This ASSET
PURCHASE AGREEMENT (this “ Agreement ”) is made
by and between EPIX Pharmaceuticals, Inc., a Delaware corporation
(“ Seller ”), and Lantheus Medical Imaging,
Inc., a Delaware corporation (“ Buyer ”), as of
the date first written above (the “ Execution Date
”). Buyer and Seller also may be referred to herein each as a
“ Party ” and collectively as the “
Parties .”
All capitalized
terms used in this Agreement are defined in Section 1.1
below.
WHEREAS, Seller
(i) has collaborated in the development of the Product with
Bayer, (ii) presently conducts, either directly or indirectly, the
business of the Exploitation of the Product in the Territory,
(iii) has received regulatory approval to market the Product
in the Territory from the FDA, Health Canada or the ATGA, as
applicable, and (iv) is willing to transfer to Buyer all
rights in, and certain assets and liabilities relating to, the
Product in the Territory on the terms and conditions set forth
herein; and
WHEREAS, the
Parties desire that Seller sell, transfer and assign (or cause the
sale, transfer and assignment) to Buyer, and Buyer acquire and
assume, all of the Purchased Assets and Assumed Liabilities,
subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in
consideration of the premises and the mutual promises herein made,
and in consideration of the representations, warranties, and
covenants herein contained, the Parties agree as
follows:
DEFINITIONS;
INTERPRETATION
1.1
Definitions . The following terms shall have the following
meanings for purposes of this Agreement:
“
Affiliate ” as applied to any Person, means any other
Person directly or indirectly controlling, controlled by, or under
common control with, that Person. For the purposes of this
definition, “ control ” (including, with
correlative meanings, the terms “ controlling ,”
“ controlled by ” and “ under common
control with ”), as applied to any Person, means the
possession, directly or indirectly, of the power to direct or cause
the direction of the management and policies of that Person,
whether through the ownership of voting securities or by contract
or otherwise.
“
Agreement ” has the meaning set forth in the
Preamble.
“
Approvals ” means any approvals, permits, franchises,
authorizations (including Marketing Authorizations and variations
thereto), licenses, consents, waivers, exemptions,
applications
(including any new drug applications and investigational new drug
applications), certifications or similar approvals or rights issued
by Governmental Authorities (including the FDA, the Drug
Enforcement Administration, Health Canada, the ATGA and any other
Governmental Authorities in the Territory engaged in the regulation
of pharmaceuticals or biohazardous materials) that are required to
be obtained or maintained under any applicable Law (including
Environmental Law), in each case, in connection with the Purchased
Assets, the Exploitation of the Product in the Territory or the
testing, handling, processing, recordkeeping, storage, warehousing,
disposal, packaging, labeling, promotion, import or export of the
Product in the Territory.
“
Assigned Contract Rights ” has the meaning set forth
in Section 2.1(e)(ii) .
“
Assigned Contracts ” has the meaning set forth in
Section 2.1(e) .
“
Assigned Intellectual Property ” has the meaning set
forth in Section 2.1(a) .
“
Assignment and Assumption Agreement ” means an
Assignment and Assumption Agreement in substantially the form of
Exhibit A hereto.
“ Assumed
Liabilities ” has the meaning set forth in
Section 2.3(a) .
“
ATGA ” means the Australian Therapeutic Goods
Administration and any Governmental Authority successor
thereto.
“
Australian Drug Law ” means the Therapeutic Goods Act
1989 and implementing regulations, as each has been or may be
amended.
“ Basket
Amount ” has the meaning set forth in
Section 8.3(b) .
“
Bayer ” means Schering Aktiengesellschaft.
“ Bayer
Collaboration Agreement ” mean the Strategic
Collaboration Agreement between Seller and Bayer dated as of
June 9, 2000 (as amended).
“ Bill of
Sale ” means a Bill of Sale in substantially the form of
Exhibit B hereto.
“
Business Day ” means, any day other than (i) a
Saturday or a Sunday or (ii) a day on which banks are
authorized to close in New York, NY.
“
Buyer ” has the meaning set forth in the
Preamble.
“ Buyer
FDA Letters ” means the letters from Buyer to the FDA,
duly executed by Buyer, to be delivered to Seller at the Closing,
with regard to the Vasovist NDA and MS-325 IND 51,172, the forms of
which are attached hereto as Exhibits C-1 and C-2 ,
respectively.
“
Buyer’s Indemnified Persons ” has the meaning
set forth in Section 8.1 .
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“ Cap
” has the meaning set forth in Section 8.3(b)
.
“
Canadian Drug Law ” means the Canadian Food and Drugs
Act and implementing regulations, as each has been or may be
amended.
“
Closing ” has the meaning set forth in
Section 3.3 .
“ Closing
Date ” has the meaning set forth in
Section 3.3 .
“
Code ” means the United States Internal Revenue Code
of 1986, as amended.
“
Competing Product ” means a magnetic contrast agent
for (i) magnetic resonance angiography or (ii) any other
use that was investigated for the Product under an investigational
new drug application with the FDA, Health Canada or the ATGA;
provided that in no event shall EP-2104R or EP-3600 (or any
other magnetic contrast agent targeted at thrombus or
collagen-binding contrast agent) be deemed a “Competing
Product” hereunder.
“
Confidential Information ” has the meaning set forth
in Section 10.1(a) and (b) .
“
Contract ” means any contract, agreement, lease,
license, commitment, indenture, mortgage, note, bond loan or other
arrangement, understanding, undertaking, commitment or obligation,
whether written or oral.
“
Convertible Senior Notes ” means Seller’s 3.0%
Convertible Senior Notes due June 15, 2024 issued pursuant to
the Indenture.
“
Covidien ” means collectively, Mallinckrodt Inc. and
United States Surgical Corporation.
“
Disclosing Party ” has the meaning set forth in
Section 10.1(a) .
“
Environmental Law ” means any Law in any way relating
to the protection of human health and safety, the environment or
natural resources, including the Comprehensive Environmental
Response, Compensation and Liability Act (42 U.S.C. § 9601 et
seq.), the Hazardous Materials Transportation Act (49 U.S.C. App.
§ 1801 et seq.), the Resource Conservation and Recovery Act
(42 U.S.C. § 6901 et seq. ), the Clean Water Act (33
U.S.C. § 1251 et seq. ), the Clean Air Act (42 U.S.C.
§ 7401 et seq. ), the Toxic Substances Control Act (15
U.S.C. § 2601 et seq. ), the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. § 136 et seq.
), and the Occupational Safety and Health Act (29 U.S.C. § 651
et seq. ), and the regulations promulgated pursuant thereto,
as each has been amended.
“
Exchange Act ” has the meaning set forth in
Section 4.15 .
“
Excluded Assets ” has the meaning set forth in
Section 2.2 .
“
Excluded Liabilities ” has the meaning set forth in
Section 2.3(b) .
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“
Exclusive Negotiation Period ” has the meaning set
forth in Section 6.8(b) .
“
Execution Date ” has the meaning set forth in the
Preamble.
“
Exploitation ” (including, with correlative meanings,
the terms “ Exploit ” and “
Exploited ”) means research, development,
manufacturing, marketing, distribution, commercialization, sale,
use or other exploitation.
“ FDA
” means the United States Food and Drug Administration and
any Governmental Authority successor thereto.
“
FFDCA ” means the Federal Food, Drug, and Cosmetic Act
and implementing regulations, as each has been or may be
amended.
“
Fundamental Representations ” has the meaning set
forth in Section 8.3(a)
“
GAAP ” means generally accepted accounting principles
in the United States as of the date hereof.
“ General
IP Assignment ” means a general assignment of the
Assigned Intellectual Property (other than the Patents assigned
pursuant to the Patent Assignments) in substantially the form of
Exhibit D hereto.
“
Governmental Authority ” means any government or
governmental or regulatory body thereof, or political subdivision
thereof, whether foreign, federal, state or local, or any
department, commission, bureau, agency, board, instrumentality or
authority thereof, or any court or arbitrator (public or private)
and including specifically those of each country in the
Territory.
“
Hatch-Waxman Act ” means the “Drug Price
Competition and Patent Term Restoration Act of 1984,” Pub. L.
No. 98-417, 98 Stat. 1585 (1984).
“ Health
Canada ” means Health Canada and any Governmental
Authority successor thereto.
“
Indebtedness ” of any Person means and includes the
principal of and accreted value and unpaid interest in respect of:
(i) indebtedness for borrowed money or indebtedness issued or
incurred in substitution or exchange for indebtedness for borrowed
money; (ii) amounts owing as the deferred purchase price for
property or services; (iii) indebtedness evidenced by any
note, bond, debenture or other debt instrument or debt security,
the payment of which such Person is responsible or liable;
(iv) obligations of the type referred to in clauses (i)
through (iii) of any Persons the payment of which such
Person is responsible or liable, directly or indirectly, as
obligor, guarantor, surety or otherwise; and (v) obligations of the
type referred to in clauses (i) through (iii) of
other Persons secured by any Lien on any property or asset of such
Person.
“
Indemnification Claim ” has the meaning set forth in
Section 8.4(b) .
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“
Indemnifying Party ” has the meaning set forth in
Section 8.4(b) .
“
Indemnified Persons ” shall mean the Buyer’s
Indemnified Persons or the Seller’s Indemnified Persons, as
the case may be.
“
Indenture ” means the Indenture relating to the
Convertible Senior Notes, dated as of June 7, 2004, into which
Seller, as issuer, and U.S. Bank National Association, as trustee,
have entered, as may by amended, modified or supplemented from time
to time.
“
Intellectual Property ” means all right, title and
interest in or relating to intellectual property, whether
protected, created or arising under the Laws of the United States
or any other jurisdiction, including: (i) all patents and
applications therefor, including all continuations, divisionals,
patents of additions and continuations-in-part thereof and patents
issuing thereon, along with all reissues, reexaminations and
extensions thereof, including all supplemental protection
certificates (collectively, “ Patents ”);
(ii) all trademarks, service marks, trade names, service
names, brand names, trade dress rights, logos, corporate names,
trade styles, logos and other source or business identifiers and
general intangibles of a like nature, together with the goodwill
associated with any of the foregoing, along with all applications,
registrations, renewals and extensions thereof (collectively,
“ Marks ”); (iii) all Internet domain names;
(iv) all copyrights and all mask work, database and design
rights, whether or not registered or published, all registrations
and recordations thereof and all applications in connection
therewith, along with all reversions, extensions and renewals
thereof; (iv) all trade secrets; and (v) all other
intellectual property rights arising from or relating to
Technology.
“ Law
” means any law, statute, regulation, ordinance, rule, Order,
settlement, Contract or governmental requirement enacted,
promulgated, entered into, or imposed by, any Governmental
Authority (including, for the sake of clarity, common
law).
“ Legal
Proceeding ” means any judicial, administrative or
arbitral actions, suits, proceedings, hearings or investigations
(in each case, whether public or private and whether civil,
criminal or administrative) by or before a Governmental
Authority.
“
Liability ” means, collectively, any Indebtedness,
guaranties, endorsements, claims, losses, damages, deficiencies,
costs, expenses, fines, penalties, liabilities, obligations or
responsibilities, whether fixed or unfixed, known or unknown,
choate or inchoate, liquidated or unliquidated, secured or
unsecured, direct or indirect, matured or unmatured, determinable
or indeterminable, absolute, contingent or otherwise, or in
contract, tort, strict liability or otherwise, including any
product liability and any related costs and expenses of any
defense.
“
Lien ” means any lien, encumbrance, pledge, mortgage,
deed of trust, security interest, claim, lease, charge, option,
right of first refusal, easement, servitude or transfer
restriction.
“
Loss ” and “ Losses ” have the
meanings set forth in Section 8.1 .
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“
Marketing Authorization ” means any current marketing
authorizations and pending applications for marketing
authorizations granted by a Governmental Authority for the purpose
of promoting, marketing, selling and distributing the Product in,
and importing the Product into, the Territory in accordance with
applicable Law.
“
Material Adverse Effect ” means a material adverse
effect on (a) the Exploitation of the Product in the Territory
or (b) the ability of Seller to consummate the Transactions;
provided , however , that none of the following
shall, by itself, constitute a “ Material Adverse
Effect ”: (i) changes that are the result of factors
generally affecting the industries or markets in which the Product
is Exploited that do not disproportionately affect the Exploitation
of the Product as compared to other companies of similar size and
scope that operate in the same industry or business as Seller;
(ii) except for purposes of Section 4.3 , any adverse
change, effect or circumstance arising out of or resulting from
actions contemplated by the Parties in connection with this
Agreement or the pendency or announcement of the Transactions;
(iii) changes in Laws or GAAP as applied on a consistent basis
or the interpretation thereof that do not disproportionately affect
the Exploitation of the Product as compared to other companies of
similar size and scope that operate in the same industry or
business as Seller; (iv) any action taken at the written
request of Buyer; (v) any legal or investment banking fees or
expenses of Seller, incurred or made in connection with the
Transactions; (vi) any failure, in and of itself and occurring
prior to the Closing, of Seller to meet any projection or forecast
(including with respect to the Product); and (vii) changes
that are the result of economic factors affecting the national,
regional or world economy or acts of war or terrorism that do not
disproportionately affect the Exploitation of the Product as
compared to other companies of similar size and scope that operate
in the same industry or business as Seller.
“
Necessary Buyer Consents ” has the meaning set forth
in Section 5.3(b) .
“
Necessary Seller Consents ” has the meaning set forth
in Section 3.4(a)(v) .
“
Noteholder Consent ” means the consent executed by
certain holders of Convertible Senior Notes in form and substance
reasonably acceptable to Buyer and Seller.
“
Offerors ” has the meaning set forth in
Section 6.8(a) .
“
Order ” means any order, injunction, judgment,
doctrine, decree, ruling, writ, assessment, award or arbitration
award of a Governmental Body.
“
Ordinary Course of Business ” means the ordinary and
usual course of normal day-to-day operations relating to the
Product in the Territory and the Purchased Assets, as conducted by
or on behalf of Seller, consistent in all material respects with
past practice.
“
Party ” and “ Parties ” have the
meanings set forth in the Preamble.
“ Patent
Assignments ” means short form Patent Assignment
Agreements, each in substantially the form of Exhibit E
hereto.
6
“ Patent
Term Extension ” means the extension of a patent term
under 35 U.S.C. § 156.
“
Patents ” has the meaning set forth in the definition
of the term “Intellectual Property.”
“
Permitted Transaction ” means (a) any
consolidation or merger of Seller with or into any other Person, or
any other corporate reorganization or transaction (including the
acquisition of capital stock of Seller), whether or not Seller is a
party thereto, in which the stockholders of Seller immediately
prior to such consolidation, merger, reorganization or transaction,
own capital stock either (i) representing directly, or
indirectly through one or more entities, less than fifty percent
(50%) of the economic interests in, or voting power of, Seller (or
other surviving entity) immediately after such consolidation,
merger, reorganization or transaction or (ii) that does not
directly, or indirectly through one or more entities, have the
power to elect a majority of the entire board of directors of
Seller (or other surviving entity) immediately after such
consolidation, merger, reorganization or transaction;
provided that (x) if within an Exclusive Negotiation
Period, the ROFN Assets are excluded from any such transaction and
(y) Seller (or other surviving entity) expressly acknowledges
Buyer’s rights, and expressly reaffirms Seller’s (or
other surviving entity’s) obligations, under the post-Closing
covenants set forth in the Transaction Documents (including under
Section 6.8 of this Agreement); or (b) any sale,
lease or other disposition of all or substantially all of
Seller’s assets other than, if within an Exclusive
Negotiation Period, the ROFN Assets.
“
Person ” means an individual, a partnership, a
corporation, a limited liability company, an association, a joint
stock company, a trust, a joint venture, an unincorporated
organization, any other business entity or a Governmental
Authority.
“
Pharmacovigilance Provider ” means, (a) within
the U.S. Territory, TMC Pharma Services Ltd. (b) within Canada
and Australia and outside the Territory (i) prior to the
transfer of the Marketing Authorization in the European Union by
Bayer to a third party, Bayer and (ii) thereafter, TMC Pharma
Services Ltd.
“
Product ” means the injectable intravascular magnetic
resonance angiography contrast agent currently known as
Vasovist ® (gadofosveset trisodium) and, (a) with
respect to the U.S. Territory, approved by the FDA pursuant to the
Vasovist NDA, (b) with respect to Canada, approved by Health
Canada pursuant to the Vasovist NDS and, (c) with respect to
Australia, approved by the ATGA pursuant to the Vasovist
MAA.
“ Product
Records ” means all files, reports, books, records,
documents and similar materials (in each case, whether or not in
electronic form) owned or licensed by Seller (whether inside or
outside of the Territory) and primarily pertaining to (a) the
Product in the Territory or the Purchased Assets or (b) the
Exploitation of the Product in the Territory, regulatory approval,
testing, clinical trialing, handling, processing, recordkeeping,
storage, warehousing, disposal, packaging, labeling, promotion,
import or export of the Product in the Territory (including copies
of all ledgers, journals, operating data and plans, technical
documentation (including design specifications, functional
requirements, operating instructions, logic manuals, flow charts
and similar items), user documentation (including user manuals,
training materials, release notes,
7
working papers
and similar items), marketing studies and documentation (including
sales brochures, flyers, pamphlets, web pages and similar items),
customer and supplier lists, consultant reports, invention
disclosures, laboratory notebooks and records, physician databases,
correspondence and other materials, internal memoranda and notes
relating to interactions with Governmental Authorities, and all
complaint files and adverse event files); provided ,
however , that “ Product Records ” shall
not include any books, documents, records, files and similar
materials (in each case, whether or not in electronic form)
(A) prepared in connection with the Transaction,
(B) maintained by Seller and/or its Representatives, agents or
licensees in connection with their respective ongoing Tax
requirements or (C) primarily pertaining to the Exploitation
of the Product outside the Territory or any other business of
Seller.
“
Purchase Price ” has the meaning set forth in
Section 3.1 .
“
Purchased Assets ” has the meaning set forth in
Section 2.1 .
“
Receiving Party ” has the meaning set forth in
Section 10.1(a) .
“
Representatives ” means, with respect to any Person,
the Affiliates, directors, officers, employees, agents or advisors
(including attorneys, accountants, financial advisors and
consultants) of such Person and representatives of any of the
foregoing; and, with respect to Buyer, the term “
Representatives ” shall also include Buyer’s
lenders and their respective Representatives.
“
Required Payments ” has the meaning set forth in
Section 6.1(b) .
“ ROFN
Acquisition Transaction ” has the meaning set forth in
Section 6.8(b) .
“ ROFN
Assets ” has the meaning set forth in
Section 6.8(a) .
“ ROFN
Notice ” has the meaning set forth in
Section 6.8(b) .
“ ROFN
Period ” has the meaning set forth in
Section 6.8(f) .
“
Scheduled Approvals ” has the meaning set forth in
Section 4.8(a) .
“ SEC
” means the Securities and Exchange Commission and any
successor Governmental Authority.
“ SEC
Documents ” has the meaning set forth in
Section 4.15 .
“
Seller ” has the meaning set forth in the
Preamble.
“ Seller
FDA Letters ” means the letter from Seller to the FDA,
duly executed by Seller, to be delivered to Buyer at the Closing,
with regard to the Vasovist NDA and MS-325 IND 51,172, the forms of
which are attached hereto as Exhibits F-1 and F-2 ,
respectively.
8
“
Seller’s Indemnified Persons ” has the meaning
set forth in Section 8.2 .
“
Seller’s Knowledge ” means the actual knowledge
of those individuals set forth on Schedule 1.1 , after
their due inquiry of the employees and/or consultants of Seller
materially involved with respect to the matter in
question.
“
Specified Contracts ” has the meaning set forth in
Section 2.1(e)(i) .
“
Sublicensed Intellectual Property ” has the meaning
set forth in Section 6.3(c) .
“
Subsidiary ” means any Person of which (i) a
majority of the outstanding share capital, voting securities or
other equity interests are owned, directly or indirectly, by
another Person or (ii) another Person is entitled, directly or
indirectly, to appoint a majority of the board of directors or
managers or comparable supervisory body of such Person.
“ Tax
” or “ Taxes ” means any and all taxes,
assessments, levies, tariffs, duties or other charges or
impositions in the nature of a tax imposed by any Governmental
Authority, including, without limitation, income, gross receipts,
license, payroll, employment, excise, severance, stamp, occupation,
premium, windfall profits, environmental, franchise, profits,
withholding, social security (or similar), unemployment,
disability, real property, personal property, sales, use, transfer,
real property transfer, recording, registration, value added,
alternative or add-on minimum, estimated, or other tax of any kind
whatsoever (whether payable directly or by withholding and whether
or not requiring the filing of a Tax Return), including any
interest or penalty thereon or addition thereto and any interest in
respect of such additions or penalties.
“ Tax
Return ” means any report, return (including any
information return), claim for refund, election, estimated Tax
filing or payment, request for extension, document, declaration or
other information or filing supplied or required to be supplied to
any Governmental Authority with respect to Taxes.
“
Technology ” means, collectively, all information,
designs, formulae, algorithms, procedures, methods, techniques,
ideas, know-how, research and development, technical data,
programs, subroutines, tools, materials, specifications, processes,
inventions (whether patentable or unpatentable and whether or not
reduced to practice), apparatus, creations, improvements, works of
authorship and other similar materials, and all recordings, graphs,
drawings, reports, analyses, and other writings, and other tangible
embodiments of the foregoing, in any form whether or not
specifically listed herein, and all related technology, that are
used in, incorporated in, embodied in, displayed by or relate to,
or are used in connection with the foregoing.
“
Termination Agreement ” means the Termination
Agreement, dated as of April 6, 2009, by and among Bayer, TMC
Pharma Services, Ltd. Seller and, with respect to certain
provisions, Buyer.
“
Territory ” means the U.S. Territory, Canada and
Australia.
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“ Total
Consideration ” has the meaning set forth in
Section 3.1 .
“
Transaction Documents ” means this Agreement, the Bill
of Sale, the Assignment and Assumption Agreement, the Patent
Assignment, the General IP Assignment and the other documents,
instruments, exhibits, annexes, schedules or certificates
contemplated hereby and thereby.
“
Transactions ” means the transactions contemplated by
the Transaction Documents.
“
Transfer Taxes ” has the meaning set forth in
Section 9.2 .
“ U.S.
Territory ” means the United States of America, including
the states thereof, the District of Columbia and the Commonwealth
of Puerto Rico, but excluding each of its other
territories.
“
Vasovist Authorization ” means each of (a) in the
U.S. Territory, the Vasovist NDA, (b) in Canada, the Vasovist
NDS and (c) in Australia, the Vasovist MAA.
“
Vasovist MAA ” means the registration approvals
(including ARTG Nos. 115,498, 115,546 and 115,547) granted by the
ATGA for the manufacture, importation, storage, promotion, sale or
other distribution of the Product in Australia, including any
submissions, resubmissions, variations or supplements thereto, and
any official correspondence with or from the ATGA regarding such
approval, application, submissions, resubmissions, variations or
supplements, as of the Closing Date.
“
Vasovist NDA ” means the investigational new drug
application 51,172 and the new drug application 21-711, including
any submissions, resubmissions or supplements thereto, and any
official correspondence with the FDA regarding such applications,
submissions, resubmissions or supplements, as of the Closing
Date.
“
Vasovist NDS ” the new drug submission control number
096420, including any submissions, resubmissions or supplements
thereto, any official correspondence with Health Canada regarding
such application, submissions, resubmissions or supplements, and
the notice of compliance for Vasovist, as of the Closing
Date.
“
Worldwide IP ” means all Intellectual Property owned,
used, held for use, currently contemplated to be used, filed by or
licensed to Seller or its Subsidiaries and primarily pertaining to
the Exploitation of the Product anywhere in the world, including
the Assigned Intellectual Property.
1.2
Interpretation . References in this Agreement to any gender
include references to all genders, and references to the singular
include references to the plural and vice versa. The words
“include,” “includes” and
“including” when used in this Agreement shall be deemed
to be followed by the phrase “without limitation.”
Unless the context otherwise requires, references in this Agreement
to Articles, Sections, Exhibits and Schedules shall be deemed
references to
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Articles and
Sections of, and Exhibits and Schedules to, this Agreement. Unless
the context otherwise requires, the words “hereof,”
“hereby” and “herein” and words of similar
meaning when used in this Agreement refer to this Agreement in its
entirety and not to any particular Article, Section or provision of
this Agreement. The table of contents and headings contained in
this Agreement are for reference purposes only and shall not affect
in any way the meaning or interpretation of this Agreement. Any
reference to any Law shall be deemed also to refer to all rules and
regulations promulgated thereunder, unless the context requires
otherwise.
PURCHASE AND SALE
OF ASSETS AND ASSUMPTION OF LIABILITIES
2.1 Purchase
and Sale of Assets . On the terms and subject to the conditions
set forth in this Agreement, at the Closing, for the Total
Consideration, Seller shall sell, transfer, assign, convey and
deliver to Buyer (or its designated Affiliate or Affiliates), and
Buyer (or its designated Affiliate or Affiliates) shall purchase,
acquire and accept from Seller or its designee, all right, title
and interest in, to and under the Purchased Assets, free and clear
of all Liens (other than Liens pursuant to the terms of the
Assigned Contracts (as defined below)). The “ Purchased
Assets ” shall mean all right, title and interest in and
to the following assets and rights owned or held by Seller as of
the Closing:
(a)
(i) all Patents primarily pertaining to the Product in the
Territory owned by Seller, all of which are set forth on
Schedule 2.1(a)(i) ; and (ii) all trade secrets,
know-how and copyrights owned by Seller and primarily pertaining to
the Product in the Territory (the Intellectual Property described
in clauses (i) and (ii) is referred to herein
collectively as the “ Assigned Intellectual Property
”);
(b)
all regulatory filings, drug master files and other regulatory
dossiers and Approvals primarily pertaining to the Product in the
Territory owned or licensed by Seller, all of which are set forth
in Schedule 2.1(b) ;
(c)
all other preclinical and clinical data, information, results and
other materials to the extent primarily pertaining to the Product
in the Territory owned or licensed by Seller (including a copy of
Seller’s magnetic resonance image database in the Territory),
all of which are described on Schedule 2.1(c)
;
(d)
all Product Records; provided that Seller shall be entitled
to retain (subject to Article X ) a copy of all Product
Records;
(e)
other than Contracts listed on Schedule 2.2(g) ,
(i) those Contracts to which Seller is a party primarily
pertaining to the Product in the Territory or any of the Purchased
Assets set forth on Schedule 2.1(e)(i) (the “
Specified Contracts ”) and (ii) the benefit of
all non-disclosure, confidentiality, standstill, non-compete and
non-solicitation agreements or obligations and invention assignment
obligations of all current and former employees,
11
consultants and
agents of Seller or third parties pursuant to Contracts between
such persons and Seller, in each case, to the extent relating to
the Product in the Territory or any of the Purchased Assets or any
portion of any of the foregoing, all of which are set forth on
Schedule 2.1(e)(ii) (the “ Assigned Contract
Rights ”) (the Specified Contracts and the Assigned
Contract Rights are referred to collectively as the “
Assigned Contracts ”); and
(f)
all claims, credits, causes of action and other rights of Seller
against third parties in respect of (i) the Purchased Assets
described in clauses (a) through (e) above or
(ii) the Assumed Liabilities, including those set forth on
Schedule 2.1(f) .
2.2 Excluded
Assets . The Parties acknowledge and agree that Seller shall
not convey, transfer, deliver or assign to Buyer, and Buyer shall
not purchase, take delivery of, or acquire, any rights to any
assets, properties, interests or rights of Seller other than the
Purchased Assets specifically enumerated in Section 2.1
(collectively the “ Excluded Assets ”),
including all of the rights, title and interests of Seller and its
Subsidiaries and Affiliates in the following:
(a)
all rights pertaining to products, services, business and prospects
of Seller and its Subsidiaries, other than, or with respect to, the
Purchased Assets;
(b)
all rights of Seller to the extent relating to the Product outside
the Territory (except, for the avoidance of doubt, as expressly set
forth in Section 6.8 );
(c)
all Seller’s employees;
(d)
all claims, credits, causes of action and other rights of Seller
against third parties pertaining to any Excluded Asset;
(e)
the retained copies of the Product Records and Seller’s
magnetic resonance image database;
(f)
any and all Tax assets of Seller and its Subsidiaries, including,
without limitation, any Tax claims or rights to Tax refunds, other
than Tax claims or rights to Tax refunds in respect of Taxes for
which Buyer is liable pursuant to Section 2.4 or
Section 9.2 hereof;
(g)
those Contracts to which Seller is a party primarily pertaining to
the Product in the Territory or any of the Purchased Assets set
forth on Schedule 2.2(g) ; and
(h)
all rights of Seller under this Agreement or any of the Transaction
Documents.
2.3 Assumption
of Liabilities .
(a)
On the terms and subject to the conditions set forth in this
Agreement, at the Closing, Buyer shall (or shall cause its
designated Affiliate or Affiliates to) assume, effective
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as of the
Closing, and shall, from and after the Closing, perform, satisfy
and discharge only the following Liabilities of Seller
(collectively, the “ Assumed Liabilities
”):
(i) subject to
Section 2.3(b)(ii) , all Liabilities of Seller under
the Specified Contracts and Approvals arising out of, or relating
to, the Product in the Territory, but only to the extent relating
to the period from and after the Closing; and
(ii) subject to
Section 2.3(b)(iii) , all Liabilities arising out of,
relating to, or otherwise in respect of the Purchased Assets from
and after the Closing.
(b)
Buyer will not assume or be liable for any Excluded Liabilities (as
defined below). Seller shall retain, be responsible for, perform,
satisfy and discharge all Excluded Liabilities in all respects.
“ Excluded Liabilities ” shall mean all
Liabilities of Seller other than the Assumed Liabilities, including
all of the following Liabilities:
(i) all
Liabilities arising out of, relating to, or otherwise in respect
of, (A) the Purchased Assets or the Product in respect of the
period before the Closing, (B) Seller’s business, assets
and operations outside of the Territory or (C) the Product
outside of the Territory;
(ii) all
Liabilities under the Assigned Contracts and Approvals in respect
of the Exploitation of the Product by the Seller during the period
before the Closing, including the Required Payments;
(iii) all
Liabilities incurred as a result of any Legal Proceedings
(regardless of when asserted or initiated) to the extent that such
Legal Proceeding arises out of, or relates to, (A) any action,
omission, occurrence, event, circumstance, or condition relating to
the Product, the Exploitation or the ownership or operation of the
Purchased Assets that occurred or existed at or before the Closing
(whether asserted before, at or after the Closing) or (B)
Seller’s business, assets and operations, the Product or the
Purchased Assets to the extent the basis for which arose out of, or
related to, any actions or omissions that occurred outside of the
Territory;
(iv) all Taxes of
Seller and its Subsidiaries for any period, including (x) any Taxes
for which Seller or any of its Subsidiaries may be liable under
Treasury Regulations Section 1.1502-6 or any similar provision
of state, local or foreign law, or as transferee or successor, by
Contract or otherwise, (y) all Taxes relating to the Excluded
Assets or Excluded Liabilities for any period and (z) all
Taxes relating to the Purchased Assets or the Assumed Liabilities
for any taxable period prior to the Closing Date and, with respect
to any taxable period beginning before and ending after the Closing
Date, for the portion of such taxable period ending on the Closing
Date, other than any Transfer Taxes as set forth in
Section 9.2 hereof; and
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(v) all
Liabilities arising out of, relating to, or otherwise in respect
of, the Excluded Assets.
2.4
Prorations . Seller and Buyer agree that all of the items
listed below relating to the Purchased Assets will be prorated as
of the Closing Date, with Seller liable to the extent such items
relate to any time period up to and including the Closing Date and
Buyer liable to the extent such items relate to periods subsequent
to the Closing Date: (a) property, ad valorem and other
similar Taxes, if any, attributable to the Purchased Assets; and
(b) the amount of any license or registration fees with
respect to any Approvals which are being assigned or transferred
hereunder. Each of Seller and Buyer agrees to furnish the other
Party with such documents and other records as such other Party
reasonably requests in order to confirm all adjustment and
proration calculations made pursuant to this
Section 2.4 . Seller shall promptly forward to Buyer
all invoices relating to the Purchased Assets that Seller receives.
Buyer shall pay the full amount of all such invoices and any other
invoices received by it and shall submit a request for
reimbursement to Seller for Seller’s share of such expenses.
Seller shall promptly reimburse Buyer for Seller’s share of
such expenses.
3.1 Payment
. The aggregate consideration for the Purchased Assets shall be
(a) an amount in cash equal to $28,000,000 (the “
Purchase Price ”) and (b) the assumption of the
Assumed Liabilities (together with the Purchase Price, the “
Total Consideration ”).
3.2 Payment
Method . On the Closing Date, Buyer shall pay the Purchase
Price to, or on behalf of, Seller by wire transfer of immediately
available funds into the accounts designated by Seller in writing
not fewer than one Business Day before the Closing Date.
3.3 The
Closing . The consummation of the purchase and sale of the
Purchased Assets and the assumption of the Assumed Liabilities
provided for in Article II hereof (the “
Closing ”) shall take place at the offices of Weil,
Gotshal & Manges LLP located at 100 Federal Street, 34th Floor,
Boston, MA 02110 (or at such other place as the parties may
designate in writing) at 10:00 a.m. (Boston time) on the date
hereof unless another time, date or place is agreed to in writing
by the Parties (the date on which the Closing occurs is referred to
herein as the “ Closing Date ”).
(a) Deliveries
by Seller . At the Closing, Seller shall deliver or cause to be
delivered to Buyer the following:
(i) a certificate
duly executed by Seller’s Chief Executive Officer or Chief
Financial Officer, in a form and substance reasonably satisfactory
to Buyer, dated as of the Closing Date, to the effect that each of
the conditions specified in Sections 7.1(a) and
7.1(b) has been satisfied in all respects;
14
(ii) (A) a
duly executed Bill of Sale; (B) a duly executed Assignment and
Assumption Agreement; (C) duly executed Patent Assignments;
and (D) a duly executed General IP Assignment;
(iii) a copy of
the executed Seller FDA Letters and a copy of each Vasovist
Authorization;
(iv) all
instruments and documents necessary to release any and all Liens on
the Purchased Assets, including appropriate UCC financing statement
amendments (termination statements);
(v) evidence
reasonably satisfactory to Buyer that the consents listed on
Schedule 3.4(a)(v) (the “ Necessary Seller
Consents ”) have been obtained;
(vi) evidence that
Seller has made, or has caused to be made, all Required
Payments;
(vii) an affidavit
of non-foreign status of Seller that complies with Section 1445 of
the Code;
(viii) a copy of
the executed Noteholder Consent; and
(ix) all other
documents as Buyer may reasonably request, including
secretary’s certificates, evidence of corporate existence and
good standing, evidence of corporate approvals and other similar
documents.
(b) Deliveries
by Buyer . At the Closing, Buyer shall deliver to Seller the
following:
(i) a certificate
duly executed by Buyer’s Chief Executive Officer or Chief
Financial Officer, in a form and substance reasonably satisfactory
to Seller, dated as of the Closing Date, to the effect that each of
the conditions specified in Sections 7.2(a) and
7.2(b) has been satisfied in all respects;
(ii) a duly
executed Assignment and Assumption Agreement;
(iii) evidence
reasonably satisfactory to Seller that the Necessary Buyer Consents
have been obtained;
(iv) a copy of the
executed Buyer FDA Letters;
(v) evidence of
wire transfer(s) of the Purchase Price referred to in
Section 3.2 ; and
15
(vi) all other
documents as Seller may reasonably request, including
secretary’s certificates, evidence of corporate existence and
good standing, evidence of corporate approvals and other similar
documents.
REPRESENTATIONS AND WARRANTIES OF
SELLER
Seller represents
and warrants to Buyer as follows as of the Execution Date and as of
the Closing Date:
4.1
Organization and Corporate Power . Seller is a corporation
duly organized, validly existing and in good standing under the
Laws of the State of Delaware. Seller has the requisite corporate
power and authority to own, operate or lease the properties that it
purports to own, operate or lease and to carry on its business as
it is now being conducted and is duly licensed or qualified to do
business in each jurisdiction in which the nature of the business
conducted by it or the character or location of the properties
owned or leased by it makes such licensing or qualification
necessary, except where the failure to be so licensed or qualified
would not have, or would not be reasonably expected to have, a
Material Adverse Effect.
4.2 Due
Authorization . Seller has the requisite corporate power and
authority to execute and deliver the Transaction Documents and to
consummate the Transactions. The execution, delivery and
performance by Seller of the Transaction Documents and the
consummation by Seller of the Transactions have been duly
authorized by all necessary corporate action on the part of Seller,
and no other corporate proceeding is necessary for the execution
and delivery of the Transaction Documents by Seller the performance
by Seller of its obligations thereunder and the consummation by
Seller of the Transactions. This Agreement has been duly executed
and delivered by Seller and constitutes the legal, valid and
binding obligation of Seller, enforceable against Seller in
accordance with its terms, except as the same may be limited by
bankruptcy, insolvency, moratorium, reorganization or other Laws of
general applicability relating to or affecting the enforcement of
creditor’s rights and general principles of equity. When
executed and delivered in accordance herewith, the other
Transaction Documents will have been duly executed and delivered by
Seller and will constitute legal, valid and binding obligations of
Seller enforceable against Seller in accordance with their
respective terms, except as the same may be limited by bankruptcy,
insolvency, moratorium, reorganization or other Laws of general
applicability relating to or affecting the enforcement of
creditor’s rights and general principles of
equity.
4.3 No
Violation; Consents .
(a)
The execution, delivery and performance by Seller of the
Transaction Documents do not and will not: (i) violate any
material Law or Order applicable to Seller or any of its properties
or assets (including the Purchased Assets); (ii) violate or
conflict with, result in a breach of, constitute a default (or an
event which, with or without notice or lapse of time or both, would
constitute a default) under, permit cancellation of, or result in
the creation of any Lien
16
upon any of
Seller’s properties or assets (including the Purchased
Assets) under, any material Contract to which Seller is a party or
by which it or its properties and assets are bound (including the
Indenture, the Convertible Senior Notes and the Assigned
Contracts); or (iii) violate or conflict with any provision of
Seller’s certificate of incorporation and by-laws.
(b)
Except for the approvals, notices and consents of, and filings
with, the Governmental Authorities or other Persons not a party to
this Agreement set forth on Schedule 4.3(b) , no
consents, notices or approvals of, or filings or registrations by
Seller with, any Governmental Authority or any other Person not a
party to this Agreement are necessary in connection with the
execution, delivery and performance of the Transaction Documents or
the Transactions or the continuing validity and effectiveness
immediately following the Closing of any Assigned Contracts or
Approvals.
4.4
Intellectual Property .
(a)
Seller owns, or licenses pursuant to the Specified Contracts set
forth on Schedule 2.1(e)(i) , free and clear of all Liens
(other than Liens pursuant to the terms of the Assigned Contracts),
all Intellectual Property used, held for use or contemplated for
use by Seller or its Subsidiaries with respect to the Exploitation
of the Product in the Territory in the approved formulations and
indications set forth in the applicable Vasovist Authorization, and
the consummation of the Transactions will not conflict with, alter
or impair any such rights in any material respect.
(b)
Schedule 4.4(b) contains a complete and accurate list
of the following Worldwide IP used or held for use in the
Exploitation of the Product: (i) all issued, registered and
applications to register Intellectual Property, (ii) all
material unregistered trademarks, and (iii) all Contracts
granting any licenses, options or other rights to any Intellectual
Property. For each item listed on such Schedule,
Schedule 4.4(b) sets forth (A) the owner,
(B) the jurisdiction where issued, registered, legally
sanctioned, filed or the equivalent and (C) to the extent such
Intellectual Property is owned by Seller, the particulars of any
registrations or issuances including, without limitation, all
relevant dates, inventors’ names, application numbers and the
status thereof.
(c)
Schedule 4.4(c) lists all royalties payable to any
third party with respect to the Exploitation of the Product in the
Territory or the use of any of the Assigned Intellectual Property
and Sublicensed Intellectual Property as of the Closing (whether or
not payable before, at or after the Closing). Except as set forth
on Schedule 4.4(c) , (i) there is no restriction or
limitation on Seller’s right to transfer any Assigned
Intellectual Property and Sublicensed Intellectual Property to
Buyer, as herein contemplated, and (ii) neither Seller nor any
of its Subsidiaries has licensed any third party to use any of the
Assigned Intellectual Property and Sublicensed Intellectual
Property.
(d)
All Assigned Intellectual Property and Sublicensed Intellectual
Property is valid and subsisting and to Seller’s Knowledge
enforceable, and all necessary registration, prosecution,
maintenance, renewal, and other relevant filing fees due in
connection therewith
17
have been
timely paid and all necessary actions (including the filing of
documents and certificates in connection therewith) have been
timely taken with the relevant authorities for the purposes of
prosecuting and/or maintaining such Intellectual Property in full
force and effect. Except as set forth on
Schedule 4.4(d) , as of the date of this Agreement,
there are no filings, payments or similar actions that must be
taken within ninety (90) days following the date hereof for
the purposes of obtaining, maintaining, perfecting or renewing any
registrations and applications to such Intellectual
Property.
(e)
To Seller’s Knowledge, none of the use of Assigned
Intellectual Property and Sublicensed Intellectual Property by
Seller or its Affiliates in the Exploitation of the Product in the
Territory in the approved formulations and indications set forth in
the applicable Vasovist Authorization, or the Exploitation of the
Product in the Territory in the approved formulations and
indications set forth in the applicable Vasovist Authorization,
infringes, misappropriates, otherwise violates or is in conflict
with the rights of others or the rights granted to Seller under any
applicable Laws, and, to Seller’s Knowledge, there is no
basis for any such claim or demand. No Legal Proceeding is pending
or, to Seller’s Knowledge, threatened or asserted in writing,
against Seller or any of its Subsidiaries by any person before any
Governmental Authority (including the U.S. Patent and Trademark
Office or equivalent authority anywhere in the world) with respect
to (i) the ownership, validity, enforceability, effectiveness
or use of any Assigned Intellectual Property and Sublicensed
Intellectual Property, or (ii) allegations of any
infringement, misappropriation, or other violation or conflict
(including under any unfair competition or trade practices claim)
related to the Product in the Territory or the Exploitation of the
Product in the Territory, in each case, in the approved
formulations and indications set forth in the applicable Vasovist
Authorization.
(f)
To Seller’s Knowledge, no Person is infringing upon or
otherwise violating any of the Assigned Intellectual Property and
Sublicensed Intellectual Property. Neither Seller nor any of its
Subsidiaries has brought or asserted any Legal Proceeding against
any person for infringing, misappropriating or otherwise violating
any Assigned Intellectual Property and Sublicensed Intellectual
Property, and, to Seller’s Knowledge, there is no basis for
any such Legal Proceeding.
(g)
Except as would not and would not reasonably be expected to
materially impair (i) the Exploitation of the Product in the
Territory in the approved formulations and indications set forth in
the applicable Vasovist Authorization or (ii) the Purchased
Assets, all confidential Assigned Intellectual Property and
Sublicensed Intellectual Property and other confidential and
proprietary information and Technology of Seller to the extent
relating to the Exploitation of the Product in the Territory in the
approved formulations and indications set forth in the applicable
Vasovist Authorization or included in the Purchased Assets has been
maintained in confidence in accordance with Seller’s
customary protection procedures, which are reasonably adequate and
in accordance with industry standards, and Seller has executed
written confidentiality and invention assignment agreements in a
form provided to Buyer with all past and present employees,
consultants and independent contractors who have materially
contributed to or been retained in connection with the development
of the Assigned Intellectual Property
18
pursuant to
which such employees, consultants and independent contractors have
assigned to Seller all their rights in and to all Assigned
Intellectual Property they developed in the course of their
employment or retention.
4.5 Litigation
and Claims .
(a)
There is no Legal Proceeding (whether in or outside the Territory)
pending or, to Seller’s Knowledge, threatened or asserted in
writing, against or affecting (i) Seller that would prohibit
or materially hinder, delay or otherwise impair Seller’s
ability to perform its obligations under the Transaction Documents,
including the assignment of the Purchased Assets, that would affect
the legality, validity or enforceability of the Transaction
Documents, or that would prevent or materially delay the
consummation of the Transactions, (ii) the Exploitation of the
Product (whether in or outside the Territory), (iii) the
Product (whether in or outside the Territory) or (iv) the
Purchased Assets.
(b)
None of Seller, any of its Subsidiaries or, to the Knowledge of
Seller, any of their respective Affiliates, directors, officers,
agents or employees is subject to any Order (whether in or outside
the Territory) that is related to the Exploitation of the Product
(whether in or outside the Territory), the Product (whether in or
outside the Territory) or the Purchased Assets.
(c)
Seller has paid to Covidien and any of its Affiliates all
Liabilities due and payable or otherwise accrued before, or in
connection with, the Closing and/or the Transactions under the
Amended and Restated Strategic Collaboration Agreement between
Seller and Covidien, dated as of June 9, 2000, as amended to
date, in full satisfaction of all Liabilities owed or accrued
thereunder.
4.6 Good and
Valid Title . Except as set forth on Schedule 4.6,
Seller has, or as of the Closing Date will have the right to
acquire and transfer to Buyer, good and valid title to the
Purchased Assets, in each case free and clear of all Liens (other
than Liens pursuant to the terms of the Assigned
Contracts).
4.7 Assigned
Contracts . Except as set forth on Schedule 4.7 ,
the Assigned Contracts represent all Contracts of Seller or any of
its Affiliates to the extent relating to the Product in the
Territory or the Purchased Assets, including all Contracts
(a) to the extent relating to the acquisition, use, transfer,
development or sharing of, or granting any license, option or other
rights to, the Assigned Intellectual Property (including any
license or other Contract under which Seller is a licensee or
licensor of any such Assigned Intellectual Property) and
Sublicensed Intellectual Property, (b) to the extent relating
to the joint development of, or any strategic alliance, partnership
or sharing of profits or proprietary information with respect to,
the Product in the Territory or the Assigned Intellectual Property
and Sublicensed Intellectual Property, (c) containing any
covenants restricting or prohibiting the owner and operator of the
Purchased Assets from competing in any line of business or in any
geographical area or from soliciting or hiring any Person, or any
covenants of another Person restricting or prohibiting such Person
from doing any of the foregoing, (d) restricting any use of
the Purchased Assets, (e) to the extent
19
relating to the
Exploitation of the Product in the Territory and (f) providing
for royalties on the sale of the Product in the Territory (whether
payable before, at or after Closing). Seller has provided Buyer
with true and complete copies of each Assigned Contract, including
all amendments, supplements and modifications to each such Assigned
Contract. All of the Assigned Contracts are the valid, binding
obligations of Seller, enforceable by and against Seller in
accordance with their respective terms, except as the same may be
limited by bankruptcy, insolvency, moratorium, reorganization or
other Laws of general applicability relating to or affecting the
enforcement of creditor’s rights and general principles of
equity. Neithe
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