EXHIBIT 2.2
ASSET PURCHASE AGREEMENT
BETWEEN
MIDDLEBROOK PHARMACEUTICALS, INC.
AND
LEX
PHARMACEUTICALS, INC.
TABLE OF CONTENTS
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ARTICLE
I
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DEFINITIONS;
CONSTRUCTION
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1.1
Definitions
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1.2
Construction
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ARTICLE
II
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PURCHASE AND
SALE
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2.1 Sale and
Purchase of Assets
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2.2 Assumed
Liabilities
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2.3 Excluded
Liabilities
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ARTICLE
III
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PRICE, PAYMENT
AND CLOSING
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3.1 Part 1
Purchase Price
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3.2 Part 1
Closing
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3.3 Part 2
Purchase Price
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3.4 Part 2
Purchase Conditions and Closing
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ARTICLE
IV
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REPRESENTATIONS
AND WARRANTIES OF SELLER
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4.1
Organization
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4.2 Authority;
Enforceability
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4.3 No Violation;
Enforceability
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4.4 No
Proceedings
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4.5 Financial
Condition
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4.6 Brokers,
Etc
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4.7 Title
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4.8
Registrations
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4.9 Intellectual
Property
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ARTICLE
V
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REPRESENTATIONS
AND WARRANTIES OF BUYER
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5.1
Organization
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5.2 Authority;
Enforceability
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5.3 No Violation;
Enforceability
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5.4 No
Proceedings
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5.5 Financial
Condition
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5.6 Brokers,
Etc
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5.7 Due
Diligence
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ARTICLE
VI
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COVENANTS
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6.1 Information
Exchange
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6.2 Commercially
Reasonable Efforts
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6.3 Further
Assurances
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6.4 Bulk Sales
Laws
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ARTICLE
VII
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INDEMNIFICATION
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7.1 Survival
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7.2
Indemnification by Seller
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7.3
Indemnification by Buyer
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7.4 Procedure for
Indemnification – Third-Party Claims
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7.5 Limitation on
Damages
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ARTICLE
VIII
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GENERAL
PROVISIONS
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8.1 No Joint
Venture
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8.2 Expenses
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8.3 Amendment and
Modification
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8.4 Waiver of
Compliance; Consents
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8.5 Notices
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8.6
Publicity
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8.7 Assignment; No
Third-Party Rights
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8.8 Governing
Law
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8.9 Access to
Records
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8.10
Severability
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8.11
Construction
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8.12
Counterparts
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8.13 Entire
Agreement
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ii
ASSET PURCHASE AGREEMENT
This ASSET PURCHASE AGREEMENT
(this “ Agreement ”), dated as of
November 7, 2007, is entered into by and between
MiddleBrook Pharmaceuticals, Inc. , a Delaware corporation
(“ Seller ”), and Lex Pharmaceuticals,
Inc. , a Delaware corporation (“ Buyer
”).
Background Statement
Seller is the owner of trademarks,
regulatory rights, technical data and certain other assets relating
to antibiotic pharmaceutical products sold under the name
“Keflex.” The parties to this Agreement wish to provide
for (i) Seller’s sale of such assets to Buyer and
(ii) Buyer’s licensing back to Seller of such assets,
all in accordance with and subject to the terms and conditions of
this Agreement (as more fully defined herein).
Statement of Agreement
The parties hereto agree as
follows:
ARTICLE I
DEFINITIONS; CONSTRUCTION
1.1 Definitions . Capitalized
terms used in this Agreement have the meanings given to them in
Appendix 1 .
1.2 Construction .
(a) The article and section
headings contained in this Agreement are solely for the purposes of
reference and convenience, are not part of the agreement of the
parties, and shall not in any way limit, modify or otherwise affect
the meaning or interpretation of this Agreement.
(b) References to
“Sections” or “Articles” refer to
corresponding Sections or Articles of this Agreement unless
otherwise specified.
(c) References to
“Exhibits” refer to the exhibits attached hereto.
(d) Unless the context requires
otherwise, the words “include,” “including”
and variations thereof mean without limitation; the words
“hereof,” “hereby,” “herein,”
“hereunder” and similar terms refer to this Agreement
as a whole and not any particular section or article in which such
words appear; and any reference to a statute, regulation or law
shall include any amendment thereof or any successor thereto and
any rules and regulations promulgated thereunder.
(e) Unless the context requires
otherwise, words in the singular include the plural, words in the
plural include the singular, and words importing any gender shall
be applicable to all genders.
(f) References to time are to
prevailing time in New York, New York.
(g) References to a number of
days refer to calendar days unless Business Days are specified.
Except as otherwise specified, whenever any action must be taken on
or by a day that is not a Business Day, then such action may be
validly taken on or by the next day that is a Business Day.
ARTICLE II
PURCHASE AND SALE
2.1 Sale and Purchase of
Assets .
(a) Purchased Assets
.
(i) On the terms and subject to the
conditions of this Agreement, at and as of the Part 1 Closing,
Seller shall sell, convey, assign, transfer and deliver to Buyer,
and Buyer shall purchase, acquire and accept from Seller, all
right, title and interest of Seller (it being understood that the
use or sale of such assets and rights shall be limited to the
United States and Puerto Rico) in and to (A) the approved new
drug applications number 50-405 and 50-406, including all
supplements and amendments thereto and all related regulatory
rights (cumulatively, the “ NDA ”), (B) all
drug master files, clinical results, product development
information, manufacturing know-how and other physical or
electronic embodiments of any documents or data related to the
Products (the “ Technical Data Embodiments ”),
that may be marketed now or in the future under the NDA and all
intellectual property rights therein, including copyrights and
trade secrets (collectively, the “ Technical Data
”) and (C) the trademark KEFLEX and all registrations
and applications for registration thereof set forth on
Schedule 2. 1(a)(i) , including the domain name
“Keflex.com” ((C) alone, the “ Marks
,” and (A)-(C) collectively, the “ Part 1
Assets ”), free and clear of all Encumbrances except for
Permitted Encumbrances.
(ii) Upon satisfaction or waiver of
the conditions set forth in Sections 3. 4(b)
, 3.4(c) and 3.4(e) , Seller shall, on the terms and
subject to the other conditions of this Agreement, at and as of the
Part 2 Closing, sell, convey, assign, transfer and deliver to
Buyer, and Buyer shall purchase, acquire and accept from Seller,
all right, title and interest of Seller (it being understood that
the use or sale of such assets and rights shall be limited to the
United States and Puerto Rico) in and to (A) the
investigational new drug application number 73,767, including any
approval thereof and all supplements and amendments thereto and all
related regulatory rights (cumulatively, the “ IND
”) and (B) (i) a copy of all Technical Data Embodiments
and (ii) all intellectual property rights therein, including
copyrights and trade secrets, as the relate to any Product ((A) and
(B) collectively the “ Part 2 Assets ”),
free and clear of all Encumbrances except for Permitted
Encumbrances.
(b) Excluded Assets .
For the avoidance of doubt, and notwithstanding anything in this
Agreement to the contrary, the Purchased Assets shall not include
any assets of Seller or its Affiliates not specifically described
in Section 2. 1(a) or set forth in
Schedule 2. 1(a)(i) .
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2.2 Assumed Liabilities . As
of the Part 1 Closing with respect to the Part 1 Assets,
and as of the Part 2 Closing with respect to the Part 2
Assets, Buyer agrees to assume and pay, satisfy, discharge or
perform those regulatory obligations arising after the Part 1
Closing and Part 2 Closing, as applicable, that it is required
by Legal Requirements to assume as owner of the Registrations and
the Marks purchased at each such Closing (the “ Assumed
Liabilities ”).
2.3 Excluded Liabilities .
Notwithstanding any other provision of this Agreement, Buyer shall
not assume any Liability other than those expressly included as
Assumed Liabilities.
ARTICLE III
PRICE, PAYMENT AND CLOSING
3.1 Part 1 Purchase Price
. In consideration of the sale of the Part 1 Assets, at the
Part 1 Closing and subject to the conditions set forth herein,
Buyer shall pay to Seller an amount (the “ Part 1
Purchase Price ”) equal to Five Million Two Hundred Fifty
Thousand Dollars ($5,250,000) payable in cash by wire transfer of
immediately available funds.
3.2 Part 1 Closing
.
(a) At the Part 1 Closing
Seller shall execute (as applicable) and deliver the following
items to Buyer:
(i) a bill of sale and assumption
substantially in the form of Exhibit A (the “
Part 1 Bill of Sale ”);
(ii) letters from Seller to the FDA
substantially in the form of Exhibit B ;
(iii) an Agreement Regarding
Regulatory Responsibilities substantially in the form of
Exhibit C (the “ Regulatory Responsibility
Agreement ”);
(iv) a Trademark Assignment
substantially in the form of Exhibit D (the “
Trademark Assignment ”);
(v) a Registration and Trademark
License Agreement substantially in the form of Exhibit E
(the “ Registration License ”);
(vi) a Contingent Manufacturing
Assignment Agreement substantially in the form of
Exhibit F (the “ Contingent Manufacturing
Assignment ”);
(vii) a letter specifying the payoff
amount with respect to indebtedness owed by Seller pursuant to the
Credit and Security Agreement, dated as of June 30, 2006, by
and among Seller, the various financial institutions party thereto
and Merrill Lynch Capital (the “ Credit Agreement
”);
(viii) a certificate of
Seller’s Secretary certifying as to Seller’s
certificate of incorporation, bylaws, board of directors’
resolutions authorizing the transactions
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contemplated by
this Agreement and the Related Agreements and as to the incumbency
of the officers of Seller executing this Agreement, the Related
Agreements and any documents contemplated thereby; and
(ix) such other documents and
instruments as may be reasonably necessary to effect or evidence
the transactions contemplated by this Agreement and the Related
Agreements.
(b) At the Part 1 Closing,
Buyer shall execute (as applicable) and deliver the following items
to Seller:
(i) the Part 1 Purchase Price,
in full, by wire transfer of immediately available funds pursuant
to the following wire transfer instructions:
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Amount:
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$ 5,250,000 |
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Bank Name:
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State Street Bank
and Trust Company |
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ABA/Routing#:
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011000028 |
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Account #:
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17039843 |
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Account Name:
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MiddleBrook
Pharmaceuticals, Inc. |
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Ref:Attention:
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Kevin Hughes |
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For credit to:
DE1715 |
(ii) the Part 1 Bill of
Sale;
(iii) the Regulatory Responsibility
Agreement;
(iv) the Trademark Assignment;
(v) the Registration License;
(vi) the Contingent Manufacturing
Agreement;
(vii) a certificate of Buyer’s
Secretary certifying as to Buyer’s certificate of
incorporation, bylaws, board of directors’ resolutions
authorizing the transactions contemplated by this Agreement and the
Related Agreements and as to the incumbency of the officers of
Buyer executing this Agreement, the Related Agreements and any
documents contemplated thereby; and
(viii) such other documents and
instruments as may be reasonably necessary to effect or evidence
the transactions contemplated by this Agreement and the Related
Agreements.
(c) FDA Letters . Not
later than ten (10) days after the Part 1 Closing, Buyer
shall deliver to the FDA (i) a letter substantially in the
form of Exhibit G , duly executed by an authorized
officer of Buyer and (ii) the original of Seller’s
letter to the FDA delivered by Seller to Buyer pursuant to
Section 3. 2(a)(ii) .
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3.3 Part 2 Purchase Price
. In consideration of the sale of the Part 2 Assets, at the
Part 2 Closing and subject to the conditions set forth herein,
the Buyer shall pay to the Seller an amount (the “
Part 2 Purchase Price ”) equal to Five Hundred
Thousand ($500,000) payable in cash by wire transfer of immediately
available funds.
3.4 Part 2 Purchase
Conditions and Closing .
(a) Seller shall have the right
to require Buyer to purchase the Part 2 Assets, subject to the
conditions precedent set forth in Sections 3.
4(b) and 3.4(c) , by delivering a written notice
thereof to Buyer substantially in the form of Exhibit H
(the “ Part 2 Notice ”) on any day that is
a Business Day on or prior to June 30, 2008. The Part 2
Notice shall specify a Part 2 Closing Date not earlier than
five (5), and not later than thirty (30), Business Days after
delivery of the Part 2 Notice. The Part 2 Notice shall
constitute a binding obligation of the Buyer to purchase, and the
Seller to sell, the Part 2 Assets pursuant to the terms and
conditions of this Agreement.
(b) The obligation of the
parties to purchase and sell the Part 2 Assets shall be
subject to the satisfaction (or waiver, if permissible under
applicable Legal Requirements) of the following conditions:
(i) No Legal Requirement, temporary
restraining order, preliminary injunction or permanent injunction,
judgment or ruling enacted, promulgated, issued, entered, amended
or enforced by any Governmental Authority shall be in effect
enjoining, restraining, preventing or prohibiting the purchase and
sale of the Part 2 Assets.
(ii) Seller shall have delivered the
Part 2 Notice to Buyer on or prior to June 30,
2008.
(c) The obligation of Buyer to
purchase the Part 2 Assets shall be subject to the
satisfaction (or waiver, if permissible under applicable Legal
Requirements) of the following conditions:
(i) Seller shall have received from
the FDA either (A) an approval letter for marketing the
Seller’s Amoxicillin PULSYS product, pursuant to the
Seller’s New Drug Application number 50-813 or (B) an
approvable letter for the Seller’s Amoxicillin PULSYS
product, pursuant to the Seller’s New Drug Application number
50-813 containing only such conditions or requirements that in the
reasonable determination of both the Buyer and the Seller, and
subject to negotiation between the two parties, are deemed to be
acceptable.
(ii) Each of the representations and
warranties of Seller set forth in this Agreement, disregarding all
qualifications and exceptions contained therein relating to
materiality or Material Adverse Effect, shall be true and correct
in all respects, in each case as of the date of this Agreement and
as of the Part 2 Effective Time as though made on and as of
the Part 2 Effective Time, except where the failure or
failures to be true and correct would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse
Effect.
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(iii) Seller shall have performed in
all material respects all obligations and complied with all
covenants required to be performed by it under this Agreement at or
prior to the Part 2 Closing.
(iv) No event or events shall have
occurred or circumstance or circumstances exist that, individually
or in the aggregate, would reasonably be expected to have a
Material Adverse Effect with respect to (A) the Seller’s
business of developing, manufacturing, distributing, marketing,
selling and using the Products or (B) the Seller.
(d) The obligation of Seller to
sell the Part 2 Assets shall be subject to the satisfaction
(or waiver, if permissible under applicable Legal Requirements) of
the following conditions:
(i) Each of the representations and
warranties of Buyer set forth in this Agreement, disregarding all
qualifications and exceptions contained therein relating to
materiality or Material Adverse Effect, shall be true and correct
in all respects, in each case as of the date of this Agreement and
as of the Part 2 Effective Time as though made on and as of
the Part 2 Effective Time, except where the failure or
failures to be true and correct would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse
Effect.
(ii) Buyer shall have performed in
all material respects all obligations and complied with all
covenants required to be performed by it under this Agreement at or
prior to the Part 2 Closing.
(e) At the Part 2 Closing
Seller shall execute (as applicable) and deliver the following
items to Buyer:
(i) a bill of sale and assumption
substantially in the form of Exhibit I (the “
Part 2 Bill of Sale ”);
(ii) a letter from Seller to the FDA
substantially in the form of Exhibit J ;
(iii) a certificate of Seller’s
Secretary certifying as to Seller’s certificate of
incorporation, bylaws, board of directors’ resolutions of
Seller’s authorizing the transactions contemplated by the
Part 2 Closing and as to the incumbency of the officers of
Seller executing the documents to be executed by Seller at the
Part 2 Closing;
(iv) a certificate, executed by
Seller’s chief executive officer or president, certifying to
the matters set forth in Sections 3. 4(c)(ii)
-(iv) ; and
(v) such other documents and
instruments as may be reasonably necessary to effect or evidence
the transactions contemplated by this Agreement to occur at the
Part 2 Closing.
(f) At the Part 2 Closing
Buyer shall execute (as applicable) and deliver the following items
to Seller:
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(i) the Part 2 Purchase Price,
in full, by wire transfer of immediately available funds pursuant
to an account that Seller shall designate in writing to Buyer at
least two (2) Business Days prior to the Part 2 Closing
Date;
(ii) the Part 2 Bill of
Sale;
(iii) a certificate of Buyer’s
Secretary certifying as to Buyer’s certificate of
incorporation, bylaws, board of directors’ resolutions
authorizing the transactions contemplated by the Part 2
Closing and as to the incumbency of the officers of Buyer executing
the documents to be executed by Buyer at the Part 2
Closing;
(iv) a certificate, executed by
Buyer’s chief executive officer or president, certifying to
the matters set forth in Sections 3. 4(d)(i) and
3. 4(d)(ii) ; and
(v) such other documents and
instruments as may be reasonably necessary to effect or evidence
the transactions contemplated by this Agreement to occur at the
Part 2 Closing.
(g) FDA Letters . Not
later than ten (10) days after the Part 2 Closing, Buyer
shall deliver to the FDA (i) a letter substantially in the
form of Exhibit K , duly executed by an authorized
officer of Buyer, and (ii) the original of Seller’s
letter to the FDA delivered by Seller to Buyer pursuant to
Section 3. 4(e)(ii) .
ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF SELLER
Seller represents and warrants to
Buyer that:
4.1 Organization . Seller is a
corporation duly organized, validly existing and in good standing
under the laws of the State of its organization. Seller has all
requisite corporate power and authority to own, lease and operate
its properties and to carry on its business as is now being
conducted.
4.2 Authority; Enforceability
. Seller has all requisite corporate power and authority to
execute, deliver and perform its obligations under this Agreement,
and the execution and delivery of this Agreement and the
performance of all of its obligations hereunder have been duly
authorized by Seller. 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 enforceability may be limited or affected by
applicable bankruptcy, insolvency, moratorium, reorganization or
other laws of general application relating to or affecting
creditors’ rights generally.
4.3 No Violation;
Enforceability . The signing, delivery and performance of this
Agreement by Seller is not prohibited or limited by, and will not
result in the breach of or a default under, any provision of the
certificate of incorporation, bylaws or other formation documents
of Seller, or of any material agreement or instrument binding on
Seller, or of any
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applicable law, order, writ, injunction or decree of any
Governmental Authority, except for such prohibition, limitation or
default as would not prevent consummation by Seller of the
transactions contemplated hereby. The execution, delivery and
performance of this Agreement by Seller, and Seller’s
compliance with the terms and provisions hereof, do not and will
not conflict with or result in a breach of any of the terms and
provisions of or constitute a default, with or without the passage
of time and the giving of notice, under any Contract or other
instrument or obligation binding or affecting the Purchased
Assets.
4.4 No Proceedings . Except as
set forth on Schedule 4.4 , there is no action, suit,
litigation, Proceeding, claim, governmental investigation or
administrative action pending or, to Seller’s Knowledge,
threatened, directly or indirectly involving the Purchased Assets
or the transactions contemplated hereby or Seller’s ability
to perform its obligations hereunder. Seller is not a party or
subject to or in default under any material judgment, order,
injunction or decree of any Governmental Authority or arbitration
tribunal applicable to Seller or the Purchased Assets.
4.5 Financial Condition . No
insolvency Proceeding of any character, including, without
limitation, bankruptcy, receivership, reorganization, composition
or arrangement with creditors, voluntary or involuntary, has been
commenced by or against Seller or any of its assets or properties,
nor, to Seller’s Knowledge, is any such Proceeding
threatened. Seller does not contemplate and has not taken any
action in contemplation of the institution of any such insolvency
Proceedings.
4.6 Brokers, Etc . No broker,
investment banker, agent, finder or other intermediary acting on
behalf of Seller or under the authority of Seller is or will be
entitled to any broker’s or finder’s fee or any other
commission or similar fee directly or indirectly in connection with
any of the transactions contemplated hereby.
4.7 Title . (i) Except
for encumbrances arising from the Credit Agreement, which
encumbrances shall be terminated in connection with the Part 1
Closing, Seller is the sole and exclusive owner of the Purchased
Assets and has the unencumbered right to convey all of the
Purchased Assets; (ii) no licenses have been granted to any
third party under any of the Purchased Assets (other than licenses
granted pursuant to this Agreement or the Related Agreements); and
(iii) the Purchased Assets are subject to no Encumbrances
other than the rights of Buyer hereunder and Permitted
Encumbrances.
4.8 Registrations .
(a) The Registrations are in
full force and effect, and, to Seller’s Knowledge, no
Governmental Authority intends or is contemplating any action to
terminate or suspend any of the Registrations.
(b) Seller’s operation of
and actions with respect to the Registrations has been, and as of
the Closing Date is or will be (as applicable), in compliance in
all material respects with the Act and other comparable state and
local statutes, rules and regulations applicable to the
Registrations.
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(c) Seller has completed and
timely filed all annual or other reports required by the FDA or any
other Governmental Authority in order to maintain the Registrations
and satisfy all Legal Requirements relating to the
Registrations.
(d) Seller has not received any
written notification (i) from the FDA alleging that any
Product is misbranded or adulterated as defined in the Act,
(ii) from the FDA or any other applicable Governmental
Authority contesting the approval, uses, labeling or promotion of a
Product or (iii) otherwise alleging any violation by Seller of
any Legal Requirement in connection with any Product.
(e) To Seller’s Knowledge,
there are no reasonably foreseeable adverse effects caused by the
use of any of the Products that are not disclosed in the package
insert for such Products.
4.9 Intellectual Property .
Schedule 4.9 lists all trademarks owned, applied for or
used by Seller in connection with the sale, offer for sale,
promotion or marketing of the Products. The manufacture, use,
import, registration, sale, offer for sale, promotion and marketing
of the Products pursuant to and in association with the Marks do
not conflict with, infringe upon, contribute to or induce the
infringement of, or misappropriate or violate a
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