PRODUCT ACQUISITION AND LICENSE AGREEMENT (Adderall®)

Exhibit 10.3

PRODUCT ACQUISITION AND LICENSE AGREEMENT
(Adderall®)

BY AND AMONG

SHIRE LLC,

SHIRE PLC

AND

DURAMED PHARMACEUTICALS, INC.

DATED AS OF AUGUST 14, 2006

i

ii

iii

PRODUCT ACQUISITION AND LICENSE AGREEMENT

      THIS PRODUCT ACQUISITION AND LICENSE AGREEMENT is dated as of August 14, 2006, by and among Shire LLC, a Kentucky limited liability company (together with its Affiliates, " Shire "), Shire plc a British public limited company, and Duramed Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware (" Duramed "). Shire and Duramed are sometimes referred to herein individually as a " Party " and together as the " Parties ".

RECITALS

      WHEREAS , Shire is in the business of formulating, manufacturing, marketing and distributing the pharmaceutical product known as Adderall IR®;

      WHEREAS , Shire owns the pharmaceutical product known as Adderall IR® and all the assets relating to the Adderall Business; and

      WHEREAS , Shire desires to sell, transfer, convey and license to Duramed, and Duramed desires to purchase, acquire and license from Shire, certain rights to the Adderall IR® product and certain assets relating to the Adderall Business, and Duramed wishes to assume certain liabilities relating to such product, all on the terms set forth herein;

      NOW, THEREFORE , in consideration of the mutual covenants and agreements set forth in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto hereby agree as follows:

ARTICLE
1 DEFINITIONS

      The following terms shall have the following meanings as used in this Agreement:

      1.1 " Act " means the United States Federal Food, Drug and Cosmetic Act, as amended.

      1.2 " Adderall Business " means the business of formulating, manufacturing, and distributing the pharmaceutical product known as Adderall IR®; provided, however, that the Adderall Business shall not include any Adderall product other than the Product, including Adderall XR or [ SPD465 ] .

      1.3 " Adderall XR " means the extended release mixed amphetamine pharmaceutical product currently sold under NDA #21-303.

      1.4 " Affiliate " means a Person that, directly or indirectly, through one or more intermediates, controls, is controlled by, or is under common control with, the Person specified. For the purposes of this definition, control shall mean the direct or indirect ownership of (a) in the case of corporate entities, securities authorized to cast more than fifty percent (50%) of the votes in any election for directors, (b) in the case of non-corporate entities, more than fifty

percent (50%) ownership interest with the power to direct the management and policies of such non-corporate entity, or (c) such lesser percentage as may be the maximum percentage allowed to be owned by a foreign corporation under the applicable laws or regulations of a particular jurisdiction of the equity having the power to vote in the election of directors or to direct the management and policies of such Person.

      1.5 " Agreement " means this Agreement and all exhibits and schedules attached hereto.

      1.6 " Books and Records " means all books, records, manuals and other materials (in any form or medium) relating primarily to the Purchased Assets or the Adderall Business, including all records and materials maintained at the headquarters of Shire, advertising matter, catalogues, price lists (including any pricing for the Product made available to any Federal, State or local authorities), correspondence, mailing lists, lists of customers, distribution lists, photographs, production data, sales and promotional materials and records, purchasing materials and records, manufacturing and quality control records and procedures, blueprints, research and development files, records, data and laboratory books, accounting records, and sales order files.

      1.7 " Business Day " means any day except a Saturday, Sunday or a day on which a commercial bank in New York, New York is authorized to close.

      1.8 " Duramed Labeled Product " means Product sold or distributed after the Closing by or on behalf of Duramed bearing the NDC number of Duramed or any of its Affiliates.

      1.9 " Duramed Material Adverse Effect " means any adverse change, circumstance or effect that, individually or in the aggregate with all other adverse changes, circumstances and effects, has or is reasonably likely to have, a material adverse effect on the ability of Duramed to consummate the transactions contemplated by this Agreement, including the ability to pay the Purchase Price when due.

      1.10 " Contract " means any agreement, contract, commitment or other instrument or arrangements (whether written or oral) (x) by which any of the Purchased Assets are bound or affected or (y) to which Shire is bound relating to the Purchased Assets, in each case as amended, supplemented, waived or otherwise modified.

      1.11 " Excluded Intellectual Property " means the (a) Shire Trademark, (b) Product Trademark, (c) Licensed Patents, (d) Product Trade Dress, and (e) Intellectual Property that does not primarily relate to the Product.

      1.12 " FDA " means the United States Food and Drug Administration, and any successor agency thereto.

      1.13 " Finished Goods " means a manufactured Product packaged and ready for sale to the ultimate customer in the Territory.

      1.14 " Governmental Authority " means any federal, state, local or other government or any court of competent jurisdiction, legislature, governmental agency, administrative agency

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or commission or other governmental authority or instrumentality having jurisdiction in the Territory.

      1.15 " HSR Act " means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

      1.16 " Intellectual Property " means all (a) Patents, (b) mask works and copyrights in works of authorship of any type, including computer software and industrial designs, registrations and applications for registration thereof, (c) trademark registrations and applications for registration thereof, (d) trade secrets, know-how and other confidential or proprietary technical, business and other information, and all rights in any jurisdiction to limit the use or disclosure thereof, and (e) rights to sue and recover damages or obtain injunctive relief for past and future infringement, dilution, misappropriation, violation or breach thereof; in each case, solely to the extent the foregoing relates to the Territory.

      1.17 " Liabilities " means any and all debts, liabilities and obligations, whether accrued or fixed, absolute or contingent, matured or unmatured, or determined or determinable, including those arising under any laws, action or governmental order and those arising under any contract, agreement, arrangement, commitment or undertaking, or otherwise.

      1.18 " Licensed Patents " mean the Patent(s) listed in Schedule 1.18 .

      1.19 " Lien " means any mortgage, pledge, hypothecation, right of others, claim, security interest, encumbrance, lease, sublease, license, occupancy agreement, adverse claim or interest, easement, covenant, encroachment, burden, title defect, title retention agreement, voting trust agreement, interest, equity, option, lien, , whether arising by Contract or otherwise.

      1.20 " Losses " means any and all Liabilities, damages, fines, penalties, deficiencies, losses and expenses (including interest, court costs, amounts paid in settlement, reasonable fees of attorneys, accountants and other experts or other reasonable expenses of litigation or other proceedings or of any claim, default or assessment); provided, however, that the term "Losses" shall not include any special, consequential, indirect, punitive or similar damages, except to the extent actually paid by a Party pursuant to any Third Party Claim.

      1.21 " NDA " means a New Drug Application pursuant to Section 505 of the Act (21 U.S.C. Section 355) submitted to the FDA or any successor application or procedure.

      1.22 " Patents " means all patents, patent applications and statutory invention registrations, including reissues, divisions, continuations, continuations-in-part, supplementary protection certificates, extensions and reexaminations thereof, all inventions disclosed therein, all rights therein provided by international treaties and conventions, and all rights to obtain patents and registrations thereto.

      1.23 " Permitted Liens " means (i) Liens for Taxes not yet due and payable or which are being contested in good faith and by appropriate proceedings if adequate reserves with respect thereto are maintained on Shire’s books or (ii) Liens that, individually and in the aggregate, do not restrict, hinder, or otherwise encumber or impair the ownership of or right to use the Purchased Assets or sell of Product.

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      1.24 " Person " means any individual, firm, corporation, partnership, limited liability company, trust, unincorporated organization or other entity or a government agency or political subdivision thereto, and shall include any successor (by merger or otherwise) of such Person.

      1.25 " Pharmacovigilance Agreement " means the Pharmacovigilance Agreement to be executed at Closing by Shire and Duramed substantially in the form attached hereto as Exhibit A .

      1.26 " Product " means the pharmaceutical product in all dosage forms identified in NDA #11-522.

      1.27 " Product Domain Name " means the domain name "adderall.com" and all other domain names that include "Adderall" in any manner or form and that are owned or registered by Shire.

      1.28 " Product Material Adverse Effect " means any adverse event, circumstance, fact, condition or effect that is materially adverse to the operations or results of operation, properties or prospects of the Adderall Business, the Purchased Assets, the Licenses, or the Product Trademark, other than any event, change, circumstance or effect relating to (a) the economy of the United States in general, (b) in general to the industries in which the Product is sold and not specifically relating to the Product, or (c) changes, circumstances and effects relating to the announcement of the transactions contemplated by this Agreement.

      1.29 " Product NDA " means NDA #11-522, and any and all supplements or amendments filed pursuant to FDA requirements.

      1.30 " Product Trade Dress " means the tablet logo, including the lettering of the Product name and, specifically, the letters "AD", the size, shape and color of the tablet, together with all other features that are intrinsic to the tablet as currently marketed and sold, provided that Product Trade Dress does not include any packaging associated with the sale, marketing or distribution of the Product.

      1.31 " Product Trademark " means the trademark, trade names, brand names, including all registrations and applications for registration thereof and all renewals, modifications and extensions thereof, listed on Schedule 1.31 , used by Shire or its Affiliates in connection with the manufacture, marketing, sale and distribution of the Product, and any rights existing under common law relating thereto.

      1.32 " Regulatory Approval " means the technical, medical and scientific licenses, registrations, authorizations, approvals, permits, consents (including approvals of NDAs, supplements and amendments, pre- and post- approvals, pricing and third party reimbursement approvals, and labeling approvals) of any Regulatory Authority necessary for the development (including the conduct of clinical trials), distribution, marketing, promotion, offer for sale, use, import, export or sale of Product in the Territory.

      1.33 " Regulatory Authority " means any national ( e.g. , the FDA), regional, state or local regulatory agency, department, bureau, commission, council, court or other Governmental Authority in the Territory.

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      1.34 " Settlement Agreement " means that certain Settlement Agreement, dated as of August 14, 2006, by and between the Parties.

      1.35 " Shire Labeled Product " means Product bearing the NDC number of Shire or any of its Affiliates.

      1.36 " Shire Trademark " means the "Shire" name or any variation thereof and, other than the Product Trade Dress, the Product Trademark and the Product Domain Name, all trademarks, trade names, brand names, trade dress, logo types, symbols, domain names (including registrations and applications for registration thereof and all renewals, modifications and extensions thereof) used by Shire or its Affiliates in connection with the manufacture, marketing, sale and distribution of their products.

      1.37 " Supply Agreement " means the Supply Agreement to be executed at Closing by Shire or its Affiliate and Duramed for the supply of Product, in substantially the form attached hereto as Exhibit C .

      1.38 " Survival Period " means the period of survival of representations and warranties as set forth in Section 4.4.

      1.39 " Taxes " (and with correlative meaning, " Tax ," " Taxes ," and " Taxable ") shall mean all taxes of any kind imposed by a federal, state, local or foreign Governmental Authority, including those on, or measured by or referred to as, income, gross receipts, financial operation, sales, use, ad valorem, value added, franchise, profits, license, excise, stamp, premium, property, transfer or windfall profits taxes, customs, duties or similar fees, assessments or charges of any kind whatsoever, together with any interest and any penalties, additions to tax or additional amounts imposed by such Governmental Authority with respect to such amounts.

      1.40 " Technical Data " means all technical, scientific, chemical, biological, pharmacological, and toxicological data generated primarily for the Product.

      1.41 " Territory " means the United States and the states, territories, possessions and protectorates thereof, the District of Columbia and the Commonwealth of Puerto Rico.

      1.42 " Trademark License Agreement " means the Trademark License Agreement to be executed at Closing by Shire or its Affiliate and Duramed relating to the use of the Product Trademark, in substantially the form attached hereto as Exhibit B .

Interpretation . Unless the context of this Agreement otherwise requires, (a) words of one gender include the other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms "hereof," "herein," "hereby," and other similar words refer to this entire Agreement; (d) "including" shall be deemed followed by "without limitation", "but not limited to" or words of similar meaning; and (e) the terms "Article" and "Section" refer to the specified Article and Section of this Agreement. Whenever this Agreement refers to a number of days, unless otherwise specified, such number shall refer to calendar days.

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Additional Definitions . Each of the following definitions is set forth in the Section of this Agreement indicated below:

ARTICLE 2
SALE OF ASSETS, LICENSES AND CLOSING

      2.1 Sale of Assets .

           (a) On the Closing Date, and subject to the terms and conditions of this Agreement, Shire will, and will cause its Affiliates to, sell, assign, convey and transfer to Duramed, and Duramed will purchase and accept from Shire and its Affiliates, all of Shire’s and its Affiliates’ right, title and interest in and to the following assets (collectively, the " Purchased Assets "):

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                (i) the Product NDA;

                (ii) the Book and Records; provided that any lists included therein may be redacted as necessary to conceal information pertaining to products other than the Product;

                (iii) the Technical Data;

                (iv) all unfulfilled customer orders for the Product arising in the Territory as of the Closing Date (a list of such orders to be provided to Duramed on or prior to the Closing) and any future customer orders received by Shire for the Product;

                (v) to the extent their transfer is permitted by law, all Regulatory Approvals, including all applications therefor;

                (vi) all refunds or credit of Taxes relating to the foregoing attributable to any period following the Closing;

                (vii) any guarantees, warranties, indemnities and similar rights in favor of Shire or its Affiliates with respect to any of the foregoing; and

                (viii) all rights to causes of action, lawsuits, judgments, claims and demands of any nature available to or being pursued by Shire or its Affiliates with respect to the Adderall Business or the ownership, use, function or value of any of the foregoing, whether arising by way of counterclaim or otherwise.

           (b) Notwithstanding Section 2.1(a) above, the transfer of the Product NDA shall occur in accordance with the provisions of Article 3.

           (c) For purposes of clarification, the Purchased Assets shall not include any assets, rights or interests other than those specifically listed or described in Section 2.1(a) . Without limiting the generality of the foregoing, the Parties agree and acknowledge that the Purchased Assets shall not include: (i) the Excluded Intellectual Property, (ii) any and all NDAs or other product approvals and Technical Data related to Adderall XR or anything else related to the approval, sale, marketing or manufacturing of Adderall XR, (iii) any Adderall product other than the Product, and (iv) any plant, real property, equipment, accounts receivable, cash and cash equivalents, employees or any refund or credit of Taxes attributable to any period of time prior to the Closing Date (collectively, the " Excluded Assets "). Duramed acknowledges and agrees that Shire may retain a copy of all or part of the Books and Records that it delivers to Duramed under Section 2.1(a)(ii) for use with products of Shire or its Affiliates other than the Product or to the extent required under applicable law provided that the copy of the Books and Records so retained shall be treated as Duramed’s confidential information.

      2.2 Licenses and Other Rights .

           (a) Subject to the terms and conditions of this Agreement, Shire hereby grants, or shall cause its Affiliates to grant, to Duramed the following licenses (collectively, the " Licenses "):

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                (i) a worldwide, irrevocable, perpetual, fully-paid, exclusive (even as to Shire) right and license, with the right to sublicense under the Licensed Patents, to use, market, have marketed, offer for sale, import for sale, sell and have sold Products in the Territory;

                (ii) an irrevocable, fully-paid, perpetual, exclusive (even as to Shire) right and license under the Product Trade Dress solely to the extent necessary for Duramed to distribute, market and sell the Product in the Territory.

           (b) With respect to this Agreement, any Intellectual Property or other rights of Shire not expressly granted to Duramed under the provisions of this Agreement shall be retained by Shire, including the right to conduct such studies and clinical trials within and without the Territory as may be necessary or useful for Shire to obtain Regulatory Approvals solely for the purpose of selling products other than Product.

      2.3 [*]. From and after the Closing Date, Shire [*] Duramed or its Affiliates [*] Duramed’s [*] Product in the Territory on the basis that such [*] Shire or of [*] as of the Closing Date or [*].

      2.4 Assumed Liabilities .

           (a) As of the Closing Date, Duramed shall assume, be responsible for and pay, perform and discharge when due the following (collectively, the " Assumed Liabilities "):

                (i) any Liabilities arising from the sale of any Product after the Closing Date, including any product liability, breach of warranty, Patent or trademark infringement claim, or any other action or claim (excluding any Liabilities relating to voluntary or involuntary recalls of Shire Labeled Product, or any Liabilities of Shire under the Supply Agreement) brought, asserted or filed by any third party or Regulatory Authority;

                (ii) any Liabilities arising after the Closing Date relating to the Purchased Assets;

                (iii) subject to Section 6.7, all Medicare, Medicaid and state program rebates in connection with Duramed Labeled Product sold after the Closing Date;

                (iv) subject to Section 6.7, all chargebacks, rebates or any other post-sale rebates, refunds, price adjustments and other similar payments, credits or liabilities in connection with the Duramed Labeled Product, sold after the Closing Date; and

                (v) subject to Section 6.7, credits, utilization based rebates, reimbursements, and similar payments to buying groups, insurers and other institutions in connection with Duramed Labeled Product sold after the Closing Date.

           (b) Notwithstanding any provision hereof or any schedule or exhibit hereto or thereto, and regardless of any disclosure to Duramed, Duramed shall not assume any liabilities, obligations or commitments of Shire other than the Assumed Liabilities, including such liabilities

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relating to or arising out of the ownership of the Purchased Assets on or prior to the Closing (the " Retained Liabilities ").

      2.5 Purchase Price . Subject to the terms and conditions set forth herein, in consideration of the sale, assignment, conveyance, license and delivery of the Purchased Assets and the Licenses, and as consideration for the execution and delivery of the Trademark License Agreement, Duramed will pay to Shire a cash payment of Sixty-Three Million Dollars ($63,000,000), in the manner described in Section 2.7(b), (the " Purchase Price ").

      2.6 Independence of Purchase Price Obligation . All payments made or to be made by Duramed to Shire in respect of Purchase Price shall be non-refundable and independent of any obligations that Shire or its Affiliates may have to Duramed under any other agreement.

      2.7 Closing .

           (a) The closing of the transactions contemplated hereby (the " Closing ") will take place at the offices of Morgan, Lewis & Bockius LLP in Princeton, New Jersey at 10:00 A.M. Eastern Time on the third (3rd) Business Day following the satisfaction or waiver of all conditions or obligations of the Parties set forth in Sections 5.1 and 5.2, or at such other time, date and place as Duramed and Shire agree. The actual date of the Closing is referred to as the " Closing Date ."

           (b) At the Closing, Duramed will pay the Purchase Price in full in cash without any deductions or offsets by wire transfer of immediately available funds to a bank account or accounts to be designated by Shire prior to Closing.

           (c) At the Closing, Shire will assign and transfer to Duramed all of Shire’s right, title and interest in and to the Purchased Assets, by delivery of a general assignment, assumption and bill of sale in the form of Exhibit D (the " General Assignment and Assumption ") or any other bill of sale or assignment documents reasonably requested by Duramed.

           (d) At the Closing, Duramed will assume from Shire the due payment, performance and discharge of the Assumed Liabilities by delivery of the General Assignment and Assumption.

           (e) At or prior to the Closing, the Parties shall execute and deliver to one another the agreements listed in Sections 5.1(h) and 5.2(h) .

      2.8 Allocation of Purchase Price . The Purchase Price shall be allocated among the Purchased Assets, the Licenses, the Trademark License Agreement and the Supply Agreement as set forth on Schedule 2.8 hereto. Duramed and Shire agree to report the sale and purchase of the Purchased Assets, and the rights granted or assets transferred under the Licenses and the Trademark License Agreement for Tax purposes in accordance with the allocations set forth on Schedule 2.8 hereto, or as otherwise agreed to at a later date by the Parties if such Schedule is not attached as of the Closing Date.

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      2.9 Delivery of Purchased Assets . At the Closing or as soon as possible thereafter, Shire shall deliver to Duramed, all of the Purchased Assets. Following the Closing, Shire shall reasonably cooperate with Duramed and grant to Duramed and its employees, attorneys, accountants, officers, representatives, and agents, reasonable access to Shire’s personnel to fully transfer and disclose to Duramed all of the Purchase Assets.

ARTICLE 3
REGULATORY MATTERS

      3.1 Filings with Regulatory Authorities Regarding Transfer of Registrations . Prior to Closing, Shire and Duramed will establish a mutually acceptable and prompt communication and interaction process to ensure to Duramed the prompt and orderly transfer of the Product NDA. Promptly after Closing, the Parties shall file with the FDA and any other relevant Regulatory Authorities all information required in order to transfer the Product NDA from Shire to Duramed, including the letter to the FDA authorizing the transfer in the form attached hereto as Exhibit E (the " FDA Letter "). Where required, Duramed shall also promptly file an application or license variation to Regulatory Authorities or other government/health agencies. Shire shall file the information required of a former owner, and Duramed shall file the information required of a new owner, at each Party’s own expense. Both Duramed and Shire also agree to use all commercially reasonable efforts to take any actions required by the Regulatory Authorities or other government/health agencies to effect the transfer of the Product NDA from Shire to Duramed, and hereby further agree to cooperate with each other in order to effectuate the foregoing transfer of Product NDA at Duramed’s expense. The Parties agree to use all commercially reasonable efforts to complete the filing of the transfer of the Product Registrations within [*] from the Closing Date. Shire may retain an archival copy of the Product Registrations, including supplements and records that are required to be kept under 21 C.F.R. §314.81, but such retention shall not be deemed a license to Shire of such information nor be deemed to constitute any Shire ownership interest therein.

      3.2 Responsibility for the Product . From and after the Closing Date, and in no event later than the effective date of the transfer to Duramed of the applicable NDA, Duramed shall assume all regulatory responsibilities under applicable laws in connection with the Product and the Product NDA, including (a) responding to all medical inquiries, (b) responsibility for reporting any adverse drug events in connection with the Product, (c) responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time, and (d) responsibility for any and all fee obligations for holders or owners of approved NDAs and Regulatory Approvals relating to the Product, including those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. In connection therewith, Shire shall promptly after Closing deliver to Duramed all records, documentation and other information that Shire has prepared or has had prepared regarding the development, efficacy, safety and legal compliance of the Product, including all correspondence with Regulatory Authorities or other government/health agencies related to the Product. Shire acknowledges that pursuant to the terms of the Pharmacovigilance Agreement, Shire shall be responsible for compliance with certain of the foregoing obligations following the Closing. Without limiting Shire’s obligations under the Pharmacovigilance Agreement, Shire shall cooperate with Duramed following the Closing to provide reasonable assistance in connection with Duramed’s regulatory obligations related to the Product for a period of [*].

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      3.3 Marketing Activities . Immediately following the Closing, Shire and Duramed shall send correspondence to each customer and supplier of the Product, and any other relevant third party agreed to by Shire and Duramed, informing each such party of the sale and transfer of the Product to Duramed, in substantially the form attached hereto as Exhibit F .

      3.4 Right of Reference . Duramed shall grant Shire a right of cross-reference or right of reference, including as that term is defined in 21 C.F.R. Section 314.3(b), to all existing Regulatory Approvals, Drug Master Files (" DMFs "), and other regulatory submissions relating to the Product. At Shire’s request [*], Duramed shall provide a copy of any regulatory application or file relating to Product that is the subject of a right of cross-reference or right of reference pursuant to this Section.

ARTICLE 4
REPRESENTATIONS AND WARRANTIES

      4.1 Representations and Warranties of Shire . Shire represents and warrants to Duramed solely as of the date of this Agreement, subject to such exceptions as are specifically disclosed in the disclosure schedule supplied by Shire to Duramed and dated as of the date hereof (the " Shire Disclosure Schedule ") as follows:

           (a) Organization and Standing . Shire is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its formation, with full corporate power and authority to carry on the Adderall Business and to own or lease and to operate its properties in the places where such business is conducted and such properties are owned, leased or operated.

           (b) Power and Authority . Shire has all requisite corporate power and authority to execute, deliver, and perform this Agreement, and the other Transaction Agreements, and the other agreements and instruments to be executed and delivered by it pursuant hereto and thereto, and to consummate the transactions contemplated herein and therein.

           (c) No Conflicts . The execution, delivery and performance by Shire of this Agreement and the other Transaction Agreement, and the consummation of the transactions contemplated hereby and thereby, do not and will not conflict with or result in a violation of or a default under (with or without the giving of notice or the lapse of time or both) (i) any applicable law, (ii) the certificate of incorporation or by-laws or other organizational documents of Shire, or (iii) any Contract or other contract, agreement, instrument, judgment, order or decree to which Shire is a party or by which Shire may be bound or affected.

           (d) Financial Information . Shire has provided to Duramed [*], and for the [*] (" Financial Information "). Such information was derived from the books and records of Shire and was prepared by Shire in good faith and fairly presents, in all material respects, the sales of Product in the Territory for the periods shown. No representations or warranties whatsoever are made with respect to any financial projections.

           (e) Corporate Action; Binding Effect . Shire has duly and properly taken all action required by law, its organizational documents, or otherwise, to authorize the execution, delivery, and performance by it of this Agreement, the other Transaction Agreements, and the

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other agreements and instruments to be executed and delivered by it pursuant hereto and thereto and the consummation of transactions contemplated hereby and thereby. This Agreement has been duly executed and delivered by Shire and constitutes, and the other Transaction Agreements and the other agreements and instruments contemplated hereby and thereby when duly executed and delivered by Shire will constitute, legal, valid, and binding obligations of Shire enforceable against it in accordance with their respective terms, except as enforcement may be affected by bankruptcy, insolvency, or other similar laws and by general principles of equity.

           (f) Consents . No consent or approval of, or filing with or notice to, any Regulatory Authority or Governmental Authority is required or necessary to be obtained by Shire or on its behalf in connection with the execution, delivery, and performance of this Agreement or to consummate the transactions contemplated hereby and thereby, except (i) in connection with the transfer of the Product Registrations, (ii) the notification requirements of the HSR Act, or (iii) as relates solely to Duramed.

           (g) Assets .

           (i) Shire or one of its Affiliates owns and has good and marketable title to all the Purchased Assets, in each case free and clear of any and all Liens other than Permitted Liens.

                (ii) Except for Excluded Assets, there are no assets or properties used in the operation of the Adderall Business and owned by any Person other than Shire that will not be sold or licensed to Duramed hereunder. The Purchased Assets [*] for the [*] or are [*], and [*] and, [*] Shire [*] the Purchased Assets [*] or in the [*] with the [*].

           (a) Litigation or Disputes . Except as set forth on Schedule 4.1(h) , there is no claim, action, suit, demand, citation, grievance, subpoena, inquiry, proceeding, investigation, or arbitration relating to the Product, the Purchased Assets or the Adderall Business pending or, to Shire’s knowledge, threatened against Shire or any of its Affiliates by or before any Regulatory Authority, federal, state, or other governmental court, department, commission, or board (whether domestic or foreign). Except as set forth on Schedule 4.1(h) , there is not currently outstanding against Shire or any of its Affiliates any judgment, decree, injunction, rule or order of any Regulatory Authority or Governmental Authority relating to the Purchased Assets or the Adderall Business.

           (i) Licensed Patents, Technical Data and Other Intellectual Property .

                (i) Shire owns or has the lawful right and license to use the Licensed Patents.

                (ii) Shire has not received any written notice, and Shire otherwise has no knowledge of, the infringement by any Person of any Licensed Patent or the Technical Data.

                (iii) Shire owns all of the Technical Data. The Technical Data contains all of the technical, scientific, chemical, biological, pharmacological and toxicological data generated by Shire for the Product.

                (iv) Shire has the full right, power and authority to grant the Licenses as described herein.

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                (v) The Licensed Patents have been duly registered with, filed in or issued by, as the case may be, the United States Patent and Trademark Office and the Canadian Intellectual Property Office.

                (vi) No claim or demand of any Person has been made nor is there any proceeding that is pending, or to the knowledge of Shire, threatened, which (i) challenges the rights of Shire in respect of the Licensed Patents, Technical Data, Product Trademark or Product Trade Dress or (ii) asserts that Shire or any of its Affiliates is infringing, or is otherwise in conflict with, or is required to pay any royalty, license fee, charge or other amount with regard to, any such Intellectual Property of any third party. None of the Licensed Patents, Technical Data, Product Trademark or Product Trade Dress is subject to any outstanding order, ruling, decree, judgment or stipulation by or with any court, arbitrator, or administrative agency. To Shire’s knowledge, the sale of the Product does not infringe or otherwise conflict with any rights of any Person in respect of any Intellectual Property.

           (j) Compliance with Laws . Shire has conducted its operations in connection with the Purchased Assets and the manufacture and sale of the Product in the Territory in material compliance with all applicable laws. Except as set forth on Schedule 4.1(j) , Shire has not received any written notice of violation of any applicable law from any Regulatory Authority or Governmental Authority relating to the Adderall Business, the Purchased Assets or the Product within the past [*].

           (k) Regulatory Issues . Except as set forth in Schedule 4.1(k) , during the [*] prior to the date of this Agreement, with respect to the Product in the Territory, the Purchased Assets or the Adderall Business, neither Shire nor any of its Affiliates has received or been subject to (i) any FDA Form 483’s relating to the Product, (ii) any FDA Notices of Adverse Findings relating to the Product, or (iii) any warning letters or other written correspondence from the FDA or any other Regulatory Authority concerning the Product in which the FDA or such other Regulatory Authority asserted that the operations of Shire were not in compliance with applicable law, with respect to the Product or the Adderall Business. Except as discussed in Schedule 4.1(k) or as would not have a Product Material Adverse Effect, during the last [*] there has not been any occurrence of any product recall, market withdrawal or replacement, or post-sale warning conducted by or on behalf of Shire concerning the Product, any product recall, market withdrawal or replacement conducted by or on behalf of any entity as a result of any alleged defect in the Product or the Technical Data.

           (l) Product Warranties . Except for warranties arising solely pursuant to applicable law, (i) Shire has not made any warranties express or implied, written or oral, to any third party with respect to the Product and (ii) there are no pending or threatened claims with respect to any such warranty, and except for the warranties arising solely pursuant to applicable law, Shire has no any liability with respect to any such warranty, whether known or unknown, absolute, accrued, contingent or otherwise and whether due or to become due.

           (m) Taxes . There are no Liens for Taxes upon the Purchased Assets or the rights granted under the Licenses except for Permitted Liens. None of the Purchased Assets is "tax-exempt use property" within the meaning of Section 168 of the Code.

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           (n) Other . In the past [*], to Shire’s knowledge (i) there has not been a Product Material Adverse Effect that is not otherwise generally known to the public, and (ii) the Product has been distributed by Shire only in the United States.

      4.2 Disclaimer of Warranties . EXCEPT AS EXPRESSLY PROVIDED HEREIN, SHIRE PROVIDES THE PURCHASED ASSETS AND LICENSES "AS IS" AND SHIRE DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH REGARD TO THE PURCHASED ASSETS AND THE LICENSES, INCLUDING THE WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

      4.3 Representations and Warranties of Duramed . Duramed represents and warrants to Shire, subject to such exceptions as are specifically disclosed in the disclosure schedule supplied by Duramed to Shire and dated as of the date hereof (the " Duramed Disclosure Schedule "), as follows:

           (a) Organization and Standing . Duramed is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its formation.

           (b) Power and Authority . Duramed has all requisite corporate power and authority to execute, deliver, and perform this Agreement, and the other Transaction Agreements, and the other agreements and instruments to be executed and delivered by it pursuant hereto and thereto, and to consummate the transactions contemplated herein and therein.

           (c) No Conflicts . The execution, delivery and performance by Duramed of this Agreement and the other Transaction Agreement, and the consummation of the transactions contemplated hereby and thereby, do not and will not conflict with or result in a violation of or a default under (with or without the giving of notice or the lapse of time or both) (i) any law applicable to Duramed, (ii) the certificate of incorporation or by-laws or other organizational documents of Duramed or (iii) except as set forth in Section 4.3(c) of Duramed Disclosure Schedule, any Contract or other contract, agreement, instrument, judgment, order or decree to which Duramed is a party or by which Duramed may be bound or affected, except in the case of clauses (iii), as would not have a Duramed Material Adverse Effect.

           (d) Corporate Action; Binding Effect . Duramed has duly and properly taken all action required by law, its organizational documents, or otherwise, to authorize the execution, delivery, and performance by it of this Agreement, the other Transaction Agreements, and the other agreements and instruments to be executed and delivered by it pursuant hereto and thereto and the consummation of transactions contemplated hereby and thereby. This Agreement has been duly executed and delivered by Duramed and constitutes, and the other Transaction Agreements and the other agreements and instruments contemplated hereby and thereby when duly executed and delivered by Duramed will constitute, legal, valid, and binding obligations of Duramed enforceable against it in accordance with their respective terms, except as enforcement may be affected by bankruptcy, insolvency, or other similar laws and by general principles of equity.

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           (e) Litigation or Disputes; Compliance with Laws . There is no claim, action, suit, demand, citation, grievance, subpoena, inquiry, proceeding, investigation, or arbitration pending or, to Duramed’s knowledge, threatened against Duramed by or before any Regulatory Authority, federal, state, or other governmental court, department, commission, or board (whether domestic or foreign) and, to Duramed’s knowledge, Duramed is not in violation of or in default with any applicable law, the result of any of which, either individually or cumulatively, would have a Duramed Material Adverse Effect.

           (f) Consents . No consent or approval of, or filing with or notice to, any Regulatory Authority or Governmental Authority is required or necessary to be obtained by Duramed in connection with the execution, delivery, and performance of this Agreement or the other Transaction Agreements or to consummate the transactions contemplated hereby and thereby, except (i) in connection with the transfer of the Product Registrations, (ii) the notification requirements of the HSR Act or (iii) as relates solely to Shire.

           (g) Financing . As of the date of this Agreement, Duramed has access to, and as of the Closing Date, Duramed will have, sufficient funds necessary to pay the Purchase Price.

      4.4 Survival of Representations/Warranties . All of the representations and warranties of Shire contained in Section 4.1 shall survive the Closing and continue in full force and effect for a period of [*] thereafter, provided that (a) all representations and warranties provided in Sections 4.1(b), 4.1(c), 4.1(f), and 4.1(g), shall survive [*] and (b) the representations and warranties set forth in Section 4.1(m) shall survive until [*] after the end of the applicable statute of limitations. All of the representations and warranties set forth of Duramed contained in Section 4.3 shall survive the Closing and continue in full force and effect for a period of [*] thereafter, provided that all representations and warranties provided in Sections 4.3(b), 4.3(c), 4.3(d) and 4.3(f) shall survive [*].

      4.5 Brokers . Each Party represents that no agent, broker, investment banker, financial advisor or other Person, is or will be entitled to any brokers’ or finder’s fee or any other commission or similar fee in connection with this Agreement or any of the transactions contemplated hereby.

ARTICLE 5
CONDITIONS TO CLOSING

      5.1 Conditions to Obligations of Duramed . The obligations of Duramed hereunder to consummate the transactions contemplated by this Agreement are subject to the fulfillment, at or before the Closing, as applicable, of each of the following conditions (all or any of which may be waived in whole or in part by Duramed, but only in writing, in its sole discretion):

           (a) Representations and Warranties . The representations and warranties made by Shire in this Agreement shall be true and correct in all material respects on and as of the Closing Date as though made on and as of the Closing Date or, in the case of representations and warranties made as of a specified date earlier than the Closing Date, on and as of such earlier date.

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           (b) Performance . Shire shall have performed and complied with, in all material respects, the agreements, covenants and obligations required by this Agreement to be so performed or complied with by Shire at or before the Closing.

           (c) Orders and Laws . There shall not be in effect on the Closing Date any judgment, order, decree, ruling or charge restraining, enjoining or otherwise prohibiting or making illegal the consummation of any of the transactions contemplated by this Agreement. No court or other Governmental Authority shall have determined any applicable law to make illegal the consummation of the transactions contemplated hereby, and no proceeding with respect to the application of any such applicable law to such effect shall be pending.

           (d) HSR . The applicable waiting period under the HSR Act, if any, shall have been terminated or expired.

           (e) Effective Date . The Settlement Agreement shall have become effective in accordance with its terms.

           (f) Deliveries . Shire shall have executed and delivered the item described in Section 2.7(d) .

           (g) FDA Letter . The FDA Letter shall have been executed by Duramed and Shire in preparation for filing.

           (h) Product Material Adverse Effect . There shall not have occurred, or be continuing, a Product Material Adverse Effect.

           (i) Other Agreements . Duramed and Shire or its Affiliate shall have executed and delivered the other Transaction Agreements.

      5.2 Conditions to Obligations of Shire . The obligations of Shire hereunder to consummate the transactions contemplated by this Agreement are subject to the fulfillment, at or before the Closing, as applicable, of each of the following conditions (all or any of which may be waived in whole or in part by Shire, but only in writing, in its sole discretion):

           (a) Representations and Warranties . The representations and warranties made by Duramed in this Agreement shall be true and correct in all material respects on and as of the Closing Date as though made on and as of the Closing Date or, in the case of representations and warranties made as of a specified date earlier than the Closing Date, on and as of such earlier date.

           (b) Performance . Duramed shall have performed and complied with, in all material respects, the agreements, covenants, and obligations required by this Agreement to be so performed or complied with by Duramed at or before the Closing.

           (c) Orders and Laws . There shall not be in effect on the Closing Date any judgment, order, decree, ruling or charge restraining, enjoining, or otherwise prohibiting or making illegal the consummation of any of the transactions contemplated by this Agreement. No court or other Governmental Authority shall have determined any applicable law to make illegal

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the consummation of the transactions contemplated hereby or by the other Transaction Agreements, and no proceeding with respect to the application of any such applicable law to such effect shall be pending.

           (d) HSR . The applicable waiting period under the HSR Act, if any, shall have been terminated or expired.

           (e) Effective Date . The Settlement Agreement shall have become effective in accordance with its terms.

           (f) Deliveries . Duramed shall have executed and delivered to Shire the items described in Section 2.7(b) and 2.7(d) .

           (g) FDA Letter . The FDA Letter shall have been executed by Shire and Duramed in preparation for filing.

           (h) Other Agreements . Duramed and Shire or its Affiliate shall have executed and delivered the other Transaction Agreements.

ARTICLE 6
COVENANTS

      6.1 HSR Filing .

           (a) To the extent necessary, each of Duramed and Shire shall simultaneously with the filing of the Settlement Agreement with the Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice, file with the Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice 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. The Parties shall 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 and in the response to any request for information, including any Second Request for information issued under the HSR Act. Each Party shall be responsible for its own costs and expenses associated with any filing under the HSR Act; provided, however, that Duramed shall be responsible for all filing fees required by the HSR Act.

           (b) Duramed and Shire will cooperate and use all reasonable efforts to make all other registrations, filings and applications, to give all notices and to obtain as soon as practicable all governmental and other consents, transfers, approvals, orders, qualifications, authorizations, permits and waivers, if any, and to do all other things, necessary or desirable for the consummation of the transactions contemplated hereby.

           (c) Duramed shall be [*] of this Agreement, or [*] of the HSR waiting period by the FTC and/or DOJ, including [*] Section 7A(e) of the Clayton Act and 16 C.F.R. Section 803.20 .

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      6.2 Conduct of the Business Until Closing . Except for the actions taken or omitted to be taken pursuant to the prior written consent of Duramed, which consent shall not be unreasonably withheld or delayed, from the date of this Agreement until the Closing, Shire shall:

           (a) carry on the Adderall Business in, and only in, the ordinary course, in substantially the same manner as heretofore conducted;

           (b) perform in all material respects all of its obligations under any agreements and instruments relating to or affecting the Purchased Assets, and comply in all material respects with all laws applicable to it, the Purchased Assets or the Adderall Business;

           (c) not enter into or assume any material agreement, contract or instrument relating to the Purchased Assets, or enter into or permit any material amendment, supplement, waiver or other modification in respect thereof; and

           (d) not make any material change in the selling, distribution, pricing, advertising or collection practices for the Product, including any special effort or program to sell, consign or solicit order for the Product to customers or to discount, factor or collect sooner than normal any accounts receivable.

      6.3 Post-Closing Orders and Payments . From and after the Closing Date, Shire shall (i) not accept any purchase orders on behalf of Duramed, (ii) promptly deliver to Duramed any purchase orders for Product received after the Closing and any payments received from third parties for Product purchased from Duramed after the Closing, and (iii) refer all inquiries it shall receive with respect to the Product, to Duramed or its designee. Likewise, Duramed shall promptly deliver to Shire any payments Duramed receives from third parties for Product purchased from Shire prior to the Closing.

      6.4 Right to Investigate . After the date hereof up to the Closing, Shire shall afford to representatives of Duramed reasonable access to offices, plants, properties, books and records of Shire relating to the Product and the Purchased Assets, during normal business hours, in order that Duramed may have an opportunity to make such reasonable investigations as it desires with respect to the Product.

      6.5 Retention of Records . Shire will, and will cause each of its Affiliates to, retain all books and records relating to the Adderall Business and the Purchased Assets in the United States in accordance with Shire’s record retention policies as presently in effect or as otherwise required by law.

      6.6 Non-Solicitation .

           (a) During the period commencing upon the signing of this Agreement and ending upon the first anniversary of the Closing Date, Duramed (which for purposes of this Section 6.6 includes its Affiliates) shall not, either directly or indirectly, solicit, recruit, induce, encourage or attempt to solicit, recruit, induce or encourage any employee of Shire or its Affiliates who work, or at any time within [*] prior to the Closing Date, worked, on matters involving the Product to terminate his or her employment relationship with Shire or its Affiliates and become employed by Duramed or become employed by an independent contractor for

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Duramed, whether or not such employee is a full-time employee and whether or not such employment relationship is pursuant to a written agreement or is at-will. Nothing in this Section 6.6(a) shall apply if the employee is hired in response to a public advertisement or general solicitation disseminated by either Party.

           (b) Prior to the Closing Date, neither Shire nor any of its Affiliates or any Person acting on their behalf shall (i) solicit or encourage any inquiries or proposals for, or enter into any discussions with respect to, the acquisition of any properties and assets held for use in connection with, necessary for the conduct of, or otherwise material to, the Adderall Business (an " Acquisition Transaction ") or (ii) furnish or cause to be furnished any non-public information concerning the Adderall Business to any Person (other than Duramed), for purposes of facilitating an Acquisition Transaction. Shire shall promptly notify Duramed of any inquiry or proposal received by Shire with respect to any such Acquisition Transaction. Shire shall not sell, transfer or otherwise dispose of, grant any option or proxy to any Person with respect to, create any Lien upon, or transfer any interest in, any Purchased Asset, other than in the ordinary course of business and consistent with this Agreement.

      6.7 Managed Markets .

           (a) On the Closing Date and to the extent permitted by applicable law, Duramed shall become responsible for the marketing and promotion of Duramed Labeled Product across all managed market and government segments in the Territory and with respect thereto, shall have exclusive responsibility for: (i) contract execution, (ii) government reporting, rebate and chargeback processing and payment, federal supply schedule calculations and pricing schedules, (iii) contract compliance, monitoring and audits, and (iv) contract administration and claims processing (collectively, the " Managed Market Activities "). Without limiting the generality of the foregoing, with respect to rebates under Medicaid and federal supply service contracts, Duramed shall assume following the Closing Date responsibility therefor under its own Medicaid and federal supply service contracts. On or prior to the Closing Date Duramed shall have obtained its own NDC number for the Product and shall ensure that all sales of Product by Duramed can be accomplished under the NDC number of Duramed. Duramed shall use its new NDC numbers on all invoices, orders and other communications with customers and Regulatory Authorities or other governmental entities. Following the Closing Date, Duramed shall be responsible for the processing, payment, administration and support of ( x ) all chargebacks under any government, managed market or other contract (" Chargebacks ") and ( y ) all rebates due pursuant to any United States government (federal or state) rebate program under any government, managed market or other contract (" Rebates ") for Duramed Labeled Product. Shire shall be responsible for the processing, payment, administration and support of all Chargebacks and Rebates for Shire Labeled Product.

           (b) Shire shall provide Duramed with all information relating to the Product and the prices thereof that Duramed reasonably requires in order to comply with applicable rules and regulations relating to Medicaid Rebates. When requested, such information shall be provided by Shire to Duramed promptly, and in any event, within [*] after Duramed’s written request therefor. Promptly after the Closing Date, Shire shall provide Duramed with the baseline Average Manufacturers Price (" AMP ") for the Product. Within [*] after the end of the [*] after

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the Closing Date, Duramed shall calculate a unit (tablet/capsule) AMP and "Best Price" for the Product and provide such calculations in writing to Shire.

           (c) Shire shall provide to Duramed within [*] after request therefor all information reasonably requested by Duramed to enable Duramed to calculate the price to be paid for each Product by a "covered entity" under the Public Health Service Act, as defined in 42 U.S.C. § 256b(a)(4).

           (d) Shire shall use reasonable best efforts to terminate all Contracts providing for the payment of commercial Rebates with respect to the Product (" Rebate Contracts ") as of the [*] following the Closing. Shire shall not assign to Duramed, and Duramed shall not assume from Shire, any of the Rebate Contracts. Shire shall continue processing Rebates owed under the Rebate Contracts with respect to Product dispensed prior to the termination of such Rebate Contracts. Upon Closing, Shire shall issue a letter to commercial Rebate customers advising such customers of Shire’s responsibilities in connection with Rebate Contracts and associated Rebates.

           (e) Shire shall use reasonable best efforts to terminate all Contracts providing for payment of Chargebacks to government and commercial customers with respect to Product (" Chargeback Contracts ") upon Closing. Shire shall not assign to Duramed, and Duramed shall not assume from Shire, any of the Chargeback Contracts. Upon Closing, Shire shall issue a letter to the trade (wholesalers and distributors) and to commercial Chargeback customers advising such customers of Shire’s responsibilities in connection with Chargeback Contracts and associated Chargebacks and administrative fees.

      6.8 Returns . From and after the Closing Date (a) Shire shall be solely responsible, at its own cost and expense, for the processing, payment, administration and support of all returns of Shire Labeled Product, regardless of when the return is made, and (b) Duramed shall be solely responsible, at its own cost and expense, for the processing, payment, administration and support of all returns of Duramed Labeled Product. If any quantities of Duramed Labeled Products are returned to Shire, Shire shall notify Duramed as soon as practicable and ship them to the facility designated by Duramed at Duramed’s cost. Shire, at its option, may advise the customer who made the return that Duramed Labeled Products should have been returned to Duramed. At Duramed’s request, Shire shall destroy the Duramed Labeled Products and Duramed shall reimburse Shire for such cost of destruction. If any quantities of Shire Labeled Products are returned to Duramed, Duramed shall notify Shire as soon as practicable and ship them to the facility designated by Shire at Shire’ cost. At Shire’s request, Duramed shall destroy Shire Labeled Products and Shire shall reimburse Duramed for such cost of destruction.

      6.9 Certain Sales . Duramed shall not sell any Product following the Closing Date under Shire’s NDC Number or any Shire labeling or packaging material for the Product. Shire shall not sell any Product following the Closing except pursuant to the Supply Agreement.

ARTICLE 7
INDEMNIFICATION

      7.1 Indemnification by Shire . From and after the Closing, Shire shall reimburse and indemnify Duramed, Duramed’s Affiliates, and their respective officers, directors, employees,

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and agents in respect of, and hold each of them harmless from and against, any and all Losses suffered, incurred, or sustained by any of them or to which any of them becomes subject, resulting from, arising out of, or relating to:

           (a) the Retained Liabilities or the Excluded Assets;

           (b) any misrepresentation or breach of representation or warranty by Shire made or contained in this Agreement;

           (c) any failure of Shire to materially perform or observe any covenant or agreement to be performed or observed by Shire pursuant to this Agreement;

           (d) any action or inaction of Shire with respect to the Purchased Assets prior to the Closing Date, except for Losses arising as a result of Liabilities expressly included in the Assumed Liabilities; and

           (e) any product liability claim with respect to the Shire Labeled Product sold prior to the Closing.

      7.2 Indemnification by Duramed . From and after the Closing, Duramed shall reimburse and indemnify Shire, Shire’s Affiliates and their respective officers, directors, employees, and agents in respect of, and hold each of them harmless from and against, any and all Losses suffered, incurred, or sustained by any of them or to which any of them becomes subject, resulting from, arising out of, or relating to:

           (a) the Assumed Liabilities;

           (b) any misrepresentation or breach of representation or warranty by Duramed made or contained in this Agreement;

           (c) any failure by Duramed to materially perform or observe any covenant or agreement to be performed or observed by Duramed pursuant to this Agreement; and

           (d) any action or inaction of Duramed with respect to the Purchased Assets after the Closing Date.

      7.3 Limitation of Liability .

           (a) Notwithstanding anything to the contrary contained in this Agreement, no amounts of indemnity shall be payable as a result of any claim in respect of a Loss arising under Section 7.1 unless and until the indemnified parties thereunder have suffered, incurred, sustained, or become subject to Losses referred to in such Sections in excess of [*] in the aggregate (in which event the indemnifying Party shall be liable for the entire amount of such Losses).

           (b) The maximum aggregate liability of Shire under this Article 7 shall not exceed [*], provided, however, that Losses related to or arising out of any Third Party Claim shall not be subject to any such limitation.

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           (c) Notwithstanding anything to the contrary contained in this Agreement, no amounts of indemnity shall be payable as a result of any claim in respect of a Loss arising under Sections 7.1 or 7.2:

                (i) with respect to any Loss, to the extent that the Party seeking indemnification had a reasonable opportunity, but failed, in good faith to mitigate the Loss; or

                (ii) with respect to any Loss, to the extent that such Loss is caused by (A) any misrepresentation or breach of warranty, covenant or agreement by the Party seeking indemnification in the Agreement or (B) the gross negligence or intentional misconduct of such Party or its Affiliates or any of their respective officers, directors, employees, or agents.

           (d) No Party hereto shall be entitled to any indemnification under Section 7.1(b) or Section 7.2(b), as applicable, if (i) the other Party shall have notified such Party in writing on or prior to the Closing Date, or disclosed to such Party in the Shire Disclosure Schedule or the Duramed Disclosure Schedule, as applicable and as may be supplemented or amended prior to the Closing Date, of the breach of, or inaccuracy in, such representation or warranty and (ii) such Party has permitted the Closing to occur.

      7.4 No Consequential Damages . IN NO EVENT SHALL ANY PARTY BE LIABLE TO ANY OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, EXCEPT TO THE EXTENT THAT SUCH DAMAGES ARISE FROM THIRD PARTY CLAIMS SUBJECT TO INDEMNIFICATION UNDER ARTICLE 7.

      7.5 Procedures for Indemnification for Third Party Claims .

           (a) In the case of a third party claim or demand (" Third Party Claim ") made by any Person who is not a Party to this Agreement (or an Affiliate thereof) as to which a Party (the " Indemnitor ") may be obligated to provide indemnification pursuant to this Agreement, such Party seeking indemnification hereunder (" Indemnitee ") will notify the Indemnitor in writing of the Third Party Claim (and specifying in reasonable detail the factual basis for the Third Party Claim and to the extent known, the amount of the Third Party Claim) reasonably promptly after becoming aware of such Third Party Claim; provided, however, that failure to give such notification will not affect the indemnification provided hereunder except to the extent the Indemnitor shall have been actually prejudiced as a result of such failure.

           (b) If a Third Party Claim is made against an Indemnitee, the Indemnitor will be entitled, within [*] after receipt of written notice from the Indemnitee of the commencement or assertion of any such Third Party Claim, to assume the defense thereof (at the expense of the Indemnitor) with counsel selected by the Indemnitor and reasonably satisfactory to the Indemnitee, for so long as the Indemnitor is conducting a good faith and diligent defense. Should the Indemnitor so elect to assume the defense of a Third Party Claim:

                (i) the Indemnitor will not be liable to the Indemnitee for any legal or other expenses subsequently incurred by the Indemnitee in connection with the defense thereof; provided, however, that if under applicable standards of professional conduct a conflict of

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interest exists between the Indemnitor and the Indemnitee in respect of such claim, such Indemnitee shall have the right to employ separate counsel (which shall be reasonably satisfactory to the Indemnitor) to represent such Indemnitee with respect to the matters as to which a conflict of interest exists and in that event the reasonable fees and expenses of such separate counsel shall be paid by such Indemnitor; and provided further, that the Indemnitor shall only be responsible for the reasonable fees and expenses of one separate counsel for such Indemnitee;

                (ii) so long as the Indemnitor is conducting the defense of the Third Party Claim in accordance with Section 7.1 or 7.2, as the case may be, the Indemnitee may retain separate co-counsel at its sole cost and expense and participate if reasonably practicable in the defense of the Third Party Claim;

                (iii) the Indemnitor will promptly supply to the Indemnitee copies of all material correspondence and documents relating to or in connection with such Third Party Claim and keep the Indemnitee informed of developments relating to or in connection with such Third Party Claim, as may be reasonably requested by the Indemnitee (including providing to the Indemnitee on reasonable request updates and summaries as to the status thereof); and

                (iv) all Indemnitees shall reasonably cooperate with the Indemnitor in the defense thereof (such cooperation to be at the expense, including reasonable legal fees and expenses, of the Indemnitor).

           (c) If the Indemnitor does not elect to assume control of the defense of any Third Party Claim within the [*] period set forth above, or if such good faith and diligent defense is not being or ceases to be conducted by the Indemnitor, the Indemnitee shall have the right, at the expense of the Indemnitor, after [*] notice to the Indemnitor of its intent to do so, to undertake the defense of the Third Party Claim for the account of the Indemnitor (with counsel selected by the Indemnitee), and to compromise or settle such Third Party Claim, exercising reasonable business judgment.

           (d) If the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee for a Third Party Claim, the Indemnitee will agree to any settlement, compromise, or discharge of such Third Party Claim that the Indemnitor may recommend that by its terms obligates the Indemnitor to pay the full amount of Losses (whether through settlement or otherwise) in connection with such Third Party Claim and unconditionally and irrevocably releases the Indemnitee completely from all Liability in connection with such Third Party Claim; provided, however, that, without the Indemnitee’s prior written consent, the Indemnitor shall not consent to any settlement, compromise, or discharge (including the consent to entry of any judgment), and the Indemnitee may refuse to agree to any such settlement, compromise, or discharge, that provides for injunctive or other nonmonetary relief affecting the Indemnitee. If the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee for a Third Party Claim, the Indemnitee shall not (unless required by law) admit any liability with respect to, or settle, compromise or discharge, such Third Party Claim without the Indemnitor’s prior written consent (which consent shall not be unreasonably withheld or delayed).

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      7.6 Losses That Are Not Third Party Claims . Any claim on account of Losses which does not involve a Third Party Claim shall be asserted by reasonably prompt written notice (stating in reasonable detail, the basis of such claim and a reasonable estimate of the amount thereof) given by the Indemnitee to the Indemnitor. For a period of [*] from and after receipt of the written notice, the Parties shall attempt in good faith to resolve such claim for indemnification. If the Parties are unable to resolve such claim, the Indemnitee may thereafter pursue any and all remedies at its disposal to enforce said indemnification claim.

      7.7 Termination of Indemnification Obligations . The obligations of each Party to indemnify, defend and hold harmless the other Party and other Indemnitees (a) pursuant to Sections 7.1(b) and 7.2(b) shall terminate when the applicable Survival Period expires pursuant to Section 4.4, and (b) pursuant to Sections 7.1(a), (c), (d) and (e), and Sections 7.2(a), (c) and (d) shall survive until the earlier of the expiration of the applicable statute of limitations, if any, and the sixth (6th) anniversary of the Closing Date; provided, however, that such obligations to indemnify, defend, and hold harmless shall not terminate with respect to any individual item as to which the Indemnitee shall have before the expiration of the Survival Period, made a claim by delivering a written notice (stating in reasonable detail the basis of such claim and a reasonable estimate of the amount thereof) to the Indemnitor.

      7.8 Other Matters . In the event of payment in full by an Indemnitor to any Indemnitee in connection with any Third Party Claim, such Indemnitor will be subrogated to and shall stand in the place of such Indemnitee as to any events or circumstances in respect of which such Indemnitee may have any right or claim relating to such Third Party Claim against any claimant or plaintiff asserting such Third Party Claim or against any other Person. Such Indemnitee will cooperate with such Indemnitor in a reasonable manner, and at the cost and expense of such Indemnitor, in prosecuting any subrogated right or claim.

      7.9 Other Limitations .

           (a) For the avoidance of doubt and without limitation to the provisions of Articles 4 and 5, an Indemnitor shall have no obligation to indemnify, defend and hold harmless an Indemnitee from and against any portion of Losses under Section 7.1 or Section 7.2 to the extent that such portion of such Losses results directly from any action taken by, or at the express written request of, such Indemnitee. Neither Party nor any of its respective Affiliates shall have or be subject to any liability to the other Party, its Affiliates or any other Person resulting from the distribution to, or use of any information, documents or materials made available to it by the other Party, including any information, documents or materials in any data rooms, management presentations or other form in expectation of the transactions contemplated hereby.

           (b) No liability shall arise in respect of any breach of any representation, warranty, covenant or agreement herein to the extent that liability for such breach occurs (or is increased) directly as a result of any retrospective application of a change in applicable law, or in accounting policies, procedures or practices, announced by a Governmental Authority or, if not announced in advance of taking effect, taking effect, after the Closing Date, unless Shire or Duramed, as the case may be, knew of any such retrospective application of a change in applicable law, or in such accounting policies, procedures or practices at the time of Closing.

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           (c) No Party shall be entitled to recover any Losses or other amounts due from the other Party pursuant to this Agreement by retaining or setting off amounts (whether or not such amounts are liquidated or reduced to judgment) against any amounts due or to become due from such first Party to such second Party hereunder or under any Transaction Agreement or under any document or instrument delivered pursuant hereto or thereto or in connection herewith or therewith. For the avoidance of doubt, the foregoing is without prejudice to any right of set-off expressly provided for in any Transaction Agreement, which does not involve setting off amounts due under this Agreement.

           (d) All amounts paid by Shire or Duramed under this Article 7 shall be treated for all purposes as adjustments to the Purchase Price except to the extent such treatment is not permitted by applicable law. In the event that treatment as an adjustment to the Purchase Price is disputed by any taxing authority, the Party receiving notice of such dispute shall promptly notify and consult with the other Party concerning resolution of such dispute.

      7.10 Exclusive Remedy . Other than in the case of fraud, the indemnification provided to any Person pursuant to this Article 7 shall be such Person’s sole remedy for any claims arising hereunder, or otherwise in connection with or arising out of the transactions described herein, including any breach by any Party hereto of any representation, warranty, or covenant contained in this Agreement, or in any certificate or document (to the extent such certificate or documents relate to matters covered by the representation, warranties, or covenants contained herein) required to be delivered in connection herewith, provided that nothing herein shall limit the rights of either Party to seek and obtain injunctive relief to specifically enforce the other Party’s obligations.

      7.11 Net Losses and Subrogation .

           (a) Notwithstanding anything contained herein to the contrary, the amount of any Losses incurred or suffered by an Indemnitee shall be calculated after giving effect to: (i) any insurance proceeds received by the Indemnitee (or any of its Affiliates) with respect to such Losses; (ii) any Tax benefit realized by the Indemnitee (or any of its Affiliates) arising from the facts or circumstances giving rise to such Losses; and (iii) any recoveries obtained by the Indemnitee (or any of its Affiliates) from any other third party. Each Indemnitee shall exercise its reasonable efforts to obtain such proceeds, benefits and recoveries, provided that the Indemnitee shall not be obligated to make such an insurance claim if the Indemnitee in its reasonable judgment believes that the cost of pursuing such an insurance claim together with any corresponding increase in insurance premiums or other chargebacks to the Indemnitee, as the case may be, would exceed the value of the claim for which the Indemnitee is seeking indemnification. If any such proceeds, benefits or recoveries are received by an Indemnitee (or any of its Affiliates) with respect to any Losses after the Indemnitee (or any Affiliate) has received the benefit of any indemnification hereunder with respect thereto, the Indemnitee (or such Affiliate) shall pay to the Indemnitor the amount of such proceeds, benefits or recoveries (up to the amount of the Indemnitor’s payment).

           (b) Upon making any payment to an Indemnitee in respect of any Losses, the Indemnitor will, to the extent of such payment, be subrogated to all rights of the Indemnitee (and its Affiliates) against any third party in respect of the Losses to which such payment relates. Such

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Indemnitee (and its Affiliates) and Indemnitor will execute upon request all instruments reasonably necessary to evidence or further perfect such subrogation rights.

ARTICLE 8
TERMINATION

      8.1 Termination Prior to Closing . This Agreement may be terminated at any time prior to Closing:

           (a) by mutual written consent of Duramed and Shire;

           (b) by Duramed or Shire in the event that any competent Governmental Authority indicates its intention to initiate a judicial or administrative action to obtain an order, decree or ruling to restrain, enjoin, or otherwise prohibit the transactions contemplated by this Agreement, and such order, decree, ruling, or other action shall have become final and non-appealable; or

           (c) by a Party in the event that the other Party (the " Defaulting Party ") shall have breached, or failed to comply with, any of such Defaulting Party’s obligations under this Agreement, or any representation or warranty made by the Defaulting Party shall have been incorrect in any material respects when made; or

           (d) by either Duramed or Shire if the Closing is not consummated pursuant to the terms of this Agreement prior to December 31, 2006, provided that the right to terminate the Agreement under this Section 8.1 (c) shall not be available to a Party hereto if such Party has failed to perform in all material respects its obligation under this Agreement and such failure has been the cause of, or results in, the failure of the Closing to occur on or before such date.

      8.2 Effect of Termination Prior to Closing . In the event of termination of this Agreement as provided in Section 8.1, this Agreement shall forthwith become void and there shall be no liability on the part of either Party hereto except (a) as set forth in Section 11.1, and (b) nothing herein shall relieve either Party from Liability for any breach of this Agreement prior to such termination.

ARTICLE 9
PATENT PROSECUTION, MAINTENANCE AND ENFORCEMENT

      9.1 Discretionary Duty to Maintain . Shire may, at its sole discretion and cost, maintain the Licensed Patents.

      9.2 Abandonment of Maintenance by Shire . Shire shall notify Duramed in the event it decides at any time to discontinue the maintenance of any Licensed Patent. Such notification shall be given at least [*] prior to the date on which such patent will become abandoned. Duramed shall then have the option, exercisable upon written notification to Shire, to assume full responsibility, at its discretion and sole cost, for prosecution of the affected maintenance of such patent. In the event Duramed exercises such option, such Licensed Patent shall be assigned to Duramed. Shire shall provide all assistance reasonably necessary to assign to the Duramed all rights, interests and titles of such Licensed Patent.

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      9.3 Patent Marking . Duramed and its sublicensees and Affiliates shall mark all Products made under this Agreement with a notice in accordance with 35 U.S.C. §287.

      9.4 Suits for Infringement of the Licensed Patents . If Shire or Duramed becomes aware of infringement of any patent included in the Licensed Patents by a third party, such Party shall promptly notify the other Party in writing to that effect. If, prior to the expiration of [*] from said notice, Shire has not obtained a discontinuance of such infringement or brought suit in such country against the third party infringer and such infringement is relevant in a material respect to a Product or the Purchased Assets, then Duramed shall have the right to bring suit in such country against such infringer and join Shire as a party. The foregoing shall not preclude the Parties from jointly seeking such discontinuance or bringing suit and, in any event, each Party will cooperate with the other in any suit and will have the right to consult with the other and be represented by its own counsel at its own expense. Prior to disposition of any moneys recovered, the expenses of the Parties in bringing suit shall be reimbursed out of the moneys recovered, with the Party bringing the suit being reimbursed first, then fifty percent (50%) of the remainder, if any, of moneys recovered by either Party upon final judgment or settlement of any infringement suit shall be retained by the Party bringing the suit, and fifty percent (50%) shall be paid to the other Party; provided, however, that (a) if Shire has not obtained a discontinuance of such infringement or brought suit against the third party infringer and Duramed determines to bring such suit, Duramed shall be entitled to one hundred percent (100%) of such remainder, and (b) in no event shall any Party who has not voluntarily joined in the relevant action be entitled to recovery of any damages hereunder. No settlement by a Party bringing a suit shall diminish the rights or interests of the other Party without the other Party’s written consent.

ARTICLE 10
DISPUTE RESOLUTION

      10.1 Disputes . The Parties hereby agree that all disputes arising under this Agreement shall be referred to a senior executive of Duramed and a senior executive of Shire (the " Representatives "). If any such matter has not been resolved within [*] of such referral to the Representatives either Party may invoke the provisions of Section 10.2 for such dispute. No dispute resolution procedure set forth in this Agreement shall be construed as an agreement to arbitrate under any federal or state arbitration Law, including the Federal Arbitration Act, and shall not deprive a court of competent jurisdiction from resolving any dispute arising under, or related to, this Agreement.

      10.2 Litigation . Any dispute that is not resolved as provided in the preceding Section 10.1, whether before or after termination of this Agreement, may be submitted by either Party only to any court of competent jurisdiction. This Agreement shall be governed by, and construed in accordance with, the Laws of the State of New York. The Parties unconditionally and irrevocably agree and consent to the exclusive jurisdiction of the courts located in New York, NY and waive any objection with respect thereto, for the purpose of any action, suit or proceeding arising out of or relating to this Agreement or the transactions contemplated hereby and further agree not to commence any such action, suit or proceeding except in any such court.

      10.3 Injunctive Relief . Notwithstanding anything to the contrary in this Agreement, either Party shall have the right to seek temporary injunctive relief in any court of competent

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jurisdiction as may be available to such Party under the Laws and rules applicable in such jurisdiction with respect to any matters arising out of the other Party’s performance of its obligations under this Agreement.

ARTICLE 11
GENERAL PROVISIONS

      11.1 Payment of Transaction Expenses . All legal fees and other expenses incurred on behalf of Shire in connection with the negotiation of this Agreement and the consummation of the transactions contemplated herein will be borne by Shire, whether or not the Closing shall have occurred. All legal fees and other expenses incurred on behalf of Duramed in connection with the negotiation of this Agreement and the consummation of the transactions contemplated herein will be borne by Duramed, whether or not the Closing shall have occurred.

      11.2 Access to Information Post-Closing . After the Closing, Duramed agrees to cooperate with Shire and to grant to Shire and its employees, attorneys, accountants, officers, representatives, and agents, during normal business hours and upon at least [*] advance notice, reasonable access to Duramed’s management personnel and to the records relating to the Product (including the Product Registrations) and to permit copying at Shire’s expense or, where reasonably necessary, to loan original documents relating to the Purchased Assets during the period the Purchased Assets were owned by Shire for the sole purposes of (a) any financial reporting or tax matters (including any financial and tax audits, tax contests, tax examination, preparation of any Shire’s tax returns or financial records) relating to the Product, (b) any claims or litigation involving Shire and the Purchased Assets relating to the Product, (c) any investigation of Shire being conducted by any federal, state, or local governmental authority relating to the Product, (d) any matter relating to any indemnification or representation or warranty or any other term of this Agreement, or (e) any similar or related matter. Duramed shall maintain, to the extent required by applicable law, but in any event for not less than six (6) years, all such records and documents in the United States of America and shall not destroy or dispose of any such records and documents prior to the end of such required or six (6) year period without the prior written consent of Shire.

      11.3 Notices . All notices or other communications that are required or permitted under this Agreement shall be in writing and delivered personally, sent by facsimile (and promptly confirmed by personal delivery or overnight courier as provided in this Agreement), or sent by internationally-recognized overnight courier to the addresses below. Any such communication shall be deemed to have been given (a) when delivered, if personally delivered or sent by facsimile on a Business Day (so long as promptly confirmed by personal delivery or overnight courier as provided in this Agreement), and (b) on the second Business Day after dispatch, if sent by internationally-recognized overnight courier. Unless otherwise specified in writing, the mailing addresses of the Parties shall be as described below.

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      11.4 Entire Agreement; Amendment . This Agreement, the Pharmacovigilance Agreement, the Trademark License Agreement and the Supply Agreement, including the exhibits and schedules attached hereto and thereto (each of which is herby and thereby incorporated herin and therein by reference) (collectively, the " Transaction Agreements "), sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto and supersedes and terminates all prior agreements and understandings between the Parties, which shall continue to govern the obligations of the Parties with respect to information disclosed thereunder with respect to periods prior to the Effective Date. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party. For the avoidance of doubt, the Parties agree that all covenants, promises, agreements, warranties, representations, conditions, and understandings set forth herein are made and deemed effective as of the Effective Date, and that the execution of this Agreement shall not constitute a waiver of any right or claim of either Party as of the Effective Date.

      11.5 Assignment . Neither this Agreement nor any of the rights or obligations of the Parties hereunder may be assigned by either Party without the prior written consent of the other Party; provided, however, that (a) Shire or Duramed may assign this Agreement to an Affiliate, and (b) following the Closing, either Party shall be entitled, without the prior written consent of the other, to assign its rights and obligations hereunder in connection with a merger or similar reorganization or the sale or all or substantially all of its assets. Any attempted assignment or delegation in contravention hereof shall be null and void. Subject to the foregoing, this

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Agreement and all rights and powers granted and obligations created hereby will bind and inure to the benefit of the Parties and their respective successors and assigns.

      11.6 Headings . The headings for each article and section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular article or section.

      11.7 Independent Parties . In making and performing this Agreement, Shire and Duramed shall act at all times as independent contractors and nothing contained in this Agreement shall be construed or implied for any purpose to create an agency, partnership, limited partnership, joint venture or employer and employee relationship between Shire and Duramed and this Agreement shall not be construed to suggest otherwise. At no time shall one Party make commitments or incur any charges or expenses for or in the name of the other Party.

      11.8 No Waiver . Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the fut