Back to top

ASSET ACQUISITION AGREEMENT

Asset Purchase Agreement

ASSET ACQUISITION AGREEMENT | Document Parties: MAYNE PHARMA plc | SUPERGEN, INC | EUROGEN PHARMACEUTICALS, LTD You are currently viewing:
This Asset Purchase Agreement involves

MAYNE PHARMA plc | SUPERGEN, INC | EUROGEN PHARMACEUTICALS, LTD

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: ASSET ACQUISITION AGREEMENT
Governing Law: Delaware     Date: 11/28/2006
Industry: Biotechnology and Drugs     Sector: Healthcare

ASSET ACQUISITION AGREEMENT, Parties: mayne pharma plc , supergen  inc , eurogen pharmaceuticals  ltd
50 of the Top 250 law firms use our Products every day

Exhibit 2.1

ASSET ACQUISITION AGREEMENT

dated November 25, 2006

FOR THE ACQUISITION OF

Certain of the

Assets Related to Nipent®

By and among

MAYNE PHARMA plc

And

SUPERGEN, INC. and EUROGEN PHARMACEUTICALS, LTD.

 



ASSET ACQUISITION AGREEMENT

This Asset Acquisition Agreement (this “Agreement”), dated as of November 25, 2006, is by and among Mayne Pharma plc, a company incorporated and registered in England and Wales and/or its designee(s) (“Buyer”), EuroGen Pharmaceuticals, Ltd., a company incorporated and registered in England and Wales (“EuroGen”), and SuperGen, Inc., a Delaware corporation (“Seller”).

BACKGROUND : Seller and EuroGen are in the business of marketing, promoting, selling and distributing the Product (as defined below) in the Territory (as defined below) (collectively, “Seller Business”).  On June 21, 2006, Seller and Mayne Pharma (USA) Inc. entered into a separate Asset Acquisition Agreement, pursuant to which Seller has agreed to sell to Mayne Pharma (USA) Inc., among other things, certain assets used by Seller in marketing, promoting, selling, and distributing the Product in the United States, Canada and Mexico (the “U.S. Agreement”).  The parties desire that Seller and EuroGen (to the extent EuroGen holds any right, title or interest therein) sell and Buyer buys substantially all of the assets, tangible and intangible, related to the Seller Business, all on the terms and subject to the conditions set forth in this Agreement.

Intending To Be Legally Bound , in consideration of the foregoing and the mutual agreements contained herein and subject to the satisfaction of the terms and conditions set forth herein, the parties hereto agree as follows:

SECTION 1. DEFINED TERMS

Certain defined terms used in this Agreement and not specifically defined in context are defined in this Section 1 as follows:

1.1                                “API” means the active pharmaceutical ingredient of the Product, pentostatin.

1.2                                “Asset” means any real, personal, mixed, tangible or intangible property of any nature including prepayments, deposits, escrows, Tangible Property, Contract Rights, Intangibles, Marketing Authorizations, Product Registrations, Regulatory Documentation, goodwill, claims, causes of action and other legal rights and remedies.

1.3                                “Books and Records”   means copies of all paper and electronic versions of files, documents, instruments, papers, books, ledgers, plans, correspondence, memoranda, maps, diagrams, photographs, and videotapes, in each case (i) created in the three years prior to the Closing Date and (ii) only to the extent exclusively pertaining to the Specified Assets or Product (other than Marketing Materials, Regulatory Documentation and Product Registrations), but in all events excluding invoices as well as any of the foregoing items that refer to financial data.

1.4                                Change of Control ” shall mean the direct or indirect acquisition of either (i) the majority of the voting stock of such party, or (ii) all or substantially all of the assets of such party, by another entity in a single transaction or series of related transactions if more than fifty percent (50%) of the combined voting power of the continuing or surviving entity’s securities outstanding immediately after such transaction or series of related transactions is owned by

 



persons who were not stockholders of such party immediately prior to such transaction or series of related transactions.

1.5                                “cGMP” means current good manufacturing practice in accordance with the Guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), as amended from time to time, as applied by the Relevant Regulatory Authority.

1.6                                “Claims Adjustment” has the meaning specified in Section 3.2.2.

1.7                                “Clinical Trial Agreement” has the meaning specified in Section 4.8.1.

1.8                                “Closing Payment” has the meaning specified in Section 3.1.1.

1.9                                “Consent” means any consent, approval, order or authorization of, or any declaration, filing or registration with, or any application, notice or report to, or any waiver by, or any other action (whether similar or dissimilar to any of the foregoing) of, by or with, any Person, which is necessary in order to take a specified action or actions in a specified manner and/or to achieve a specified result.

1.10                         “Contract” means any written or oral contract, agreement, instrument, order, arrangement, or commitment including sales orders, purchase orders, leases, subleases, data processing agreements, maintenance agreements, license agreements, sublicense agreements, loan agreements, promissory notes, security agreements, pledge agreements, deeds, mortgages, guaranties, indemnities, warranties, employment agreements, consulting agreements, sales representative agreements, joint venture agreements, buy-sell agreements, options or warrants.

1.11                         “Contract Right” means any right, power or remedy of any nature under any Contract including rights to receive property or services or otherwise derive benefits from the payment, satisfaction or performance of another party’s Obligations, rights to demand that another party accept property or services or take any other actions, and rights to pursue or exercise remedies or options.

1.12                         “Deferred Payments” has the meaning specified in Section 3.3.1.

1.13                         “Deferred Payment Year” has the meaning specified in Section 3.3.1.

1.14                         “Development Plan Payments” has the meaning specified in Section 2.1.3(A).

1.15                         “EMEA” means the European Medicines Agency.

1.16                         “Employment Regulations” means the UK Transfer of Undertakings (Protection of Employment) Regulations 2006 or any other local enactment of the European Community Acquired Rights Directive (77/187/EEC, as amended by Directive 98/50 EC and consolidated in 2001/23/EC).

1.17                         “Encumbrance” means any lien, superlien, security interest, pledge, right of first refusal, charge (fixed or floating), trust, right of set off, mortgage, easement, covenant,

2

 



restriction, reservation, prior assignment, or other encumbrance, claim, burden or charge of any nature (whether legal or equitable).

1.18                         “Entity” means any corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any company limited by shares, limited liability company or joint stock company), firm, society or other enterprise, association, organization or entity.

1.19                         “Environmental Laws” means all applicable Laws (including consent decrees and administrative orders) relating to the public health and safety and protection of the environment including those governing the use, generation, handling, storage and disposal or cleanup of Hazardous Substances, all as amended.

1.20                         “GAAP” means generally accepted accounting principles under current United States accounting rules and regulations, consistently applied.

1.21                         “Good Distribution Practices” means the current good distribution practices as promulgated under Applicable Law, including any applicable guidance on good distribution practices adopted pursuant to Article 84 of Directive 2001/83/EC, in particular the European Commission’s Guidelines on Good Distribution Practice of Medicinal Products for Human Use.

1.22                         “Governmental Body” means any: (a) nation, principality, republic, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) national, federal, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including, without limitation, the EMEA) and any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court, tribunal (including a judicial tribunal); or (d) multi-national organization or body.

1.23                         “HMRC” means HM Revenue and Customs in the United Kingdom.

1.24                         “Hazardous Substance” means any substance, waste, contaminant, pollutant or material that has been determined by any Governmental Body to be capable of posing a risk of injury or damage to health, safety, property or the environment including (a) all substances, wastes, contaminants, pollutants and materials defined, designated or regulated as hazardous, dangerous or toxic pursuant to any Law, and (b) asbestos, polychlorinated biphenyls (“PCBs”), petroleum, petroleum products and urea formaldehyde, and toxic mold.

1.25                         “Holdback Amount” has the meaning specified in Section 3.2.2.

1.26                         “including” means including but not limited to.

1.27                         “Indemnification Holdback Amount” has the meaning specified in Section 3.2.2.

1.28                         “Indemnification Holdback Period” has the meaning specified in Section 3.2.2.

1.29                         “Independent Accountant” means a nationally or internationally recognized accounting firm (other than a firm which has provided services to Buyer, EuroGen or Seller)

3

 



mutually agreed upon by Buyer, EuroGen and Seller; provided, however, that should the parties be unable to agree on such accounting firm within thirty days after the determination of need for such Independent Accountant pursuant to Section 9.9 hereof, such firm shall be determined in Buyer’s reasonable discretion (it being agreed that such firm selected by Buyer shall not have provided services to Buyer, EuroGen or Seller).

1.30                         “Insurance Policy” means any product liability insurance policy.

1.31                         “Intangible” means any and all of the following and any and all rights and interests in, arising out of, or associated therewith, throughout the world: (a) all domain names, logos, symbols, corporate names, fictitious names, trademarks, trademark applications, service marks, service mark applications, trade names, trade dress, brand names, product names, and slogans, and all goodwill associated therewith and/or symbolized thereby; (b) all inventions (whether patentable or not), formulas, algorithms, methods, processes, discoveries, invention disclosures and trade secrets; (c) all patents and patent applications and all reissues, substitutes, divisions, reexaminations, renewals, extensions, provisionals, continuations and continuations-in-part thereof; (d) copyrights, copyright registrations, renewals, and applications therefor, and all other rights corresponding thereto, including rights in designs (whether or not registered or pending); (e) all websites, and all designs related thereto; (f) all rights in databases and data collections; (g) all moral, integrity, paternity, and economic rights of authors and inventors, however denominated; (h) any similar or equivalent rights to any of the foregoing, whether or not in use, under development or design, or inactive; and (i) the right to sue for past, present, and future infringement of any or all of the foregoing and to retain any damages awarded pursuant to such action.

1.32                         “Inventory” means the API applicable to the Product together with all inventory of raw materials (including, without limitation, all crude unpurified pentostatin), packaging materials (including vials and stoppers), all work in progress related to the Product and all finished goods inventory of the Product, whether held at a location or facility of EuroGen or Seller (or of any other Person on behalf of EuroGen or Seller) or in transit to or from EuroGen or Seller (or any such other Person) ), including, without limitation, any inventory or packaging materials repurchased from Wyeth pursuant to the Wyeth Distribution Agreement.

1.33                         “Inventory Purchase Price” shall have the meaning set forth in Section 3.4.

1.34                         “Judgment” means any order, writ, injunction, citation, award, decree or other judgment of any nature of any Governmental Body.

1.35                         “knowledge of Seller” or “Seller’s Knowledge” and similar phrases mean that none of EuroGen, Seller, or the directors or officers of EuroGen or Seller, respectively (including Michael Molkentin and Ed Jacobs) or Mark Lewis has any actual knowledge after due inquiry that the statement made is incorrect.

1.36                         “Law” means any provision of any foreign, national, supra-national, federal, state or local law, statute, ordinance, treaty, code, rule, or regulation, including common law.

4

 



1.37                         “Local Representative” means a company (other than the Marketing Authorisation holder) registered with a Relevant Regulatory Authority to sell the Product on behalf of the Marketing Authorisation holder in that Market.

1.38                         “Market” means each country or jurisdiction in the Territory for which a Marketing Authorization is set forth on Schedule 1.39.

1.39                         “Marketing Authorization” means each grant of registration approval or license provided by the Relevant Regulatory Authority with respect to each country or jurisdiction in the Territory for the importation, storage, promotion, sale or distribution of the Product in such country or jurisdiction.  Schedule 1.39 sets forth a complete list of all Marketing Authorizations.

1.40                         “Marketing Materials” means all paper and electronic versions of all market research, marketing plans, media plans, advertising, marketing related clinical study plans and results, form letters and medical queries, promotion and sales training materials, customer lists, supplier lists, labeling, package inserts and posters and abstract displayed or circulated at medical conferences or meetings, display materials, trade show booth panels, banners, stands and the like, and information with respect to sales of the Product (including, without limitation, to doctors, group purchasing organizations (GPOs) and pharmacists), marketing books and records owned by Seller or EuroGen and only to the extent exclusively pertaining to the marketing and promotion of the Product.

1.41                         “Market Transfer Date” means the date upon which the Relevant Regulatory Authority in any Market approves the transfer of the Marketing Authorization in that Market to Buyer.

1.42                         “Material Adverse Effect” means any adverse effect on (a) the financial condition, or financial performance directly related to the manufacture, promotion and sale of the Product, or (b) the Specified Assets, or (c) any of the assets of third parties which are used in and are material to the Seller Business and are not readily replaceable; which adverse effect is or will be material, to the Seller Business as a whole, including, without limitation, circumstances that would reasonably be expected to make accomplishment of the Sigma Aldrich Conditions unlikely or impossible.

1.43                         “Multi-Product Contracts” has the meaning specified in Section 4.8.3.

1.44                         “Net Sales” means the gross amount invoiced on sales of the Product within the Territory, less reasonable and customary deductions for (a) credits for returns, including withdrawals and recalls; (b) sales rebates and chargebacks; (c) sales, value-added and other taxes (but in the case of value added taxes only to the extent such taxes are not reimburseable or refundable); (d) customs duties on sales made by such seller to the customer; (e) wholesaler fee-for-service discounts; and (f) group purchasing organization (GPO) fees; but in the case of (a) and (b) only to the extent accrued under accounting principles generally accepted for deductions to be actually given to and taken by the customer, and in the case of (c) and (d) only to the extent separately itemized or attributable to the product sale and paid by the customer or Buyer to a government agency.  If a Product is sold for consideration other than solely cash, the fair market value of such other consideration shall be included in the calculation of Net Sales.  For purposes

5

 



of calculating Net Sales, transfers of a Product to an Affiliate for end use by such Affiliate in a country within the Territory shall be treated as a sale at the greater of the actual Net Sales and the average Net Sales price for fully arms-length sales of such Product in such country during the applicable calendar quarter.

1.45                         “Obligation” means any debt, liability or obligation of any nature, whether secured, unsecured, recourse, nonrecourse, liquidated, unliquidated, accrued, absolute, fixed, contingent, ascertained, unascertained, known, unknown or otherwise.

1.46                         “Permit” means any license, permit, approval, certification, waiver, order, authorization, right or privilege of any nature, granted, issued, approved or allowed by any Governmental Body.

1.47                         “Permitted Encumbrances” means (i) any Encumbrance for inchoate mechanics’ and materialmen’s liens for construction in progress and workmen’s, repairmen’s warehousemen’s and carrier’s liens arising in the ordinary course of business, and (ii) any Encumbrance for Taxes not yet due and payable.

1.48                         “Person” means any individual, Entity or Governmental Body.

1.49                         “Privacy Law” means any Law pertaining to the privacy of any Person, including, without limitation, the European Data Protection Directive (95/46/EC), the implementing laws of each of the member states of the European Union, and any rules or regulations promulgated under any such Law.

1.50                         “Proceeding” means any demand, claim, suit, action, litigation, investigation,  arbitration or administrative enforcement hearing.

1.51                         “Product” means, collectively, each of the following within the Territory: (i) the drug to which each Marketing Authorization set forth on Schedule 1.39 relates (such drug referred to herein as “Nipent®”), in whatever formulation; and (ii) any drugs owned by Seller or EuroGen other than Nipent® for which the active ingredient is pentostatin and the indication for use is to treat an oncological disease or Graft Versus Host Disease (collectively, “Seller Pentostatin-Based Oncology Drugs”), in whatever formulation.

1.52                         “Product Registrations” means the approvals, registrations, applications, licenses and Permits (including, but not limited to, each dossier, Marketing Authorization application, Marketing Authorization, variation, pricing or reimbursement approval, and European Drug Master File) for the Product which have been prepared, submitted and/or approved (including in preliminary and/or draft form, if applicable) in order lawfully to manufacture (or have manufactured), market, distribute, or sell the same in the Territory, each of which is set forth on Schedule 1.52 attached hereto.

1.53                         “Regulatory Documentation” means all (a) regulatory filings and supporting documents, chemistry, manufacturing and controls data and documentation (including, but not limited to, batch records, master batch production records, standard operating procedures, testing logs, sample logs, laboratory logs, and stability logs) in each case to the extent pertaining to the Product, preclinical or clinical studies or tests for the Product, (b) records maintained under

6

 



record-keeping or reporting requirements of any Governmental Body, including any Relevant Regulatory Authority, with respect to the Product, (c) the complete complaint, adverse event and medical inquiry filings with respect to the Product, (d) all documentation relating to any Relevant Regulatory Authority or any other Governmental Body inspections to the extent pertaining to the Product and any written communication with any Relevant Regulatory Authority or any other Governmental Body to the extent pertaining to the Products, including correspondence and written minutes of telephone calls or meetings, and (e) all documentation related to any Relevant Regulatory Authority or any other Governmental Body inspections of the facilities of ChemWerth USA, King Pharmaceuticals, Sigma Aldrich Corp., American Type Culture Collection, Tetrionics, Hauser, Wyeth or Livingston, or any other Entity conducting material activities relating to the manufacture or sale of the Product, in each of (a) through (e) only to the extent (i) Seller or EuroGen possess and can legally transfer such information, and (ii) such information exclusively pertains to the Product in the Territory, and in all events exclusive of Product Registrations.

1.54                         “Relevant Regulatory Authority” in relation to a country or jurisdiction in the Territory, means the Governmental Body, whether national, federal, state or local, including, without limitation, the EMEA and European Commission, regulating the development, importation, manufacture, marketing, sale and/or distribution of therapeutic substances and the grant of Marketing Authorization in such country or jurisdiction.

1.55                         “Seller Intangibles” means any and all Intangibles within the Territory that are owned by Seller or EuroGen or licensed to Seller or EuroGen from any Third Party (i) that are set forth on Schedule 1.55 or (ii) that otherwise exclusively pertain to the Product.

1.56                         “Sellers’ Monthly Volume” means the average monthly unit sales volume of Seller or EuroGen and their distributors, including, without limitation, Wyeth, for the Product for the twelve months ended on the date hereof.

1.57                         “Sigma Aldrich Agreement” has the meaning specified in Section 2.1.3(A).

1.58                         “Sigma Aldrich Conditions” has the meaning specified in Section 3.2.1.

1.59                         “Specified Assets” has the meaning specified in Section 2.1.2 hereof.

1.60                         “Specified Contracts” has the meaning specified in Section 4.8.1.

1.61                         “Specified Liabilities” has the meaning specified in Section 2.1.3 hereof.

1.62                         “Supply Holdback Amount” has the meaning specified in Section 3.2.1.

1.63                         “Tangible Property” means any furniture, fixtures, leasehold improvements, vehicles, office equipment, computer equipment, other equipment, machinery, tools, forms, supplies or other tangible personal property of any nature.

1.64                         Tax” means (a) any foreign, federal, state or local income, earnings, profits, gross receipts, franchise, capital stock, net worth, sales, use, value added, occupancy, general property, personal property, intangible property, transfer, fuel, excise, payroll, withholding,

7

 



workers compensation, unemployment compensation, social security, retirement, escheat, unclaimed property or other tax of any nature; (b) any foreign, federal, state or local organization fee, qualification fee, annual report fee, filing fee, occupation fee, assessment, sewer rent or other fee or charges of any nature; or (c) any deficiency, interest or penalty imposed with respect to any of the foregoing.

1.65                         “Tax Return” means any return (including any information return), report, statement, schedule, notice, form, declaration, claim for refund or other document or information filed with or submitted to, or required to be filed with or submitted to, any governmental body in connection with the determination, assessment, collection or payment of any Tax or in connection with the administration, implementation or enforcement of or compliance with any law relating to any Tax, including any amendment thereto.

1.66                         “Taxing Authority” shall mean any domestic, foreign, federal, national, state, county or municipal or other local government, any subdivision, agency, commission or authority thereof, or any quasi-governmental body exercising tax regulatory authority.

1.67                         “Transition Services Agreement” has the meaning specified in Section 8.1.11(c).

1.68                         “Territory” means all countries and jurisdictions worldwide, except for (i) the fifty states of the United States of America, the District of Columbia, and all territories and possessions of the United States of America (including, without limitation, Puerto Rico), (ii) Canada, and (iii) Mexico.

1.69                         “Third Party” means any Person other than the Buyer, the Seller, EuroGen, any of their respective affiliates or any successors, assigns or express licensees of Buyer, Seller, EuroGen or their respective affiliates.

1.70                         “U.S. Drug Safety Agreement” means that certain Drug Safety Agreement dated August 22, 2006 by and between Seller and Buyer.

1.71                         “Validation” means confirmation that from an administrative (and not substantive) perspective, all of the documents required by a Relevant Regulatory Authority for a filing with such Relevant Regulatory Authority have been included in a package to be submitted to that Relevant Regulatory Authority.

1.72                         “VAT” means value added tax chargeable in the European Union or under the VATA or under any legislation replacing it or under any legislation which the VATA replaced or equivalent tax levied elsewhere in the world and further means value added tax at a rate in force when the relevant supply is made and any tax of a similar nature which is introduced in substitution for such value added tax.

1.73                         “VATA” means the Value Added Tax Act 1994 in the United Kingdom.

1.74                         “Wyeth Distribution Agreement” means the Amended and Restated Supply and Distribution Agreement related to the Product by and between Wyeth and Seller effective June 1, 2006, as amended from time to time.

8

 



SECTION 2. THE TRANSACTION

2.1                                Sale and Purchase of Specified Assets .

On the Closing Date, effective to the fullest extent possible at 12:01 a.m. Eastern Time on the Closing Date, subject to the other terms and conditions of this Agreement, Seller shall sell, transfer, assign and convey to Buyer, and Buyer shall purchase, all right, title and interest in and to all of the Seller Assets, free and clear of any Encumbrances, other than Permitted Encumbrances.  At the Closing, Seller shall (and Seller shall cause EuroGen to) assign to Buyer, and Buyer shall assume, the Specified Liabilities of Seller and EuroGen.

2.1.1.                   Seller Assets.   Subject to Section 2.1.2 hereof, the “Seller Assets” means all Assets (within the Territory) of Seller owned (legally or beneficially) and exclusively pertaining to the Product as of the Closing Date, wherever located within the Territory and whether or not reflected on Seller’s books and records set forth in subsections (A) through (K) below (but excluding (a) the Assets specifically excepted below, (b) those Assets defined as Specified Assets under the U.S. Agreement, and (c) those Assets listed on Schedule 2.1.1, which Schedule 2.1.1 shall set forth those assets owned by Seller that are material to the Seller Business but are not among the assets being sold, transferred, conveyed and assigned to Buyer) (collectively, such items expressly excluded below and contained on Schedule 2.1.1 shall be referred to herein as the “Excluded Assets”):

(A)                                All rights, title and interest in and to the Product, exclusive of Seller Intangibles.

(B)                                All Seller Intangibles of Seller.

(C)                                All Product Registrations, Marketing Authorizations and Regulatory Documentation of Seller, whether or not in the name of or held in trust by EuroGen.

(D)                                All Marketing Materials and Books and Records of Seller.

(E)                                  All rights, title and interest in and to prepaid establishment fees and prepaid product fees with respect to the Product.

(F)                                  All of Seller’s prepayments exclusively pertaining to the Seller Business (including prepaid purchase orders) but excluding all prepaid premiums and other prepayments and deposits, in each case, with respect to Seller’s Insurance Policies, Seller’s Group Insurance plans and Seller’s Retirement Plans.

(G)                                All of Seller’s Tangible Property set forth in Schedule 2.1.1(G) used by Seller or EuroGen exclusively in connection with the Seller Business.

(H)                                All of Seller’s and EuroGen’s Contract Rights under the Specified Contracts exclusive of Multi-Product Contracts and further excluding Contract Rights under (1) this Agreement and any other Contracts entered into by Seller or EuroGen with Buyer in connection with the transactions contemplated by this Agreement; (2) Contracts that constitute or evidence Employee Benefit Plans of Seller or EuroGen, (3) all Contracts relating to the

9

 



acquisition of Seller or any of Seller’s predecessors or affiliates, provided that the Seller Assets shall include the rights of either Seller or EuroGen with respect to all indemnification, noncompetition, nondisclosure and other restrictive covenants made for the benefit of Seller or EuroGen or its or their predecessors in any such Contract; and (4) all Contract Rights under any Specified Contracts requiring a Consent that is not obtained on or before the Closing Date (“Non-Assigned Contracts”); provided that, once such Consent is obtained, the Contract Rights under such Non-Assigned Contract (but excluding Multi-Product Contracts) shall be deemed, automatically and without further action by the parties, to be included in the Seller Assets as of the date such Consent is delivered to Buyer.

(I)                                     All of Seller’s goodwill with respect to the Product.

(J)                                  Content of databases (including with respect to clinical trials and data with respect thereto), applicable drug information and data exclusively pertaining to the Product, in all cases excluding such items included as part of the Regulatory Documentation.

(K)                                All of Seller’s claims, causes of action and other legal rights and remedies, whether or not known as of the Closing Date, with respect to Seller’s ownership of the Seller Assets or the operation of the Seller Business, but excluding causes of action and other legal rights and remedies of Seller (1) against Buyer with respect to the transactions contemplated by this Agreement; (2) relating to Seller’s Assets not included in the Seller Assets or to Seller’s liabilities not included in the Specified Liabilities; and (3) relating to refunds of Taxes.

2.1.2.                   EuroGen Assets.   On the Closing Date, effective to the fullest extent possible at 12:01 a.m. Eastern Time on the Closing Date, subject to the other terms and conditions of this Agreement, EuroGen shall sell, transfer, assign and convey to Buyer, and Buyer shall purchase all right, title and interest in and to all of Inventory owned by EuroGen, free and clear of any Encumbrances, other than Permitted Encumbrances (the Seller Assets and the Inventory shall be referred to collectively herein as the “Specified Assets”).  For purposes of this Agreement, it is acknowledged that all Assets of the Seller Business that are within the categories of Assets that are included within the Seller Assets (other than Inventory) to which EuroGen holds legal title are held in trust for the benefit of Seller and are included within the Seller Assets referenced in Section 2.1.1.

2.1.3.                   Specified Liabilities of Seller and EuroGen .  On the Closing Date for those Contracts assigned on the Closing Date as specified on Schedule 2.1.3 as Contracts to be assigned on the Closing Date, or on the applicable date of assignment for those Contracts assigned on some other date as set forth on Schedule 2.1.3, as the case may be, Seller and EuroGen shall assign to Buyer, and Buyer shall assume, the Specified Liabilities of Seller and EuroGen; provided, however, that the Specified Liabilities shall not include any Specified Liabilities under the U.S. Agreement (as defined pursuant to the U.S. Agreement).  The “Specified Liabilities” of Seller and EuroGen means the following specifically described liabilities of Seller or EuroGen as of the Closing Date or the applicable date of assignment:

(A)                                The liabilities of either Seller or EuroGen under those Specified Contracts as set forth on Schedule 2.1.3 (provided, however, that any such liabilities shall only

10

 



be assumed at such time as such Specified Contract is assigned to Buyer in accordance with Schedule 2.1.3) related to the Product and the Seller Business to which either Seller or EuroGen is a party, provided that the incurrence or existence of any such liability or Contract does not constitute a breach or failure of, or a default under, any representation, warranty, covenant or other provision of this Agreement, but only to the extent that such liabilities arise in the ordinary course of performing such Specified Contracts, in accordance with their respective terms, after the Closing Date or the applicable date of assignment for such Contract, as the case may be, and are not due to any breach or default by either Seller or EuroGen under any such Specified Contract.  Notwithstanding the foregoing, the Specified Liabilities of Seller and EuroGen shall not include the liabilities of Seller or EuroGen under (1) this Agreement or any other Contracts entered into by either Seller or EuroGen with Buyer in connection with the transactions contemplated by this Agreement; (2) any Contracts that constitute or evidence Employee Benefit Plans of either Seller or EuroGen, (3) any Contracts relating to the acquisition of Seller or any of Seller’s predecessors or affiliates; (4) any Non-Assigned Contracts unless and until such contracts constitute part of the Specified Assets as contemplated by Section 2.1.1(H); (5) any remaining payments (the “Development Plan Payments”), whether known or unknown, in connection with the Development Plan contemplated by the Drug Substance Validation and Supply Agreement (the “Sigma Aldrich Agreement”) dated October 5, 2004 between Seller and Sigma Aldrich (F/K/A Tetrionics, Inc.), and (6) any spending obligations under any existing Clinical Trial Agreements.

2.2                                No Other Liabilities .  Notwithstanding any other provisions of this Agreement, Buyer shall not purchase the Specified Assets subject to, and Buyer shall not in any manner assume or be liable or responsible for any Obligations of Seller or EuroGen other than the Specified Liabilities.  All Obligations of Seller or EuroGen other than the Specified Liabilities shall remain the sole responsibility of Seller or EuroGen, as the case may be, and Seller or EuroGen shall pay and discharge such Obligations in full as the same become due.  Without limiting the generality of the foregoing, and in addition to the liabilities excluded from the Specified Liabilities under Section 2.1.3 hereof, Buyer shall not in any manner assume or be liable or responsible for, or acquire any Assets of Seller or EuroGen subject to, any of the following Obligations of Seller or EuroGen identified in this Section 2.2 and the Obligations set forth on Schedule 2.2 attached hereto:

2.2.1.                   Affiliates . Any Obligation to a shareholder or any current or former shareholder, member, partner, director or controlling Person of either Seller or EuroGen, or to any other Person affiliated with either Seller or EuroGen, or either of their affiliates and predecessors including Obligations for dividends declared but not paid.

2.2.2.                   Taxes . Except as otherwise provided in Sections 3.5 and 9.4(a), any Obligation for any Tax of either Seller or EuroGen including, (a) any Tax payable by either Seller or EuroGen with respect to the operation of the Seller Business; (b) any Tax payable by any Seller or EuroGen with respect to the ownership, possession, purchase, lease, sale, disposition or use of any of Seller’s or EuroGen’s Assets at any time on or before the Closing Date; and (c) any Tax of either Seller or EuroGen resulting from the sale of the Specified Assets to Buyer or otherwise resulting from the transactions contemplated by this Agreement.

11

 



2.2.3.                   Post-Closing .  Any Obligation of Seller or EuroGen that is incurred or arises after the Closing Date, or that relates to any Proceeding of either Seller or EuroGen or other event that occurs or circumstances that exist after the Closing Date, but in all events subject to Section 9.6.

2.2.4.                   Transaction Related .  Any Obligation that was or is incurred in connection with the negotiation, execution or performance of this Agreement and any other Contracts entered into between Buyer and Seller and/or EuroGen, or among Seller, EuroGen, Buyer and other parties, in connection with the transactions contemplated by this Agreement.

2.2.5.                   Defaults .  Any Obligation, the incurrence or existence of which constitutes or will constitute a breach or failure of, or a default under, any representation, warranty, covenant or other provision of this Agreement including any Obligation, whether or not known to Seller or EuroGen, that has not been disclosed to Buyer in writing in this Agreement or the Schedules and Exhibits hereto.

2.2.6.                   Employees .  Any Obligation to any or all employees or contractors of Seller or EuroGen including Obligations for accrued vacation and sick pay, accrued but unpaid bonuses, and Obligations under either Seller’s or EuroGen’s payroll savings, profit sharing and/or other retirement plans, Obligations under either Seller’s or EuroGen’s Group Insurance Plans and Obligations for severance pay and other termination benefits.

2.2.7.                   Infringement .  Any Obligation with respect to either Seller’s or EuroGen’s (or any of their respective predecessors’) infringement or alleged infringement, violation, or misappropriation of any Intangible of any Person.

2.2.8.                   Encumbrances .  Any Encumbrance on or affecting Seller’s or EuroGen’s Assets including the Specified Assets, other than Permitted Encumbrances.

2.2.9.                   Debt .  Any Obligations for borrowed money or other debt (including debt owed to affiliates or third parties other than Specified Liabilities).

2.2.10.            Multi-Product Contracts .  Any Obligations of either Seller or EuroGen pursuant to Multi-Product Contracts.

2.2.11.            Product Liability and Warranty Claims .  Any Obligations of either Seller or EuroGen arising from product warranties or product liability claims with respect to the Product invoiced, sold or shipped by either Seller or EuroGen on or prior to the Closing Date.

2.2.12.            Rebates, Returns, Recalls .  Any Obligations of either Seller or EuroGen for discounts, chargebacks, returns, recalls, rebates and similar items under Section 9.6.

2.2.13.            Development Plan Payments .  Any Obligations related to the Development Plan Payments.

12

 



 

SECTION 3. Purchase Price

3.1                                Purchase Price and Allocation .

3.1.1.                   Subject to the adjustments described in this Section 3, the total purchase price for the Seller Assets (“Purchase Price”) shall consist of: (a) (i) a payment of immediately available funds (the “Closing Payment”) in an amount equal to three million seven hundred fifty thousand dollars ($3,750,000) (comprised of $5,000,000 minus the $1,000,000 Supply Holdback Amount, minus the $250,000 Indemnification Holdback Amount), payable at the Closing by Buyer to Seller, plus (ii) the Holdback Amount (which Holdback Amount shall be governed by Section 3.2 hereof), plus (iii) VAT, if any; (b) the Deferred Payments, payable in accordance with Section 3.3; and (c) the assumption of the Specified Liabilities by Buyer.  Each party shall allocate the Purchase Price (including the capitalizable Specified Liabilities) and report such allocation on its respective tax returns as it deems appropriate and in accordance with applicable Law.

3.1.2.                   At Closing, for the Inventory, Buyer shall pay to EuroGen the Inventory Purchase Price.

3.2                                Holdback Amount .  At the Closing, Buyer shall retain the amounts set forth below in accordance with the following:

3.2.1.                   Supply Holdback.

(a)                                   At the Closing, Buyer shall retain One Million Dollars ($1,000,000) of the Purchase Price (the “Supply Holdback Amount”) to be held until such time as: (i) a variation has been approved in each of France, Spain, Germany, Italy and the United Kingdom authorizing Sigma Aldrich or Buyer to manufacture purified pentostatin, and (ii) a supply agreement on commercially reasonable terms (including commercially reasonable terms with respect to quality) is offered by Sigma Aldrich to Buyer with respect to such purified pentostatin (it being agreed that Buyer shall enter into such commercially reasonable supply agreement if offered), provided that if this condition (ii) is satisfied under Section 3.2.1 of the U.S. Agreement it shall be deemed satisfied under this Agreement, and (iii) after entering into such commercially reasonable supply agreement, Buyer shall have received first delivery of the purified pentostatin and shall have accepted such delivery pursuant to the terms of such supply agreement, provided that if this condition (iii) is satisfied under Section 3.2.1 of the U.S. Agreement, it shall be deemed satisfied under this Agreement (collectively, such items reflected in (i) - (iii) above shall be referred to as “Sigma Aldrich Conditions”).  Each of Buyer on the one hand and Seller and EuroGen on the other hand shall use commercially reasonable efforts (and assist as reasonably necessary or desirable) to cause the Sigma Aldrich Conditions to be satisfied; provided, however, that this obligation to use commercially reasonable efforts shall not require Buyer to enter into a supply agreement that is not commercially reasonable;

(b)                                   Buyer shall promptly pay to Seller the Supply Holdback Amount upon full satisfaction of the Sigma Aldrich Conditions; provided, however, that the Purchase Price shall be reduced by, and neither Seller nor EuroGen shall have any right to, the Supply Holdback Amount upon the passage of September 30, 2007 if at such time no inventory of

13

 



 

pentostatin exists in either the United States or the EU that may be released in the EU (“Stock Out”) or if inventory of pentostatin does exist as of September 30, 2007 in either the United States or the EU that may be released in the EU, then the date that a Stock Out occurs thereafter (the “Nipent® Stock Out Date”) without the full satisfaction of the Sigma Aldrich Conditions; provided, further, that if Buyer secures supply of purified pentostatin prior to the Nipent® Stock Out Date from a source other than Sigma Aldrich and Seller reimburses Buyer for actual costs incurred by Buyer in connection with securing such supply as required by the U.S. Agreement, then Seller shall be entitled to payment of the Supply Holdback Amount within five (5) days of the date of reimbursement by Seller.

3.2.2.                   Two Hundred Fifty Thousand Dollars ($250,000) (the “Indemnification Holdback Amount” and together with the Supply Holdback Amount, the “Holdback Amount”) shall be held by Buyer to secure Seller’s and/or EuroGen’s indemnification obligations pursuant to this Agreement.  The Purchase Price shall be reduced by the full aggregate amount (the “Claims Adjustment”) owed to Buyer by Seller and/or EuroGen as a result of any Claims (as defined in Section 10.2) arising during the period commencing on the Closing Date and ending eighteen (18) months following the Closing Date (“Indemnification Holdback Period”).  If the Claims Adjustment is less than the amount of the Indemnification Holdback Amount, then Buyer shall pay to Seller and/or EuroGen the amount by which the Indemnification Holdback Amount exceeds the Claims Adjustment.  If the Claims Adjustment is more than the Indemnification Holdback Amount, then Buyer shall retain the full amount of the Indemnification Holdback Amount, and Seller and/or EuroGen shall promptly pay to Buyer the amount by which the Claims Adjustment exceeds the amount of the Indemnification Holdback Amount, subject to applicable indemnification caps contained in Section 10 of this Agreement.  If any Claims are disputed and pending at the termination of the Indemnification Holdback Period, Buyer shall have the right, upon notice to Seller and EuroGen, to withhold payment of the applicable portion of the Indemnification Holdback Amount, until final determination of such pending Claims.  Upon such final determination, the balance of the Indemnification Holdback Amount, if any, remaining after satisfaction of the disputed and pending Claim(s) shall be promptly paid to Seller.

3.3                                Deferred Payments .

3.3.1.                   Each twelve month period ended on each of the first, second, third, fourth and fifth anniversaries of the Closing Date shall be referred to as a “Deferred Payment Year” and collectively as the “Deferred Payment Years.”  Subject to setoff rights contained in Section 10.7 of this Agreement, Buyer shall pay to Seller a payment equal to $400,000, $500,000, and $700,000, on the first, second, and third anniversaries of the Closing Date respectively, and Buyer shall pay to Seller a payment equal to $700,000 on each of the fourth and fifth annual anniversaries of the Closing Date (each such payment, a “Deferred Payment,” and collectively, the “Deferred Payments”).

3.4                                Inventory Purchase Price.   Five days before Closing, EuroGen shall prepare and deliver to Buyer a report (the “Closing Inventory Report”) reflecting the Inventory owned by EuroGen, including any Inventory repurchased from Wyeth pursuant to Section 3.9 of the Wyeth Distribution Agreement, and identifying the expiration date with respect to all such Inventory and the amount that EuroGen paid for such Inventory.  At Closing, Buyer shall reimburse

14

 



 

EuroGen for the amount paid by EuroGen with respect to such Inventory (which for the Inventory repurchased from Wyeth shall be the amount paid to Wyeth under Section 3.9 of the Wyeth Distribution Agreement and which for all other Inventory shall be the amount paid by Seller to Mayne Pharma (USA) Inc.) (the “Inventory Purchase Price”), excluding any finished Product Inventory that has a shelf life of less than seven (7) months from the expected date of sale, calculated using Seller’s Monthly Volume in the Territory on a “first in first out” basis.

3.5                                Allocation of Expenses .  The following expenses attributable to the Seller Business shall be allocated between and shall be assumed by Buyer and Seller or EuroGen as follows:

3.5.1.                   All applicable ad valorem Taxes on personal property (“ Property Taxes ”) shall be prorated between Buyer and Seller or EuroGen as of the Closing, computed by multiplying the amount of Property Taxes for the fiscal year for which the same are levied by a fraction, the numerator of which is the number of days in such fiscal year up to and including the Closing Date and the denominator of which is the number of days in such fiscal year.  In connection with such proration of Property Taxes, in the event that actual Property Tax figures are not available at the Closing Date, proration of Property Taxes shall be based upon the actual Property Taxes for the preceding fiscal year for which actual Property Tax figures are available, and re-prorated when actual Property Tax figures become available.

3.5.2.                   All prorations and/or other adjustments contemplated by Section 3.5.1 shall be made, insofar as feasible, on the Closing Date, and the Closing Payments or Inventory Purchase Price, as the case may be, shall be adjusted.  During the three-month period subsequent to the Closing Date, Seller and EuroGen shall advise Buyer and Buyer shall advise Seller and EuroGen of any actual changes to such prorations or adjustments, and the Purchase Price and/or Inventory Purchase Price shall be increased or decreased, as applicable, at the end of such three-month period.  In the event Buyer or Seller or EuroGen shall receive bills after the Closing Date for expenses incurred prior to the Closing Date that were not prorated in accordance with Section 3.5.1 or that were re-prorated in accordance with this Section 3.5.2, then Buyer or Seller or EuroGen, as the case may be, shall promptly notify the other party as to the amount of the expense subject to proration and the responsible party shall pay its portion of such expense (or, in the event such expense has been paid on behalf of the responsible party, promptly reimburse the other party for its portion of such expenses).

3.5.3.                     Notwithstanding anything else in this Agreement, all amounts payable under this Agreement shall be exclusive of VAT thereon.

3.5.4.                   To the extent required by Applicable Law, the Buyer shall account for VAT to HMRC pursuant to section 8 of the VATA and shall provide the Seller with written notification that it has done so within two months of the end of the Buyer’s first relevant VAT accounting period after Closing.

3.5.5.                   To the extent that EuroGen makes any taxable supply (as defined by section 4(2) VATA) under this Agreement in respect of Inventory referred to at Clause 3.1.2 then the Buyer shall pay to EuroGen the appropriate amount of VAT five (5) business days following receipt of a valid VAT invoice (as defined by section 6(15) VATA).

15

 



 

3.5.6.                   To the extent that EuroGen or the Seller makes any taxable supply (as defined by section 4(2) VATA) under this Agreement in respect of Assets (other than Inventory referred to in clause 3.5.5. above) then the Buyer shall pay to EuroGen or the Seller (as appropriate) the appropriate amount of VAT on the later of five (5) business days following receipt of a valid VAT invoice (as defined by section 6(15) VATA) and, where the Buyer has already accounted for VAT (or purported VAT) to HMRC pursuant to clause 3.5.4 above and has not previously made any recovery of such VAT under this Agreement or from HMRC, receipt of reimbursement from EuroGen, the Seller or HMRC pursuant to clause 3.5.7 below or otherwise.

3.5.7.                   If the Buyer has already accounted for VAT or purported VAT to HMRC pursuant to clause 3.5.4 above (and has not previously recovered any such VAT from HMRC or pursuant to this Agreement) then, provided the Buyer has given the Seller written notification of the VAT which the Buyer paid to HMRC pursuant to clause 3.5.4 above (including details of the amount and time of such payment), the Buyer shall not be obliged to account for VAT to EuroGen or the Seller (as appropriate) in respect of the same supply of goods or services under clause 3.5.6 unless EuroGen  or the Seller (as appropriate) has reimbursed the Buyer for such VAT which the Buyer has already paid to HMRC pursuant to clause 3.5.4 in respect of the same supply and which the Buyer has not previously recovered.

3.5.8.                   Where section 3.5.7 applies and the Buyer has accounted for VAT or purported VAT to HMRC pursuant to clause 3.5.4 above, the Buyer shall:

(a)                                   upon receipt of written notice by EuroGen or the Seller (as appropriate), promptly notify EuroGen or the Seller (as appropriate) of all relevant details concerning the VAT for which the Buyer has accounted to HMRC (including details of the amount of the VAT and the time of payment) if not previously supplied to EuroGen or the Seller (as appropriate) pursuant to clause 3.5.6;

(b)                                   promptly (and in any event, within 10 Business Days of the receipt of written notice by EuroGen or the Seller (as appropriate)) take all appropriate steps to enforce recovery from HMRC of the VAT or purported VAT the Buyer has previously paid to HMRC (at the expense of EuroGen or the Seller (as appropriate));

(c)                                   keep EuroGen or the Seller (as appropriate) fully informed of the progress of action for recovery and provide EuroGen or the Seller (as appropriate) with copies of all correspondence with HMRC;

(d)                                   not agree any settlement with HMRC (for an amount less than the VAT paid by the Buyer to HMRC pursuant to clause 3.5.4 above) without the written consent of EuroGen or the Seller (as appropriate) (such consent not to be unreasonably withheld or delayed);

(e)                                   promptly pay EuroGen or the Seller (as appropriate) the amount of VAT so recovered (or the amount of VAT which would be recovered but for the offset or credit of that VAT against any output tax arising to the Buyer) together with an amount equal to any

16

 



 

interest payment (after tax) or repayment supplement received by (or otherwise credited to) the Buyer in connection with the recovery.

(f)                                     Currency.   All dollar amounts stated in this Agreement are stated in United States’ currency, and all payments required under this Agreement shall be paid in United States’ currency.

SECTION 4. Representations Of Seller And Eurogen

Seller and EuroGen, jointly and severally, represent and warrant to Buyer and covenant with Buyer, as set forth in this Section 4, subject to exceptions contained in the Schedules delivered to Buyer as of the date hereof.

4.1                                Organization .

4.1.1.                   EuroGen is a company, duly organized and validly existing under the laws of England and Wales.  Seller is a corporation, duly organized, validly existing and in good standing under the laws of the State of Delaware.  Each of Seller and EuroGen possesses the full corporate power and authority to enter into and perform its obligations under this Agreement.  Each of Seller and EuroGen possesses the full corporate power and authority to own, hold, and use its Assets in the manner in which such Assets are currently owned, held, and used.  Each of Seller and EuroGen is duly qualified or registered to do business, and is in good standing (if applicable), in each jurisdiction where such qualification or registration is required by applicable Law, except where the failure to be so qualified or registered would not reasonably be expected to have a Material Adverse Effect.

4.2                                Authority; Non-Contravention.

4.2.1.                   Each of Seller and EuroGen has the requisite right, power and authority to enter into, execute, deliver and perform its obligations under this Agreement and the ancillary agreements, documents and instruments executed and delivered by it to Buyer at Closing hereof (collectively, the “Seller Ancillary Documents”), and the execution, delivery and performance of this Agreement and the Seller Ancillary Documents and the consummation of the transactions contemplated hereby and thereby by each of Seller and/or EuroGen has been and upon the Closing shall be, duly authorized by all necessary corporate actions.  Without in any way limiting the previous sentence, each of Seller’s and EuroGen’s execution of this Agreement and the Seller Ancillary Documents and the consummation of the transactions contemplated hereby and thereby do not require the approval of either Seller’s or EuroGen’s stockholders.  Each of this Agreement and the Seller Ancillary Documents constitutes and shall constitute, as the case may be, the legal, valid and binding agreement of Seller and/or EuroGen, as applicable, enforceable against Seller and/or EuroGen in accordance with its terms.

4.2.2.                   Neither the execution, delivery and performance of this Agreement and the Seller Ancillary Documents nor the consummation or performance of any of the transactions contemplated hereby or thereby by each of Seller or EuroGen will directly or indirectly (with or without notice or lapse of time):

17

 



 

(a)                                   contravene, conflict with or result in a violation of any of the provisions of the certificate of incorporation, bylaws or other organizational documents of either Seller or EuroGen, respectively;

(b)                                   to Seller’s knowledge, contravene, conflict with or result in a violation of, or give any Governmental Body or other Person the right to challenge any of the transactions contemplated hereby or to exercise any remedy or obtain any relief under, any Law or any Judgment to which either Seller or EuroGen or any of the Specified Assets is subject;

(c)                                   contravene, conflict with or result in a violation of any of the terms or requirements of, or give any Governmental Body the right to revoke, withdraw, suspend, cancel, terminate or modify, any Permit within the Specified Assets that is held by either Seller or EuroGen relating to the Specified Assets;

(d)                                   contravene, conflict with or result in a violation or breach of, or result in a default under, any provision of, any Specified Contract to which either Seller or EuroGen is a party or by which either Seller or EuroGen is bound; or

(e)                                   result in the imposition or creation of any Encumbrance upon or with respect to any Specified Asset other than Permitted Encumbrances.

4.2.3.                   Except as otherwise set forth in this Agreement, neither Seller nor EuroGen is nor will be required to make any filing with or give any notice to, or obtain any Consent from, any Person in connection with the execution and delivery of this Agreement and the Seller Ancillary Documents or the consummation or performance of any of the transactions contemplated hereby or thereby.

4.2.4.                   Seller is not and will not be a taxable person for VAT purposes in respect of any supply made by it pursuant to this Agreement and Seller is beneficial owner of the Seller Assets.

4.2.5.                   EuroGen is a taxable person for VAT purposes and is beneficial owner of the Inventory set forth on the Closing Inventory Report.

4.3                                Compliance with Laws.

4.3.1.

(a)                                   Each of Seller and EuroGen has conducted and complied and each is complying in all material respects with all Laws applicable to the Seller Business or otherwise to the development, manufacture, promotion or sale of the Product.

(b)                                   Each Product Registration is in full force and effect, and there are no Proceedings pending or, to the Seller’s Knowledge, threatened that would result in the revocation, cancellation, suspension or modification of any Product Registration.  Except with respect to those activities for which Buyer is responsible under the U.S. Drug Safety Agreement since August 22, 2006, EuroGen has timely filed with the Relevant Regulatory Authority all required notices, supplemental applications and annual or other reports or documents, including

18

 



 

adverse experience reports, with respect to the Marketing Authorizations and Product.  With respect to the Product, each of Seller and EuroGen has acted, and to the Seller’s Knowledge, all other Persons who have performed operations covered by any Marketing Authorization have acted, in material compliance with cGMP, applicable Laws, and the terms and conditions of such Marketing Authorizations.  There are no pending or, to Seller’s Knowledge, scheduled regulatory inspections of any Entity conducting material activities relating to the manufacture or sale of the Product.

(c)                                   The Inventory, as of the Closing, meets the applicable specifications for the Inventory set forth in the applicable Marketing Authorization.  The Inventory sold and delivered to Buyer hereunder at the Closing shall be free from defects and conform to its specifications and Marketing Authorization and shall not be adulterated or misbranded and is free and clear of all liens and encumbrances.  The Inventory has been manufactured, packaged, labeled, stored and loaded for shipment, as the case may be, in accordance with its specifications, cGMP, and all Laws in all material respects, including, without limitation, those relating to environmental law and safety.  Any packed Inventory has been appropriately released by an approved qualified person (QP).  The inventory delivered in connection with the U.S. Agreement, at the time of closing under such U.S. agreement, (i) complied in all material respects with cGMPs and all Laws applicable to the development, manufacture, promotion and sale of the Product in Europe, (ii) met the specifications set forth in the applicable Marketing Authorization, and (iii) was not adulterated.

(d)                                   Neither Seller nor EuroGen has received any written notice that any Governmental Body has commenced, or, to Seller’s Knowledge, threatened any action to withdraw any approval or request the recall of the Product, or has commenced or threatened in writing to initiate any action to enjoin production of the Product at any facility and, to the Seller’s Knowledge, no circumstances exist which would make any recall of any Product necessary or appropriate.

4.3.2.                   Schedule 4.3.2 accurately lists all of the Marketing Authorization applications, variations, renewals or transfers in progress that either Seller or EuroGen has submitted to any Relevant Regulatory Authority, and the Seller and/or EuroGen have provided Buyer with all material written communications from any such Relevant Regulatory Authority relating to those applications and submissions.

4.3.3.                   With respect to the Product, Seller and/or EuroGen has delivered and/or made available to Buyer copies of all (i) Marketing Authorizations, Product Registrations and Regulatory Documentation, (ii) reports of inspectional observations in the Seller’s or EuroGen’s possession with respect to any manufacturers or suppliers of Product or components thereof, (iii) establishment inspection reports in Seller’s or EuroGen’s possession, (iv) to the extent Seller or EuroGen is permitted to provide them, certificates of analysis for each lot of Inventory, (v) warning or untitled letters as well as any other documents received by either Seller or EuroGen from the Relevant Regulatory Authority or any other Governmental Body to the extent related to the Product or the Seller Business that assert lack of compliance with any applicable Law or regulatory requirements (including those of the Relevant Regulatory Authority) by either Seller or EuroGen with respect to any manufacturers or suppliers of Product or components thereof.

19

 



4.3.4.                   The documentation provided by Seller and/or EuroGen to Buyer regarding discussions with the MHRA with respect to compliance of the API and the Product with applicable Laws and GMPs provides a materially accurate and complete description of such discussions.

4.4                                Financial Statements .  The source data provided by Seller and EuroGen to Buyer and attached hereto in Schedule 4.4 is true and accurate in all material respects.

4.5                                Assets .

4.5.1.                   Each of Seller and EuroGen owns and has, and on the Closing Date will own and have, good, valid and marketable title to, the Specified Assets that are purported to be owned by it and has the right to transfer all rights, title and interest (legal and beneficial) in such Specified Assets, free and clear of any Encumbrance, other than Permitted Encumbrances (but exclusive of claims described in Section 4.7.2).

4.5.2.                   No Third Party has any right under any of the Marketing Authorizatio


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more