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iASSET PURCHASE AGREEMENT

Asset Purchase Agreement

iASSET PURCHASE AGREEMENT | Document Parties: LEX PHARMACEUTICALS, INC | MIDDLEBROOK PHARMACEUTICALS, INC You are currently viewing:
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LEX PHARMACEUTICALS, INC | MIDDLEBROOK PHARMACEUTICALS, INC

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Title: iASSET PURCHASE AGREEMENT
Governing Law: New York     Date: 11/13/2007
Industry: Biotechnology and Drugs     Law Firm: Robinson Bradshaw     Sector: Healthcare

iASSET PURCHASE AGREEMENT, Parties: lex pharmaceuticals  inc , middlebrook pharmaceuticals  inc
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EXHIBIT 2.2
ASSET PURCHASE AGREEMENT
BETWEEN
MIDDLEBROOK PHARMACEUTICALS, INC.
AND
LEX PHARMACEUTICALS, INC.

 


 
TABLE OF CONTENTS
         
    Page
ARTICLE I
 
DEFINITIONS; CONSTRUCTION
 
       
1.1 Definitions
    1  
1.2 Construction
    1  
 
       
ARTICLE II
 
PURCHASE AND SALE
 
       
2.1 Sale and Purchase of Assets
    2  
2.2 Assumed Liabilities
    3  
2.3 Excluded Liabilities
    3  
 
       
ARTICLE III
 
PRICE, PAYMENT AND CLOSING
 
       
3.1 Part 1 Purchase Price
    3  
3.2 Part 1 Closing
    3  
3.3 Part 2 Purchase Price
    5  
3.4 Part 2 Purchase Conditions and Closing
    5  
 
       
ARTICLE IV
 
REPRESENTATIONS AND WARRANTIES OF SELLER
 
       
4.1 Organization
    7  
4.2 Authority; Enforceability
    7  
4.3 No Violation; Enforceability
    7  
4.4 No Proceedings
    8  
4.5 Financial Condition
    8  
4.6 Brokers, Etc
    8  
4.7 Title
    8  
4.8 Registrations
    8  
4.9 Intellectual Property
    9  
 
       
ARTICLE V
 
REPRESENTATIONS AND WARRANTIES OF BUYER
 
       
5.1 Organization
    9  
5.2 Authority; Enforceability
    9  

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    Page
5.3 No Violation; Enforceability
    9  
5.4 No Proceedings
    10  
5.5 Financial Condition
    10  
5.6 Brokers, Etc
    10  
5.7 Due Diligence
    10  
 
       
ARTICLE VI
 
COVENANTS
 
       
6.1 Information Exchange
    10  
6.2 Commercially Reasonable Efforts
    11  
6.3 Further Assurances
    11  
6.4 Bulk Sales Laws
    11  
 
       
ARTICLE VII
 
INDEMNIFICATION
 
       
7.1 Survival
    12  
7.2 Indemnification by Seller
    12  
7.3 Indemnification by Buyer
    12  
7.4 Procedure for Indemnification – Third-Party Claims
    12  
7.5 Limitation on Damages
    13  
 
       
ARTICLE VIII
 
GENERAL PROVISIONS
 
       
8.1 No Joint Venture
    14  
8.2 Expenses
    14  
8.3 Amendment and Modification
    14  
8.4 Waiver of Compliance; Consents
    14  
8.5 Notices
    15  
8.6 Publicity
    15  
8.7 Assignment; No Third-Party Rights
    16  
8.8 Governing Law
    16  
8.9 Access to Records
    16  
8.10 Severability
    16  
8.11 Construction
    16  
8.12 Counterparts
    16  
8.13 Entire Agreement
    17  

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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:
         
Amount:
  $ 5,250,000  
Bank Name:
  State Street Bank and Trust Company
ABA/Routing#:
  011000028  
Account #:
  17039843  
Account Name:
  MiddleBrook Pharmaceuticals, Inc.
Ref:Attention:
  Kevin Hughes
 
  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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