimum Sales:    

        (a)   The
agreed minimum annual sales in Net Sales (the "Minimum Sales") for years [**] of commercialization of Licensed Products in Territory
(following launch in the U.S.) are set forth in Exhibit E. The Minimum Sales in units for any subsequent years will be agreed upon between the
Parties by [**] of each calendar year. 

18

 

        (b)   If
the Minimum Sales are not achieved in accordance with Section 7.4 (a) for reasons within SEPRACOR's reasonable control, the licenses granted to SEPRACOR
pursuant to Sections 2.1 and 2.3 will become non-exclusive upon [**] prior written notice from BIAL; provided, however that such licenses will remain
exclusive if within [**] following such notification SEPRACOR [**]. It is however clearly understood that SEPRACOR's right to avoid
non-exclusivity pursuant to this Section 7.4(b) is exercisable only for up to [**]. 

        (c)   If
the Minimum Sales are not achieved in accordance with Section 7.4 (a) for reasons within SEPRACOR's reasonable control for [**],
BIAL will have the right to terminate this Agreement and the Supply Agreement with immediate effect. 

        (d)   For
the purposes of this Section 7.4, circumstances outside of SEPRACOR's reasonable control will include, without limitation, [**]. 

        7.5    Resources:    SEPRACOR will use Commercially Reasonable Efforts to at all times deploy the appropriate
resources, including without limitation the numbers and type of field based personnel, in order to maximize the commercial value of the Licensed Products during the lifecycle. SEPRACOR will market and
promote the Licensed Products in accordance with the Approvals. 

        7.6    Sales Information:    

        (a)   SEPRACOR
will regularly through the JSC and promptly upon BIAL's written reasonable request, keep BIAL fully informed of the status of the commercialization of the
Licensed Products in the Territory. Notwithstanding the above, SEPRACOR will provide BIAL with the following information: 

        (i)    by
the [**] Business Day of each month, a summary of [**]; 

        (ii)   by
the [**] Business Day of each month following the end of each calendar quarter, [**]; and 

        (iii)  by
the [**] Business Day of each month, [**]. 

        (b)   During
the Term and for a period of [**] thereafter, SEPRACOR and its Affiliates will keep full and accurate books of accounts and other records
in sufficient detail so that the Net Selling Price and Net Sales of the Licensed Products can be properly ascertained. SEPRACOR, its Affiliates and sublicensee, at BIAL's request with
reasonable written notice, will permit an independent certified public accountant selected by BIAL and reasonably acceptable to SEPRACOR, at its sole expense, access during SEPRACOR's ordinary
business hours, to such books and records as
may be necessary to determine the correctness of any calculation associated with the sale of the Licensed Products under this Agreement; provided,  however,
that (i) BIAL will be permitted only one (1) such audit in any twelve (12) month period, and (ii) such accountant
will only have access to that portion of SEPRACOR's books and records that relate to this Agreement and the Licensed Products. Prior to the audit, such accountant will enter into a confidentiality
agreement with SEPRACOR that is no less restrictive than the confidentiality obligations set forth in Article 10 of this Agreement. SEPRACOR will use Commercially Reasonable Efforts to obtain
BIAL's right to access the books and records of SEPRACOR's sublicensee in a manner and for purposes consistent with this Section 7.6(b). 

        7.7    Non Competing Products:    

        (a)   During
the Term of this Agreement, SEPRACOR and its Affiliates will not promote, distribute, market, commercialize, offer for sale, or sell any Competing Product within
the Field and Territory. SEPRACOR will use Commercially Reasonable Efforts to cause its sublicensee not to promote, distribute, market, commercialize, offer for sale, or sell any Competing Product
within the Field and Territory during the Term. 

19

 

        (b)   During
the period of [**] after the first commercial sale of the BIA 2-093 Product, or, subject to Section 14.5(b)(i), during
the Term if the Agreement is terminated prior to the expiration of such [**] period, BIAL and its Affiliates will not promote, distribute, market, commercialize, offer for
sale, or sell any Competing Product within the Field and Territory. 

ARTICLE 8  

REGULATORY AND CLINICAL DEVELOPMENT ISSUES  

        8.1    Cooperation:    

        (a)   BIAL
will keep SEPRACOR informed as to development efforts of Licensed Products in the Field outside of the Territory, and will use reasonable efforts not to, and will
use reasonable efforts to [**]. Each Party will cooperate as reasonably requested by the other Party in an effort to ensure that the development of the Licensed Products are
coordinated worldwide, provided however that this will not be interpreted or construed as [**]. 

        (b)   Outside
the JSC, cooperation will include, without limitation, and without prejudice to the provisions of Article 6 and Section 10.5: 

        (i)    [**]

        (ii)   [**]

        SEPRACOR
will also provide BIAL with any documents, data and information encompassed by this Section 8.1 (b)(i) and (ii) that its sublicensee or contractors may develop
during the Term of this Agreement, provided that such sublicensee or contractors have agreed in writing that SEPRACOR may disclose such items to BIAL and that BIAL may use such items in the manner set
forth in Section 8.1 (d). BIAL will also provide SEPRACOR with any documents, data and information encompassed by this Section 8.1 (b)(i) and (ii) that its licensees or
distributors for the Licensed Products outside the Territory have or may in the future develop, provided that such licenses or contractors have agreed in writing that BIAL may disclose such items to
SEPRACOR and that SEPRACOR may use such items in the manner set forth in Section 8.1 (d). Cooperation will also include discussions regarding other activities of the JSC concerning supply and
commercialization of the Licensed Products. 

        To
the extent that providing a copy of a draft regulatory filing pursuant to Section 8.1(b)(i) is not practicable, each Party will give access thereof to the other Party and
provide the other Party with [**] notice prior to the date such draft may be accessed by such other Party. Notwithstanding the foregoing, each Party will have the right, to the
extent reasonably practicable, to request copies of portions of such draft regulatory filings. 

        (c)   BIAL
will only share SEPRACOR's documents, data and information encompassed by Section 8.1 (b)(i) and (ii) with those of its licensees or distributors for
the Licensed Products outside the Territory that have agreed, in writing, to (i) provide to SEPRACOR any similar data, documents and information that they have or may develop and
(ii) comply with confidentially obligations with respect to such data, documents and information that are no less restrictive than those set forth in Article 10 of this Agreement. For
clarity, access to SEPRACOR data, documents and information provided hereunder to a BIAL licensee or distributor is not contingent upon the licensee or distributor having similar data to share, but
rather its willingness to issue authorization set forth in Section 8.1 (b). 

        (d)   BIAL
and its Affiliates outside the Territory will be entitled to use SEPRACOR's and SEPRACOR's Affiliates or sublicensee's documents, data and information encompassed
by Section 8.1 (b)(i) and (ii) for the purposes of filing and obtaining any Approvals or marketing 

20

 

authorizations
outside the Territory and licensing any Third Parties to distribute, promote and commercialize products under such Approvals or marketing authorizations. SEPRACOR and its Affiliates
will be entitled to use BIAL data and information encompassed by Section 8.1 (b)(i) and (ii) for the purposes of filing and obtaining any Approvals or marketing authorizations within the
Territory. 

        (e)   SEPRACOR
will promptly provide BIAL with copies of any correspondence received from or sent to any regulatory authority in the Territory with respect to BIA
2-093 and/or Licensed Products. BIAL will promptly provide SEPRACOR with copies of any correspondence received from or sent to the European Medicines Evaluation Agency ("EMEA") with
respect to BIA 2-093 and/or Licensed Products whenever BIAL considers it materially relevant to the development of the Licensed Products in the Territory. 

        8.2    Rights to Use and Reference SEPRACOR Data; Marketing Materials:    

        (a)   In
addition to the authorization granted in Section 8.1 (d) and the SEPRACOR Know-How license granted pursuant to Section 6.8, any data
(including without limitation any preclinical and clinical data) Controlled by SEPRACOR during the Term relating to any Licensed Products in the Territory will be made fully available to BIAL at no
cost whatsoever and BIAL and its Affiliates will have a fully paid up, royalty-free, perpetual, right to use and cross-reference such SEPRACOR data in seeking Approvals for such Licensed
Products outside the Territory and/or in connection with commercialization of the Licensed Product outside the Territory. 

        (b)   Such
fully paid up, royalty-free, perpetual, right to use and cross-reference the SEPRACOR data may be extended by BIAL to its licensees or distributors
outside the Territory so long as such licensees or distributors have agreed to grant a corresponding right to SEPRACOR. For clarity, this right to use and reference any SEPRACOR data by a BIAL
licensee or distributor is not contingent upon the licensee or distributor having similar data, but rather its willingness to grant SEPRACOR rights to use and reference such data to the extent it
exists. 

        (c)   [**]
per year or promptly upon the other Party's reasonable request, each Party will provide the other Party with specimens of its marketing
materials for Licensed Products in the Field for informational purposes only. Neither Party, its Affiliates, licensees, distributors or other Third Parties will use the other Party's marketing
materials to market, sell or offer for sale Licensed Products without such Party's prior written consent. 

        8.3    Adverse Events:    

        (a)   Promptly
following the Effective Date, but in no event later than [**] thereafter, the Parties will develop and agree upon safety data exchange
procedures in a separate and detailed Pharmacovigilance Exchange Agreement ("PVEA"). BIAL will be responsible for all Pharmacovigilance related activities until such agreement is signed. BIAL will
have all relevant Affiliates and other licensees become a party to such PVEA or to enter into similar agreement(s) with BIAL in order to ensure global regulatory compliance. The PVEA will describe the
collection, investigation, analysis, reporting, and exchange of information concerning adverse events, product safety and product complaints relating to the Licensed Products, sufficient to permit
each Party, its Affiliates, sublicensees or licensees to comply with its legal or regulatory obligations, including to the extent applicable, those obligations contained in ICH guidelines. 

        (b)   If
a Licensed Product becomes subject to a pattern of Serious Adverse Reactions (as defined in the ICH Guidelines) or either Party receives notice from a regulatory
authority relating to a significant concern for patient safety, the Parties will in good faith analyze and agree on risk minimization measures and other reasonable actions to be carried out, by either
Party or both Parties, in relation to such Licensed Product, including without limitation, the modification of the relevant Approval 

21

 

        8.4    Quality Agreement.    Simultaneous with the execution of the Supply Agreement, the Parties will enter into a
Quality Agreement with terms appropriate for the manufacture of finished products for commercial distribution. 

ARTICLE 9  

INTELLECTUAL PROPERTY  

        9.1    Ownership of Development Intellectual Property:    All Development Intellectual Property conceived solely by
the employees of a Party will be owned by that Party. Development Intellectual Property conceived by employees of both Parties will be jointly owned by the Parties, each having an equal and undivided
interest in such Development Intellectual Property. 

        (a)   Any
Development Intellectual Property that BIAL Controls or is jointly owned by the Parties will be encompassed by the licenses set forth in Sections 2.1 and 2.2
without additional consideration other than the payments set forth in Article 3, provided however that the Licensed Products will be subject to the transfer price and/royalty provisions of
Article 4. 

        (b)   SEPRACOR
grants BIAL an exclusive (even as to SEPRACOR), royalty-free, fully paid-up, perpetual license, with the right to grant sublicenses,
under any Development Intellectual Property that SEPRACOR Controls or is jointly owned by the Parties, to make, have made, use, import, develop, offer for sale and sell products (including without
limitation Licensed Products) or processes outside of the Territory for as long as BIAL Controls (by license or otherwise) outside the Territory any patent, patent application, or other intellectual
property right which would be infringed by the making, importation, use, development, sale or offer for sale of any product or process encompassed by such Development Intellectual Property ("Blocking
BIAL IP"). After expiration of such Blocking BIAL IP, the license under this Section 9.1(b) will convert to a Semi-Exclusive, royalty-free, fully paid-up,
perpetual license, with the right to grant sub-licenses under any Development Intellectual Property that SEPRACOR Controls to make, have made, use, import, develop, offer for sale and sell
any products (including without limitation Licensed Products) or processes outside of the Territory. For the purposes of this Section 9.1(b), the term "Semi-Exclusive License" means
that, in addition to BIAL, SEPRACOR will have the right, directly or through one licensee, to make, have made, use, import, offer for sale and sell such products (including without limitation Licensed
Products) or processes outside of the Territory under the SEPRACOR Development Intellectual Property. 

        (c)   Subject
to SEPRACOR's rights set forth in Section 2.2(a), SEPRACOR also grants BIAL a royalty-free, fully paid-up, perpetual,
non-exclusive license, with the right to grant sublicenses, under any Development Intellectual Property that SEPRACOR Controls to the extent necessary to allow BIAL, its Affiliates, and
Third Party licensees to develop products (including without limitation Licensed Products) or processes within the Territory for use outside of the Territory. 

        (d)   During
the Term of this Agreement, SEPRACOR will use Commercially Reasonable Efforts to retain all right, title and interest in any Development Intellectual Property
that is conceived solely by the SEPRACOR sublicensee or a contractor or jointly by SEPRACOR and the SEPRACOR sublicensee or a contractor. If SEPRACOR, despite such efforts, is unable to retain all
right, title and interest in any such Development Intellectual Property it will use Commercially Reasonable Efforts to negotiate an exclusive, world-wide license under such Development
Intellectual Property to make, have made, use, import, develop, offer for sale and sell products (including without limitation Licensed Products) or processes, with the right to grant BIAL
(a) an exclusive (even as to licensor and SEPRACOR) sublicense, with the right to grant further sublicenses, under such Development Intellectual Property to make, have made, use, import,
develop, offer for sale and sell products (including without limitation Licensed Products) or processes outside the Territory and (b) a non-exclusive sublicense, with the right to
grant further 

22

 

sublicenses,
under such Development Intellectual Property to develop products (including without limitation Licensed Products) or processes within the Territory for use outside of the Territory,
provided that BIAL agrees, in writing, to: (i) comply with any terms that may apply to such disclosure/sublicensing; (ii) pay [**]; and (iii) pay
[**]. SEPRACOR will use Commercially Reasonable Efforts to obtain reasonable terms when negotiating BIAL's sublicense. 

        (e)   Any
license granted under Sections 9.1 (b), (c) and (d) will expire upon the last to expire of the licensed patents encompassed by such license. 

        (f)    The
Parties agree that, to the extent it is required by the laws of any country, the Parties will execute necessary documentation to reflect or record any licenses under
jointly owned Developmental Intellectual Property licenses or sublicenses granted in accordance with this Agreement under any Developmental Intellectual Property. 

23

 

  
        9.2    Prosecution of Development Intellectual Property:    

        (a)   Each
Party may, at its own expense, file, prosecute, maintain, defend and enforce the patents and patent applications relating to Development Intellectual Property which
are owned solely by that Party. 

        (b)   Notwithstanding
Section 9.2(a), SEPRACOR will have the first opportunity to file U.S. and foreign patent applications on any Development Intellectual
Property Controlled solely by SEPRACOR or jointly owned by SEPRACOR and its sublicensee or a contractor. SEPRACOR will cause a copy of any such patent application and all communications between its
agents and any patent office regarding each such patent application and/or patent to be provided to BIAL or its agent for comment, within a reasonable deadline prior to submitting such communications
to the patent office. Provided that BIAL responds within the specified deadline, SEPRACOR will consider or cause its agents to consider, in good faith, any comments BIAL may have regarding that
application or communication, provided that all final prosecution decisions will rest solely with SEPRACOR. BIAL will be responsible for any expenses that it may incur in providing such comments.
SEPRACOR (or its sublicensee or a contractor) will pay all official taxes, annuities, renewal and maintenance fees required to keep in force all issued patents for Development Intellectual Property
solely Controlled by the SEPRACOR or jointly owned by SEPRACOR and its sublicense or any of its contractors. 

        (c)   BIAL
has the right to file a patent application for Development Intellectual Property Controlled by SEPRACOR in any country in which SEPRACOR decides not to file.
SEPRACOR will notify BIAL of the decision not to file a patent application in a particular country within [**] of making that decision, but not later than
[**] prior to the time when any statutory bar might foreclose filing of a patent application in that country. Upon receipt of such notification, BIAL has the option to assume
full responsibility, at its own discretion and expense, to file a patent application in any such country, in which event SEPRACOR will reasonably cooperate and assist BIAL, at
BIAL's expense, in executing a written assignment of the Development Intellectual Property to BIAL in that country and provide any other conveyance instruments, documents or assistance
as may be necessary or desirable to establish ownership or to support of the prosecution of the application. In the event that such patent application becomes the subject of an opposition or related
proceeding, or if any patent(s) to issue becomes involved in any adversary proceeding (e.g. litigation, nullity or revocation proceedings), BIAL will provide SEPRACOR notice of such proceeding
and BIAL will provide SEPRACOR reasonable opportunity to comment and advise to BIAL. 

        (d)   SEPRACOR
will advise BIAL if it no longer desires to continue prosecution or pay maintenance fees, on any patent application or patent either in the United States or any
foreign country for Development Intellectual Property Controlled by SEPRACOR. Such notification will be in writing and will be provided not less than [**] before the expiration
of a response period or the payment due date for a maintenance fee. Upon receipt of such notification, BIAL has the option, exercisable upon written notification to SEPRAOR, to assume the prosecution
and/or maintenance of the patent application or patent, in which event SEPRACOR will reasonably cooperate with and assist BIAL, at BIAL's expense, in executing a written assignment of
the patent application or patent to BIAL and provide any other conveyance instruments, documents, or assistance as may be necessary or desirable to establish ownership of the patent or patent
application or to support of the prosecution of the application. 

        (e)   BIAL
will use Commercially Reasonable Efforts to file, prosecute and maintain patents and patent applications filed inside and outside the Territory on all Development
Intellectual Property jointly-owned by the Parties. All costs including legal fees, official taxes, annuities, renewal, and maintenance fees required to prosecute all such applications and keep in
force all 

24

 

issued
patents that are jointly owned by the Parties, will be [**] with respect to patents and patent applications in the Territory and [**] with
respect to patents and patent applications outside the Territory. If BIAL desires to discontinue its participation in the prosecution of any jointly-owned patent application or maintenance fee of an
issued patent, it will notify SEPRACOR in writing not less than [**] before the expiration of a response period or the payment due date for a maintenance fee. Upon receipt of
such notification, SEPRACOR has the option to assume full responsibility, at its discretion and expense, for the prosecution and maintenance of the affected patent application(s) or patent(s) in or
outside the Territory, in which event BIAL will reasonably cooperate with and assist SEPRACOR, at SEPRACOR's expense, in executing a written assignment of the patent application or patent to other
Party and provide any other conveyance instruments, documents, or assistance as may be necessary or desirable to establish ownership of the patent or patent application or to support the prosecution
of the application. Except as otherwise provided in Section 2.1(a), neither Party [**] 

ARTICLE 10  

CONFIDENTIALITY, PUBLICITY AND PRESS RELEASES  

        10.1    Confidential Information:    As used in this Agreement, the term "Confidential Information" means all
technology, formulations, materials, samples, prototypes, processes, data, know-how and all other information or data, whether written or oral, technical or non-technical,
including, without limitation, BIAL Know-How, SEPRACOR Know-How, Commercialization Plans, Development Plans, BIAL Protocols, financial statements, reports, pricing, trade
secrets, secret processes, formulas, customer data (including customer lists), business information, business methods, business plans, and pricing, cost, supplier and manufacturing information, that
is disclosed by or on behalf of either Party (including by or on behalf of or through a parent, subsidiary, Affiliate, contractor, licensee or sublicensee) to or for the benefit of the other Party
(including by or on behalf of or through a parent, subsidiary, Affiliate, contractor, licensee or sublicensee) in the performance of this Agreement or the Supply Agreement. The term "Confidential
Information" does not include any such items for which the receiving Party can show by competent written proof or other reasonable support that such item: 

        (a)   was
known to and existed in documentary or other physical form in the possession of the receiving Party at the time of disclosure; 

        (b)   subsequent
to the receipt hereunder, is made available to the receiving Party by a Third Party which is legally entitled to make such information available; 

        (c)   was
or becomes publicly known through no fault of the receiving Party; or 

        (d)   is
independently developed by the receiving Party without access to Confidential Information disclosed hereunder. 

        10.2    Obligations of Confidentiality:    During the Term of this Agreement and for a period equal to the
[**] or [**] after the termination or expiration of this Agreement, whichever is longer, each Party agrees to: 

        (a)   to
preserve the confidentiality of all Confidential Information received from the other Party, and not to disclose any such Confidential Information to a Third Party
without first obtaining the written consent of the disclosing Party, except as may be otherwise provided herein; 

        (b)   to
take all necessary steps to ensure that Confidential Information received from the other Party is securely maintained and to inform those who are authorized to
receive such Confidential Information of their obligations under this Agreement; and 

25

 

        (c)   to
use any and all Confidential Information received from the other Party solely in connection with, or as permitted by, this Agreement and the Supply Agreement and for
no other use. 

All
Confidential Information will remain the property of the disclosing Party. 

        10.3    Right to Disclose:    

        (a)   Nothing
herein will be construed as preventing either Party from disclosing any Confidential Information received from the other Party to its employees, Affiliates,
distributors, licensees, sublicensees, consultants, agents and contractors, in each case where such person or entity has a reasonable need to know such Confidential Information, provided that, with
respect to Affiliates, distributors, licensees, sublicensees consultants, agents and contractors, such entities have undertaken similar obligations of confidentiality with respect to the Confidential
Information. 

        (b)   Nothing
contained in this Article restricts the Parties from disclosing Confidential Information as reasonably required for: (i) seeking any Approval or other
authorization required under or for the purposes of this Agreement, including without limitation [**], (ii) regulatory, tax or customs reasons, (iii) audit
purposes, (iv) the development, manufacture, use, sale, external testing or marketing trials of products in a manner consistent with the terms of this Agreement, the Supply Agreement, the PVEA
and Quality Agreement, (v) the filing or prosecuting patent applications contemplated by this Agreement, without violating the above secrecy provision; it being understood that publication of
such applications within eighteen (18) months of filing will not violate such secrecy provisions, or (vi) by court order or other government order or request. With respect to disclosing
Confidential Information pursuant to a court order or other government order or request, prompt notice of such order or request will be provided to the disclosing Party and the disclosure will not
occur until the disclosing Party either approves the disclosure or has had the opportunity to seek a protective order or other appropriate remedy to curtail such disclosure. In the event that the
disclosing Party is unsuccessful in preventing the disclosure of Confidential Information to the court or government, the other Party will take reasonable efforts to protect the confidentiality of the
Confidential Information and will disclose only that portion of Confidential Information which it is legally required to disclose. 

        10.4    Disclosure of Financial and Other Terms:    Except as required by applicable laws, treaties or agreements
(including securities laws), the Parties agree that the terms of this Agreement, the Supply Agreement, the PVEA and Quality Agreement will be considered Confidential Information of both Parties.
Notwithstanding the foregoing, (a) either Party may disclose such terms as are required to be disclosed in its publicly-filed financial statements or other public statements, pursuant to
applicable laws, regulations or stock exchange rules (e.g., U.S. Securities and Exchange Commission, NASDAQ, NYSE or any other stock exchange on which
securities issued by either Party may be listed); provided, to the extent possible, such Party will provide the other Party with a copy of the proposed
text of such statements or disclosure (including any exhibits containing this Agreement or the Supply Agreement) sufficiently in advance of the scheduled release or publication thereof to afford such
other Party a reasonable opportunity to review and comment upon the proposed text (including redacted versions of this Agreement or the Supply Agreement), (b) either Party has the right to
disclose this Agreement under a confidentiality obligation no less protective than that set forth in this Agreement, to any potential acquirer, merger partner, providers of financing, or potential
providers of financing and their advisors, (c) upon the execution of this Agreement, the Parties will be permitted to issue the joint press release attached hereto as Exhibit F, and
(d) after the Effective Date, each Party has the right to disclose the existence and execution of this Agreement and the Supply Agreement and the general nature of its terms, provided that the
specifics of such terms are not disclosed including, without limitation, the financial terms set forth herein. Neither Party will make any other statement to the public regarding the execution and/or
any other aspect of the subject matter of this Agreement or the 

26

 

Supply
Agreement, except: (i) where a Party reasonably believes disclosure is required under applicable laws or ethical commercial practice; and (ii) either Party may use the text of a
statement previously approved by the other Party. 

        10.5    Publications:    

        (a)   SEPRACOR
will submit to BIAL drafts of all proposed publications related to SEPRACOR's development or commercialization activities in the Territory with respect to the
Licensed Products no later than [**], prior to the intended submission date for publication, for review and approval by BIAL, provided however that BIAL's
approval will not be unreasonably withheld or delayed. For the purposes of this Section 10.5(a), BIAL's approval will only be considered reasonably withheld in the event that
(i) the publication contains Confidential Information disclosed by BIAL or on BIAL's behalf, (ii) information that creates potential statutory bars to filing a U.S.,
Canadian or foreign patent application, or (iii) the proposed publication will [**]. In the event of a dispute between the Parties as to whether a publication proposed
by SEPRACOR will [**], the dispute will be submitted to the JSC and will be decided in accordance with the mechanism set forth in Sections 5.5 and
[**]. 

        (b)   BIAL
will submit to SEPRACOR drafts of all proposed publications related to BIAL's and its licensees development activities in the Territory with respect
to the Licensed Products no later than [**], prior to the intended submission date for publication, for review and approval by SEPRACOR, provided however that SEPRACOR's
approval will not be unreasonably withheld or delayed. For the purposes of this Section 10.5(b), SEPRACOR's approval will only be
considered reasonably withheld in the event that (i) the publication contains Confidential Information disclosed by SEPRACOR or on SEPRACOR's behalf, (ii) information that creates
potential statutory bars to filing a U.S. or Canadian patent application, or (iii) the proposed publication will [**]. In the event of a dispute between the Parties as
to whether a publication proposed by BIAL will [**], the dispute will be submitted to the JSC and will be decided in accordance with the mechanism set forth in
Sections 5.5 and [**]. 

        (c)   Notwithstanding
anything to the contrary contained herein, neither Party can withhold approval of a publication of the other Party if legally obligated to make such
publication. 

        (d)   For
the avoidance of doubt, the provisions of Section 10.5(b) apply solely to publications related to BIAL's development activities in the
Territory and are not applicable with respect to any of BIAL's activities, including without limitation development activities, outside the Territory. SEPRACOR acknowledges that
publications relating to such BIAL activities outside the Territory may, by their own nature, be made available on a worldwide basis, including in the Territory. 

        10.6    Consequences of Breach:    The Parties understand that monetary damages may be inadequate or insufficient to
protect any breach of any of the provisions of this Article 10 by either Party or employees, Affiliates, distributors, licensees, sublicensees and contractors, or any other person or entity
acting in concert with it or on its behalf. Accordingly, the non-breaching Party will be able to seek all remedies available at law or in equity, including the right to request injunctive
relief, specific performance of the provisions of this Article 10 and/or to claim damages in a court of competent jurisdiction. 

27

 

  ARTICLE 11  

PATENT PROSECUTION AND MAINTENANCE  

        11.1    Duty to Prosecute and Maintain BIAL Patents Controlled Solely by BIAL:    BIAL will,
[**], use its reasonable efforts to prosecute or cause to be prosecuted or continue to prosecute to allowance in the Territory all of the patent applications included in the
BIAL Patents Controlled solely by BIAL. BIAL will pay all official taxes, annuities, renewal and maintenance fees required to keep in force all issued patents included in the BIAL Patents in the
Territory. If BIAL desires to discontinue the prosecution or payment of a maintenance fee on any patent application or patent included in the BIAL Patents, it will notify SEPRACOR in writing not less
than [**] before the expiration of a response period or the payment due date for a maintenance fee. Upon receipt of such notification, SEPRACOR has the option to assume full
responsibility, at its discretion and expense, for the prosecution and maintenance of the affected patent application(s) or patent(s) in the Territory, in which event BIAL will reasonably cooperate
with and assist SEPRACOR, [**], in executing a written assignment of the patent application or patent to SEPRACOR and provide any other conveyance instruments, documents, or
assistance as may be necessary or desirable to establish ownership of the patent or patent application or to support of the prosecution of the application. [**]. 

        11.2    SEPRACOR's Right to Consult:    SEPRACOR has the right to review and comment upon the content of all patent
applications included in the BIAL Patents Controlled solely by BIAL, prior to filing by BIAL in the Territory. BIAL will cause a copy of the patent application and all communications between
BIAL's agents and any patent office in the Territory regarding that patent application and/or patent to be provided to SEPRACOR or its agent for comment, within
[**] prior to submitting such communications to the patent office. Provided that SEPRACOR responds within the specified deadline, BIAL will consider or cause its agents to
consider, in good faith, any comments SEPRACOR may have regarding that application or communication, provided that all final prosecution decisions will rest solely with BIAL. SEPRACOR will be
responsible for any expenses that it may incur in providing such comments. BIAL will pay all official taxes, annuities, renewal and maintenance fees required to keep in force all issued BIAL
Patents. The above notwithstanding, BIAL is under no obligation to disclose any patent application or related correspondence that contains Third Party confidential information to SEPRACOR until such
information is published as part of the application. In the event such patent application contains Third Party confidential information, BIAL will make reasonable efforts to obtain the Third Party's
consent to disclose the confidential information to SEPRACOR. 

        11.3    Abandonment of Opposition Contest:    BIAL will provide SEPRACOR with advance written notice of any decision
by BIAL not to defend a priority, opposition or reexamination in any patent office within the Territory relating to a BIAL Patent. SEPRACOR will have [**] from receipt of such
notice to elect to continue prosecuting and defending such patent or patent applications. If SEPRACOR elects to continue, SEPRACOR [**] and will control that contest. BIAL will
[**], provide SEPRACOR with reasonable assistance including, but not limited to, providing available documents and making witnesses available reasonably requested or required
by SEPRACOR to continue prosecuting and defending such patent or patent applications, including [**]. BIAL, [**], will have the right to participate in
such contest, or designate its own counsel to so participate, throughout each step of the contest. [**] SEPRACOR under this Agreement or the Supply Agreement. If SEPRACOR
elects to continue prosecuting and defending any patent or patent application pursuant to this Section 11.3, BIAL will reasonably cooperate with and assist SEPRACOR,
[**], in executing a written assignment of the patent application or patent to SEPRACOR and provide any other conveyance instruments, documents, or assistance as may be
necessary or desirable to establish ownership of the patent or patent application or to support of the prosecution of the application. 

28

 

        11.4    Notices of Issued Patent:    BIAL will notify SEPRACOR within [**] of: (a) the
issuance of each U.S. patent included among the BIAL Patents along with the date of issuance and the patent number for each such patent; and (b) communications pertaining to any patent included
among the BIAL Patents, which BIAL receives as patent owner pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, including without limitation any notice pursuant to
Sections 101 and 103 of that act from persons who have filed an ANDA or a Paper NDA. 

        11.5    Authorization Relating to Patent Term Extension:    In the event that applicable law in any country within the
Territory provides for the extension of the term of any patent included among the BIAL Patents, BIAL will apply for and use its reasonable efforts to obtain such an extension. SEPRACOR agrees to
cooperate with BIAL in obtaining such extension. Should the law require SEPRACOR to apply for such an extension directly, BIAL will cooperate with SEPRACOR in obtaining such an extension and will
execute such documents and take such additional actions as SEPRACOR may reasonably request in connection therewith. Should applicable law in a country within the Territory require that any such
authorization be held in the name of SEPRACOR, such authorization will be held by SEPRACOR solely for the benefit of and in trust for BIAL and, upon termination or expiration of the Term of this
Agreement, SEPRACOR agrees to assign such authorization to BIAL, its Affiliate or nominee and to provide any other conveyance, instruments, documents or assistance as may
be necessary or desirable to establish ownership of such authorization in BIAL. Notwithstanding anything to the contrary contained herein, the Parties will, if necessary and appropriate, use
reasonable efforts to agree upon a joint strategy relating to patent term extensions, but, in the absence of mutual agreement with respect to any extension issue, a BIAL Patent will be extended
[**]. 

        11.6    Patent Certifications:    

        (a)   Each
Party will immediately give written notice to the other of any certification of which it becomes aware that has been filed pursuant to 21 U.S.C.
§ 355(b)(2)(A)(iv), or § 355(j)(2)(A)(vii)(IV) (or any amendment or successor statute thereto or Canadian equivalent statute) claiming that the BIAL Patents
covering the Licensed Product are invalid, unenforceable, and/or that infringement will not arise from the manufacture, use, sale or offer for sale, of such Third Party product by a Third Party. If
BIAL decides not to bring infringement proceedings against the Third Party making such a certification with respect to any Licensed Product, BIAL will give notice to SEPRACOR of its decision not to
bring suit within [**] after receipt of notice of such certification (or, if the time period permitted by law is less than [**], within half of the time
period permitted by law for SEPRACOR to commence such action). SEPRACOR may then, but is not required to, bring suit against the Third Party that filed the certification. Any suit by either Party may
be in the name of either or both Parties, as may be required by law. For this purpose, the Party not bringing suit will execute such legal papers necessary for the prosecution of such suit and will
provide assistance at the other Party's expense as may be reasonably requested by the Party bringing suit. 

        (b)   If
BIAL commences infringement proceedings against the Third Party, [**], even if BIAL names SEPRACOR as a co-plaintiff or otherwise
brings SEPRACOR into the lawsuit. BIAL will seek the advice of and consult with SEPRACOR regarding the strategy and prosecution of the lawsuit. BIAL will seek SEPRACOR's approval of counsel selected
to prosecute the lawsuit. [**]. 

        (c)   If
SEPRACOR commences infringement proceedings against the Third Party, [**], even if SEPRACOR names BIAL as a co-plaintiff or
otherwise brings BIAL into the lawsuit. SEPRACOR will seek the advice of and consult with BIAL regarding the strategy and prosecution of the lawsuit. SEPRACOR will seek BIAL's approval
of counsel selected to prosecute the lawsuit. [**]. 

29

 
ARTICLE 12  

INFRINGEMENT  

        12.1    Infringement of the BIAL Patents:    

        (a)   If
either Party identifies a Third Party infringement of an issued BIAL Patent (including any BIAL Patent that is jointly owned by the Parties) in the Territory it will
promptly notify the other Party of the alleged infringement. BIAL will have [**], from the date that BIAL either receives a notice of alleged infringement from SEPRACOR or
provides such a notice to SEPRACOR, to: [**]. If BIAL initiates a suit against the infringer, SEPRACOR will cooperate fully with BIAL, [**], including
joining in the action as a party to the extent necessary to permit BIAL to pursue the action. [**]. 

        (b)   If
BIAL does not complete one of the three actions describe in Section 12.1 (a) within [**] after the notice, SEPRACOR may initiate
the action against the infringer and BIAL will cooperate fully with SEPRACOR, [**], including joining the action to the extent necessary to permit SEPRACOR to pursue the
action. [**]. 

        (c)   Any
damages or other monetary awards recovered in any action brought by one of the Parties against an infringer of a BIAL Patent will be applied to the reimbursement of
the Parties for their respective out-of-pocket expenses (including reasonable attorneys' fees and expenses) incurred in prosecuting such infringement action on a pro rata basis
based upon their respective out-of-pocket expenses until all such expenses have been recovered, and any remaining balance, if any, will be divided
[**] percent ([**]%) to SEPRACOR and [**] percent ([**]%) to BIAL.
[**] to the terms of any sublicense granted under Section 12.1 (a) or the settlement of any law suit initiated by one of the Parties. 

        12.2    Alleged Infringement of Third Party Patents:    

        (a)   If
either Party learns that the making, packing, labeling, handling, storage, importation, transportation, use, distribution, promotion, offer for sale, marketing or
sale of a Licensed Product within Field and Territory infringes or is alleged to infringe a Third Party patent, it will promptly notify the other Party. The Parties will thereafter attempt to agree
upon a course of action which may include, without limitation: [**]. 

        (b)   In
the event the Parties do not agree upon a course of action, [**]. 

        (c)   Subject
to SEPRACOR's indemnity obligations of Section 15.1(d), BIAL agrees to pay to SEPRACOR [**] percent
([**]%) of any license fees, settlement payments, milestone payments, and royalties due by SEPRACOR to a Third Party, to enable SEPRACOR to [**] in the
Territory, provided, however (i) that BIAL's obligation under this Section 12.2 (c) is contingent on
[**]. Any amounts payable by BIAL under this Section 12.2 (c) will [**]. Should the amount payable by BIAL under this Section 12.2
(c) exceed the [**] in any given calendar year, the amount by which [**] will not be exceeded in any calendar year. For the avoidance of doubt,
BIAL's obligation hereunder applies only to [**]. 

        (d)   Except
as expressly provided in Section 12.2 (c), any costs incurred by SEPRACOR in connection with the actions that it may take pursuant to this
Section 12.2, or any license fees, milestones, royalties or other payments due to a Third Party as consideration for a license of intellectual property rights used to develop, import,
distribute, sell or offer for sale any Licensed Products in the Territory will be [**]. 

30

 
ARTICLE 13  

REPRESENTATIONS AND ACKNOWLEDGEMENTS  

        13.1    Representations and Warranties by BIAL:    

        (a)   As
of the Effective Date, BIAL represents and warrants that: (i) BIAL has and will continue to have the legal power and authority to grant the licenses set forth
in Sections 2.1-2.4 of this Agreement and that it has not made and will not make any commitments to any Third Party inconsistent with or in derogation of such rights;
(ii) the patents and patent applications set forth on Exhibit A are all the patents and patent applications in the Territory as of the Effective Date that relate to the Licensed
Products; and (iii) BIAL exclusively Controls all right, title and interest to the BIAL Patents listed in Exhibit A and that any issued patent listed in Exhibit A is in full force
and effect and in good standing in the Territory and have been maintained and/or prosecuted in good faith. 

        (b)   As
of the Effective Date, BIAL represents that, to the Knowledge of BIAL, it knows of no material deficiencies with respect to the BIAL Know-How which could
materially impact the rights granted to SEPRACOR hereunder. 

        (c)   As
of the Effective Date, BIAL represents and warrants that, to the Knowledge of BIAL, it has complied in all material respects with all applicable laws, permits,
governmental licenses, registrations, approvals, concessions, authorizations, orders, injunctions and decrees with respect to the development and/or manufacture of the Licensed Products. 

        (d)   As
of the Effective Date, BIAL represents and warrants that it has not received any communications from a regulatory authority which would reasonably be expected to
adversely impact the development, manufacture, use, import, offer for sale, sale, or marketing of any Licensed Product. 

        (e)   As
of the Effective Date, BIAL represents that, to the Knowledge of BIAL, the [**], does not infringe nor will infringe any Third Party's valid
patents issued prior to the Effective Date or constitutes a misappropriation of a Third Party's trade secrets or other intellectual property rights in BIAL's possession as of the
Effective Date. 

        (f)    As
of the Effective Date, BIAL represents and warrants that, to the Knowledge of BIAL, there is no Third Party infringing any of the BIAL Patents or misappropriating
BIAL Know-How in derogation of the rights granted to SEPRACOR in this Agreement with respect to the Licensed Products. 

        (g)   BIAL
represents and warrants that, to the Knowledge of BIAL, it is the exclusive owner of all right, title and interest in the BIAL Trademarks and that the
aforementioned trademarks are subject to pending applications for registration in the Territory. 

        (h)   Except
for [**] BIAL represents, to the Knowledge of BIAL, that there are no [**] in the Territory as of the Effective
Date involving the Licensed Products, BIAL Patents, BIAL Know-How or the BIAL Trademarks by or against BIAL, or any of its Affiliates. 

        (i)    As
of the Effective Date, BIAL represents and warrants that to the Knowledge of BIAL, there is no actual, pending, alleged or threatened product liability action with
respect to any Licensed Product or BIA 2-093 anywhere in the world and BIAL is not aware of any facts or circumstances that would cause BIAL to believe that there is a basis for such a
product liability claim. 

        (j)    As
of the Effective Date, BIAL represents that, to the Knowledge of BIAL, it has not failed to furnish SEPRACOR with any information requested by SEPRACOR, or
intentionally concealed from SEPRACOR any information requested by SEPRACOR and in its possession 

31

 

which
BIAL reasonably believes would be material to SEPRACOR's decision to enter into this Agreement and undertake the commitments and obligations set forth herein. 

        (k)   As
of the Effective Date, BIAL represents and warrants that (i) there are no Competing Products Controlled by or on behalf of BIAL or its Affiliates, and
(ii) no products are under development or currently being considered for development by or on behalf of BIAL or its Affiliates that are aimed to result in a pharmaceutical product for the
treatment of epilepsy. 

        13.2    Representation and Warranties by SEPRACOR:    

        (a)   SEPRACOR
represents and warrants that it will use its Commercially Reasonable Efforts to ensure that all promotional labeling and post-marketing Licensed
Products communications, complaint handling and reports of Adverse Events known to SEPRACOR will be in full compliance with all material laws and regulations of countries within the Territory. 

        (b)   As
of the Effective Date, SEPRACOR represents and warrants that it has the financial resources and capability to meet its obligations under this Agreement. 

        (c)   As
of the Effective Date, SEPRACOR represents and warrants that (i) there are no Competing Products Controlled by or on behalf of SEPRACOR or its Affiliates, and
(ii) no products are under development or currently being considered for development by or on behalf of SEPRACOR or its Affiliates that are aimed to result in a pharmaceutical product for the
treatment of epilepsy. 

        13.3    Mutual Representations:    Each Party hereby represents to the other Party as of the Effective Date, that: 

        (a)   Such
Party will at all times in connection with its obligation hereunder and pursuant to the Supply Agreement, Safety and Pharmacovigilance Agreement and Quality
Agreement be in compliance with all material laws and regulations applicable to such Party. 

        (b)   Such
Party is a corporation duly organized, validly existing and in good standing under the laws of its place of incorporation. 

        (c)   The
execution and delivery of this Agreement by such Party has been duly authorized by all necessary corporate actions on the part of such Party. Such Party has full
power, authority and legal right to execute and deliver this Agreement and to perform its obligations hereunder. This Agreement has been duly executed and delivered by such Party, is a legal and valid
obligation binding upon such Party and enforceable against such Party in accordance with its terms, except as such enforceability may be limited by applicable insolvency and other laws affecting
creditors rights generally or by the availability of equitable remedies. 

32

 

 

        (d)   The
execution, delivery and performance of this Agreement does not and will not violate (i) the organizational documents or by-laws of such Party, or
(ii) any provision of any agreement or other instrument or document to which such Party is a party or by which any of its assets or properties is bound or affected. 

        13.4    Prior Knowledge:    No liability for any breach of any warranty or representation given by a Party under this
Article 13 will arise to the extent the other Party has knowledge at the Effective Date that such representation or warranty is untrue or inaccurate. 

        13.5    Negation of Implications:    Except as expressly stated herein, nothing in this Agreement will be construed
as: 

        (a)   An
obligation on the part of either Party to bring or prosecute actions or suits against Third Parties for infringement of any of the BIAL Patents or other intellectual
property rights of the Parties; 

        (b)   Conferring
on either Party a right to use in advertising, publicity, or otherwise any trademark, service mark, or trade name of the other Party; 

        (c)   Granting
by implication, estoppel, or otherwise, any licenses or rights under patents or other intellectual property of a Party other than those rights expressly granted
herein; or 

        13.6    Non Reliance; Disclaimer:    

        (a)   The
representations of each Party set forth in this Agreement are intended for the sole and exclusive benefit of the other Party hereto, and may not be relied upon by
any Third Party. 

        (b)   EXCEPT
AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, CONCERNING
THE LICENSED PRODUCTS OR ANY
PATENTS, KNOW-HOW, TRADEMARKS OR OTHER INTELLECTUAL PROPERTY DISCLOSED, DEVELOPED, OR LICENSED UNDER THIS AGREEMENT. EXCEPT TO THE EXTENT EXPRESSLY SET FORTH HEREIN, EACH PARTY EXPRESSLY
DISCLAIMS REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, CONCERNING THE LICENSED PRODUCTS OR ANY PATENTS, KNOW-HOW, TRADEMARKS OR OTHER INTELLECTUAL PROPERTY
DISCLOSED, DEVELOPED, OR LICENSED UNDER THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY WARRANTY OR REPRESENTATION OF NON-INFRINGEMENT, MERCHANTABILITY, AND FITNESS FOR A PARTICULAR
PURPOSE. 

ARTICLE 14  

TERM AND TERMINATION  

        14.1    Term:    

        (a)   This
Agreement commences as of the Effective Date and will remain in force in each country within the Territory, unless otherwise terminated in accordance with any of
the provisions of this Article 14, until the later of: (i) ten (10) years after the first commercial sale following Approval of any Licensed Products in such country; (ii) expiry
of the last to expire of the BIAL Patents in the respective country; or (iii) expiry of the last to expire of the Exclusivity Rights in the relevant country (the "Term"). 

        (b)   The
Parties have the right to extend the Term of this Agreement on the following terms and conditions: 

        (i)    either
Party notifies the other in writing at least six (6) months prior to the anticipated expiration of the Term of this Agreement that it desires to extend the
Term, and 

33

 

will
include a term sheet with its proposal for the terms of such extension, including the length of the extended term, which may include conditions of supply of Licensed Products. 

        (ii)   upon
receipt of such notice, the Parties will enter into good faith negotiations regarding the terms of such extension. If the Parties reach an agreement on such terms
at any time prior to the expiration of the original Term, the Parties will execute an amendment to this Agreement reflecting such terms. 

        14.2    Termination:    Prior to expiration of the Term as set forth in Section 14.1, this Agreement may be
terminated, without prejudice to any other remedies available to it at law or in equity, upon the occurrence of any of the following events ("Termination Events"); 

        (a)   by
either Party, upon [**] written notice to the other Party, if the other Party materially breaches or defaults in the performance of any of its
obligations hereunder (with the exception of payment obligations) and fails to cure such breach within [**] following receipt of such notice or, if such default cannot be cured
within such [**] period, if the other Party does not commence and diligently continue actions to cure such default during such [**] period; 

        (i)    Upon
any notice under this Section 14.2(a), the Parties will in good-faith meet and discuss if a plan to remedy the alleged breach or default within a
period exceeding the [**] period, or to commence actions towards the remedy within such an extended period, can be mutually agreed. 

        (b)   by
BIAL, upon [**] written notice to SEPRACOR, if SEPRACOR materially breaches or defaults in the performance of any payment obligation hereunder
and fails to cure such breach within the said [**] following receipt of such notice; 

        (c)   by
either Party if the other Party commits an act of bankruptcy, is declared bankrupt, voluntarily files or has filed against it a petition for bankruptcy or
reorganization, enters into a procedure of winding up to dissolution, or should a trustee or receiver be appointed for its business assets or operations; 

        (d)   In
the event that SEPRACOR has undergone a Change of Control involving any of the following circumstances (i) to (iii), BIAL will have the right to terminate this
Agreement, at BIAL's sole discretion, upon thirty (30) days written advance notice to SEPRACOR within twelve months of becoming aware of such Change of Control if: (i) the
Third Party involved in the Change of Control, whether by absorption of, absorption by, acquisition of, acquisition by, consolidation or merger with, SEPRACOR or otherwise (the "Change of Control
Entity") is selling, offering for sale, importing, promoting or commercializing a Competing Product in and/or outside the Territory and such Change of Control Entity does not (A) provide notice
to BIAL within thirty (30) days of the Change of Control of its intention to divest itself of such Competing Product; (B) having provided such notice to BIAL does not use Commercially
Reasonable Efforts to divest itself of such Competing Product within six (6) months of such Change of Control; or (C) having provided such notice to BIAL does not actually divest itself
of such Competing Product within one (1) year of such acquisition; or (ii) the Change of Control Entity has infringed or is infringing any BIAL Patent, BIAL Trademarks or other
intellectual property right of BIAL or its Affiliates, relating to the Licensed Products, in and/or outside the
Territory; or (iii) the Change of Control Entity does not have the financial capability to meet SEPRACOR's obligations under this Agreement. 

        (e)   by
either Party, with immediate effect, if the Approvals for a Licensed Product covered by this Agreement is permanently revoked or cancelled by the FDA or Health Canada
due to patient safety reasons; 

34

 

        (f)    If,
following good-faith discussions with BIAL, including without limitation those set forth in Section 8.3(b), SEPRACOR determines, in its reasonable
judgment, that the Licensed Products have become subject to a pattern of Serious Adverse Reactions (as defined in the ICH Guidelines) and, in good faith, reasonably believes that it would
significantly impact the long-term viability of the Licensed Products, SEPRACOR will have the right to terminate this Agreement upon ten (10) days' prior written notice to BIAL
setting forth the reasons therefore in reasonable detail; 

        (g)   by
BIAL, with immediate effect, in the event of termination of the Supply Agreement (i) by SEPRACOR, other than as a result of a material breach by BIAL, or
(ii) by BIAL as a result of a material breach by SEPRACOR; 

        (h)   SEPRACOR
will have the right to terminate this Agreement at will on written notice to BIAL at any time after the Effective Date: (i) prior to the receipt of the
first Approval for a BIA 2-093 Product in the Territory, provided that BIAL is given at least six (6) months' prior written notice, or (ii) anytime thereafter, provided that
BIAL is given at least twelve (12) months' prior written notice. 

        (i)    by
either Party, in accordance with Section 16.3. 

        (j)    by
SEPRACOR, within ninety (90) days of its receipt of written notice from BIAL pursuant to 7.4(c) that the licenses granted to SEPRACOR pursuant to
Section 2.1 and 2.3 will become non-exclusive. 

        (k)   by
either Party, immediately upon a generic version of the Licensed Products exceeding ten percent (10%) of the total Net Sales of Licensed Products in the Territory, if
(i) pursuant to the mechanism set forth in the Supply Agreement as contemplated in Section 4.4, the Parties are unable to negotiate in good faith a new transfer price reflecting the
impact of the applicable transfer price as a result of such
generic entry, and (ii) following such generic entry, SEPRACOR is unwilling to pay the floor price (as set forth in the Supply Agreement) for commercial supply of the BIA 2-093
Product. 

        (l)    by
BIAL, pursuant to 7.4(c). 

        14.3    Waiver of Termination Event; Termination Disputes.    The right of either Party to terminate this Agreement as
provided in Section 14.2 will not be affected in any way by such Party's waiver or failure to take action upon the occurrence of a previous Termination Event. Any dispute as to whether a Party
is entitled to terminate under Section 14.2 will be resolved as provided in Section 14.2 will be resolved as provided in Section 16.1 hereof. 

        14.4    Rights and obligations upon Expiration of Term or Termination (other than termination for breach or termination at will under
Section 14.2(h)):    Unless the Agreement is terminated for breach by the other Party, the following rights and obligations will survive the expiration and
termination of this Agreement: 

        (a)   All
licenses granted by BIAL under this Agreement or the Supply Agreement will terminate upon expiration or termination of this Agreement and SEPRACOR will have the
right to sell-off over the six (6) months immediately following such termination, any Licensed Products then in its inventory or on order from BIAL, under the BIAL Trademarks,
provided SEPRACOR complies with all relevant provisions of this Agreement. 

        (b)   SEPRACOR
will promptly assign to BIAL, or to its Affiliate or nominee, all right, title and interest in the BIA 2-093 IND, and SEPRACOR will notify the FDA
and other applicable regulatory bodies in writing that ownership of the BIA 2-093 IND has been assigned to BIAL or its Affiliate or nominee. 

35

 

        (c)   SEPRACOR
will promptly assign to BIAL or its Affiliate or nominee, any Approval(s), and any pending or approved NDAs and INDs, relating to BIA 2-093 and/or
Licensed Products in the Territory. 

        (d)   Any
authorizations relating to patent term extensions that, in accordance with Section 11.5 are held in SEPRACOR's name, will be immediately assigned to BIAL, its
Affiliate or nominee as soon as reasonably practicable. 

        (e)   The
licenses granted to BIAL by SEPRACOR under this Agreement will continue in effect as fully paid-up, royalty-free, and perpetual. 

        (f)    The
following terms and provisions will survive the expiration or termination of the Agreement under Section 14.4: Articles 10, 14, 15 and
Sections 2.5, 2.7(c), 6.6(g), 6.8, 7.6(b), 8.1(c)(d); 8.2(a)(b), 8.3(a), 9.1, 9.1(b)(c)(d)(e)(f), 9.2, 11.5, 13.4, 13.5, 13.6, 16.1, 16.6, 16.7, 16.8, 16.10, 16.11 and 16.12. 

        (g)   Expiration
or termination of this Agreement will not relieve the Parties of any obligations or liability accruing prior to such termination or expiration, including,
without limitation, the payment obligations set forth in Article 3. 

        14.5    Rights and obligations upon Termination of the Agreement for Breach or at will:    

        (a)   If
the Agreement is terminated by BIAL for breach by SEPRACOR, or by SEPRACOR at will: 

        (i)    All
licenses granted by BIAL under this Agreement or the Supply Agreement will terminate and SEPRACOR will have the right to sell-off over the six
(6) months immediately following such termination, any Licensed Products then in its inventory or on order from BIAL, under the BIAL Trademarks, provided SEPRACOR complies with all relevant
provisions of this Agreement. 

        (ii)   SEPRACOR
and its Affiliates will not promote, distribute, market, commercialize, offer for sale or sell within the Field and Territory, any Competing Product for the
period of [**] after the date of termination; 

        (iii)  SEPRACOR
will promptly assign to BIAL, or to its Affiliate or nominee, all right, title and interest in the BIA 2-093 IND and SEPRACOR will notify the FDA
and other applicable regulatory bodies in writing that ownership of the BIA 2-093 IND has been assigned to BIAL or its Affiliate or nominee. 

        (iv)  SEPRACOR
will promptly assign to BIAL or its Affiliate or nominee, any Approval(s), and any pending or approved NDAs and INDs (or Canadian equivalents), relating to BIA
2-093 and/or Licensed Products in the Territory. 

        (v)   Any
authorizations relating to patent term extensions that, in accordance with Section 11.5 are held in SEPRACOR's name, will be immediately assigned to BIAL, its
Affiliate or nominee as soon as reasonably practicable; 

        (vi)  The
licenses and sublicenses granted to BIAL by SEPRACOR under this Agreement will continue in effect as fully paid-up, royalty-free, and
perpetual, and will convert to worldwide licenses; 

        (vii) SEPRACOR
will promptly assign and deliver to BIAL or its Affiliate all right, title and interest in any Development Intellectual Property owned solely by SEPRACOR or
jointly by the Parties, in and outside the Territory, [**], including without limitation, documents, material, data, reports, health authority or development correspondence,
rights and 

36

 

information,
Controlled by SEPRACOR, directly relating to or concerning the relevant Licensed Products; and 

        (viii)  In
the event of termination by SEPRACOR at will, SEPRACOR will, during the period between the notice of termination and the effective date of termination, use
Commercially Reasonable Efforts with respect to SEPRACOR's activities under this Agreement, including without limitation development and commercialization activities; provided, however, SEPRACOR will
not be obligated to pay any additional milestone and expense payments pursuant to Section 3.1(b). SEPRACOR will also diligently cooperate with BIAL or its nominee in good faith to effect a
smooth and orderly transition in the development, sale and marketing, promotion and commercialization of the Licensed Products in the Territory and, at BIAL's written request, SEPRACOR
will use its Commercially Reasonable Efforts to (1) complete any ongoing SEPRACOR Development Studies or, to the extent so requested by BIAL, to promptly transfer of such Development Studies or
portions thereof to BIAL or its nominee and (2) to comply with SEPRACOR's obligations under Sections 14.5(a)(iii), (iv), (v) and (vii) prior to the effective date of
termination and soon as reasonably practicable upon BIAL's written request. 

        (b)   If
the Agreement is terminated by SEPRACOR for breach by BIAL: 

        (i)    BIAL
and its Affiliates will not promote, distribute, market, commercialize or sell within the Field and Territory, any Licensed Products for the period of
[**] after the date of termination; 

        (ii)   The
licenses granted to SEPRACOR by BIAL pursuant to Section 2 will be fully paid-up, royalty-free, and perpetual and all right, title
and interest to all Approval(s), any NDAs and INDs (or Canadian equivalents), relating to BIA 2-093 and/or Licensed Products in the Territory will vest with SEPRACOR;  provided, however, that
SEPRACOR will pay BIAL a trade mark royalty of [**] percent ([**]%) of Net Sales of Licensed Products for as long as they are sold in the
Territory. Notwithstanding anything to the contrary contained herein, the rights granted to SEPRACOR pursuant to this Section 14.5(b)(i) and (ii) [**]. 

        (c)   Termination
of this Agreement will not relieve the Parties of any obligation or liability accruing prior to such termination or expiration, including, without
limitation, the payment obligations set forth in Article 3. 

        (d)   The
following terms and provisions will survive the termination of the Agreement under Section 14.5: Articles 10, 14, 15 and Sections 2.5, 2.7(c),
6.6(g), 6.8, 7.6(b), 8.1(c)(d); 8.2(a)(b), 8.3(a), 9.1(b)(c)(d)(e)(f), 9.2, 11.5, 13.4, 13.5, 13.6, 16.1, 16.6, 16.7, 16.8, 16.10, 16.11 and 16.12 and, if terminated by SEPRACOR pursuant to 14.5(b),
Article 11 and Sections 12.1 and 12.2 (a)(b)(d). 

ARTICLE 15  

INDEMNIFICATION  

        15.1    Indemnity by SEPRACOR:    Except as otherwise provided in Sections 15.2 and 15.3, SEPRACOR will
indemnify, defend, and hold harmless, BIAL, its Affiliates, directors, officers, shareholders, employees, representatives, agents, successors and assigns from and against any and all liabilities,
claims, suits, demands, assessments, fines, damages, losses, costs and expenses (including, without limitation, the reasonable costs and expenses of attorneys and other professionals) (collectively,
"Liabilities") arising in connection with Third Party claims or suits or demands based on (a) alleged or actual bodily injury or property damage resulting from the manufacturing, packing,
labeling, handling, storage, transportation, use, distribution, promotion, marketing, offer for sale or sale of the Licensed 

37

 

Products
by or on behalf of SEPRACOR, its Affiliates, sublicensee or contractors including any Product liability Claim (in accordance with Section 15.7); (b) liabilities arising from
clinical trials conducted by or on behalf of SEPRACOR in connection with any Licensed Products and/or the filing and processing of the NDA (including, without limitation, the studies mentioned in
Section 6.4 (c)); (c) the gross negligence or willful misconduct of SEPRACOR or its Affiliates, sublicensee, contractors, or any of its agents, directors, officers or employees; and
(d) subject only to BIAL's obligations under Section 12.2(c), any claim of infringement or misappropriation of any patent, trade secret, copyright, or trademark or other
proprietary right arising out of the packing, labeling, handling, storage, importation, transportation, use, distribution, promotion, marketing, offer for sale or sale of the Licensed Products. 

        15.2    Indemnity by BIAL:    Except as otherwise provided in Section 15.1 and 15.3, BIAL will indemnify,
defend, and hold harmless, SEPRACOR, its Affiliates, directors, officers shareholders, employees, representatives, agents, successors and assigns, harmless from and against any and all Liabilities
arising in connection with Third Party claims or suits or demands based on (a) alleged or actual bodily injury or property damage resulting from the manufacturing, packing, labeling, handling,
storage, transportation, use, distribution of Licensed products by or on behalf of BIAL, its licensees (other than SEPRACOR) or Affiliates, including any Product liability Claim (in accordance with
Section 15.7); (b) liabilities arising from clinical trials conducted by or on behalf of BIAL in connection with any Licensed Products; and (c) the gross negligence or willful
misconduct of BIAL or its Affiliates, sublicensees, or any of its agents, directors, officers or employees. Subject to the conditions set forth in Section 12.2 (c), BIAL agrees to reimburse
SEPRACOR for a portion of any license fees, settlement payments, milestone payments and royalties due by SEPRACOR for a license, under a Third Party patent, [**] within the
Territory. 

        15.3    Mutual Indemnity:    In addition to Sections 15.1 and 15.2, each Party ("Indemnifying Party") will
indemnify, defend, and hold harmless, the other Party and its Affiliates, directors, officers, shareholders, employees, representatives, agents, successors and assigns (the "Indemnitees") from and
against any and all Liabilities arising in connection with Third Party claims or suits or demands to the extent arising out of or resulting from a false representation or the breach by the
Indemnifying Party of any warranty, covenant or obligation contained in this Agreement. 

        15.4    Conditions of Indemnification:    If a Party hereunder seeks indemnification under this Article 15, such Party
must: (a) promptly inform the Indemnifying Party of any claim, suit or demand threatened or filed, (b) permit the Indemnifying Party to assume direction and control of the defense of
claims resulting therefrom (including the right to settle such claims at the sole discretion of the Indemnifying Party, but subject to the approval of the other Party, not to be unreasonably withheld,
if such
settlement provides for injunctive or other non-monetary relief affecting the Indemnitees or any admission of liability), and (c) cooperate as requested (at the expense of the
Indemnifying Party) in the defense of such claims. Notwithstanding anything to the contrary contained herein, a Party's failure to promptly notify the Indemnifying Party of a claim for which it is
seeking indemnification, will only relieve the Indemnifying Party of its obligations under this Section 15 if and to the extent the Indemnifying Party is actually prejudiced thereby. 

        15.5    Limits of Indemnity:    An Indemnifying Party's (including sublicensee's) obligations under this Article 15
will not extend to any Liabilities to the extent (a) arising from the Indemnified Party's failure to comply with the terms and conditions of this Agreement, (b) arising from the
negligence or willful misconduct of the Indemnitee, its agents or employees or (c) such claim falls within the scope of the indemnification obligations of the Indemnitee. No Party will be
liable under any provision of this Agreement for any punitive, exemplary, multiplied or consequential damages. 

        15.6    Recalls.    

        (a)    Voluntary and Mandatory Recalls: Decision-Making.    To the extent that: (i) any regulatory authority in
the Territory issues a directive or order or requests that a Licensed Product be 

38

 

recalled
or withdrawn, (ii) a court of competent jurisdiction orders a recall or withdrawal of a Licensed Product in the Territory, or (iii) SEPRACOR determines that an event, incident
or circumstance has occurred that warrants a Licensed Product should be recalled or withdrawn voluntarily in the Territory, the Parties will recall or withdraw the Licensed Product as set forth in
this Section 15.6. As between the Parties, SEPRACOR will control and coordinate all activities that SEPRACOR deems reasonably necessary in connection with such recall or withdrawal of the
Licensed Product in the Territory, including making all contact with relevant regulatory authorities; provided, however, that SEPRACOR will not take any action with respect to any such recall without
first notifying BIAL in writing, and to the extent practical, consulting in good faith with BIAL. SEPRACOR will consider in good faith any comments of BIAL in connection with any aspect of the
management of any such recall. For clarity, all matters relating to a withdrawal or recall of a Licensed Product outside of the Territory will be determined, controlled and coordinated solely by BIAL. 

        (b)    Costs of Recall.    All actual direct and documented out-of-pocket expenses for the
execution of any recall or withdrawal of a Licensed Product supplied to SEPRACOR by BIAL ("Recall Costs") pursuant to Section 15.6(a) above, will initially be shared equally between the
Parties, provided that (i) in each case, responsibility for the Recall Costs will be subject to the final allocation between the Parties as set out in paragraphs (i) and
(ii) below, and (ii) BIAL will reimburse SEPRACOR for all amounts paid by SEPRACOR for the recalled products in excess of BIAL's Fully Burdened Manufacturing Costs. For
clarity, Recall Costs do not include any lost or refunded sales. In the event that it is finally determined, or agreed between the Parties, that such recall or withdrawal: 

        (i)    is
caused by breach of BIAL's representations or warranties as set forth in this Agreement or the Supply Agreement, including failure to supply Licensed
Product conforming to the specifications set forth in the Supply Agreement or Quality Agreement, or the gross negligence or willful misconduct of BIAL or BIAL's failure to comply with
applicable laws and regulations including cGMP (to be defined in the Quality Agreement) (collectively, the "Fault of BIAL"), BIAL will be responsible for all Recall Costs; and 

        (ii)   is
caused by breach of SEPRACOR's representations or warranties as set forth in this Agreement or the Supply Agreement, including failure of SEPRACOR, or its
Affiliates, its sublicensee or contractors, to handle, store, transport, market, promote, distribute, sell or use the Licensed Product in accordance with applicable laws and regulations or the terms
of the applicable Approval, the Supply Agreement, the Quality Agreement or the gross negligence or willful misconduct of SEPRACOR, its Affiliates, sublicensee or contractors (collectively, "Fault of
SEPRACOR"), SEPRACOR will be responsible for all Recall Costs. 

        15.7    Product Liability Claims.    

        (a)    Notification to the Other.    Each Party will notify the other Party as promptly as practicable if any Third
Party claim is commenced or threatened against such Party alleging product liability, product defect, design, packaging or labeling defect, failure to warn or any similar action relating to the use or
safety of any Licensed Product sold by or under authority of SEPRACOR, its Affiliates or sublicensee in the Territory (a "Product Liability Claim"). BIAL will notify SEPRACOR as promptly as
practicable of any Product Liability Claim with respect to any Licensed Product sold by or under authority of BIAL outside of the Territory. 

39

 

 

        (b)    Cooperation, Counsel and Control.    Each Party will cooperate with the other Party in connection with any such
Product Liability Claim that is commenced or threatened against the other Party. If a Product Liability Claim is asserted against both Parties, each Party will have the right to designate counsel to
defend itself in the Product Liability Claim. If a Product Liability Claim is brought against one Party but not the other Party, the named Party will control the defense and/or settlement thereof at
its own expense with counsel of its choice, subject to this Section 15.7. In such case, the other Party may participate in the defense and/or settlement thereof at its own expense with counsel
of its choice. In any event, the Party that is subject to a Product Liability Claim (if not asserted against both Parties) agrees to keep the other Party hereto informed of all material developments
in connection with any such Product Liability Claim. 

        (c)    Settlement, Admissions and Asserting Positions.    Neither Party will settle any Product Liability Claim, or
make any admissions or assert any position in such Product Liability Claim, in a manner that would adversely affect the other Party, the Licensed Product or the development, manufacture, use or sale
thereof without the prior written consent of the other Party, which will not be unreasonably withheld or delayed. 

        (d)    Bearing the Liabilities.    To the extent a Product Liability Claim is caused by: (i) the Fault of BIAL,
BIAL will bear all Liabilities from such Product Liability Claim to the extent of its fault, (ii) the Fault of SEPRACOR, SEPRACOR will bear all Liabilities from such a Product Liability Claim
to the extent of its fault, or (iii) circumstances other than those described in Sub-section (i) or (ii), above, [**]. 

ARTICLE 16  

MISCELLANEOUS  

        16.1    Dispute Resolution:    

        (a)   Any
dispute, controversy or claim arising out of or relating to the alleged breach, termination, or invalidity of this Agreement will be submitted in the first instance
to the Chief Executive Officer ("CEO") of BIAL, or such person's designee of equivalent or superior position, and the CEO of SEPRACOR, or such person's designee of equivalent or superior position. 

        (b)   If
the CEO's cannot resolve the dispute within [**] of receipt by the CEO's, the Parties agree that either Party may submit the dispute for
arbitration in accordance with the Rules of the International Chamber of Commerce ("ICC") in effect on the date of filing of the arbitration (the "Rules"), except as modified herein. 

        (c)   If
the amount in controversy, including claims and counterclaims, is less than [**] dollars (US$[**]) or if only
injunctive relief is requested, there will be one arbitrator, who will be selected jointly by SEPRACOR and BIAL within [**] of receipt by respondent of a copy of the demand for
arbitration. Such arbitrator will have [**] from the date of appointment to render a decision. If the amount in controversy may be [**] dollars
(US$[**]) or more, or if the dispute involves the termination of this Agreement, there will be three neutral and impartial arbitrators, one appointed by SEPRACOR and one
appointed by BIAL within [**] of receipt by respondent of a copy of the demand for arbitration, and the third arbitrator, who will serve as chair of the arbitral tribunal, will
be appointed by agreement of the Party-appointed arbitrators within [**] of the appointment of the second arbitrator. 

        (d)   Any
arbitrator appointed in accordance with Section 16.1(c) will have significant experience with the arbitration of similar large, complex, commercial disputes
between pharmaceutical companies. All arbitration proceedings will be conducted in the English language. The arbitration proceeding will be held and the award issued in London, England although the
Parties may agree in writing to conduct the arbitration proceedings in a different location. The 

40

 

Parties
agree that only documents directly relevant to the issues in dispute must be produced in any such arbitration. The arbitration will be conducted as expeditiously as practicable, and the
Parties and the arbitrators will use their best efforts to hold the hearing on the merits no later than [**] after the appointment of the arbitration tribunal and the
arbitrators will use their best efforts to issue a final award within [**] after the close of the hearing. 

        (e)   In
addition to damages, the arbitration tribunal may award any remedy provided for under applicable law and the terms of this Agreement, including, without limitation,
specific performance or other forms of injunctive relief. The arbitration tribunal is not empowered to award damages in excess
of compensatory damages, and each Party hereby irrevocably waives any right to recover punitive, exemplary, multiplied (including without limitation treble), consequential or similar damages with
respect to any dispute. The arbitration award must be in writing and will state, in English and in reasonable detail, the findings of fact and conclusions of law on which it is based. The arbitration
award will be final and binding on the parties and will not be appealable except as otherwise provided for by applicable treaty or law and may be entered and enforced in any court having competent
jurisdiction. 

        (f)    Each
Party will pay its own expenses of arbitration and the expenses of the arbitration tribunal and the ICC will be equally shared, except that if, in the opinion of
the arbitration tribunal, any claim by a Party hereto or any defense or objection thereto by the other Party was unreasonable, the arbitration tribunal may in their discretion assess as part of the
award all or any part of the arbitration expenses of the other Party (including reasonable attorneys' fees) and the fees and expenses of the arbitration tribunal and the ICC against the Party raising
such unreasonable claim, defense or objection. 

        16.2   Either
Party may, without inconsistency with this agreement to arbitrate, apply to a court to seek pre-arbitral provisional injunctive relief
to maintain the status quo or prevent irreparable harm, pre-arbitral attachment, or any other relief or order in aid of arbitration proceedings and the enforcement of any award. Without
prejudice to such provisional remedies as may be available under the jurisdiction of a court, the arbitration tribunal will have full authority to grant provisional remedies and to direct the Parties
to request that any court modify or vacate any temporary or preliminary relief issued by such court, and to award damages for the failure of any Party to respect the arbitrator(s)' orders to that
effect. 

        16.3    Force Majeure:    If any circumstance beyond the reasonable control of either Party occurs which delays or
renders impossible the performance of that Party's obligations under this Agreement on the dates herein provided (a "Force Majeure"), such obligation will be postponed for such time as the event of
Force Majeure exists, provided such Party notifies the other Party in writing as soon as practicable, but in no event more than ten (10) Business Days after the inception of such event of Force
Majeure. The Party so affected will give to the other Party a good faith estimate of the continuing effect of the Force Majeure condition and the anticipated duration of the affected Party's
non-performance. Notwithstanding the foregoing, if the period of any previous actual non-performance of a Party because of Force Majeure conditions plus the anticipated future
period of non-performance because of such conditions will exceed an aggregate of one hundred eighty (180) days, then the Party unaffected by such event may terminate this Agreement
by not less than sixty (60) days written notice of termination to the other Party; provided that, if the Force Majeure event ceases within such sixty (60) day period, this Agreement will
remain in full force and effect. Events of Force Majeure will include, without limitation, war, revolution, invasion, insurrection, riots, mob violence, sabotage or other civil disorders, acts of God,
limitations imposed by exchange control regulations or foreign investment regulations or similar regulations, laws, regulations or rules of any government or governmental agency, any inordinate delays
in the regulatory review or governmental approval process that are within the sole control of such government or governmental agency. A Party will be considered 

41

 

affected
by an event of Force Majeure to the extent that any of its suppliers or contractors is affected by such an event. 

        16.4    Assignment:    Except as set forth in Section 14.2(d), neither Party may assign, transfer or otherwise
dispose of this Agreement or any rights or obligation with respect thereto, to any other party without the prior written consent of the other Party, provided however that BIAL may assign or transfer
this Agreement, or any part or right or obligation thereof, to any Affiliate, or in connection with the transfer or sale of all or substantially all of its assets related to the Licensed Products or
the business to which this Agreement relates, without SEPRACOR's consent. Any attempted or purported assignment or transfer of rights or obligations other than provided herein will be void. 

        16.5    Performance by Affiliates:    Either Party may exercise any of its respective rights and perform any of its
respective obligations hereunder through any of its Affiliates. 

        16.6    No Third Party Beneficiaries:    This Agreement does not confer any rights or remedies upon any person or
entity other than SEPRACOR and BIAL and their respective successors and permitted assigns and sublicensees. 

        16.7    Waiver:    The waiver by a Party, whether express or implied, of any provisions of this Agreement, or of any
breach or default of a Party, will not be construed to be a continuing waiver of such provision, or of any succeeding breach or default, or a waiver of any other provisions of this Agreement. 

        16.8    Governing Law:    All matters affecting the interpretation, validity, and performance of this Agreement will
be governed by the laws of New York, U.S.A. without regard to its choice or conflict of law principles. 

        16.9    Unenforceable Provisions:    Any provision hereof that is prohibited or unenforceable in any jurisdiction
will, as to such jurisdiction, be ineffective only to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof or affecting the validity or
enforceability of such provision in any other jurisdiction. The Parties will replace such ineffective provision for such jurisdiction with a valid and enforceable provision which most closely
approaches the idea, intent, and purpose of this Agreement, and in particular, the provision to be replaced. 

        16.10    Relationship Between the Parties:    BIAL and SEPRACOR are independent contractors and will not be deemed to
be partners, joint venturers or each other's agents, and neither will have the right to act on behalf of the other except as may be expressly agreed to in writing. 

        16.11    Entire Agreement:    It is the mutual desire and intent of the Parties to provide certainty as to their
future rights and remedies against each other by defining the extent of their mutual undertakings as provided herein. The Parties have in this Agreement incorporated all representations, warranties,
covenants, commitments and understandings on which they have relied in entering into this Agreement and, except as provided for herein, neither Party has made any covenant or other commitment to the
other concerning its future action. Accordingly, this Agreement, the Supply Agreement, the PVEA and Quality Agreement and the exhibits attached hereto and thereto (i) constitute the entire
agreement and understanding between the Parties with respect to the matters contained herein, and there are no promises, representations, conditions, provisions or terms related thereto other than
those set forth in this Agreement, and (ii) supersedes all previous understandings, agreements and representations between the Parties, written or oral relating to the subject matter hereof.
The Parties hereto may from time to time during the continuance of this Agreement modify, vary or alter any of the provisions of this Agreement, but only by written agreement of all Parties hereto. 

42

 

        16.12    Notices:    All communications, reports, payments, and notices required by this Agreement will be addressed
to the Parties at their respective addresses set forth below or to such other address as requested by a Party by notice in writing to the other Party. 

	 
	 	 

	If to BIAL:	 	BIAL

Attention: Dr. Luis Portela, President and Chief Executive Officer

BIAL

Avenida da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

Fax: +351 229 866 199
	

 	
 	

With a copy to:

Ricardo Chorão

Director, Legal Department

BIAL

Avenida da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

Fax: +351 229 866 190
	

If to SEPRACOR:	
 	

SEPRACOR INC.

Attention: Adrian Adams, President and Chief Executive Officer

SEPRACOR INC.

84 Waterford Drive

Marlborough, MA 01752

USA

Fax: 508-357-7492
	

 	
 	

With a copy to:

Andrew I. Koven, Executive Vice President, General Counsel & Corporate Secretary

SEPRACOR INC.

84 Waterford Drive

Marlborough, MA 01752

USA

Fax: 508-357-7511

        All
such notices, reports, payments, and communications will be made by First Class mail, postage prepaid, or by reputable overnight courier providing evidence of receipt, or by
facsimile (and promptly confirm by mail or overnight courier), and will be considered made as of the date of confirmed receipt. 

        16.13    Headings:    All headings in this Agreement are for convenience only and will not affect the meaning of any
provision hereof. 

        16.14    Counterparts:    This Agreement may be executed simultaneously in any number of counterparts, but all such
counterparts taken together will constitute one and the same agreement. This Agreement, to the extent signed (and initialed in all pages) and delivered by means of a facsimile machine, will be treated
in all manner and respects and for all purposes as an original agreement or instrument and will be considered to have the same binding legal effect as if it were the original signed version thereof
delivered in person. 

[Signature
Page Follows] 

43

 

        IN
WITNESS WHEREOF, and intending to be legally bound, the parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date. 

	BIAL—PORTELA & Ca, S.A	 	SEPRACOR INC.
	

By:	

/s/ Isabel Morgado	
 	

By:	

/s/ Adrian Adams
	 	
	 	 	

	

Its:	

Member of the Board	
 	

Its:	

President and CEO
	

Date:	

December 31, 2007	
 	

Date:	

December 31, 2007
	

By:	

/s/ José Redondo	
 	

 	

 
	 	
	 	 	 
	

Its:	

Member of the Board	
 	

 	

 
	

Date:	

December 31, 2007	
 	

 	

 

44

 

 EXHIBIT A  

BIAL PATENTS  

[**] 

45

 
EXHIBIT B  

BIAL TRADEMARKS  

[**]

46

 
EXHIBIT C  

BIAL LOGO  

  

47

 
EXHIBIT D  

BIAL STUDIES  

BIAL ONGOING OR PLANNED STUDIES  

Non-Clinical:  

[**] 

Clinical:  

[**]

Others  

[**] 

48

 
EXHIBIT E  

MINIMUM SALES  

        The agreed minimum annual sales in Net Sales (the "Minimum Sales") for years [**] of commercialization of Licensed Products in Territory
following launch in the U.S. are: 

[**] 

49

 

  EXHIBIT F  

PRESS RELEASE  

Sepracor Inc. and Bial Announce Exclusive Licensing Agreement for Development and Commercialization of Anti-Epileptic Compound in United States and Canada  

BIA
2-093, Eslicarbazepine Acetate, has Completed Large-Scale Phase III Clinical Studies 

Submission
of U.S. New Drug Application (NDA) Anticipated Late 2008 or Early 2009 

U.S.
Anti-Epileptic Market Estimated at Approximately $4 Billion in 2006 

MARLBOROUGH,
Mass. & S. MAMEDE DO CORONADO, Portugal—(BUSINESS WIRE)—Jan. 2, 2008—Sepracor Inc. (Nasdaq: SEPR) and Bial today announced an
exclusive licensing agreement for the development and commercialization of Bial's anti-epileptic compound BIA 2-093 in the United States and Canada. Under the terms of the
agreement, Sepracor will be responsible for filing the U.S. NDA and seeking marketing approval from the U.S. Food and Drug Administration (FDA), and contingent on obtaining
regulatory approval, commercialization of the product in the U.S. Sepracor anticipates that the NDA will be submitted to the FDA in late 2008 or early 2009 with a potential product launch in late 2009
or early 2010, subject to FDA approval. In exchange, Bial is entitled to receive an upfront payment of $75 million and subsequent payments upon accomplishment of various development and
regulatory milestones, which could include up to an additional $100 million if all milestones are met. Bial will also receive compensation for providing finished product and milestone payments
upon FDA approval of additional indications, if any. 

"We
are very pleased with the addition of this late-stage asset to our growing product pipeline," said Adrian Adams, President and Chief Executive Officer of Sepracor. "Strategically, BIA
2-093 further strengthens our existing central nervous system portfolio, which includes LUNESTA(R) brand eszopiclone for the treatment of insomnia, as well as earlier-stage candidates for
various central nervous system disorders. This milestone in-licensing event is reflective of our overall global corporate strategy to fully leverage our product franchises and commercial
infrastructure while driving enhanced research and development productivity and successfully pursuing aligned and value-enhancing corporate development and licensing initiatives." 

"In
Sepracor we have found a partner who truly shares our vision and commitment to this compound and a company with a proven commercial track record in the U.S. market. This is a landmark event for
BIAL and represents the first result of our R & D work within the CNS area. I am very proud of the people within BIAL who have helped to make this happen through their hard work and dedication"
said Luis Portela, President and Chief Executive Officer of Bial. 

BIA
2-093 (eslicarbazepine acetate) is a new chemical entity which has been designed to offer patients suffering with partial epilepsy additional control of their seizures and improved
quality of life. Bial is currently completing clinical evaluation of BIA 2-093 for the adjunctive use in partial seizures in adults with epilepsy. 

Eslicarbazepine
acetate has been shown in clinical studies to be safe and effective in the control of seizures as adjunctive therapy in adults. Bial has tested the compound in three Phase III
trials in 22 countries with over one thousand patients randomized to an 18-week acute double-blind therapy and subsequently followed in a one year, open label extension study. The
potential for once-daily administration could be an important clinical advantage for patients with epilepsy in the U.S. and Canada. In addition, there may be benefits to patients such as
reduced drug-drug interactions, which may distinguish this drug from commonly used compounds such as carbamazepine. 

50

 

According
to the National Institute of Neurological Disorders and Stroke, epilepsy is a brain disorder in which clusters of nerve cells, or neurons, in the brain sometimes signal abnormally. In
epilepsy, the normal pattern of neuronal activity becomes disturbed, causing strange sensations, emotions, and behavior or sometimes convulsions, muscle spasms, and loss of consciousness. Epilepsy is
a disorder with many possible causes. Anything that disturbs the normal pattern of neuron activity—from illness to brain damage to abnormal brain development—can lead to
seizures. Epilepsy may develop because of an abnormality in brain wiring, an imbalance of nerve signaling chemicals called neurotransmitters, or some combination of these factors. 

About
Sepracor 

Sepracor Inc.
is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products
that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central
nervous system disorders. Currently marketed products include LUNESTA brand eszopiclone, XOPENEX(R) brand levalbuterol HCl Inhalation Solution, XOPENEX HFA(R) brand levalbuterol tartrate Inhalation
Aerosol and BROVANA(R) brand arformoterol tartrate Inhalation Solution. Sepracor's corporate headquarters are located in Marlborough, Massachusetts. 

About
Bial 

Bial
is a Portuguese research-based pharmaceutical company headquartered in S. Mamede do Coronado, Portugal, whose goal is to improve health and wellbeing. Bial was founded in 1924 and is the largest
Portuguese pharmaceutical company with an international presence in over 30 countries. It is the partner of choice for many global companies wishing to commercialize products within the Iberian
Peninsula, Latin America and Africa. Research and development is focused on the central nervous and cardiovascular systems and Bial currently has several other innovative programs under development,
which the company expects to bring to the market within the next years. 

Sepracor
Forward-Looking Statement 

This
news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of BIA 2-093;
the timing and success of regulatory events relating to BIA 2-093, including the possible submission of an NDA late 2008 or early 2009 and potential commercialization in late 2009 or early
2010; and future payments by Sepracor to Bial. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: clinical benefits,
efficacy and safety of BIA 2-093; the timing and success of submission, acceptance, and approval of regulatory filings for BIA 2-093; unexpected delays in commercial
introduction of, and the commercial success of, BIA 2-093; the success of Sepracor's alliance with Bial; Sepracor's ability to obtain favorable reimbursement approval levels, or obtain
reimbursement approval at all, for BIA 2-093, if approved for commercialization; the scope of Bial's and/or Sepracor's patents and the patents of others; the ability of Sepracor and Bial
to attract and retain qualified personnel; and certain other factors that may affect future operating results that are detailed in Sepracor's quarterly report on Form 10-Q for the
quarter ended September 30, 2007 filed with the Securities and Exchange Commission. 

In
addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may
cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release. 

Lunesta,
Xopenex, Xopenex HFA and Brovana are registered trademarks of Sepracor Inc. 

51

 

For
a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com. 

CONTACT:
Sepracor Inc.

David Southwell, 508-481-6700

Chief Financial Officer

or

Jonae R. Barnes, 508-481-6700

Sr. Vice President

Investor Relations 

SOURCE:
Sepracor Inc. 

"Safe
Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Sepracor Inc.'s business which are not historical facts are
"forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which
could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently
ended fiscal year. 

52

QuickLinks

Exhibit 10.44QuickLinks
 -- Click here to rapidly navigate through this document

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions. 

 
 

Exhibit 10.45    
    

Distribution and Development Agreement

for Ciclesonide in the USA  

By and between 

        
Nycomed GmbH

(formerly known as ALTANA Pharma AG)

Byk Gulden-Strasse 2

78467 Konstanz

Federal Republic of Germany 

and 

Sepracor Inc.

84 Waterford Drive

Marlborough, MA 01752

USA 

  Table of Contents  

	 
	 	 
	 	Page

	
 Recitals 	
 	

 	
 	

3
	

Article 1	
 	

Definitions	
 	

3
	

Article 2	
 	

Grant of Rights	
 	

19
	

Article 3	
 	

Consideration	
 	

22
	

Article 4	
 	

Governance	
 	

24
	

Article 5	
 	

Regulatory Affairs	
 	

30
	

Article 6	
 	

Development and Financial Terms of Development	
 	

33
	

Article 7	
 	

Intellectual Property	
 	

37
	

Article 8	
 	

Trademarks	
 	

45
	

Article 9	
 	

Commercialization	
 	

47
	

Article 10	
 	

Manufacturing and Supply	
 	

54
	

Article 11	
 	

Financial Terms of Commercialization	
 	

62
	

Article 12	
 	

Compliance with Law, Insurance and Product Recall	
 	

67
	

Article 13	
 	

Representations and Warranties	
 	

70
	

Article 14	
 	

Indemnification and Liability	
 	

72
	

Article 15	
 	

Reports, Records and Audits	
 	

74
	

Article 16	
 	

Confidentiality; Publications	
 	

77
	

Article 17	
 	

Competition	
 	

79
	

Article 18	
 	

Term and Termination	
 	

79
	

Article 19	
 	

Rights and Duties upon Termination	
 	

83
	

Article 20	
 	

Governing Law, Dispute Resolution and Arbitration	
 	

86
	

Article 21	
 	

Force Majeure	
 	

87
	

Article 22	
 	

Coming into Force and Antitrust Clearance Requirements	
 	

88
	

Article 23	
 	

Miscellaneous	
 	

89

	 

	List of Schedules	 	92
	
Schedule 1.1 (Compound Specifications)	
 	

93
	Schedule 1.2 (Detail Cost)	 	94
	Schedule 1.3 (Nycomed Drug Master File)	 	95
	Schedule 1.4 (Manufacturing Cost)	 	96
	Schedule 1.5 (Sepracor Patents)	 	98
	Schedule 1.6 (Nycomed Patents)	 	99
	Schedule 1.7 (Product Specifications)	 	100
	Schedule 1.8 (Trademarks)	 	101
	Schedule 1.9 (3M Development Agreement)	 	102
	Schedule 1.10 (3M Supply Agreement)	 	103
	Schedule 9.6.1.1 (Minimum Marketing Investment Obligations)	 	104
	Schedule 9.6.2.1 (Minimum Sales Obligations)	 	105
	Schedule 10.2.4 (Quality Agreement)	 	106
	Schedule 10.3.2 (Format of Rolling Monthly Net Requirements Plan)	 	107
	Schedule 10.3.3 (Minimum Batch Sizes)	 	108
	Schedule 12.4 (Ciclesonide Pre- and Post Marketing Surveillance {SOP})	 	109

 

  
        This Distribution and Development Agreement relating to the pharmaceutical compound ciclesonide, dated this January 25th, 2008 is being entered into by and between
Nycomed GmbH (formerly known as ALTANA Pharma AG), a corporation organized and existing under the laws of Germany and having its principal office at Byk-Gulden-Strasse 2, 78467
Konstanz, Federal Republic of Germany ("Nycomed"), and Sepracor Inc., a corporation organized and existing under the laws of the state of
Delaware and having its principal office at 84 Waterford Drive, Marlborough, MA 01752, USA ("Sepracor"). Each or both of Nycomed and Sepracor are
hereinafter referred to as "Party" or "Parties", as intended in the given context. 

WITNESSETH  

        WHEREAS, Nycomed and its Affiliates Control certain Nycomed Technology relating to its proprietary Compound (INN) and certain products incorporating such Compound
including, without limitation, the Alvesco® MDI Product, an innovative inhaled corticosteroid (ICS) providing asthma control in all patient groups regardless of asthma severity, and the
Omnaris® AQ Product, an innovative intranasal steroid formulation exhibiting significant therapeutic effects in seasonal as well as perennial allergic rhinitis (SAR/PAR); 

        WHEREAS,
Sepracor and its Affiliates have material capabilities, resources and experience in the development and commercialization of pharmaceutical products in the Territory including,
without limitation, the facilities, personnel and expertise to Distribute, Commercialize and Develop Products incorporating the Compound in the Territory and in the Field; 

        WHEREAS,
Nycomed wishes to grant Sepracor Exclusive rights under the Nycomed Technology and the Nycomed Trademarks to Distribute, Commercialize and Develop Products incorporating the
Compound in the Territory and in the Field in accordance with all terms and conditions of this Agreement; 

        WHEREAS,
Nycomed wishes to exclusively supply Sepracor with its requirements of the Original Products and Compound, as may be applicable, subject to the terms and conditions of this
Agreement and, subject to further agreement, when appropriate, Sepracor's requirements of Additional Products; 

        WHEREAS,
Sepracor wishes to accept such rights, and to exclusively purchase its requirements of the Original Products or Compound, as the case may be, and, subject to further agreement,
when appropriate, Sepracor's requirements of Additional Products, from Nycomed or its appointee for such purpose, in accordance with all terms and conditions of this Agreement; 

        NOW,
THEREFORE, in consideration of the mutual promises, covenants and agreements hereinafter set forth, the sufficiency of which is hereby acknowledged, and intending to be legally
bound, the Parties to this Agreement mutually agree as follows: 

Article 1

Definitions  

        For the purposes of this Agreement, the following terms, whether used in the singular or plural, shall be ascribed the following meaning: 

        "Act" means the Federal Food, Drug and Cosmetic Act of the United States, and all regulations promulgated thereunder, each as amended from
time to time. 

        "Actual Manufacturing Costs" shall have the meaning set forth in Section 11.1.1.2. 

        "Actual Supply Price of Clinical Samples" shall have the meaning set forth in Section 11.1.4.3. 

        "Actual Supply Price of Commercial Product" shall have the meaning set forth in Section 11.1.2.3. 

        "Actual Supply Price of Compound" shall have the meaning set forth in Section 11.1.5.3. 

3

 

        "Actual Supply Price of Promotional Samples" shall have the meaning set forth in Section 11.1.3.3. 

        "Additional Product" means any Line Extensions of any of the Original Products or any Improved Product, collectively. 

        "Additional Product Agreement" shall have the meaning set forth in Section 6.2.1.3. 

        "Additional Product Supply Agreement" shall have the meaning set forth in Section 6.2.1.4. 

        "ADR" or "Adverse Drug Reaction" shall have the meaning set forth in Section 2.2.2 of  Schedule 12.4. 

        "AE" or "Adverse Event" shall have the meaning set forth in Section 2.2.1 of  Schedule 12.4. 

        "Affiliate" of either Party means any corporation, firm, partnership, organization or entity, whether de jure or de facto, which such
Party directly or indirectly controls, is controlled by or is under common control with. For the purpose of this definition, the term "control" means  (i) direct or indirect ownership of fifty percent
(50%) or more of the outstanding equity voting stock (or such lesser percentage which is the maximum
allowed to be owned by a foreign corporation in a particular jurisdiction) of a Party or other entity or (ii) the possession, direct or indirect, of the
power to direct or cause the direction of the management and policies of a Party or other entity, whether through the ownership of voting securities, by contract, or otherwise. 

        "Agreement" means this distribution and development agreement including all schedules thereto. 

        "Alliance Manager" shall have the meaning set forth in Section 4.8. 

        "Altana" means Altana Pharma AG, Byk-Gulden-Strasse 2, D-78467 Konstanz, Germany and the company name under which
Nycomed has been trading prior to the name change from "Altana" to "Nycomed". 

        "Alvesco® MDI Product" means the Product in its presentation form as Alvesco® HFA metered dose inhaler
incorporating the Compound as sole active ingredient, as finished product in its presentation form as of the Effective Date ready for sale to the customer, as further described in  Schedule 1.7 in the Respiratory Field, subject to Section 2.1.1.5. 

        "ANDA" means an abbreviated new drug application filed pursuant to 21 U.S.C. §355 by a Third Party for a generic equivalent of
Product under the Waxman Hatch Act (codified as amended 21 U.S.C. §§ 301 et seq.) as amended. 

        "A&P Expenses" means (a) all out-of-pocket costs and expenses
incurred (i. e., paid to Third Parties or accrued therefor) by Sepracor in connection with the advertising (including, without limitation,
direct-to-consumer advertising), marketing and promotion of the Products in the Territory pursuant to a Marketing Plan and in accordance with Legal Requirements, including
out-of-pocket costs incurred for: (i) marketing publications and the planning and development thereof, and market research,  (ii) non-personal promotion and
advertising (including costs of journal advertising, promotional materials, direct mail, reminder
promotions, and web-based promotions); (iii) public relations; (iv) professional relations
and medical education programs (including speakers' programs, symposia and conference presentations); (v) advisory boards; and  (vi) promotional meetings,
including meeting and facilities rental and administration costs; (vii)
distribution and stocking allowances and service fees paid to wholesalers, distributors, and retail accounts, (viii) as well as all rebates paid to
managed care, and (ix) all rebates or comparable compensation paid to patients, whether directly or indirectly, on account of crediting patients any
self-retained costs of medical treatment not covered by medical insurance; (b) the supply price paid by Sepracor to Nycomed for Promotional
Samples pursuant to Section 11.1.3; (c) always (i) only to the extent directly directed at the
sales promotion of Products and (ii) only to the extent conforming with applicable US codes of ethics and all other 

4

 

applicable
Legal Requirements; and (d) (i) to the express exclusion, however, of the costs and expenses incurred by Sepracor  (w) related to any public relations or
general promotional activities that are not predominantly related to Product and  (x) generic investment in the Field that is not predominantly linked to the Product; and (ii)
 to the
express exclusion of overheads. 

        "Assumptions" shall have the meaning set forth in Section 9.6.3.1. 

        "Audited Party" shall have the meaning set forth in Section 15.3.2. 

        "Auditing Party" shall have the meaning set forth in Section 15.3.2. 

        "Auditor" shall have the meaning set forth in Section 15.3.2. 

        "Aventis" means Aventis Pharmaceuticals Inc., a corporation organized and existing under the laws of Delaware and having its
principal office at 300 Somerset Corporate Boulevard, Bridgewater, New Jersey 08807-0800, USA. 

        "Base Manufacturing Costs" shall have the meaning set forth in Section 11.1.1.1. 

        "Base Supply Price of Clinical Samples" shall have the meaning set forth in Section 11.1.4.2. 

        "Base Supply Price of Commercial Product" shall have the meaning set forth in Section 11.1.2.2. 

        "Base Supply Price of Compound" shall have the meaning set forth in Section 11.1.5.2. 

        "Base Supply Price of Promotional Samples" shall have the meaning set forth in Section 11.1.3.2. 

        "Breach" shall have the meaning set forth in Section 18.2.1. 

        "Business Day" means any day on which banking institutions in the Commonwealth of Massachusetts, United States and Constance, Germany are
open for business. 

        "Call" means a personal visit by a Sales Representative to a person legally permitted to prescribe prescription drugs in the Territory
during which such Sales Representative Details no more than three (3) products as a Primary, Secondary and Tertiary Detail, one of them being the Product as Primary, Secondary or Tertiary
Detail. 

        "Canister" shall have the meaning set forth in Section 6.1.2.2. 

        "cGCP" means the then current Good Clinical Practices required for the Clinical Development of Product as promulgated by the FDA under the
Act, and the foreign equivalents in countries in which a Party is actively performing Clinical Development. 

        "cGMP" means the then current Good Manufacturing Practices (i) in the country where such
manufacture occurs and (ii) in the Territory where Sepracor is actively Commercializing Product, as promulgated by the FDA under the Act, and the
foreign equivalents, as applicable. 

        "Change of Control" with respect to Sepracor means (i) the acquisition (directly or
indirectly, whether by merger, consolidation, purchase and sale, share exchange or otherwise) by any Third Party (other than an Affiliate or any trust or fund created under a profit-sharing or other
benefit plan for employees of Sepracor) of a beneficial interest in the securities of Sepracor representing more than fifty percent (50%) of the combined voting power of Sepracor's then outstanding
securities; or (ii) the transfer, sale or assignment of more than fifty percent (50%) of the assets of Sepracor to a Third Party other than an Affiliate
of Sepracor; or (iii) any other transfer to a Third Party of the power to control Sepracor. 

        "Ciclesonide" means the name of the Compound specified in the International Nonproprietary Name system for pharmaceutical substances
maintained by the World Health Organization. 

        "Claims" shall have the meaning set forth in Section 14.1.1. 

5

 

        "Clinical Development" means, with respect to a Product, the performance pursuant to a Clinical Development Plan of all
pre-clinical, clinical and regulatory activities required to obtain Regulatory Approvals of such Product in the Territory in the Field (including, but not limited to, Phase IIIa
clinical trials), as well as the performance of any Phase IIIb Studies, all in accordance with the applicable Clinical Development Plan. For clarity, Clinical Development shall not include
Phase IV studies or related activities. 

        "Clinical Development Plan" means the plan designed to achieve the Clinical Development of a specific Product or of a specific
Improvement, as may be applicable, including, without limitation, (i) the budget and nature, number and schedule of Clinical Development activities,  (ii)
the Clinical Development responsibilities to be undertaken by each Party, (iii) a time schedule for
the implementation of the Clinical Development activities concerned, (iv) the financial responsibilities to be assumed by each Party in relation to the
Clinical Development activities assigned to it, (v) all such other issues as may reasonably have to be addressed under such Clinical Development Plan,
as it may be agreed and amended by the Parties from time to time in accordance with this Agreement. 

        "Clinical Development Costs" means for all studies or activities performed in accordance with a Clinical Development Plan for any Product
in the Territory, the following: (a) All out-of-pocket costs and expenses incurred (i.
e., paid to Third Parties or accrued therefor) by the applicable Party or Parties or any of their permitted designees including, without limitation, the costs of clinical trial
insurance, (b) the costs of internal personnel engaged in the performance of such studies or activities, which costs shall be determined based on FTE
costing or such other basis as may be agreed by the Parties, if relevant, and (c) the costs of Clinical Supplies for such studies or activities, which
costs shall include (i) the Clinical Supply Price, (ii)
out-of-pocket costs and expenses incurred in purchasing comparator drug and in packaging comparator drug and/or such Product, as applicable, shipping Clinical Supplies to
centers, or disposal of Clinical Supplies, and (iii) actual costs of packaging Clinical Samples and comparator drug, as applicable, if done by a Party.
Notwithstanding the foregoing, Clinical Development Costs shall not include any costs or expenses incurred in connection with manufacturing process development and validation, manufacturing
scale-up, stability testing, or quality assurance/quality control development. 

        "Clinical Development Data" means all information and data resulting from Clinical Development activities, and specifically the results of
related clinical studies. 

        "Clinical Samples" means Product to be supplied by Nycomed in accordance with the terms of this Agreement for purposes of  (i) Phase IV Studies pursuant to a
Phase IV Development Plan or (ii) the Clinical
Development pursuant to a Clinical Development Plan, as applicable, (iii) in both cases referred to in (i) and (ii) including placebo. 

        "Clinical Supplies" means (a) Clinical Samples and  (b) comparator drug, both for purposes of (i)
 Phase IV Studies pursuant to a Phase IV
Development Plan or (ii) the Clinical Development pursuant to a Clinical Development Plan, as applicable,  (iii) in both cases referred to in (i) and
(ii) including placebo. 

        "Clinical Supply Price" means (i) the supply price of Clinical Samples, as determined in
accordance with Section 11.1.4, and (ii) the out- of-pocket costs of a Party of comparator drug. 

        "Combination Product" means any product incorporating the Compound and one or more other compounds as active ingredients for use in the
Field, whether Inhaled Combination Products or Nasal Combination Products. 

        "Commercialization" means any and all activities directed to importing, marketing, promoting, advertising, distributing, storing, offering
for sale, using and selling Product, including, without limitation, the distribution of Promotional Samples to targeted prescribers (to the extent applicable), in 

6

 

the
Territory and in the Field, and conducting Phase IV Studies of Product. When used as a verb, "Commercialize" means to engage in
Commercialization. 

        "Commercially Reasonable Efforts" mean efforts and resources used for a product of a market potential similar to the market potential of
the applicable Product at a similar stage of its product life, taking into account the establishment of the product in the marketplace, the competitiveness of the marketplace, the proprietary position
of the product, the regulatory status involved, the profitability of the product, in the case of each such factor as in existence and as reasonably projected to be in existence during the Term, as
well as other relevant factors, and corresponding at least to the same type (quality and quantity) of channels, methods, investments and staff (including, without limitation, sales force), which are
used by reputable pharmaceutical companies of similar size and scope as the Parties that are engaged in the pharmaceutical business in the marketing of their own products with a similar potential in
the Territory. 

        "Competing Product" shall have the meaning set forth in Section 17.2.1. 

        "Compound" means the compound ciclesonide, including all its current and future formulations and delivery modes, dosages, isomers,
titrates, hydrates, metabolites, polymorphs, prodrugs, epimers and salts. 

        "Compound Specifications" means the specifications of Compound attached hereto as  Schedule 1.1. 

        "Confidential Information" shall have the meaning set forth bin Section 16.1. 

        "Confidentiality Agreement" means the confidentiality agreement entered by and between the Parties dated September 28, 2007. 

        "Control" or "Controlled" means that a right is owned or possessed by a Party with the
right to license or sublicense. 

        "Contract Year" means (a) with respect to the first Contract Year, the period beginning on the Effective Date and ending on
December 31, 2008 (the "First Contract Year"), (b) with respect to each subsequent Contract Year other than the last Contract Year, the
one (1) year period beginning on the day following the end of the First Contract Year and each succeeding one (1) year period thereafter, and (c) with respect to the last Contract
Year, the period beginning on January 1 of such last Contract Year and ending on the date as of which this Agreement expires or is terminated (the "Last Contract
Year"). Each Contract Year (other than the First Contract Year or the Last Contract Year) shall be divided into four (4) "Contract
Quarters" comprised of successive three (3) month periods. In the First Contract Year, the first Contract Quarter shall end on the first day following the Effective Date
that is the last day of a Contract Quarter, and in the Last Contract Year, the last Contract Quarter shall end upon expiration or termination of the Agreement. 

        "Core Nycomed Promotional Materials" shall have the meaning set forth in Section 9.2.1.1. 

        "Core Sepracor Promotional Materials" shall have the meaning set forth in Section 9.2.1.1. 

        "Costs of Nationalization" means, with respect to the importation of Product, Clinical Samples and Promotional Samples in the Territory,
governmental duties and levies and non-governmental fees and charges accruing in the course of such importation including, without limitation, customs duties, costs of customs clearance,
value added tax on importation of goods and handling charges. 

        "Defect" means, with respect to Products, Clinical Samples or Promotional Samples and, if applicable, Compound, supplied by Nycomed or its
appointee to Sepracor, the failure of the Product, Clinical Samples or Promotional Samples and, if applicable, Compound, as the case may be, to comply with the related Product Specifications and, if
relevant, Compound Specifications, in all cases at the time of dispatch by Nycomed or its appointee, and in all cases as determined on the basis of the pertaining Methods of Analysis. 

7

 

        "Deficiency" shall have the meaning set forth in Section 10.4.1(v). 

        "Deficient" shall have the meaning set forth in Section 10.4.1(v). 

        "Deficient Product" shall have the meaning set forth in Section 10.4.1(v). 

        "Detail" means that part of an in person, face-to-face sales Call during which a Sales Representative, who is
trained and knowledgeable with respect to the applicable Product, including its label and package insert, and the use of the applicable promotional materials, makes a presentation of such Product to a
medical professional with prescribing authority. Any activities performed by medical information scientists, market development specialists, managed care account directors and other personnel who are
not conducting face-to-face sales Calls as provided in the preceding sentence shall not constitute a "Detail". Further,
E-details and presentations made at conventions or similar gatherings shall not constitute a "Detail". Sample drops and reminder details
shall not constitute a Detail. When used as a verb, "Detail" means to engage in Detailing activities. 

        "Detail Cost" means the cost of each position of Detail for a Product for each Call, set each Contract Year by the Parties in accordance
with the principles outlined in Schedule 1.2. 

        "Detailing Expenses" means, with respect to the relevant period, the Detail Cost spent by Sepracor for the aggregate Details for Product
performed by Sepracor in such relevant period for Product that may be accounted for pursuant to Schedule 9.6.1.1. 

        "Development" means the scientific, medical, technical, and clinical, regulatory and other activities necessary to obtain Regulatory
Approval to Commercialize a Product in the Territory and in the Field, including, without limitation, Technical Development, Clinical Development and the preparation, filing, prosecution and
administration of INDs and NDAs, in accordance with a Development Plan that has been agreed pursuant to the terms and conditions of this Agreement. When used as a verb,  "Develop" means to engage in
Development. 

        "Development Costs" means (i) Technical Development Costs and  (ii) Clinical Development Costs, collectively. 

        "Development Milestone" shall have the meaning set forth in Section 3.3.1. 

        "Development Milestone Fee" shall have the meaning set forth in Section 3.3.1. 

        "Development Plan" means, for a specific Product, the Technical Development Plan and the Clinical Development Plan, as required, and as
coordinated in accordance with Article 4. 

        "Device" means with respect to any Product the device used for administering the Compound to a patient. 

        "Dispute" shall have the meaning set forth in Section 20.2. 

        "Disputed Patent" means a Third Party Patent with respect to which an assertion is made by a Third Party, including its licensee, that the
manufacture, use, offer to sell, sale in the Territory, or importation into the Territory, of Compound, of an Original Product or of an Additional Product, in each case in the Field, or the
manufacturing of Compound or a Product at a manufacturing site within the
European Union or any other agreed manufacturing site outside the European Union for Sepracor, infringes, induces the infringement of or contributorily infringes such Third Party's Patent. 

        "Distributor" means a person engaging in the Commercialization of Product. 

        "DOJ" shall have the meaning set forth in Section 22.1.2. 

        "EC" or "EEC" means the European Community. 

        "Effective Date" means the date of the execution of this Agreement by both Parties. 

8

 

        "EONIA" shall have the meaning set forth in Section 3.5.2. 

        "EU" means the European Union. 

        "Excess Increased Capacity" shall have the meaning set forth in Section 10.2.1.3. 

        "Exclusive" shall mean that a right that is granted to or entered into with Sepracor with respect to the Territory hereunder must not be
granted to, entered into with, or executed by any other Person (for clarity, including Nycomed or Affiliates of Nycomed). 

        "Execution Payment" shall have the meaning set forth in Section 3.2. 

        "Existing Regulatory Approvals" shall mean all Regulatory Approvals held or Controlled by Nycomed for the Original Products in the
Territory as at the Effective Date, including all relevant approvals regarding price and reimbursement, if applicable. 

        "Expert" shall have the meaning set forth in Section 20.4. 

        "FDA" means the U.S. Food and Drug Administration and any successor agency thereto. 

        "Field" means all prophylactic and therapeutic uses in humans in any formulation or dosage form for any and all indications including,
without limitation, the Nasal Field and the Respiratory Field, subject to Section 2.1.1.5. 

        "First Commercial Sale" shall mean the first sale or other disposition for value of a Product, in a final dosage form packaged for the
ultimate consumer, to an independent Third Party following applicable Regulatory Approval, by Sepracor, its Affiliates or permitted sublicensees. 

        "Force Majeure Event" shall have the meaning set forth in Section 21.4. 

        "Formoterol Combination Product" means an inhaled Combination Product incorporating the Compound and the proprietary Sepracor compound
R'R'-formoterol (INN), whether or not in combination with one or several other additional active ingredients, as active ingredients for use in the Field, Developed by Sepracor in accordance with the
terms of this Agreement. 

        "FTC" shall have the meaning set forth in Section 22.1.2. 

        "FTE" means a full time equivalent person year, based upon a total of forty-seven weeks or 1,750 hours per year of scientific,
technical or managerial work, on or directly related to Technical Development or Clinical Development. 

        "FTE Cost" means the product of (i) the number of FTEs, which are documented using a
reasonably reliable tracking system, actually used by Nycomed or Sepracor in performing activities in accordance with this Agreement and (ii) an FTE
rate to be agreed by and between the Parties, if and when relevant. 

        "Further Clinical Trials" shall have the meaning set forth in Section 19.1.3. 

        "GAAP" means the "United States Generally Accepted Accounting Principles" as determined by the US Financial Accounting Standards Board
(FASB). 

        "Gross Sales" means, with respect to any applicable period and any Product, the gross amounts invoiced by Sepracor to unrelated Third
Parties for sales of such Product. 

        "HSR Act" shall have the meaning set forth in Section 22.1.1. 

        "ICC" shall have the meaning set forth in Section 20.4.1. 

        "Improved Product" means any Product in the Field, other than the Original Products and other than any Line Extension thereof, that
incorporates an Improvement. 

9

 

        "Improvement" means any Know-How, including, without limitation, findings, discoveries, inventions, additions, modifications,
formulations or changes, whether patentable or not, made and/or Controlled by either Party during the Term insofar as such Improvement relates to the Compound or the Products including, without
limitation, Line Extensions, provided, however, "Improvement" shall not include findings, discoveries, inventions, etc. which are not derived from or based on the Compound or the Product. 

        "Improvement Technology" means all Know-How that is developed and all inventions that are conceived and reduced to practice by
one or more employees, agents or consultants of Nycomed and/or one or more employees, agents or consultants of Sepracor during the Term and in connection with the performance of the Technical
Development, Clinical Development and the Commercialization of Product and Improvements thereof, together with any Patents that claim any such Know-How and/or inventions. 

        "Increased Capacity" shall have the meaning set forth in Section 10.2.1.3. 

        "IND" means an investigational new drug application submitted to the FDA in respect of a new drug. 

        "Indemnified Party" shall have the meaning set forth in Section 14.1.3. 

        "Indemnifying Party" shall have the meaning set forth in Section 14.1.3. 

        "Infringement Claim" shall have the meaning set forth in Section 7.3.1. 

        "Infringement Date" shall have the meaning set forth in Section 7.2.5.5.2. 

        "Initiating Party" shall have the meaning set forth in Section 7.2.4.1. 

        "Insolvency Event" shall have the meaning set forth in Section 18.2.2. 

        "Installment" shall have the meaning set forth in Section 3.1. 

        "Jointly-Owned Improvement Technology" shall have the meaning set forth in Section 7.1.1.1. 

        "Jointly-Owned Patents" shall have the meaning set forth in Section 7.2.3. 

        "Know-How" means all scientific, medical, technical, clinical, regulatory, marketing and other information relating to the
Compound and/or the Product that is Controlled by a Party hereto, and that is in existence as of the Effective Date or coming into existence during the Term. 

        "Latent Deficiency" means a Deficiency of Product that is not readily discoverable upon reasonable visual inspection of a shipment of
Product. 

        "Launch Date" means, with respect to the first presentation form of the Product, the date of the first commercial sale of such Product in
the Territory. 

        "Launch Period" shall have the meaning set forth in Section 10.3.2. 

        "Launch Period Net Requirements Plan" shall have the meaning set forth in Section 10.3.2. 

        "Launch Quantities" shall have the meaning set forth in Section 10.3.2. 

        "Legal Requirements" means any and all acts of the US legislative bodies, and any and all regulations, instruments, rules, orders, codes
of practice and guidance made under such acts having legal force in the Territory without further enactment and in each case being specifically applicable to or having specific application to the
Products including, without limitation, the manner in which Nycomed manufactures and supplies Products, and in which Sepracor Develops and Commercializes Products. 

        "Line Extensions" means [**]. 

10

 

  
        "Logistically Available Overall Capacities" shall have the meaning set forth in Section 10.2.1.2. 

        "Logistically Available Sepracor Capacities" shall have the meaning set forth in Section 10.2.1.2. 

        "Losses" shall have the meaning set forth in Section 14.1.1. 

        "Major Market Country" means any of the countries France, Germany, Italy, Spain, the UK and Japan. 

        "Manufacturing Cost" means the Manufacturing Cost as set forth in Schedule 1.4. 

        "Marketing Expenses" means, with respect to the relevant period, the A&P Expenses and the Detailing Expenses spent by Sepracor,
collectively. 

        "Marketing Plan" shall have the meaning set forth in Section 9.5.2.1. 

        "MDI Product" means the metered dose inhaler product formerly clinically co-developed by Aventis and Nycomed pursuant to the
terms and conditions of MDI Collaboration and Development Agreement by and between Aventis and Nycomed that has been terminated by Aventis effective October 17, 2007. 

        "MDPI Product" means the metered dose dry powder inhaler combination product incorporating the Compound and formoterol formerly
co-developed by Aventis and Nycomed pursuant to the terms and conditions of the MDPI Collaboration and Development Agreement by and between Aventis and Nycomed that has been terminated
with effect from December 31, 2007 pursuant to a related MDPI Termination Agreement. 

        "Methods of Analysis" shall mean the methods of analysis on the basis of which the compliance of Products, Clinical Samples, Promotional
Samples and, if relevant, Compound with the related Product Specifications or, if relevant, Compound Specifications is determined and that shall form part of the Product Specifications and Compound
Specifications. 

        "Milestone Fees" mean Development Milestone Fees and Sales Milestone Fees, collectively. 

        "Minimum Obligations" shall have the meaning set forth in Section 9.6. 

        "Minimum Marketing Investment Obligations" shall have the meaning set forth in Section 9.6.1.1. 

        "Minimum Sales Obligations" shall have the meaning the minimum sales obligations of Sepracor pursuant to Section 9.6.2.1. 

        "Minutes" shall have the meaning set forth in Section 4.6.1. 

        "Monthly Detailing Report" shall have the meaning set forth in Section 15.1.2. 

        "Monthly Sales Report" shall have the meaning set forth in Section 15.1.3. 

        "Nasal Combination Product" means any nasal combination product incorporating the Compound and one or more other compounds as active
ingredients for use in the Nasal Field. 

        "Nasal Field" means the indications of seasonal and perennial rhinitis, subject to Section 2.1.1.5. 

        "NDA" means (a) a New Drug Application submitted to the FDA pursuant to 21 U.S.C.
Section 355(b)(1), and/or Section 355(b)(2) or any successor application or procedure and  (b) all supplements and amendments, including
supplemental New Drug Applications that may be filed with respect to the foregoing (each, a
"SNDA"). 

        "Nebules Product" means a Product incorporating the Compound in the presentation form of an inhalation solution for use with nebulization
in the Respiratory Field Developed by Sepracor in accordance with the terms of this Agreement. 

11

 

        "Net Profits" shall have the meaning set forth in Section 7.2.5.5.2. 

        "Net Sales" means, with respect to any period, the Gross Sales of the Product, less the following deductions to the extent included in the
gross invoiced sales price for the Product or otherwise directly paid or incurred by Sepracor, its permitted Affiliates and its permitted sublicensees with respect to the sale of the Product and not
otherwise recoverable by the paying party: (a) trade, quantity, or cash discounts, chargebacks, returns, allowances or rebates to the extent  (i) customary
to the industry in the Territory or applied by Sepracor to its own proprietary products of a similar market potential and stage of
lifecycle and (ii) actually allowed, given or accrued in the ordinary course of trading (including, but not limited to, cash, governmental and managed
care rebates, hospital or other buying group chargebacks); (b) adjustments, rejections, recalls and returns to the extent made in the ordinary course of
trading, to the extent the customer has been credited the original sales price or a portion thereof; (c) sales, excise, turnover, inventory,
value-added, customs duties and similar taxes and governmental charges assessed on the sale of the Product; (d) the portion of any management fees paid
during the relevant time period to group purchasing organizations that relate specifically to the sale of such Product to such organizations, (e)
service fees paid or allowances conceded to wholesalers pursuant to Distribution Services Agreements or similar contracts by and between Sepracor and wholesalers for logistic and other services such
as, without limitation, stock-keeping; (f) [**]; (g)
[**]; (h) always provided that any deductions made outside the orderly course of business such as, without limitation, rebates
granted by means of product bundling and selling Products in combination with other products of Sepracor (so-called package deals), shall not be considered; and  (i) always provided that the items
referred to in (a) to (e) above shall be determined pursuant to GAAP. 

        Sales,
transfers or dispositions of Product for charitable, promotional (including samples), pre-clinical, clinical, or regulatory purposes shall be excluded from Net Sales,
as shall sales or transfers of Product among a Party and its Affiliates. 

        Upon
any sale or other disposal of any Product for any consideration other than an exclusively monetary consideration on bona fide arm's
length terms then, for the purposes of calculating the Net Sales under this Agreement, such Product shall be deemed to be sold exclusively for money at the fair market price generally achieved for
such Product in the Territory. 

        Any
discounts or allowances made by Sepracor outside the ordinary course of trading shall not be accounted for in determining Sepracor's Net Sales. For clarity and without limitation,
this shall apply to direct and indirect discounts and allowances to customers regarding Product associated with product bundling and selling the Product in combination with other Sepracor products (so
called "package deals"). Upon any sale or other disposal of any Product for any consideration outside the ordinary course of trading, for the purposes of calculating the Net Sales under this
Agreement, Product shall be deemed to be sold exclusively for money at the fair market price generally achieved in bona fide arm's length trading for
such Product in the Territory when such Product is sold alone, and not with or in combination with products other than Product. 

        "Non-Exclusive" means that a right which is granted by a Party hereto (the
"Licensor") to the other Party (the "Licensee") under this Agreement may, in addition to Licensor and
any of its present and future licensees and their sub-licensees, which may be Affiliates of the Licensor or Third Parties, be granted to, entered into with, and exercised by Licensee and,
to the extent that sub-licenses are permitted, its sub-licensees. 

        "Non-Initiating Party" shall have the meaning set forth in Section 7.2.4.1. 

        "Non-Owning Party" shall have the meaning set forth in Section 7.2.3. 

        "Nycomed Additional Patents" means (i) the Patents listed as number 2.1 to 2.8 in  Schedule 1.6 and
(ii) any Patent Controlled by Nycomed at any time during the Term in the
Territory and in the Field with a claim relating to the Compound and/or the Products or a component of either of them, or 

12

 

a
method of manufacture of any of the foregoing, or a method of treatment using any of the foregoing that is not determined by Nycomed to be a Nycomed Core Patent and that is not determined by the SC
to be a Nycomed Ancillary Patent. 

        "Nycomed Ancillary Patents" means (i) the Patents listed as number 3.1 to 3.10 in  Schedule 1.6 and
(ii) any Patent Controlled by Nycomed at any time during the Term in the
Territory and in the Field with a claim relating to the Compound and/or the Products or a component of either of them, or a method of manufacture of any of the foregoing, or a method of treatment
using any of the foregoing that is not a Nycomed Core Patent or a Nycomed Additional Patent. 

        "Nycomed Company Trademark" means "Nycomed", used as a trademark, service mark, trade name or domain name and/or any accompanying design
or logo of Nycomed or its Affiliates, which may or may not be registered or pending in the Territory. 

        "Nycomed Core Patents" means (i) the Patents listed as number 1.1 to 1.8 in  Schedule 1.6 and
(ii) any Patent Controlled by Nycomed at any time during the Term in the
Territory and in the Field with a claim relating to the Compound and/or the Products or a component of either of them, or a method of manufacture of any of the foregoing, or a method of treatment
using any of the foregoing that Nycomed designates as a Nycomed Core Patent. 

        "Nycomed DMF" or "Nycomed Drug Master File" means the drug master file for the Compound
specifying at least the items set forth in Schedule 1.3.

        "Nycomed Improvement Technology" means the Nycomed Know-How and the Nycomed Patents forming part of  (i) Nycomed's Solely Owned Improvement Technology, (ii) Nycomed's rights and interest in any Jointly
Owned Improvement Technology, and (iii) the Improvement Technology owned by Nycomed pursuant to Section 7.1.1.2. 

        "Nycomed Indemnified Persons" shall have the meaning set forth in Section 14.1.2. 

        "Nycomed Know-How" means the Know-How Controlled by Nycomed that Sepracor reasonably requires for the Development
and Commercialization of the Products, in the Territory and in the Field. For clarity, (i) Nycomed Know-How shall not include any
Know-How relating directly and specifically to the manufacture of the Compound or Product, unless and to the extent specifically permitted pursuant to this Agreement for the purposes of
obtaining and maintaining Regulatory Approvals for Product in the Territory or manufacturing Compound and/or Product, as applicable, and (ii) Nycomed
Know-How shall not include any 3M Know-How and Teijin Know-How that is not Controlled by Nycomed. 

        "Nycomed Material Adverse Impact" shall have the meaning set forth in Section 18.3.2.2. 

        "Nycomed Patents" means (i) the Nycomed Core Patents,  (ii) the Nycomed Additional Patents and (iii) the Nycomed Ancillary Patents. For clarity, Nycomed
Patents shall not include any Third Party Patents, whether or not listed in Schedule 1.6, to the extent not Controlled by Nycomed. 

        "Nycomed's Solely-Owned Improvement Technology" shall have the meaning set forth in Section 7.1.1.1. 

        "Nycomed Technology" means the Nycomed Know-How and the Nycomed Patents and Nycomed Improvement Technology, collectively. 

        "Officers" shall have the meaning set forth in Section 20.2. 

        "Omnaris® AQ Product" means the Product in its presentation form as Omnaris® AQ nasal spray incorporating the
Compound as sole active ingredient, as finished product in its presentation form as of the Effective Date ready for sale to the customer, as further described in  Schedule 1.7 in the Nasal
Field, subject to Section 2.1.1.5. 

13

 

        "Omnaris® HFA Product" means the Product in its presentation form as Omnaris® HFA nasal spray incorporating the
Compound as sole active ingredient, as finished product in its presentation form as of the Effective Date ready for sale to the customer, as further described in  Schedule 1.7 in the Nasal
Field, subject to Section 2.1.1.5. 

        "Original Products" means (i) the Omnaris® AQ Product,  (ii) the Omnaris® HFA Product, (iii) the Alvesco® MDI Product, and  (iv) subject to Sections 6.1, 6.2 and 6.3, any Line Extension thereof, and subject to Section 2.1.1.5. 

        "Original Trademarks" means the trademark Omnaris® under which Sepracor has been granted a license to Commercialize the
Omnaris® AQ Product and the Omnaris® HFA Product in the Territory as further described Schedule 1.8, and the trademark
Alvesco® under which Sepracor has been granted a license to Commercialize the Alvesco® MDI Product in the Territory as further described  Schedule 1.8. 

        "Ownership Rights" shall mean any and all right, title and interest under patent, copyright, trade secret and trademark law, or any other
intellectual property or other law, in and to any Know-How or Patent. 

        "Owning Party" shall have the meaning set forth in Section 7.2.2. 

        "Party" or "Parties" shall mean either Party as the context requires, or both Nycomed and
Sepracor. 

        "Patent Challenge Notice" shall have the meaning ser forth in Section 7.2.5.1. 

        "Patent Deficiency" means a Deficiency of Product that may be readily discovered upon reasonable visual inspection of a shipment of
Product. 

        "Patents" shall mean all existing patents and patent applications and all patent applications hereafter filed, including, without
limitation, any continuations, continuations-in-part, divisions, utility models, provisionals or substitute applications, any patent issued with respect to any such patent
applications, any reissue, reexamination, renewal, amendment or extension (including any supplementary protection certificate and any patent term extension) of any such patent, and any confirmation
patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing. 

        "Patent Right(s)" means any right, title or interest in a Patent. 

        "PDE" or "Primary Detail Equivalent" means  (i) one Primary Detail or (ii)
two Secondary Details, or  (iii) three Tertiary Details. 

        "PDE Requirement" shall have the meaning set forth in Schedule 9.6.1.1. 

        "Person" means any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or
government or political subdivision thereof. 

        "Phase IV Development" shall have the meaning set forth in Section 9.5.3.1. 

        "Phase-Out Period" shall have the meaning set forth in Section 18.3.2.3. 

        "Primary Detail" means a Detail that is in the first position and receives the most emphasis or focus during a Call
(i. e., no other product receives more emphasis or focus during the Call). 

        "Primary Detail Equivalent" or "PDE" means  (i) one Primary Detail or (ii)
two Secondary Details, or  (iii) three Tertiary Details. 

        "Product(s)" means (i) the Original Products and  (ii) any Additional Products, collectively, (iii)
 in each case in the applicable Field and subject to
Section 2.1.1.5. 

14

 

        "Product Specifications" means, as of the Effective Date, the Specifications of the Original Products as described in  Schedule 1.7 and, after the Effective
Date, as amended by mutual agreement of the Parties from time to time subject to the provisions hereof,
together with the specifications of any Additional Products agreed to by the Parties, if and when relevant and as attached to the applicable Additional Product Supply Agreement. 

        "Product Year" shall have the meaning set forth in Section 9.6.1.1. 

        "Profit Multiplier" shall have the meaning set forth in Section 7.2.5.5.2. 

        "Promotional Samples" means Product for distribution as samples in the Territory. 

        "Proposal" shall have the meaning set forth in Section 20.4.2. 

        "Quality Agreement" means the agreement on the pharmaceutical responsibilities of the Parties attached to this Agreement as  Schedule 10.2.4 and any Supply
Agreement, in each case in its respective current version as amended by mutual agreement of the Parties. 

        "Quarterly A&P Expense Report" shall have the meaning set forth in Section 15.1.1. 

        "Quarterly Payment Report" shall have the meaning set forth in Section 15.1.4. 

        "Recall" means a recall of Product pursuant to Sections 12.6.1, 12.6.2 or 12.6.3. 

        "Recall Expenses" means all out-of pocket costs and expenses associated with a Recall, including, without limitation,
out-of-pocket costs of Third Parties, the out-of-pocket costs of notifying customers, the out-of-pocket costs of examining and
re-packaging Product, if applicable, and the out-of-pocket costs associated with shipment of such recalled Product and the costs and expenses of the necessary
replacement and destruction of such Product which are removed from the market. 

        "Regulatory Agent" shall have the meaning set forth in Section 5.1.2.2. 

        "Regulatory Approval" means approval and authorization granted by the FDA in the Territory for a specific disease indication or method of
treatment with respect to the Products upon a relating IND, NDA or SNDA in order to enable the Development and Commercialization of Product in the Territory including, without limitation, any price
and reimbursement and advertising approvals for Product and the Existing Regulatory Approvals. 

        "Regulatory Authority" means, with respect to the Territory, the FDA or any equivalent or additional governmental or regulatory agencies
in the Territory, and with respect to countries other than the Territory, the foreign equivalents of such governmental or regulatory agencies. 

        "Regulatory Rights" shall have the meaning set forth in Section 19.1.2. 

        "Rejection Notice" shall have the meaning set forth in Section 18.2.1.4. 

        "Representatives" shall have the meaning set forth bin Section 16.2. 

        "Remedy Period" shall have the meaning set forth in Section 18.2.1.2. 

        "Remedy Plan" shall have the meaning set forth in Section 18.2.1.2. 

        "Respiratory Combination Product" means any respiratory combination product incorporating the Compound and one or more other compounds as
active ingredients for use in the Respiratory Field. 

        "Respiratory Field" means the prevention, control and/or treatment of human respiratory diseases including, without limitation, asthma,
and chronic obstructive pulmonary disease (COPD) and specifically excluding the Nasal Field and subject to Section 2.1.1.5. 

        "Responsible Regulatory Party" shall have the meaning set forth in Section 5.1.1. 

15

 

        "Launch Period" shall have the meaning set forth in Section 10.3.2. 

        "Rolling Monthly Net Requirements Plan" or "NRP" shall have the meaning set forth in
Section 10.3.2. 

        "Rough Cut Capacity Planning" shall have the meaning set forth in Section 10.3.1. 

        "ROW" means all countries and territories outside the Territory. 

        "Royalty" shall have the meaning set forth in Section 11.2.1. 

        "Royalty Payment" shall have the meaning set forth in Section 11.2.1. 

        "Sales Representative" means an appropriately trained individual who engages in Detailing and other promotional efforts with respect to
the Products and who has been trained by a trainer of Sepracor. 

        "Sales Force" means the Sales Representatives Detailing product in the Territory, collectively. 

        "Sales Milestone(s)" shall have the meaning set forth in Section 3.4.1. 

        "Sales Milestone Fee(s)" shall have the meaning set forth in Section 3.4.1. 

        "SC" or "Steering Committee" means the committee established and conducted in accordance
with the procedures set forth in Section 4.2. 

        "SC Improved Product Resolution" shall have the meaning set forth in Section 6.2.1.3. 

        "Secondary Detail" means a Detail that is in the second position and receives the second most emphasis or focus during a Call
(i.e., only the Product or, if a Primary Detail is performed for a product other than the Product, such other product receives more emphasis or focus
during the Call). 

        "Sepracor Acquisition" shall have the meaning set forth in Section 18.3.2.1. 

        "Sepracor Competing Product" shall have the meaning set forth in Section 17.2.2. 

        "Sepracor Indemnified Persons" shall have the meaning set forth in Section 14.1.1. 

        "Sepracor Know-How" means the Know-How Controlled by Sepracor related to the Compound and/or the Products
including, without limitation, their formulation and their use. 

        "Sepracor Merger Notice" shall have the meaning set forth in Section 18.3.2.3. 

        "Sepracor Patent(s)" shall mean any and all Patents Controlled by Sepracor at any time during the Term which contain a claim relating to
the Compound and/or the Products or a component of either of them, or a method of manufacture of any of the foregoing, or a method of treatment using any of the foregoing. The Sepracor Patents
existing on the Effective Date in the Territory are identified on Schedule 1.5, as it may be amended from time to time.
For the avoidance of doubt, an inclusion with respect to any Sepracor Patent coming into existence after the Effective Date shall occur automatically upon the first filing of a provisional or
non-provisional application in respect of such Sepracor Patent, and the subsequent amendment of Schedule 1.5 shall only serve
declaratory purposes. 

        "Sepracor's Solely-Owned Improvement Technology" shall have the meaning set forth in Section 7.1.1.1. 

        "Sepracor Supply Agreement" shall have the meaning set forth in Section 6.2.1.4. 

        "Sepracor Technology" means the Sepracor Know-How and the Sepracor Patents, collectively. 

        "Shortfall Amount" shall have the meaning set forth in Section 9.6.1.2. 

        "Shortfall Amount Payment Period" shall have the meaning set forth in Section 9.6.1.2. 

16

 

        "sNDA" means a supplemental NDA. 

        "SOP" means at any time during the Term a Nycomed standard operating procedure in its then current version. 

        "Special Stability Testing" shall have the meaning set forth in Section 10.3.6. 

        "Special Stability Testing Report" shall have the meaning set forth in Section 10.3.6. 

        "Stability Testing" shall have the meaning set forth in Section 10.3.6. 

        "Subcommittee" shall have the meaning set forth in Section 4.2.3. 

        "Substance Patent" means US Patent 5,482,934 listed as number 1.1 in  Schedule 1.6. 

        "Supply Agreement" means any supply agreement to be entered pursuant to Article 10 and any future Additional Product Supply
Agreement by and between Nycomed and Sepracor covering the supply by
Nycomed or its permitted appointee to Sepracor of any Product (whether semi-finished or finished) or components thereof regarding Product other than the Original Products and the
Alvesco® MDI Product, to be attached hereto in accordance with Article 6 and Article 10, in each case in its respective current version as amended by mutual agreement of the
Parties. 

        "Supply Price" shall have the meaning set forth in Section 11.1. 

        "Technical Development" means the process development activities, other than clinical studies, which directly relate to  (i) the technical development of the
Omnaris® HFA Product and the Alvesco® MDI Product,  (ii) the technical development of any Line Extension of an Original Product, (iii) the technical
development of any Improved Product including, without limitation, development of new formulations, modifications to any Device and any modifications required for obtaining and maintaining Regulatory
Approvals for such Product, and in all cases referred to in (i) to (iii) expressly excluding the technical development of a technology incorporated in the Omnaris® HFA
Product, the Alvesco® MDI Product, any Line Extension or Improved Product that is Controlled by a Third Party, without such Third Party's express written consent. 

        "Technical Development Costs" means, for any Technical Development of a Product, the documented out-of-pocket
costs and expenses incurred pursuant to a Development Plan and actually paid to Third Parties and/or the Cost of FTEs to the extent dedicated to such Technical Development. For the purposes of
clarity, Technical Development Costs do not include capital expenditures. 

        "Technical Development Plan" means a plan designed to achieve the Technical Development of a specific Product, including, without
limitation, (i) the budget and nature, number and schedule of Technical Development activities, (ii) the
Technical Development responsibilities to be undertaken by the relevant Party, (iii) a time schedule for the implementation of the Technical Development
activities concerned, (iv) the financial responsibilities to be assumed by the relevant Party or Parties in relation to the Technical Development
activities as may be assigned to a Party, (v) all such other issues as may reasonably have to be addressed under such Technical Development Plan, as it
may be agreed and amended by mutual agreement of the Parties from time to time in accordance with this Agreement. 

        "Teijin" means Teijin Limited, 6-7 Minami-hommachi 1-chome, Chuo-Ku, Osaka 541-8587,
Japan. 

        "Teijin Know-How" means the Know-How owned by Teijin relating to the Development of the Omnaris® AQ
Product. 

        "Teijin Patents" mean the Patents referred to as number 1.3 and number 1.4 in  Schedule 1.6. 

        "Term" shall have the meaning set forth in Section 18.1. 

        "Territory" or "US" means the United States of America, its territories and possessions,
including, without limitation, the Commonwealth of Puerto Rico. 

17

 

        "Tertiary Detail" means a Detail that is in the third position and receives the third most emphasis or focus during a Call. 

        "Third Party" shall mean any Person other than the Parties and their Affiliates. 

        "Third Party Patent Counsel" shall have the meaning set forth in Section 7.2.5.5.1(i). 

        "Third Party Supply Agreement" shall have the meaning set forth in Section 6.2.1.4. 

        "Third Party Technology" means the patents and know-how controlled by a Third Party regarding a technology that may be
required for the Development and Commercialization of an Additional Product in accordance with this Agreement. 

        "3M" means 3M Health Care Limited, a British company, having an address of 1 Morley Street, Loughborough, Leicestershire, LE11 1EP,
England. 

        "3M Development Agreement" means the development agreement directed to the development of the MDI Product entered into by and between 3M
and Nycomed on [**], attached hereto as Schedule 1.9 (in redacted form). 

        "3M Drug Master Files" shall have the meaning set forth in Section 5.2.2.2. 

        [**]

        "3M Know-How" means the Know-How owned by 3M relating to the Development of the Alvesco® MDI Product
and of the Omnaris® HFA Product. 

        "3M Patents" mean the Ownership Rights of 3M (jointly with Nycomed) in the Patents referred to as number 1.7 and number 1.8
in Schedule 1.6. 

        "3M Supply Agreement" means the purchase agreement entered into by and between Nycomed and 3M on [**] attached
hereto as Schedule 1.10 (in redacted form). 

        "3M Technology" means the 3M Know-How and the 3M Patents, collectively. 

        "To the best of Nycomed's knowledge" shall have the meaning set forth in Section 13.1.1. 

        "To the best of Sepracor's knowledge" shall have the meaning set forth in Section 13.2.6. 

        "Trademark" shall mean (i) the Original Trademarks,  (ii) any additional trademark owned by Nycomed and selected and
assigned pursuant to Section 8.3.2 to an Additional Product, and  (iii) any substitute Trademark selected for any of the foregoing pursuant to Section 8.8.4(c), collectively. 

        "UltrahalerTM Technology" means Aventis' proprietary dry powder inhaler technology incorporated in the MDPI Product. 

        "Unit" shall mean, for each presentation form, dosage and package size of Product in the Territory (including Promotional Samples), one
(1) package of the finished Product for resale to the customer or, in case of Promotional Samples, for distribution as sample, and, in case of Clinical Supplies, for each presentation form,
dosage and package size of Product, placebo or comparator drug, one (1) package of the finished Product, placebo or comparator drug for use in clinical trials. 

        "Valois" means Valois SAS, a corporation organized under the laws of France, having its principal place of business at Le
Prieuré, 27110, Le Neubourg, France. 

        "Valois Actuator" shall have the meaning set forth in Section 6.1.2.2. 

        "Valois Dose Counter" shall have the meaning set forth in Section 6.1.2.2. 

        "Valois Development and Pilot Scale Supply Agreement" shall have the meaning set forth in Section 6.1.2.2. 

18

 

        "Valid Claim" means a claim of an issued Patent which claim has not been held invalid or unenforceable by final decision of a court or
other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which is not admitted to be invalid or unenforceable through reissue, disclaimer
or otherwise. 

        "Withdrawal Notice" shall have the meaning set forth in Section 12.7.1. 

Article 2

Grant of Rights  

2.1   Grant of Rights.  

        2.1.1    Grant of Rights by Nycomed to Sepracor.    Subject to all
terms and conditions of this Agreement, Nycomed hereby grants to Sepracor, and Sepracor accepts, for the Term, the following rights in the Territory and in the applicable Field: 

        2.1.1.1    Appointment as Exclusive Distributor for Original
Products.    Nycomed hereby appoints Sepracor, and Sepracor hereby accepts such appointment, as the Exclusive Distributor of the Original Products in the Territory,
with the sole and exclusive right, exclusive even as to Nycomed, to Commercialize these Products in the Territory, with the limited right pursuant to Section 2.2 to sublicense and subcontract; 

        2.1.1.2    Grant of Rights under Nycomed Technology to Develop and Commercialize
Products.    An Exclusive right under the Nycomed Technology in the Territory to Develop and Commercialize Products in the Field; and 

        2.1.1.2.1    Grant of Rights under the Teijin Patents to Develop and Commercialize
Products.    Subject to the payments to be made pursuant to this Agreement, a right and irrevocable during the Term, fully paid up sublicense under the Teijin Patents
to Develop and Commercialize Products in the Field. 

        2.1.1.2.2    Grant of Rights under the 3M Patents to Develop and Commercialize
Products.    A right and irrevocable during the Term, fully paid up non-exclusive license under the 3M Patents to Develop and Commercialize Products in
the Field. 

        2.1.1.3    Grant of Rights under Nycomed Trademarks to Commercialize
Product.    Subject to Article 8, Sections 9.2 and 9.3, an Exclusive right and license under the Nycomed Trademarks, to Commercialize Products in the
Territory and in the Field exclusively under such Trademarks, as assigned by Nycomed through the SC to each Product pursuant to Section 8.1 and Section 8.2 (and not as
non-branded generic), with the limited right pursuant to Section 2.2, to sublicense and subcontract. 

        2.1.1.4    Commercialization of Non-Branded Rx
Generic.    The Parties agree that reasonably prior to the earlier to occur of (a) [**],  (b) [**], and
(c) [**] they shall, in good faith,
[**] Commercialization of a non-branded prescription generic version of the affected Product, such that a non-branded prescription genericversion of the
applicable Product [**] (i) always provided, however, that each Party may, [**], and  (ii) always [**] notwithstanding. 

        2.1.1.5    Commercialization of OTC Products.    The Parties agree
that reasonably prior to [**], they shall, in good faith [**] Commercialization of an OTC version of the relevant Product or Products. Only if
considered [**] by both Parties, shall they agree in good faith on the terms and conditions for the [**], subject to [**]. 

        2.1.1.6    Third Party Technologies.    

        2.1.1.6.1    Teijin Technology and 3M Technology.    Sepracor
acknowledges that Sepracor's rights to any 3M Technology and Teijin Technology forming part of the Nycomed Technology are only provided to the extent Controlled by Nycomed. 

19

 

  
        2.1.1.6.2    Aventis UltrahalerTM Technology.    Sepracor
acknowledges that Nycomed has no access rights to and does not Control Aventis' proprietary UltrahalerTM Technology incorporated in the MDPI Product formerly co-developed by
Aventis and Nycomed pursuant to the terms and conditions of the MDPI Collaboration and Development Agreement by and between Aventis and Nycomed, but may, until December 31, 2009, request
Aventis to negotiate in good faith a license to such UltrahalerTM Technology. 

        2.1.1.7    Access Rights of Sepracor to Nycomed Improvement Technology Covering Additional
Products.    

        2.1.1.7.1    Access Rights.    Subject to all terms and conditions of
this Agreement, without limitation, Sepracor's rights pursuant to Section 7.1.1.2, Nycomed hereby grants to Sepracor, and Sepracor accepts, for the Term an Exclusive right to practice the
Nycomed Improvement Technology that is incorporated in any Additional Products in the Territory to Develop and Commercialize Products in the Field. 

        2.1.1.7.2    Consideration for License Grant in Case of Improvements Not Co-Developed by
Sepracor.    If Sepracor should Develop or Commercialize in the Territory an Additional Product incorporating any Nycomed Improvement Technology without Sepracor
having co-financed the related Technical or Clinical Development Costs in accordance with an agreed Development Plan, then Section 2.1.1.7.1 shall apply subject to the provisos: 

[**]
shall compensate [**] for a reasonable part of [**] related technical and clinical development costs. The basis of such
allocation shall be a good faith estimation of [**], in each case within the Field. 

        However
and as a general principle, (i) all [**] shall be borne by [**],  (ii) [**] shall bear [**] and (iii) there
shall be a
reasonable adjustment of such [**] if there should be any change regarding the [**], such adjustment to be made [**]. In the
event that the Parties should be [**], such adjustment shall be finally determined by means of [**]. 

        2.1.2    Grant of Rights by Sepracor to Nycomed.    Subject to all
terms and conditions of this Agreement, Sepracor hereby grants to Nycomed, and Nycomed accepts, for the Term, the following rights and licenses: 

        2.1.2.1    Grant of Rights under Sepracor Technology to Develop
Product.    A Non-Exclusive, non-royalty bearing right and license under the Sepracor Technology to perform Product Development in the Field
in the ROW only; 

        2.1.2.2    Grant of Rights under Sepracor Technology to Manufacture and Import Product into the
Territory.    An Exclusive, non-royalty bearing right and license under the applicable Sepracor Technology, to manufacture and import into the Territory
Sepracor's requirements of Product. 

        2.2    Appointment of Sublicensees and Subcontractors.    

        2.2.1    Sublicensing and Subcontracting by Sepracor.    

        2.2.1.1    Sublicensing.    Subject to Section 2.2.1.2,
Sepracor shall not sublicense its rights and obligations under this Agreement, whether in whole or in part, to a Third Party, without the prior written consent of Nycomed, such consent to be given or
withheld within Nycomed's sole discretion. 

        2.2.1.2    Permitted Subcontracting by Sepracor.    Sepracor may
subcontract activities to be performed by Sepracor according to this Agreement as follows: 

        Sepracor
may subcontract regulatory, Development and Commercialization work relating to the Products, however, in all cases: (i) Sepracor
shall maintain close oversight of and direct responsibility for such work; (ii) Sepracor shall consider any reasonable suggestions from the SC with
regard to 

20

 

vendor
selection and (iii) Sepracor shall, if requested in writing by Nycomed, inform Nycomed of any such subcontractors and the activities that have
been subcontracted. 

        2.2.2    Sublicensing and Subcontracting by Nycomed.    

        2.2.2.1    General Principle.    Except as expressly restricted
hereinafter, Nycomed may sublicense or subcontract its rights and obligations under this Agreement, whether to an Affiliate of Nycomed or to a Third Party, without the prior written consent of
Sepracor. Notwithstanding the foregoing, Nycomed may sublicense or subcontract any of its rights and obligations under this Agreement that relate to (i)
Sepracor Technology or (ii) Know-How owned or developed by Sepracor not relating to the Compound or a Product, in each case whether to an
Affiliate of Nycomed or to a Third Party, only with the prior written consent to Sepracor, such consent not to be unreasonably withheld or delayed (for example, due to a legal obligation relating to
Sepracor Technology). 

        2.2.2.2    Appointment of Subcontractors for Product
Manufacturing.    Nycomed may subcontract the manufacturing of the Original Products and, to the extent applicable, Products other than the Original Products and
Compound or components thereof to Affiliates or Third Parties. Any change of the initial manufacturers or subcontractors appointed for the manufacturing of Product shall be subject to the change
control provisions of the applicable Quality Agreement. Until such Quality Agreement or Supply Agreements and such change control procedures are agreed, Nycomed may only appoint subcontractors for the
manufacturing of Product with the prior written consent of Sepracor, such consent not to be unreasonably withheld or delayed. 

        2.2.3    Vicarious Liability.    Unless provided otherwise herein, a
Party sublicensing, subcontracting or designating Development, manufacturing or Commercialization activities to an Affiliate, Third Party or permitted designee in accordance with the provisions of
this Article 2 shall be liable for the performance of any responsibilities so delegated as if they had been performed by the delegating Party. 

        2.3    Access Rights of Nycomed to Sepracor Technology.    

        2.3.1    License Grant.    Nycomed's rights pursuant to
Sections 2.3.4 (Supply of Product), Section 5.7 (Right to Access and Reference Use of Regulatory Approvals) and 7.1.1.2 (Ownership to Certain Sepracor Improvements) notwithstanding,
during the Term, Sepracor grants Nycomed a world-wide, unrestricted (except, during the Term, in the Field and in the Territory, restricted by and subject to the terms of this Agreement),
perpetual, Non-Exclusive and irrevocable license (including the right to sub-license) to practice the Sepracor Technology for the purposes of developing, having developed,
making, having made, using and selling Original Products and Additional Products, whether alone or in combination with one or several other active ingredients. Such license shall be subject to  (i) a
reasonable compensation of Development Costs incurred by Sepracor pursuant to Section 2.3.2, and  (ii) royalties pursuant to Section 2.3.3. 

        2.3.2    Development Cost Sharing.    If Nycomed exercises its access
rights pursuant to Section 2.3.1, the Parties shall agree in good faith on a reasonable compensation of Sepracor for the technical and clinical development costs incurred by Sepracor for the
relevant Additional Product always provided, however, that Nycomed shall not owe Sepracor any such contribution for technical and clinical development costs incurred by Sepracor for the
[**]. The basis of such determination of the share of Sepracor's technical and clinical development costs to be borne by [**] shall be a good faith
estimation of [**], in relation to [**]. 

        There
shall be a reasonable adjustment of such development cost compensation payment if there should be any change regarding the relevant countries of the ROW in which Nycomed
commercializes the applicable Additional Product and the related sales potential, compared with the sales potential of the relevant Additional Product in the Territory, such adjustment to be made
[**]. In the event that the Parties should be unable to determine any such development cost compensation payment or permitted adjustment thereof within a period of three
(3) months from the date of receipt by a Party of the 

21

 

written
request of the other Party to make any such adjustment, such adjustment shall be finally determined by means of Third Party Expert Determination in accordance with Section 20.4. 

        2.3.3    Royalties.    

        2.3.3.1    Formoterol Combination Product.    In the event that
Sepracor should Develop a Formoterol Combination Product incorporating Sepracor's proprietary Compound RR-Formoterol covered by any Patent Controlled by Sepracor, then Nycomed shall make
payment to Sepracor, for the duration of such Sepracor Patent in the relevant countries, of a royalty on its Net Sales of such Formoterol Combination Product, which corresponds in respect of the
amount and the applicable thresholds to the royalty rates specified in Article 11.2 hereof as of the Effective Date. 

        2.3.3.2    Other Additional Products Incorporating Sepracor
Technology.    Section 2.3.3.1 shall apply accordingly to any other Additional Product, other than the Nebules Product, Developed by Sepracor that incorporates
any Patent Controlled by Sepracor always provided, however, that the Parties shall negotiate the applicable royalty rate at an appropriate time in consideration of all relevant factors including,
without limitation, the contribution of the relevant Sepracor Patents to the overall commercial value of any such Additional Product, and always further provided that Nycomed shall owe no royalties
for any Original Product or the Nebules Product. 

        2.3.4    Supply of Product by Sepracor or its Appointee.    In the
event that Nycomed should elect to avail itself of its rights pursuant to Section 2.3.1 with regard to any Additional Product and the Parties have agreed pursuant to Section 6.2.1.4 that
any such Additional Product shall be manufactured by Sepracor or its appointee, then, with respect to the financial and other terms and conditions of any such supplies of any such Additional or
Original Product, as the case may be, Section 10.1.3 shall apply. 

        2.3.5    Exercise of Rights.    Nycomed may elect to exercise its
rights pursuant to this Section 2.3 during the Term by giving Sepracor related written notice. 

        2.4    Generic Competition.    In the event that there is a generic
version of any Product that is sold in the Territory, (i) the Parties, acting through the SC, shall agree on reasonable amendments to the terms under which the Products affected by the generic
competition will be sold, including all changes of assumptions under which the Parties will operate during the remaining term of the Agreement, (ii) the Royalties will be discussed by the
Parties acting through the SC, (iii) clause (g) of the definition of Net Sales shall be disregarded and no longer applicable, and (iv) the Parties shall agree on all other aspects
relating to the sale of such Product and the continued viability of the Agreement with respect to such Product in light of the generic competition. 

Article 3

Consideration  

        3.1    Consideration for Grant of Rights.    As part of the
consideration for the grant of rights by Nycomed to Sepracor under this Agreement, Sepracor agrees to make payment to Nycomed of an Execution Payment, Development Milestone Fee, and Sales Milestone
Fees (individually, each an "Installment" and collectively, the "Installments"), in accordance with this
Article 3. 

        3.2    Execution Payment.    

        3.2.1    General.    Sepracor agrees to make payment to Nycomed of an
execution payment totaling 

US dollars 150 million ($150,000,000)  

(the "Execution Payment"). This Execution Payment is considered to be a lump sum reimbursement of Nycomed's development costs
attributable to the development of the Omnaris® AQ Product and the Alvesco® MDI Product for the Territory that has been accomplished by Nycomed prior to the Effective Date. 

22

 

        3.2.2    Due Date of Execution Payment.    The Execution Payment shall
be due upon the Effective Date, and Sepracor shall make payment of such Execution Payment in accordance with Section 3.5 no later than thirty (30) days after the Effective Date. 

        3.3    Development Milestone Fee.    

        3.3.1    General.    Further, upon the achievement of the milestone
referred to in Section 3.3.2, Sepracor agrees to make payment to Nycomed of the following related milestone fee (a "Development Milestone" and a
pertaining "Development Milestone Fee"): 

        3.3.2    Development Milestone and Fee.    

        3.3.2.1    Alvesco® MDI Product Development Milestone
Fee.    Upon the [**] which contains a [**], Sepracor shall make payment to Nycomed of a one-time
Development Milestone Fee of 

US dollars [**] ($[**]).  

        3.3.3    Due Date of Development Milestone
Fee.    The Development Milestone Fee referred to in Sections 3.3.1 and 3.3.2 above shall become due upon the date as of which the Development Milestone has
been accomplished, and Sepracor shall make payment of the Development Milestone Fee in accordance with Section 3.5 within 10 Business Days from the date as of which the Development Milestone
has been so accomplished. 

        3.4    Sales Milestone Fees.    

        3.4.1    General.    Further, upon the achievement of the milestones
referred to in Sections 3.4.2 to 3.4.6, Sepracor agrees to make payment to Nycomed of the related milestone fees set out below (each, a "Sales
Milestone" and a pertaining "Sales Milestone Fee"). Thereby and for the avoidance of doubt, it is understood that any Sales
Milestone that has been achieved and triggered a Sales Milestone Fee in any given Contract Year shall not trigger another corresponding Sales Milestone Fee if such Sales Milestone is again achieved in
any following Contract Year. Also and for clarity, if Sepracor should achieve, in any Contract Year and in each case for the first time, more than one Sales Milestone, all related Milestone Fees shall
become due and payable. 

        3.4.2    First Sales Threshold.    Upon the first time the Net Sales
of the Products in the Territory equal or exceed, in any calendar year, [**] US Dollars (US$[**]),
Sepracor shall make payment to Nycomed of a Sales Milestone Fee of 

US dollars [**] ($[**]).  

        3.4.3    Second Sales Threshold.    Upon the
first time the Net Sales of the Products in the Territory equal or exceed, in any calendar year, [**] US Dollars
(US$[**]), Sepracor shall make payment to Nycomed of a Sales Milestone Fee of 

US dollars [**] ($[**]).  

        3.4.4    Third Sales Threshold.    Upon the
first time the Net Sales of the Products in the Territory equal or exceed, in any calendar year, [**] US Dollars
(US$[**]), Sepracor shall make payment to Nycomed of a Sales Milestone Fee of 

US dollars [**] ($[**]).  

        3.4.5    Fourth Sales Threshold.    Upon the
first time the Net Sales of the Products in the Territory equal or exceed, in any calendar year, [**] US Dollars
(US$[**]), Sepracor shall make payment to Nycomed of a Sales Milestone Fee of 

US dollars [**] ($[**]).  

23

 

        3.4.6    Fifth Sales Threshold.    Upon the
first time the Net Sales of the Products in the Territory equal or exceed, in any calendar year, [**] US Dollars
(US$[**]), Sepracor shall make payment to Nycomed of a Sales Milestone Fee of 

US dollars [**] ($[**]).  

        3.4.7    Due Date of Sales Milestone
Fees.    The Sales Milestone Fees referred to in Sections 3.4.1 to .4.6 above shall become due upon the end of the Contract Quarter within which the applicable
Sales Milestone has been reached, and Sepracor shall make payment of any such Sales Milestone Fee in accordance with Section 3.5 within two (2) weeks from the end of the relevant
Contract Quarter. 

        3.5    Payment of Execution Payment, Development Milestone Fees and Sales Milestone
Fees.    

        3.5.1    Period of Payment.    Payment of the Execution Payment, the
Development Milestone Fee, and each Sales Milestone Fee shall be made within the periods referred to in Sections 3.2.2, 3..3.3 and 3.4.7. 

        3.5.2    Payment.    Sepracor shall make payment of each Installment
by means of bank wire transfer in immediately available funds to the following bank account of Nycomed, whereby each Party shall bear bank charges arising on its side associated with any such
transfer: 

Credit Institute: [**]

Bank Account: [**]

SWIFT Code: [**]

IBAN-No.: [**]

VAT Identification number: [**]  

In the event that Sepracor should fail to make timely payment of any Installment pursuant to this Agreement, interest shall accrue at a rate of interest of
[**] percent ([**]%) above the monthly average rate(s) of the Euro OverNight Index Average
("EONIA") applying to the specific days of each of the months during which a default of payment occurs, as calculated by the European Central Bank and
as quoted in the website of the Deutsche Bundesbank currently located at http://www.bundesbank.de/ sub "Monatsbericht" (or such other source as may be
mutually agreed by the Parties) from time to time, effective for the applicable days of the period of default. 

        3.6    No Refund of Development of Execution Payment Milestone Fees, Development Milestone Fee, and
Sales Milestone Fees.    It is expressly understood that the Execution Payment, the Development Milestone Fee and each Sales Milestone Fee paid by Sepracor shall
neither be refundable nor refunded for any reason whatsoever. 

Article 4

Governance and Oversight  

        4.1    General.    During the Term, the Development and
Commercialization of the Product in the Territory shall be managed, coordinated and overseen by a committee and in the manner described below. All decisions of the Parties shall be made on the basis
of the best interest of the Development and Commercialization of the Product in the Territory and in the Field, thereby reasonably considering the effects in the ROW, and Sepracor shall be obligated
to use Commercially Reasonable Efforts to maximize profits and optimize sales of the Product in the Territory during the Term. The Parties anticipate that the committee shall perform the functions
described below; however, the functions and operations of the committee may be altered from time to time during the Term by the mutual agreement of the Parties. 

24

 

        4.2    Establishment and Responsibilities of Steering Committee and
Subcommittees.    

        4.2.1    Establishment.    Promptly following the Effective Date, the
Parties shall establish a Steering Committee (the "SC") that shall consist of an equal number of representatives of senior management from each Party,
each such representative having the authority to act on behalf of the Party such individual represents. Initially, the SC shall consist of six (6) individuals; three (3) of whom shall be
nominated by Sepracor; and three (3) of whom shall be nominated by Nycomed. Any member of the SC may designate a substitute to attend and perform the functions of that member at any meeting of
the SC. Each Party may, with the consent of the other Party, such consent not to be unreasonably withheld or delayed, invite non-member, non-voting representatives of such
Party to attend meetings of the SC. Each Party shall, on an alternate Contract Yearly basis designate the chairperson, and the other Party shall designate the secretary of the SC. The initial
chairperson shall be designated by Sepracor; and the initial secretary shall be designated by Nycomed. 

        4.2.2    Responsibilities of SC.    The SC shall perform the following
responsibilities always provided, however, that the SC or any Subcommittee shall in no event have any power to modify or amend this Agreement: 

	(i)
	Oversee
and coordinate the overall strategy for the Development and Commercialization of Products in the Territory including, without limitation, Line Extensions;

	(ii)
	Facilitate
communication between the two Parties and provide a forum to review any Development, regulatory, manufacturing and Commercialization or other matters
pertaining to the Product;

	(iii)
	Provide
a forum for communication of Sepracor's activities in the Territory and Nycomed's activities in the ROW, both with respect to the Products and the Compound;

	(iv)
	Coordinate
scientific, clinical and regulatory issues regarding Product or Compound in the Territory and in the ROW, including, without limitation, scientific as well
as clinical positioning of Product, clinical trials, pharmacovigilance, preparation and prosecution of applications submitted to Regulatory Authorities in the Territory, and responding to requests and
recommendations from such Regulatory Authorities, and similar activities, each with respect to Product in accordance with the terms of this Agreement;

	(v)
	Approve
and then undertake a bi-annual (two times per Contract Year) review of the status of any Development Plan and the Marketing Plan, including, without
limitation, the applicable timelines, and provide direction to the conduct of the Development Plan and Marketing Plan, as necessary;

	(vi)
	Review
and approve any proposed Development Plan and any fundamental amendments or modifications thereto;

	(vii)
	Review
and approve the proposed Marketing Plan and any fundamental amendments or modifications thereto;

	(viii)
	Monitor
compliance by Sepracor with annual budgets as set out in the Contract Yearly Marketing Plan for the Commercialization of Product including, without
limitation, Sepracor's Minimum Marketing Investment Obligations pursuant to Section 9.6.1 and Sepracor's Minimum Sales Obligations pursuant to Section 9.6.2,

	(ix)
	Review
and consider implications of any clinical development regarding products incorporating the Compound performed or planned to be performed by Nycomed in the in
ROW;

	(x)
	Review
and approve the strategy for the Commercialization proposed by Sepracor for the Territory; 

25

 

	(xi)
	Discuss
any potential benefits from synergies of Commercialization activities in the Territory with efforts in the ROW;

	(xii)
	Review
and approve any additional brand names and Other Trademarks, subject to Article 8;

	(xiii)
	Discuss,
monitor and coordinate supply and manufacturing strategy and issues,

	(xiv)
	Coordinate,
oversee and delegate the activities of any Subcommittees established pursuant to Section 4.2.3 of this Agreement;

	(xv)
	Resolve
disputes, disagreements and deadlocks unresolved by any Subcommittees established pursuant to Article 20 of this Agreement;

	(xvi)
	Perform
such other responsibilities as may be assigned to the SC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time; and

	(xvii)
	Consider
whether any new Patents shall be considered to be Ancillary Patents instead of Additional Patents, and with respect to the Patents listed in
clause (i) of the definition of Nycomed Ancillary Patents, as soon as reasonably practical following the Effective Date, the Parties shall cause their respective intellectual property counsel
to meet and review the Patents listed in such clause (i) to determine whether any of such Patents should be submitted to the SC for consideration for inclusion as a Nycomed Additional Patent,
subject to Nycomed's consent, not to be unreasonably withheld. 

        4.2.3    Subcommittees.    From time to time, the JSC may establish
one or more Subcommittees to oversee particular projects or activities within the scope of authority of the SC, as it deems necessary or advisable (each, a  "Subcommittee"). Each Subcommittee shall
consist of such equal number of representatives of each Party as the SC determines is appropriate from time to
time. Each Subcommittee shall meet with such frequency as the SC shall determine. All decisions of each Subcommittee shall be made by unanimous vote or written consent, with the representatives of
each Sepracor and Nycomed, in each case collectively, having one vote in all decisions. If, with respect to a matter that is subject to a Subcommittee's decision-making authority, the Subcommittee
cannot reach unanimity, the matter shall be referred to the SC, which shall resolve such matter in accordance with Section 4.3. The Parties envisage that the SC will establish Subcommittees
shortly after the Effective Date to oversee each of the following areas: (i) regulatory matters; (ii)
transition activities; (iii) optimum commercial strategies; and (iv) supply matters. If one Party
expressly requires that a Subcommittee be appointed, then it will be promptly established by the SC. Each Party shall, on an alternate Contract Yearly basis designate the chairperson of each relevant
Subcommittee, and the other Party shall designate the secretary of each relevant Subcommittee. The initial chairperson of each relevant Subcommittee shall be designated by Sepracor; and the initial
secretary shall be designated by Nycomed. 

        4.3    General Principles Applying to the SC and Subcommittees.    

        4.3.1    Meetings.    All SC and Subcommittee meetings shall be as
often as the members may determine, but in any event SC meetings shall occur not less than twice per calendar year. Such meetings may be held in person, or any means of telecommunications or video
conference, as the members deem necessary or appropriate; provided, however, that at least one SC meeting per year shall be held in person and the
location of such in person meeting shall alternate between Sepracor's and Nycomed's offices. Either Party may convene a special meeting of the SC by providing good reason and at least ten
(10) Business Days written notice to the other Party specifying the date, time, place and proposed agenda. 

        4.3.2    Quorum.    A quorum for SC or Subcommittee meetings shall be
four (4) members, with at least two (2) members from each Party. Any decision made by the SC or a Subcommittee without a 

26

 

quorum
shall be null and void, unless subsequently ratified by all of the members of the SC or Subcommittee concerned. 

        4.3.3    Decision-Making.    Each Party shall have one vote on the SC
and each Subcommittee on all matters that are within the responsibility of the SC and the applicable Subcommittee. Section 4.3.2 notwithstanding, both Parties must vote in the affirmative to
allow the SC or a Subcommittee to take any action that requires the vote of the SC or the relevant Subcommittee. The members of the SC and each Subcommittee shall be obliged to use Commercially
Reasonable Efforts to reach consensus on any disputes concerning the matters within their roles and functions. Resolutions of the SC and each Subcommittee shall be in accordance with this Agreement.
Neither the SC nor any Subcommittee shall not have the authority to alter or amend the terms of this Agreement. 

        4.4    Right to Make Final Determination    

        4.4.1    Either Party's Right to Make Final Determination in Certain
Cases.    If any matter in dispute is not resolved within sixty (60) days by the SC, then such matters in dispute shall,  (i) always subject to
Section 4.4.2 and (ii) always provided that the decision is made in good
faith, that there is a reasonable basis for the decision, that the decision is not inconsistent with the Regulatory Approvals for the Product (if applicable), and that the decision is otherwise
consistent with the terms of this Agreement, be finally determined as follows: 

        4.4.1.1    Right of Sepracor to Make Final Determination.    Sepracor
may, always subject to Sections 4.4.1 and 4.4.2, and always subject to Nycomed's rights pursuant to Section 4.4.1.2(iv), make the final determination in the following matters: 

	(i)
	To
the extent that any such Development is financed exclusively by Sepracor and subject to Nycomed's rights pursuant to Section 4.4.1.2(ii), in all conflicts
relating to the Development of any Product in the Territory and in the applicable Field;

	(ii)
	In
all conflicts relating to the Commercialization of Product in the Territory including, without limitation, Sepracor's Annual Marketing Plan, adjustments or the
execution thereof, or other matters regarding the Commercialization of Product by Sepracor in the Territory;

	(iii)
	All
matters regarding development and commercialization of Products incorporating Compound in the ROW, if and to the extent a conflict relates to Sepracor Technology
incorporated in the relevant product incorporating Compound, always, provided, however, that an exercise of such right is, within Sepracor's reasonably exercised discretion, required in order to
safeguard Sepracor's global development and commercialization strategy for the relevant Sepracor Technology incorporated in any such product. 

        4.4.1.2    Right of Nycomed to Make Final Determination.    Nycomed
may, always subject to Sections 4.4.1 and 4.4.2, and always subject to Sepracor's rights pursuant to Section 4.4.1.1, make the final determination in the following matters: 

	(i)
	In
all conflicts relating to the development of products incorporating the Compound in the ROW;

	(ii)
	In
all conflicts relating solely to Nycomed's compliance with legal or regulatory rules governing any product incorporating the Compound in the Territory or in the ROW;

	(iii)
	In
all conflicts relating to the commercialization of products incorporating the Compound in the ROW;

	(iv)
	In
all conflicts relating to the global development and commercialization strategy of Nycomed for the Compound and products incorporating the Compound that would have a
material adverse, safety, regulatory or financial impact on the development or commercialization of 

27

 

Product
in any of the Major Market Countries without having a material adverse financial impact on the Development or Commercialization of Products in the Territory; and 

	(v)
	In
any determination in accordance with the provisions set forth in Section 4.2.2 (xvii) whether any of the Nycomed Ancillary Patents listed in
clause (i) of the definition of Nycomed Ancillary Patents shall be included as a Nycomed Additional Patent or whether they shall continue to be Nycomed Ancillary Patents. 

        4.4.2    Joint Approval Required.    Neither Party may determine any
of the following matters that shall always require the approval of both Parties: 

        4.4.2.1    General Matters.    The following general matters shall
always require the approval of both Parties: 

	(i)
	Issues
that would (x) excuse a Party from any of its obligations under this Agreement,  (y) deprive a Party of its contractual rights or (z) impose upon a Party obligations exceeding those
assumed by such Party under this Agreement, without limitation, modifying Minimum Marketing Investment Obligations or Minimum Sales Obligations for Sepracor, or establishing additional Minimum
Marketing Investment Obligations or Minimum Sales Obligations for Sepracor, or modifying Supply Prices or Royalties, or cause a Party to incur out-of pocket expenses or pay any royalty
(other than the Royalty);

	(ii)
	Issues
that would cause a Party to violate bona fide contractual obligations towards a Third Party;

	(iii)
	Issues
that would expose a Party to undue risks resulting from an alleged infringement of a Third Party Patent;

	(iv)
	Issues
that would expose a Party to increased product liability risks;

	(v)
	Payment
obligations of the other Party;

	(vi)
	Increases
in the level of deductions above the amount set forth in clause (g) of the definition of "Net Sales"; and

	(vii)
	Subject
to Section 4.2.2(xvii), any determination that a new Patent shall be classified as an Ancillary Patent instead of as an Additional Patent. 

        4.4.2.2    Specific Matters.    The following specific matters shall,
if and to the extent not set out in this Agreement, always require the approval of both Parties: 

	(i)
	Section 2.1.1.6
notwithstanding, issues regarding the Technical Development of the Omnaris® HFA Product and the Alvesco® MDI Product or
any other Product incorporating [**] by Sepracor;

	(ii)
	Section 2.1.1.6
notwithstanding, issues regarding the Technical Development of the Omnaris® HFA Product, the Omnaris® AQ Product and the
Alvesco® MDI Product or any other Product incorporating any technology of Valois by Sepracor;

	(iii)
	Issues
related to the manufacturing of Compound and any Product including, without limitation, the determination of the manufacturer and the manufacturing site, unless
agreed by the Parties including, without limitation, pursuant to the change control provisions of a Quality Agreement and always provided that Sepracor shall not unreasonably withhold or delay its
consent to a relocation of any processing facility for Compound and Product by Nycomed or its permitted appointees; 

28

 

 

	(iv)
	Any
decision to launch an OTC brand of a Product or a non-branded prescription version of a Product in the Territory;

	(v)
	Adjustments
to the operation and function of the SC;

	(vi)
	The
determination of any Minimum Obligations, of the compliance by Sepracor with any Minimum Obligations, of any Shortfall Amounts and of any compensation pursuant to
Section 11.4.2(iii);

	(vii)
	The
designation of a Trademark to a Product pursuant to Section 8.2.1, Section 8.3.2 and Section 8.8.4(c); and

	(viii)
	The
determination of periods required by Nycomed to modify or set-up, as the case may be, to manufacture Sepracor's requirements of any Line Extensions or
Additional Products that have been incorporated into this Agreement. 

        4.4.2.3    Disputes Regarding Interpretation or Alleged Breach.    Notwithstanding this Section 4.4.2, any
dispute regarding the interpretation of this Agreement or any alleged breach of this Agreement will be resolved in accordance with the terms of Section 20.2 and 20.3, and without limiting
either Party's rights pursuant to Section 20.5. 

        4.4.3    Decision Deemed to be Made by SC.    For all purposes under this Agreement, any decision made pursuant to
Section 4.4 shall be deemed to be the decision of the SC. 

        4.5    Dispute Resolution.    

        4.5.1    General Principle.    In case the SC is unable to come to a decision within sixty (60) days of an
issue being presented to it and neither Party is entitled to make the final determination pursuant to Section 4.4.1, the matter shall be referred to further dispute resolution pursuant to
Section 20.2. 

        4.5.2    Treatment of Disputed Matter Pending Dispute Resolution.    Pending dispute resolution pursuant to
Sections 20.2 and 20.3, the relevant matter shall be tabled, and, subject to Section 20.5, no action regarding the relevant matter shall be taken. 

        4.6    Minutes.    

        4.6.1    Minutes of Meetings of SC.    The SC shall summarize its discussions and resolutions in minutes that shall be
signed by duly authorized representatives of each Party (in each case and collectively, the "Minutes" of SC discussions and resolutions). Such Minutes
for each of the SC meetings shall provide a description in reasonable detail of the discussions had at the meeting and a list of any actions, decisions or determinations approved by the SC, and shall
be drafted by the secretary of the meeting and sent to the chairperson of the applicable committee for comment promptly after each such meeting (but in no event more than thirty (30) days). All
actions noted in the Minutes are to be reviewed and approved at subsequent meetings of the SC; provided, that if the Parties cannot agree as to the
content of the Minutes, such Minutes will be finalized to reflect such disagreement. Final minutes of each meeting shall be distributed to the members of the SC by the chairperson. All minutes of
meetings shall be kept in the English language. 

        4.6.2    Minutes of Meetings of Subcommittees.    Each relevant Subcommittee shall summarize its discussions and
resolutions in Minutes, whereby Section 4.6.1 shall apply accordingly. 

        4.7    Expenses.    Each Party shall bear all its own costs, including expenses incurred by the members nominated by
it in connection with their activities as members of the SC or any Subcommittee. 

        4.8    Alliance Managers.    Promptly after the Effective Date, each Party shall appoint an individual to act as the
alliance manager for such Party (each an "Alliance Manager" of a Party). Each Alliance Manager who is not otherwise a member of the SC shall thereafter
be permitted to attend meetings of 

29

 

the
SC. The Alliance Managers shall be the primary contact for the Parties regarding the activities contemplated by this Agreement and shall facilitate all such activities hereunder. Each Party may
replace its Alliance Manager with an alternative representative at any time with prior written notice to the other Party. The Alliance Managers shall not, in any manner, take over the role of the SC
and shall not have any rights, powers or discretion except as expressly granted to the Alliance Managers hereunder. In no event shall the Alliance Managers have any power to modify or amend this
Agreement. 

Article 5

Regulatory Affairs  

        5.1    Responsibility for Regulatory Issues.    

        5.1.1    General.    The Parties shall designate a Party that shall, always subject to Section 5.2.2,
Section 12.4, Schedule 12.4 and Section 4.4, be exclusively responsible for managing, overseeing, monitoring and coordinating all
regulatory actions with respect to the Original Product and/or Additional Products in the Territory, including, without limitation, for obtaining and maintaining Regulatory Approvals for the Products
in the Territory (the "Responsible Regulatory Party"). 

        5.1.2    Responsible Regulatory Party for Original Products.    

        5.1.2.1    General Principle.    Unless otherwise agreed or required by the Legal Requirements, Nycomed shall serve as
the Responsible Regulatory Party for the Original Products. 

        5.1.2.2    Sepracor's Role as Regulatory Agent.    Nycomed exclusively appoints Sepracor to be its agent for purposes
of effectuating its role as the Responsible Regulatory Party (Sepracor being the "Regulatory Agent"). Sepracor shall  (i) use Commercially Reasonable
Efforts to obtain and maintain all Regulatory Approvals for and on behalf of Nycomed, shall
(ii) be the sole authorized interface with the FDA in regards to the Products in the Territory, shall  (iii) exclusively handle all regulatory interactions
with the FDA, including maintaining existing Regulatory Approvals as well as filing for any
additional Regulatory Approvals, and shall (iii) act as recipient of complaints raised by Customers or Third
Parties regarding Products in the Territory, all (iv) unless otherwise required or permitted under Legal Requirements and this Agreement. 

        5.1.2.3    Specific Coordination Requirements.    When acting as Nycomed's Regulatory Agent, Sepracor shall timely
coordinate with Nycomed at SC level any regulatory action or any decision to omit any regulatory action, that may adversely affect Nycomed's interests related to the Products and the Compound in the
Territory or in the ROW. 

        5.1.3    Regulatory Responsibility and Action Regarding DMF of Compound, Alvesco® MDI Product and Omnaris® HFA
Product.    Further to its role as Responsible Regulatory Party for the Original Products, Nycomed, at its own cost, shall be responsible for  (i) the DMF
relating to the manufacture of the Compound in accordance with Section 5.2.2.1, (ii)
the DMF regarding the Alvesco® MDI Product in accordance with Section 5.2.2.2 and (iii) the DMF regarding the Omnaris®
HFA Product, in accordance with Section 5.2.2.2. 

        5.1.4    Costs Related to Regulatory Activities.    The costs associated with Sepracor's actions taken as Regulatory
Agent shall be borne by [**], and those associated with being the Responsible Regulatory Party, including all FDA fees, shall be paid by [**] and shall
be reimbursed to [**] by [**] against appropriate documentation, subject to Section 5.1.3. 

        5.1.5    Additional Regulatory Approvals.    The parties shall cooperate on any and all Regulatory Activities for
Additional Products as set forth herein. 

30

 

        5.2    Title to and Ownership of Regulatory Approvals.    

        5.2.1    General Principle.    Nycomed or its designee shall be the owner of Regulatory Approvals for the Original
Products in the Territory. If and to the extent that Nycomed determines not to own the Regulatory Approvals for, and serve as the Responsible Regulatory Party with respect to, any Additional Product,
the Parties agree that Sepracor may elect to exclusively own such Regulatory Approvals for such Additional Product in the Territory and exclusively act as Responsible Regulatory Party with respect to
such Additional Product. For clarity, neither Party shall be obliged to act as Responsible Regulatory Party for an Additional Product. 

        5.2.2    Restricted Access Regarding Drug Master Files.    

        5.2.2.1    Nycomed Drug Master File.    Always subject to Sepracor's obligations of confidentiality and
non-use pursuant to Article 16 of this Agreement, the Parties agree that the access of Sepracor to Nycomed's Drug Master File (the "Nycomed
DMF") shall be restricted as follows: 

        5.2.2.1.1    General.    The Nycomed DMF contains an unrestricted part and a restricted part. It is agreed that
Sepracor shall have no access rights to the restricted part of the Nycomed DMF, and that Nycomed shall not be obliged to disclose to Sepracor the restricted part of the Nycomed DMF or any part
thereof, except to the extent that such direct access and disclosure is necessary for Sepracor to carry out its obligations under this Agreement to Develop and Commercialize Products, and always
subject to Sepracor's obligations of confidentiality and non-use pursuant to Article 16 of this Agreement. 

        5.2.2.1.2    Filing of Nycomed DMF.    The filing of the Nycomed DMF with the responsible Regulatory Authorities in
the Territory shall be performed by Nycomed, the costs of such filing to be borne by [**]. 

        5.2.2.1.3    Right of Sepracor to Reference Nycomed DMF.    In the event and to the extent required under applicable
laws and regulations of the Territory, Nycomed shall provide Sepracor with a letter of authorization pursuant to which Sepracor shall have the right to reference the Nycomed DMF for purposes of
obtaining the Regulatory Approval in the Territory always provided, however, that such letter of authorization shall not entitle Sepracor to access the restricted part of such Nycomed DMF, except to
the extent that such direct access is necessary for Sepracor to carry out its obligations under this Agreement to Develop and Commercialize Product. 

        5.2.2.1.4    Answering of Deficiency Letters Related to the Compound or Nycomed DMF.    In the event of any deficiency
letters in relation to Compound and/or the Nycomed DMF issued by a Regulatory Authority of the Territory, Nycomed shall assist Sepracor in amending applications for Regulatory Approval and answering
such deficiency letters, and Sepracor shall closely coordinate with Nycomed the answers to any such deficiency letters. Sepracor shall have direct access to the Nycomed DMF to the extent it is
necessary for Sepracor to carry out its obligations under this Agreement to Develop and Commercialize Products. 

        5.2.2.2    3M Drug Master Files.    Sepracor acknowledges that Nycomed [**]. 

        5.3    Regulatory Interface.    Always subject to Section 5.2.2 [**], the Parties agree
to cooperate in good faith as follows in regulatory issues: 

        5.3.1    Coordination.    The Parties shall establish procedures to ensure that the Parties exchange on a timely basis
all necessary information to enable Sepracor as the Distributor of Product in the Territory and, where applicable, as Regulatory Agent or Responsible Regulatory Party, and Nycomed as the Responsible
Regulatory Party, and Nycomed as the Party commercializing Compound and products incorporating the Compound in the ROW, to comply with all regulatory obligations relating to Compound, Products and
products incorporating the Compound on a global basis, including without limitation filing updates, pharmacovigilance filings and investigator notifications. 

31

 

        5.3.2    Regulatory Meetings and Correspondence.    The Regulatory Agent and, where Sepracor is not acting as
Regulatory Agent, the Responsible Regulatory Party, shall, always subject to Section 5.2.2, be responsible for interfacing, corresponding and meeting with the applicable Regulatory Authority
with respect to the Product in the Field, within the Territory. 

        Sepracor
as Regulatory Agent shall timely inform Nycomed of, and, where Sepracor is not acting as Regulatory Agent, the Responsible Regulatory Party shall timely inform the other Party
of, and representatives of Nycomed or such other Party may participate, in all meetings between representatives of Sepracor or the Responsible Regulatory Party, as the case may be, and the Regulatory
Authority with respect to the Product in the Territory and in the Field unless such other party is prohibited by operation of law or regulation from doing so. For the purposes of clarity and further
to Section 5.2.2, Sepracor and its representatives shall not be privy to, and shall not be permitted to participate in, those parts of any such meetings, discussions and correspondence that
relates to the [**] or restricted part of the Nycomed DMF, except with the prior written consent of Nycomed. 

        Nycomed
shall be exclusively entitled to interface, correspond and meet with the applicable Regulatory Authorities outside the Territory with respect to the Product in the Field outside
the Territory, as Nycomed deems appropriate within its sole discretion. 

        To
the extent reasonably practicable and subject to any Third Party confidentiality obligations, the Responsible Regulatory Party and, where relevant, Sepracor as Regulatory Agent, shall
provide the other Party with drafts of any material documents or correspondence pertaining to the Product and prepared for submission to the FDA sufficiently in advance of submission so that the other
Party may review and comment on the substance of such material documents or correspondence. The Responsible Regulatory Party and, where relevant, Sepracor as Regulatory Agent, shall promptly provide
the other Party with copies of any material documents or other correspondence received from the FDA pertaining to the Product (including without limitation any meeting minutes). If the other Party has
not commented on such material documents or correspondence within five (5) Business Days of provision of such material documents or correspondence to such other Party, then such other Party
shall be deemed to have no comments on such material documents or correspondence. 

        5.4    Mutual Duties to Assist.    Further to Section 5.3, each Party shall support the other, as may be
reasonably necessary, including providing necessary documents or other materials reasonably required, to maintain and obtain Regulatory Approvals for the Product. 

        5.5    Patent Notice.    Each Party shall provide the other Party (i)
notice of any Patent relevant to any NDA relevant to any Product, Compound or a use thereof, prior to the time the NDA is filed in the Territory, and  (ii) immediate notice of the issuance in the
Territory of any Patent that may be a Patent relevant to any Product, Compound or a use thereof, giving the
date of issue and Patent number for each such Patent, and the Parties will jointly decide within thirty (30) days of the Patent issuance if the Patent is to be listed in the Orange Book
pursuant to any NDA submitted for such Product, or the Compound. Similarly, each Party shall provide the other Party immediate notice of any approved NDA and any Patent term extension in the Territory
of any such relevant Patent. The Parties will cooperate with each other in the preparation and filing of Patent listings for the Orange Book and Patent term extensions, whereby Nycomed will proceed in
filing of appropriate listing and Patent term extension documents. Each Party will provide prompt notice to the other Party of any inquiries as to any relevant patent, which has claims to
manufacturing processes, which inquiries are provided pursuant to 35 U.S.C. §287, and will cooperate with respect to responses thereto. In all circumstances, the Party owning the NDA shall
be solely responsible for filing the necessary documentation with the FDA to list an issued Patent in the Orange Book and confirming that the issued Patent was duly and properly listed. 

32

 

        5.6    Information and Data.    

        5.6.1    Transfer of Nycomed Know-How.    As soon as reasonably practicable after the Effective Date,
Nycomed, as coordinated by the SC, shall disclose to Sepracor all then existing Nycomed Know-How. Thereafter, during the Term, Nycomed will promptly disclose to Sepracor any additional
Nycomed Know-How. Sepracor will be entitled to (i) receive, keep and use for regulatory purposes all clinical protocols, registration
applications and other substantive regulatory documents including, but not limited to, all toxicological and clinical data, and (ii) access and
reference all regulatory dossiers and filings, produced by Nycomed, its Affiliates and sublicensees and contractors pertaining to the Compound or the Product to the extent Controlled by Nycomed and as
is reasonably necessary for Sepracor to exercise its rights and fulfill its obligations under this Agreement. 

        5.6.2    Transfer of Sepracor Know-How.    During the Term, Sepracor, as coordinated by the SC, shall
promptly disclose to Nycomed all Sepracor Know-How as further provided hereinafter. Nycomed will be entitled to (i) receive, keep and use
for regulatory purposes all clinical protocols, registration applications and other substantive regulatory documents including, but not
limited to, all toxicological and clinical data, and (ii) access and reference all regulatory dossiers and filings, produced by Sepracor, its Affiliates
and sublicensees and contractors pertaining to Sepracor Technology to the extent Controlled by Sepracor and as is reasonably necessary for Nycomed to exercise its rights and fulfill its obligations
under this Agreement. 

        5.6.3    Know-How Controlled by Third Party.    To the extent that any Know-How related to a
Product is Controlled by a Third Party, each Party agrees to use its reasonable efforts to arrange direct access to the portions of such Know-How that is relevant to the activities of a
Party regarding a Product always provided, however, that neither Party will be obliged to provide such Know-How to the other Party if the Third Party is unwilling to provide the applicable
Party access to the relevant Know-How Controlled by such Third Party. 

        5.7    Right to Access and Reference Use of Regulatory Approvals.    Nycomed and its designees shall have the
unrestricted (except, during the Term, in the Field and in the Territory, restricted by and subject to the terms of this Agreement) right and license, free of charge (except for Nycomed's obligations
pursuant to Section 2.3), to access, use and reference Regulatory Approvals applied for or granted for Product in the Territory and held by Sepracor as Responsible Regulatory Party, and to
access, use and reference the pertaining regulatory documentation, for the purposes of developing, obtaining regulatory approval for and Commercializing pharmaceutical products, whether within or
outside the Territory, and whether within or outside the Field (except, during the Term, in the Field and in the Territory, restricted by and subject to the terms of this Agreement). 

Article 6

Development and Financial Terms of Development  

        6.1    Development of Original Products.    

        6.1.1    Clinical Development of Alvesco® MDI Product.    Sepracor shall use Commercially Reasonable
Efforts to perform, subject to coordination by the SC pursuant to Article 4 [**], the further Clinical Development of the Alvesco® MDI Product for such
indications as Sepracor, within its reasonably exercised discretion, deems appropriate. For such purpose, Sepracor shall set up a pertaining Clinical Development Plan that shall be coordinated at SC
level in accordance with Article 4. Sepracor acknowledges that Nycomed has informed Sepracor that, as of the Effective Date, there are no substantial ongoing Clinical Development activities by
or for Nycomed regarding the Alvesco® MDI Product. For the avoidance of doubt, Nycomed shall have access rights to the Sepracor Technology resulting from Sepracor's Clinical Development of
the Alvesco® MDI Product in accordance with Section 2.3. 

33

 

        6.1.2    Development of Omnaris® HFA Product.    

        6.1.2.1    Responsibility for Development of Omnaris® HFA Product.    Sepracor shall use Commercially
Reasonable Efforts to perform, subject to coordination by the SC pursuant to Article 4 [**], the Technical and Clinical Development of the Omnaris® HFA
Product under its exclusive responsibility always subject to Sections 6.1.2.2 and 6.1.2.3. For such purpose, Sepracor shall set up a pertaining Technical and Clinical Development Plan that
shall be coordinated at SC level in accordance with Article 4. 

        6.1.2.2    Cooperation Partners of Nycomed in Development, Manufacturing and Supply of Omnaris® HFA
Product.    Sepracor acknowledges that [**] is Nycomed's supplier of the pressurized aerosol canister including a metered dose valve (the
"Canister") that forms the core element of the Omnaris® HFA Product. 

        Sepracor
also acknowledges that Nycomed is, as of the Effective Date, [**] 

        Sepracor
further acknowledges that Nycomed is [**]. 

        As
a consequence, Sepracor agrees to reasonably coordinate its Development activities regarding the Omnaris® HFA Product with the purview of possibly continuing Nycomed's
development efforts, and to timely inform Nycomed if Sepracor should wish to [**]. Upon either Party's reasonable request, the Parties shall lay down their related
understandings in a pertaining amendment to this Agreement. 

        6.1.2.3    Costs of Development of Omnaris® HFA Product.    

        6.1.2.3.1    General Principle.    From the Effective Date, the costs and expenses of the Technical and Clinical
Development of the Omnaris® HFA Product shall be borne [**]. 

        6.1.2.3.2    Omnaris® HFA Product Technical Development Activities Conducted for Nycomed as of Effective
Date.    [**], shall be determined by [**] in good faith, and [**] shall make according
payment to [**] in accordance with the terms and conditions of [**] by and between the Parties in good faith [**]. 

        6.1.2.3.3    Omnaris® HFA Product Clinical Development Activities.    Sepracor acknowledges that, as of
the Effective Date, [**] regarding the Omnaris® HFA Product. From the Effective Date, the costs and expenses of the Clinical Development of the Omnaris®
HFA Product shall be borne [**]. 

        6.1.2.3.4    Omnaris® HFA Product Development Plan.    Sepracor shall set up a Technical and Clinical
Development Plan for the further Development of the Omnaris® HFA Product that shall be coordinated at SC level in accordance with Article 4. 

        6.1.2.3.5    Access Rights of Nycomed.    For the avoidance of doubt, Nycomed shall have access rights to the Sepracor
Technology resulting from Sepracor's Development of the Omnaris® HFA Product in accordance with Section 2.3. 

        6.2    Development of Additional Products.    

        6.2.1    Development of Additional Products.    

        6.2.1.1    General; Proposal for Commercialization.    Sepracor's rights and license pursuant to
Section 2.1.1.2 notwithstanding, the Parties shall discuss the Development and Commercialization of Additional Products at SC level. If a Party believes that any Additional Product, whether
Controlled by such Party or by the other Party, is suitable for Commercialization in the Territory and therefore wishes to have such Additional Product Developed for Commercialization in the
Territory, such Party shall give the other Party notice in writing, thereby submitting to the other Party, subject to its obligations of confidentiality and non-use pursuant to
Article 16 of this Agreement, reasonably detailed information on the applicable Additional Product. The matter shall then be discussed and coordinated by the SC in accordance with the
principles set out in Article 4. 

34

 

        6.2.1.2    Line Extensions.    Sepracor may Develop and Commercialize Line Extensions without the prior consent of
Nycomed, but subject to coordination by the SC in accordance with Article 4. Whenever reasonably required under the circumstances, the SC shall prepare a resolution for the inclusion of the
relevant Line Extension addressing the issues referred to in the second sub-paragraph of Section 6.2.1.3 to the extent relevant. Without limitation, the Parties shall reasonably
coordinate at SC level reasonable periods as Nycomed may require to modify or set up, as the case may be, at Nycomed or its suppliers, manufacturing facilities regarding the applicable Line Extension
in accordance with Section 10.1.2. 

        6.2.1.3    SC Inclusion of Improved Products; Improved Product Resolution.    Sepracor may Develop and Commercialize
any Improved Products subject to the consent of Nycomed, which consent shall not be unreasonably withheld or delayed after consideration at SC level in accordance with the following principles: 

        Within
a reasonable period of receipt of any request pursuant to Section 6.2.1.1, the SC (or a Subcommittee appointed by the SC) shall have evaluated the proposed Improved Product
and shall submit to each Party a reasonable resolution (subject to Sepracor's right to Develop and Commercialize Line Extensions in accordance with Section 6.2.1.2) regarding the Development
and Commercialization of the relevant Improved Product in the Territory. To the extent relevant under the circumstances, such resolution shall appropriately address, among other relevant issues and
with respect to the applicable Improved Product, [**] (each, an "SC Improved Product
Resolution"). 

        Whenever
reasonably required under the circumstances, any additional covenants made between the Parties regarding an Improved Product following any such SC Improved Product Resolution
shall be set forth in an "Additional Product Agreement". 

        6.2.1.4    Supply of Additional Product.    If an Additional Product is intended to be supplied by Nycomed to
Sepracor, the Parties shall enter into an "Additional Product Supply Agreement", and, if such Additional Product is to be manufactured by Sepracor or a
Third Party and Nycomed wishes to Commercialize such Additional Product in the ROW, the Parties shall enter into a "Sepracor Supply Agreement" or a
"Third Party Supply Agreement". 

        6.2.1.5    Development Plan.    If the SC determines that the applicable Additional Product should be Developed, then
Sepracor shall set up a Development Plan for review and coordination by the SC in accordance with the principles set out in Article 4 that shall be attached to the relevant Additional Product
Agreement. 

        6.2.1.6    Formoterol Combination Product.    Sections 6.2.1.1 to 6.2.1.5 notwithstanding, Sepracor agrees to
use its Commercially Reasonable Efforts to Develop and Commercialize an Additional Product in form of the Formoterol Combination Product based on a delivery technology yet to be determined in
accordance with Article 4. 

        6.2.1.7    Nebules Product.    Sections 6.2.1.1 to 6.2.1.5 notwithstanding, Sepracor agrees to use its
Commercially Reasonable Efforts to Develop and Commercialize the Nebules Product in accordance with Article 4. For the avoidance of doubt, Nycomed shall have access rights to the Sepracor
Technology resulting from Sepracor's technical and clinical development of the Nebules Product in accordance with Section 2.3. 

        6.2.2    Costs of Development of Additional Products and Co-Development.    

        6.2.2.1    General Principle.    Subject to Section 6.2.2.2, the costs of the Technical and Clinical
Development of any Additional Product for ultimate sale in the Territory only shall be borne by [**]. 

        6.2.2.2    Development Cost Sharing.    In the event that Nycomed should wish to Commercialize an Additional Product
in the ROW and exercise its respective access right, then except for the costs of the further technical and clinical development of the Original Products and the Nebules Product, Nycomed 

35

 

agrees
to co-finance the related Development Costs, and the Parties will, at SC level, in the course of determining the applicable Development Plan, negotiate an appropriate allocation of
the applicable Development Costs in accordance with Section 2.3. 

        6.2.2.3    Co-Development.    If and to the extent that Nycomed should wish to participate in such
Development by rendering certain Development work, the Parties will, at SC level, agree on the Development work to be performed by Nycomed. 

        6.2.2.4    Financial Reconciliation.    If and when relevant, Development Costs subject to Development Cost sharing
shall only be submitted in accordance with Section 11.3.4 to the extent made or incurred in conjunction with an approved budget line item in an Development Plan as approved and revised from
time to time by the SC in accordance with Article 4. 

        6.2.3    Standard of Care.    Sepracor and, if and to the extent relevant pursuant to Section 6.2.2.3, Nycomed,
shall use Commercially Reasonable Efforts to perform, subject to coordination by the SC pursuant to Article 4, the Development of any Additional Product. 

        6.2.4    Disputed Patents and In-Licensing of Third Party Technology.    

        6.2.4.1    Disputed Patents Regarding Additional Products.    In the event that an Infringement Claim pursuant to
Section 7.3.1 that relates to an Additional Product is brought against one Party or its Affiliates only in the Territory, Section 7.3 shall apply always provided, however, that the costs
of defending infringements claims pursuant to Section 7.3.4.3 and Third Party royalties pursuant to Section 7.3.4.4 shall be borne [**] to the extent that the
alleged infringement relates only to Sepracor Technology incorporated in the relevant Additional Product, otherwise, the Third Party royalties shall be borne by the Parties as provided in
Section 7.3. 

        6.2.4.2    In-Licensing of Third Party Technology Regarding Line Extensions and Additional Products.    If
a Party can establish to the reasonable satisfaction of the other Party pursuant to Section 7.4 that license(s) under any Third Party Disputed Patent or a Third Party Patent are necessary or
advisable in relation to any Third Party Patent conflict related solely to Sepracor Technology incorporated in any Additional Product, then any related Third Party Patent royalties and other
consideration for the use of such Disputed Patent so as to render (i) the manufacture (if relevant), use, offer to sell or sale in the Territory, or
importation into the Territory, of the relevant Additional Product in the Field by Sepracor, or (ii) the manufacturing of the relevant Additional
Product outside the Territory solely for exportation into the Territory for sale by Sepracor, non-infringing, shall be [**]. 

        6.2.5    Use of Clinical Data Generated by or for Sepracor in the Course of Clinical Development of Additional
Products.    For clarity, Nycomed, its Affiliates and its Third Party licensees and sub-distributors shall have access rights to Clinical Development Data
pertaining to Additional Products generated by or for Sepracor in accordance with Section 6.3.5. 

        6.2.6    Access Rights of Nycomed.    For the avoidance of doubt, Nycomed shall have access rights to the Sepracor
Technology resulting from Sepracor's Development of any Additional Product in accordance with Section 2.3. 

        6.3    Principles Applying to all Products.    Unless expressly contracted out in any additional covenant as may be
agreed by and between the Parties, the following principles shall apply to all Products: 

        6.3.1    Development.    The Development of Product shall be overseen and coordinated by the SC in accordance with
Article 4 and all applicable terms and conditions of this Agreement, including, without limitation, this Article 6. 

36

 

        6.3.2    Commercialization.    The Commercialization of Product shall be overseen and coordinated by the SC in
accordance with Article 4 and all applicable terms and conditions of this Agreement, including, without limitation, Articles 9 and 11. 

        6.3.3    Supply of Products and Compound.    The Original Products, any Additional Products and Compound, if and when
relevant, shall be supplied to Sepracor in accordance with and all applicable terms and conditions of this Agreement, including, without limitation, Articles 10 and 11 and, whenever applicable,
the relevant Supply Agreements. 

        6.3.4    Change Control and Related Regulatory Issues.    When negotiating manufacturing and supply issues regarding
the relevant Additional Product pursuant to Section 10.1.2 or when negotiating applicable change control issues related to an Original Product, the Parties shall appropriately consider related
change control and regulatory issues in accordance with the change control procedures and the applicable notification and consent requirements as set forth in the applicable Quality Agreement. Where
applicable, until such Quality Agreement and such change control procedures are agreed, the Specifications of Compound or any relevant Product may be changed with the written consent of both Parties
(not to be unreasonably withheld or delayed), or as required by Regulatory Authorities. 

        6.3.5    Use of Clinical Data Generated by or for Sepracor in the Course of Clinical Development of Additional
Products.    Nycomed, its Affiliates and its permitted Third Party licensees and sub-distributors shall have the right and license to use, free of charge
(except for Nycomed's share of the Clinical Development Costs, to the extent agreed and relevant), all Clinical Development Data (including those generated by or for Sepracor)  (i) during and following
the Term, outside of the Territory, (ii) during the Term, within the Territory
and outside the Field, (iii) following the Term, within the Territory inside and outside the Field and  (iv) during the Term, within the Territory and in
the Field; provided that, in all cases, the exercise of such right shall be restricted by the terms
and conditions of this Agreement. 

        6.3.6    Dispute Resolution.    Disputes regarding the Development and Commercialization of Products shall be settled
in accordance with Article 4, and Sections 20.2 and 20.3. Pending dispute resolution pursuant to Sections 4.5, 20.2 and 20.3, the relevant matter shall be tabled, and, except for
dispute resolution and each Party's rights pursuant to Section 20.5, no action regarding the relevant matter shall be taken. 

Article 7

Intellectual Property  

        7.1    Ownership, Assignment, Prosecution and Maintenance of Ownership Rights.    

        7.1.1    Ownership and Assignment of Ownership Rights.    

        7.1.1.1    Ownership in General.    Except as provided in Section 7.1.1.2 and subject to the licenses and
rights granted pursuant to this Agreement, (i) Nycomed shall own the Nycomed Technology and all Ownership Rights therein,  (ii) Sepracor shall own the
Sepracor Technology and all Ownership Rights therein; (iii) each Party shall
solely own all Improvement Technology that is conceived and reduced to practice exclusively by such Party ("Nycomed's Solely-Owned Improvement
Technology" or "Sepracor's Solely-Owned Improvement Technology", as the case may be) and all Ownership Rights therein, and  (iv) the
Parties shall jointly own all Improvement Technology that is conceived or reduced to practice jointly by the Parties
("Jointly-Owned Improvement Technology") and all Ownership Rights therein in equal shares. 

        7.1.1.2    Ownership to Certain Improvement Technology.    Any and all Improvement Technology of Sepracor (whether or
not jointly owned with Nycomed) that relates exclusively and directly to the Compound and/or any Original Product shall be the sole and exclusive property of Nycomed and shall form part of the Nycomed
Improvement Technology. Sepracor shall receive reasonable compensation 

37

 

from
Nycomed with respect to the use of any such Improvement Technology outside the Field. Sepracor shall assign all of its rights, title and interest in and to any such Improvement Technology to
Nycomed. Upon Nycomed's request and sole expense, Sepracor shall deliver to Nycomed all instruments and other documents and shall take such other actions as may be necessary or reasonably requested by
Nycomed, so that Nycomed may protect and defend its rights in and to such Improvement Technology which relates exclusively and directly to the Compound and/or the Product. For the use of any such
Improvement Technology of Sepracor that relates exclusively and directly to the Compound and/or the Product, Ownership Rights to which have been transferred to Nycomed and which shall be included in
the license grant by Nycomed to Sepracor pursuant to Section 2.1.1, Sepracor shall not owe any additional royalty or other payments to Nycomed and Sepracor shall have an unrestricted,
perpetual, Non-Exclusive, royalty-free and irrevocable right (including the right to sub-license) to practice such Improvement Technology of Sepracor. 

        7.1.1.3    Responsibility for Compensation Related to Improvement Technology.    Each Party shall be exclusively
responsible for any compensation payable to any of its employees, subcontractors and sublicensees in respect of any Improvement Technology. 

        7.1.1.4    Practice of Jointly-Owned Improvement Technology.    For clarity, each of the Parties shall have a
world-wide, unrestricted (except, during the Term, in the Field and in the Territory, restricted by and subject to the terms of this Agreement), perpetual, Non-Exclusive,
royalty-free and irrevocable right (including the right to sub-license) to practice the Jointly-Owned Improvement Technology independently of the other Party. The costs of
acquiring any Third-Party technology necessary to exploit such Jointly-Owned Improvement Technology shall be born by the party seeking to exploit it. 

        7.1.2    Prosecution and Maintenance of Patents.    In relation to the prosecution and maintenance of Patents, the
Parties agree as follows: 

        7.1.2.1    Responsibility of Nycomed in Relation to the Nycomed Technology and Nycomed's Solely-Owned Improvement
Technology.    Nycomed shall, in its sole discretion, prepare, file, prosecute and maintain all Patents covering the Nycomed Technology and Nycomed's Solely-Owned
Improvement Technology always provided, however, that Nycomed shall maintain the Nycomed Core Patents. Should Nycomed elect not to prepare, file, prosecute or maintain any Nycomed Additional Patent,
then Nycomed shall, always provided that Nycomed is not subject to existing and future bona fide obligations towards [**] that
prevent Nycomed from doing so, (i) provide Sepracor with written notice in sufficient time before any statutory bar date to permit Sepracor to prepare,
file, prosecute and maintain such Patent, (ii) give Sepracor the right, at its election and sole expense, to prepare, file, prosecute or maintain such
Patent in Sepracor's name, (iii) offer reasonable assistance to Sepracor in connection with such preparation, filing, prosecution or maintenance at no
charge to Sepracor except for reimbursement of reasonable out-of-pocket expenses incurred in rendering such assistance, and (iv)
assign to Sepracor at Sepracor's cost any such Patent that Sepracor elects to prepare, file, prosecute or maintain in its name pursuant to this Section 7.1.2.1 and use all reasonable efforts to
co-operate with Sepracor in any such transfer. If Nycomed has an existing obligation to [**] that prevents it from carrying out its obligations pursuant
(i)—(iv) above, Nycomed shall use its reasonable efforts to obtain [**] consent to disclose information to Sepracor. 

        7.1.2.2    Responsibility of Sepracor in Relation to Sepracor Technology and Sepracor's Solely-Owned Improvement
Technology.    Always subject to Section 7.1.1.2, Sepracor shall, in its sole discretion, prepare, file, prosecute and maintain all Patents covering the
Sepracor Technology and Sepracor's Solely-Owned Improvement Technology. Should Sepracor elect not to prepare, file, prosecute or maintain any Patent covering the Sepracor Technology including, without
limitation, Sepracor's Solely-Owned Improvement Technology, then Sepracor shall (i) provide Nycomed with written notice in sufficient time before any
statutory bar date to permit Nycomed to prepare, file, prosecute and maintain such Patent, (ii) give Nycomed the right, at its election and sole
expense, to 

38

 

prepare,
file, prosecute or maintain such Patent in Nycomed's name, (iii) offer reasonable assistance to Nycomed in connection with such preparation,
filing, prosecution or maintenance at no charge to Nycomed except for reimbursement of reasonable out-of-pocket expenses incurred in rendering such assistance, and  (iv) assign to Nycomed at Nycomed's
cost any such Patent that Nycomed elects to prepare, file, prosecute or maintain in its name pursuant to this
Section 7.1.2.2 and use all reasonable efforts to co-operate with Nycomed in any such transfer. 

        7.1.2.3    Responsibility in Relation to Jointly-Owned Improvement Technology.    Always subject to
Section 7.1.1.2, Nycomed shall be responsible for the preparation, filing, prosecution and maintenance of all Patents covering Jointly-Owned Improvement Technology. Nycomed shall be deemed to
be the Owning Party of such Patent for the purposes of this Section 7.1.2.3, Section 7.1.2.4 and Section 7.2. Should Nycomed elect not to prepare, file, prosecute or maintain any
Patent covering Jointly-Owned Improvement Technology, then Nycomed shall (i) provide Sepracor with written notice in sufficient
time to permit Sepracor to prepare, file, prosecute and maintain such Patent, (ii) give Sepracor the right, at its election, to prepare, file, prosecute
or maintain such Patent, and (iii) offer reasonable assistance to Sepracor in connection with such preparation, filing, prosecution or maintenance at no
charge to Sepracor. All costs incurred by Nycomed or Sepracor, as the case may be, in carrying out the foregoing responsibilities shall be borne [**], unless otherwise agreed
in writing. 

        7.1.2.4    Coordination of Patent Prosecution and Maintenance.    The Non-Owning Party shall have full
rights of consultation with the Owning Party and the patent counsel selected by the Owning Party in all matters related to the Nycomed Core Patents and the Nycomed Additional Patents in the Territory,
the Sepracor Patents and the Jointly Owned Patents. The Owning Party shall use reasonable efforts to implement all reasonable requests made by the Non-Owning Party with regard to the
preparation, filing, prosecution, maintenance and/or defense of the Nycomed Core Patents in the Territory, the Sepracor Patents and the Jointly-Owned Patents. Nycomed will use its Commercially
Reasonable Efforts to notify Sepracor if it intends to abandon any of the Nycomed Additional Patents. 

39

 

          7.1.2.5    Rights in Assigned Patents.    In case the Owning Party elects not to prepare, file, prosecute and
 maintain
Patents and such Patents are being assigned to the Non-Owning Party in accordance with the provisions of Section 7.1.2, the Party assigning its rights in such Patents shall retain a
world-wide, Non-Exclusive, perpetual, unrestricted, fully-paid up and irrevocable right and license (with the right to sub-license) to practice such
assigned Patents. 

        7.2    Enforcement of Ownership Rights.    The Parties agree as follows on the enforcement of Ownership Rights
regarding Nycomed Technology in the Territory, Sepracor Technology or any Improvement Technology: 

        7.2.1    Reports of Infringement.    Each Party shall promptly report in writing to the other Party during the term of
this Agreement any (i) known infringement or suspected infringement of any Nycomed Core Patents and the Nycomed Additional Patents or Sepracor Patents
or of the Jointly-Owned Patents by the development or commercialization of a Third Party product in the Field, or (ii) unauthorized use or
misappropriation in the Field of any Nycomed Technology, any Sepracor Technology or any Jointly-Owned Improvement Technology by a Third Party of which it becomes aware, and shall provide the other
Party with all available evidence in its possession supporting said claim of infringement, suspected infringement or unauthorized use or misappropriation. 

        7.2.2    Right to Institute Suit.    Subject to Section 7.2.5 and except as provided in Section 7.2.3,
the Party owning or Controlling the relevant Patents or Nycomed or Sepracor Technology (the "Owning Party") shall have the first right to initiate an
infringement or other appropriate suit against any Third Party which at any time has infringed or is suspected of infringing, any Nycomed Patents or, Sepracor Patents as the case may be, or is using
without proper authorization or misappropriating all or any portion of the Nycomed Technology, Sepracor Technology or Jointly-Owned Improvement Technology, as the case may be. 

        7.2.3    Right of the Non-Owning Party to Institute Suit.    The Owning Party shall promptly advise the
other Party (the "Non-Owning Party") of its intent not to initiate an infringement or other appropriate suit related to the enforcement of
the Nycomed Core Patents in the Territory or the Sepracor Patents or any Patents claiming Jointly-Owned Improvement Technology ("Jointly-Owned
Patents"), as the case may be, pursuant to Section 7.2.2. In the event that the Owning Party, and in case of Nycomed as the Owning Party, any contractual partner of
Nycomed permitted to do so, does not initiate an infringement or other appropriate suit related to the enforcement of the Nycomed Core Patents and the Nycomed Additional Patents in the Territory or
the Sepracor Patents or
any Jointly-Owned Patents, as the case may be, pursuant to Section 7.2.2 within a reasonable period of time not exceeding ninety (90) days of becoming aware of a known or suspected
infringement or unauthorized use or misappropriation of the Owning Party's Patents in the Field, then (i) the Non-Owning Party may, always
subject to Section 7.2.5, take such action as is reasonably appropriate to enforce the Owning Party's Patents (in the case of the Nycomed Core Patents or the Sepracor Patents) or to enforce the
Jointly-Owned Patents; provided, however, that Sepracor shall not initiate an infringement or any other suit regarding the [**] without the prior written consent of Nycomed,
such consent not to be unreasonably withheld or delayed, and (ii) the Parties shall follow the procedures set forth in Section 7.2.4. Sepracor
acknowledges that [**] to enforce the [**] Patents, unless otherwise agreed between [**] and Nycomed, and that
[**] to enforce the [**] Patents, and that Nycomed may enforce the [**] Patents only if [**] should fail
to do so within a certain period. 

        7.2.4    Conduct of Suit.    

        7.2.4.1    Conduct of Suit in General.    Subject to Section 7.2.5, a Party who initiates an infringement or
other appropriate suit pursuant to Section 7.2.2 or Section 7.2.3 (the "Initiating Party") shall have the sole and exclusive right to
select counsel for any such suit. The Initiating Party shall, except as provided in Section 7.2.4.1 and 7.2.4.2, below, pay all expenses of the suit, including, without limitation, attorney's
fees and court costs, and keep all damages, settlement fees or other 

40

 

consideration
for past infringement received as a result of such suit. In all cases, (i) the Initiating Party shall keep the other Party (the
"Non-Initiating Party") promptly informed of the status of such suit on an ongoing basis and shall provide the Non-Initiating
Party with copies of all documents filed in, and all written communications relating to, such suit; (ii) the Non-Initiating Party shall
offer reasonable assistance to the Initiating Party in connection with such suit at no charge to the Initiating Party except for reimbursement of reasonable expenses incurred in rendering such
assistance; (iii) if necessary, the Non-Initiating Party shall join as a party to the suit but shall be under no obligation to participate
except to the extent that such participation is legally required and except as provided below, and (iv) the Non-Initiating Party shall have
the right to join such suit, to the extent permitted by law, and be represented in any such suit by its own counsel at its own expense. 

        7.2.4.2    Cost Sharing by Non-Initiating Party.    In case of a suit relating to  (a)
 the Improvement Technology or (b) any Nycomed Patents or Sepracor Patents, the infringement or
misappropriation of which by a Third Party would result in damage to the Non-Initiating Party, the Non-Initiating Party may, within sixty (60) days after its receipt of
written notice from the Initiating Party of the commencement of such suit, elect to contribute up to an amount not to exceed [**] percent ([**]%)
of the costs of such suit, and any damages, settlement fees or other consideration for past infringement received as a result of such suit shall be shared by the Initiating Party and
Non-Initiating Party pro-rata based on their respective sharing of the costs of such suit. The Initiating Party shall not settle any such action or otherwise consent to an
adverse judgment in any such action
that adversely affects the rights or interests of the Non-Initiating Party or imposes additional obligations on the Non-Initiating Party without the prior written consent of
the Non-Initiating Party, such consent not to be unreasonably withheld or delayed. 

        7.2.5    ANDA Litigation.    

        7.2.5.1    Notice of Certification.    With respect to the United States, Nycomed and Sepracor each shall immediately
give written notice to the other of its receipt or knowledge of any certification filed under the "U.S. Drug Price Competition and Patent Term Restoration Act of 1984" claiming that a Nycomed Patent,
a Sepracor Patent or a Jointly-Owned Patent is invalid, unenforceable and/ or that infringement will not arise from the manufacture, use, offer to sell or sale of Product by a Third Party (a  "Patent Challenge
Notice"). 

        7.2.5.2    Exclusive Right to Conduct ANDA-Related Patent Litigation.    Subject to the provisions of
Section 7.2.5.5, in the event of the filing of an ANDA by a Person seeking approval to begin commercialization of a generic version of the Product in the Territory, Nycomed,
[**], respectively, as pioneer Patent owners, shall have the sole right to bring patent infringement suit. 

        Subject
to the provisions of Section 7.2.5.5 and subject to Sepracor's rights under Section 7.2.3, the decision of whether or not to file suit in response to a Patent
Challenge Notice shall be within Nycomed's, [**] sole discretion as further set forth hereinafter. If any such ANDA related patent infringement suit pertains to the
Omnaris® AQ Product, Nycomed [**], as owners of the patents listed in the Orange Book, shall have the sole right to bring patent infringement suit. Subject to the
provisions of Section 7.2.5.5 and subject to Sepracor's rights under Section 7.2.3, the decision of whether or not to file suit shall be within Nycomed's and [**]
sole discretion. If any such ANDA-related patent infringement suit pertains to the Omnaris® HFA Product or the Alvesco® MDI Product, Nycomed
[**], as owners of the patents which are intended to be listed in the Orange Book, shall have the sole right to bring patent infringement suit. Subject to the  provisions of Section 7.2.5.5 and
subject to Sepracor's rights under Section 7.2.3, the decision of whether or not to file suit shall be
within Nycomed's and [**] sole discretion. In all cases referred to above also involving [**], Nycomed shall undertake reasonable efforts to have
[**] to also enforce their respective Patent rights. 

        7.2.5.3    Conduct of Suit by Nycomed.    If Nycomed, [**], as the case may be, bring suit
against the Person having filed the relevant ANDA, Nycomed, [**], as the case may be, shall have the sole and 

41

 

exclusive
right to select counsel for any such suit. Notwithstanding the foregoing, and always subject to bona fide confidentiality obligations towards
[**], Nycomed shall keep Sepracor reasonably informed of the status of such suit on an ongoing basis, shall provide Sepracor with copies of all documents filed in, and all
written communications relating to, such suit, and shall obtain Sepracor's consent to the selection of reputable experienced patent counsel for Nycomed, which consent shall not unreasonably be
withheld or delayed by Sepracor. Sepracor shall offer reasonable assistance (e. g., including, but not limited, to reasonable access to witnesses and
documents) to Nycomed in connection with such suit at no charge to Nycomed except for reimbursement of reasonable expenses incurred in rendering such assistance in accordance with
Section 7.2.5.4 below. In no event shall Nycomed name Sepracor as a co-plaintiff or party to any such lawsuit without the express prior written consent of Sepracor. 

        7.2.5.4    Cost Sharing and Recovery of Damages.    [**]. 

        7.2.5.5    Specific Covenants of Nycomed Regarding ANDA-Related Patent Litigation    

        7.2.5.5.1    Third Party Patent Counsel Assessment.    In the event that a Third Party prepares to or is
manufacturing, importing, using, offering to sell, selling, or seeking approval to begin the commercialization of a generic version of an Original Product in the Territory by filing of an ANDA, then
Nycomed shall, as soon as known to Nycomed and legally and contractually permitted pursuant to Section 7.2.5.5.1(i) and (ii) and always subject to Section 7.2.5.5.1(iii),
[**]. 

        7.2.5.5.2    Liquidated Damages.    If the legal opinion referenced in Section 7.2.5.5.1 is not issued and no
responsive suit for the relevant Nycomed Core Patent is timely filed by or on behalf of Nycomed, Nycomed shall pay to Sepracor as liquidated damages an amount equal to the
[**], always provided that the [**], and (ii) [**], and  (B) [**], (C) always further provided, however, that
no liquidated damages shall
be payable if [**]. 

        7.3    Disputed Patents.    

        7.3.1    Mutual Information.    The Parties shall immediately notify each other  (i)
 of any Patent that may be considered a Disputed Patent or (ii) if a claim or proceedings are
threatened or brought against either Party or its Affiliates alleging that the manufacture, use, offer to sell or sale in the Territory, or the importation into the Territory, of Compound or Product,
or the manufacturing of Compound or a
Product for Sepracor, infringes, induces the infringement of, or contributorily infringes the Patents of a Third Party (each an "Infringement Claim").
Any notice shall set forth the facts of the Infringement Claim as known to such Party providing such notice. 

        7.3.2    Infringement Claims Against Both Parties.    If an Infringement Claim is brought against either or both
Parties or their Affiliates in the Territory, the Parties shall immediately consult on how to further proceed, and the Parties shall proceed as set out in this Section 7.3. 

        7.3.3    Infringement Claims Against One Party.    In the event that an Infringement Claim is brought against one
Party or its Affiliates only in the Territory, the other Party shall (to the extent permitted by law) have the right to join any such proceedings as a Party or otherwise as may be admissible under
applicable procedural laws at its own expense by counsel of its own choice. In any such proceedings brought against one Party or both Parties hereto, the Parties shall render each other all reasonable
assistance in defending any such suit or claim, subject to Section 7.3.4.3 at the assisting Party's expense. 

        7.3.4    Coordination of Defense.    The final decision whether or not and, as the case may be, how to, defend or
settle any Infringement Claim will be determined as follows: 

        7.3.4.1    Defense of Infringement Claim.    The Parties shall first determine whether or not the Infringement Claim
should be defended. If the Parties cannot agree, (a) Nycomed shall be entitled to make the final decision  (i) in case an Infringement Claim is brought
solely against Nycomed, (ii) in cases related to the
[**], if Sepracor is not named as defendant, and (iii) always subject to Nycomed's rights pursuant to Sections 7.3.4.2
and 7.3.4.4; (b) Sepracor shall be entitled to make the final decision 

42

 

 (i) in case an Infringement Claim is brought solely against Sepracor, and (ii) always subject to Sepracor's rights pursuant to
Sections 7.3.4.2 and 7.3.4.4. (c) In case an Infringement Claim is brought against both Parties, the Infringement Claim shall be defended with
the proviso that, if a Party should have elected not to defend such Infringement Claim, the Party electing to defend such Infringement Claim shall bear all out of pocket costs incurred by the Parties
in the preparation of a defense against, and in defending such Infringement Claim (including, without limitation, amounts paid to the Third Party by way of settlement or damages), and shall be
entitled to receive any amounts recovered by way of costs or otherwise. 

        If
infringement claims are asserted against both Parties, each Party shall be entitled to be represented by reputable international patent litigation counsel of its own choice. In all
cases, the Parties shall, based on the advice of their legal counsel, endeavor to agree in good faith on a uniform strategy in defending any such Infringement Claim. 

        7.3.4.2    Determination of Defense Strategy.    With respect to how the defense of any such Infringement Claim shall
be conducted, the Parties shall endeavor to agree on their instructions to counsel, but failing agreement, (a) Nycomed shall be entitled to determine
the defense strategy (i) in case an Infringement Claim is brought solely against Nycomed, (ii) in cases
related to the [**], if Sepracor is not named as defendant; (b) Sepracor shall be entitled to determine the defense strategy  (i) in case an Infringement
Claim is brought solely against Sepracor. 

        The
Parties shall in all cases involving the defense of Infringement Claims (i) closely coordinate the further action to be taken on the
basis of the advice of reputable international patent litigation counsel retained by each or both Parties pursuant to Sections 7.3.3 and 7.3.4.1, and  (ii) jointly instruct reputable international
patent litigation counsel selected by the Parties in good faith to act in the best interests of both
Parties, taking into account their interests under this Agreement, in conducting the defense of any such Infringement Claim, the other Party's right to join any such proceedings by counsel of its own
choice pursuant to Section 7.3.3 notwithstanding. 

        7.3.4.3    Costs of Defending Infringement Claim.    The out of pocket costs incurred by each Party in the preparation
of a defense against, and in defending any such action or proceeding (not including amounts paid to the Third Party by way of settlement or damages), and any amounts recovered by way of costs, shall
be borne and shared, as applicable, by the Parties in equal shares to the extent that any such action or proceeding relates to a Product. Otherwise and to the extent that any such action or proceeding
relates solely to Sepracor Technology incorporated in an Additional Product, the out of pocket costs, the costs incurred by each Party in the preparation of a defense against, and in defending any
such action or proceeding (not including amounts paid to the Third Party by way of settlement or damages), and any amounts recovered by way of costs, shall be borne and kept, as applicable, by
Sepracor in accordance with the principles applying pursuant to Section 6.2.4.1. Subject always to the provisions of Section 7.3.4.2, (i)
neither Party shall settle any action or consent to an adverse judgment if to do so would adversely affect the rights or interests of the other Party or impose additional obligations on the other
Party without the prior written consent of the other Party, such consent not to be unreasonably withheld or delayed; and (ii) neither Party shall settle
any action or proceeding unless such settlement provides a full release for both Parties. 

        7.3.4.4    Settlement of Infringement Claim.    Notwithstanding Section 7.3.4.2, in the event of a disagreement
between the Parties regarding a decision to propose or accept a settlement of an Infringement Claim regarding an Original Product, then each Party shall have the right to propose or accept any
settlement and to conclude a license in respect of such Disputed Patent, and the other Party shall be bound by such license, always provided (i) that
the other Party is afforded a reasonable opportunity to participate in and to influence the negotiation process, (ii) that the cumulative royalties
payable to Third Parties in respect of Net Sales in the relevant Field in the Territory (including any royalties payable in connection with such settlement and fees and royalties payable in connection
with any other settlements or licenses entered into in accordance with this Agreement) shall not exceed in 

43

 

the
aggregate the Third Party Royalty Threshold of [**] percent ([**]%) of Net Sales in the relevant Field and in the Territory,  (iii) and imposes upon the Parties no other obligations other than the
obligation to make payment of royalties to the relevant Third Party and further
provided, and (iv) if any such settlement is proposed or accepted by Sepracor, that such settlement only relates to the Territory and not to any
countries of the ROW. In determining whether the applicable threshold is exceeded, all amounts paid as a lump sum and/or in respect of the period of time before settlement shall be taken into account
by the Parties in a fair and reasonable manner. 

        Notwithstanding
Section 7.3.4.2, to the extent that any such action or proceeding relates solely to Sepracor Technology incorporated in an Additional Product, the principles
applying pursuant Section 6.2.4.1 shall govern. 

        7.4    Third Party Licenses.    In the event that a Party can establish to the reasonable satisfaction of the other
Party, at any time during the Term of this Agreement, that license(s) under any Third Party Disputed Patent is necessary or advisable for purposes of enabling the Parties, to perform the manufacture,
use, offer to sell or sale in the Territory, or importation into the Territory, of Compound, an Original Product or an Additional Product, in the Field, or the manufacturing of Compound or a Product
outside the Territory or exportation into the Territory for Sepracor, the Parties shall reasonably co-operate to obtain such Third Party license for the benefit of both Parties and, where
applicable, for the benefit of Nycomed in the ROW further to the cost allocations and other principles of Section 7.3.4.4. 

        7.5    Updating of Patent Schedules.    To the extent applicable,  Schedule 1.5 and Schedule 1.6 shall be updated on a continuous basis but in no event less
than on an annual basis. 

Article 8

Trademarks  

        8.1    Original Trademarks.    Nycomed has registered the Original Trademarks in the Territory. Sepracor shall use the
Original Trademark "Alvesco" for the Commercialization in the Territory of the Alvesco® MDI Product, and the Original Trademark Omnaris® for the Commercialization in the
Territory of the Omnaris® AQ Product and the Omnaris® HFA Product. 

        8.2    Additional Trademarks.    

        8.2.1    General Principle.    In the event that applicable Legal Requirements should necessitate the use of a
trademark other than any of the Original Trademarks for the Commercialization of an Additional Product, or in the event that a Product is assigned an alternative Trademark pursuant to
Section 8.8.4(c), Nycomed shall, as coordinated at SC level, either (i) designate an additional Trademark owned by Nycomed for use with the
relevant Product, (ii) engage a Third Party US branding institute appointed with the prior written consent of both Parties, to select a suitable
additional Trademark for use with the relevant Product, whereby Nycomed shall bear the costs of the activities of such international branding institute, or  (iii) designate a Trademark proposed by
Sepracor for use with the relevant Product. 

        8.2.2    Ownership of Additional Trademarks.    Each such additional Trademark shall be owned by Nycomed. In the cases
referred to in Section 8.2.1(ii), Nycomed agrees to cause the applicable branding institute to transfer to Nycomed ownership to any such additional Trademark in the Territory. In the cases
referred to in Section 8.2.1(iii), Sepracor shall, Section 8.2.4 notwithstanding, promptly transfer all rights regarding such additional Trademark for the Territory to Nycomed, whereby
Nycomed shall bear the related out-of-pocket costs of Sepracor associated with any such transfer against reasonable documentation. 

        8.2.3    Representations of Nycomed Regarding Additional Trademarks.    Section 8.8.1 notwithstanding, with
respect to each additional Trademark proposed by Nycomed pursuant to 

44

 

Section 8.2.1(i)
or Section 8.2.1(ii), Nycomed shall represent and warrant that, in each case as of the date the designation of such additional Trademark for use with the applicable
Product in the Territory by Sepracor pursuant to this Agreement, (i) Nycomed Controls any such additional Trademark in the Territory;  (ii) Nycomed has the
authority and is entitled to license any such additional Trademark in the Territory; and  (iii) Nycomed's trademark department is not aware of and has, as of the date of such designation by Nycomed,
received no notice alleging that the use of
any such additional Trademark in the Territory by means of the Commercialization of Product infringes, violates or misappropriates the rights of a Third Party in the Territory. 

        8.2.4    Representations of Sepracor Regarding Additional Trademarks.    With respect to each additional Trademark
originally owned by Sepracor and proposed by Nycomed pursuant to Section 8.2.1(iii), Sepracor shall represent and warrant that, as of the date the designation of such additional Trademark for
use with the applicable Product in the Territory by Sepracor pursuant to this Agreement, Sepracor's trademark department is not aware of and has received no notice alleging that the use of any such
additional Trademark in the Territory by means of the Commercialization of Product infringes, violates or misappropriates the rights of a Third Party in the Territory. 

        8.3    Trademark Licenses of Sepracor for Products.    

        8.3.1    General.    Sections 2.1.1.3, 9.2 and 9.3 notwithstanding, all rights not expressly granted in
Trademarks are reserved by Nycomed, and Sepracor acknowledges that nothing in this Agreement shall confer to Sepracor any right, title or interest in the Trademarks other than those conferred to
Sepracor pursuant to Section 2.1.1.3 and this Article 8. 

        8.3.2    Commercialization of Product Exclusively under the Trademarks.    Further and subject to Section, 8.8.4(c),
each Original Product shall be distributed and sold by Sepracor in the Territory only under the Trademark assigned to it pursuant to Section 8.1, and each Additional Product shall be
distributed and sold by Sepracor in the Territory only under the Trademark assigned to it pursuant to Section 8.2.1. 

        8.4    Restricted use of the Trademark.    Sections 9.2.2 and 9.3.2 notwithstanding, Sepracor agrees to use the
Trademarks in the Territory solely in connection with the Product. Further, Sepracor agrees neither to apply for, nor to register, nor to use, any trademark identical with or confusingly similar to
the Trademarks. 

        8.5    Nycomed's Rights in the Trademark.    The entire right, title and interest in the Trademarks in the Territory
shall remain the sole and exclusive property of Nycomed and Sepracor shall make no representations inconsistent with the foregoing. If Sepracor or an Affiliate of Sepracor acquires (by operation of
law or howsoever) any right, title and interest in the Trademarks or a trademark confusingly similar thereto, then Sepracor shall assign or cause such Affiliate of Sepracor to assign such rights to
Nycomed at Nycomed's first request and, at the latest, upon expiry or termination of this Agreement free of charge except transfer fees, as Nycomed may direct. 

        8.6    Maintenance of the Trademark.    Nycomed shall be responsible for the maintaining and defending the Trademarks
in the Territory at its own cost. Nycomed shall use Commercially Reasonable Efforts in obtaining, maintaining, and renewing any registrations for the Trademarks at its sole expense. 

        8.7    Defense of Trademark Against Third Party Infringement.    Sepracor agrees to notify Nycomed in writing of any
known or suspected conflicting use of any Trademark, and the application for registration or use of trademarks confusingly similar thereto, or of any known or suspected infringements or of
unfair competition involving the Trademark in the Territory promptly after it acquires knowledge thereof. Nycomed shall be responsible for the defense of the Trademark and will use Commercially
Reasonable Efforts to defend the Trademark. At the reasonable request of Nycomed, Sepracor shall cooperate with Nycomed and render Nycomed its commercially reasonable assistance in the defense of the
Trademark, subject to reimbursement of the related out of pocket expenses of Sepracor. Any damages and costs recovered shall be for Nycomed's sole benefit. 

45

 

        In
case Nycomed decides not to defend the Trademark within thirty (30) days of Sepracor's written request to do so, Sepracor shall be entitled to do so at its own expense in
cooperation and with the commercially reasonable assistance of Nycomed and, in such case, any damages and costs recovered shall be for Sepracor's sole benefit, subject to reimbursement of the out of
pocket expenses of Nycomed related to Nycomed's assistance. 

        8.8    Representations of Nycomed Regarding Original Trademarks as to Third Party Trademark Claims; Defense against Third Party Infringement
Claims.    

        8.8.1    Representations of Nycomed Regarding Original Trademarks.    Section 8.2.3 notwithstanding, Nycomed
represents that, in each case as of the Effective Date, (i) Nycomed Controls the Original Trademarks in the Territory;  (ii) Nycomed has the authority and
is entitled to license the Original Trademarks in the Territory; and  (iii) as of the Effective Date, to the best of Nycomed's knowledge as defined in Section 13.1.1, Nycomed is not aware of and has
received no
notice alleging that the use of the Original Trademarks in the Territory by means of the Commercialization of Product infringes, violates or misappropriates the rights of a Third Party in the
Territory. 

        8.8.2    Information on Third Party Infringement Claims.    The Parties shall promptly notify each other if a claim or
proceedings are threatened or brought against either Party or its Affiliates alleging that the use of a Trademark in the Territory by means of the Commercialization of Product infringes, violates or
misappropriates the rights of a Third Party in the Territory. 

        8.8.3    Defense against Third Party Trademark Claims.    If a claim or proceedings as described in
Section 8.8.2 should be brought against either Party or both Parties, the Parties shall immediately consult on how to further proceed. The final decision whether or not and, as the case may be,
how to defend or settle such claim or proceedings shall be with Nycomed. In the event that proceedings are brought against Nycomed only, then Sepracor shall have the right to join any such proceedings
as a Party thereto at its own expense by counsel of its own choice. In the event that proceedings are brought against Sepracor only, Sepracor shall have the right to call Nycomed in any such
proceedings as an indemnifying party thereto, and Nycomed agrees to join such proceedings at its own expense by counsel of its own choice. Subject to Section 8.8.4, in any such proceedings
brought against a Party
hereto, the other Party shall render such Party all reasonable assistance in defending any such suit or claim at such Party's expense. Sepracor may settle any such claim or proceedings only with the
prior written consent of Nycomed, such consent not to be unreasonably withheld or delayed. 

        8.8.4    Indemnification by Nycomed.    In the event of a determination by final court decision or under a definitive
settlement by Nycomed pursuant to Section 8.8.3 that the Commercialization of Product in the relevant Field and in the Territory, on account of the use of a Trademark, infringes the trademark
rights of a Third Party in the Territory, then, to the extent that Nycomed has breached any of its representations and warranties pursuant to Section 8.8.1 or Section 8.2.3 and to the
express exclusion of any Trademark originally owned by Sepracor and designated to a Product pursuant to Section 8.2.1(iii), Nycomed shall (a)
indemnify and hold Sepracor harmless against any such Third Party claim or proceeding referred to in Section 8.8.3 above brought against Sepracor including damages and reasonable attorney's
fees; provided, however, that: (i) any obligation to indemnify shall be excluded if Sepracor fails to promptly notify Nycomed of the assertion of any
such claims, to the extent that such failure is prejudicial to Nycomed's interests, and/or (ii) if Sepracor recognizes or settles part of or all of any
such claims without Nycomed's prior written consent; and (b) replace, free of charge, all Products on stock at Sepracor that are no longer saleable on
account of the infringement of a Third Party trademark with Products showing the new trademarks determined pursuant to Section 8.8.4(c). (c)
Regardless of whether or not Nycomed has breached any of its representations and warranties pursuant to Section 8.8.1 or Section 8.2.3, Nycomed shall, as coordinated at SC level, propose
alternative trademarks that shall replace the relevant Trademark pursuant to this Agreement and to which Article 8 (and all other relevant provisions of this Agreement) shall likewise apply; 

46

 

        8.9    Goodwill of Trademark.    Sepracor shall use its Commercially Reasonable Efforts to establish and maintain the
goodwill in the Territory of the Trademarks in the course of performing its obligations under this Agreement. Sepracor agrees that all use of Nycomed's Trademark will inure to the benefit of Nycomed.
Without limitation, to the extent permitted by law, all goodwill deriving from the use of the Trademark pursuant to the terms of this Agreement or otherwise arising out of this Agreement shall accrue
solely and exclusively to Nycomed. 

Article 9

Commercialization  

        9.1    Commercialization in General.    

        9.1.1    Standard of Care and Costs of Commercialization.    Sepracor shall use Commercially Reasonable Efforts to
Commercialize and to maximize the sales of the Original Products and Additional Products in the Territory on its behalf and [**]. 

        9.1.2    Compliance.    Section 12.1 notwithstanding, Sepracor undertakes that package make-up,
package inserts and other elements relating to Packaging as well as of Promotional Materials and claims, and its Commercialization activities, will comply with the Legal Requirements and Regulatory
Approvals applicable in the Territory, and to make marketing claims for the Product only in conformity with the Regulatory Approvals for the Product. 

        9.2    Promotional Materials.    

        9.2.1    Development of Promotional Materials.    

        9.2.1.1    Core Promotional Materials.    Promptly after the Effective Date, Nycomed shall submit to Sepracor samples
of all draft promotional materials existing as of the Effective Date for the then existing Products (the "Core Nycomed Promotional Materials"). Sepracor
shall, create representative samples of advertising, promotional, educational and communication materials it intends to use for marketing, advertising and promotion of the Products (the
"Core Sepracor Promotional Materials"). The Core Sepracor Promotional Materials shallSection 12.1 notwithstanding, be submitted to Nycomed for
Nycomed's prior written approval, which approval shall not be unreasonably withheld or delayed, and which approval shall be deemed to have been given if Nycomed does not raise any written objections
within fifteen (15) Business Days from receipt of such Sepracor Core Promotional Materials. 

        9.2.1.2    Development of Promotional Materials by Sepracor.    Further promotional materials developed by Sepracor
(the "Promotional Materials") shall, to the extent consistent with the Sepracor Core Promotional Materials, shall not require the prior written consent
of Nycomed, always subject to Section 9.2.3. 

        9.2.2    Nycomed Company Trademark.    Except as necessitated by the Legal Requirements and Section 9.3.2
notwithstanding, Sepracor shall not be entitled to, and shall refrain from, using the Nycomed Company Trademark in any manner whatsoever related to Commercializing the Product and shall, without
limitation, refrain from using the Nycomed Company Trademark on or in connection with the use of any promotional materials always provided, however, that, if and when requested by Nycomed and subject
to the Legal Requirements and Section 12.1, Sepracor shall display on any Promotional Materials used in connection with the Product to be sold by Sepracor a legend like
"Manufactured by: Nycomed GmbH, D 78467 Konstanz, Germany" and Nycomed's logo in easily legible, adequately prominent types in the English
language. In the event that Nycomed should request any such marking, Article 8 shall apply accordingly to the Nycomed Company Trademark. 

        9.2.3    Submission of Samples of Promotional Materials.    Section 9.2.1.1 notwithstanding, upon Nycomed's
reasonable request, Sepracor shall submit to Nycomed reasonable quantities of specimens of any Promotional Material used by Sepracor for the Commercialization of Product in the Territory. It is 

47

 

expressly
agreed that Nycomed assumes no obligation to examine compliance of any such promotional Material with relevant Regulatory Approvals and applicable Legal Requirements, and that ensuring
compliance of Promotional Material with relevant Regulatory Approvals and applicable Legal Requirements shall be the exclusive responsibility of Sepracor. 

        9.2.4    Title to and Ownership of Promotional Materials.    Nycomed retains all rights, interest in and to the Core
Nycomed Promotional Materials. Nycomed shall have the right to use, free of charge, during and after the Term and always at its own risk, any promotional concepts and slogans assigned to it by the SC
included in the Core Sepracor Promotional Materials, in Nycomed's own promotional materials always provided, however, that Nycomed shall not be permitted to refer to Sepracor, its company name and
logo including, without limitation, to Sepracor as the originator, in any such promotional materials of Nycomed. 

        9.3    Packaging and Package Inserts.    

        9.3.1    General Principle.    Promptly after Effective Date, the Parties shall come to a common understanding on the
layout of the package make-up, package inserts and other elements relating to Packaging. Sepracor shall submit to Nycomed its proposals for Nycomed's written approval, such approval not to
be unreasonably withheld or delayed. Further, Sepracor shall forward to Nycomed specimens of any packaging material including package inserts and other elements relating to packaging planned in
connection with the Commercialization of Product for Nycomed's prior written approval, such approval not to be unreasonably withheld or delayed. If Nycomed raises no objections within twenty
(20) Business Days after receipt of Sepracor's applicable proposal, Nycomed's approval shall be deemed to have been granted. 

        9.3.2    Nycomed Company Trademark.    Except as necessitated by Legal Requirements and Section 9.2.2
notwithstanding, Sepracor shall not be entitled to, and shall refrain from, using the Nycomed Company Trademark in any manner whatsoever related to performing Development or Commercializing Product
and shall, without limitation, refrain from using the Nycomed Company Trademark on the packaging and package inserts of Product, or on or in connection with the use of any Promotional Material always
provided, however, that, if and when requested by Nycomed and subject to the Legal Requirements in the Territory and Section 12.1, Sepracor shall display on any packaging and pack inserts used
in connection with the Product to be sold by Sepracor a legend like "Manufactured by: Nycomed GmbH, D 78467 Konstanz, Germany" and Nycomed's logo
in easily legible, adequately prominent types in the English language. In the event that Nycomed should request any such marking, Article 8 shall apply accordingly to the Nycomed Company
Trademark. 

        9.3.3    Patent Marking.    Upon either Party's reasonable request, the Parties agree to mark any Product packaging
sold or distributed in the Territory with up to two (2) material and applicable United States patent numbers, in accordance with 35 U.S.C. Section 287 and to respond to any requests for
disclosure under 35 U.S.C. Section 287(b)(4)(b) by notifying Nycomed as the Party Controlling the relevant Patent of the request for disclosure, in easily legible, adequately prominent types in
the English language. 

        9.3.4    Submission of Artwork for Manufacturing by Nycomed.    Following coordination of the final package
make-up and pack insert, Sepracor shall provide Nycomed, at Sepracor's cost and expense, without undue delay with the films for printing and such other data (including, without limitation,
electronic data in suitable format) that Nycomed reasonably requires for the manufacture of Products and the related packaging material. Sepracor's obligations pursuant to Section 12.1
notwithstanding, Sepracor shall be exclusively responsible for, and Nycomed shall not be obliged to examine, the compliance of the artwork so submitted with the agreed layout of the final package
make-up and pack insert, and any failure of such artwork to do so. 

48

 

          9.3.5    Changes of Packaging and Pack Inserts.    Subject to compliance with the change control procedures and
 the
applicable notification and consent requirements as set forth in the applicable Quality Agreement, Sections 9.3.1 to 9.3.4 shall apply accordingly in case of any later changes of packaging and
pack inserts. Until such Quality Agreement and such change control procedures are agreed, the packaging and pack inserts may be changed with the written consent of both Parties (not to be unreasonably
withheld or delayed), or as required by Regulatory Authorities. 

        9.4    Distribution of Product and Promotional Samples in Territory.    

        9.4.1    Distribution of Product in Territory.    Sepracor shall be exclusively responsible for distributing the
Product in the Territory. Sepracor shall have the sole right to (i) receive, accept and fill orders for the Product,  (ii) control invoicing, order
processing and collection of accounts receivable for Product sales, (iii)
record Product sales in its books of account, and (iv) establish and modify the commercial terms and conditions with respect to the sale and
distribution of the Product, including matters such as the price at which the Product will be sold and whether any discounts, rebates or other deductions should be made, paid or allowed, provided that
all discounts, rebates, allowances and price reductions shall be reasonable and customary for sales of pharmaceutical products and not exceed the levels for Sepracor's other products at a similar
stage of their product lifecycle. 

        9.4.2    Distribution of Promotional Samples.    Sepracor agrees that Sepracor and to the extent applicable and
permitted, its sublicensees will use Promotional Samples exclusively for purposes of distribution as samples to physicians or other health care professionals capable of prescribing the Products in the
Territory in accordance with the Legal Requirements and Sepracor's usual sampling practices in the Territory, and for no other purpose, and to reasonably document such use to Nycomed upon Nycomed's
reasonable written request. Without limitation, Sepracor shall use samples in accordance with the then current Marketing Plan and shall distribute samples in compliance with all applicable Laws,
including the requirements of the Prescription Drug Marketing Act of 1987, as amended (the "PDM Act"). 

        9.5    Coordination of Commercialization.    

        9.5.1    Co-Operation in Commercialization.    The Parties agree to closely coordinate the
Commercialization of Product in the Territory through the SC and Subcommittees, if and when applicable, as provided herein. 

        9.5.2    Marketing Plan.    

        9.5.2.1    General.    Reasonably in advance of each Contract Year and, as regards the first Contract Year, without
undue delay following the Effective Date, Sepracor shall have prepared and submitted to Nycomed through its SC members an annual draft marketing plan
for such Contract Year for review and commenting by Nycomed (each, a "Marketing Plan"). Further, Sepracor shall prepare and submit to Nycomed through
its SC members a draft update of the then current Marketing Plan for review and commenting by Nycomed through its SC members whenever material changes (including, without limitation, changes of the
Assumptions referred to in Section 9.6.3) should occur that require an adjustment of the then current Marketing Plan. Sepracor agrees to reasonably consider any comments submitted by Nycomed
through its SC members regarding Sepracor's then current Marketing Plan without limitation, in cases where Commercialization activities of Sepracor in the Territory by or for Nycomed would have an
adverse impact on the commercialization of products incorporating Compound in the ROW. 

        9.5.2.2    Contents of Marketing Plan.    Each Marketing Plan shall define, among other things, the following items:

	(i)
	The
goals and objectives for Commercializing and detailing the Product in the Territory in the pertinent Contract Year. 

49

 

	(ii)
	Market
research and strategy (including market and competitive analysis, sales trends, product positioning and other matters).

	(iii)
	All
advertising and promotion programs and strategies (including, but not limited to, development of materials, media plans, use of symposia, academic speakers,
activation of a key opinion leader cascade, a public relations program, and a direct-to consumer campaign and other matters) and other matters).

	(iv)
	Sales
plans and activities (including Sales Force training, sampling strategy, product detail effort), development of appropriate sales training materials, and program
and budget for Promotional Samples, and Sales Force incentives or compensation programs.

	(v)
	Phase IV
studies to be conducted for the Territory that have been agreed by the Parties pursuant to Section 9.5.3, and a related Phase IV
Development Plan.

	(vi)
	Plans
for addressing significant regulatory issues for existing Indications and forms of the Product and for registration of new Indications and forms of the Product,
if applicable.

	(vii)
	The
projected number of Units of Product to be sold in the Territory to Third Parties in the applicable Contract Year and the expected gross and Net Sales of Product,
with detailed review of gross-to-net assumptions, including, but not limited to, managed care/medicare rebates and similar rebates.

	(viii)
	The
target audiences for Product.

	(ix)
	The
A&P Expenses projected to be expended by Sepracor in the Commercialization of Product for the applicable Contract Year.

	(x)
	The
Marketing Plan shall identify the A&P Expenses, Detailing Expenses and related Marketing Mix projected to be expended and invested in the applicable Contract Year,
and the number of Sales Representatives to be employed in the performance of Primary Details for Product in the applicable Contract Year, the Minimum Marketing Investment Obligations and the Minimum
Sales Obligations consistent with Sepracor's obligations pursuant to Sections 9.1.1 and 9.6 and the related Schedule 9.6.1.1 and  Schedule 9.6.2.1. 

        9.5.3    Phase IV Clinical Studies.    

        9.5.3.1    Phase IV Development.    All proposed Phase IV activity that Sepracor intends to perform in
the Territory (in each case, "Phase IV Development") is to be included by Sepracor in the relevant Development Plan and submitted to the SC. To
the extent legally permitted, Sepracor shall act as sponsor and shall be solely responsible for implementing any Phase IV Development. 

        9.5.3.2    Costs of Implementing Phase IV Study under Phase IV Development Plan.    It is understood
that Sepracor shall, as a general principle and unless otherwise agreed by the Parties, bear all of its internal and external costs of any such Phase IV Development including, without
limitation, the cost of Clinical Supplies required to conduct the Phase IV Development, and that such costs shall not form part of Sepracor's A&P Expenses. 

        9.5.3.5    Support of Phase IV Development by Nycomed.    Nycomed shall supply, at the Clinical Supply Price,
all quantities of the Clinical Samples required for such Phase IV Development, subject to timely notification of Nycomed of Sepracor's requirements at least six (6) months in advance of
the scheduled delivery dates. 

        9.5.3.6    Access to Results of Phase IV Studies.    Subject to applicable data protection legislation, all
results of any Phase IV clinical studies involving the Product that are conducted by Sepracor in the Territory and Controlled by Sepracor shall be made available to Nycomed free of charge in
electronic format, to the extent applicable and required together with suitable data processing software, for 

50

 

unrestricted
use (except, during the Term, in the Field and in the Territory, restricted by and subject to the terms of this Agreement), free of charge, by Nycomed, its Affiliates and its Third Party
licensees and sub-distributors for purposes of the development and Commercialization of the Compound and the Products in any country. 

        9.6    Minimum Obligations.    Sepracor's obligations pursuant to Section 9.1.1 notwithstanding, Sepracor
shall, in each Contract Year covered by the Term, be subject to the Minimum Marketing Investment Obligations and Minimum Sales Obligations (collectively, the "Minimum
Obligations") established for the Original Products pursuant to this Section 9.6. 

        9.6.1    Minimum Marketing Investment Obligations.    

        9.6.1.1    General.    Sepracor's obligations pursuant to the first sentence of Section 9.1.1 notwithstanding,
Sepracor shall invest, and the Marketing Plan shall foresee for each Contract Year, Minimum Marketing Investment Obligations, expressed as minimum A&P investment obligations and minimum Detailing
obligations and a specific marketing mix, corresponding at least to the minimum marketing investments and marketing mix indicated for each applicable Original Product Year in  Schedule 9.6.1.1 (collectively for each Original Product Year and as may be adjusted pursuant to Section 9.6.3, the
"Minimum Marketing Investment Obligations"). The term "Product Year" means, with respect to any Original
Product, each twelve calendar month period commencing on the first day of the calendar month following the month in which the launch date of such Product occurs. 

        9.6.1.2    Shortfall Amount.    In the event that Sepracor should have failed to achieve at least
[**] percent ([**]%) of the Minimum Marketing Investment Obligations required for any Product Year pursuant to Section 9.6.1.1 and  Schedule 9.6.1.1, then Sepracor shall pay to
Nycomed an amount equal to the relevant shortfall, multiplied by a multiplier as set forth below
(the "Shortfall Amount"). 

	Actual Percentage of Minimum Marketing Investment Delivered

in the relevant Product Year
 
	 	Multiplier

	[**]% up to, but not including [**]% of Minimum Marketing Investment Obligations 	 	[**]
	

[**]% up to, but not including [**]% of Minimum Marketing Investment Obligations 	
 	

[**]
	

[**]% up to, but not including [**]% of Minimum Marketing Investment Obligations 	
 	

[**]
	

[**]% up to, but not including [**]% of Minimum Marketing Investment Obligations 	
 	

[**]
	

Below [**]% of Minimum Marketing Investment Obligations 	
 	

[**]

        Such
Shortfall Amount shall be payable within [**] following the end of the Product Year with respect to which the Minimum Marketing Investment Obligations were
not achieved (the "Shortfall Amount Payment Period"), without the requirement of a preceding reminder by Nycomed. In the event that there is a Shortfall
Amount as a result of Sepracor failing to achieve a minimum number of PDEs as set forth on Schedule 9.6.1.1, the Shortfall Amount attributable to
such PDEs shall be calculated in accordance with Schedule 1.2. 

        9.6.1.4    Acknowledgement of Shortfall Amount.    The Parties acknowledge that Sepracor's failure to meet its Minimum
Marketing Investment Obligations may have a material adverse impact on the Commercialization and market potential of Original Products in the Territory, and that damages shall not be readily
ascertainable or determinable in terms of actual money amounts. The Parties therefore further acknowledge and agree that the Shortfall Amount is a fair and equitable determination of such damages and
shall be the sole and exclusive remedy for such failure to meet the Minimum Marketing Investment Obligations, subject only to Section 18.3.1. 

51

 

        9.6.2    Minimum Sales Obligations.    

        9.6.2.1    Minimum Sales Obligations Regarding Original Products.    During the [**] Product
Years commencing immediately after [**], Sepracor shall achieve the minimum sales for the Original Products set forth on  Schedule 9.6.2.1 (collectively, as may be adjusted pursuant to
Section 9.6.3, Sepracor's "Minimum Sales
Obligations"). 

        9.6.2.2    Acknowledgement of Termination Right.    The Parties acknowledge that Nycomed's sole remedy for Sepracor's
failure to meet its Minimum Sales Obligations is set forth in Section 18.3.1, and that the Minimum Sales Obligations are not a guarantee by Sepracor that any specific sales levels will be
obtained with respect to any Product. 

        9.6.3    Adjustment of Minimum Obligations.    

        9.6.3.1    Assumptions Underlying Minimum Obligations.    Sepracor's obligations pursuant to Section 9.1.1
notwithstanding, the Parties acknowledge that the Minimum Obligations of Sepracor set out in Schedule 9.6.1.1 (Minimum Marketing Investment
Obligations) and Schedule 9.6.2.1 (Minimum Sales Obligations) are based, as of the date when these Minimum Obligations have been determined, on
certain assumptions, including those set out in romanettes (i)-(viii) hereinafter (collectively, the  "Assumptions"): (i) The reimbursement price of each
applicable presentation of the Products corresponds
to the reimbursement price applicable or expected as of the date as of which the relevant Minimum Obligations have been determined; (ii) the
reimbursement status of the Products is the same as of the date as of which the relevant Minimum Obligations have been determined; (iii) the patent
protection status of the Products corresponds to the status as of the date as of which the relevant Minimum Obligations have been determined; (iv) no
compulsory rebates have been imposed on any presentation of the Products that have not been accounted for in the then current Minimum Obligations; (v)
no new chemical entity (NCE) has been launched in the Territory and achieved in any Contract Year a market share in value of more than [**] per cent
([**]%) in IMS class R3D in the Territory, (vi) Nycomed or its appointee have continuously supplied in accordance with the terms
and conditions of this Agreement all of Sepracor's requirements of Products ordered by Sepracor in the orderly course of business; (vii) Sepracor's
Minimum Obligations have continued to correspond to at least Commercially Reasonable Efforts as defined in Article 1, and (viii) no other
material and sustained changes related to the Commercialization of the Product in the Territory have occurred in the relevant period from the date of the last fixing of Minimum Obligations that
reasonably require an adjustment of the then current Minimum Obligations. 

        9.6.3.2    Procedure in Case of Change of Assumptions.    If any changes of the Assumptions should have occurred that
are so material and sustained that the Party requesting an adjustment cannot be reasonably expected to adhere to the then current Minimum Obligations agreed prior to the occurrence of the relevant
change or changes, (i) Sepracor's continuing obligation to use Commercially Reasonable Efforts in the Commercialization of Product notwithstanding,
Sepracor's Minimum Obligations shall be suspended (and Nycomed may not terminate this Agreement pursuant to Section 18.3.1 commencing on the date of such change or changes and until revised
Minimum Obligations are established in accordance with Section 9.6.3.3, and (ii) the Parties shall, upon either Party's request, promptly meet
and negotiate in good faith revised Minimum Obligations for the then current Product Year in accordance with the principles set forth in Section 9.6.3.3. 

        9.6.3.3    Adjustment of Minimum Obligations for Change of Assumptions.    If a Party, based on sound and objective
criteria, reasonably demonstrates to the other Party during a Product Year that the then current Minimum Obligations have become inappropriate for relevant changes of any of the Assumptions and should
therefore be adjusted, then such Party, with the written consent of the other Party, such consent not to be unreasonably withheld or delayed, shall be entitled to reasonably modify such then current
Minimum Obligations, thereby giving appropriate consideration to the relevant effects of the applicable changes of the Assumptions the related Minimum Obligations. Such Party shall 

52

 

provide
the proposed revised Minimum Obligations and an accordingly revised Schedule 9.6.1.1 and/or  Schedule 9.6.2.1, as may be applicable,
to the other Party in writing. 

        9.6.3.4    Dispute on Adjustment of Minimum Obligations for Change of Assumptions.    If the Parties cannot agree on a
reasonable adjustment of the then current Minimum Obligations and an according revision of Schedule 9.6.1.1 and/or  Schedule 9.6.2.1
within one (1) month following a related written request by a Party, a reasonable adjustment of the then current Minimum
Obligations and an according
revision of Schedule 9.6.1.1 and/or Schedule 9.6.2.1 shall, upon either Party's written
request, be subject to the dispute resolution procedures set forth in Section 20.2. 

        9.6.4    Obligation to Timely Launch Omnaris® AQ Product and Alvesco® MDI Product.    

        9.6.4.1    Obligation to Timely Launch Omnaris® AQ Product.    Sepracor shall use Commercially Reasonable
Efforts to launch the Omnaris® AQ Product within the first allergy season in the Territory (February until May 2008) after the Effective Date. 

        9.6.4.2    Obligation to Timely Launch Alvesco® MDI Product.    Sepracor shall use Commercially Reasonable
Efforts to launch the Alvesco® MDI Product during [**] of 2008. 

        9.6.4.3    Launch Supplies.    For clarity, the obligations of Sepracor pursuant to Sections 9.6.4.1 and
9.6.4.2 shall be conditioned upon Nycomed supplying to Sepracor, one (1) month prior to the anticipated launch date, reasonably sufficient launch quantities of the Omnaris® AQ
Product and of the Alvesco® MDI Product in accordance with Sepracor's Launch Period Net Requirements Plan submitted to Nycomed pursuant to Section 10.3.2. 

        9.6.5    Monitoring of Compliance with Minimum Obligations; Quarterly Reports on Detailing and Marketing
Investments.    

        9.6.5.1    Monitoring of Compliance with Minimum Marketing Investment Obligations.    

        9.6.5.1.1    Monitoring of Minimum Marketing Investment Obligations Regarding A&P Expenses.    Nycomed may monitor
compliance by Sepracor with its Minimum Marketing Investment Obligations as regards A&P Expenses on the basis of Sepracor's Quarterly A&P Expense Reports pursuant to Section 15.1.1. 

        9.6.5.1.2    Monitoring of Minimum Marketing Investment Obligations Regarding Detailing.    Nycomed may monitor
compliance by Sepracor with its Minimum Marketing Investment Obligations regarding Detailing and Detailing Expenses on the basis of Sepracor's Monthly Detailing Reports pursuant to
Section 15.1.2 and of CAM Global Data Base and/or other reliable Third Party sources if agreed by the Parties in writing. 

        9.6.5.2    Monitoring of Minimum Sales Obligations.    Nycomed shall monitor compliance by Sepracor with its Minimum
Sales Obligations on the basis of Sepracor's Monthly Sales Reports pursuant to Section 15.1.3. 

        9.6.5.3    Audit Rights.    In addition to the foregoing, Nycomed shall be entitled to monitor compliance by Sepracor
with its Minimum Marketing Investment Obligations and Minimum Sales Obligations in the course of audits performed by Nycomed pursuant to Section 15.3. 

        9.6.6    Dispute on Compliance with Minimum Marketing Investment Obligations.    In the event that the Parties
disagree whether Sepracor has accomplished its Minimum Marketing Investment Obligations and/or its Minimum Sales Obligations, the issue shall be referred to the SC for resolution. If the SC is unable
to resolve the matter within thirty (30) days of submission (and there shall not be a casting vote on this matter), then the Parties shall submit the matter to dispute resolution in accordance
with Section 20.2 

53

 
Article 10

Manufacturing and Supply  

        10.1    General Issues of Supply by Nycomed and Sepracor.    

        10.1.1    Manufacturing and Supply of Original Products by Nycomed.    Nycomed or its permitted appointee shall
manufacture and supply exclusively to Sepracor, and Sepracor agrees to purchase exclusively from Nycomed, its requirements of the Original Products in the Territory pursuant to the terms and
conditions of this Agreement. It is understood, however, that the supply obligations of Nycomed regarding Omnaris® HFA Product shall extend to the supply of bulk MDI Canisters only unless
and until Sepracor has successfully completed the Development of the Omnaris® HFA Product on the basis of a nasal actuator as finally agreed by the Parties, who currently anticipate Valois
to be the supplier of the nasal actuator to Nycomed, with Nycomed on its reasonable written request, to be the product finisher, with any changes to be agreed to by the SC. 

        10.1.2    Manufacturing and Supply of Additional Products or Compound by Nycomed or its Appointee.    

        10.1.2.1    Supply of Additional Products by Nycomed or its Appointee.    In the event that Sepracor elects to Develop
and Commercialize an Additional Product, the Parties agree that, upon Nycomed's reasonable written request, Nycomed or its appointee shall use Commercially Reasonable Efforts to exclusively
manufacture, or have manufactured, and supply, or have supplied to Sepracor, and that Sepracor shall exclusively purchase from Nycomed or its permitted appointee, its requirements of the applicable
Additional Product, as the case may be. 

        In
such case, the terms and conditions of the supply of the applicable Additional Product by Nycomed shall, mutatis mutandis and unless
reasonably required otherwise under the circumstances, basically correspond to the terms and conditions set forth in Articles 10 and 11 of this Agreement. 

        10.1.2.2    Supply of Compound by Nycomed.    If the Parties, in the course of the negotiations referred to in
Section 6.2.1.3, should agree that a Person other than Nycomed or an appointee of Nycomed shall manufacture the relevant Additional Product, as the case may be, or in the event that the Parties
should agree (subject to Nycomed Controlling manufacturing rights) that Sepracor or its appointee shall manufacture any Original Product or Additional Product, the Compound required for any such
manufacture shall be supplied by Nycomed or its permitted appointee in accordance with this Agreement. 

        10.1.3    Supply of Additional Products to Nycomed by Sepracor or its Appointee.    In the event that Nycomed should
elect to avail itself of its right pursuant to Section 2.3 with respect to any Additional Product and the Parties have agreed pursuant to Section 6.2.1.4 that the relevant Additional
Product shall be manufactured by Sepracor, then Sepracor agrees to use Commercially Reasonable Efforts to supply exclusively to Nycomed or its permitted appointees, and Nycomed agrees to, and agrees
to cause its permitted appointees to, purchase exclusively from Sepracor, its requirements of such Additional Product for Commercialization by Nycomed in the ROW in accordance with the terms of this
Agreement. The terms and conditions of supply shall be negotiated in good faith always provided that such terms and conditions shall, Section 2.3 notwithstanding,  mutatis mutandis and unless
reasonably required otherwise under the circumstances, basically reciprocate the terms and conditions of the supply of the
applicable Product or Compound by Nycomed to Sepracor. 

        10.2    General Terms of Supply by Nycomed.    

        10.2.1    Capacity Planning and Protection of Manufacturing Investment.    

        10.2.1.1    General.    Nycomed shall base its manufacturing capacity planning on Sepracor's Rough Cut Capacity
Planning pursuant to Section 10.3.1, and shall use its Commercially Reasonable Efforts so 

54

 

as
to set up and maintain, at Nycomed or its suppliers, manufacturing capacities that are reasonably sufficient so as to meet the quantities of Product forecasted to be purchased by Sepracor in its
Rough Cut Capacity Planning. 

        10.2.1.2    Logistically Available Sepracor Capacities.    At the beginning of each Contract Year, the Parties shall
determine, on a Product-by-Product basis, the manufacturing capacities then currently available to Nycomed for the manufacture of the relevant Product, expressed in numbers of
Units of Product per Contract Year (for each Product, the "Logistically Available Overall Capacities") and the percentage of such Logistically Available
Overall Capacities that will, Section 10.2.2.1 notwithstanding, be reserved for supplies to Sepracor (for each applicable Product, expressed in numbers of Units of Product per Contract Year,
the "Logistically Available Sepracor Capacities"), whereby back-up supply sources established pursuant to Section 10.2.5.2(iii) shall
be considered when available. 

        For
any given Contract Year and any specific Product, Nycomed's supply obligations shall, Section 10.2.2.1 notwithstanding, in no event exceed quantities corresponding to the then
currently available Logistically Available Sepracor Capacities as determined at the beginning of such Contract Year, and to use Commercially Reasonable Efforts to supply quantities exceeding such
Logistically Available Sepracor Capacities. 

        10.2.1.3    Failure of Sepracor to Use Logistically Available Sepracor Capacities; Investment Amortization.
    Sepracor acknowledges that, in setting-up, and maintaining and adjusting the Logistically Available Sepracor Capacities, Nycomed relies on Sepracor's Rough Cut Capacity
Planning, related forecasts and order volume estimations. In the event that Nycomed and Sepracor mutually agree that Sepracor's Rough Cut Capacity Planning requires Nycomed to increase the
Logistically Available Sepracor Capacities, and, therefore, the Logistically Available Overall Capacities (such increase in the Logistically Available Overall Capacities is referred to as the
"Increased Capacity"), Sepracor agrees to share in Nycomed's investment to obtain the Increased Capacity as follows: 

        In
the event that Sepracor should, in any given Contract Year, have failed to purchase a portion of the agreed upon Increased Capacity, then Sepracor shall make payment to Nycomed,
within [**] from the end of each relevant Contract Year, of an amount calculated as the product of (i) the number of Units equal
to the difference of (a) the number of Units of Product in the Increased Capacity (such difference is referred to as the "Excess
Increased Capacity") and (b) the numbers of Units of Product actually purchased and paid by Sepracor in such Contract Year from
such Increased Capacity, and (ii) in case of the Omnaris® AQ Product to be 50% of the Actual Manufacturing Cost, in case of the
Omnaris® HFA Product to be 50% of the Actual Manufacturing Cost, and in case of the Alvesco® HFA Product to be [**]% of the Actual Manufacturing Cost,  provided,  however, that in the event Nycomed is able to sell or use all or a portion of the Excess Increased Capacity, Sepracor shall not be required to pay
Nycomed for such Excess Increased Capacity. 

        Notwithstanding
anything above in this Section 10.2.1.3, Sepracor's aggregate payments to Nycomed pursuant to this Section 10.2.1.3 shall not exceed an amount equal to
[**] percent ([**]%) of Nycomed's actual investment in connection with the Increased Capacity. 

        10.2.2    Failure to Supply.    

        10.2.2.1    Allocation of Supply in Supply Shortage Scenarios.    In case of a shortage of supply of Product or
Compound such that Nycomed is unable to supply all of Sepracor's requirements of Product or Compound, as the case may be, the supply of Product or Compound within Nycomed's control shall first be
allocated on a pro rata basis among the Territory, and the Major Market Countries based on (i) in the
case of a shortage of a Product, the net sales of the relevant Product; and, (ii) in the case of a shortage of supply of Compound, the net sales of
Products incorporating the Compound as an active ingredient; in each of (i) and (ii) in those regions in the most recent Contract Year in which there was 

55

 

not
an allocation of supply. Any supply that remains unallocated or comes available after the preceding pro rata allocation shall be allocated on a first priority basis to the Territory. 

        10.2.2.2    General.    In the event that Nycomed shall fail to supply on a timely basis at least
[**] percent ([**]%) of Sepracor's requirements of Product, Promotional Samples and Clinical Samples (if relevant) forecasted and ordered
pursuant to Sections 10.3.1 to 10.3.3 and accepted by Nycomed pursuant to Section 10.3.4, and always provided that (i) the relevant orders
are not outside the scope of orders which Nycomed is obligated to accept in accordance with the provisions of Section 10.3.4 and (ii) such
failure to supply has been caused by the negligence or fault of Nycomed or Nycomed's Third Party suppliers, and is not attributable to a Force Majeure Event (in each case, a
"Supply Failure"), then the following principles shall apply: 

        10.2.2.3    Failure to Supply Exceeding [**] Consecutive Months.    If such failure to supply
continues longer than [**] consecutive months and provided that Sepracor has sold out its existing stock of the respective Product to be held in accordance with
Section 10.2.3, Nycomed shall make payment to Sepracor of liquidated damages amounting to [**] percent ([**]%) of the net invoice value of
the Product, Promotional Samples and Clinical Samples Products subject to the relevant supply failure for each calendar day of any such Supply Failure, commencing with the [**]
Business Day from the delivery date specified in the Sepracor purchase order forecasted and placed pursuant to Sections 10.3.1 to 10.3.3 and accepted by Nycomed in
accordance with Section 10.3.4, and ending with the calendar day in which delivery has been made pursuant to Section 10.3.5, always provided that the entire amount of liquidated damages
for the Supply Failure of any specific quantity of Product, Promotional Samples and Clinical Samples Product shall never exceed [**] percent
([**]%) of the net invoice value of the Product, Promotional Samples and Clinical Samples Products subject to the relevant supply failure. 

        10.2.2.4    Timely Supply.    For purposes of this Section 10.2.2, Product shall be deemed to have been
supplied on a timely basis if such Product is delivered within [**] of the delivery date specified in the Sepracor purchase order forecasted and placed pursuant to
Sections 10.3.1 to 10.3.3 and accepted by Nycomed in accordance with Section 10.3.4. No Supply Failure shall be deemed to have occurred if timely delivery of Product has failed to occur
for reasons not attributable to the fault or negligence of Nycomed or Nycomed's Third Party suppliers including, without limitation, a Force Majeure Event. 

        10.2.2.5    Failure to Supply and Minimum Obligations.    Sepracor shall not be in breach of any obligation to meet
Minimum Obligations to the extent caused by any failure of Nycomed to Supply Product on a timely basis in accordance with this Agreement or a Supply Agreement. 

        10.2.2.6    Exclusive Remedy.    The remedies set forth in Section 10.2.2.3 and Nycomed's obligation to
establish and pre-qualify with the FDA second manufacturing lines for each of the Products as set forth in Section 10.2.5.2(iii) shall be Sepracor's sole remedy in the event Nycomed
fails to meet its supply obligations for other than Nycomed's willful misconduct. 

        10.2.3    Stock-Keeping and Inventory.    Sepracor undertakes to use Commercially Reasonable Efforts to keep at its
distribution facilities an adequate inventory of Product that shall be sufficient for a continuous supply to its customers in the Territory for a period of [**]. The inventory
of Products shall at all times be stored in accordance with the Regulatory Approvals and Nycomed's reasonable handling and storage instructions for the Product to be taken into consideration in the
context of the set-up of the Quality Agreement. Nycomed's audit rights in the Quality Agreement that will be attached hereto as  Schedule 10.2.4 notwithstanding, Nycomed or its appointee,
with a Sepracor representative present at all times, shall, unless required otherwise
under the circumstances, no more frequently than [**], during normal business hours and with reasonable prior notice, be entitled to inspect all of Sepracor's and its permitted
designees distribution facilities where Products are handled and stored, to ascertain proper storage and handling of Product. 

56

 

        10.2.4    Quality Agreement.    

        10.2.4.1    Set-Up of Quality Agreement.    The pharmaceutical responsibilities of the Parties in relation
to the supply by Nycomed or its permitted designee to Sepracor of Products will be agreed upon and will be attached to this Agreement as  Schedule 10.2.4 by the parties with dispatch after
the Effective Date. 

        10.2.4.2    Pharmaceutical Audit Rights of Sepracor.    Sepracor shall be entitled to ascertain in accordance with
this Article 10 that Nycomed is manufacturing and testing Product properly and in accordance with the instructions on manufacture and testing. Nycomed agrees to ensure that Nycomed's suppliers
will be periodically audited by Nycomed in order to (i) keep their cGMP or, where not applicable, other appropriate qualification status current, and  (ii)
maintain compliance with the Product(s)' approved labeling. To the extent permitted to do so pursuant to its agreements with its suppliers, Nycomed
will provide to Sepracor summaries of the audit reports and, when requested by Sepracor and required under the circumstances, the full audit reports, regarding its suppliers to Sepracor in order to
keep Sepracor informed. 

        If
Sepracor should not be satisfied with the provided audit information and upon Sepracor's reasonable written request, Sepracor may audit Nycomed's relevant manufacturing and quality
control facilities, upon reasonable prior notice and during normal business hours, [**], accompanied by Nycomed representatives as may be appointed by Nycomed. Such audit right
shall include the right of Sepracor to audit suppliers of Product, together with representatives of Nycomed and representatives of such suppliers, always provided, however, that any audit rights of
Sepracor regarding suppliers shall be limited by pre-existing bona fide agreements with any such suppliers and/or confidentiality
obligations undertaken by Nycomed towards such suppliers; provided, however, that Nycomed shall use its reasonable efforts to (i) obtain audit rights
for Sepracor under such pre-existing agreements and (ii) obtain, in any future agreements with suppliers, audit rights to the same extent as
to which Nycomed has audit rights. The costs and expenses of Sepracor associated with any such audits shall be borne by [**]. 

        In
case Sepracor should wish to conduct audits more frequently than foreseen pursuant to this Section 10.2.4.2, Sepracor shall promptly [**], unless the
applicable audit has been caused by the failure of Nycomed and/or the relevant supplier to properly manufacture, perform quality control and package Product in accordance with this Article 10. 

        10.2.5    Disruption of Supplies and Protective Strategies.    

        10.2.5.1    General.    The Parties acknowledge that the Compound and the Original Products are manufactured in part
by Nycomed, and in part by various Third Party suppliers, and that any Additional Products may be manufactured by other Third Parties, specifically in view of a possible use of a Third Party delivery
technology. As a consequence, the Parties have agreed with respect to the Alvesco® Supply Agreement, the Omnaris® Supply Agreement and the Compound Supply Agreement, and shall
discuss and agree in good faith with respect to any Additional
Product in a related Supply Agreement, on reasonable strategies protecting Sepracor's interest in an uninterrupted availability of a sufficient supply of each Product and a Product-specific basis in
the context of each relevant Supply Agreement. 

57

 

          10.2.5.2    Eligible Strategies.    As regards any Product, the Parties acknowledge that eligible strategies may
 be,
depending on the applicable Product and its components: 

	(i)
	Nycomed
shall use Commercially Reasonable Efforts to keep reasonably sufficient safety stocks of the key components necessary to produce Product and of Compound kept at
Nycomed or its suppliers, corresponding to at least [**] average requirements of the stock of the key components necessary to produce Product, and no less than
[**] average requirements of the stocks of Compound;

	(ii)
	Sepracor
shall use its Commercially Reasonable Efforts to keep reasonably sufficient safety stocks of Product kept at Sepracor, its logistic agents and its
distributors, corresponding to at least [**] average requirements in accordance with Section 10.2.3;

	(iii)
	As
regards the Omnaris® AQ Product, Nycomed will, promptly following the Effective Date, start the set-up of a back-up
manufacturing line relating to bulk manufacturing steps of the Omnaris® AQ Product. As regards the Alvesco® HFA Product and the Omnaris® HFA Product, Nycomed will,
promptly following the Effective Date, use its reasonable efforts to cause its supplier, [**], to promptly start the set-up of a back-up manufacturing
line relating to bulk manufacturing steps of the Canister forming the main part of the Alvesco® HFA Product and the Omnaris® HFA Product. The related qualification and
submission costs shall be borne by [**]. The pertaining activities shall be subject to the availability of a Rough Cut Capacity Plan by Sepracor; and

	(iv)
	To
the extent that Nycomed Controls manufacturing rights, the grant of a timely limited manufacturing license to Sepracor or its appointee until such time as of which
Nycomed may fully resume supplies. 

        10.3    Forecasting, Ordering, Shipping and Delivery.    With respect to order planning and ordering of Products, the
following principles shall apply: 

        10.3.1    Rough Cut Capacity Planning.    Reasonably prior to and in any event no later than in the month of July of
the first Contract Year and in the month of [**] of all subsequent Contract Years, Sepracor agrees to submit to Nycomed and update its best estimate rough cut capacity planning
of its anticipated requirements of Products for the subsequent [**] period on which Nycomed's manufacturing capacity planning will be based (the "Rough
Cut Capacity Planning" and each, a "Rough Cut Capacity Plan"). The first three (3) years of each such Rough Cut Capacity
Plan shall be subject to Section 10.2.1.3. 

        10.3.2    Rolling [**] Net Requirements Plan.    Promptly following the Effective Date, the
Parties shall agree in good faith and subject to reasonably available production capacities at Nycomed and/or its designee on Sepracor's initial requirements of Units of Product and Promotional
Samples intended to be delivered by Nycomed to Sepracor prior to the Launch Date and during the [**] thereafter, thereby specifying the applicable quantities and relevant
scheduled delivery dates (the "Launch Period", the "Launch Period Net Requirements Plan" and the
"Launch Quantities"). 

        Promptly
following the Effective Date and thereafter within the first [**] of each calendar month and as regards Sepracor's requirements of Units of Product,
Promotional Samples and Clinical Samples, as may be applicable, following the Launch Period, Sepracor undertakes to submit to Nycomed and update its rolling monthly net requirements plan (the
"Rolling Monthly Net Requirements Plan" or "NRP") of its anticipated requirements of Products,
Promotional Samples and Clinical Samples, as may be relevant, for the subsequent [**] period in the format attached to this Agreement as  Schedule 10.3.2. The quantities indicated in the
first [**] of such NRP shall be binding on Sepracor and Nycomed. 

58

 

        10.3.3    Placement of Orders.    As regards Launch Quantities, promptly following the date as of which the Parties
have agreed upon the Launch Period Net Requirements Plan, Sepracor shall place its binding orders for each package size and dosage form of the Product and Promotional Samples, as may be relevant, to
be delivered in accordance with the Launch Period Net Requirements Plan during the Launch Period. 

        For
all quantities of Product and Promotional Samples to be delivered following the Launch Period, Sepracor shall, together with each Rolling Monthly Net Requirements Plan, and starting
no later than [**] prior to expiry of the Launch Period and thereafter within the first
[**] of each calendar month (M), place its binding orders for each package size and dosage form of the Product and Promotional Samples, as may be relevant, to be delivered in
month [**]. Thereby and always subject to Section 10.3.4, Sepracor shall be obliged to order and purchase a quantity of at least
[**] percent ([**]%) of the quantities indicated for the applicable month in its last non-binding Rolling Monthly Net Requirements
Plan for such month (i. e., when such month was [**]), and Nycomed shall be obliged to supply up to
[**] percent ([**]%) of such amount. 

        In
placing orders for Products and Promotional Samples, Sepracor shall explicitly specify whether (i) Sepracor orders Products for
purposes of resale in the Territory, or (ii) whether Sepracor orders Products as Promotional Samples to the extent applicable, in order to enable
Nycomed to invoice Sepracor accordingly. 

        Order
planning and ordering concerning Clinical Samples shall be done by Sepracor [**] each calendar year, based on the requirements set forth in a Clinical
Improvement Development Plan or Phase IV Development Plan and consistent with Sepracor's Rolling Monthly Net Requirements Plan. 

        The
minimum order volume of any orders of Product and Promotional Samples shall be the applicable batch sizes as set out in  Schedule 10.3.3, or multiples thereof. The minimum volume order of any
orders of Clinical Samples shall be mutually agreed upon by the Parties
pursuant to Article 4. 

        10.3.4    Acceptance of Orders and Supply Obligations of Nycomed.    Always subject to Section 10.2.1.2,
Nycomed undertakes use Commercially Reasonable Efforts to accept orders placed by Sepracor for delivery within the Launch Period that comply with the Launch Period Net Requirements Plan agreed
pursuant to Section 10.3.2, and orders for delivery following the Launch Period regarding [**] placed by Sepracor within the time frames set forth in
Section 10.3.3. 

        Nycomed
further agrees to use Commercially Reasonable Efforts to manufacture and supply quantities in excess of the quantities referred to in the preceding paragraph provided that
Nycomed shall be entitled to give due and proportionate consideration to requirements of other customers. 

        10.3.5    Shipping and Delivery.    All shipments of Product including Clinical and Promotional Samples shall be made
at [**] terms related to such other facility within the EU or the US as may be mutually agreed by the Parties. Nycomed shall invoice Sepracor for the Products shipped to
Sepracor in accordance with Article 11 of this Agreement. 

        10.3.6    Stability Testing.    Nycomed agrees to perform the annual stability testing of Product pursuant to the
Quality Agreement attached hereto as Schedule 10.2.4 and as may be agreed between the Parties from time to time, including any testing required
by a Regulatory Authority (the "Stability Testing"). The costs of any Stability Testing shall form part of Nycomed's Manufacturing Cost. 

        For
any additional stability testing specially requested by Sepracor (the "Special Stability Testing"), Sepracor shall compensate Nycomed
an amount of Euro [**] (€ [**]) per hour for all work carried out in respect of Special Stability Testing relating
to the Product. Nycomed shall be entitled to review the hourly rate as of the 1st of January each year, and Nycomed may reasonably increase such hourly rate upon reasonable
justification and in any event by a percentage reflecting at least the applicable rate of inflation and wage increases. Nycomed may invoice for such Special Stability Testing in accordance with 

59

 

Sections 11.3.2
and 11.3.3 as and when it presents the corresponding Special Stability Testing report exhibiting, summarizing and evaluating all applicable data to the Customer (each, an
"Special Stability Testing Report"), and Sepracor shall make payment within [**] of receipt of each Special Stability Testing
Report. 

        10.4    Product Warranty and Deficient Product.    With respect to deficiencies of Products supplied by Nycomed or its
designee to Sepracor for Commercialization by Sepracor in the Territory, the Parties agree as follows: 

        10.4.1    Warranty of Nycomed for Product.    Nycomed represents and warrants to Sepracor as follows: 

	(i)
	Products,
Clinical Samples and Promotional Samples to be delivered to Sepracor hereunder shall, at the time of dispatch by Nycomed pursuant to Section 10.3.5,
have a remaining shelf life of at least [**] percent ([**]%) of the approved shelf life;

	(ii)
	Products,
Clinical Samples and Promotional Samples shall, at the time of dispatch by Nycomed or its appointee pursuant to Section 10.3.5, be free from any
Defects;

	(iii)
	Products,
Clinical Samples and Promotional Samples shall, at the time of delivery by Nycomed pursuant to Section 10.3.5, not be adulterated or misbranded by
Nycomed; and

	(iv)
	Products,
Clinical Samples and Promotional Samples shall be manufactured by or for Nycomed in accordance with all applicable laws, rules and regulations, including
without limitation the then current Good Manufacturing Practices as promulgated by the European Union and the FDA.

	(v)
	For
the purposes of this Section 10.4, the term "Deficient Product" shall mean Products, Promotional Samples and
Clinical Samples not conforming to the warranty assumed by Nycomed pursuant to Section 10.4.1 (i)-(iv), and the terms "Deficiency" or  "Deficient"
shall refer to any deficiency covered by Nycomed's warranty pursuant to Section 10.4.1 (i)-(iv). 

        10.4.2    Inspection and Acceptance.    Sepracor agrees to inspect and confirm incoming shipments of Products and
associated documents, including, but not limited to a compliance certificate and certificate of analysis (the "Product Documentation") as follows: 

        10.4.2.1    Incoming Inspection.    Sepracor agrees to inspect Products and the Product Documentation supplied by
Nycomed for [**] and, as far as reasonably possible, any other [**] within [**] following arrival at Sepracor's warehouse. 

        10.4.2.2    Additional Quality Control Procedures.    Sepracor may perform additional quality control procedures as
may be agreed between the Parties in the Quality Agreement attached hereto as Schedule 10.2.4 or otherwise in writing with respect to Products
supplied by Nycomed in order to check if the Products supplied meet the Product Specifications. 

        10.4.2.3    Notification of Deficiencies. (i)    Sepracor agrees to provide written notice to Nycomed of any
Patent Deficiencies within [**] after arrival at Sepracor's warehouse. (ii) Sepracor shall provide written notice to Nycomed of
any Latent Deficiencies, whether detected in the course of quality control procedures agreed pursuant to Section 10.4.2.2 or otherwise, within [**] of discovery by
Sepracor, provided that, in relation to Latent Deficiencies, any notification of the relevant Latent Deficiency must be made by Sepracor within the shelf life of the allegedly Deficient Products plus
[**]. 

        10.4.2.4    Disagreement on Deficiencies.    Any non-compliance of Products with the Product
Specifications shall be confirmed or rejected by the quality control laboratory of Nycomed or its designee. If Sepracor does not agree to Nycomed's findings, the question of whether or not the
allegedly Deficient Products fail to meet the Product Specifications or are otherwise Deficient shall be submitted to an independent laboratory reasonably agreed by both Parties, for determination.
Such 

60

 

independent
laboratory shall determine the conformity of the Products under evaluation with the Product Specifications in conformity with the Methods of Analysis forming part of the Product
Specifications. The determination of such independent laboratory shall be binding upon the Parties, and the costs of the activities of such laboratory shall be paid by [**]. If
so requested by Sepracor in writing, Nycomed shall use Commercially Reasonable Efforts to effect, as soon as reasonably possible, a replacement delivery of a similar quantity of the allegedly
Deficient Products to Sepracor, free of charge (the "Preliminary Replacement Delivery"). In the event of a determination that the delivery under
evaluation was not Deficient, Sepracor shall make payment to Nycomed of the [**] applicable to such Preliminary Replacement Delivery pursuant to Section 11.3, within
[**] of such determination. 

        10.4.2.5    Acceptance of Shipment.    Failure of Sepracor (i) to
perform the incoming inspection pursuant to Section 10.4.2.1 and to notify Nycomed in the applicable time period specified in Section 10.4.2.3 above of any [**];
or (ii) to perform quality control procedures as may be agreed pursuant to Section 10.4.2.2 and to notify Nycomed within the agreed time periods
in Section 10.4.2.3 above of any Latent Deficiency; or (iii) to notify Nycomed within the applicable time periods specified in
Section 10.4.2.3 above of any Latent Deficiency after its discovery by Sepracor, [**]. 

        10.4.3    Remedies.    Subject to appropriate notification of Nycomed of Deficiencies of Products in accordance with
Section 10.4.2.3 above and a confirmation of any disputed Deficiencies in accordance with Section 10.4.2.4 above, Nycomed shall, at the election of Sepracor  (i) use Commercially Reasonable
Efforts to promptly replace any such Deficient Products with non-Deficient Products or  (ii) credit Sepracor the Supply Price paid by Sepracor for any such Deficient Products, in both cases referred to
in (i) and (ii) only
unless Nycomed has not made a Preliminary Replacement Delivery pursuant to Section 10.4.2.4; in the event that Nycomed has made a Preliminary Replacement Delivery, the Preliminary Replacement
Delivery shall be subject to the terms of this Article 10. In addition, Nycomed shall reimburse additional reasonable out-of-pocket expenses incurred by Sepracor in the
transportation, inspection and disposal of such Deficient Product. Nycomed shall only responsible for the Costs of Nationalization spent by Sepracor for Deficient Product to the extent that a related
credit or reimbursement (including, without limitation, a credit against the Costs of Nationalization of replacement delivery) for Costs of Nationalization of Deficient Product is not available under
the laws of the Territory. 

        10.4.4    Exclusion of Further Remedies.    Subject always to Nycomed's obligations under Section 12.6.4
(Recall Expenses) and Section 14.1.1 (Indemnification by Nycomed) hereof and subject to Section 14.2 (General Limitation of Liability), any warranties or remedies in addition to those
set forth above, whether expressed or implied, in particular claims for damages resulting from Deficient Products including, without limitation, any claims for loss of profit or any compensation for
delayed replacement
delivery of Products not conforming to Nycomed's warranty pursuant to Sections 10.4.1(i)—10.4.1(iv), are expressly excluded. 

        10.4.5    Risk of Expiry of Product, Promotional Samples and Clinical Samples.    Subject to compliance by Nycomed
with shelf life requirements of Products set out in Section 10.4.1, the risk of expiry of Product, Promotional Samples and Clinical Samples supplied to Sepracor shall be borne exclusively by
Sepracor. For clarity, expired Product, Promotional Samples and Clinical Samples shall, for purposes of the first sentence of this Section 10.4.5, be evaluated at the Supply Price actually paid
by Sepracor pursuant to Sections 11.1.1 to 11.1.3. The Parties shall cooperate with each other to obtain the necessary Regulatory Approvals in the Territory to extend the shelf life of the
Products to the maximum extent reasonably possible. 

        10.4.6    Change of Specifications.    Any changes of the Specifications of Compound or any Product shall be subject
to the change control procedures and the applicable notification and consent requirements as set forth in the relevant Quality Agreement. Where applicable, until such Quality Agreement and such change
control procedures are agreed, the Specifications of Compound or any 

61

 

relevant
Product may be changed with the written consent of both Parties (not to be unreasonably withheld or delayed), or as required by Regulatory Authorities. 

Article 11

Financial Terms of Commercialization  

        11.1    Supply Price of Commercial Product, Promotional Samples, Clinical Samples and Compound.    The Supply Price of
each presentation form and dosage of the Product, and the Supply Price for Promotional Samples and Clinical Samples, as may be applicable, and the Supply Price of Compound shall be calculated and
reviewed each Contract Year in accordance with the principles set forth below (in each case, a "Supply Price"). 

        11.1.1    Manufacturing Costs.    The Supply Prices shall be based on [**] of each
presentation form of Product, Promotional Samples and Clinical Samples, and of Compound. 

        11.1.1.1    Base Manufacturing Costs.    Nycomed shall establish its Manufacturing Costs of each presentation form of
Product, Promotional Samples, Clinical Samples and Compound anticipated for the subsequent Contract Year in the fourth (4th) calendar quarter preceding such Contract Year in accordance
with the principles set forth in Schedule 1.4 (the "Base Manufacturing Costs"), and such Base
Manufacturing
Costs shall apply to the calculation of the Base Supply Prices of commercial Product, Promotional Samples, Clinical Samples and Compound for the entire relevant Contract Year unless the relevant
Manufacturing Costs should change by more than [**] percent ([**]%), in which case Nycomed may in cases of increases, and shall in case of
decreases, adjust its applicable Base Manufacturing Costs. Nycomed shall use Commercially Reasonable Efforts to minimize the Base Manufacturing Costs and the Manufacturing Costs. 

        11.1.1.2    Actual Manufacturing Costs.    The actual Manufacturing Costs of Product, Promotional Samples, Clinical
Samples and Compound shall be equal to the actual Manufacturing Cost of Nycomed in Euro of each Unit of Product in the preceding Contract Year as established by Nycomed in accordance with the
principles set forth in Schedule 1.4 (the "Actual Manufacturing Costs"). 

        11.1.2    Supply Price of Commercial Product.    

        11.1.2.1    Base Supply Price and Actual Supply Price of Commercial Product; Reconciliation.    For each Contract
Year, the Parties shall establish a Base Supply Price of Commercial Product in Euro in accordance with Section 11.1.2.2. During such Contract Year, commercial Product shall be supplied at the
Base Supply Price of Commercial Product. At the end of each Contract Year, the Actual Supply Price of Commercial Product shall be calculated and reconciled with the Base Supply Price of Commercial
Product in accordance with Section 11.1.6. 

        11.1.2.2    Base Supply Price of Commercial Product.    The base Supply Price for supplies of each Unit of commercial
Product in any Contract Year shall correspond to the Base Manufacturing Costs of Nycomed of each Unit of commercial Product in Euro plus a base profit margin of
[**] percent ([**]%) of such Base Manufacturing Costs (hereinafter referred to as the "Base Supply Price of Commercial
Product"). 

        11.1.2.3    Actual Supply Price of Commercial Product.    For each Contract Year, the actual Supply Price of
Commercial Product shall be equal to the Actual Manufacturing Cost of Nycomed in Euro of each Unit of Product in the preceding Contract Year plus a base profit margin of
[**] percent ([**]%) of such Actual Manufacturing Costs (hereinafter referred to as the "Actual Supply Price of
Commercial Product"). 

        11.1.3    Supply Price of Promotional Samples.    

        11.1.3.1    Base Supply Price and Actual Supply Price of Promotional Samples; Reconciliation.    For each Contract
Year, the Parties shall establish a Base Supply Price of Promotional Samples in Euro in accordance with Section 11.1.3.2. During such Contract Year, Promotional Samples shall be supplied 

62

 

at
the Base Supply Price of Promotional Samples. At the end of each Contract Year, the Actual Supply Price of Promotional Samples shall be calculated and reconciled with the Base Supply Price of
Promotional Samples in accordance with Section 11.1.6. 

        11.1.3.2    Base Supply Price of Promotional Samples.    The base Supply Price for supplies of each Unit of
Promotional Samples in any Contract Year shall correspond to the Base Manufacturing Costs of Nycomed of each Unit of Promotional Samples in Euro always provided, however, that Nycomed shall be
entitled to charge an additional handling fee of [**] percent ([**]%) of such Base Manufacturing Costs for each relevant Product in relation to
orders of Promotional Samples (i) that are scheduled to be delivered or (ii) that would have been
ordered and delivered in the orderly course of business, after the first anniversary date of the launch of the relevant Product (hereinafter referred to as the "Base Supply
Price of Promotional Samples"). 

        11.1.3.3    Actual Supply Price of Promotional Samples.    For each Contract Year, the actual Supply Price of
Promotional Samples shall be equal to the Actual Manufacturing Costs of Nycomed in Euro of each Unit of Promotional Samples in the preceding Contract Year always provided, however, that Nycomed shall
be entitled to charge an additional handling fee of [**] percent ([**]%) of such Actual Manufacturing Cost for each relevant Product in relation
to orders of Promotional Samples (i) that are scheduled to be delivered or (ii) that would have been
ordered and delivered in the orderly course of business, after the first anniversary date of the launch of the relevant Product (hereinafter referred to as the "Actual Supply
Price of Promotional Samples"). 

        11.1.4    Supply Price of Clinical Samples.    

        11.1.4.1    Base Supply Price and Actual Supply Price of Clinical Samples; Reconciliation.    For each Contract Year,
the Parties shall establish a Base Supply Price of Clinical Samples in Euro in accordance with Section 11.1.4.2. During such Contract Year, Clinical Samples shall be supplied at the Base Supply
Price of Clinical Samples. At the end of each Contract Year, the Actual Supply Price of Clinical Samples shall be calculated and reconciled with the Base Supply Price of Clinical Samples in accordance
with Section 11.1.6. 

        11.1.4.2    Base Supply Price of Clinical Samples.    The Base Supply Price for supplies of each Unit of Clinical
Samples in any Contract Year shall correspond to the Base Manufacturing Costs of Nycomed of each Unit of Clinical Samples in Euro (hereinafter referred to as the "Base Supply
Price of Clinical Samples"). 

        11.1.4.3    Actual Supply Price of Clinical Samples.    For each Contract Year, the actual Supply Price of Clinical
Samples shall be equal to the Actual Manufacturing Costs of Nycomed in Euro of each Unit of Clinical Samples in the preceding Contract Year in Euro (hereinafter referred to as the  "Actual Supply Price of Clinical
Samples"). 

        11.1.5    Supply Price of Compound.    

        11.1.5.1    Base Supply Price and Actual Supply Price of Compound; Reconciliation.    For each applicable Contract
Year, if and when relevant, the Parties shall, establish a Base Supply Price of Compound in Euro in accordance with Section 11.1.5.2. During such Contract Year, Compound shall be supplied at
the Base Supply Price of Compound. At the end of each Contract Year, the Actual Supply Price of Compound shall be calculated and reconciled with the Base Supply Price of Compound in accordance with
Section 11.1.6. 

        11.1.5.2    Base Supply Price of Compound.    The Base Supply Price for supplies of Compound in any Contract Year
shall correspond to the Base Manufacturing Costs of Nycomed of Compound in Euro per kilogram plus a base profit margin of [**] percent ([**]%) of
such Base Manufacturing Costs (hereinafter referred to as the "Base Supply Price of Compound"). 

        11.1.5.3    Actual Supply Price of Compound.    For each Contract Year, the actual Supply Price of Compound shall be
equal to the Actual Manufacturing Cost of Nycomed in Euro per kilogram in the 

63

 

preceding
Contract Year plus a base profit margin of [**] percent ([**]%) of such Actual Manufacturing Costs (hereinafter referred to as the  "Actual Supply Price of Compound"). 

        11.1.6    Contract Yearly Reconciliation.    Within [**] following the end of each Contract
Year, Nycomed shall separately calculate for each presentation form and dosage of Product, Promotional Samples, Clinical Samples on a per Unit basis,
and for Compound on a per kilogram basis, as may be applicable, the product of (i) the applicable Actual Supply Price less the applicable Base Supply
Price, and (ii) the relevant quantity sold for the immediately preceding Contract Year, expressed, in case commercial Product, Promotional Samples and
Clinical Samples, in Units of each presentation form and dosage, and, in case of Compound, in kilogram. If the result of any such calculation pursuant to this Section 11.1.6 is positive,
Sepracor shall pay the resulting amount to Nycomed. If the result of the calculation of this Section 11.1.6 is negative, Nycomed shall pay the resulting amount to Sepracor. 

        11.1.7    Third Party Royalties.    Sepracor shall not be entitled to credit against any Supply Price claims of
Nycomed Nycomed's share of Third Party royalties pursuant to Section 7.4 to the extent such Third Party royalties are not paid directly by Nycomed. 

        11.1.8    Payment Terms, Payment of Base Supply Price of Commercial Product, Promotional Samples, Clinical Samples and Compound, and Reconciliation
Amounts.    All invoices payable in connection with the supply of commercial Product, Promotional Samples, Clinical Samples, Compound or reconciliation amounts
hereunder shall be payable in Euro, or such other currency as may be agreed by the Parties, within [**] from the date of invoice, which shall correspond to the date of
dispatch. If paid in a currency other than Euro as may be agreed by the Parties, then the conversion shall be based on an unweighted average of the daily exchange rates for the applicable Contract
Year, all in a manner consistent with a Party's normal practices used to prepare its audited financial statements for internal and external reporting purposes. 

        11.1.9    Costs of Nationalization.    Sepracor's rights regarding Costs of Nationalization related to Deficient
Product, Sepracor, its Affiliates or permitted sublicensees shall bear the Costs of Nationalization of Product, Promotional Samples and Clinical Samples. The Parties agree to use Commercially
Reasonable Efforts to minimize the Costs of Nationalization of Product, Promotional Samples and Clinical Samples. 

        11.1.10    Retention of Title; Security Interest; Counterclaims.    Title to any Delivery of Products shall remain
with Nycomed until Sepracor has paid the pertaining Supply Price in full, and Sepracor shall, upon Nycomed's request, create an appropriate security interest, provided, however, that Sepracor shall be
entitled to resell Products in the ordinary course of business. Sepracor shall not be entitled to set off any payments due to Nycomed against any counterclaims of Sepracor against Nycomed or exercise
a relating right of retention. 

        11.2    Quarterly Royalty Payment.    

        11.2.1    Quarterly Royalty Payment and Payment Thereof.    Within [**] following the end of
each Contract Quarter and based on Sepracor's Quarterly Payment Reports pursuant to Section 15.1.4, Sepracor shall pay to Nycomed an amount equal to 

	(i)
	[**] percent ([**]%) of Net Sales up to $[**]
($[**]) during any Contract Year;

 
	(ii)
	[**] percent ([**]%) of Net Sales over
$[**] ($[**]) to $[**] ($[**]) during any Contract Year; and

 
	(iii)
	[**] percent ([**]%) of Net Sales over
$[**] ($[**]) during any Contract Year,  

plus an additional amount equal to: 

[**] percent ([**]%)

[**].

64

 

        11.2.3    Third Party Royalties.    Section 11.1.7 notwithstanding, Sepracor shall be entitled to credit
against such Royalty Payments Nycomed's share of Third Party royalties pursuant to Section 7.4 to the extent that such Third Party royalties are not paid directly by Nycomed and have accrued,
are due and payable in the relevant Contract Quarter. 

        11.3    Payment Provisions.    

        11.3.1    Currency.    Unless otherwise expressly provided to the contrary in this Agreement, all payments under this
Agreement shall be made in United States dollars. If and to the extent that there is a sharing and reconciliation of Development Costs incurred by a Party in currencies other than US dollars, any such
costs incurred in a currency other than US dollars will be converted to US dollars, based on an unweighted average of the daily exchange rates for the applicable period, all in a manner consistent
with a Party's normal practices used to prepare its audited financial statements for internal and external reporting purposes. 

        11.3.2    Payment.    All sums due to either Party shall be payable within the time periods specified in this
Agreement, and absent any such specification, within [**] from the date of receipt of invoice, by bank wire transfer in immediately available funds to such bank account as each
of Nycomed and Sepracor shall designate. Nycomed shall notify Sepracor by facsimile transmission (at such number as may be indicated by Sepracor) as to the date and amount of any such wire transfer by
Nycomed one Business Day prior to such transfer. Sepracor shall notify Nycomed by facsimile transmission (at such number as may be indicated by Nycomed) as to the date and amount of any such wire
transfer by Sepracor one Business Day prior to such transfer. Each Party shall bear bank charges arising on its side associated with any such transfer. 

        11.3.3    Late Payments.    In the event that either Party should fail to make timely payment of any amount due and
payable pursuant to this Agreement, interest shall accrue at a rate of interest of [**] percent ([**]%) above the average rate(s) of the London
Inter-Bank Offering Rate ("LIBOR") for U.S. dollars, as quoted on the British Banker's Association's website currently located at
www.bba.org.uk (or such other source as may be mutually agreed by the Parties) from time to time, effective for the applicable days of the period of default provided, that if such failure to pay
continues for more than [**], the applicable rate(s) of interest shall be the applicable monthly average rate(s) of LIBOR plus [**] percent
([**]%) for the entire period of default. The applicable LIBOR period shall be the period closest to the period for which interest is calculated. 

        11.3.4    Settlement of Budgeted Expenses Only.    If and to the extent that there is a sharing and reconciliation of
Development Costs, a Party may submit any such costs for reconciliation and cost sharing only to the extent made or incurred in conjunction with an approved budget line item in a Development Plan as
approved and revised from time to time by the SC in accordance with Article 4. 

        11.4    Taxes and Taxation.    

        11.4.1    Withholding Tax.    Except as expressly set forth in this Agreement, each Party shall be solely responsible
for all taxes payable with respect to any payments or other compensation received by it under this Agreement. In the event that, in the absence of double taxation treaties or similar arrangements, or
under existing Double Taxation Treaties, withholding tax should be levied on any payments to be made by a Party to the other Party under this Agreement, the owing Party (the
"Debtor") shall be entitled to deduct such withholding tax from payments to be made to the Party entitled to any such payment (the
"Creditor") hereunder and pay such withholding tax to the competent tax authorities of the relevant country following prior information of and
coordination with the Creditor. In such case, the Debtor shall procure proper tax receipts, and shall forward these tax receipts to the Creditor in order to enable the Creditor to obtain any available
withholding tax credit. Should any tax exemption for withholding tax purposes then be available under the laws of the relevant country, a double taxation treaty or any similar arrangement in force at
that time, the Debtor shall use Commercially Reasonable Efforts to enable the Creditor to obtain such exemption. 

65

 

        11.4.2    U.S. Withholding Tax Certificates and Other Forms.    

	(i)
	Sepracor
shall, to the extent required by applicable law, withhold from each payment due to Nycomed hereunder U.S. withholding taxes at the appropriate rate and any
amount so withheld shall be treated as paid to Nycomed for all other purposes of this Agreement.

	(ii)
	Nycomed
shall furnish Sepracor on the date of execution of this Agreement and on each date on which Sepracor requests, a properly completed and currently effective IRS
Form W-8BEN (or applicable successor form). Nycomed represents and warrants that such form shall be true and correct in all respects, that it will be the beneficial owner of each
payment to be received by it hereunder and that each such payment will not be effectively connected with the conduct of a trade or business by it within the United States. Sepracor shall inform
Nycomed reasonably in advance whenever Nycomed may be required to issue a new IRS Form W-8BEN (or applicable successor form).

	(iii)
	Nycomed
shall indemnify and hold harmless Sepracor on an after-tax basis for (x) any claim for U.S.
withholding taxes which Sepracor improperly fails to withhold on payments to Nycomed if such failure to withhold is a direct result of the failure by Nycomed to provide an IRS form as required by this
Section 11.4.2 or any false, inaccurate or untrue statement in any such form provided by Nycomed pursuant to this Section 11.4.2 and (y)
any and all liabilities, losses, costs and expenses incurred by Sepracor with respect to any U.S. withholding taxes described in clause (x).

	(iv)
	The
respective rights, obligations, liabilities and agreements of Nycomed and Sepracor in this Section 11.4.2 shall survive the termination of this Agreement and
shall remain in full force and effect until all such obligations have been fully performed and all such liabilities have been paid in full. 

        11.4.3    Value Added Tax, Sales and Excise Taxes for Supply of Goods.    All prices quoted in this Agreement for the
supply of goods are to be considered net of, and not inclusive of, value added taxes, sales taxes, excise taxes and similar taxes. 

        11.4.4    Value Added Tax for Services Rendered.    To the extent that this Agreement covers the rendering of services
and such services and the pertaining compensation are subject to value added tax under the tax laws where such services are rendered, the Party rendering such services shall be entitled to invoice
value added tax on such services to the other Party, unless such other Party demonstrates that, in relation to the services in question, it is subject to value added tax under the tax laws of the
state of such other Party's domicile or place of business. 

        11.4.5    Additional Tax Matters.    Each Party shall be entitled to all tax benefits, including tax credits and/or
tax deductions attributable to amounts that such Party may have funded regarding Technical Development, Clinical Development and Phase IV Development hereunder. Each Party shall file its
federal, state, and local tax returns on a basis consistent with this Agreement. In the event that a Party, in its reasonable judgment, determines that it must obtain information and verification
regarding the use or application of such expenditures in order to prepare its tax returns or to respond to any inquiry during a tax audit or any other inquiry relating to such treatment of its tax
return, or to defend its tax position in any proceeding including litigation, then, to the extent that there is a cost sharing pursuant to this Agreement, the other Party shall reasonably cooperate
with the requesting Party and furnish it with such information as it may reasonably require at the requesting Party's request and expense. 

        11.4.6    Minimization of Exposure to Value Added Tax.    Each Party shall use Commercially Reasonable Efforts in
assisting the other Party in minimizing any applicable value added tax. 

66

 
Article 12

Compliance with Law, Insurance and Product Recall  

        12.1    Compliance with law.    In performing this Agreement, Sepracor undertakes to, and to cause its permitted
designees and permitted sublicensees and subcontractors to, comply, with all applicable Legal Requirements. In performing this Agreement, Nycomed undertakes to, and to cause its permitted designees
and permitted sublicensees and subcontractors to, comply, with Legal Requirements and such other legal requirements as may be applicable in the ROW to Nycomed's activities pursuant to this Agreement
or by operation of law. To the extent that this Agreement requires Nycomed's approval regarding any activity of Sepracor pertaining to the Territory (e.
g., Sections 9.2.3 and 9.3.1 in the context of packaging and Promotional Materials), any such approval shall not relieve Sepracor of its duty of compliance with Legal
Requirements, and regardless of any such approval of Nycomed, Sepracor shall refrain from any of such activities if there are reasonable doubts as to the compliance of such activities with the Legal
Requirements applicable in the Territory, until the matter has been finally clarified by competent counsel or advice by the competent Regulatory Authority. To the extent that this
Agreement requires Sepracor's approval regarding any activity of Nycomed pertaining to a country of the ROW, any such approval shall not relieve Nycomed of its duty of compliance with legal
requirements in the applicable country of the ROW, and regardless of any such approval of Sepracor, Nycomed shall refrain from any of such activities if there are reasonable doubts as to the
compliance of such activities with the legal requirements applicable in the relevant country of the ROW, until the matter has been finally clarified by competent counsel or advice by the competent
Regulatory Authority in such country of the ROW. 

        12.2    Duties to Inform.    The Parties shall, among other things, cooperate to keep each Party informed, commencing
within [**] of notification of any action by, or notification or other information which it receives (directly or indirectly) from a Regulatory Authority, whether in the
Territory or in the ROW, (i) which raises any material concerns regarding the safety or efficacy of any Product or Compound,  (ii) which indicates or
suggests a potential material liability for either Party to Third Parties arising in connection with any Product or Compound, or
(iii) which is reasonably likely to lead to a recall or market withdrawal of any Product or Compound. Subject always to Sections 12.1, 12.3 and
12.4, neither Party shall be obliged to disclose such information in breach of any contractual restriction which it could not reasonably have avoided. 

        12.3    Notification.    Each Party shall without delay notify the other Party of any of the following, including any
corrective actions initiated by such Party and copies of all relevant documentation relating thereto, to the extent Controlled by such Party: 

	(i)
	Governmental
or regulatory inspections of manufacturing, distribution or other related facilities used for any Product or Compound;

	(ii)
	Inquiries
by Regulatory Authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other
related parties) relating to Product;

	(iii)
	Any
communication from Regulatory Authorities pertaining to the manufacture, sale, promotion or distribution of Product or Compound in the Territory and, as regards
Nycomed, any communication from Regulatory Authorities in the ROW received by Nycomed pertaining to material issues regarding the quality and safety of Product or Compound;

	(iv)
	Any
other Regulatory Authority reviews or inquiries relating to Product or Compound in the Territory or investigations of any Product;

	(v)
	Receipt
of a warning letter of any Regulatory Authority relating to Product or Compound; or

	(vi)
	An
initiation by any Regulatory Authority of any investigation, detention, recall, seizure or injunction concerning any Product or Compound. 

67

 

          12.4    Pharmacovigilance.    The Parties undertake to co-operate in the collection, review, assessment,
tracking and filing of information related to Adverse Events and Adverse Drug Reactions associated with the Product and, in the case of Nycomed, other products incorporating the Compound for use in
fields other than the Field, in accordance with US 21 CFR 312.32, 314.80 and the Pharmacovigilance Standard Operating Procedure (SOP) ("Ciclesonide Pre- and Post Marketing Surveillance
Standard Operating Procedures (SOP)") and a Pharmacovigilance Exchange Agreement (PVEA) the definitive terms of which will be agreed by the parties within ninety (90) days of the Effective Date
(and in any event, prior to the sale of any Product) and will be attached as Schedule 12.4 to this Agreement. Without limitation, the Parties
agree to promptly communicate to each other all information that comes to their attention pertaining to Adverse Events and Adverse Drug Reactions or side effects developing in persons who have been
administered the Product. Information regarding serious (as defined in Schedule 12.4) Adverse Events and serious Adverse Drug Reactions (whether
expected or unexpected) of which a Party becomes aware shall be transmitted to the impacted Party without undue delay within the time periods specified in  Schedule 12.4. Nycomed shall be
responsible for maintaining a global safety database for the Product consistent with industry practices, to which
Sepracor shall have access at all times during the Term, except during such limited times that the database is offline for routine maintenance. Sepracor shall be responsible for AE and ADR processing,
expedited, and periodic reporting of AEs and ADRs to the Regulatory Authorities in accordance with all applicable AE regulatory reporting requirements in the Territory, and Nycomed shall be
responsible for such activities in the ROW, both at their cost and expense. Nycomed shall provide summary reports of adverse events at regular intervals consistent with the intervals required under
international reporting requirements for period reporting (U.S. Periodic Reporting requirements and Periodic Safety Reporting requirements in the EU), and at other times, upon reasonable written
request by Sepracor, such summary reports to be set up in accordance with Periodic Safety Reporting requirements in the EU. 

        12.5    Discontinuance of Commercialization.    Subject to Section 12.7, Nycomed and Sepracor, at any time,
shall be entitled to cease, permanently or temporarily, Commercialization of Product in the Territory if continued sale of such Product in such country shall be in violation of any applicable laws or,
with reasonable prior consultation with the other Party, if Nycomed and/or Sepracor, in good faith, believe(s) that it (they) has(ve) an ethically valid, compelling reason based on medical or
scientific concerns relating to the safety of such Product. Nycomed and Sepracor shall have no liability whatsoever to each other if a Regulatory Authority does not grant, or does not maintain or
revokes, Regulatory Approval for any Product based on medical or safety concerns, or if Nycomed and/or Sepracor, in good faith, cease(s) the sale of any Product as provided pursuant to this
Section 12.5. 

        12.6    Product Recall in the Territory.    

        12.6.1    Recall Ordered by Regulatory Authority.    In the event of a recall of Product in the Territory required by
the Regulatory Authority, any such recall shall be administered by Sepracor with Nycomed's reasonable assistance, in a manner which is appropriate and reasonable under the circumstances and in
conformity with any requests or orders of such Regulatory Authority as well as accepted trade practices. 

        12.6.2    Recall of Product for Failure to Meet Product Specifications.    In the event that any batch of Product or
part thereof should fail to meet the Product Specifications, then the Responsible Regulatory Party that is holding the regulatory Approval for the relevant Product in the Territory, in its sole
responsibility and discretion, shall be entitled to make all decisions with respect to any recall, market withdrawals or other corrective action related to such Product in the Territory, with
reasonable prior consultation with the other Party. Prior to making any such recall decision, such Responsible Regulatory Party shall notify the other Party in writing. If any such recall, market
withdrawal or other corrective action could be reasonably foreseen to damage or adversely affect the Product, whether inside or outside the Territory, then the other Party shall have the right to
review, comment upon and, 

68

 

with
the Responsible Regulatory Party's consent (not to be unreasonably withheld or delayed), participate in any such statements to the extent feasible and appropriate under the circumstances;
provided, however, that the Responsible Regulatory Party shall have the final responsibility and sole discretion to implement and execute any such recall, market withdrawal or other corrective action.
For clarity, to the extent that Sepracor should be acting as Nycomed's Regulatory Agent, Nycomed (and not Sepracor as its Regulatory Agent) shall be entitled to make the final decision pursuant to
this Section 12.6.2. 

        12.6.3    Recall of Product in Other Circumstances.    If Nycomed or Sepracor intends to recall Product for reasons
other than a recall ordered by a Regulatory Authority or failure of any Product to comply with the Product Specifications or due to any health or safety problem, the issue shall be discussed and
handled through the SC in accordance with Article 4. 

        12.6.4    Costs Associated with Product Recall.    Sepracor's rights and obligations regarding Compound or Product
pursuant to this Agreement and relevant Supply Agreements notwithstanding, the Recall Expenses associated with any such recall shall be borne by [**] as a result of Nycomed's
or its subcontractor's or Sepracor's breach of their respective obligations or representations or warranties under this Agreement (including an applicable Supply Agreement) and related Quality
Agreement. If neither Party is in breach, Nycomed shall bear [**] percent ([**]%) of Sepracor's Recall Expenses. 

        12.6.5    Batch Tracing.    Sepracor undertakes to use reasonable efforts to establish, and to cause its permitted
designees to use reasonable efforts to establish, within the Territory a batch tracing and recall system that will enable Sepracor or its permitted designees, to the extent reasonably possible, to
identify, as quickly as reasonably possible, customers who have been supplied by Sepracor and its
permitted designees with Products of any particular batch, and to recall such Products from such customers. 

        12.7    Continuing Purchase Obligations of Sepracor in the Event of a Product Withdrawal or a Product Recall; Reimbursement of
Costs.    

        12.7.1    Withdrawal Notice.    The Parties shall immediately notify each other of any discontinuance of sales
pursuant to Section 12.5 or any Product recall pursuant to Section 12.6 hereof (the "Withdrawal Notice"). 

        12.7.2    Cessation of Sepracor's Obligations.    In the event of a withdrawal or recall pursuant to
Section 12.5 or Section 12.6 that is attributable predominantly to the fault of Nycomed or its permitted designees, Sepracor shall be entitled to cancel any orders for Product,
Promotional Samples or Clinical Samples previously placed by Sepracor and any of its permitted designees and Sepracor shall be released from any obligation to order any specified quantity of Product
in any month. 

        12.7.3    Continuation of Sepracor's Obligations.    

        12.7.3.1    Cancellation of Orders.    In the event of a withdrawal or recall pursuant to Section 12.5 or
Section 12.6, Sepracor may cancel any orders for shipments of Product, Promotional Samples and Clinical Samples that have not yet been shipped by Nycomed to Sepracor at the time when any such
Withdrawal Notice is being issued and, pending resolution of the issue of a continuation of supplies and Commercialization, Sepracor shall be released from any obligation to order any specified
quantity of Product in any month. 

        If
the event of a withdrawal or recall pursuant to Section 12.5 or 12.6 that is predominantly attributable to the fault of Sepracor or its permitted appointees, the Withdrawal
Notice shall not affect shipments of Product, Promotional Samples and Clinical Samples that have already been shipped by Nycomed to Sepracor, and all of the provisions of this Agreement shall continue
to apply to such shipments notwithstanding the service of any such Withdrawal Notice. Otherwise, in the event of a withdrawal or recall pursuant to Section 12.5 or 12.6 that is not attributable
to the fault of Sepracor or 

69

 

its
permitted appointees and that implies Deficiencies of Product, Sepracor may exercise its rights pursuant to Section 10.4. 

        12.7.3.2    Completion of Processing and Packaging.    Unless instructed by Sepracor to the contrary, Nycomed shall
complete or cause the completion of the processing and packaging of any Units of
Product, Promotional Samples and Clinical Samples that are in the process of being packaged or processed by Nycomed on the date upon which any Withdrawal Notice is issued, and such Product,
Promotional Samples and Clinical Samples shall be shipped, invoiced and warrantied in accordance with the terms of this Agreement. 

        12.7.3.3    Reimbursement of Cost.    Where Sepracor has instructed Nycomed to cease the processing and packaging of
Product, Promotional Samples or Clinical Samples pursuant to Section 12.7, Sepracor shall not reimburse Nycomed for any costs that Nycomed may have incurred (or to which Nycomed may be
committed) in connection with materials used in the packaging or processing of Product, Promotional Samples or Clinical Samples by Nycomed before any Withdrawal Notice has been issued unless Nycomed
can establish that the withdrawal or recall is not attributable predominantly to the fault of Nycomed or its permitted appointees, under which circumstances Sepracor will pay
[**] percent ([**]%) of such costs. 

        12.8    Withdrawal or Recall of Compound, Products and Products other than Products Incorporating Compound in
ROW.    Nycomed's obligations pursuant to Section 12.3, 12.3 and 12.4 and under laws and regulations applicable in the ROW notwithstanding, nothing in this
Agreement shall restrict Nycomed its Affiliates, licensees and distributors in deciding upon a withdrawal or recall of Compound, Products or products other than Product incorporating Compound (whether
alone or in combination with other active ingredients) in the ROW. 

        12.9    Survival of Obligations.    The provisions of this Article 12 shall survive any expiry or termination
of this Agreement. 

Article 13

Representations and Warranties  

        13.1    Representations and Warranties of Nycomed.    Further to its representations and warranties pursuant to
Section 8.2.3 (Representations of Nycomed Regarding Additional Trademarks) and Section 8.8.1 (Representations of Nycomed Regarding Original Trademarks) and its warranties for Compound or
Product, to the extent supplied by Nycomed, Nycomed represents and warrants to Sepracor that, in each of the cases referred to in Sections 13.1.1 to 13.1.5 below, as of the Effective Date: 

        13.1.1    Intellectual Property.    Section 13.4 notwithstanding, 

	(i)
	Nycomed
has the full right and authority to grant the rights and licenses, including sublicenses, provided herein;

	(ii)
	Nycomed
Controls the Nycomed Patents listed in Schedule 1.6 (subject to the patent listed in 2.8 which shall be
assigned by Sanofi-Aventis to Nycomed after the Effective Date) as of the Effective Date;

	(iii)
	Nycomed
has not previously granted any right, license or interest in or to the Nycomed Technology, or any portion thereof, or the Trademarks, or any confusing similar
trademarks, that is in conflict with the rights or licenses granted to Sepracor under this Agreement;

	(iv)
	To
the best of Nycomed's knowledge, there are no actual or threatened, pending or alleged actions, suits, claims, reexaminations, interference proceedings or
governmental investigations that have been initiated or threatened by a Third Party in the Territory involving the Original 

70

 

Products,
the Compound, the Nycomed Core Patents listed in Schedule 1.6 or the Trademarks by or against Nycomed; 

	(v)
	To
the best of Nycomed's knowledge, there is no actual, pending, alleged or threatened product liability action or intellectual property right litigation in relation to
the Original Products in the Territory;

	(vi)
	To
the best of Nycomed's knowledge, to the extent that Nycomed manufactures and packages the Original Products, Nycomed owns or possesses adequate licenses to
manufacture and package the Products for sale in the Territory; and

	(vii)
	To
the best of Nycomed's knowledge, Nycomed has no actual knowledge of any U.S. patent or trademark which would be infringed by the manufacture, marketing,
distribution, development, use, promotion, offer for sale, or sale of the Original Products in the Territory. 

        For
purposes of Sections 8.8.1, 13.1.1 and 13.1.5, the phrase "To the best of Nycomed's knowledge" means the actual knowledge of
the attorneys in Nycomed's legal department and the members of Nycomed's corporate senior management team as of the Effective Date, after due investigation. 

        13.1.2    Power to Enter into Agreement.    Nycomed has taken all necessary actions on its part to authorize the
execution, delivery and performance of the obligations undertaken in this Agreement. This Agreement has been duly executed and delivered by and on behalf of Nycomed and constitutes legal, valid and
binding obligations enforceable against Nycomed in accordance with its terms. 

        13.1.3    Corporate Standing.    Nycomed is a limited liability company, duly organized, validly existing and in good
standing under the laws of the Federal Republic of Germany, with the power and authority to sign, deliver and perform all of its obligations under this Agreement. 

        13.1.4    Violation of Laws or Contractual Obligations.    The execution, delivery and performance of this Agreement:
 (i) do not, in any material respect, conflict with or violate any applicable statute, law, rule or regulation;  (ii) do not conflict with or violate any
organizational, charter or internal governance document of Nycomed; and  (iii) do not conflict with or constitute a default under any contract, agreement or obligation of Nycomed. 

        13.1.5    Additional Information.    To the best of Nycomed's knowledge, Nycomed has disclosed to Sepracor all
material information known to Nycomed relating to the safety of the Original Products. Based on Nycomed's good faith assessment, Nycomed has provided to Sepracor all material information known to it
relating to the Original Products. 

        13.2    Representations and Warranties of Sepracor.    Further to its representations and warranties pursuant to
Section 8.2.4 (Representations of Sepracor Regarding Additional Trademarks), Sepracor represents and warrants to Nycomed that, in all cases referred to in Sections 13.2.1 to 13.2.5 below
as of the Effective Date: 

        13.2.1    Intellectual Property.    Other than as disclosed in Sepracor's filings with the U.S. Securities and
Exchange Commission: (i) To the best of Sepracor's knowledge, no claims or proceedings have been brought or threatened by a Third Party against Sepracor
challenging ownership of any of the Sepracor Patents in the Territory; and (ii) To the best of Sepracor's knowledge, no claims or proceedings have been
brought or threatened by a Third Party against Sepracor alleging the invalidity, misuse, unregisterability, unenforceability in whole or in part of any of the Sepracor Patents in the Territory. 

        13.2.2    Power to Enter into Agreement.    Sepracor has taken all necessary actions on its part to authorize the
execution, delivery and performance of the obligations undertaken in this Agreement. This
Agreement has been duly executed and delivered by and on behalf of Sepracor and constitutes legal, valid and binding obligations enforceable against Sepracor in accordance with its terms. 

71

 

        13.2.3    Corporate Standing.    Sepracor is a corporation, duly organized, validly existing and in good standing
under the laws of the State of Delaware, United States of America, with the power and authority to sign, deliver and perform all of its obligations under this Agreement. 

        13.2.4    Violation of Laws or Contractual Obligations.    The execution, delivery and performance of this Agreement:
 (i) do not, in any material respect, conflict with or violate any applicable statute, law, rule or regulation;  (ii) do not conflict with or violate any
organizational, charter or internal governance document of Sepracor; and
(iii) do not conflict with or constitute a default under any contract, agreement or obligation of Sepracor. 

        13.2.5    Litigation.    To the best of Sepracor's knowledge, (i)
there is no actual, pending, alleged or threatened product liability action, and (ii) there is no actual, pending, alleged or threatened infringement in
the Territory by a Third Party of any of the Sepracor Technology related to RR-Formoterol in the Territory other than as disclosed in Sepracor's filings with the U.S. Securities and
Exchange Commission. 

        13.2.6    Sepracor's Knowledge.    For purposes of this Section 13.2, the phrase "To
the best of Sepracor's knowledge" means the actual knowledge of the attorneys in Sepracor's legal department and the members of Sepracor's corporate senior management team. 

        13.3    Mutual Warranties and Representations of the Parties.    Each Nycomed and Sepracor further represent and
warrant to each other that with respect to all Regulatory Approvals for the Compound, Promotional Samples and Product in the Field in the Territory (i)
to the best of its knowledge, the data and information in its submissions to the Regulatory Authorities regarding the Compound and Product are and shall be free from fraud;  (ii) to the best of its
knowledge, Regulatory Approvals for the Compound, Promotional Samples and Product have not been and will not be prosecuted by it
either through bribery or the payment of illegal gratuities; and (iii) to the best of its knowledge, Regulatory Approvals for the Compound, Promotional
Samples and Product were obtained and shall be obtained without illegal behavior of any kind by it or its Affiliates. 

        13.4    DISCLAIMER OF WARRANTIES BY NYCOMED.    EXCEPT FOR THE WARRANTIES SET FORTH IN SECTIONS 8.2.3, 8.8.1,
10.4.1, 13.1 AND 13.3 HEREOF AND ANY WARRANTIES GIVEN BY NYCOMED PURSUANT TO A SUPPLY AGREEMENT, NYCOMED HEREBY
DISCLAIMS ANY WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE NYCOMED TECHNOLOGY, THE [**], THE COMPOUND, THE ORIGINAL PRODUCT AND ANY ADDITIONAL PRODUCT, INCLUDING,
WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN PARTICULAR BUT WITHOUT LIMITATION, NYCOMED ASSUMES NO WARRANTIES AND MAKES NO REPRESENTATIONS WHATSOEVER IN
RELATION TO THE VALIDITY AND ENFORCEABILITY OF THE [**]. 

Article 14

Indemnification and Liability  

        14.1    Indemnification    

        14.1.1    Indemnification by Nycomed.    Nycomed hereby agrees to defend Sepracor and its Affiliates and their
respective directors, officers, employees, agents, successors and assigns (collectively, the "Sepracor Indemnified Persons") against any and all legal
claims, suits, demands or actions of a Third Party (collectively, the "Claims") for, and to indemnify and hold the Sepracor Indemnified Persons harmless
from and against any and all losses, damages, costs, penalties, liabilities (including strict liabilities), judgments, amounts paid in settlement, fines and expenses (including court costs and 

72

 

reasonable
fees of attorneys and other professionals) arising out of any Claims (individually and collectively, the "Losses"), for bodily injury,
personal injury, death and property damage caused by: 

        14.1.1.1  In the event and to the extent that Nycomed or its permitted appointee supplies Compound and/or a specific Product,
Defects inherent in Compound, Product, Clinical Samples or Promotional Samples at the time of dispatch by Nycomed or Nycomed's permitted appointee; 

        14.1.1.2  the negligence or willful misconduct or wrongdoing of Nycomed or any Person for whose actions or omissions Nycomed
is legally liable. 

        14.1.1.3  a breach by Nycomed of its representations, warranties and/or covenants hereunder; or 

        14.1.1.4  the development and commercialization of Product by Nycomed and its designees (except Sepracor and its designees) in
the ROW; 

        14.1.1.5    provided, however, Nycomed shall have no liability or obligations pursuant to this Section 14.1.1 to the
extent that such Claims or Losses were caused by: (i) the negligence or willful misconduct or wrongdoing of Sepracor or any Person for whose actions or
omissions Sepracor is legally liable or (ii) any breach by Sepracor of its representations, warranties and/or covenants hereunder. 

        14.1.2    Indemnification by Sepracor.    Sepracor hereby agrees to defend Nycomed and its Affiliates and their
respective directors, officers, employees, agents, successors and assigns (collectively, the "Nycomed Indemnified Persons") against any and all Claims
for, and to indemnify and hold the Nycomed Indemnified Persons, harmless from and against any and all Losses arising out of any and all Claims for bodily injury, personal injury, death and property
damage caused by: 

        14.1.2.1  the Development and Commercialization of Product by Sepracor and its designees in the Territory; 

        14.1.2.2  the negligence or willful misconduct or wrongdoing of Sepracor or any Person for whose actions or omissions Sepracor
is legally liable; or 

        14.1.2.3  a breach by Sepracor of its representations, warranties and/or covenants hereunder; 

        14.1.2.4  provided, however, Sepracor shall have no liability or obligations pursuant to this Section 14.1.2 to the
extent that such Claims or Losses were caused by (i) the negligence or willful misconduct or wrongdoing of Nycomed or any Person for whose actions or
omissions Nycomed is legally liable or (ii) any breach by Nycomed of its representations, warranties and/or covenants hereunder. 

        14.1.3    Indemnification Procedure.    Any Party seeking to be indemnified hereunder (the  "Indemnified Party") shall provide prompt written notice to the other Party (the "Indemnifying Party")
no later than thirty (30) days after becoming aware of any actual Claim in respect of which indemnification may be sought; provided, however, that the failure by the Indemnified Party to
provide such prompt notice to the Indemnifying Party shall only be a bar to recovering Losses to the extent that the Indemnifying Party can demonstrate that it was actually prejudiced and directly
damaged by such failure. In the event of any such actual or threatened Loss or Claim therefor, each Party shall provide the other information and assistance as the other shall reasonably request for
purposes of defense, and each Party shall receive from the other all necessary and reasonable cooperation in such defense, including, but not limited to, the services of employees or agents of the
other Party who are familiar with the transactions or occurrences out of which any such Loss may have arisen. The primary responsibility for defending any such Loss or claim shall be with the
Indemnifying Party; provided, however, that the Indemnified Party shall have the right to participate in and with respect to the defense of any Loss with counsel of its own choosing, whose fees shall
be borne by [**]. The Indemnified Party shall not be entitled to settle any claim or agree to the entry of any judgment or 

73

 

other
relief without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld or delayed. 

        14.2    GENERAL LIMITATION OF LIABILITY.    EXCEPT FOR NYCOMED'S INDEMNIFICATION OBLIGATIONS PURSUANT TO
SECTION 8.8.4 (TRADEMARK INDEMNIFICATION) AND NYCOMED'S OBLIGATIONS TO MAKE PAYMENT OF LIQUIDATED DAMAGES IN ACCORDANCE WITH SECTION 7.2.5.5.2 OR FOR SUPPLY FAILURE IN ACCORDANCE WITH
SECTION 10.2.2.3, EXCEPT FOR NYCOMED'S INDEMNIFICATION OBLIGATIONS PURSUANT TO SECTION 11.4.2(iii), EXCEPT FOR SEPRACOR'S OBLIGATION TO MAKE PAYMENT OF SHORTFALL AMOUNTS PURSUANT TO
SECTION 9.6.1.2, EXCEPT FOR SEPRACOR'S OBLIGATION TO MAKE PAYMENTS DUE TO FAILURE OF SEPRACOR TO USE LOGISTICALLY AVAILABLE SEPRACOR CAPACITIES PURSUANT TO SECTION 10.2.1.3, EXCEPT FOR
EACH PARTY'S INDEMNIFICATION OBLIGATIONS PURSUANT TO SECTION 12.6.4 (RECALL EXPENSES), SECTION 14.1.1 AND 14.1.2, NEITHER PARTY SHALL HAVE ANY LIABILITY TO THE OTHER PARTY OR ITS
AFFILIATES FOR ANY DAMAGES SUCH AS LOSS OF PROFITS, DIRECT, SPECIAL, INDIRECT, CONSEQUENTIAL, EXEMPLARY, PUNITIVE OR INCIDENTAL DAMAGES ARISING OUT OF OR RELATING TO THIS AGREEMENT HOWEVER CAUSED AND
ON ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE), WHETHER OR NOT A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, UNLESS SUCH DAMAGES HAVE BEEN CAUSED, IN CASE OF PERMITTED CONTRACTING
OUT BY WILLFULL MISCONDUCT; OTHERWISE BY THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF THE OTHER PARTY OR ITS AFFILIATES. 

        14.3    Adequate Insurance.    During the Term and for a period of five (5) years after its expiration or
termination, both Parties shall obtain and/or maintain, respectively, at their sole cost and expense, product liability insurance that meets the following requirements:  (i) the insurance shall insure
the respective Party and its Affiliates against all legal liability related to Product (whether a Party's or its
Affiliate's legal liability arises from such Party's or Affiliate's conduct or by virtue of a Party's or its Affiliate's participation in this Agreement), including legal liability for bodily injury,
property damage, wrongful death, and any pertaining contractual indemnity obligations imposed by this Agreement; and  (ii) the insurance shall be in amounts, respectively, that are required by operation
of law and reasonable and customary in the industry. 

        14.4    Survival of Indemnification obligations.    The provisions of this Article 14 shall survive any expiry
or termination of this Agreement. 

Article 15

Reports, Records and Audits  

        15.1    Reporting Duties of Sepracor.    Sepracor undertakes to submit to Nycomed the following reports: 

        15.1.1    Quarterly Reports on Sepracor's A&P Expenses.    Within [**] following the end of
each Contract Quarter, Sepracor shall provide Nycomed with a report setting forth (each, a "Quarterly A&P Expense Report"), 

	(i)
	The
aggregate A&P Expenses spent by Sepracor during such Contract Quarter, by month;

	(ii)
	A
reasonably detailed description of the marketing activities associated therewith and the related A&P Expenses;

	(iii)
	Upon
Nycomed's request, Sepracor shall further reasonably document such data, e. g., by submitting pertaining invoices
of Third Parties; and 

74

 

	(iv)
	Upon
Nycomed's written request, each such report shall be confirmed by Sepracor's auditors. 

        15.1.2    Monthly Reports on Sepracor's Detailing Activities.    Within [**] following the end
of each calendar month, Sepracor shall provide Nycomed with a report setting forth, for the most recently completed calendar month (each, a "Monthly Detailing
Report"), 

	(i)
	The
aggregate number of Calls and Details performed during such calendar month;

	(ii)
	The
position of each Detail performed during such calendar month;

	(iii)
	The
number of Calls and Details, by position for each Detail, performed by Sales Representatives of Sepracor; and

	(iv)
	The
number of Calls and Details, by position for each Detail, performed by Sales Representatives of Affiliates or subcontractors (contract sales forces) of Sepracor,
for each relevant Affiliate and contract sales force. 

        15.1.3    Monthly Sales Reports.    Within [**] following the end of each calendar month,
Sepracor shall provide Nycomed with a report setting forth, for the most recently completed calendar month and for each dosage, application form and pack size of each Product (each, a
"Monthly Sales Report"), 

	(i)
	The
Gross Sales and the Net Sales of Product, subdivided into all major sectors including, without limitation, commercial managed care, Medicaid, chargebacks Medicare
Part D & Cash & non-rebated sales;

	(ii)
	The
number of Units of Product sold;

	(iii)
	The
number of Units of Product distributed as Promotional Samples;

	(iv)
	The
number of Units of Product in inventory at its distribution facilities;

	(v)
	Market
share data and share of voice data (including competitors). 

        15.1.4    Quarterly Payment Reports.    Within [**] following the end of each Contract
Quarter, and based on Sepracor's applicable Monthly Sales Reports, Sepracor shall make quarterly payment reports to Nycomed for the preceding Contract Quarter (each, a
"Quarterly Payment Report"). Each report shall cover the most recently completed Contract Quarter and shall show, based on the Net Sales of Product sold
during the most recently completed Contract Quarter indicated in the applicable Monthly Sales Reports, (i) the Royalty Payment in US dollars, payable by
Sepracor with respect to such Net Sales of Product; and (ii) the method used to calculate the Royalty Payment owed to Nycomed. If no sales of Products
or a specific Product are made during any reporting period, a statement to this effect is required. 

        15.1.5    Further Information.    Further to Section 15.1.3(v), during the Term, Sepracor agrees to promptly
submit to Nycomed, [**], all information regarding the relevant US marketplace that may have a material impact on the implementation of this Agreement, including, without
limitation, any major publications concerning the Product, changes of its reimbursement status, changes affecting the cooperation with wholesalers, changes of Sepracor's discount and rebate policy,
material developments in the cooperation between Sepracor and managed care organizations. 

        15.1.6    Information Submitted by Third Parties.    For any report requiring information from a Third Party, the time
for a Party to report shall be no less than [**]. 

75

 

          15.2    General Record-Keeping Obligations.    Each Party shall keep, and cause its applicable Affiliates and
permitted designees to keep, at its and its applicable Affiliates' respective main place of business, full, true and accurate books and records and reasonable supporting documentation which may be
necessary for the purpose of determining each Party's financial rights, and for the purpose of determining compliance of each Party its financial and other obligations towards the other Party
hereunder. Such books and records shall be kept in accordance with applicable laws and regulations and generally accepted accounting principles consistently applied by the recording Party across its
entire pharmaceutical business and for as long as required by the laws and regulations applying to the relevant Party and in sufficient detail in order to enable the other Party to accurately
determine any sums payable hereunder, and so as to accurately determine compliance by the recording Party with its obligations pursuant to this Agreement. 

        15.3    Audits.    

        15.3.1    General.    Each Party may exercise audit rights in accordance with this Section 15.3. 

        15.3.2    Audit Right of Each Party.    Each Party entitled to or required to make payments hereunder (the
"Auditing Party") shall have the right, during normal business hours and upon reasonable prior notice, to have an independent, reputable international
auditing firm of its choice reasonably acceptable to the other Party (PWC and KPMG are accepted by both Parties) (the "Auditor") to inspect such books
records and pertaining documentation of the other Party (the "Audited Party") to the extent reasonably necessary in order to determine, and to determine
compliance with, payment or other obligations of the Audited Party towards the Auditing Party hereunder. Such audits shall occur at the Audited Party's, and its applicable Affiliate's, places of
business where such records are to be kept and shall take place during regular business hours during the Term of this Agreement and for a period of [**] years following its
termination or such longer period as may be required by law; provided, however, that any such audit shall not take place more often than [**] per year and shall not cover
records and supporting documentation for more than the preceding [**] years. Subject to the execution by such Auditor of a reasonable standard form confidentiality undertaking
prepared by such Auditor pursuant to which such Auditor shall be permitted to disclose his findings to the Auditing Party for the purposes of enforcing any claims of the Auditing Party against the
Audited Party resulting from such Audit, such Auditor shall have the right to examine the such books records and pertaining documentation of the Audited Party kept pursuant to this Agreement and
report to the Auditing Party the findings (but not the underlying data) of said examination of records as are necessary to evidence that the records were or were not maintained and used in accordance
with this Agreement, and as to evidence and determine any resulting payment obligations pursuant to this Agreement. A copy of any report provided to the Auditing Party by such Auditor shall be
submitted concurrently to the Audited Party. 

        15.3.3    Results and Costs of Audit.    The results of each such audit, if any, shall be binding on both Parties. The
Auditing Party shall pay for any such audit, except that in the event that, as a result of any such audit, the Audited Party is finally required to make an adjustment payment of sums payable to the
Auditing Party during the period of time subject to such inspection, of more than [**] percent ([**]%), then the Audited Party shall reimburse
the Auditing Party for its out-of-pocket costs incurred in connection with conducting any such audit. Any resulting payments shall be made by the Audited Party within
[**] of receiving such audit report. 

        15.3.4    Delay of Audit.    The Audited Party shall not unreasonably delay an audit that the Auditing Party is
entitled to perform in accordance with Section 15.3.2. The Audited Party shall be deemed to unreasonably delay an audit if it fails to permit the Auditing Party to conduct any such audit within
[**] from the Auditing Party's pertaining first written request. 

76

 
Article 16

Confidentiality, Publications  

        16.1    Confidential Information.    For the purposes of this Agreement, the term  "Confidential
Information" shall mean any and all information of a Party hereto that may be exchanged between the Parties at any time and from time to
time before and during the Term in relation to the subject matter covered by this Agreement. Confidential Information as defined herein shall, without limitation, be deemed to include all notes,
analyses, compilations, studies, interpretations or other documents, whether in tangible form or on electronic or other data storage media, prepared by the receiving Party and its Representatives as
defined hereinafter, which contain, reflect or are based on, in whole or in part, Confidential Information furnished to the receiving Party or its Representatives by the disclosing Party or its
Representatives hereunder. Results pertaining to the Development of Compound or Product shall be deemed to constitute Confidential Information disclosed by Nycomed. 

        16.2    Duties of Confidentiality and Non-Use.    During the Term, and for a period of
[**] years thereafter, each Party hereto will maintain in confidence all Confidential Information disclosed to it as a "receiving" Party by the other Party as a "disclosing"
Party. The receiving Party shall use, disclose or grant use of such other Party's Confidential Information except as permitted under this Agreement. To the extent that disclosure is authorized by this
Agreement, the receiving Party shall obtain prior written agreement from its employees, agents, consultants, Affiliates, subcontractors and sublicensees (collectively, the
"Representatives") to whom disclosure is to be made to hold in confidence and not make use of such information for any purpose other than those
permitted by this Agreement, unless such Representatives are already bound by law or contract to obligations of confidentiality and non-use no less stringent than those assumed by the
receiving Party hereunder. Each receiving Party shall use at least the same standard of care as it uses to protect its own Confidential Information to ensure that such Representatives do not disclose
or make any unauthorized use of such Confidential Information of the disclosing Party. Each receiving Party shall promptly notify the other disclosing Party upon discovery of any unauthorized use or
disclosure of Confidential Information by the receiving Party or any of its Representatives. Confidential Information shall not include any information which: 

        16.2.1  was already known to the receiving Party, other than under an obligation of confidentiality to the disclosing Party,
at the time of disclosure by the disclosing Party; 

        16.2.2  was generally available to the public or otherwise part of the public domain at the time of its disclosure to the
receiving Party; 

        16.2.3    becomes generally available to the public or otherwise part of the public domain after its disclosure and other than
through any act or omission of the receiving Party in breach of this Agreement; 

        16.2.4  was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no
obligation to the disclosing Party not to disclose such information; or 

        16.2.5  was independently developed by the receiving Party without reference to the disclosure by the disclosing Party. 

        16.3    Compulsory Disclosure.    If a receiving or any of a receiving Party's Representatives are requested or become
legally compelled (by oral questions, interrogatories, requests for information or documents, subpoena, civil or criminal investigative demand, or similar process) or is required by a regulatory body
to make any disclosure that is prohibited or otherwise constrained pursuant to this Article 16, the receiving Party will, and will cause such of its Representatives to, as the case may be,
provide the disclosing Party with prompt written notice of such request so that the disclosing Party may seek an appropriate protective order or other appropriate remedy. Subject to the foregoing, the
receiving Party may, and may cause such Representatives to, furnish that portion (and only that 

77

 

portion)
of the Confidential Information that, in the written opinion of its counsel reasonably acceptable to the disclosing Party, the receiving Party is legally compelled or is otherwise required to
disclose or else stand liable for contempt or suffer other material censure or material penalty; provided, however, that the receiving Party must, and must cause its Representatives to, use reasonable
efforts to obtain reliable assurance that confidential treatment will be accorded any Confidential Information so disclosed. 

        16.4    Terms Confidential.    The Parties agree that the terms of this Agreement shall be considered the Confidential
Information of both Parties and shall not be disclosed by either Party except pursuant to Section 16.2 or Section 16.6 except (i) as
required by applicable law or (ii) to a Third Party with whom Nycomed or Sepracor, as applicable, has entered into or proposes to enter into a business
relationship related to the subject matter hereof or (iii) to a Third Party with whom Nycomed or Sepracor is in due diligence relating to a merger or an
acquisition or a financing, and provided that such Third Parties are subject to appropriate confidentiality agreements providing for obligations of confidentiality and non-use at least as
stringent as those pursuant to this Article 16. 

        16.5    Duties of Confidentiality and Non-Use in Relation to the Confidential Information of
3M.    Sepracor's obligations of confidentiality and non-use shall further include obligations corresponding to those of Nycomed
[**]. 

        16.6    Permitted Disclosure.    Each Party and its Representatives may disclose Confidential Information to the
extent such disclosure is reasonably necessary for the purpose of the implementation of this Agreement, including without limitation, for purposes of the filing or prosecuting of patent applications,
prosecuting or defending litigation, or complying with any applicable statute or governmental regulation. 

        16.7    Public Announcements.    Except as set forth in Section 16.8 and in Section 23.12, neither Party
shall originate any publicity, news release or public announcements relating to this Agreement (including, without limitation, its existence, its subject matter, the Parties' performance, any
amendment hereto or performances hereunder), whether to the public or press, stockholders or otherwise, without the prior written consent of the other Party, save only such announcements that are
required by law or the rules of any relevant stock exchange to be made or that are otherwise agreed to by the Parties. If a Party decides to make an announcement, whether required by law or otherwise,
it shall give the other Party reasonable advance notice, of the text of the announcement so that the other Party shall have an
opportunity to comment upon the announcement. To the extent that the receiving Party reasonably requests the deletion of any information in any such announcement, the disclosing Party shall delete
such information unless, in the opinion of the disclosing Party's legal counsel, such Confidential Information is required by law or the rules of any relevant stock exchange to be fully disclosed. 

        16.8    Publications.    Whenever reasonably requested by Nycomed through the SC, Sepracor shall submit to Nycomed all
written abstracts, articles, letters, reviews and the like intended for publication in scientific, medical, pharmaceutical industry and healthcare-related journals, periodicals, books, websites and
the like or presentations at symposia or the like, in each case relating to the Development or Commercialization of the Compound or any Product, for Nycomed's prior written approval that shall not be
unreasonably withheld or delayed. Nycomed will respond within [**] of receipt of such a pertaining request from Sepracor. In the event that Nycomed does not raise any
objections within such period, the Sepracor shall be free to make the intended publication subject, however, to Sepracor's obligations of confidentiality and non-use under this Agreement. 

        Neither
Party shall issue any publications regarding any Jointly-Owned Improvement Technology that may have a priority-creating effect prejudicing a Party's efforts to obtain Patent
protection for any such Jointly-Owned Improvement Technology. 

78

 

        Notwithstanding
anything else in this Agreement, Sepracor shall in no way be limited or restricted from making any required safety reporting of any information, however sourced, to any
Regulatory Authority or as otherwise required by law or regulation and upon any relevant timelines set by any Regulatory Authority, law or regulation. 

        Neither
Party shall use the name of the other Party in any publicity or advertising without the prior written consent of the other Party. 

Article 17

Competition  

        17.1    Exports.    To the extent legally permitted, each Party undertakes, and shall cause its Affiliates, not to
export, distribute nor sell Products, whether directly or indirectly, outside the Territory with respect to Sepracor, or into the Territory with respect to Nycomed. 

        17.2    Non-Compete Obligations.    

        17.2.1    Reciprocal Non-Compete Obligations.    During the Term, neither Party nor its Affiliates, shall,
either alone or in collaboration with a Third Party, engage in any activity directed to the development or commercialization of Competing Products in the Territory. For the purposes of this Agreement,
the term "Competing Product" means any [**], in the Field. 

        17.2.2    Additional Non-Compete Obligations of Sepracor.    During the Term, neither Sepracor nor its
Affiliates, shall, either alone or in collaboration with a Third Party, engage in any activity directed to the commercialization of Sepracor Competing Products in the Territory. For the purposes of
this Agreement, the term "Sepracor Competing Product" means any [**]. 

        17.3    Activities Related to Competing Products and Sepracor Competing Products before Termination or
Expiration.    Each Party shall, however, be entitled to develop Competing Products, and Sepracor shall be entitled to develop Sepracor Competing Products, within a
reasonable time period prior to the end of the Term in order to obtain Regulatory Approval for any such Competing Product or Sepracor Competing Product, as the case may be, in a timely fashion, and to
take all such other steps as may be reasonably required so as to be able to commence Commercialization of Competing Product or Sepracor Competing Product without delay following the Term, and each
Party releases the respective other Party from its undertakings of confidentiality and non-use pursuant to Article 6 of this Agreement in order to achieve such purpose. 

        17.4    Commercialization Rights of Nycomed in ROW.    For clarity, nothing in this Agreement shall restrict or
prevent Nycomed from commercializing in the ROW Compound or products incorporating Compound, whether alone or in combination with one or several additional active ingredients, within or outside the
Field. 

Article 18

Term and Termination  

        18.1    Term.    If not terminated by either Party pursuant to Section 18.2 to 18.4, this Agreement shall
become effective on the Effective Date and shall continue in effect until fifteen (15) Contract Years from the last Launch Date of any Original Product or Improved Product (the
"Term"). 

        18.2    Either Party's Right to Terminate for Cause.    Each Party my terminate this Agreement for cause in any of the
following events and subject to the following terms and conditions. 

        18.2.1    Termination for Material Breach.    Without prejudice to any remedy or claim it may have against the other
Party for material breach or non-performance of this Agreement, each Party shall 

79

 

have
the right to terminate this Agreement for cause in the event that the other Party fails to materially comply with or perform any material provision of this Agreement (in each case, a  "Breach") in
accordance with the following provisions: 

        18.2.1.1    Reminder.    The non-breaching Party shall notify the breaching Party of any such Breach in
writing, specifying such Breach in reasonable detail and stating that it believes such Breach constitutes grounds for termination under Section 18.2.1 of this Agreement (the  "Reminder").

        18.2.1.2    Remedy Plan and Remedy Period.    The Party receiving the Reminder shall have [**]
from its receipt of the Reminder in which to prepare and deliver to the other Party a written response to the Reminder that shall (i) provide in
reasonable detail a commercially reasonable plan for curing the alleged Breach set forth in the Reminder (the "Remedy Plan") and  (ii) set forth a time
period within which the Remedy Plan shall be complete and such alleged Breach shall be cured (the "Remedy
Period"). 

        18.2.1.3    Acceptance of Remedy Plan and Obligation to Cure.    In the event that the Party sending the Reminder
believes that the Remedy Plan is sufficient to cure the alleged Breach, then such other Party shall cure such alleged Breach in accordance with such Remedy Plan and the related time frame. 

        18.2.1.4    Failure to Accept Remedy Plan and Termination for Failure to Perform Remedy Plan.    In the event that the
Party sending the Reminder believes (i) that the Remedy Plan is insufficient to cure the alleged Breach or  (ii) that the Breaching Party fails to properly
perform under an accepted Remedy Plan and cure in all material respects the Breach within the time frame
set forth in an accepted Remedy Plan, then the Party sending the reminder may provide written notice to the Party receiving the Reminder that it rejects  (y) the Remedy Plan or (z) performance thereunder, as may be applicable, and the reasons therefor in
reasonable detail (the "Rejection Notice"). A Rejection Notice shall constitute a written notice of a Dispute under Section 20.2. The Party
giving Rejection Notice may,
together with such Rejection Notice, give a written notice of termination of this Agreement (a "Termination Notice"). 

        18.2.1.5    Effectiveness of Notice of Termination Following Dispute Resolution Under Section 20.3.    A
Termination Notice shall be effective thirty (30) Business Days after final dispute resolution pursuant to Section 20.2 or, if the issue has not been resolved by dispute resolution
pursuant to Section 20.2, by arbitration proceedings pursuant to Section 20.3, provided that such proceedings have not been resolved in favor of the Breaching Party or otherwise resulted
in a final conclusion that the terminating Party is not entitled to terminate this Agreement for the reasons set forth in the Termination Notice. 

        18.2.1.6    Injunctive Relief.    For clarity, each Party's rights pursuant to Section 20.5 shall remain
unaffected. 

        18.2.2    Termination for Reasons of Insolvency or Termination of Business Activities.    Always subject to compulsory
insolvency legislation applying to the impacted Party under the laws of the state of its incorporation, each Party may terminate this Agreement in its entirety upon written notice to the other  (i) if
the other Party files in any court or agency under any statute or regulation of any state or country, a petition in bankruptcy or insolvency or
for reorganization or for the appointment of a receiver or trustee of the other Party or of its assets, or (ii) if the other Party proposes a written
agreement of composition or extension of its debts, or (iii) if the other Party is served with an involuntary petition against it, filed in any
insolvency proceeding, and the petition is not stayed or dismissed within sixty (60) Business Days after the filing thereof, or (iv) if the other
Party is a party to any dissolution or liquidation, or (v) if the other Party discontinues its business activities completely or with respect to its
business activities which are the subject matter of this Agreement, or (vi) if the other Party makes an assignment for the benefit of creditors (each,
an "Insolvency Event"). Such termination right may be exercised within three (3) months following the date as of which the Party entitled to
terminate receives knowledge of the Insolvency Event affecting the other Party, by giving such other 

80

 

Party
written notice. The Party affected by an Insolvency Event or a petition against it filed in any bankruptcy, insolvency or similar proceeding shall promptly communicate to the other party in
writing that such Insolvency Event has occurred or that such petition has been filed. 

        18.2.3    Termination for Severe Safety Reasons.    In the event (i)
that there is a discontinuance of Commercialization of Product in the Territory in accordance with Section 12.5, or (ii) a recall of Product in
the Territory ordered by a Regulatory Authority in accordance with Section 12.6.1, then the Parties shall reasonably cooperate in good faith to consider the continued viability of this
Agreement and discuss in good faith what, if any, modification of the terms of this Agreement may be required, including without limitation immediate termination of this Agreement, in order to arrive
at an equitable resolution. In the event that the Parties are unable to agree on the appropriate course of conduct within 30 Business Days of the date of such discontinuance or recall, then either
Party shall be entitled to immediately send a Rejection Notice under Section 18.2.1.4, in which case the Parties shall follow the procedures set forth in Section 18.2.1.5,
Section 20.2 and Section 20.3. 

        18.3    Termination for Cause by Nycomed.    Further to and Section 18.2 notwithstanding, Nycomed may terminate
this Agreement for cause in any of the following events and subject to the following conditions: 

        18.3.1    Termination for Failure by Sepracor to Comply with Minimum Obligations.    In the event that, after the
second Product Year following the Launch Date for the Alvesco MDI Product, Sepracor (i) fails to achieve at least [**]% of the
Minimum Marketing Investment Obligations for any Product Year, (ii) fails to pay to Nycomed the Shortfall Amount arising from such failure achieve
[**]% of such Minimum Marketing Investment Obligations, and (iii) fails to achieve to achieve the Minimum Sales Obligations for
any two consecutive Product Year period including the Product Year for which [**]% of the Minimum Marketing Investment Obligations was not achieved, then Nycomed may terminate
this Agreement by giving Sepracor a Termination Notice within ninety (90) Business Days of end of the last Product Year in which Sepracor failed to achieve [**]% of the
Minimum Obligations giving rise to Nycomed's right of termination, in which case the Parties shall follow the procedures set forth in Section 18.2.1.5, Section 20.2 and
Section 20.3. For clarity, Nycomed's right to claim payment of Shortfall Amounts shall remain unaffected. 

        18.3.2    Termination for Change of Control or Acquisition Affecting Sepracor.    

        18.3.2.1    General Principle.    Nycomed may terminate this Agreement  (i) if Sepracor undergoes a Change of Control, or (ii) if Sepracor or an Affiliate of Sepracor acquires
a Third Party ("Sepracor Acquisition"), and (iii) if any such Change of Control affecting Sepracor or
any such Sepracor Acquisition has a Nycomed Material Adverse Impact. 

        18.3.2.2    Material Adverse Impact in Case of Sepracor Acquisition.    For purposes of this Section 18.3.2, a
Change of Control affecting Sepracor or a Sepracor Acquisition shall be considered to have a material adverse impact on the business interests of Nycomed ("Nycomed Material
Adverse Impact") if the relevant Third Party is marketing in the Territory (i) any Competing Product(s) or  (ii) any Sepracor
Competing Product, at the time any such Change of Control affecting Sepracor or Sepracor Acquisition becomes effective, the continuing
obligations of the Person resulting from any such Change of Control affecting Sepracor or Sepracor Acquisition pursuant to Article 17 (without limitation, Section 17.2.1 and
Section 17.2.2) of this Agreement and Nycomed's related rights in case of an infringement of such obligations notwithstanding. 

        18.3.2.3    Notice.    Sepracor shall inform Nycomed without undue delay  (i) to the extent legally and contractually permitted, if a reasonable probability of any Change of Control or Sepracor Acquisition has arisen, and  (ii) of the execution and the date of execution of
a transaction resulting in a Change of Control affecting Sepracor or a Sepracor Acquisition
simultaneously with any public disclosure of such event by Sepracor, and (iii) of the effective date of any such Change of Control 

81

 

affecting
Sepracor or any such Sepracor Acquisition (in each of the cases referred to in Section 18.3.2.3(iii), a "Sepracor Merger Notice")
always provided that such Sepracor Merger Notice must be given on or following the date on which any such Change of Control affecting Sepracor any such or Sepracor Acquisition has become effective. If
a Change of Control affecting Sepracor or a Sepracor Acquisition occurs and has a Nycomed Material Adverse Impact, then Nycomed may exercise its termination right under this Section 18.3.2
within the ninety (90) Business Day period following receipt of the Sepracor Merger Notice, by giving Sepracor six (6) months prior written notice (such notice period hereinafter being
referred to as the "Phase-Out Period"). 

        18.3.2.4    Right of Sepracor to Avert Termination by Nycomed.    In the event of a Change of Control affecting
Sepracor or a Sepracor Acquisition and following the related Sepracor Merger Notice pursuant to Section 18.3.2.3(iii), Sepracor may avert termination by Nycomed, if prior to the expiry of the
Phase-Out Period, Sepracor divests itself or definitively and permanently ceases the commercialization of all Competing Product(s) and Sepracor Competing Products(s), in which case any
termination by Nycomed for reasons of the applicable Sepracor Acquisition shall retroactively be deemed to be ineffective, and this Agreement shall continue to remain in full force and effect in
accordance with its terms. In the event that Sepracor disputes Nycomed's right to terminate this Agreement under this Section or Nycomed disputes Sepracor's right to avert such termination, then
either Party may send a Rejection Notice to the other Party in accordance with 18.2.1.4. If such a Rejection Notice is delivered, then the Parties shall follow the procedures set forth in
Sections 18.2.1.5, Section 20.2 and Section 20.3. 

        18.3.3    Challenge of Licensed Patents.    Nycomed may terminate this Agreement by giving Sepracor ninety
(90) Business Days prior written notice, if Sepracor challenges any Valid Claim of any Patents Controlled by Nycomed related to the Compound, the Product or a use thereof, or if Sepracor
actively supports such any related action brought through an Affiliate of Sepracor or a Third Party and if Sepracor, following a written reminder by Nycomed, fails to permanently discontinue any such
challenge within a period of one (1) month from receipt of such reminder; provided that Sepracor's taking any action that it is legally required to take, including without limitation responding
to any subpoena or other legal process, shall not be deemed to be "active support" of any such action. Nycomed may exercise such termination right at any time for as long as Sepracor is continuing or
supporting continuance of such an action, by giving Sepracor a written Termination Notice in accordance with 18.2.1.4. If such a Termination Notice is delivered, then the Parties shall follow the
procedures set forth in Sections 18.2.1.5, Section 20.2 and Section 20.3. 

        18.3.4    Termination for Competing Activities.    Nycomed may terminate this Agreement by giving Sepracor 30 Business
Days prior written notice if Sepracor engages in competitive activities that are prohibited pursuant toSection 17.2 hereof including, without limitation, the commercialization of a Competing
Product or a Sepracor Competing Product, and fails to cease such competitive activities within such 30
Business Day period. The termination right of Nycomed under this Section 18.3.4 may be exercised by Nycomed by delivering a Termination Notice within 90 Business Days of the end of such 30
Business Day period. If such a Termination Notice is delivered and is disputed by Sepracor, then the Parties shall immediately follow the procedures set forth in clause (B) of
Section 20.2 and, thereafter, Section 20.3. 

        18.4    Termination of Agreement as to Specific Product.    The termination rights pursuant to this Article 18
may only be exercised by the Party entitled to terminate with respect to the Agreement as a whole. 

        18.5    Ordinary Course of Business and Initiation of Smooth Transfer Prior to Expiry or upon Notification of
Termination.    

        18.5.1    Ordinary Course of Business Prior to Expiry or upon Notification of Termination.    Notwithstanding the
upcoming expiry of this Agreement for any reason, and, in case of the termination 

82

 

of
this Agreement to an earlier date, notwithstanding that a notification of termination of this Agreement has been served, Sepracor shall continue conducting business with the Product in an ordinary
course of business until the expiry or termination of this Agreement becomes effective. Sepracor shall use its Commercially Reasonable Efforts so as to enable Nycomed or its designee to continue
business with the Product following its expiry or termination on a continuing basis without suffering any losses attributable to a conduct of business by Sepracor outside the ordinary course, without
limitation, such that sales that would in the normal course of business have been made by Nycomed or its designee following the effective date of termination are anticipated prior to the effective
date of termination in an effort to secure Sepracor additional sales and sales revenues prior to the effective date of termination. Without limiting the generality of the forgoing, Sepracor shall,
prior to the effective date of expiry or termination, refrain from any activities in the distribution channels outside of the ordinary course of business such as, without limitation, limitation,  (i)
anticipating sales into the period prior to the effective date of expiry or termination, when in the ordinary course of trading of the business
prior to such date, such sales would not have arisen in such period; (ii) overstocking wholesalers outside the ordinary course of business;  (iii)
increasing orders for or stocks of Product above the normal course and outside the ordinary course of business, without limitation, for the
purposes referred to in the preceding romanettes (i) and (ii); (iv) granting rebates and discounts outside the ordinary course of business,
without limitation, by means of product bundling and selling the Product in combination with other Sepracor products (so called "package deals"); and  (v) fulfilling its obligations under Article 9
of the Agreement prior to the effective date of termination in any other way than in the ordinary
course of trading. For clarity, expiry or termination notwithstanding, Nycomed may audit Sepracor's books, records and accompanying documentation pursuant to Section 15.3 in order to ascertain
compliance by Sepracor with its obligations pursuant to this Section 18.5.1. 

        18.5.2    Initiation and Implementation of Smooth Transfer.    [**] prior to the expiry of
this Agreement and, in case of the early termination of this Agreement, following notification of termination, the Parties shall commence cooperating so as to ensure a smooth transition of
Sepracor's business with the Product to Nycomed or its designee, such transfer to become effective upon the effective date of expiry or termination, as the case may be, and such transition to
coordinated and performed in accordance with Article 19. For such purpose, Sepracor agrees to cooperate with Nycomed in good faith so as to enable Nycomed or its designee, in the form required
by the laws and regulations applicable in the Territory, to fully exercise the rights under the Regulatory Approvals for Product from the date as of which the expiry or termination of this Agreement
becomes effective including, without limitation, by releasing Nycomed from its obligations of confidentiality and non-use pursuant to Article 16 of this Agreement to the extent
required for that purpose. Sepracor undertakes to give Nycomed, at Nycomed's expense, all reasonable assistance as may be required to achieve such transfer 

Article 19

Rights and Duties upon Expiry or Termination  

        19.1    Specific Rights and Duties Upon Expiration or Termination.    Upon expiry or termination of this Agreement for
any reason whatsoever, the Parties shall have the specific rights and obligations set forth in this Section 19.1. 

        19.1.1    Termination of Grant of Rights and Licenses.    Without prejudice to the provisions of this Agreement
related to the grant of post contractual rights and licenses (including, without limitation, Section 2.3 {Access Rights of Nycomed to Sepracor Technology}, Section 6.3.5 {Use of Clinical
Development Data}, Section 7.1.1.2 {Ownership Rights to Improvement Technology}, Section 7.1.2.3 {Jointly-Owned Improvement Technology}, Section 19.1.3 {Clinical Development and
Phase IV Development}, Section 19.1.7 {Transfer of Stocks}), the rights to Commercialize Product and, to the 

83

 

extent
applicable, perform Clinical Development in the Territory and in the Field granted by Nycomed to Sepracor hereunder shall terminate upon the effective date of any expiration or termination of
this Agreement. 

        19.1.2    Regulatory Rights.    Section 18.5.2 notwithstanding, Sepracor shall forthwith take all actions
necessary, in the form required by the laws and regulations applicable in the Territory, so as to ensure that Nycomed or its designee may exercise Nycomed's rights under the Regulatory Approvals for
Product in the Territory in a full and unrestricted way as from the date as of which the expiry or Termination of this Agreement becomes effective. 

        Section 5.2.1,
Section 5.2.2 and Section 18.5.2 notwithstanding, to the extent that any Regulatory Rights as hereinafter defined should have vested in Sepracor or a
designee of Sepracor, Sepracor shall, upon Nycomed's first request, forthwith take all actions necessary in order to effect the most expeditious transfer to Nycomed or its designee, in the form
required by the laws and regulations applicable in the Territory, all regulatory rights relating to the Compound and the Product in the Field including, without limitation, all Regulatory Approvals,
and scientific dossiers, governmental authorizations, social security approvals and other similar rights or benefits held by or for Nycomed which may be attached to the Product in the Territory
(collectively, the "Regulatory Rights") such that title to and ownership of such Regulatory Rights vests in Nycomed or its appointee as from the date as
of which the expiry or Termination of this Agreement becomes effective. In case of any delays, if necessary, Sepracor expressly permits Nycomed or its designee to Sepracor's Regulatory Rights for the
registration and/or Commercialization of the Product in the Territory and in the Field. 

        To
the extent relevant and required by applicable legislation in the Territory, until such date as of which any such transfer may be completed, Sepracor agrees to confer to Nycomed
Commercialization rights in the form as may be required under the Legal Requirements including, without limitation, the appointment of Nycomed or its designee, as the case may be, as Sepracor's sales
agent, so as to permit and assist Nycomed in an uninterrupted Commercialization of the Products under the Trademark in the Territory. 

        The
costs and expenses incurred by Sepracor in carrying out its obligations under this Section 19.1.2 shall be (i)
[**] if this Agreement has been terminated primarily due to the fault of Nycomed, (ii) borne by [**] if
this Agreement has been terminated primarily due to the fault of Sepracor, and (iii) [**] if this Agreement has been terminated
without either Party being primarily at fault. 

        19.1.3    Clinical Development and Phase IV Development.    Sepracor shall, without undue delay, coordinate
with Nycomed, to the extent relevant and still applicable at that time, the continuation or cancellation by Nycomed or Nycomed's designee, as the case may be, of all clinical studies related Clinical
Development or Phase IV Development that are ongoing at the effective date of Termination or expiry, or that were scheduled to be initiated within six (6) months from such date, under
the sponsorship of Sepracor (the "Further Clinical Trials"). The final decision whether or not any such Further Clinical Trial shall be continued or
terminated shall be with Nycomed. 

        In
the event that any such Further Clinical Trial is continued, Sepracor shall fully and reasonably co-operate with Nycomed in order to ensure an orderly transfer to Nycomed
or Nycomed's designee of any such Further Clinical Trial. In order to achieve such purpose, Sepracor undertakes to continue conducting any such Further Clinical Trial for a reasonable period of time
following the date of termination of this Agreement in close coordination with Nycomed. 

84

 

  
        The costs and expenses incurred by Sepracor in carrying out its obligations under this Section 19.1.3 shall be (i)
[**] if this Agreement has been terminated primarily due to the fault of Nycomed, (ii) borne by [**] if
this Agreement has been terminated primarily due to the fault of Sepracor, and (iii) [**] if this Agreement has been terminated without either Party being primarily at
fault. 

        19.1.4    Termination of Commercialization Activities.    Save as provided in Section 19.1.7.1, Sepracor shall
terminate its activities under this Agreement and shall, without limitation, cease to Commercialize Product in the Territory. In addition, save as provided herein, Sepracor undertakes to refrain from
using the Trademark, or any trademark confusingly similar thereto. 

        19.1.5    Use of Nycomed Technology.    Save as otherwise provided herein, Sepracor shall no longer be entitled to,
and shall refrain from using, the Nycomed Technology including the Nycomed Know-How. 

        19.1.6    Continuing Obligations of Confidentiality and Non-Use.    Save as otherwise provided herein,
without limitation regarding post-contractual access rights to intellectual property of a Party, the expiration or termination of this Agreement for any reason whatsoever notwithstanding,
the Parties shall continue to be bound by the obligations of secrecy and non-use pursuant to Article 16. 

        19.1.7    Transfer of Stocks.    

        19.1.7.1    General.    Upon expiry or termination of this Agreement Nycomed shall decide within its reasonably
exercised discretion (i) whether Sepracor shall sell to Nycomed or Nycomed's nominee all remaining stocks of the Product to which Sepracor has retained
title and/or, if Nycomed so elects, Promotional and Clinical Samples, which are in good salable condition and which have a normal remaining shelf life of at least [**] for the
purposes of sell-out or, in case of Promotional and Clinical Samples, distribution by Nycomed or its designee, (ii) or whether Sepracor
shall be entitled to sell out such stocks under the conditions as set forth herein during a period of six (6) months after expiry or termination. In the event Nycomed requires Sepracor to sell
the relevant stocks of Product, Promotional and Clinical Samples to Nycomed or its designee, the related transfer price shall be equal to [**] for such Product, Promotional and
Clinical Samples. 

        In
case that Nycomed should elect to proceed pursuant to Section 19.1.7.1(i), to the extent legally permitted, Sepracor grants Nycomed or its appointee the right to sell out the
applicable stocks of Product in the original package make-up and such additional stock of Product in its make-up pursuant to this Agreement as Nycomed may reasonably require
and manufacture for a smooth transfer of Sepracor's business activities related to Product to Nycomed or its appointee, using Sepracor's Promotional Materials. 

        19.1.7.2    Destruction of Stocks.    Stocks of the Products not handed over to Nycomed or Nycomed's nominee or stocks
not sold out by Sepracor in accordance with the preceding sub-paragraph shall be destroyed. The costs of such destruction shall be borne by [**], if Nycomed has
terminated this Agreement pursuant to Section 18.2.1 or 18.2.2 for Breach by or an Insolvency Event affecting Sepracor. The costs of such destruction shall be borne by
[**], if Sepracor has terminated this Agreement pursuant to Section 18.2.1 or 18.2.2 for Breach by or an Insolvency Event affecting Nycomed. Otherwise,
[**] unless the Parties are able to reach an amicable solution. Nycomed or its duly authorized representative shall have the right to supervise any such destruction. 

        19.1.8    Execution Payment, Development Milestone Fee and Sales Milestone Fees.    Section 3.6 and
Section 7.2.5.5.2 notwithstanding, it is expressly understood that the Execution Payment, the Development Milestone Fees and Sales Milestone Fees paid by Sepracor shall neither be refundable
nor refunded in case of the early termination of this Agreement for any reason whatsoever. 

        19.2    General Provisions Applying upon Expiration or Termination of this Agreement.    

        19.2.1    Outstanding Payments.    Save as otherwise provided, payments to be made by either Party arising out of the
expiration or termination of this Agreement shall be due within [**] after the 

85

 

expiration
or termination of this Agreement (for any reason whatsoever) provided that the amount may be calculated at that time; if this is not the case, such payments shall become due within
[**] of the amount being calculated and such amount being correctly billed to the other Party. 

        19.2.2    Survival of Obligations.    The expiration or termination of this Agreement for any reason whatsoever shall
be without prejudice to any obligations or rights on the part of either Party which have accrued prior to such expiration or termination, and shall not affect or prejudice any provision of this
Agreement which is either expressly (without limitation, Section 2.3 {Access Rights of Nycomed to Sepracor Technology} Section 6.3.5 {Use
of Clinical Data Generated by or for Sepracor in the Course
of Clinical Development of Additional Products}, Section 11.2.1 {Quarterly Royalty Payment and Payment Thereof}, Article 12 {Compliance with Law, Insurance and Product Recall},
Article 14 {Indemnification and Liability}, Section 15.3 {Audits}, Article 16 { Confidentiality, Publications}, Article 19 {Rights and Duties upon Expiry or Termination or
Expiration}) or by implication (without limitation, Section 5.7 {Right to Access and Reference Use of Regulatory Approvals},
Section 7.1.1.2 {Ownership of certain Improvement Technology}, Section 7.1.2 {Prosecution and Maintenance of Patents}, Section 8.5 {Nycomed's Rights in the Trademark},
Section 11.1.6 {Reconciliation Regarding Supply Price}, Section 11.2.1 {Quarterly Royalty and Payment Thereof}, Section 15.1 { Reporting Duties of Sepracor}, Section 15.2
{General Record-Keeping Obligations}, Article 20 {Governing Law, Dispute Resolution and Arbitration}, Article 23 {Miscellaneous}), provided to come into effect on, or continue in effect,
after such expiration or termination. 

Article 20

Governing Law, Dispute Resolution and Arbitration  

        20.1    Governing Law.    This Agreement and the respective rights of the Parties hereunder shall be governed by and
construed in accordance with, the laws of Switzerland, without giving effect to the choice of law principles thereof. The UNCITRAL Convention for the International Sale of Goods as well as any other
unified law relating to the conclusion and implementation of contracts relating to the international sale of goods shall not apply. 

        20.2    Dispute Resolution.    Save for disputes expressly assigned to Third Party determination pursuant to
Section 10.4.2.4 and Section 15.3 or to Third Party Expert Determination in accordance with Section 20.4 in accordance with the terms and conditions of this Agreement, any
dispute, controversy or claim (a "Dispute") arising out of or relating to this Agreement which (A) the
Parties are unable to amicably settle themselves within a period of sixty (60) Business Days, shall, (B) upon either Party's written request
after such 60 Business Day period, be referred to the Chief Executive Officers of the Parties (together, the "Officers") within seventy-two
(72) hours following receipt by the other Party of any such request, and such Officers shall attempt to resolve the dispute within a reasonable time, but in no case more than thirty
(30) Business Days from the time that any such request has been made. The Officers shall issue their resolution in writing. If such Officers should fail to reach consensus on the applicable
issue within such term of thirty (30) Business Days, such issue shall be subject to arbitration pursuant to Sections 20.3, 20.4 and 20.6. 

        20.3    Arbitration.    Save for disputes expressly assigned to Third Party determination pursuant to
Section 10.4.2.4 and Section 15.3 or to Third Party Expert Determination in accordance with Section 20.4 in accordance with the terms and conditions of this Agreement, any
dispute, controversy or claim arising out of or relating to this Agreement which the Parties are unable to amicably settle themselves shall be finally decided, without recourse to the courts, by
arbitration proceedings held in Paris and administered by a tribunal (the "Tribunal") according the Rules of Conciliation and Arbitration of the
International Chamber of Commerce in Paris (the "ICC" and the "ICC Rules", respectively) as in force at
the time such arbitration is commenced. All such proceedings shall be conducted in the English language. The Tribunal shall consist of three (3) arbitrators, appointed in accordance with the
ICC Rules. All of the arbitrators shall have significant legal or business experience 

86

 

in
pharmaceutical matters. The award rendered shall be in writing, shall set forth in reasonable detail the facts of the dispute, and the reasons for the Tribunal's decision, and shall apportion the
costs of the arbitration. The award shall not be appealable and shall be binding upon the Parties. The prevailing Party may enter the arbitral award in any court having jurisdiction. 

        20.4    Third Party Expert Determination.    Wherever in this Agreement (other than the cases referred to in
Section 10.4.2.4 and Section 15.3) the Parties have indicated that the matter shall be referred to an expert (the "Expert") for final
determination (the "Third Party Expert Determination"), the following provisions shall apply: 

        20.4.1    Nomination.    Such expert shall be agreed by the Parties within 10 Business Days of the request of either
Party to appoint such an expert, failing which as nominated by the International Center for Expertise of the International Chamber of Commerce (the  "ICC") in Paris. The nomination shall be subject to
the conditions that (i) the Expert shall be a
national or resident of the US and shall have significant legal or business experience in pharmaceutical matters, (ii) the Expert shall undertake to
render his or her opinion within two (2) calendar months of the date of the submission by both Parties of their Proposals pursuant to Section 20.4.2, and  (iii) the Expert shall undertake to
deliver a written opinion evidencing the basis of his or her decision. 

        20.4.2    Party Proposals.    Within in a period of thirty (30) Business Days from the nomination by such
Expert by the Parties or the ICC, each Party shall submit to such Expert its proposal for the resolution of the conflict under evaluation (each, a  "Proposal"). 

        20.4.3    Expert Decision.    Except for the cases referred to in Section 22.2, such Expert shall select one of
the Parties' Proposals in its entirety, without any modifications or other changes, and to the exclusion of the other Party's Proposal. 

        Further,
such Expert shall determine the procedure for reaching his/her decision as he/she thinks fit provided that he/she provides each of Nycomed and Sepracor with at least one
opportunity to present their views (both in writing and in person) and aims to reach a decision within two (2) calendar months
of the submission by both Parties of their Proposals pursuant to Section 20.4.2. With respect to the costs of Third Party Expert Determination, Section 20.6 shall apply. 

        20.5    Injunctive Relief.    By agreeing to arbitration or Third Party Expert Determination, the Parties do not
intend to deprive any competent court of such court's jurisdiction to issue a pre-arbitral injunction, pre-arbitral attachment or other order in aid of the arbitration or Third
Party Expert Determination proceedings and the enforcement of any award or judgment. Without prejudice to such provisional remedies in aid of arbitration or Third Party Expert Determination
proceedings as may be available under the jurisdiction of a national court, the court of arbitration shall have full authority to grant provisional remedies and to award damages for failure of any
Party to respect the court of arbitration's order to that effect. 

        20.6    Expenses of Third Party Expert Determination.    The expenses of any Third Party Expert Determination shall be
borne by the Parties in proportion as to which each Party prevails or is defeated in such Third Party Expert Determination. Each Party shall bear the expenses of its counsel and other experts. 

Article 21

Force Majeure  

        21.1    Force Majeure Affecting Either Party.    Notwithstanding any other provision of this Agreement, Nycomed and
Sepracor shall each be excused for any delay or default in performing any of their respective obligations hereunder if such delay or default is caused by conditions beyond its reasonable control
including, but not limited to, acts of God, government restrictions (including import and export restrictions), wars, insurrections, terrorism, labor disturbances, shortages of equipment, fuel or
labor, destruction of facilities or materials by fire, earthquake, storm or other casualty, any law, rule, 

87

 

order,
decision, decree, judgment or injunction of any court, governmental officer or regulatory body, epidemic, or failure of public utilities or common carrier. When such circumstances arise, the
Parties shall discuss in good faith what, if any, modification of the terms of this Agreement may be required in order to arrive at an equitable solution. 

        21.2    Force Majeure Affecting Nycomed.    Notwithstanding any other provision of this Agreement, Nycomed's delay or
default caused by its suppliers' or manufacturers' delay or default or by its suppliers' or manufacturer's termination of or failure to renew any agreements with such suppliers or manufacturers, shall
be considered a Force Majeure Event if Nycomed has fulfilled all of its material
obligations under such agreements and has used reasonable efforts to maintain such agreements in force. 

        21.3    Blocking Patent.    In the event that the Parties agree that a license from a Third Party is necessary in
order to operate under this Agreement, the inability to obtain such a license under Third Party intellectual property in case of a Third Party patent conflict despite fulfillment of all obligations
and procedures set forth in Section 7.3 or Section 7.4 of this Agreement shall constitute a Force Majeure Event. 

        21.4    Consequences of Persisting Force Majeure.    The Party affected by a Force Majeure Event pursuant to
Sections 21.1 to 21.3 (in each case, a "Force Majeure Event") shall notify the other Party without undue delay in writing of any such Force
Majeure Event and the underlying reasons for the delay or default. The Parties shall then reasonably cooperate in good faith so as to seek a resolution of the delay or failure to perform and to
reasonably remove the Force Majeure Event, the costs and expenses of so removing any such Force Majeure Event to be borne by the Party so affected unless otherwise agreed in writing, and such Party
shall use all reasonable diligence to avoid, remove or mitigate any such causes of non-performance. The Party whose performance is affected by a Force Majeure Event shall continue
performance with reasonable dispatch wherever such causes have been removed. 

Article 22

Coming into Force and Antitrust Clearance Requirements  

        22.1    Reporting and Waiting Requirements under the HSR Act.    

        22.1.1    Good Faith Determination of Size of Transaction.    Each Party undertakes to determine in good faith and at
its cost and expense whether the transaction contemplated under this Agreement will satisfy the size of the transaction test as defined under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended (15 U.S.C. Sec. 18a), and the rules and regulations promulgated thereunder (collectively, the "HSR Act"), and will, to the
extent required and at its cost and expense, make a filing under the HSR Act. 

        22.1.2    HSR Filing.    In the event that a Party makes the good faith determination that a filing of a Notification
and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in this Agreement under the HSR Act is required, each of Sepracor
and Nycomed will, within fifteen (15) Business Days after the Execution Date of this Agreement, file with the United States Federal Trade Commission (the  "FTC") and the antitrust division of the
United States Department of Justice (the "DOJ"), any
notification and report form
required of it in the reasonable opinion of both Parties under the HSR Act with respect to the transactions contemplated hereby, together with all required documentary attachments thereto. The Parties
will cooperate with one another to the extent necessary in the preparation of any notification and report form required to be filed under the HSR Act. Each Party will be responsible for its own costs,
expenses, and filing fees associated with any filing under the HSR Act. 

        22.2    Antitrust Clearance Requirements under EU Antitrust Law.    Relying on the advice of reputable counsel
experienced in the competition law of the European Union, the Parties have made or 

88

 

will
make the good faith determination that the transaction covered by this Agreement is not subject to the competition law of the European Union, as it will have no effects within the European Union
(whether or not it would otherwise have benefited from an exemption or have been exempted pursuant to Article 81(3) of the EC Treaty). 

        In
the event that either Party should allege that any term of this Agreement does not so comply with the laws and regulations of the European Community, the Parties shall amend this
Agreement in good faith so as to conform to such relevant laws and regulations of the European Community in a way that most closely approximates the purpose and economic effect of the invalid
provision and the Parties' presumed intentions, thereby adjusting, to the extent reasonably required, the terms and conditions of this Agreement in order to resolve any inequities. Section 23.5
notwithstanding, if the Parties should have been unable to agree on the issue of whether or not this Agreement complies with the laws of the European Community and/or an appropriate amendment so as to
harmonize this Agreement with such laws and regulations within three months from the first written request of a Party to do so, the issues of the compliance of this Agreement with the laws and
regulations of the European Community shall be resolved and, if applicable, a corresponding amendment this Agreement shall be determined, by a Third Party Expert Determination pursuant to
Section 20.4 always provided, however, that Section 20.4.3 shall not apply, and that such Third Party Expert shall be entitled to determine the appropriate amendments to be made to this
Agreement in accordance with this clause. 

Article 23

Miscellaneous  

        23.1    Entire Agreement.    This Agreement constitutes the entire understanding of the Parties with respect to the
subject matter hereof and supersedes and replaces all prior understandings between the Parties hereto including, without limitation, the Confidentiality Agreement. 

        23.2    Prevailing Agreement.    In the event of any conflict between the provisions of this Agreement and a schedule
attached hereto, the provisions of this Agreement shall prevail, unless the relevant clause of the relevant schedule expressly provides that it shall prevail, thereby referencing the clause of this
Agreement over which the applicable schedule is intended to prevail. 

        23.3    Amendments.    Modifications and amendments to this Agreement shall be effective only if made in writing; this
also applies to a waiver of the written form. Evidence for the contents of this Agreement may only be produced in the form of written documents duly executed by each of the Parties hereto. 

        23.4    Notices.    Unless otherwise provided for in this Agreement, any notice or request required or permitted to be
given under or in connection with this Agreement or the subject matter hereof, shall be given in the English language in writing by prepaid registered or first-class airmail, by reputable
same-day or overnight courier, or facsimile to the recipient at its address as set forth hereunder or to such other address or addressee as may have therefor been furnished in writing by
the recipient to the sending Party in accordance with this clause provided, however, that any notice of termination shall be given reputable same-day or overnight courier. Any such
aforementioned notice or request shall be 

89

 

deemed
to be effective upon receipt by the Party to which it is addressed. Any notice to be sent by a Party pursuant to this Agreement shall be addressed: 

	If directed at Nycomed:
 
	 	If directed at Sepracor:
 

	Nycomed GmbH

Attention: Legal Department

Byk-Gulden-Strasse 2

D-78467 Konstanz

Federal Republic of Germany	 	Sepracor Inc.

Attention: Adrian Adams, President & CEO

84 Waterford Drive

Marlborough, MA 01752

USA
	

 	
 	

With a courtesy copy to, and provided that notification of Sepracor's CEO will suffice to constitute effective notice:
	

 	
 	

Andrew I. Koven

Exec. Vice President, General Counsel

& Corporate Secretary
	

Telephone: ++49.7531.84.1496	
 	

Telephone: ++1.508.481.6700
	

Facsimile: ++49.7531.84.2982	
 	

Facsimile: ++1.508.357.7511

        Any
change of these addresses shall be promptly communicated in writing to the other Party. 

        23.5    Severability and Gaps.    Subject to Section 22.2, in the event of the invalidity of any provisions of
this Agreement or of this Agreement containing any gaps, the Parties agree that such invalidity or gap shall not affect the validity of the remaining provisions of this Agreement. The Parties will
replace an invalid provision or fill any gap with valid provisions that most closely approximate the purpose and economic effect of the invalid provision or, in case of a gap, the Parties' presumed
intentions. In the event that the terms and conditions of this Agreement are materially altered as a result of the preceding sentences, the Parties shall renegotiate the terms and conditions of this
Agreement in order to resolve any inequities. Nothing in this Agreement shall be interpreted so as to require either Party to violate any applicable laws, rules or regulations. Nothing contained in
this Section shall permit modification of the Execution Payment, the Development Milestone Fee and Sales Milestone Fees pursuant to Article 3. 

        23.6    Waiver and Estoppel.    Failure of either Party to insist upon a strict and punctual performance of any of the
provisions hereof shall not constitute a waiver nor an estoppel against asserting the right to require such performance, nor shall a waiver or estoppel in one instance constitute a waiver or estoppel
with respect to a later breach, whether of similar nature or otherwise. The observance of any term of this Agreement may be waived (either generally or in a particular instance and either
retroactively or prospectively) by the Party entitled to enforce such term, but any such waiver shall be effective only if in writing signed by the Party against whom such waiver is to be asserted. 

        23.7    No Agency, No Joint Venture, No Partnership.    Nothing herein contained shall be deemed to create an agency,
joint venture, amalgamation, partnership or similar relationship between Nycomed and Sepracor, and this Agreement shall not be deemed a partnership agreement. Notwithstanding any of the provisions of
this Agreement, neither Party shall at any time enter into, incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment,
expense, or liability whatsoever, and all contracts, expenses and liabilities undertaken or incurred by one Party in connection with or relating to the development, manufacture, promotion or sale of
Products shall be undertaken, incurred or paid exclusively by that Party, and not as an agent or representative of the other Party. 

90

 

        23.8    Assignment.    The terms and provisions of this Agreement shall inure to the benefit of, and be binding upon,
Nycomed, Sepracor and, subject to Section 18.3.2, their respective successors by operation of law and permitted assigns. Nycomed may assign or otherwise transfer this Agreement and its rights
and obligations thereunder (i) in connection with any merger, reorganization, or sale of all or substantially all of its assets to which this Agreement
relates (without limitation, the sale of its respiratory business); and (ii) to an Affiliate of Nycomed. Sepracor may assign or otherwise transfer this
Agreement and its rights and obligations thereunder (y) in connection with any merger or sale of all or substantially all of its assets to which this
Agreement relates (without limitation, the sale of its respiratory business); and (z) to an Affiliate of Sepracor. In the event of any such assignment
or transfer by either Party, each of Nycomed and Sepracor, respectively, shall continue to be responsible for their performance under this Agreement. 

        23.9    Reasonable Damages.    The Parties acknowledge and agree that under certain circumstances contemplated by this
Agreement, damages shall not be readily ascertainable or determinable in terms of actual money amounts and therefore acknowledge and agree that the monetary remedies identified in such circumstances
are a fair and equitable determination of such damages. Unless otherwise specified, this is without prejudice to any other remedy a Party may have available to it. 

        23.10    Construction and Interpretation.    

        23.10.1    Headings; Singular and Plural.    The heading references herein are for convenience purposes only, do not
constitute a part of this Agreement and shall be deemed not to limit or affect any of the provisions hereof and their interpretation. The singular and plural numbers can be substituted for each other
when the context requires such substitution. 

        23.10.2    Original Version to Govern.    This original English version of this Agreement shall be binding upon the
Parties and shall prevail over any translations thereof as may be made by a Party. 

        23.10.3    Use of Terms "and" or "or".    The word "and" or "or" shall be deemed to mean "and", "or" or "and/or",
where the context so admits or requires. 

        23.10.4    Use of Term "Including".    The term "including" as used herein means including without limitation.

        23.10.5    Use of the Term "May".    As used herein, "may" shall mean having the right to do something and "may not"
means the prohibition of something. 

        23.10.6    Good Faith.    Regardless of whether so specified in each instance, when the Parties discuss, negotiate,
agree, conduct their business with each other, or decide or take any other action with respect to each other, they shall do so in good faith. 

        23.10.7    Mutual Agreement.    The Parties acknowledge that they may, from time to time, reach agreements, which
modify their rights and obligations pursuant to this Agreement. Nothing herein shall limit their right to do so, provided, however, that any such agreement shall be in writing, duly signed on behalf
of both of the Parties. 

        23.11    Legal Costs of this Agreement.    Each Party shall bear its own legal costs pertaining to the negotiation and
execution of this Agreement. 

        23.12    Initial Press Release.    The timing and content of the initial press release relating to this Agreement,
including its existence, the subject matter to which it relates and the transactions contemplated herein will, except as otherwise required by law or any stock exchange rules, be determined jointly by
the Parties. 

        23.13    Counterparts.    This Agreement may be executed in duplicate, which may be delivered via facsimile or other
means of electronic communication, both of which shall be deemed to be originals, and both of which shall constitute one and the same Agreement. 

[Remainder of page intentionally left blank]

91

 

  
        IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the day and year first above written by their duly authorized representatives. 

	NYCOMED GMBH
	 	SEPRACOR INC.
	 	 

	Name:	 	Dr. Barthold Piening	 	Name:	 	Mr. Adrian Adams	 	 
	
Title:	
 	

Executive Vice President Operations	
 	
Title:	
 	

President & CEO	
 	

 
	
Signature:	
 	

/s/  BARTHOLD PIENING      	
 	
Signature:	
 	

/s/  ADRIAN ADAMS      
	 	 	
	 	 	 	
	 	 
	

Name:	
 	

Anders Ullmann	
 	

 	
 	

 	
 	

 
	
Title:	
 	

Member of the Board of Management, R&D	
 	

 	
 	

 	
 	

 
	
Signature:	
 	

/s/  ANDERS ULLMANN      	
 	

 	
 	

 	
 	

 
	 	 	
	 	 	 	 	 	 
	
Place, Date: Konstanz,	
 	

Jan. 25, 2008	
 	

Place, Date:	
 	

Marlborough, Jan. 24, 2008	
 	

 
	 	 	
	 	 	 	
	 	 

List of Schedules to this Agreement  

	Schedule 1.1:	 	Compound Specifications
	Schedule 1.2:	 	Detail Cost
	Schedule 1.3:	 	Nycomed Drug Master File
	Schedule 1.4:	 	Manufacturing Cost
	Schedule 1.5:	 	Sepracor Patents
	Schedule 1.6:	 	Nycomed Patents
	Schedule 1.7:	 	Product Specifications
	Schedule 1.8:	 	Trademarks
	Schedule 1.9:	 	3M Development Agreement
	Schedule 1.10:	 	3M Supply Agreement
	Schedule 9.6.1.1:	 	Minimum Marketing Investment Obligations
	Schedule 9.6.2.1:	 	Minimum Sales Obligations
	Schedule 10.2.4:	 	Quality Agreement
	Schedule 10.3.2:	 	(Format of Rolling Monthly Net Requirements Plan)
	Schedule 10.3.3:	 	Minimum Batch Sizes
	Schedule 12.4:	 	Ciclesonide Pre- and Post Marketing Surveillance (SOP)

92

 
SCHEDULE 1.1  

to
the Distribution and Development Agreement on Ciclesonide

between Nycomed and Sepracor regarding the USA 

Compound Specifications  

[**]

93

 
SCHEDULE 1.2  

to
the Distribution and Development Agreement on Ciclesonide

between Nycomed and Sepracor regarding the USA 

Detail Cost  

        In the event that there is a Shortfall Amount as a result of Sepracor failing to achieve a minimum number of PDEs as set forth on  Schedule 9.6.1.1,
 the Shortfall Amount attributable to such PDEs pursuant to Section 9.6.1.2 and  Schedule 9.6.1.2 shall be calculated at a rate of $[**] per PDE required to be
but not performed during such Product
Year. 

94

 
SCHEDULE 1.3  

to
the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA

Nycomed Drug Master File  

	 
	 	Restricted Part
	 	Applicants Part

	Name(s) and Site(s) of ASM	 	+	 	+
	Specification and routine test	 	 	 	+
	Nomenclature	 	 	 	+
	Description	 	 	 	+
	Previous use in medicinal products	 	+	 	 
	Manufacturing method	 	 	 	 
	— Brief outline (flow-chart)	 	 	 	+
	— Detailed description	 	+	 	 
	QC during manufacture	 	+	 	 
	Process validation and evaluation of data	 	+	 	 
	Development chemistry	 	 	 	 
	— Evidence of structure	 	 	 	+
	— Potential isomerism	 	 	 	+
	— Physicochemical characterization	 	 	 	+
	Analytical validation	 	 	 	+
	Impurities	 	 	 	+
	Batch analysis (incl. Impurities)	 	 	 	+
	Stability	 	 	 	+

95

 

  SCHEDULE 1.4  

to
the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Manufacturing Cost  

1.     Manufacturing Cost  

        Manufacturing Cost related to the Manufacturing (as defined in Article 1 of the Quality Agreement attached hereto as  Schedule 10.2.4) of (i) Product ("Manufacturing Cost") is defined as the per Unit cost of
output for Product, and (ii) Compound is defined as the per kilogram cost of output for Compound at a good or best level of performance for a plant and its labor force. Manufacturing Cost
should not include more than a proportional share of the supporting activities related to the process of (i) Formulation or Manufacture of Product or (ii) Manufacture of Compound. 

        The
Manufacturing Cost consist of: 

	•
	Direct
Cost

	•
	Indirect
Plant Related Cost

	•
	Nycomed's
Central Manufacturing Support Services Cost 

2.     Cost Definitions  

2.1   Direct Cost  

        Direct Cost includes, but is not limited to: 

	•
	Direct
material as defined in the approved bill of material based on the average annual actual costs per unit expected or negotiated to be paid, including any applicable
freight, taxes, duties, customs or import fees, and less any discounts or free goods.

	•
	Direct
external activities such as toll manufacturing and toll packaging under a Toll Manufacturing or Contract Manufacturing agreement based on the average annual actual
costs per unit expected or negotiated to be paid, including any applicable freight, taxes, duties, customs or import fees, and less any discounts or free goods.

	•
	Direct
labor cost for personnel of production & quality control including wages, taxes, social benefits routinely paid or government mandate respectively collective
agreement bonuses. 

        All
these cost components called "Direct Cost" shall be expressed as a part of the Manufacturing Cost (i) per unit per Product or
(ii) per kilogram of Compound. 

2.2.  Indirect Plant Related Cost  

        Indirect Plant Related Cost is calculated as a part of the Manufacturing Cost (i) per unit cost of the Product or (ii) per kilogram cost of Compound
and includes the facilities, equipment, supervisory and other support personnel (i.e., material handlers, line mechanics/engineers, administrative supports, etc.), facility rent/occupancy
costs, depreciation/rent for equipment, maintenance, energy, miscellaneous supplies (not included on the BOM), utilities, applicable contract services, insurance and taxes, plus reasonable proportion
for people-related support costs (i.e., plant management, human resources, training, cafeteria, safety, industrial hygiene, etc.) and site support services (i.e., facilities,
office/administrative services, security, cost accounting, purchasing and receiving of non-inventory items, information systems, communications, etc.). Additionally all costs related to
activities such as process engineering, package engineering, warehousing of materials and supplies, production planning, 

96

 

purchasing
and receiving of materials and supplies, quality assurance, regulatory fees, and other similar activities, shall be included in the Indirect Plant Related Cost. 

        All
these cost components called "Indirect Plant Related Cost" shall be expressed as a part of the Manufacturing Cost (i) per unit per Product or (ii) per kilogram of
Compound. 

2.3   Nycomed's Central Manufacturing Support Services Cost  

        Operations and plant support services required to support the Manufacture of (i) the Product and/or (ii) the Compound and not being part of Indirect
Plant Related Cost, include Nycomed's central manufacturing support activities "Nycomed's Central Manufacturing Support"). Nycomed's Central
Manufacturing Support Services Cost is calculated as a part of the Manufacturing Cost (i) per unit per Product and/or (ii) per kilogram of Compound and includes all costs related to the
following central activities such as production planning, purchasing, quality assurance, regulatory affairs, analytical support, technology and formulation management as well as other administration
functions (e.g. accounting, human resources, etc.). 

        All
these cost components called "Nycomed's Central Manufacturing Support Services Cost" shall be expressed as a part of the Manufacturing Cost (i) per unit per Product and/or
(ii) per kilogram of Compound. 

3      Base Manufacturing Cost for the First Contract Year (subject to Section 11.1.1)  

3.1   Alvesco MDI Product  

	[**]	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]
	[**]	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]

3.2   Omnaris AQ Product  

	[**]	 	[**]
	[**]	 	[**]

97

 
SCHEDULE 1.5  

to
the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Sepracor Patents  

None

98

 
SCHEDULE 1.6  

to
the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

	No.
 
	 	Application Number
	 	Filing Date
	 	Publication or Patent Number
	 	Issue Date
	 	Expiry Date
	 	Assignee

	Nycomed Core Patents	 	 	 	 
	1.1	 	08/278112	 	07.09.1990	 	5482934	 	09.01.1996	 	09.01.2013	 	Nycomed
	1.2	 	10/110629	 	20.10.2000	 	6767901	 	27.07.2004	 	21.10.2020	 	Nycomed
	1.3	 	09/446276	 	21.04.1999	 	6939559	 	06.09.2005	 	21.04.2019	 	Teijin
	1.4	 	10/201303	 	24.07.2002	 	7235247	 	26.06.2007	 	21.04.2019	 	Teijin
	1.5	 	09/147675	 	29.08.1997	 	6787533	 	07.09.2004	 	24.01.2019	 	Nycomed
	1.6	 	530173	 	31.03.1994	 	5733901	 	31.03.1998	 	31.03.2015	 	Nycomed
	1.7	 	09/076958	 	13.05.1998	 	6120752	 	19.09.2000	 	13.05.2018	 	Nycomed and 3M
	1.8	 	09/440797	 	13.05.1998	 	6264923	 	24.07.2001	 	13.05.2018	 	Nycomed and 3M
	
Nycomed Additional Patents	
 	

 	
 	

 
	2.1	 	10/110632	 	20.10.2000	 	not published	 	 	 	 	 	Nycomed
	2.2	 	10/537356	 	11.12.2003	 	2006/0025392	 	 	 	 	 	Nycomed
	2.3	 	10/519484	 	02.07.2003	 	2006/0166953	 	 	 	 	 	Nycomed
	2.4	 	10/559383	 	09.06.2004	 	2006/0127323	 	 	 	 	 	Nycomed
	2.5	 	10/571311	 	15.09.2004	 	2007/0025923	 	 	 	 	 	Nycomed
	2.6	 	11/578294	 	19.04.2005	 	2007/0134165	 	 	 	 	 	Nycomed
	2.7	 	10/582499	 	15.12.2004	 	2007/0117783	 	 	 	 	 	Nycomed
	2.8	 	11/325875	 	08.07.2004	 	2006/0104917	 	 	 	 	 	Sanofi-Aventis, to be assigned to Nycomed
	
Nycomed Ancillary Patents	
 	

 	
 	

 
	3.1	 	704574	 	07.03.1995	 	5728826	 	17.03.1998	 	17.03.2015	 	Nycomed
	3.2	 	08/809687	 	27.09.1995	 	5891844	 	06.04.1999	 	27.09.2015	 	Nycomed
	3.3	 	10/399689	 	06.11.2001	 	2005/0080063	 	 	 	 	 	Nycomed
	3.4	 	10/549631	 	26.03.2004	 	2006/0128954	 	 	 	 	 	Nycomed
	3.5	 	10/513598	 	03.05.2003	 	2005/0222193	 	 	 	 	 	Nycomed
	3.6	 	10/524821	 	29.08.2003	 	2005/0245493	 	 	 	 	 	Nycomed
	3.7	 	10/570986	 	15.09.2004	 	2006/0211668	 	 	 	 	 	Nycomed
	3.8	 	10/572316	 	22.09.2004	 	2007/0023034	 	 	 	 	 	Nycomed
	3.9	 	10/589871	 	25.02.2005	 	2007/0185067	 	 	 	 	 	Nycomed
	3.10	 	11/661150	 	08.09.2005	 	not yet published	 	 	 	 	 	Nycomed

Patent Term Extensions  

	No.
 
	 	Application Number
	 	Filing Date
	 	Publication or Patent Number
	 	Issue Date
	 	Expiry Date
	 	Assignee

	Nycomed Core Patents	 	 	 	 
	1.1	 	08/278112	 	15.12.2006	 	5482934	 	 	 	 	 	Nycomed

[**] 

99

 

  SCHEDULE 1.7  

        to the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

        Within
10 Business Days after the Effective Date, whether or not prior to the finalization of the Quality Agreement, the Parties will attach the relevant Product Specifications for
Omnaris AQ, which shall be based on the regulatory specifications approved by the FDA, and upon which Nycomed will consider any reasonable suggestions of Sepracor. 

Product Specifications of Omnaris® AQ Product  

        [See Appendix 1 Section 1.1 and Appendix 2 Section 3.1 of the Quality Agreement attached hereto] 

Product Specifications of Omnaris® HFA Nasal Spray  

        [See Appendix 1 Section 1.2 and Appendix 2 Section 3.2 of the Quality Agreement attached hereto] 

Product Specifications of Alvesco® MDI Product  

        [See Appendix 1 Section 1.3 and Appendix 2 Section 3.3 of the Quality Agreement attached] 

100

 
SCHEDULE 1.8  

        to the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Trademarks  

1.     Trademark for Omnaris® AQ and HFA Product  

	Country
 
	 	Trademark
	 	Registration No./

Application No.
	 	Registration Date/

Application Date
	 	Next Renewal

	USA	 	OMNARIS®	 	Registration No.:

Application No.:

78/949782	 	10 August 2006

(Notice of allowance issued)	 	 

2.     Trademark for Alvesco® MDI Product  

	Country
 
	 	Trademark
	 	Registration No./ Application No
	 	Registration Date/ Application Date
	 	Next Renewal

	USA	 	ALVESCO®

ALVESCO*	 	Registration No.:

2860362

Application No.:

77/074621	 	06 July 2004

02 January 2007

(Notice of allowance issued)	 	06 July 2014

	*
	This
trademark application is pending. It has been filed in addition to the existing registered Trademark "Alvesco®" for the purposes of extending the protection period in
case of an eventual failure to use such originally registered Trademark. The pertaining notice of allowance for registration has been issued. 

3.     Other Products  

        To be determined at an appropriate time in accordance with Section 8.2. 

101

 
SCHEDULE 1.9  

        to the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

3M Development Agreement

(Redacted Copy)  

To
be provided. 

102

 
SCHEDULE 1.10  

        to the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

3M Supply Agreement

(Redacted Copy)  

To
be provided. 

103

 
SCHEDULE 9.6.1.1  

        to the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Minimum Marketing Investment Obligations  

        [**]. 

104

 
SCHEDULE 9.6.2.1  

        to the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Minimum Sales Obligations  

        For the periods described below, minimum Net Sales of: 

	(a)
	with respect to the Alvesco MDI Product: 

        [**]
after the Launch Date for such Product: $[**] 

        [**]
after the Launch Date for such Product: $[**] 

        [**]
after the Launch Date for such Product: $[**] 

	(b)
	in the aggregate with respect to the Omnaris AQ and Omnaris HFA Products: 

        [**]
after the Launch Date for such Products: $[**] 

        [**]
after the Launch Date for such Products: $[**] 

        [**]
after the Launch Date for such Products: $[**] 

105

 

  SCHEDULE 10.2.4  

to
the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Quality Agreement  

[To be attached at an appropriate time in accordance with Section 10.2.4.1]  

106

 
SCHEDULE 10.3.2  

to
the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Format of Rolling Monthly Net Requirements Plan  

[Nycomed to Propose]

107

 
SCHEDULE 10.3.3  

to
the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Minimum Batch Sizes  

The
minimum batch sizes shall be: 

Omnaris
AQ: 

[**] 

Alvesco: 

[**] 

Nycomed
will consider any reasonable suggestions of Sepracor as to adjustment to batch sizes. 

108

 
SCHEDULE 12.4  

to
the Distribution and Development Agreement on Ciclesonide between

Nycomed and Sepracor regarding the USA 

Ciclesonide Pre- and Post Marketing Surveillance (SOP)  

[To be attached at an appropriate time in accordance with Section 12.4]  

109

QuickLinks

Exhibit 10.45

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00137-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00137-of-00352.parquet"}]]