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,
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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)
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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.
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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.
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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