ASSET PURCHASE AGREEMENT by and among Vidara Therapeutics International Limited (as Purchaser), Vidara Therapeutics Holdings LLC (as Parent), Vidara Therapeutics Research Limited (as Opco) and InterMune, Inc. (as Seller) May 17, 2012 TABLE OF CONTENTS

Contract Categories: Business Finance - Purchase Agreements
EX-2.1A 2 d370181dex21a.htm ASSET PURCHASE AGREEMENT Asset Purchase Agreement

Exhibit 2.1A

Execution Copy

 

 

 

ASSET PURCHASE AGREEMENT

by and among

Vidara Therapeutics International Limited

(as Purchaser),

Vidara Therapeutics Holdings LLC

(as Parent),

Vidara Therapeutics Research Limited

(as Opco)

and

InterMune, Inc.

(as Seller)

May 17, 2012

 

 

 


TABLE OF CONTENTS

 

          Page  
ARTICLE I   
Definitions   
Section 1.1    Defined Terms      1   
Section 1.2    Construction      13   
ARTICLE II   
The Transaction   
Section 2.1    Purchase and Sale of Purchased Assets      14   
Section 2.2    Excluded Assets      15   
Section 2.3    Assumed Liabilities      15   
Section 2.4    Excluded Liabilities      16   
Section 2.5    Closing Date      16   
Section 2.6    Purchaser Obligations      16   
Section 2.7    Seller Obligations      17   
Section 2.8    Allocation of Purchase Price      17   
Section 2.9    Assignability and Consents      18   
Section 2.10    License Grant      18   
ARTICLE III   
Representations and Warranties of Seller   
Section 3.1    Organization and Authority      19   
Section 3.2    Purchased Assets; Title to Purchased Assets.      19   
Section 3.3    Consents; Non-Contravention      19   
Section 3.4    Regulatory Approvals      20   
Section 3.5    Compliance with Laws and Litigation      20   
Section 3.6    No Material Adverse Change      21   
Section 3.7    Assumed Contracts      21   
Section 3.8    Inventory and Returns.      22   
Section 3.9    Tax Matters      22   
Section 3.10    Intellectual Property      23   
Section 3.11    Product Records      24   
Section 3.12    Brokers, Finders, etc.      24   
Section 3.13    Financial Statements      25   
Section 3.14    Insurance      25   
Section 3.15    Regulatory Compliance      25   
Section 3.16    No Other Warranties      27   

 

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ARTICLE IV
Representations and Warranties of Purchaser
Section 4.1    Organization and Authority    27
Section 4.2    Consents; No Violations    28
Section 4.3    Brokers, Finders, etc.    28
Section 4.4    Financing    28
Section 4.5    Litigation    28
ARTICLE V
Covenants of Seller Prior to Closing
Section 5.1    Conduct of the Product Business Prior to Closing    29
Section 5.2    Notice of Default    29
Section 5.3    No Negotiation    29
Section 5.4    Commercially Reasonable Efforts    29
Section 5.5    Notice of Government Investigations    30
ARTICLE VI
Covenants of Purchaser and Parent Prior to Closing
Section 6.1    Notice of Default    30
Section 6.2    Commercially Reasonable Efforts    30
ARTICLE VII
Closing and Termination
Section 7.1    Conditions Precedent to Obligations of Parties    30
Section 7.2    Conditions Precedent to Purchaser’s Obligations    30
Section 7.3    Conditions Precedent to Seller’s Obligations    31
Section 7.4    Termination    32
Section 7.5    Procedure and Effect of Termination    32
ARTICLE VIII
Certain Other Covenants
Section 8.1    Necessary Efforts; No Inconsistent Action    32
Section 8.2    Public Disclosures    34
Section 8.3    Product Returns, Rebates and Chargebacks    34
Section 8.4    Transitional Trademark License    34
Section 8.5    Customer Billing    35
Section 8.6    Cooperation    35
Section 8.7    Reserved    36
Section 8.8    Tax Matters    36
Section 8.9    Notice to Customers    37
Section 8.10    Adverse Experience Reports    37
Section 8.11    Regulatory Matters    37
Section 8.12    Product Records    38

 

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Section 8.13    Employees    38
Section 8.14    Non-Competition    38
Section 8.15    Seller’s Additional Covenants and Agreements    40
ARTICLE IX
Indemnification
Section 9.1    Indemnification    41
Section 9.2    Certain Limitations    42
Section 9.3    Procedures for Third Party Claims and Excluded Liabilities    43
Section 9.4    Certain Procedures    46
Section 9.5    Guaranty    46
Section 9.6    Remedies Exclusive    46
ARTICLE X   
Miscellaneous Provisions
Section 10.1    Confidentiality    46
Section 10.2    Notices    48
Section 10.3    Bulk Transfers    49
Section 10.4    Remedies Cumulative; Specific Performance    49
Section 10.5    Further Assurances; Further Cooperation    49
Section 10.6    Amendments and Waivers    50
Section 10.7    Expenses    50
Section 10.8    Binding Effect; Benefit; Assignment    50
Section 10.9    Governing Law    51
Section 10.10    Jurisdiction    51
Section 10.11    Waiver of Jury Trial    51
Section 10.12    Arbitration    52
Section 10.13    Counterparts; Effectiveness    52
Section 10.14    Entire Agreement    53
Section 10.15    Severability    53
Section 10.16    Time is of the Essence    53

 

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ASSET PURCHASE AGREEMENT

This ASSET PURCHASE AGREEMENT (as amended from time to time, the “Agreement”), dated as of May 17, 2012 (the “Agreement Date”), is made and entered into by and among Vidara Therapeutics International Limited, an Irish company (“Purchaser”), Vidara Therapeutics Holdings LLC, a Delaware limited liability company (“Parent”), Vidara Therapeutics Research Limited, an Irish company (“Opco”) and InterMune, Inc., a Delaware corporation (“Seller”). Purchaser, Parent, Opco and Seller are sometimes collectively referred to herein as the “Parties” and separately as a “Party.”

RECITALS

WHEREAS, Seller is a biopharmaceutical company focused on developing and commercializing innovative therapies in pulmonology and hepatology;

WHEREAS, Purchaser is a biopharmaceutical company focused on the development and commercialization of differentiated specialty products to treat unmet medical needs;

WHEREAS, Seller has determined that the sale of certain products and product related intellectual property rights at this time is consistent with its current business strategy;

WHEREAS, Purchaser has determined that the acquisition of those certain products and product related intellectual property rights at this time is consistent with its current business strategy;

WHEREAS, Purchaser is a wholly-owned subsidiary of Parent and Opco is a wholly-owned, indirect subsidiary of Purchaser; and

WHEREAS, Seller desires to sell such products and product-related intellectual property rights to Purchaser, and Purchaser desires to purchase such products and product-related intellectual property rights from Seller, on the terms and subject to the conditions set forth herein.

NOW, THEREFORE, in consideration of the promises, representations, warranties, covenants and agreements contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound hereby, agree as follows:

ARTICLE I

DEFINITIONS

Section 1.1 Defined Terms. For the purposes of this Agreement, the following words and phrases shall have the following meanings whether in the singular or the plural:

AAA” shall have the meaning set forth in Section 10.12(a).

Acquisition Proposal” shall mean an indication of interest, offer or proposal to acquire Seller’s right, title and interest in and to all or any substantial portion of the Purchased Assets in a single transaction or series of related transactions (other than the transactions provided for in this Agreement).


Additional Intellectual Property” shall have the meaning set forth in Section 8.15(c).

Affiliate” shall mean with respect to any Person, any other Person which controls, is controlled by, or is under common control with such Person. For purposes of this definition, a Person shall be regarded as in control of another Person if it owns or controls, directly or indirectly, (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) entitled to vote for the election of directors or otherwise having the power to vote on or direct the affairs of such Person; and (ii) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) (or the maximum ownership interest permitted by law) of the equity interest or the power to direct the management and policies of such non-corporate entities.

Agreement” shall have the meaning set forth in the first paragraph of this Agreement.

Agreement Date” shall mean the date set forth in the first paragraph of this Agreement.

Allocation Schedule” shall have the meaning set forth in Section 2.8.

Alternate Seller Bank Account” shall have the meaning set forth in Section 2.1(b)(ii)(A).

Ancillary Agreements” shall mean the Assignment and Assumption Agreements, the Bills of Sale, the Domain Name Assignment Agreement, the Patent Assignment Agreement and the Transition Services Agreement.

Annual Period” shall mean a twelve (12) month period measured from the Closing Date, or an anniversary of the Closing Date, to the next anniversary of the Closing Date.

Antitrust Regulations” shall mean the HSR Act and any other Applicable Laws or regulations relating to antitrust or competition.

Applicable Law” shall mean all applicable provisions of all statutes, Laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, guidance documents, injunctions, awards, judgments, and permits and licenses of or from Governmental Authorities relating to or governing the use or regulation of the subject item.

Assignment and Assumption Agreements” shall mean those certain assignment and assumption agreements in the form attached hereto as Exhibit B.

Assumed Contracts” shall mean (i) the Contracts identified on Schedule 1.1(d) and (ii) any purchase orders for Product received by Seller or its Affiliates prior to the Closing Date, but not shipped prior to 11:59 p.m., PDT, on the day prior to the Closing Date.

Assumed Liabilities” shall mean the Liabilities set forth in Section 2.3.

 

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B-I Purchase Orders” shall mean (i) that certain Purchase Order No. PO10395, dated as of May 2, 2012, submitted by Seller to Boehringer-Ingelheim and (ii) that certain Purchase Order No. PO10396, dated as of May 2, 2012, submitted by Seller to Boehringer-Ingelheim, both of which are appended hereto as Exhibit F.

B-I Supply Agreement” shall mean the Supply Agreement between Seller and Boehringer-Ingelheim dated as of June 29, 2007, as amended and restated as of May 15, 2012, providing for the manufacture and supply of the Product, attached as part of Exhibit E.

Basket Amount” shall have the meaning set forth in Section 9.2(a).

Bills of Sale” shall mean those certain bills of sale in the forms attached hereto as Exhibit A.

Boehringer-Ingelheim” shall mean Boehringer Ingelheim Austria GmbH or its successor-in-interest Boehringer Ingelheim RCV GmbH & Co KG.

Business Day” shall mean a day, which is not a Saturday, a Sunday, or a statutory holiday in the United States.

Cap” shall have the meaning set forth in Section 9.2(c).

Chargebacks” shall mean chargebacks and similar payments to wholesalers and other distributors in connection with the Product.

Closing” shall have the meaning set forth in Section 2.5.

Closing Cash Payment” shall have the meaning set forth in Section 2.1(b)(i).

Closing Date” shall have the meaning set forth in Section 2.5.

Code” shall mean the United States Internal Revenue Code of 1986, as amended.

Commercial Rebates” shall mean rebates to commercial customers.

Competing Product” shall mean any product that is or is being developed to be a generic equivalent of, a generic formulation of, biosimilar or interchangeable with the Product where “biosimilar” and “interchangeable” shall have the meaning ascribed to them under the Biosimilars Act 42 USC 262(i).

Confidentiality Agreement” shall have the meaning set forth in Section 10.1(a).

Confidential Information” shall mean Purchaser Confidential Information and Seller Confidential Information.

Consent” shall have the meaning set forth in Section 2.9.

Contract” shall mean any agreement, contract, lease, consensual obligation, promise, or undertaking (whether written or oral), to which Seller or any of its Affiliates is a party (i) that

 

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relates solely or primarily to the Product, the Product Business, the Purchased Assets or the Assumed Liabilities, or (ii) that, to the extent related to the Product, is necessary for the conduct of the Product Business as conducted by Seller.

Controlled” shall mean, with respect to any of the Inventory, any of the Product Intellectual Property and any of the Product Records, that is owned or licensed (as licensor or licensee) by Seller and/or any of its Affiliates, and in which Seller has the legal authority or right to grant, convey, transfer and assign to Purchaser, all of Seller’s (and any of its Affiliates’) rights, titles and interests therein and thereto.

Copyright” shall mean U.S., international or foreign copyrights, including any and all Copyright Registrations and Applications therefor, and all exclusive rights under all such copyrights, for, in and to, or otherwise based upon any and all documents, website content, data, artwork, advertising materials, product packaging, product labels, product packaging inserts and product instructions.

Copyright Registrations and Applications” shall mean U.S., international or foreign copyright registrations, recordations and applications, and any and all renewals, extensions and reversions thereof, for which a registration or serial number may be, has been or will be assigned by the relevant Governmental Authority.

Dispute” shall have the meaning set forth in Section 10.12(a).

Domain Name Assignment Agreement” shall mean that certain domain name and webpages assignment agreement in the form attached hereto as Exhibit G.

Domain Names” shall mean any and all Internet domain names, websites and URLs, and any and all applications and registrations therefor.

Earnout” shall have the meaning set forth in Section 2.1(b)(ii)(A).

Encumbrance” shall mean claims, security interests, liens, pledges, charges, escrows, options, proxies, rights of first refusal, preemptive rights, covenants not to sue, mortgages, hypothecations, assessments, prior assignments, reversionary rights, reversionary titles, reversionary interests, title retention agreements, conditional sales agreements, indentures, deeds of trust, leases, levys or security agreements of any kind whatsoever, or any other agreements to give any of the foregoing in the future, imposed upon the subject property or item.

Environmental Law” shall mean any applicable Law relating directly or indirectly to (i) the protection of the environment (including air, water vapor, surface water, groundwater, drinking water supply, surface or subsurface land), (ii) occupational health and safety or (iii) the exposure to, or the use, storage, recycling, treatment, generation, transportation, processing, handling, labeling, recycling, release or disposal of, hazardous materials.

Exchange Act” shall have the meaning set forth in Section 3.13(a).

Excluded Assets” shall mean all assets and properties (other than the Purchased Assets) of Seller and its Affiliates, including without limitation the Excluded Data and Materials.

 

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Excluded Claim” shall mean any dispute, controversy or claim arising from or related to (i) any of the representations, warranties, covenants, agreements and/or provisions set forth in Sections 3.10, 8.14 and/or 8.15 of this Agreement, and any inaccuracy or breach thereof, (ii) any of the representations, warranties, covenants, agreements and/or provisions of this Agreement that relate to the Product Intellectual Property and any inaccuracy or breach thereof and (iii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.

Excluded Data and Materials” shall mean all case report forms, data, reports, publications, abstracts and other information, materials and patient samples generated by or for Seller or its Affiliates in the conduct of the clinical development of Interferon Gamma-1b for the treatment of patients with idiopathic pulmonary fibrosis.

Excluded Liabilities” shall have the meaning set forth in Section 2.4(a).

FDA” shall mean the United States Food and Drug Administration or any successor organization.

Financial Data” shall have the meaning set forth in Section 3.13(c).

GAAP” shall mean United States generally accepted accounting principles.

Genentech License” shall mean the License Agreement for Interferon Gamma between Connectics Corporation and Genentech, Inc. dated as of May 5, 1998, as amended.

Genentech Patents” shall mean the Patent Rights granted pursuant to the Genentech License.

Governmental Authority” shall mean the government of the applicable country in the Territory and any state, province, municipality or other political subdivision thereof or therein, or any court, tribunal, judiciary body, agency, department, board, instrumentality, panel, dispute resolution agency, patent office, trademark office, copyright office and any official authority or commission (including regulatory and administrative bodies) of any of the foregoing.

HIPAA” shall have the meaning set forth in Section 3.15(b).

HITECH” shall have the meaning set forth in Section 3.15(b).

HSR Act” shall have the meaning set forth in Section 8.1(b).

Indemnification Claim Notice” shall have the meaning set forth in Section 9.4.

Indemnified Party” shall mean the Seller Indemnified Parties or the Purchaser Indemnified Parties, as applicable, in accordance with the terms of this Agreement.

Indemnifying Party” shall mean the Purchaser, Parent or the Seller, as applicable, in accordance with the terms of this Agreement.

 

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Intellectual Property” shall mean the Copyrights, Domain Names, Know-How, Patent Rights, Trademarks and Trade Secrets.

Interferon Gamma-1b” shall mean the amino acid sequence and description set forth on Exhibit 1 to the Seller Disclosure Schedule.

Inventory” shall mean the Product, and all active pharmaceutical ingredients which are used solely or primarily in the production of the Product, that are owned or Controlled by Seller or its Affiliates on the Closing Date for Seller’s marketing and sale and which (i) are of a quality usable and salable in the ordinary course of business and (ii) in the case of the Product, comprise all unsold lots.

IPF Patient Data” shall mean data accessible through Seller’s Product regulatory safety database (e.g., the annual safety update reports provided by Seller to the FDA contained therein) and the ARISg global safety database maintained by Seller, which data exists at the time such databases are transferred by Seller to Purchaser after the Closing and which may include, among other things, safety data generated by or for Seller or its Affiliates in the conduct of the clinical development of Interferon Gamma-1b for the treatment of patients with idiopathic pulmonary fibrosis; provided, however, that for purposes of clarity, IPF Patient Data shall not be deemed to include any case report forms, data (other than the data accessible through Seller’s regulatory safety database and the ARISg global safety database described herein), reports (other than the annual safety update reports described herein), publications, abstracts and other information, materials and patient samples generated by or for Seller or its Affiliates in the conduct of the clinical development of Interferon Gamma-1b for the treatment of patients with idiopathic pulmonary fibrosis.

IRS” shall mean the United States Internal Revenue Service.

Know-How” shall mean confidential or proprietary information, including, without limitation, Trade Secrets, inventions (whether or not patentable), discoveries, developments, improvements, enhancements, concepts, ideas, methods, processes, designs, schematics, drawings, formulae, data, technical data and information, specifications, instructions, research and development information, technology and databases.

Knowledge of Purchaser” or “to Purchaser’s Knowledge” or any similar such statement shall mean Bala Venkataraman, Virinder Nohria, Rick McElheny and Brian Anderson, or any executive officer or director of Purchaser or Parent, directly involved on behalf of Purchaser or Parent in the transactions contemplated herein, has or had actual knowledge, or such knowledge as would be reasonably expected to have been obtained after reasonable inquiry, of a fact or matter.

Knowledge of Seller” or “to Seller’s Knowledge” or any similar such statement shall mean Lawrence Kahn, Yip Fong Chia, Carla Fiankin, Sandy Mohan, Frank Zampella, and Bruce Tomlinson, or any executive officer of Seller directly involved in the Product Business, has or had actual knowledge, or such knowledge as would be reasonably expected to have been obtained after reasonable inquiry, of a fact or matter.

 

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Law” shall mean any foreign, federal, state or local law, statute or any rule, or regulation promulgated by any Governmental Authority.

Liability” shall mean, collectively, any liability, indebtedness, guaranty, endorsement, claim, loss, damage, deficiency, cost, expense, obligation, responsibility, or product liability, whether fixed or unfixed, known or unknown, choate or inchoate, liquidated or unliquidated, secured or unsecured, direct or indirect, matured or unmatured, or absolute, contingent or otherwise.

Losses” shall mean any and all losses, damages, Liabilities, deficiencies, claims, proceedings, causes of action, costs (including reasonable out of pocket costs of investigation) and expenses, including interest, diminution in value, penalties, settlement costs, judgments, awards, fines, costs of mitigation, losses in connection with any Environmental Law (including any clean up or remedial action), court costs and fees (including reasonable attorneys’ fees and expenses).

Material Adverse Effect” shall mean any change, circumstance, event or effect that has had or is reasonably likely to have in the future, individually or in the aggregate, a material adverse effect on (i) the condition (financial or otherwise) or results of operation of the Product Business or the Purchased Assets or (ii) the ability of Seller to consummate the transactions contemplated by this Agreement; provided that no changes, circumstances, events or effects resulting from or arising out of the following shall be taken into account in determining whether a Material Adverse Effect has occurred: (a) the public announcement of the entering into of this Agreement or the other Ancillary Agreements or the pendency of the transactions contemplated hereby or thereby (including any cancellation or delay of customer orders, any reduction in sales, any disruption in supplier, partner or similar relationships or any loss of employees), (b) the performance by Seller of any action, or the failure to take any action, in each case at Purchaser’s written request (including email) pursuant to this Agreement or the other Ancillary Agreements, (c) general economic conditions, (d) general conditions in the industry in which the Product Business is conducted, (e) changes in GAAP or Applicable Law which have general application, (f) the failure of the business to meet any internal projections or forecasts of revenue or earnings (provided that the underlying cause of such failure shall be taken into account unless such cause is otherwise included in clause (a) through (e), or (g)), or (g) fire, flood, tornado, earthquake or other acts of nature, acts of terrorism or sabotage, war, regional, national or international calamity, military action or any other similar event or any escalation or worsening thereof after the date hereof, except to the extent, in the case of the foregoing clauses (c) through (e), such changes, circumstances, events or effects referred to therein have a materially disproportionate impact on the Product Business relative to the industry in which the Product Business competes as a whole.

Opco” shall have the meaning set forth in the first paragraph of this Agreement.

Parent” shall have the meaning set forth in the first paragraph of this Agreement.

Party” or “Parties” shall have the meaning set forth in the first paragraph of this Agreement.

 

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Patent Assignment Agreement” shall mean that certain patent assignment agreement in the form attached hereto as Exhibit D.

Patent Rights” shall mean U.S., international or foreign patents, provisional patent applications, patent applications, design registrations, design registration applications, industrial designs, industrial design applications and industrial design registrations, including any and all divisions, continuations, continuations-in-part, extensions, substitutions, renewals, registrations, revalidations, reexaminations, reissues or additions, including supplementary certificates of protection, of or to any of the foregoing items.

Permitted Encumbrances” shall mean (i) Encumbrances for Taxes, assessments and other governmental charges not yet due and payable or, if due, either (a) not delinquent or (b) being contested in good faith by appropriate proceedings, (ii) mechanics’, workmen’s, repairmen’s, warehousemen’s, carriers’ or other similar Encumbrances, including all statutory Encumbrances, arising or incurred in the ordinary course of business and not yet delinquent or, (iii) Encumbrances that do not materially affect the ownership, value or use of the underlying Purchased Asset for the purpose it is being utilized by Seller or its Affiliates on the Closing Date.

Person” shall mean any natural person, corporation, unincorporated organization, partnership, association, joint stock company, joint venture, limited liability company, trust or government, or any agency or political subdivision of any government, or any other entity.

Post-Closing Tax Period” shall have the meaning set forth in Section 8.8(c).

Pre-Closing Tax Period” shall have the meaning set forth in Section 8.8(c).

Proceeding” shall mean any litigation, claim, action, dispute, lawsuit, arbitration, dispute resolution process, cancellation proceeding, opposition proceeding, concurrent use proceeding, reexamination proceeding, nullification proceeding, interference proceeding, priority contest, challenge, protest, inquiry, change demand, order, judgment, hearing, assessment, or any other proceeding (whether civil, criminal, administrative or investigative), commenced, brought, conducted, or heard by or before any Governmental Authority or arbitrator.

Product” shall mean the finished pharmaceutical product containing Interferon Gamma-1b in the formulation approved by the FDA for the reduction of the frequency and severity of serious infections related to chronic granulomatous disease and delaying time to disease progression in patients with severe, malignant osteopetrosis and sold by Seller under the Actimmune® trademark prior to the Closing.

Product Business” shall mean the manufacturing, using, developing, promoting, advertising, marketing, distributing, selling, offering to sell, importing and/or exporting of the Product in the Territory.

Product Copyrights” shall mean any and all Copyrights (including, without limitation, any and all Copyright Registrations and Applications listed on Schedule 1.1(c)) that are Controlled by Seller and/or any of its Affiliates and that relate solely to the Product and/or the Product Business.

 

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Product Domain Names” shall mean any and all active or inactive Domain Names, that are Controlled by Seller and/or any of its Affiliates and that relate solely to the Product and/or the Product Business, as identified on Schedule 1.1(c).

Product Intellectual Property” shall mean the Product Copyrights, Product Domain Names, Product Know-How, Product Patents, Product Trademarks and Product Trade Secrets, including, without limitation, each of the foregoing as listed on Schedule 1.1(c).

Product Know How” shall mean any and all Know-How that is Controlled by Seller and/or any of its Affiliates and that relates primarily to the Product and/or the Product Business, excluding the Excluded Data and Materials.

Product Master Cell Bank” or “PMCB” shall mean collectively the following cell banks relating to the Product or the Product Business: (i) the cell bank stored at Fisher BioServices Inc. located at 14665 Rothgeb Dr., Rockville, Maryland, 20850; and (ii) the working cell bank W3110 pHF CYC5, in each of which Seller or its Affiliates have ownership or other rights or interests, whether contractual or otherwise, therein or with respect thereto.

Product Master Cell Bank Records” shall mean all records and associated agreements with third party providers relating to the development, characterization and validation of the PMCB and documenting storage, dispensing and periodic testing of Product Master Cell Bank confirming its integrity and stability, that are owned or Controlled by Seller or its Affiliates.

Product Net Sales” shall mean the gross amount invoiced by Purchaser or its Affiliates for Product sales, less: (i) reasonable and customary cash discounts consistent with the Seller’s past practices, (ii) customary rebates and Chargebacks, consistent with the Seller’s past practices and (iii) sales credits, refunds, returns and allowances accrued by Purchaser in accordance with GAAP. Such amounts shall be determined from books and records maintained by Purchaser in accordance with GAAP, consistently applied. To the extent that any accrual contemplated by the foregoing clause (iii) is subsequently adjusted in accordance with GAAP, Purchaser shall notify Seller thereof in writing and the Earnout owing hereunder in respect of the Product Net Sales corresponding to such accrued amounts shall be adjusted accordingly and the next subsequent Earnout payment hereunder shall be increased or decreased accordingly.

Product Patents” shall mean any and all Patent Rights that are Controlled by Seller and/or any of its Affiliates and that relate primarily to the Product and/or the Product Business, as identified on Schedule 1.1(c), and including, without limitation, the Genentech Patents and the Snitman Patents.

Product Records” shall mean all files, documents, instruments, papers, books and records Controlled by Seller and/or any of its Affiliates, whether in electronic or tangible form, that relate primarily to the Product, the Product Business and/or the Product Intellectual Property, including, without limitation, any and all pricing lists, customer lists, vendor lists, financial data, research and development files, marketing materials, regulatory files, adverse event reports and files; equipment specifications; analytical specifications and validation reports; Product batch records; bills of material; packaging specifications; approved and rejected vendor lists and audits; Product complaints, clinical studies and all documentation relating thereto; all

 

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documentation associated with the Product Intellectual Property; copies of all filings (and supporting documentation) with Governmental Authorities, including, but not limited to, any and all Product NDAs and BLAs; component and labeling purchasing specifications; packaging and quality control SOPs; stability data, records, charts, reports and applicable SOPs; quality assurance/control data, records, charts, reports, and applicable SOPs; budgets; pricing guidelines; ledgers; journals; Assumed Contracts; Promotional Materials; operating data and plans; sales data; target lists; file histories, file wrappers, correspondence, application documents, registration documents, search reports, documents concerning the prosecution history, enforcement or maintenance of rights, or restrictions on use, with respect to the Product Intellectual Property, whether or not required to be kept or maintained under any Law; but excluding (i) the Excluded Data and Materials and (ii) any items to the extent that any Applicable Law prohibits their transfer.

Product Returns” shall mean returns of Product by customers.

Product Trademarks” shall mean any and all Trademarks that are Controlled by Seller and/or any of its Affiliates and that relate solely to the Product and/or the Product Business, as identified on Schedule 1.1(c). “Product Trademarks” shall not include the Seller Marks.

Product Trade Secrets” shall mean any and all Trade Secrets that are Controlled by Seller and/or any of its Affiliates and that relate primarily to the Product and/or the Product Business.

Promotional Materials” shall mean any and all physician lists, customer lists, marketing studies, marketing plans and strategies, sales force training materials, market research materials, and all advertising, selling, and promotional materials and other similar information and data, including, without limitation, records of sales and cost data for the twelve (12) months ended April 30, 2012, and as of the day prior to the Closing Date, to the extent the foregoing relate primarily to the Product and/or the Product Business, and to the extent the foregoing are within the Seller’s or its Affiliates’ possession as of the Closing Date.

Property Taxes” shall have the meaning set forth in Section 8.8(c).

Purchased Assets” shall mean, collectively, the assets of Seller set forth below:

 

  (i) the Product;

 

  (ii) all Inventory identified on Schedule 1.1(a);

 

  (iii) the Assumed Contracts;

 

  (iv) the Regulatory Approvals identified on Schedule 1.1(b);

 

  (v) the Promotional Materials;

 

  (vi) the Product Records;

 

  (vii) the Product Intellectual Property;

 

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  (viii) the Product Master Cell Bank and Product Master Cell Bank Records, which are listed on Schedule 1.1(e); and

 

  (ix) all of Seller’s right, title and interest in and to each and all of the foregoing assets set forth in (i) – (viii), supra, including, without limitation, any and all of Seller’s and its Affiliates’ rights to bring any and all causes of action, either in law or in equity, for past, present or future infringement of any of the Product Intellectual Property.

Purchase Price” shall have the meaning set forth in Section 2.1(b).

Purchaser” shall have the meaning set forth in the first paragraph of this Agreement.

Purchaser Confidential Information” shall have the meaning set forth in Section 10.1(b).

Purchaser Indemnified Parties” shall have the meaning set forth in Section 9.1(a).

Purchaser Labeling” shall mean the printed labels, labeling and packaging materials, including printed carton, container labels and package inserts, to be prepared by Purchaser after the Closing Date and bearing Purchaser’s name for, or in connection with, packaging of the Product.

Quality Agreement” shall mean the Quality Agreement executed by and between Seller and Boehringer-Ingelheim in connection with the execution of the B-I Supply Agreement, which Quality Agreement will be one of the Assumed Contracts to be assigned to Opco as part of the Purchased Assets.

Regulatory Approvals” shall mean all applications for regulatory approval, including new drug applications, abbreviated new drug applications, new drug submissions, and any comparable applications and submissions, together with any and all supplements or modifications or amendments thereto, whether existing, pending, withdrawn or in draft form, prepared and submitted to any Governmental Authority in the Territory with respect to the Product, along with all supporting files, data, studies and reports relating thereto (in tangible and electronic form) and all technical and other information contained therein.

Schedules” shall refer to the schedules to this Agreement which are hereby incorporated by reference into this Agreement.

Seller” shall have the meaning set forth in the first paragraph of this Agreement.

Seller Bank Account” shall have the meaning set forth in Section 2.1(b)(i).

Seller Confidential Information” shall have the meaning set forth in Section 10.1(c).

Seller Disclosure Schedule” shall have the meaning set forth in the first paragraph of Article III.

Seller Indemnified Parties” shall have the meaning set forth in Section 9.1(b).

 

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Seller Marks” shall mean all Trademarks Controlled by Seller, other than the Product Trademarks, that are used in connection with the Product Business and the Assumed Liabilities as of the Agreement Date.

Seller SEC Filing” shall have the meaning set forth in Section 3.13(a).

Snitman Patents” shall mean United States Patent No. 6,936,695, United States Patent No. 6,936,694 (now reissued as US RE39,821E), Canadian Patent No. 1,341,561, and any and all Patent Rights related to the foregoing.

Straddle Period” shall have the meaning set forth in Section 8.8(c).

Taxes” shall mean all federal, state, local, foreign and other income, net income, gross income, gross receipts, sales, use, ad valorem, transfer, capital stock, franchise, profits, license, service, add on or alternative minimum tax, occupancy, withholding, payroll, fringe benefits, employment, employees’ income withholding, foreign or domestic withholding, unemployment, disability, excise, severance, stamp, value added, occupation, premium, property (including, real property and personal property taxes and any assessments, special or otherwise), environmental, windfall profits, customs, duties or other taxes, and any fees, assessments, levies, tariffs or charges of any kind that are in the nature of a tax, together with any interest and any penalties, additions to tax or additional amounts with respect thereto (and “Tax” means any one of the foregoing Taxes).

Tax Return” shall mean any return, declaration, report or statement required to be filed with a Governmental Authority in respect to any Tax (including any attachments thereto, and any amendment thereof), including any information return, claim for refund, amended return or declaration of estimated Tax.

Territory” shall mean the United States, Canada and Japan.

Third Party” shall mean any Person other than Purchaser, Parent, Opco or Seller, or an Affiliate of any of them.

Third Party Claim” shall mean any Proceeding at law or suit in equity by or against a Third Party as to which indemnification will be sought hereunder.

Trademarks” shall mean any and all U.S., international or foreign trademarks, service marks, trade names, service names, brand names, product names, trade dress, trade styles, logos, symbols, and other product or service source identifiers and general intangibles of a like nature, together with all goodwill associated with any of the foregoing, along with all applications, registrations, renewals and extensions therefor.

Trade Secrets” shall mean information, including, without limitation, any formula, program, device, method, technique, and/or process, that: (i) derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, any Third Party who can obtain economic value from its disclosure or use, and (ii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

 

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Transaction Documents” shall mean this Agreement and the Ancillary Agreements.

Transfer Taxes” shall have the meaning set forth in Section 8.8(b).

Transition Services Agreement” shall mean that certain transition services agreement in the form attached hereto as Exhibit C.

Treasury Regulations” shall mean the income tax regulations issued under the Code.

Section 1.2 Construction.

(a) The words “hereof,” “herein” and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement.

(b) The captions herein are included for convenience of reference only and shall be ignored in the construction or interpretation hereof. References to Articles, Sections, Exhibits, and Schedules are to Articles, Sections, Exhibits, and Schedules of this Agreement unless otherwise specified.

(c) All Exhibits and Schedules annexed hereto or referred to herein are hereby incorporated in and made a part of this Agreement as if set forth in full herein. Any capitalized terms used in any Exhibit or Schedule but not otherwise defined therein, shall have the meaning as defined in this Agreement.

(d) Any singular term in this Agreement shall be deemed to include the plural, and any plural term the singular, and words denoting either gender shall include both genders as the context requires. Where a word or phrase is defined herein, each of its other grammatical forms shall have a corresponding meaning.

(e) Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation,” whether or not they are in fact followed by those words or words of like import.

(f) The use of the word “or” shall not be exclusive.

(g) A reference to any legislation or to any provision of any legislation shall include any modification, amendment, re-enactment thereof, any legislative provision substituted therefore and all rules, regulations and statutory instruments issued or related to such legislation.

(h) Any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the construction or interpretation of this Agreement. No prior draft of this Agreement nor any course of performance or course of dealing shall be used in the interpretation or construction of this Agreement. No parol evidence shall be introduced in the construction or interpretation of this Agreement unless the ambiguity or uncertainty in issue is plainly discernable from a reading of this Agreement without consideration of any extrinsic evidence.

 

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(i) The Parties agree that any exception or qualification set forth in the Seller Disclosure Schedule with respect to a particular representation or warranty contained herein shall be deemed to be an exception or qualification with respect to other representations and warranties contained in this Agreement to the extent the applicability of the disclosure to each other representation and warranty is reasonably apparent from the text of the disclosure made. Nothing in the Seller Disclosure Schedule is intended to broaden the scope of any representation, warranty or covenant of Seller contained in this Agreement.

ARTICLE II

THE TRANSACTION

Section 2.1 Purchase and Sale of Purchased Assets.

(a) Upon the terms and subject to the conditions set forth in this Agreement, at the Closing, Seller shall sell, assign, transfer, convey and deliver to Purchaser, and Purchaser shall purchase, acquire and accept, all of Seller’s right, title and interest in and to the Purchased Assets, free and clear of all Encumbrances other than Permitted Encumbrances; provided that Opco shall purchase, acquire and accept the Inventory, B-I Supply Agreement and Quality Agreement in lieu of Purchaser.

(b) As consideration for the transactions contemplated hereby (the “Purchase Price”), Purchaser shall make the following payments to Seller:

 

  (i) Closing Cash Payment. At Closing, Purchaser shall make a cash payment of Fifty Five Million Dollars ($55,000,000) (the “Closing Cash Payment”) by wire transfer of immediately available funds to a bank account in the United States identified by Seller to Purchaser in writing at least two (2) Business Days prior to the Closing Date (the “Seller Bank Account”).

 

  (ii) Additional Consideration.

A. Earnout. On each of the one (1) year and two (2) year anniversaries of the Closing, Purchaser shall pay to Seller a cash payment (each an “Earnout” and together, the “Earnouts”) by wire transfer of immediately available funds to the Seller Bank Account or, if applicable, to an alternate bank account in the United States identified by Seller to Purchaser in writing (the “Alternate Seller Bank Account”), within forty-five (45) days following the end of each Annual Period, such amount as calculated pursuant to the formulas set forth below:

 

   

12.5% of total Product Net Sales from $0 - $10,000,000; and

 

   

7.5% of total Product Net Sales from $10,000,001 - $20,000,000.

Product Net Sales shall be calculated on an Annual Period basis and payments of the foregoing Earnouts will be paid within forty-five (45) days after the end of each three (3) month period within each of the first and second Annual Periods.

 

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  (iii) Assumed Liabilities. At the Closing, Purchaser shall assume from Seller, and thereafter pay, perform and discharge when due, the Assumed Liabilities.

(c) The B-I Purchase Orders shall constitute Assumed Contracts, provided, however, Seller shall, at Seller’s expense, pay, perform and discharge on Purchaser’s behalf when due the amounts payable to Boehringer-Ingelheim under the B-I Purchase Orders. If Closing occurs prior to the transfer of title from Boehringer-Ingelheim to Seller of Product under the B-I Purchase Orders, the Parties acknowledge and agree that Purchaser may directly instruct Boehringer-Ingelheim to ship or have shipped the Product under the B-I Purchase Orders to Opco pursuant to the terms of the B-I Supply Agreement. If Closing occurs after the transfer of title from Boehringer- Ingelheim to Seller of Product under the B-I Purchase Orders, Purchaser acknowledges and agrees that such Product shall remain at the United States facilities maintained by CORD Logistics, Inc. where CORD Logistics, Inc. shall continue to store and process the Product under the Distribution Services Agreement between CORD Logistics, Inc. and InterMune Pharmaceuticals Inc., dated January 15, 1999, as amended from time to time, but title to such Product shall be transferred to Opco, without further consideration, at the time of Closing as part of the Purchased Assets.

Section 2.2 Excluded Assets. The Parties acknowledge and agree that Seller is not selling, conveying, transferring, assigning, or delivering, or assigning any rights whatsoever to the Excluded Assets to Purchaser, and Purchaser is not purchasing, taking delivery of or acquiring any rights whatsoever to the Excluded Assets from Seller.

Section 2.3 Assumed Liabilities. Upon the terms and subject to the conditions set forth in this Agreement, at the Closing, Purchaser shall assume and agree to pay, perform or otherwise discharge, in accordance with their respective terms and subject to the respective conditions thereof, only the following Liabilities (collectively, the “Assumed Liabilities”); provided that Opco shall assume any such Liability in lieu of Purchaser with respect to the Inventory, B-I Supply Agreement and Quality Agreement:

(a) Any Liability arising on or after the Closing under any Assumed Contract (other than any Liability arising out of or relating to a breach of such Assumed Contract which occurred prior to the Closing);

(b) Any Liability arising out of the conduct of the Product Business by Purchaser after the Closing, including any Liabilities and obligations arising out of or resulting from product liability claims for the Product but only with respect to Product which is sold by Purchaser after the Closing;

(c) Any Liability arising after the Closing for Taxes imposed with respect to the Product Business or the Purchased Assets that are attributable to the ownership, sale, operation or use of the Product Business or the Purchased Assets following the Closing Date;

(d) Property Taxes and Transfer Taxes to the extent specifically allocated to Purchaser pursuant to Section 8.8; and

(e) Any other Liability specifically set forth on Schedule 2.3(e) hereto.

 

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(f) For the avoidance of doubt, the Parties acknowledge that in no event shall the provisions of this Section 2.3 be construed to limit Purchaser’s, Parent’s or Opco’s obligations under Article IX.

Section 2.4 Excluded Liabilities.

(a) The Parties hereby acknowledge and agree that, other than the Assumed Liabilities, or as otherwise specifically provided in the Transaction Documents, Purchaser shall not be responsible for, assume, or be obligated to pay, perform or otherwise discharge any Liabilities or obligations of Seller, whether or not related to the Product Business (collectively, the “Excluded Liabilities”), which Excluded Liabilities shall include, but not be limited to, (i) any obligation or Liability of Seller created as a result of this Agreement, (ii) any Liability relating to Product sold prior to the Closing Date, or the operation of the Product Business prior to the Closing Date, (iii) those items set forth on Schedule 2.4(a), and (iv) all liabilities with respect to any Taxes owed by Seller, including any liability of Seller for the Taxes of any other Person under Treasury Regulation Section 1.1502-6 (or any similar provision of state, local or foreign law), as a transferee, or as a result of a Tax sharing of similar agreement, and Taxes otherwise imposed with respect to the Product Business or the Purchased Assets that are attributable to the ownership, sale, operation or use of the Product Business or the Purchased Assets on or prior to the Closing Date. For the avoidance of doubt, the Parties acknowledge that in no event shall the provisions of this Section 2.4 be construed to limit Seller’s obligations under Article IX.

(b) The Parties hereby acknowledge and agree that, other than as provided in the Transaction Documents, Seller shall not be responsible for, assume, or be obligated to pay, perform or otherwise discharge any obligations or liabilities of Purchaser. The Parties acknowledge that in no event shall the foregoing sentence be construed to limit Seller’s obligations under Article IX.

Section 2.5 Closing Date. Unless this Agreement shall have been terminated pursuant to Article VII, the consummation of the transactions contemplated by Section 2.1 (the “Closing”) shall take place at the offices of Latham & Watkins LLP, 140 Scott Drive, Menlo Park, CA 94025 at 10:00 a.m., PDT, and in such other places as are necessary to effect the transactions to be consummated at the Closing, on the fifth (5th) Business Day immediately following the satisfaction or, to the extent permitted, waiver of all of the conditions in Article VII (other than those conditions which by their nature are to be satisfied or, to the extent permitted, waived at the Closing but subject to the satisfaction or, to the extent permitted, waiver of such conditions), or at such other time, date and place as shall be determined by mutual agreement of the Parties (such date of the Closing being herein referred to as the “Closing Date”). The Closing shall be deemed to have become effective as of 12:01 a.m., PDT on the Closing Date.

Section 2.6 Purchaser Obligations. At the Closing, Purchaser shall (i) deliver to Seller the Closing Cash Payment and (ii) execute and deliver to Seller the following:

(a) the Bills of Sale;

(b) the Assignment and Assumption Agreements;

 

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(c) the Transition Services Agreement;

(d) the Patent Assignment Agreement;

(e) the certificate required by Section 7.3(a);

(f) the Domain Name Assignment Agreement;

(g) its acknowledgment to and acceptance of the waiver and consent of Boehringer-Ingelheim, as described in Section 7.2(e) hereof; and

(h) such other documents and instruments as Seller may reasonably request to consummate the transactions described in Section 2.1.

Section 2.7 Seller Obligations. At the Closing, Seller shall execute and deliver to Purchaser, the following:

(a) the Bills of Sale;

(b) the Assignment and Assumption Agreements;

(c) the Transition Services Agreement;

(d) the Patent Assignment Agreement;

(e) the Domain Name Assignment Agreement;

(f) the B-I Supply Agreement, Quality Agreement and waiver and consent of Boehringer-Ingelheim, as described in Section 7.2(e) hereof;

(g) a confirmation receipt reflecting receipt of the Closing Cash Payment;

(h) a certificate from Seller under Treasury Regulations Section 1.1445-2 certifying Seller’s non-foreign status;

(i) the certificate required by Section 7.2(a); and

(j) such other documents and instruments as Purchaser may reasonably request to consummate the transactions described in Section 2.1.

Section 2.8 Allocation of Purchase Price. Seller and Purchaser shall allocate the Purchase Price (and Assumed Liabilities, to the extent properly taken into account under the Code) among the Purchased Assets for tax purposes in accordance with Section 1060 of the Code. A draft allocation schedule shall be prepared by Purchaser and delivered to Seller not later than thirty (30) days after the Closing Date for Seller’s review and comment. Seller and Purchaser shall work in good faith to resolve any disputes relating to the draft allocation schedule (such allocation schedule as finally agreed to by Purchaser and Seller, the “Allocation Schedule”). The Allocation Schedule shall be revised as mutually agreed by Purchaser and Seller to reflect any adjustment to the Purchase Price pursuant to the provisions of this

 

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Agreement. Purchaser and Seller shall file all Tax Returns (including, but not limited to, a Form 8594 (Asset Acquisition Statement under Section 1060 of the Code)) with respect to the transactions contemplated by this Agreement consistently with the Allocation Schedule and any adjustments thereto, unless otherwise required by Applicable Law.

Section 2.9 Assignability and Consents. Notwithstanding anything to the contrary contained in this Agreement, but subject to Section 7.2, if the sale, assignment, transfer, conveyance or delivery or attempted sale, assignment, transfer, conveyance or delivery to Purchaser of any Purchased Assets (i) is prohibited by any Applicable Law or (ii) would require any consents, waivers, approvals or authorizations of a Third Party or Governmental Authority (a “Consent”) and such Consents shall not have been obtained prior to the Closing and an attempted assignment thereof without such Consent would constitute a breach thereof, then in either case, the Closing will proceed without the sale, assignment, transfer, conveyance or delivery of such Purchased Assets and this Agreement shall not constitute an agreement for the sale, assignment, transfer, conveyance or delivery of such Purchased Asset. In the event that the Closing proceeds without the sale, assignment, transfer, conveyance or delivery of any such Purchased Asset, then following the Closing, the Parties shall use their commercially reasonable efforts, and cooperate with each other, to obtain promptly such Consents; provided, however, that Purchaser shall not be required to pay any consideration to obtain any such Consent. Pending receipt of such Consents, the Parties shall cooperate with each other in any mutually agreeable, reasonable and lawful arrangements designed to provide to Purchaser the benefits of and the obligations associated with use of such Purchased Asset that it would have obtained or been subject to had the asset been conveyed to Purchaser at the Closing. To the extent that Purchaser is provided the benefits pursuant to this Section 2.9 of any Assumed Contract, Purchaser shall (x) perform for the benefit of the other parties thereto the obligations of Seller or any Affiliate of Seller thereunder, which arise after the Closing, and (y) shall satisfy any related Liabilities with respect to such Assumed Contract that, but for the lack of a Consent to assign such obligations or Liabilities to Purchaser, would be Assumed Liabilities. Once Consent for the sale, assignment, transfer, conveyance or delivery of any such Purchased Asset not sold, assigned, transferred, conveyed or delivered at the Closing is obtained or given, Seller shall promptly assign, transfer, convey and deliver such Purchased Asset to Purchaser at no additional cost to Purchaser.

Section 2.10 License Grant. Seller hereby grants Purchaser, on Seller’s behalf and on behalf of any applicable Affiliate, a non-exclusive, royalty-free, sublicenseable license, under Know-How Controlled by Seller, to use the IPF Patient Data solely for the treatment and support of patients using the Product; provided that, for the avoidance of doubt, Purchaser shall not use any of the IPF Patient Data to seek regulatory approval of or to commercialize the Product for the treatment of idiopathic pulmonary fibrosis.

 

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ARTICLE III

REPRESENTATIONS AND WARRANTIES OF SELLER

Seller represents and warrants to Purchaser as of the date hereof, but subject to such exceptions as are specifically disclosed in the disclosure schedule referencing the appropriate Sections hereof (unless the applicability and relevance of the disclosure to another representation or warranty is readily apparent on the face of such disclosure, in which case such disclosure shall also apply to such other representations or warranty) supplied by Seller and dated as of the date hereof (the “Seller Disclosure Schedule”), as follows:

Section 3.1 Organization and Authority. Seller is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. Seller has all necessary corporate power and corporate authority, and has taken all actions necessary, to execute and deliver the Transaction Documents, and the transactions contemplated thereby, and effect the transactions contemplated thereby and has duly authorized the execution, delivery and performance of the Transaction Documents and transactions or documents contemplated thereby by all necessary corporate action. Seller has all corporate power and corporate authority necessary to own its assets and carry on the Product Business as currently being conducted by Seller. The Transaction Documents will be upon the Closing, the valid and legally binding obligations of Seller, enforceable against it in accordance with their terms, subject to applicable bankruptcy moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to general equitable principles (regardless of whether in equity or at law).

Section 3.2 Purchased Assets; Title to Purchased Assets.

(a) Except as set forth on Section 3.2 of the Seller Disclosure Schedule, the Purchased Assets collectively constitute all of the properties, rights, titles, interests and other tangible and intangible assets owned by Seller and/or any of its Affiliates and used by Seller and/or any of its Affiliates to conduct the Product Business consistent with past practice.

(b) Seller has good and marketable title to the Purchased Assets owned by Seller free and clear of any Encumbrances, except for the Permitted Encumbrances. Seller has not received any notice of any adverse claims of ownership to the Purchased Assets owned by Seller, and to Seller’s Knowledge, no facts or circumstances exist which would provide a reasonable basis for any such adverse claim of ownership of any of the Purchased Assets owned by Seller. Upon delivery to Purchaser at the Closing of the Bills of Sale, Domain Name Assignment Agreement, Patent Assignment Agreement, and the Assignment and Assumption Agreements, Seller will thereby sell, transfer, convey and assign to Purchaser good and marketable title to the Purchased Assets, free and clear of all Encumbrances other than Permitted Encumbrances, subject to the terms and conditions of this Agreement.

Section 3.3 Consents; Non-Contravention.

(a) Except for the requisite filings under the HSR Act, if any, and the expiration or termination of the waiting period thereunder, and except for all filings and other actions contemplated by the Transaction Documents (including the necessary transfer of filings, notices and approvals required to transfer the Regulatory Approvals from Seller to Purchaser), the execution, delivery and performance by Seller of the Transaction Documents and the consummation by Seller of the transactions contemplated thereby will not require any notice to, filing with, or the consent, approval or authorization of, any Person or Governmental Authority.

(b) Except as set forth on Section 3.7 of the Seller Disclosure Schedule, neither the execution and delivery of the Transaction Documents nor the consummation of the transactions

 

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contemplated thereby will (i) violate or result in a breach or result in the acceleration or termination of, or the creation in any Third Party of the right to accelerate, terminate, modify or cancel, any Assumed Contract, (ii) conflict with, violate or result in a breach of any provision of the certificate of incorporation, or by-laws of Seller, (iii) conflict with or violate in any material respect Applicable Law, or (iv) conflict with, violate or result in a breach of any material agreement, instrument or arrangement to which Seller is subject, including any agreement affecting Seller’s ownership of, or ability to assign, the Product Intellectual Property.

Section 3.4 Regulatory Approvals.

(a) Section 3.4(a) of the Seller Disclosure Schedule sets forth a complete and correct list of all Regulatory Approvals. Seller has provided to Purchaser complete and correct copies of the Regulatory Approvals or Purchaser has had access to such copies of the Regulatory Approvals.

(b) Seller is in material compliance with all of the Regulatory Approvals listed on Section 3.4(a) of the Seller Disclosure Schedule, and, since the time Seller acquired its rights in the Product, Seller has not received any notification or other communication, written or oral, from any Third Party with respect to any alleged or possible violation with respect to any such Regulatory Approvals, and to Seller’s Knowledge, there are no facts or circumstances that would form a reasonable basis for any such violation.

(c) The Regulatory Approvals are in full force and effect and have been duly and validly issued. The U.S. Regulatory Approval is in good standing, has not been revoked, rescinded, amended or modified, and, to Seller’s Knowledge, no event has occurred or notification or other communication been received by Seller from the FDA or other Governmental Authority, a notified body or any other party that would materially adversely affect or otherwise jeopardize the FDA approval status of the Product. To the Knowledge of Seller, no applications made or other materials submitted by Seller to the FDA or other Governmental Authority or a notified body with respect to the Product contained an untrue statement of material fact when submitted, or omitted to state a material fact when submitted which was required to be stated therein or necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading.

(d) The Regulatory Approval files of Seller have been maintained in accordance with reasonable industry standards. Seller has in its possession or control, or has access to, copies of all the material documentation filed in connection with filings made by Seller for Regulatory Approval of the Product, including the complete regulatory chronology for each Regulatory Approval (if applicable) and Seller will, to the extent any such materials are not delivered pursuant to the terms of this Agreement, upon request of Purchaser make such materials available for review and copying by Purchaser and its representatives.

Section 3.5 Compliance with Laws and Litigation.

(a) Except with respect to any matter relating to or arising from Regulatory Approvals (which is addressed in Section 3.4), with respect to the Product, the Product Business, the Purchased Assets and the Assumed Liabilities, Seller is in material compliance with all Applicable Laws.

 

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(b) Except with respect to routine administrative proceedings conducted with respect to Regulatory Approvals conducted in the Seller’s ordinary and usual course of conduct of the Product Business, there are no Proceedings, including any action or investigation by the U.S. Department of Justice, Office of the Inspector General, or any Governmental Authority, existing, pending, or to the Knowledge of Seller, threatened against or affecting Seller, with respect to the Product, the Product Business, the Purchased Assets or the Assumed Liabilities or with respect to this Agreement or the transactions contemplated hereby, and there are no Proceedings pending in which Seller is the plaintiff or claimant and which relate to the conduct of Seller with respect to the Purchased Assets or the Product Business prior to the Closing Date. Seller is not subject to any Proceedings, nor, to the Knowledge of Seller, are any Proceedings threatened, which, in any such case, that would reasonably be expected to impair or delay its ability to perform its obligations under this Agreement.

Section 3.6 No Material Adverse Change.

(a) Except as set forth on Section 3.6 of the Seller Disclosure Schedule, since January 1, 2010, there has been no Material Adverse Effect on the Product Business or the Purchased Assets; (b) there has been no damage or impairment to, or destruction or loss of, the Purchased Assets, that had or would reasonably be expected to have a Material Adverse Effect on the Product Business or the Purchased Assets; (c) there has been no sale, assignment, transfer or Encumbrance of the Purchased Assets outside the ordinary course of business; and (d) there has been no change in the contingent obligations of Seller by way of guaranty, endorsement, indemnity, warranty or otherwise that would reasonably be expected to have a Material Adverse Effect.

(b) Since January 1, 2010, Seller has, consistent with the conduct of the Product Business during the twenty-four (24) months prior to the Agreement Date: (i) continued and conducted the Product Business in Seller’s ordinary and usual course of business, and (ii) maintained its relationships with suppliers, distributors, customers and others having material business relationships with Seller related to the Product Business.

Section 3.7 Assumed Contracts.

(a) Section 3.7 of the Seller Disclosure Schedule sets forth a complete and correct list of each of the Assumed Contracts. Except as set forth in Section 3.7 of the Seller Disclosure Schedule, the Assumed Contracts constitute all of the contracts to which Seller or any of its Affiliates is a party or is otherwise bound and that are material to or otherwise relate solely or primarily to the Purchased Assets and/or the Product Business. Seller has delivered to or made available to Purchaser true and complete copies of all such Assumed Contracts and any other contracts or agreements identified on Schedule 1.1(d). All such Assumed Contracts are, as to Seller (and, as to the other parties thereto, to the Knowledge of Seller), legal, valid and binding agreements in full force and effect and enforceable in accordance with their respective terms (subject to applicable bankruptcy moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to

 

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general equitable principles (regardless of whether in equity or at law)) and, subject to Section 2.9, may be transferred to the Purchaser pursuant to this Agreement and, as of the Closing Date and subject to the provisions of each such Assumed Contract, will continue in full force and effect in each case without the consent, approval, or act, or the making of any filing with, any other party thereto.

(b) Seller is not in material breach or default, and no event has occurred that with notice or lapse of time would constitute a material breach or default by Seller permitting termination, modification, or acceleration, under any Assumed Contract of the Seller Disclosure Schedule. To the Knowledge of Seller, no other party to any Assumed Contract is in material breach or default under, or has repudiated any material provision of, any Assumed Contract, and no event has occurred and no condition or state or facts currently exists which, with time or the giving of notice, or both, would constitute such a material default or breach by such other party.

Section 3.8 Inventory and Returns.

(a) Section 3.8(a) of the Seller Disclosure Schedule sets forth a complete and correct list of the Inventory as of May 15, 2012, as the same will be revised as of the day prior to the Closing Date. The Inventory has been produced or manufactured in accordance with all Applicable Law and Regulatory Approvals.

(b) Since January 1, 2010, Seller has not (i) materially altered its distribution practices or terms with respect to the Product, or (ii) materially altered its activities and practices with respect to inventory levels of the Product maintained at the wholesale, chain, institutional or retail levels in any material respect.

(c) Section 3.8(c) of the Seller Disclosure Schedule sets forth, on a monthly basis, the returns of the Product for the one year period ended May 15, 2012, as the same will be revised as of the day prior to the Closing Date.

(d) All Inventory included in the Purchased Assets shall be fully paid for, saleable and in good and marketable condition and shall be in compliance with all Laws applicable to its manufacture, labeling and storage.

(e) All Inventory identified on Schedule 1.1(a) shall be provided to Opco without additional consideration.

Section 3.9 Tax Matters.

(a) There are no Encumbrances for Taxes on any of the Purchased Assets other than Permitted Encumbrances (within the meaning of clause (i) of such definition).

(b) Seller has timely filed all Tax Returns that were required to be filed relating to the Product Business or the Purchased Assets and has paid all Taxes shown thereon as owing, except where the failure to file Tax Returns or to pay Taxes would not have a Material Adverse Effect.

(c) Except as disclosed on Schedule 3.9(c), there are pending or ongoing against Seller no federal, state, local or foreign audits, suits, proceedings, claims or administrative

 

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proceedings or, to the Knowledge of Seller, investigations, for Taxes of Seller relating to the Product Business or the Purchased Assets or any Tax Returns of Seller relating to the Product Business or the Purchased Assets that could result in (i) a material Encumbrance on the Purchased Assets or (ii) material Taxes for which the Purchaser Indemnified Parties may be liable.

(d) Seller has not received any written ruling concerning Taxes of Seller with respect to the Product Business or the Purchased Assets from any taxing authority.

(e) Except as disclosed on Schedule 3.9(e), during the three (3) year period ending on the date of this Agreement, no jurisdiction where Seller does not file a Tax Return has made a claim in writing that Seller is required to file a Tax Return relating to the Product Business or the Purchased Assets for such jurisdiction or that any Taxes relating to the Product Business of the Purchased Assets are due as a result of doing any business in such jurisdiction.

Section 3.10 Intellectual Property.

(a) Seller is the owner or licensee of all right, title and interest in and to, or otherwise has the right to use, the Product Intellectual Property, free and clear of any Encumbrance, except for the Permitted Encumbrances; Seller has the full and unrestricted right, power and authority to grant, convey, transfer and assign to Purchaser all of Seller’s (and any of its Affiliates’) right, title and interest in and to the Product Intellectual Property; and Seller’s grant, conveyance, transfer and assignment to Purchaser of all of Seller’s (and any of its Affiliates’) right, title and interest in and to the Product Intellectual Property will not violate or breach any Assumed Contract.

(b) Schedule 1.1(c) sets forth a true and complete list of all Product Intellectual Property, and Schedule 1.1(d) sets forth a true and complete list of all Assumed Contracts through which the Seller (and any of its Affiliates) has obtained rights to any Product Intellectual Property.

(c) None of the Product Patents is involved in any Proceeding (including, but not limited to, any Proceeding challenging the ownership, right to use, validity, enforceability, and/or any allegation of infringement, of any of the Product Patents (and whether under the Hatch Waxman Act, the Biologics Price Competition and Innovation Act, or other applicable Law)). To the Knowledge of Seller, no inequitable conduct (i.e., any conduct that would be in violation of 37 C.F.R. §1.56, or its foreign equivalent, if applicable) was committed in the prosecution of any of the Product Patents owned by Seller.

(d) Except as set forth in Section 3.10 of the Seller Disclosure Schedule, to the Knowledge of Seller, none of the Product Trademarks, Product Copyrights or Product Domains is involved in any Proceeding.

(e) To the Knowledge of Seller, all maintenance fees, annuity fees or renewal fee payments have been timely paid, as and if applicable, for each of the Product Patents, Product Trademarks, Product Copyrights and Product Domain Names owned by the Seller.

 

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(f) There are no pending or, to the Knowledge of Seller, threatened Proceedings (i) based upon, challenging, or seeking to deny or restrict, the Seller’s (or, as applicable, any of its Affiliates’) use of any of the Product Intellectual Property, and/or (ii) alleging that the manufacture, use, sale, offer for sale, import, or export of the Product by Seller (or, as applicable, by any of its Affiliates), or the operation of the Product Business, infringes the rights of any Third Party in and to any Intellectual Property.

(g) To the Knowledge of Seller, no Third Party is engaging in any activity that infringes or misappropriates the Product Intellectual Property. Neither Seller nor its Affiliates has received any notice from any Third Party, under either the Hatch Waxman Act or the Biologics Price Competition and Innovation Act, asserting any position of non-infringement, invalidity or unenforceability of any of the Product Patents.

(h) Seller has taken all action reasonable and commensurate with industry best practices: (i) to protect, preserve and maintain the secrecy, confidentiality and value of the Product Trade Secrets and the Product Know-How, and thus, to the Knowledge of Seller, the Product Trade Secrets and/or Product Know-How are not part of the public knowledge or literature, and have not been used, divulged or appropriated either for the benefit of any Third Party or to the detriment of Seller; and (ii) to vest in Seller all right, title, and interest in and to any and all Product Intellectual Property conceived, created or developed by all former and current employees and contractors of Seller or its Affiliates, and thus, to the Knowledge of Seller, no former or current employees and/or contractors of Seller or its Affiliates own, hold or possess, in their individual or any other capacities, any right, title or interest in and to any of the Product Intellectual Property. Any executed agreements obtained by Seller in connection with Seller’s actions under Sections 3.10(h)(i) and (ii), shall be retained by Seller for a period of ten (10) years following the Closing Date, unless Seller gives Purchaser notice of its intention to destroy any such executed agreements and affords Purchaser a reasonable opportunity to take possession or make copies thereof.

(i) Neither Seller nor any of its Affiliates has licensed, granted, conveyed, transferred or assigned to any Third Party any right, title or interest in and to the Product, any of the Product Intellectual Property and/or the Product Business.

Section 3.11 Product Records. All Product Records have been made available by Seller to Purchaser for examination and copying, and all Product Records are complete and correct in all material respects and have been maintained in accordance with reasonable industry standards.

Section 3.12 Brokers, Finders, etc. Other than Locust Walk Partners, whose fees, commission and expenses are the sole responsibility of Seller, Seller has not employed any broker, finder, consultant or other intermediary in connection with the transactions contemplated by the Transaction Documents who would have a valid claim for a fee or commission from Purchaser in connection with such transactions by reason of any action taken by or on behalf of Seller.

 

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Section 3.13 Financial Statements.

(a) Each form, report, schedule and document required to be filed by Seller under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) since January 1, 2010 (collectively, the “Seller SEC Filings” and individually, a “Seller SEC Filing”), solely with respect to the Product Business, (i) did, as of its date, comply in all material respects with the requirements of the Exchange Act and (ii) did not, at the time it was filed, contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.

(b) Each of the consolidated financial statements (including in each case, any notes thereto) contained in any Seller SEC Filing, solely to the extent each relates to the Product Business, (i) was prepared in accordance with GAAP applied (except as may be indicated in the notes thereto and, in the case of unaudited quarterly financial statements, as permitted by Form 10-Q under the Exchange Act) on a consistent basis throughout the periods indicated, and (ii) presented fairly the consolidated financial position, results of operations and cash flows of Seller as of the respective dates thereof and for the respective periods indicated therein (subject, in the case of unaudited statements, to normal and recurring year-end adjustments which did not result in a Material Adverse Effect).

(c) Seller has previously furnished to Purchaser or has identified to Purchaser and provided Purchaser an opportunity to confirm or review, (i) (A) sales of the Product for the three-year period ended December 31, 2011, (B) representative returns and allowances pertaining to the Product for the three-year period ended December 31, 2011, (C) gross and net sales data and cost of goods to Seller for the three-year period ended December 31, 2011 (collectively, the “Financial Data”). The summary of the Financial Data delivered to Purchaser under the file named PASO Finance Template (Q1 2012).xlsx, a copy of which is attached as Section 3.13(c) of the Seller Disclosure Schedule, was prepared by Seller in good faith from the Product Records, and fairly present, in all material respects, the financial condition and results of operations of the Product Business as of the date thereof and for the periods shown. To the Knowledge of Seller, the Financial Data furnished by Seller to Purchaser does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the facts disclosed therein not materially misleading in light of the circumstances in which disclosed.

Section 3.14 Insurance. There are no material claims currently made against any of the insurance policies of Seller relating to the Product, the Product Business, no material impairment of the amounts of coverage required thereunder, and Seller has no Knowledge of any reasonable basis for any such claims.

Section 3.15 Regulatory Compliance. To the extent applicable to the Product in the Territory:

(a) To the Knowledge of Seller, the Product has been developed, labeled, stored, tested and distributed in compliance with all applicable requirements under the Federal Food Drug and Cosmetic Act 21 U.S.C. §§301 et. seq., its implementing regulations, and all similar Applicable Laws, including those relating to investigational use, premarket clearance and

 

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applications or abbreviated applications to market a new product, except for noncompliance which individually or in the aggregate would not reasonably be expected to have a Material Adverse Effect.

(b) To the Knowledge of Seller, all pre-clinical and clinical investigations conducted by or on behalf of Seller with respect to the Product have been, and are being, conducted in compliance with all applicable recommendations, policy, and guidance issued by the FDA, 21 C.F.R. Parts 50, 54, 56, 58 and 312 and all other Applicable Laws, including those with respect to good laboratory practices, investigational new drug requirements, good clinical practice requirements (including informed consent and institutional review boards designed to ensure the protection of the rights and welfare of human subjects), and federal and state laws restricting the use and disclosure of protected health information, including but not limited to Health Information Technology for Economic and Clinical Health (“HITECH”), the Health Institute Portability and Accountability Act (“HIPAA”), and regulations related to HITECH and HIPAA, except for noncompliance which individually or in the aggregate would not reasonably be expected to have a Material Adverse Effect.

(c) To the Knowledge of Seller, with respect to the Product (i) all manufacturing operations conducted for the benefit of Seller have been and are being conducted in compliance with the FDA’s current Good Manufacturing Practice regulations for drug products, including 21 C.F.R. Parts 210 and 211, and all similar Applicable Laws, except for noncompliance which, individually or in the aggregate, would not have, or be reasonably likely to have, a Material Adverse Effect; and (ii) Seller is in compliance with all registration and listing requirements set forth in 21 U.S.C. §360 and 21 C.F.R. Part 207, and all similar Applicable Laws, except for noncompliance which individually or in the aggregate would not reasonably be expected to have a Material Adverse Effect.

(d) Since the date of acquisition of the Product (or rights thereto) by Seller, the Product has not been recalled, suspended or discontinued as a result of any action by the FDA or any other foreign Governmental Authority within the Territory, by Seller or by any licensee, distributor or marketer of the Product, within the Territory, or, to the Knowledge of Seller, outside of the Territory.

(e) Seller has not received any notice or other communication from the FDA or any other Governmental Authority alleging any violation of any Law applicable to any activity relating to the Product Business that is subject to the jurisdiction of FDA or any other Governmental Authority, nor has any Governmental Authority commenced, or threatened to initiate, any action to enjoin or place restrictions on the production of the Product.

(f) To the Knowledge of Seller, there are no facts, circumstances or conditions that would be sufficient to presently, or solely with the passage of time in the ordinary course of business, provide a reasonable basis for a recall, suspension or discontinuance of the Product.

(g) Seller is in compliance with 21 U.S.C. §355, 42 U.S.C. §262 and applicable FDA implementing regulations, including 21 C.F.R. Parts 312, 314, 600 and 601 and all similar Applicable Laws, and all terms and conditions of the applicable new drug application, biologic license application and investigational new drug exemption submission under 21 U.S.C. §355(i),

 

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except for any such failure or failures to be in compliance which individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. As to the Product, Seller and its officers, employees or agents have included in each applicable application, where required, the certification described in 21 U.S.C. §335a(k)(l) and each such certification was true, complete and correct in all material respects when made.

(h) With respect of the Product or of the Product Business, Seller has not committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any similar policy. Neither the Seller nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct with respect to the Product Business for which debarment is mandated by 21 U.S.C. §335a(a) or any similar Law or authorized by 21 U.S.C. §335a(b) or any similar Law.

(i) Seller has delivered to Purchaser or made available to Purchaser copies of all annual safety update reports prepared by Seller with respect to the Product.

Section 3.16 No Other Warranties. Except as expressly provided in the Transaction Documents, Seller does not make any representation or warranty about the Product, the Purchased Assets the Assumed Liabilities or the Product Business, whatsoever. WITHOUT LIMITING THE FOREGOING, PURCHASER ACKNOWLEDGES THAT, EXCEPT AS EXPRESSLY PROVIDED IN THE TRANSACTION DOCUMENTS, (A) THE PURCHASED ASSETS ARE BEING TRANSFERRED “AS IS,” (B) SELLER MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND OR AS BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND (C) SELLER SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES, INCLUDING ANY WARRANTY OF MERCHANTABILITY, WARRANT OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF NONINFRINGEMENT.

ARTICLE IV

REPRESENTATIONS AND WARRANTIES OF PURCHASER

Purchaser, Parent and Opco, jointly and severally, hereby represent and warrant to Seller as follows.

Section 4.1 Organization and Authority. Purchaser is a company incorporated under the laws of Ireland. Parent is a limited liability company duly organized, validly existing and in good standing under the laws of Delaware. Opco is a company incorporated under the laws of Ireland. Each of Purchaser, Parent and Opco has all requisite corporate or limited liability company, as applicable, power and authority to execute and deliver the Transaction Documents, and the transactions contemplated thereby, and effect the transactions contemplated thereby and has duly authorized the execution, delivery and performance of the Transaction Documents and transactions or documents contemplated thereby by all necessary corporate or limited liability company, as applicable, action. Each of Purchaser, Parent and Opco has all requisite corporate or limited liability company, as applicable, power and authority necessary to carry on its business as is currently being conducted. The Transaction Documents will be upon

 

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the Closing, the valid and legally binding obligations of each of Purchaser, Parent and Opco, enforceable against them in accordance with their terms, subject to applicable bankruptcy moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to general equitable principles (regardless of whether in equity or at law).

Section 4.2 Consents; No Violations.

(a) Except for the requisite filings under the HSR Act, if any, and the expiration or termination of the waiting period thereunder, and except for all filings and other actions contemplated by the Transaction Documents (including the necessary transfer of filings, notices and approvals required to transfer the Regulatory Approvals from Seller to Purchaser), the execution, delivery and performance by each of Purchaser, Parent and Opco of the Transaction Documents and the consummation by Purchaser, Parent and Opco of the transactions contemplated thereby will not require any notice to, filing with, or the consent, approval or authorization of, any Person or Governmental Authority.

(b) Neither the execution and delivery of the Transaction Documents nor the consummation of the transactions contemplated thereby will (i) violate or result in a breach or result in the acceleration or termination of, or the creation in any Third Party of the right to accelerate, terminate, modify or cancel, any indenture, contract, lease, sublease, loan agreement, note or other obligation or liability to which Purchaser, Parent or Opco is a party or is bound, (ii) conflict with, violate or result in a breach of any provision of the organizational documents of Purchaser, Parent or Opco, or (iii) conflict with or violate in any material respect Applicable Law.

Section 4.3 Brokers, Finders, etc. Purchaser, Parent, Opco and their respective Affiliates have not employed any broker, finder, consultant or other intermediary in connection with the transactions contemplated by this Agreement and the Ancillary Agreements who would have a valid claim for a fee or commission from Seller in connection with such transactions by reason of any action taken by or on behalf of Purchaser, Parent or Opco.

Section 4.4 Financing. Purchaser and Parent will collectively have funds sufficient to pay (i) the Closing Cash Payment on the Closing Date and (iii) the Earnouts, if and when applicable.

Section 4.5 Litigation. There are no lawsuits, claims or any civil, administrative or criminal actions, suits, or proceedings or governmental investigations existing, pending, or to the Knowledge of Purchaser, threatened, with respect to this Agreement or the transactions contemplated hereby. None of Purchaser, Parent or Opco is subject to any decree or order of any Governmental Authority that would impair or delay its ability to perform its obligations under this Agreement or the Ancillary Agreements.

 

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ARTICLE V

COVENANTS OF SELLER PRIOR TO CLOSING

Section 5.1 Conduct of the Product Business Prior to Closing.

(a) Subject to Applicable Law or as contemplated by this Agreement or consented to in writing by the Purchaser, Seller shall, consistent with its conduct of the Product Business during the twelve (12) months prior to the Agreement Date: (i) continue and conduct the Product Business in Seller’s ordinary and usual course of business, (ii) preserve intact the market for the Product and the goodwill associated with the Product and the Product Intellectual Property, (iii) preserve in full force and effect, and, other than in the ordinary course of business, not amend or alter, any material Contracts and/or any Assumed Contract, (iv) alter its marketing practices in respect of the Product in a manner intended to increase sales of Product prior to Closing, including the offering of incentives which are inconsistent with past practices, (v) sell the Product only in the ordinary course of business and at levels consistent with past practices for comparable periods of time and (vi) continue to maintain its relationships with suppliers, distributors, customers and others having material business relationships with it related to the Product Business.

(b) Between the Agreement Date and the Closing, Seller shall not take any affirmative action which would reasonably be expected to (i) cause Seller to violate Section 5.1(a), or (ii) have a Material Adverse Effect on the Product Business, or with, respect to (i) or (ii), refrain from taking any action which would be reasonably be expected to prevent such an event.

Section 5.2 Notice of Default. Between the Agreement Date and the Closing, Seller shall promptly notify Purchaser in writing if Seller becomes aware of any fact or condition that constitutes a breach of a representation, warranty or covenant of Seller under this Agreement. Any such notice or disclosure shall not be deemed to amend or supplement Seller’s disclosure under Article III or any schedule hereto, or to correct or cure any misrepresentation, breach of warranty or breach of covenant.

Section 5.3 No Negotiation. Seller shall not, and shall direct its representatives not to, directly or indirectly, initiate, solicit or knowingly encourage any Acquisition Proposal, or furnish any information to any other Person with respect to, or agree to or otherwise enter into, any Acquisition Proposal. Seller shall promptly notify Purchaser after receipt of any Acquisition Proposal or any request for information relating to the Purchased Assets or the Product Business by any Person who has informed Seller or any of its representatives that such Person is considering making, or has made, an Acquisition Proposal (which notice shall identify the Person making, or considering making, such Acquisition Proposal and shall set forth the material terms of any Acquisition Proposal received), and Seller shall keep Purchaser informed in reasonable detail of the terms, status and other pertinent details of any such Acquisition Proposal or request. Seller shall, and shall direct its representatives to, discontinue any solicitation efforts or negotiations with respect to or in furtherance of any Acquisition Proposal.

Section 5.4 Commercially Reasonable Efforts. Seller shall use commercially reasonable efforts to cause the conditions in Section 7.1 and 7.2 to be satisfied.

 

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Section 5.5 Notice of Government Investigations. Between the Agreement Date and the Closing, Seller shall promptly notify Purchaser in writing if Seller has received any notice from the U.S. Department of Justice, the Office of the Inspector General or any other Governmental Authority that such Governmental Authority has commenced, threatened or intends to commence any action or investigation with respect to the Product Business.

ARTICLE VI

COVENANTS OF PURCHASER AND PARENT PRIOR TO CLOSING

Section 6.1 Notice of Default. Between the Agreement Date and the Closing, Purchaser, Parent and Opco shall promptly notify Seller in writing if Purchaser, Parent or Opco becomes aware of any fact or condition that constitutes a breach of a representation, warranty or covenant of Purchaser, Parent or Opco under this Agreement. Any such notice or disclosure shall not be deemed to amend or supplement Purchaser’s, Parent’s or Opco’s disclosure under Article IV or any schedule hereto, or to correct or cure any misrepresentation, breach of warranty or breach of covenant.

Section 6.2 Commercially Reasonable Efforts. Purchaser, Parent and Opco shall use commercially reasonable efforts to cause the conditions in Section 7.1 and 7.3 to be satisfied.

ARTICLE VII

CLOSING AND TERMINATION

Section 7.1 Conditions Precedent to Obligations of Parties. The respective obligations of Purchaser, Parent, Opco and Seller to consummate the transactions contemplated by this Agreement on the Closing Date are subject to the satisfaction or waiver at or prior to the Closing Date of the following conditions:

(a) No Injunction, etc. No Governmental Authority of competent jurisdiction shall have enacted, issued, promulgated, enforced or entered any Law which is in effect on the Closing Date which would, and no Proceeding by any Governmental Authority shall have been threatened against any of the Parties or any of the officers or directors of any of them seeking to, prohibit, enjoin or restrain the consummation of the transactions contemplated by this Agreement to occur on the Closing Date or otherwise making such transactions illegal.

(b) Regulatory Authorizations. (i) All material consents of Governmental Authorities shall have been obtained and shall be in full force and effect, and (ii) the waiting period under the HSR Act, if applicable, and other any other applicable Antitrust Regulation shall have expired or been terminated.

Section 7.2 Conditions Precedent to Purchaser’s Obligations. Purchaser’s obligations to consummate the transactions contemplated by the Transaction Documents shall be subject to the fulfillment of each of the following additional conditions, any one or more of which may be waived, at Purchaser’s sole discretion, in writing by the Purchaser:

(a) Representations and Warranties. The representations and warranties of Seller in Article III (i) shall have been accurate in all material respects on the Agreement Date and

 

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(ii) shall be accurate in all material respects on the Closing Date as if made on the Closing Date (except to the extent that any such representation or warranty is made as of a specified date, in which case such representation or warranty shall be accurate in all material respects as of such date), and Purchaser shall have received a certificate signed on behalf of Seller by an authorized officer of Seller to such effect.

(b) Performance. Seller shall have performed and complied in all material respects with all covenants contained in this Agreement that are required to be performed or complied with by it on or prior to the Closing.

(c) FDA. With respect to the Product fermentation failure previously disclosed to the FDA by Seller, the FDA shall have approved in writing the Prior-Approval Supplement filed with the FDA by Seller on March 9, 2012 and as supplemented on May 10, 2012 (a true and complete copy of which shall have been provided to Purchaser) and the release and sale of the Product under the B-I Purchase Orders, and Seller shall have delivered such written approval(s) to Purchaser.

(d) No Material Adverse Effect. Since the date of this Agreement, no Material Adverse Effect shall have occurred and be continuing.

(e) B-I Supply Agreements. (i) Purchaser, on behalf of itself and Opco, shall have agreed to accept the B-I Supply Agreement, (ii) Boehringer-Ingelheim shall have waived its right to terminate the B-I Supply Agreement upon or following assignment of such agreement to Purchaser and (iii) Boehringer-Ingelheim shall have consented in writing to the assignment of the B-I Supply Agreement and Quality Agreement to Opco, each of Sections 7.2(e)(i)-(iii) in the form attached hereto as Exhibit E.

(f) Genentech License. Seller shall have delivered to Purchaser the consent of Genentech Inc. to the assignment of the Genentech License to Purchaser.

(g) Closing Documents. Purchaser shall have received the documents set forth in Sections 2.7(a) – (i) and any document reasonably requested by Purchaser pursuant to Section 2.7(j) provided that Purchaser shall have made such request for such document no less than ten (10) days prior to the Closing. Such documents shall have been executed by the parties thereto and shall be in full force and effect.

Section 7.3 Conditions Precedent to Seller’s Obligations. Seller’s obligation to consummate the transactions contemplated hereby shall be subject to the fulfillment of each of the following additional conditions, any one or more of which may be waived, at Seller’s sole discretion, in writing by Seller:

(a) Representations and Warranties. The representations and warranties of Purchaser, Parent and Opco contained in this Agreement shall have been accurate in all material respects on the date of this Agreement and shall be accurate in all material respects as of the Closing Date as if made on and as of the Closing Date (except to the extent that any such representation or warranty is made as of a specified date, in which case such representation or warranty shall be accurate in all material respects as of such date, except for such inaccuracies that, either individually or in the aggregate, have not had a material adverse effect on Purchaser, Parent or

 

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Opco, as applicable, and Seller shall have received a certificate signed on behalf of each of Purchaser, Parent and Opco by an authorized officer of Purchaser, Parent and Opco, as applicable, to such effect).

(b) Performance. Purchaser, Parent and Opco shall each have performed and complied in all material respects with all covenants contained in this Agreement that are required to be performed or complied with by them on or prior to the Closing, and Seller shall have received a certificate signed on behalf of each of Purchaser, Parent and Opco by an authorized officer of Purchaser, Parent and Opco, as applicable, to such effect.

(c) Closing Documents. Purchaser shall have executed and delivered to Seller the documents set forth in Sections 2.6(a) – (g) and any document reasonably requested by Seller pursuant to Section 2.6(h) provided that Seller shall have made such request for such document no less than ten (10) days prior to the Closing, and each such agreement and document shall be in full force and effect.

Section 7.4 Termination. This Agreement may be terminated:

(a) at any time before the Closing Date by mutual written consent of Purchaser, Parent, Opco and Seller; or

(b) by Purchaser, Parent, Opco or Seller, in writing, if the transactions contemplated hereby have not been consummated on or before October 31, 2012 (as such date may be extended pursuant to Section 10.6), provided that such failure is not due to the failure of the Party seeking to terminate this Agreement to comply in all material respects with its obligations under this Agreement, including the failure of the Party seeking to terminate this Agreement to satisfy its closing conditions set forth in this Article VII.

Section 7.5 Procedure and Effect of Termination. Upon termination of this Agreement by Purchaser, Parent, Opco or Seller pursuant to Section 7.4, written notice thereof shall forthwith be given to the other Parties and this Agreement shall terminate and the transactions contemplated hereby shall be abandoned without further action by any of the Parties. Termination of this Agreement shall terminate all outstanding obligations and liabilities between the Parties arising from this Agreement except those described in: (i) this Section 7.5, ARTICLE IX, and Section 10.1; (ii) the Confidentiality Agreement; and (iii) any other provisions of this Agreement which by their nature are intended to survive any such termination.

ARTICLE VIII

CERTAIN OTHER COVENANTS

Section 8.1 Necessary Efforts; No Inconsistent Action.

(a) Subject to the other terms and conditions of this Agreement, including the conditions set forth in Article VII, the Parties shall, and shall cause their respective Affiliates to, use their respective commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary, proper or advisable under Applicable Law to consummate and make effective the transactions contemplated by the Transaction Documents and to use their respective commercially reasonable efforts to cause the conditions to each

 

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Party’s obligation to close the transactions contemplated hereby as set forth in Article VII to be satisfied, including all actions necessary to obtain all Consents and all waivers or terminations of applicable waiting periods required for the satisfaction of the conditions set forth in Section 7.1(b), and all other Consents necessary in connection with the consummation of the transactions contemplated by the Ancillary Agreements; provided, however, that the foregoing provisions of this Section 8.1(a) shall not (i) require any Party to perform, satisfy or discharge any obligations of any other Party under this Agreement or otherwise or (ii) subject to the provisions of Section 2.9, require any Party or its Affiliates to expend any money other than for filing fees or expenses or de minimus costs or expenses or agree to any restrictions in order to obtain any Consents. The Parties shall cooperate fully with each other to the extent necessary in connection with the foregoing.

(b) In connection with the efforts referenced in Section 8.1(a), the Parties shall timely and promptly make all filings which may be required for the satisfaction of the condition set forth in Section 7.1(b) by each of them in connection with the consummation of the transactions contemplated hereby. In furtherance and not in limitation of the foregoing, if required under Applicable Law, each Party shall file, or cause to be filed, Notification and Report Forms under the Hart Scott Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), or any other similar filings under Antitrust Regulations of any other Governmental Authority as promptly as practicable following the date of this Agreement and in any event no later than (i) ten (10) Business Days following the date of this Agreement, in the case of Notification and Report Forms under the HSR Act, and (ii) the time prescribed by Applicable Law in the case of requirements under other applicable Antitrust Regulations to the extent a time is prescribed and, if no time is prescribed, as promptly as reasonably practicable. In addition, the Parties shall, and shall cause their respective Affiliates to, cooperate and use their commercially reasonable efforts and take all actions necessary to (A) respond as promptly as practicable to any requests for information from any Governmental Authority, and to avoid and/or overcome any action, including any legislative, administrative or judicial action, and (B) have vacated, lifted, reversed or overturned any judgment, injunction or other order (whether temporary, preliminary or permanent) that restricts, prevents or prohibits, or could restrict, prevent or prohibit, the consummation of the transactions contemplated by this Agreement; provided, however, that in no event shall Seller or any of its Affiliates be required or expected to retain any of the Purchased Assets in order to comply with its obligations in respect of the foregoing. Each Party shall furnish to the other such necessary information and assistance as the other Party may reasonably request in connection with the preparation of any necessary filings or submissions by it to any Governmental Authority. Except as prohibited or restricted by Applicable Law or any Antitrust Regulations, each Party or its attorneys shall provide the other Party or its attorneys the opportunity to make copies of all correspondence, filings or communications (or memoranda setting forth the substance thereof) between such Party or its representatives, on the one hand, and any Governmental Authority, on the other hand, with respect to the Transaction Documents or the transactions contemplated thereby, subject to redaction as reasonably necessary of documents filed pursuant to Item 4(c) of the Hart Scott Rodino Notification and Report Form. Without in any way limiting the foregoing, the Parties shall consult and cooperate with one another, and consider in good faith the views of one another, in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any Party in connection with proceedings under or relating to the HSR Act or any other Antitrust Regulation.

 

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Section 8.2 Public Disclosures. Unless otherwise required by Applicable Law, the rules and regulations of any stock exchange or quotation services on which such Party’s stock is traded or quoted, prior to the Closing Date, no news release or other public announcement pertaining to the transactions contemplated by this Agreement will be made by or on behalf of a Party or its Affiliates without the prior written approval of the other Party (which approval shall not be unreasonably withheld, conditioned or delayed). If in the judgment of any Party such a news release or public announcement is required by Applicable Law or the rules or regulations of any stock exchange on which such Party’s stock is traded, the Party intending to make such release or announcement shall to the extent practicable use commercially reasonable efforts to provide prior written notice to the other Party of the contents of such release or announcement and to allow the other Party reasonable time to comment on such release or announcement in advance of such issuance.

Section 8.3 Product Returns, Rebates and Chargebacks. Product Returns, Commercial Rebates and Chargebacks are to be processed by the Parties in accordance with the provisions of the Transition Services Agreement.

Section 8.4 Transitional Trademark License.

(a) As of the Closing Date and for a period of up to twenty-four months (24) months after the Closing Date, Seller hereby grants to Purchaser (or its Affiliates responsible for operating the Product Business after Closing or any Third Party manufacturers utilized by Purchaser in connection with the Product Business after the Closing Date), and Purchaser hereby accepts, a non-exclusive, non-transferable, non-sublicensable (except with respect to such Third Party manufacturers or Purchaser’s Affiliates), royalty-free, paid-up, license in the Territory under the Seller Marks, for use solely in connection with (i) Purchaser’s sale of the Inventory in the Territory, and (ii) Purchaser’s use of the Promotional Materials existing as of the Closing Date and transferred to Purchaser as part of the Purchased Assets, and (iii) the labeling on the Product manufactured by or on behalf of Purchaser as of and after the Closing; provided, however, that such license is being granted solely for transitional purposes and Purchaser shall therefore, notwithstanding the time period provided for above, use its commercially reasonable efforts to as quickly as is reasonably possible cease its use of the Seller Marks after the Closing, but in no event later than twenty-four (24) months after the Closing Date, or such later date (not to exceed an additional six (6) months) upon consent by Seller, such consent not be unreasonably withheld.

(b) To the extent that Purchaser is utilizing the transitional trademark license set forth in Section 8.4(a), Purchaser shall not (i) add any marks to, or otherwise alter, the Seller Marks as used in the Product Business as of the Closing Date (except as required by Applicable Law); (ii) change in any way the style of the Seller Marks as used in the Product Business as of the Closing Date; or (iii) otherwise use the Seller Marks in any manner other than as specifically provided in this Section 8.4.

(c) Purchaser acknowledges Seller’s ownership of the Seller Marks, shall do nothing inconsistent with such ownership, and agrees not to challenge Seller’s title to the Seller Marks. Nothing in this Agreement shall give Purchaser any right, title or interest in the Seller Marks other than the right to use the Seller Marks strictly in accordance with this Section 8.4. All use

 

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of the Seller Marks by Purchaser under this Section 8.4 shall conform to the standards followed by Seller in operating the Product Business prior to the Closing Date, and Seller shall have the right to review the standards used by Purchaser to operate the Product Business after the Closing Date to ensure Purchaser’s compliance with this requirement related to the Seller Marks.

(d) Purchaser shall not have the right to, and shall not, sublicense, assign, pledge, grant or otherwise encumber or transfer to any Third Party any rights licensed by Seller to Purchaser under Section 8.4(a) without Seller’s prior written consent. The Parties understand and agree that, in addition to all other legal remedies, Seller shall be entitled to immediate injunctive relief in order to enforce the terms of this Section 8.4.

(e) Nothing in this Section 8.4, or any other provision of this Agreement or any provision of the Ancillary Agreements, shall grant the Purchaser any rights in any of Seller’s Internet domain names, registrations or applications for registration, or renewals thereof, registered in the United States or any other country or jurisdiction throughout the world, except as such Internet domain names, registrations or applications for registration, or renewals thereof are included as part of the Purchased Assets.

(f) Following the Closing, Purchaser shall promptly and at its own expense use commercially reasonable efforts to obtain such FDA approvals necessary for Purchaser Labeling for the Product to be manufactured after the Closing and, promptly comply with such FDA approvals upon receipt thereof.

Section 8.5 Customer Billing. In the event that Seller or any of its Affiliates receives payment after the Closing Date on invoices relating to the Product Business operated by the Purchaser or sales of products or services rendered by Purchaser on or after the Closing, Seller will promptly notify Purchaser of such receipt and will promptly remit, or will cause such Affiliate to promptly remit, such payment to Purchaser without depositing such payment in an account of Seller, or such Affiliate, unless in error, and Seller, or such Affiliate, shall not be entitled to offset such payment against any payments due Seller from Purchaser. In the event Seller receives an invoice or request for payment relating to the operation of the Product Business on or after the Closing Date, or with respect to any Assumed Liability, Seller will promptly notify Purchaser of such request or invoice and forward the invoice and all other appropriate information to Purchaser for payment. In the event Purchaser or any of its Affiliates receive payment after the Closing Date on invoices issued by Seller relating to an Excluded Asset (such as Seller’s accounts receivable as of the Closing Date) or relating to product sold or services rendered by businesses other than the Product Business or the Purchased Assets, Purchaser will promptly notify Seller of such receipt and will promptly remit, or will cause such Affiliate to promptly remit, such payment to Seller without depositing such payment in an account of Purchaser, or such Affiliate, unless in error, and Purchaser, or such Affiliate, shall not be entitled to offset such payment against any payments due Purchaser from Seller.

Section 8.6 Cooperation.

(a) After the Agreement Date, the Parties shall cooperate reasonably with each other in connection with any reasonable actions required to be taken with respect to their respective obligations under this Agreement and the Ancillary Agreements, and shall (i) furnish upon

 

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reasonable request to each other such further information, and (ii) execute and deliver to each other such other reasonable documents, and (iii) do such other acts, all as the other Party may reasonably request for the purpose of carrying out the provisions of this Agreement (and the Ancillary Agreements) and the transactions contemplated hereby and thereby.

(b) The Parties will promptly notify each other in writing, of any event or fact which represents a material breach of any of their respective representations, warranties, covenants or agreements hereunder.

Section 8.7 Reserved.

Section 8.8 Tax Matters.

(a) Seller and Purchaser shall provide reasonable cooperation and information to each other in connection with (i) the preparation or filing of any Tax Return, Tax election, Tax consent or certification, or any claim for a Tax refund, (ii) any determination of liability for Taxes and (iii) any audit, examination or other proceeding in respect of Taxes related to the Product Business. Seller and Purchaser shall make themselves (and their respective employees) reasonably available on a mutually convenient basis to provide an explanation of any documents or information provided under this Section 8.8(a). Each of Seller and Purchaser shall retain all Tax Returns, work papers and all material records or other documents in its possession (or in the possession of its Affiliates) relating to Tax matters of the Product Business for any taxable period that includes the Closing Date and for all prior taxable periods until the later of (i) the expiration of the statute of limitations of the taxable period to which such Tax Returns and other documents relate, without regard to extensions, or (ii) six (6) years following the due date (without extension) for such Tax Returns. Prior to the expiration of such time, if Seller or Purchaser desire to retain any such documents in the other’s possession (or in the possession of the other party’s Affiliates), such party desiring to retain such document shall give notice to the other party at least ninety (90) days’ prior to the later of (i) the expiration of the statute of limitations of the taxable period to which such Tax Returns and other documents relate, without regard to extensions, or (ii) six (6) years following the due date (without extension) for such Tax Returns, requesting that such other party remove and retain all or any part of the such documents (at such party’s request). Any information obtained under this Section 8.8(a) shall be kept confidential pursuant to Section 10.1, except as may be otherwise necessary in connection with the filing of Tax Returns, claims for a Tax refund or in conducting any audit, examination or other proceeding in respect of Taxes.

(b) Purchaser and Seller shall each be responsible for fifty percent (50%) of all sales, use, transfer, value added and other similar Taxes (the “Transfer Taxes”), if any, arising out of the transfer by Seller of the Purchased Assets to Purchaser pursuant to this Agreement; provided that, Seller shall have no responsibility for, and Purchaser will be solely responsible for, any value added Tax payable in connection with the sale, assignment, transfer, conveyance and delivery to Purchaser of the Inventory identified on Schedule 1.1(a) and the Product under the B-I Purchase Orders pursuant to Section 2.1(c).

(c) All real property, personal property and similar ad valorem Taxes (collectively, “Property Taxes”) levied with respect to the Purchased Assets for the Tax period in which the

 

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Closing Date occurs (a “Straddle Period”) shall be apportioned between Purchaser and Seller based on the number of days of such Straddle Period included in the portion of such period ending on the Closing Date (the “Pre-Closing Tax Period”) and the number of days of such Straddle Period included in the portion of such period beginning after the Closing Date (the “Post-Closing Tax Period”). Seller shall be liable for the proportionate amount of such Property Taxes that is attributable to the Pre-Closing Tax Period, and Purchaser shall be liable for the proportionate amount of such Property Taxes that is attributable to the Post-Closing Tax Period. Upon receipt of any bill for such Property Taxes, Purchaser or Seller, as applicable, shall present a statement to the other setting forth the amount of reimbursement to which each is entitled under this Section 8.8(c) together with such supporting evidence as is reasonably necessary to calculate the proration amount. The proration amount shall be paid by the party owing it to the other within ten (10) days after delivery of such statement.

(d) Purchaser and Seller agree and acknowledge that no withholding of Taxes is required under Irish or other Applicable Law with respect to any of the payments contemplated by Section 2.1 and that no payments under Section 2.1 shall be reduced by any withholding Taxes.

Section 8.9 Notice to Customers. Seller agrees to cooperate with Purchaser, at Purchaser’s reasonable request, in the notification to customers of the transactions contemplated by this Agreement and Seller agrees not to notify any customer of such transactions without the consent of Purchaser. Such notification shall be in such form as is reasonably satisfactory to both Purchaser and Seller as agreed to prior to Closing.

Section 8.10 Adverse Experience Reports. At a mutually agreed upon time after the Closing, Seller shall provide Purchaser with information relating to the investigation and reporting of all adverse experiences regarding the Product prior to the Closing and all other information which is materially relevant to the safe use of the Product in Seller’s possession as of the Closing. After the Closing, Seller shall promptly submit to Purchaser all adverse drug experience information or customer complaints brought to the attention of Seller in respect of the Product, as well as any material events and matters concerning or affecting the safety or efficacy of the Product. After the Closing and after the time the appropriate Governmental Authorities are notified of the transfer of the applicable Regulatory Approvals, Purchaser shall have all responsibility for required reporting of adverse experiences for the Product.

Section 8.11 Regulatory Matters.

(a) Except as expressly set forth in Section 8.10 or the Transition Services Agreement, from and after the Closing, Purchaser, at its cost, shall be solely responsible and liable for (i) taking all actions, paying all fees and conducting all communication with the appropriate Governmental Authority required by Applicable Law in respect of the Regulatory Approvals, including preparing and filing all reports (including adverse drug experience reports) with the appropriate Governmental or Regulatory Authority (whether the Product is sold before or after transfer of such Regulatory Approval), (ii) taking all actions and conducting all communication with third parties in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), including responding to all complaints in respect thereof, including complaints related to tampering or

 

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contamination, and (iii) investigating all complaints and adverse drug experiences in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval).

(b) From and after the Closing, and subject to Section 8.10 hereof and the Transition Services Agreement, Seller promptly (and in any event within the time periods required by Applicable Law) shall notify Purchaser within three (3) Business Days if Seller receives a complaint or a report of an adverse drug experience in respect of the Product. In addition, Seller shall cooperate with Purchaser’s reasonable requests and use commercially reasonable efforts to assist Purchaser in connection with the investigation of and response to any complaint or adverse drug experience related to the Product sold by Seller.

(c) From and after the Closing, Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), including recalls required by any Governmental Authority and recalls of units of the Product sold by Seller deemed necessary by Seller in its reasonable discretion; provided, however, that Seller shall reimburse Purchaser for the reasonable expenses and costs of conducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Inventory, and reasonable credits extended to customers in connection with the recall. Seller shall notify Purchaser promptly in the event that a recall of the Product sold by Seller is necessary.

(d) Seller shall, within fifteen (15) days after the Closing, notify the FDA of the transfer of the Regulatory Approvals to Purchaser in accordance with all Applicable Laws.

Section 8.12 Product Records. At the Closing, or as soon as possible thereafter, Seller shall transfer to Purchaser, to the extent in Seller’s actual possession, the original copies of the Product Records and Assumed Contracts. Seller may retain one (1) archival copy of the Product Records and Assumed Contracts solely for archival purposes or as required by Applicable Law. Prior to delivering or making available any Product Records to Purchaser, Seller shall be entitled to redact therefrom any information that does not relate to the Product Business.

Section 8.13 Employees. The Parties acknowledge and agree that there is no intent or agreement that any employee of Seller will terminate his or her employment with Seller and/or commence employment with Purchaser as a result of the transactions contemplated by this Agreement.

Section 8.14 Non-Competition.

(a) Seller hereby covenants and agrees that, for a period of five (5) years from the Closing Date, neither Seller nor any of its Affiliates (either alone or in collaboration with any Third Party) shall (i) make, use, develop, promote, advertise, market, distribute, sell, offer to sell, import, export and/or commercialize the Product and/or any Competing Product, for any use, purpose, indication or treatment (whether for the treatment of idiopathic pulmonary fibrosis, or any other disease or disorder), anywhere in the Territory or elsewhere in the world, (ii) engage in

 

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any aspect of the Product Business, (iii) file any applications for regulatory approval, including new drug applications, abbreviated new drug applications, new drug submissions, and any comparable applications and submissions, with any Governmental Authority in the Territory or elsewhere in the world, with respect to the Product and/or any Competing Product, for any use, purpose, indication or treatment (whether for the treatment of idiopathic pulmonary fibrosis, or any other disease or disorder) and/or (iv) use any of the Excluded Assets or IPF Patient Data to engage in any conduct prohibited under Sections 8.14(a)(i)-(iii); provided that this Section 8.14(a) shall not apply to non-affiliated successors or assigns of Seller.

(b) Purchaser, Parent and Opco hereby covenant and agree that, for a period of five (5) years from the Closing Date, neither Purchaser, Parent, Opco nor any of their respective Affiliates (either alone or in collaboration with any Third Party) shall (i) make, use, develop, promote, advertise, market, distribute, sell, offer to sell, import, export and/or commercialize the Product for the treatment of idiopathic pulmonary fibrosis, anywhere in the Territory or elsewhere in the world, and/or (ii) file any applications for regulatory approval, including new drug applications, abbreviated new drug applications, new drug submissions, and any comparable applications and submission, with any Governmental Authority in the world, with respect to the Product for the treatment of idiopathic pulmonary fibrosis. For clarity, except as set forth in Section 2.10, nothing in this Section 8.14 or in the Transaction Documents shall operate or be construed to prevent, limit, restrict or impair Purchaser’s right to, for example but without limitation, (1) make, use, develop, promote, advertise, market, distribute, sell, offer to sell, import, export and/or commercialize the Product for any use, purpose, indication or treatment (other than for the treatment of idiopathic pulmonary fibrosis), anywhere in the Territory or elsewhere in the world, in each case, whether alone, or as a mixture or in combination with any variation(s) or any analog polypeptide(s) of the Product and/or with any other biologic(s), product(s) or composition(s), (2) file any applications for regulatory approval, including new drug applications, abbreviated new drug applications, new drug submissions, and any comparable applications and submissions, with any Governmental Authority in the Territory or elsewhere in the world, with respect to the Product for any use, purpose, indication or treatment (other than for the treatment of idiopathic pulmonary fibrosis), in each case, whether alone, or as a mixture or in combination with any variation(s) or any analog polypeptide(s) of the Product and/or with any other biologic(s), product(s) or composition(s), and/or (3) use the Product and/or any of the Product Intellectual Property to develop improvements or enhancements to the Product for purposes of engaging in any of the conduct described in this Section 8.14(b)(1)-(2); provided that this Section 8.14(b) shall not apply to non-affiliated successors or assigns of Purchaser. Seller hereby covenants and agrees that neither Seller nor any of its Affiliates (either alone or in collaboration with any Third Party) shall prevent, limit, restrict or impair any of Purchaser’s rights set forth in this Section 8.14(b).

(c) Nothing in this Section 8.14 or in the Transaction Documents shall operate or be construed as a waiver, disclaimer, abridgment, abrogation or truncation of any of Purchaser’s, Parent’s, Opco’s and/or any of their respective Affiliates’ rights, titles and/or interests in and to the Product Intellectual Property and/or in and to any Intellectual Property owned or licensed (as licensor or licensee) by Purchaser, Parent, Opco and/or any of their respective Affiliates. For the avoidance of doubt, nothing in this Section 8.14 or in the Transaction Documents shall operate or be construed as assigning, conveying, transferring or granting to Seller and/or any of its Affiliates any rights, titles, interests, licenses or authorities in and to any of the Product Intellectual Property and/or in and to any Intellectual Property owned or licensed (as licensor or licensee) by Purchaser, Parent, Opco and/or any of their respective Affiliates.

 

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(d) In order to receive the full benefit of the bargain under the Transaction Documents, the Parties hereto have knowingly and voluntarily entered into, and intend to be fully and legally bound to, the restrictive covenants of this Section 8.14, including, without limitation, as to the defined territory, duration, and prohibited conduct set forth in this Section 8.14.

Section 8.15 Seller’s Additional Covenants and Agreements.

(a) Seller hereby covenants and agrees that neither Seller nor any of its Affiliates (either alone or in collaboration with any Third Party) shall, at any time on or subsequent to the Closing Date, challenge or otherwise contest before any Governmental Authority or via any Proceeding (i) Purchaser’s right, title and interest in and to the Product, the Product Business, and the Product Intellectual Property, (ii) the validity and/or the enforceability of any of the Product Intellectual Property, (iii) Purchaser’s right to seek and obtain any copyright, patent and/or trademark protection for the Product, the Product Business, and/or any of the Product Intellectual Property, (iv) the validity and/or the enforceability of any copyright(s), patent(s) and/or trademark(s) so obtained by Purchaser for the Product, the Product Business, and/or any of the Product Intellectual Property, (v) Purchaser’s right to retain any and all income, revenue, profit, royalties, damages, claims and payments attributable thereto, payable in connection therewith, or otherwise derived therefrom, without any duty to account to Seller (excepted as otherwise provided under this Agreement), (vi) Purchaser’s right to bring any and all causes of action, either in law or in equity, for past, present or future infringement of any of the Product Intellectual Property, (vii) Purchaser’s right to exploit the Product Intellectual Property for whatever purposes Purchaser shall elect to pursue, including, without limitation, improvements, combinations and analogies thereof and commercialization for new uses and indications (other than for the treatment of idiopathic pulmonary fibrosis) or as otherwise restricted by the terms of this Agreement, and (viii) Purchaser’s right to any and all rights, titles and interests corresponding to the foregoing throughout the world.

(b) Seller hereby covenants and agrees that neither Seller nor any of its Affiliates (either alone or in collaboration with any Third Party) shall, at any time on or subsequent to the Closing Date (i) undertake any action that may damage, diminish, impair or infringe upon, any of Purchaser’s right, title and/or interest in and to the Product, the Product Business, and/or any of the Product Intellectual Property, (ii) assist any Third Party in challenging or otherwise contesting Purchaser’s rights, titles and interests in and to the Product, the Product Business and/or any of the Product Intellectual Property, anywhere in the world, (iii) use any of the Product Intellectual Property, and/or (iv) obtain or assert any right(s), title(s) or interest(s) to any patent, trademark or copyright relating to the Product, the Product Business and/or any of the Product Intellectual Property.

(c) To the extent that Seller, at the time of Closing, has any right, title or interest in Intellectual Property which, subsequent to Closing, Seller reasonably determines would materially prevent, limit, restrict or impair Purchaser’s ability to (i) commercialize the Product, (ii) engage in the Product Business, (iii) exercise or exploit any of the Product Intellectual

 

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Property, and/or (iv) bring any and all causes of action, either in law or in equity, for past, present or future infringement of any of the Product Intellectual Property, (the “Additional Intellectual Property”), the Seller shall notify Purchaser of such determination and the Parties will work in good faith to provide Purchaser with the rights to such Additional Intellectual Property solely in the Product Business.

ARTICLE IX

INDEMNIFICATION

Section 9.1 Indemnification.

(a) Subject to the terms and conditions of this Article IX, from and after the Closing, Seller shall indemnify, reimburse, defend and hold harmless Purchaser, its Affiliates and their respective officers, directors, managers, employees, stockholders, members, agents, successors and assigns (collectively, the “Purchaser Indemnified Parties”) from and against, and shall compensate and reimburse each Purchaser Indemnified Party, for any and all Losses incurred by such Purchaser Indemnified Party to the extent arising or resulting from:

(i) any inaccuracy or breach of any representation or warranty of Seller contained in this Agreement;

(ii) any breach of any covenant or agreement of Seller contained in this Agreement or in any of the Ancillary Agreements; or

(iii) the failure of Seller or any of its Affiliates to pay, perform or discharge any Excluded Liabilities; or

(iv) any Third Party claim by a Third Party relating to the conduct of the Product Business by Seller or any of its Affiliates prior to the Closing.

(b) Subject to the terms and conditions of this Article IX, from and after the Closing, Purchaser, Parent and Opco shall, jointly and severally, indemnify, reimburse, defend and hold harmless Seller, its Affiliates and their respective officers, directors, managers, employees, stockholders, agents, successors and assigns (collectively, the “Seller Indemnified Parties”) from and against, and shall compensate and reimburse each Seller Indemnified Party for, any and all Losses incurred by such Seller Indemnified Party to the extent arising or resulting from:

(i) any inaccuracy or breach of any representation or warranty of Purchaser, Parent or Opco contained in this Agreement;

(ii) any breach of any covenant or agreement of Purchaser, Parent or Opco contained in this Agreement or in any of the Ancillary Agreements;

(iii) the failure of Purchaser or any of its Affiliates to pay, perform or discharge any Assumed Liabilities; or

(iv) any Third Party Claim by a Third Party relating to the conduct of the Product Business by Purchaser of any of its Affiliates from and after Closing, except to

 

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the extent such Third Party Claim arises directly out of (1) any inaccuracy or breach of any representation or warranty of Seller contained in this Agreement or in any of the Ancillary Agreements, or (2) the negligence, recklessness, bad faith, or intentional wrongful acts or omissions of Seller or its Affiliates.

(c) NOTWITHSTANDING THE FOREGOING, PURCHASER LOSSES AND SELLER LOSSES SHALL NOT INCLUDE, AND IN NO EVENT SHALL ANY PURCHASER LOSSES OR SELLER LOSSES BE RECOVERABLE UNDER THE TERMS OF THIS AGREEMENT TO THE EXTENT SUCH DAMAGES CONSIST OF PUNITIVE, SPECIAL OR EXEMPLARY DAMAGES, EXCEPT TO THE EXTENT SUCH PUNITIVE, SPECIAL OR EXEMPLARY DAMAGES ARE AWARDED AGAINST ANY PURCHASER INDEMNIFIED PARTY OR SELLER INDEMNIFIED PARTY, AS THE CASE MAY BE, IN A THIRD-PARTY CLAIM.

Section 9.2 Certain Limitations. Notwithstanding anything to the contrary contained in this Agreement, each of the following limitations shall apply:

(a) Seller will not be required to indemnify Purchaser under Sections 9.1(a)(i) (other than Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Sections 3.1 (Organization and Authority), 3.2(b) (Title to Purchased Assets), 3.9 (Tax Matters), 3.12 (Brokers, Finders, etc.), or attributable to fraud or intentional misconduct, as to which this Section 9.2(a) shall not apply), except to the extent that the cumulative amount of the Losses under Section 9.1(a)(i) incurred by the Purchaser Indemnified Parties exceeds Two Hundred Fifty Thousand Dollars (U.S. $250,000) (the “Basket Amount”) at which point Seller will be required to pay, and will have Liability for, the cumulative amount of the Losses under Section 9.1(a)(i) incurred by the Purchaser Indemnified Parties.

(b) Purchaser, Parent and Opco will not be required to indemnify Seller under Section 9.1(b)(i) (other than Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Sections 4.1 (Organization and Authority) or 4.3 (Brokers, Finders, etc.), or attributable to fraud or intentional misconduct, as to which this Section 9.2(b) shall not apply) except to the extent that the cumulative amount of the Losses under Section 9.1(b)(i) incurred by the Seller Indemnified Parties exceeds the Basket Amount at which point Purchaser, Parent and Opco, jointly and severally, will be required to pay, and will have Liability for, the cumulative amount of the Losses under Section 9.1(b)(i) incurred by the Seller Indemnified Parties.

(c) In no event shall the aggregate out-of-pocket Liability of Seller for any Losses pursuant to Sections 9.1(a)(i) exceed Five Million Five Hundred Thousand Dollars (U.S. $5,500,000) (the “Cap”); provided, that Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Section 3.1 (Organization and Authority), 3.2(b) (Title to Purchased Assets), 3.9 (Tax Matters) and 3.12 (Brokers, Finders, etc.) shall not exceed the Purchase Price; provided, further, that the limitations set forth in this Section 9.2(c) shall not apply to Losses attributable to fraud or intentional misconduct.

(d) In no event shall the aggregate out-of-pocket Liability of Purchaser, Parent or Opco for any Losses pursuant to Sections 9.1(b)(i) (other than Losses incurred as a result of any

 

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inaccuracy or breach of any representation or warranty contained in or attributable to fraud or intentional misconduct, as to which this Section 9.2(d) shall not apply) exceed the Cap; provided, that Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Sections 4.1 (Organization and Authority) or 4.3 (Brokers, Finders, etc.) shall not exceed the Purchase Price; provided, further, that the limitations set forth in this Section 9.2(d) shall not apply to Losses attributable to fraud or intentional misconduct.

(e) In no event shall Seller, Purchaser, Parent or Opco have any Liability under Section 9.1(a)(i), or 9.2(b)(i), as the case may be, with respect to claims that are not properly asserted in writing prior to the date that is eighteen (18) months after the Closing Date (other than claims for Losses incurred as a result of any inaccuracy or breach of any representation or warranty attributable to fraud or intentional misconduct, as to which this Section 9.2(e) shall not apply); provided, however, that (i) claims for Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Sections 3.1 (Organization and Authority), 3.2(b) (Title to Purchased Assets), 3.9 (Tax Matters), 3.12 (Brokers, Finders, etc.), 4.1 (Organization and Authority) or 4.3 (Brokers, Finders, etc.), may be asserted at any time prior to expiration of the applicable statute of limitations and (ii) claims attributable to fraud or intentional misconduct, will have no expiration date.

(f) The representations and warranties made by each Party in this Agreement shall survive the Closing and shall expire eighteen (18) months after the Closing Date and any Liability of any Party with respect to such representations and warranties (other than Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in (i) Sections 3.1 (Organization and Authority), 3.2(b) (Title to Purchased Assets), 3.9 (Tax Matters), 3.12 (Brokers, Finders, etc.), 4.1 (Organization and Authority) and 4.3 (Brokers, Finders, etc.), which shall expire upon expiration of the applicable statute of limitations, or (ii) attributable to fraud or intentional misrepresentation, as to which no expiration date shall apply; provided, however, that if, at any time prior to such expiration date, notice of any case for indemnification pursuant to Section 9.1(a) or Section 9.1(b), as the case may be, shall have been given prior to the applicable expiration date and such notice describes the circumstances with respect to which such indemnification claim relates, such indemnification claim shall survive until such time as such claim is finally resolved.

Section 9.3 Procedures for Third Party Claims and Excluded Liabilities.

(a) General Procedures. Promptly (but in no event later than ten (10) days) after the receipt by any Indemnified Party of a notice of any Proceeding by any Third Party that may be subject to indemnification under this Article IX, including any Proceeding relating to any Excluded Liability or Assumed Liability, such Indemnified Party shall give written notice of such Proceeding to the Indemnifying Party, stating in reasonable detail the nature and basis of each claim made in the Proceeding and the amount thereof, to the extent known, along with copies of the relevant documents received by the Indemnified Party evidencing the Proceeding and the basis for indemnification sought. Failure of the Indemnified Party to give such notice shall not relieve the Indemnifying Party from liability on account of this indemnification, except if and only to the extent that the Indemnifying Party is actually prejudiced thereby. Thereafter, the Indemnified Party shall deliver to the Indemnifying Party, promptly after the Indemnified Party’s receipt thereof, copies of all notices and documents (including court papers) received by

 

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the Indemnified Party relating to the Proceeding. The Indemnifying Party shall have the right to assume the defense of the Indemnified Party against the Third Party Claim upon written notice to the Indemnified Party delivered within thirty (30) days after receipt of the particular notice from the Indemnified Party; provided, however, that the Indemnifying Party shall not have the right to assume the defense of the Third Party Claim if such Third Party Claim (x) seeks as a remedy the imposition of an equitable remedy that is binding upon Purchaser, Parent or Opco, the Purchased Assets or the Assumed Liabilities or (y) the amounts of Losses would be reasonably expected to exceed the amounts for which the Indemnifying Party is obligated to indemnify. So long as the Indemnifying Party has assumed the defense of the Third Party Claim in accordance herewith and notified the Indemnified Party in writing thereof, (i) the Indemnified Party may retain separate co-counsel at its sole cost and expense and participate in the defense of the Third Party Claim, it being understood that the Indemnifying Party shall pay all reasonable costs and expenses of counsel for the Indemnified Party after such time as the Indemnified Party has notified the Indemnifying Party of such Third Party Claim and prior to such time as the Indemnifying Party has notified the Indemnified Party that it has assumed the defense of such Third Party Claim, (ii) the Indemnified Party shall not file any papers or consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim without the prior written consent of the Indemnifying Party (not to be unreasonably withheld, conditioned or delayed) and (iii) the Indemnifying Party will not consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim (other than a judgment or settlement that is solely for money damages in an amount less than the remaining balance of the limitations on indemnity set forth in Section 9.2 and is accompanied by a release of all indemnifiable claims against the Indemnified Party) without the prior written consent of the Indemnified Party (not to be unreasonably withheld, conditioned or delayed). Whether or not the Indemnifying Party shall have assumed the defense, such Indemnifying Party shall not be obligated to indemnify and hold harmless the Indemnified Party hereunder for any settlement entered into without the Indemnifying Party’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed.

(b) Equitable Remedies. In the case of any Third Party Claims where the Indemnifying Party reasonably believes that it would be appropriate to settle such claim using equitable remedies (i.e., remedies involving the future use of the Purchased Assets), the Indemnifying Party and the Indemnified Party shall work together in good faith to agree to a settlement; provided, however, that no Party shall be under any obligation to agree to any such settlement.

(c) Treatment of Indemnification Payments; Insurance Recoveries. Any payment made pursuant to the indemnification obligations arising under this Agreement shall be treated as an adjustment to the Purchase Price to the extent allowable under Applicable Law. Any indemnity payment under this Agreement shall be decreased by any amounts actually received by the Indemnified Party under Third Party insurance policies with respect to such Damage prior to the time payment by the Indemnifying Party is due and payable under this Agreement (net of any premiums paid by such Indemnified Party under the relevant insurance policy and any costs incurred by such Indemnified Party in procuring such payment under such policy), each Party agreeing (i) to use commercially reasonable efforts to recover all available insurance proceeds and (ii) to the extent that any indemnity payment under this Agreement has been paid by the Indemnifying Party to or on behalf of the Indemnified Party prior to the receipt, directly or

 

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indirectly, by the Indemnified Party of any net insurance proceeds under Third Party insurance policies on account of such Loss which duplicate, in whole or in part, the payment made by the Indemnifying Party to or on behalf of the Indemnified Party, the Indemnified Party shall remit to the Indemnifying Party an amount equal to the amount of the net insurance proceeds actually received by the Indemnified Party on account of such Loss which duplicate, in whole or in part, the payment made by the Indemnifying Party to or on behalf of the Indemnified Party.

(d) In connection with any actual or threatened Third Party Claims by, or actual or threatened litigation or other disputes with, Third Parties relating to Assumed Liabilities or Excluded Liabilities, any such claims, litigation and disputes being referred to as “claims” for purposes of this Section 9.3(d), the Indemnified Party shall cooperate in the defense by the Indemnifying Party of such claim (and the Indemnified Party and the Indemnifying Party agree with respect to all such claims that a common interest privilege agreement exists between them), including, (i) permitting the Indemnifying Party to discuss the claim with such officers, employees, consultants and representatives of the Indemnified Party as the Indemnifying Party reasonably requests, (ii) permitting the Indemnifying Party to have reasonable access to the properties, books, records, papers, documents, plans, drawings, electronic mail, databases and computers of the Indemnified Party at reasonable hours to review information and documentation relative to the claim, (iii) providing to the Indemnifying Party copies of documents and samples of the Product as the Indemnifying Party reasonably requests in connection with defending such claim, (iv) permitting the Indemnifying Party to conduct privileged interviews and witness preparation of officers, employees and representatives of the Indemnified Party as the Indemnifying Party reasonably requests, (v) preserving all properties, books, records, papers, documents, plans, drawings, electronic mail and databases included in the Purchased Assets relating to matters relating to Excluded Liabilities (in the case of the Purchaser) and Assumed Liabilities (in the case of Seller) in accordance with such Party’s corporate documents retention policies, or longer to the extent reasonably requested by the other Party in connection with any actual or threatened action that would reasonably be expected to result in a claim for indemnification hereunder, (vi) promptly collecting documents and extracting information from documents for the Indemnifying Party’s review and use, as the Indemnifying Party reasonably requests, or allowing the Indemnifying Party’s representatives to do the same, (vii) notifying the Indemnifying Party promptly of receipt by the Indemnified Party of any subpoena or other Third Party request for documents or interviews and testimony, (viii) providing to the Indemnifying Party copies of any documents produced by the Indemnified Party in response to or compliance with any subpoena or other Third Party request for documents, and (ix) permitting the Indemnifying Party to conduct such other reasonable investigations and studies, and take such other actions, as are reasonably necessary in connection with the Indemnifying Party’s defense or investigation of such claim. In connection with any claims, except to the extent inconsistent with the Indemnified Party’s obligations under Applicable Law and except to the extent that to do so would subject the Indemnified Party or its employees, agents or representatives to criminal or civil sanctions, (1) unless ordered by a court to do otherwise, the Indemnified Party shall not produce documents to a Third Party until the Indemnifying Party has been provided a reasonable opportunity to review, copy and assert privileges covering such documents, (2) the transfer to the Indemnified Party by the Indemnifying Party of documents covered by the Indemnifying Party’s attorney/client or work product privileges shall not constitute a waiver of such privileges, (3) unless otherwise ordered by a court, the Indemnified Party shall withhold from production to any Third Party any

 

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documents as to which the Indemnifying Party asserts a privilege, (4) the Indemnified Party shall defend in court any such privilege asserted by the Indemnifying Party and (5) the Indemnified Party shall permit the Indemnifying Party to prepare any employees of the Indemnified Party required or requested to testify or otherwise be deposed or interviewed in connection with any claim and to be present during any such testimony or interviews.

Section 9.4 Certain Procedures. The Indemnified Party shall give the Indemnifying Party prompt written notice (an “Indemnification Claim Notice”) (but in no event more than thirty (30) days after discovery) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under Section 9.1(a) or Section 9.1(b); provided, however, that failure to give such notice shall not relieve the Indemnifying Party of its obligations hereunder except to the extent it shall have been materially prejudiced by such failure. Each Indemnification Claim Notice must contain a reasonable description of the claim and the nature and amount of such Losses (to the extent the nature and amount of such Losses are known at such time). The Indemnified Party shall furnish promptly to the Indemnifying Party (but in no event more than thirty (30) days after discovery) copies of all papers and official documents received in respect of any Losses. All indemnification claims in respect of a Party, its Affiliates or their respective directors, stockholders, members, officers, managers, employees and agents shall be made solely by such Party to this Agreement.

Section 9.5 Guaranty. Parent hereby agrees to be responsible for, and guarantee to Seller, the full performance by Purchaser, a wholly-owned subsidiary of Parent, and Opco, an indirect, wholly-owned subsidiary of Purchaser, and agrees to cause Purchaser and Opco to perform, all of their respective obligations and liabilities under or in connection with this Agreement, the Ancillary Agreements and the transactions contemplated hereby and thereby. The liability of Parent under this Section 9.5 shall be irrevocable, absolute and independent.

Section 9.6 Remedies Exclusive. Following the Closing, with the exception of remedies based on fraud, the remedies set forth in this Article IX shall constitute the sole and exclusive remedy for money damages and shall be in lieu of any other remedies for money damages that may be available to the Indemnified Parties under any other agreement or pursuant to any statutory or common law with respect to any Losses of any kind or nature incurred directly or indirectly resulting from or arising out of any of this Agreement, the Purchased Assets, the Assumed Liabilities or the Excluded Liabilities (it being understood that nothing in this Section 9.6 or elsewhere in this Agreement shall affect the Parties’ rights to specific performance or other similar non-monetary equitable remedies with respect to the covenants referred to in this Agreement to be performed after the Closing). The Parties each hereby waive any provision of any Applicable Law to the extent that it would limit or restrict the agreement contained in this Section 9.6.

ARTICLE X

MISCELLANEOUS PROVISIONS

Section 10.1 Confidentiality.

(a) Reference is made to that certain letter agreement dated July 28, 2011, by and between Seller and Parent (the “Confidentiality Agreement”). As used in this Section 10.1, the

 

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term “Evaluation Material” shall have the meaning assigned to such term in the Confidentiality Agreement. Upon the Closing, the Confidentiality Agreement shall expire and be of no further force and effect with respect to all Evaluation Material relating to the Product Business, the Purchased Assets or the Assumed Liabilities, but all such Evaluation Materials shall thereafter be governed by the provisions of Section 10.1(b); provided, however, such expiration of the Confidentiality Agreement shall in no way prejudice or adversely affect Seller’s ability to seek damages, or any other remedy available to Seller, with respect to a violation by Purchaser, Parent or Opco (or their respective Affiliates or representatives) of the Confidentiality Agreement prior to or after the Closing. Upon and after the Closing, the Confidentiality Agreement shall remain in full force and effect pursuant to its terms with respect to all other Evaluation Material that does not relate to the Product Business, the Purchased Assets or the Assumed Liabilities.

(b) From and after the Closing, all confidential information and all Evaluation Material relating to the Product Business, the Purchased Assets and the Assumed Liabilities shall constitute the “Purchaser Confidential Information” and shall be used by Seller solely as required to perform its obligations, exercise or enforce its rights under this Agreement (or any Ancillary Agreement), or comply with Applicable Law, and for no other purpose. Seller shall not disclose, or permit the disclosure of, any of the Purchaser Confidential Information to any Person except those Persons to whom such disclosure is necessary to permit Seller to perform its obligations, exercise or enforce its rights under this Agreement (or any Ancillary Agreement), or comply with Applicable Law. Seller shall treat, and will cause its Affiliates and the directors, officers, employees, agents, representatives and advisors of Seller or any of their Affiliates to treat, the Purchaser Confidential Information as confidential, using the same degree of care as Seller normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.

(c) All confidential information obtained by Purchaser, Parent or Opco (or their respective Affiliates or representatives) from Seller (or its Affiliates or representatives) other than the Purchaser Confidential Information (the “Seller Confidential Information”) shall be used by Purchaser, Parent and Opco solely as required to perform their respective obligations, exercise or enforce its rights under this Agreement (or any Ancillary Agreement), or comply with Applicable Law, and for no other purpose. Purchaser, Parent and Opco shall not disclose, or permit the disclosure of, any of Seller Confidential Information to any person except those persons to whom such disclosure is necessary to permit Purchaser, Parent and Opco to perform their respective obligations, exercise or enforce their respective rights under this Agreement (or any Ancillary Agreement), or comply with Applicable Law. Purchaser, Parent and Opco shall each treat, and will cause their respective Affiliates and the directors, officers, employees, agents, representatives and advisors of Purchaser, Parent and Opco or any of their Affiliates to treat, Seller Confidential Information as confidential, using the same degree of care as Purchaser, Parent and Opco normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.

(d) In the event any Party is requested pursuant to, or required by, Applicable Law to disclose any of any other Party’s Confidential Information (i.e., Seller Confidential Information or Purchaser Confidential Information, as applicable), it will notify the other Party in a timely manner so that such Party may seek a protective order or other appropriate remedy or, in such Party’s sole discretion, waive compliance with the confidentiality provisions of this Agreement.

 

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Each Party will co-operate in all reasonable respects, in connection with any reasonable actions to be taken for the foregoing purpose. In any event, the Party requested or required to disclose such Confidential Information may furnish it as requested or required pursuant to Applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided that such Party furnishes only that portion of the Confidential Information which such Party is advised by a reasoned opinion of its counsel is legally required, and such Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded such Confidential Information.

(e) Nothing in this Section 10.1 shall be construed as preventing or in any way inhibiting any Party from complying with Applicable Law governing activities and obligations undertaken pursuant to this Agreement, in any manner which it reasonably deems appropriate, including, for example, by disclosing to Governmental Authorities confidential or other information of the other Party.

Section 10.2 Notices. All notices, requests and other communications required or permitted under, or otherwise made in connection with, this Agreement, shall be in writing and shall be deemed to have been duly given (a) when delivered in person, (b) upon confirmation of receipt when transmitted by facsimile transmission, or (c) on the next Business Day if transmitted by national overnight courier (with confirmation of delivery), in each case, addressed as follows:

if to Seller, to:

InterMune, Inc.

3280 Bayshore Boulevard

Brisbane, CA 94005

Attention: General Counsel

Facsimile No.: (415)  ###-###-####

with a copy to (which shall not constitute notice):

Latham & Watkins LLP

140 Scott Drive

Menlo Park, CA 94025

Attention: Mark V. Roeder, Esq.

Facsimile No.: (650)  ###-###-####

if to Purchaser or Parent to:

Vidara Therapeutics International Limited

Attention: Dr. Virinder Nohria

c/o Fairisle Management Limited

The Penthouse, Washington Mall I

20 Church Street

Hamilton HM 11

Bermuda

Facsimile No.: (441)  ###-###-####

 

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if to Opco to:

Vidara Therapeutics Research Limited

Adelaide Chambers

Peter Street

Dublin 8

Ireland

Attention: David Kelly

Facsimile No.: 353-1 ###-###-####

with a copy to (which shall not constitute notice):

Burke, Warren, MacKay & Serritella, P.C.

330 North Wabash Avenue, Suite 2200

Chicago, IL 60611

Attention: Christopher R. Manning

Facsimile No.: (312)  ###-###-####

or to such other address or facsimile number as such Party may hereafter specify for the purpose by notice to the other parties hereto in accordance with the terms of this Section 10.2.

Section 10.3 Bulk Transfers. Purchaser waives compliance with the provisions of all Applicable Laws relating to bulk transfers in connection with the transfer of the Purchased Assets.

Section 10.4 Remedies Cumulative; Specific Performance. The rights and remedies of the Parties shall be cumulative (and not alternative). The Parties agree that irreparable damage would occur if any provision of this Agreement were not performed in accordance with the terms hereof and that the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement or to enforce specifically the performance of the terms and provisions of this Agreement in addition to any other remedy to which they are entitled to at law or in equity, in each case without the requirement of posting any bond or other type of security.

Section 10.5 Further Assurances; Further Cooperation. Subject to the terms and conditions hereof, each of the Parties agrees to use commercially reasonable efforts to execute and deliver, or cause to be executed and delivered, all documents and to take, or cause to be taken, all actions that may be reasonably necessary or appropriate, in the reasonable opinion of counsel for each Party, to effectuate the provisions of this Agreement, provided that all such actions are in accordance with Applicable Law. From time to time, whether at or after the Closing, (i) Seller shall execute and deliver such further documents or instruments of conveyance, transfer and assignment and take all such other action, at Purchaser’s sole expense, as Purchaser may reasonably require to more effectively convey, transfer and assign to Purchaser any and all ownership, right, title and interest in and to the Purchased Assets, including, without limitation, executing documents or instruments necessary to permit Purchaser to record the transfer, conveyance and/or assignment of any and all Product Intellectual Property with any

 

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Governmental Authority and (ii) Purchaser, Parent and Opco will execute and deliver such further instruments and take all such other action, at Seller’s sole expense, as Seller may reasonably require to more effectively assume the Assumed Liabilities. Upon reasonable request and during normal business hours, Purchaser, Parent, Opco and Seller shall cooperate with each other, and shall cause their respective representatives and Affiliates to cooperate with each other, after the Closing to ensure the orderly transition of the Purchased Assets and Assumed Liabilities to Purchaser and to minimize any disruption to the businesses of Seller, Purchaser, Parent and Opco that might result from the transactions contemplated hereby.

Section 10.6 Amendments and Waivers.

(a) Any provision of this Agreement may be amended or waived but only if, such amendment or waiver is in writing and is signed, in the case of an amendment, by each Party to this Agreement or, in the case of a waiver, by the Party against whom the waiver is to be effective. No waiver by any Party hereto of any term or condition of this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement or any future occasions.

(b) No failure or delay by any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege. The rights and remedies herein provided shall be cumulative and not exclusive of any rights or remedies provided by Applicable Law.

Section 10.7 Expenses. Except as otherwise provided herein, all costs and expenses incurred in connection with this Agreement, including all third-party legal, accounting, financial advisory, consulting or other fees and expenses incurred in connection with the transactions contemplated hereby, shall be paid by the Party incurring such cost or expense.

Section 10.8 Binding Effect; Benefit; Assignment.

(a) The provisions of this Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and assigns. Except as provided under this Agreement, no provision of this Agreement is intended to confer any rights, benefits, remedies, obligations or liabilities hereunder upon any Person other than the Parties and their respective successors and assigns.

(b) Neither this Agreement nor any right, interest or obligation hereunder may be assigned by any Party hereto (other than to an Affiliate of the Party) without the prior written consent of the other Party hereto (which consent shall not be unreasonably withheld) and any attempt to do so will be void; provided, however, that after the Closing, such prior written consent will not be required with respect to any assignment by any Party (a) to an Affiliate of such Party so long as such Party remains bound by the terms hereof, or (b) in connection with a reorganization, merger, statutory share exchange, consolidation or similar change of control transaction involving the Seller or sale or transfer of all or substantially all of the assets of Seller, or, in the case of Purchaser, a sale or transfer, regardless of form, involving all or substantially all of the assets associated with the Product Business. Except with respect to Section 8.14(a) of

 

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this Agreement which shall not apply to non-affiliated successors or assigns of Seller, and except with respect to Section 8.14(b) of this Agreement which shall not apply to non-affiliated successors or assigns of Purchaser, Parent and Opco, this Agreement is binding upon, inures to the benefit of and is enforceable by the Parties hereto and their respective successors and permitted assigns. For the avoidance of doubt, all obligations pursuant to Section 8.14(a) shall automatically and immediately terminate and cease to be enforceable against any non-affiliated successor or assign of Seller and all obligations pursuant to Section 8.14(b) shall automatically and immediately terminate and cease to be enforceable against any non-affiliated successor of Parent, Purchaser or Opco. Any attempt to assign this Agreement in violation of this Section 10.8(b) shall be void. Subject to this Section 10.8(b), any permitted assignee shall assume all obligations of its assignor under this Agreement pursuant to a written instrument reasonably acceptable to the other Parties. In addition, nothing in this Agreement shall preclude Purchaser from providing its lenders with a security interest in its rights under this Agreement in accordance with the terms of their security and collateral agreements in connection with any credit facility provided by such lenders to Purchaser or preclude such lenders from foreclosing upon such security interest in accordance with the terms of such security and collateral agreements (including, without limitation, by means of the sale of the assets or stock of Purchaser to a Third Party including Purchaser’s rights and responsibilities under this Agreement), and any such action by such lenders shall not be deemed to be a change of control for purposes of this Agreement.

(c) Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person other than the Parties and their respective successors and permitted assigns any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

Section 10.9 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to principles of conflicts of laws that would require the application of the laws of any other jurisdiction.

Section 10.10 Jurisdiction. The Parties hereto agree that any Proceeding seeking to enforce any provision of, or based on any matter arising out of or in connection with, this Agreement or the transactions contemplated hereby shall be brought in any federal court located in the State of Delaware or any Delaware state court, and each of the Parties hereby irrevocably consents to the jurisdiction of such courts (and of the appropriate appellate courts therefrom) in any such Proceeding and irrevocably waives, to the fullest extent permitted by law, any objection that it may now or hereafter have to the laying of the venue of any such Proceeding in any such court or that any such Proceeding brought in any such court has been brought in an inconvenient forum. Process in any such Proceeding may be served on any Party anywhere in the world, whether within or without the jurisdiction of any such court. Without limiting the foregoing, each Party agrees that service of process on such party as provided in Section 10.2 shall be deemed effective service of process on such Party.

Section 10.11 Waiver of Jury Trial. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.

 

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Section 10.12 Arbitration.

(a) With respect to any dispute, controversy or claim arising from or related to this Agreement or the breach thereof that is not an Excluded Claim (“Dispute”), such Dispute shall first be referred to an executive officer from each Party for attempted resolution by good faith negotiations. Any such Dispute shall be submitted to such senior executives no later than thirty (30) days following such request by any Party. Such executives shall attempt in good faith to resolve any such Dispute within thirty (30) days after the submission of the Dispute. In the event the executives are unable to resolve the Dispute, the Parties shall otherwise negotiate in good faith and use reasonable efforts to settle. If the Parties do no fully settle, and a Party wishes to pursue the matter, each such Dispute shall be finally resolved by binding arbitration in accordance with the Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes of the American Arbitration Association (“AAA”), and judgment on the arbitration award may be entered in any court having jurisdiction thereof.

(b) The arbitration shall be conducted by a panel of three (3) persons experienced in the pharmaceutical business: within thirty (30) days after initiation of arbitration, each of Purchaser and Seller shall select one person to act as arbitrator and the two selected arbitrators shall select a third arbitrator within thirty (30) days of their appointment. If the arbitrators selected by Purchaser and Seller are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by the AAA. The place of arbitration shall be San Francisco, California, and all proceedings and communications shall be in English.

(c) Any Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Any Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages. Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees of arbitration.

(d) Except to the extent necessary to confirm an award or as may be required by law, no Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of each Party. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable Delaware statute of limitations.

(e) For clarity, this Section 10.12 shall not apply to any Excluded Claim with the result that Excluded Claims shall not be subject to resolution by arbitration in the absence of a separate agreement between the Parties to do so.

Section 10.13 Counterparts; Effectiveness. This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement shall become effective when each Party shall have received a counterpart hereof signed by the other Party. Until and unless each Party has received a counterpart hereof signed by the other Party hereto,

 

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this Agreement shall have no effect, and no Party shall have any right or obligation hereunder (whether by virtue of any other oral or written agreement or other communication). The exchange of a fully executed Agreement or any Ancillary Agreement (in counterparts or otherwise) by electronic transmission in .PDF format or by facsimile shall be sufficient to bind the Parties to the terms and conditions hereof and thereof.

Section 10.14 Entire Agreement. This Agreement, the Ancillary Agreements, the Confidentiality Agreement and each of the documents, instruments and agreements delivered in connection with the transactions contemplated by this Agreement, including each of the Exhibits, the Schedules, and the Seller Disclosure Schedule, constitute the entire agreement between the Parties with respect to the subject matter of this Agreement and supersede all prior agreements and understandings, both oral and written, between the Parties with respect to the subject matter of this Agreement.

Section 10.15 Severability. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other Governmental Authority to be invalid, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions of this Agreement shall remain in full force and effect and shall in no way be affected, impaired or invalidated so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any Party. Upon such a determination, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the fullest extent possible.

Section 10.16 Time is of the Essence. Time is of the essence with respect to the performance of this Agreement.

(Signatures Pages Follow)

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the Agreement Date.

 

VIDARA THERAPEUTICS INTERNATIONAL LIMITED
By:  

/s/ Virinder Nohria

Name:   Virinder Nohria
Title:   President
VIDARA THERAPEUTICS HOLDINGS LLC
By:  

/s/ Bala Venkataraman

Name:   Bala Venkataraman
Title:   Chairman and Treasurer
VIDARA THERAPEUTICS RESEARCH
LIMITED
By:  

/s/ David G. Kelly

Name:   David G. Kelly
Title:   Director and Chief Financial Officer

Signature Page to Asset Purchase Agreement


INTERMUNE, INC.
By:  

/s/ John C. Hodgman

Name:   John C. Hodgman
Title:   Chief Financial Officer and Senior Vice President, Finance

Signature Page to Asset Purchase Agreement