Exhibit 10.1
EXECUTION COPY
AGREEMENT AND PLAN OF MERGER
BY AND AMONG
AMERICAN MEDICAL SYSTEMS, INC.
OAK MERGER CORP.
OVION INC.
AND
THE OTHER PARTIES HERETO
DATED AS OF JUNE 3, 2005
Table of Contents
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Page
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ARTICLE 1 THE MERGER; CONVERSION OF
SHARES
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1
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1
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1
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1.3 Closing of the Merger
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2
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1.4 Effects of the Merger
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2
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1.5 Certificate of Incorporation of the
Surviving Corporation
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2
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1.6 Bylaws of the Surviving
Corporation
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2
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1.7 Directors and Officers of the Surviving
Corporation
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2
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1.8 Initial Merger Consideration
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3
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1.9 Contingent Merger Consideration
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4
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1.10 Cancellation and Conversion of Company
Securities at the Effective Time
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6
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7
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1.12 Escrow Procedure; Exchange of
Certificates
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8
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ARTICLE 2 REPRESENTATIONS AND WARRANTIES OF THE
COMPANY AND THE PRINCIPAL STOCKHOLDERS
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10
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2.1 Corporate Organization and Power
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10
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11
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11
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2.4 Capitalization of the Company
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11
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12
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2.6 Consents and Approvals
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12
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2.7 Financial Statements; Undisclosed
Liabilities
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13
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2.8 Absence of Certain Changes
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13
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2.9 Assets and Properties
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15
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2.10 Manufacturing and Marketing
Rights
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15
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2.11 FDA and Regulatory Matters
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16
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2.12 Reimbursement/Billing
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17
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2.13 Compliance with Applicable Laws
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18
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18
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19
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21
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2.20 Labor and Employment Matters
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25
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2.21 Intellectual Property
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26
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2.22 Environmental Compliance
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27
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28
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28
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2.25 Bank Accounts; Powers of
Attorney
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30
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31
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i
Table of Contents
(continued)
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Page
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2.27 Product Liability Claims
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31
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2.28 No Sales or Warranties
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31
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2.29 Relations with Suppliers
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31
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2.30 Indemnification Obligations
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31
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2.31 Absence of Certain Business
Practices
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31
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32
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32
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32
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2.35 Stockholder Agreements
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32
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32
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2.37 Investigation by Parent
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32
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ARTICLE 3 REPRESENTATIONS AND WARRANTIES OF
PARENT AND MERGER SUBSIDIARY
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33
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3.1 Corporate Existence and Power
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33
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33
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3.3 Consents and Approvals
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33
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3.4 Available Capital Resources
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34
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34
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34
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35
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4.1 Conduct of the Business
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35
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4.2 Company’s Agreements as to Specified
Matters
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35
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37
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37
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4.5 Filings; Consents; Removal of
Objections
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38
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4.6 Further Assurances; Cooperation;
Notification
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38
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4.7 Approval of Stockholders
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38
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4.8 Update Disclosure; Breaches
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39
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40
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4.10 Public Announcements
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41
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4.11 Preparation of Tax Returns: Tax
Matters
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41
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4.12 Expenses Related to Certain Third-Party
Proceedings
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42
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42
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4.14 Notice to Holder of Third-Party
Right
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43
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4.15 Conduct of the Business After the
Closing
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43
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ARTICLE 5 CONDITIONS TO PARENT’S AND
MERGER SUBSIDIARY’S OBLIGATIONS
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43
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5.1 Representations and Warranties
True
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43
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ii
Table of Contents
(continued)
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Page
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44
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5.3 Filed Certificate of Merger
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44
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5.4 Required Approvals and Consents
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44
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5.5 No Proceeding or Litigation
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5.6 No Exercise of Third-Party Right
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5.8 No Material Adverse Effect
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5.10 Other Receipts; Good Standing
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44
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5.11 Opinions of Company Counsel
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45
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45
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45
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5.15 Stockholder Agreements
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45
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5.17 Resignation and Release
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45
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5.18 Tax Withholding Forms
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45
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ARTICLE 6 CONDITIONS TO COMPANY’S
OBLIGATIONS
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46
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6.1 Representations and Warranties
True
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46
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6.3 Filed Certificate of Merger
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6.5 No Proceeding or Litigation
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6.6 No Exercise of Third-Party Right
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6.9 Other Receipts; Good Standing
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47
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6.10 Opinion of Parent Counsel
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47
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47
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7.1 Methods of Termination
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47
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7.2 Procedure Upon Termination
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48
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7.3 Effect of Termination
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48
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49
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ARTICLE 8 SURVIVAL AND
INDEMNIFICATION
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49
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49
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8.2 Indemnification by Stockholders
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50
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8.3 Indemnification by Parent
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50
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iii
Table of Contents
(continued)
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Page
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8.4 Claims for Indemnification
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50
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8.5 Indemnification Limits
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52
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54
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54
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8.8 Expenses of Stockholders’
Representative
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54
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54
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54
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55
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65
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65
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11.2 Amendments; No Waivers
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66
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67
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11.4 Successors and Assigns
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67
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67
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11.6 Counterparts; Effectiveness
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67
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67
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67
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68
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68
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11.11 Cumulative Remedies
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68
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11.12 Third Party Beneficiaries
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68
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11.13 Appointment of Stockholders’
Representative; Enforcement of Rights, Benefits and
Remedies
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68
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iv
AGREEMENT AND PLAN OF MERGER
THIS AGREEMENT AND PLAN OF MERGER (this “
Agreement ”), dated as of June 3, 2005, is
entered into by and among American Medical Systems, Inc., a
Delaware corporation (“ Parent ”), Oak Merger
Corp., a Delaware corporation and a wholly-owned subsidiary of
Parent (“ Merger Subsidiary ”), Ovion Inc., a
Delaware corporation (“ Company ”), Jeffrey P.
Callister and W. Stephen Tremulis (together, the “
Principal Stockholders ”) and Jeffrey P. Callister, as
Stockholders’ Representative (“ Stockholders’
Representative ”).
WHEREAS, the Board
of Directors of each of the Company, Parent and Merger Subsidiary
have (i) determined that the Merger (as defined below) is fair and
in the best interests of their respective stockholders and
(ii) approved the Merger of Merger Subsidiary with and into
the Company, with the Company surviving, in accordance with the
terms and conditions of this Agreement.
WHEREAS, in
connection with the execution of that certain letter of intent
dated February 17, 2005, as supplemented on April 11,
2005 (the “ Letter of Intent ”), Parent made a
loan to the Company, to fund the continuing operation of the
Company, of $200,000 on February 18, 2005 (the “
First Loan ”) and another of $100,000 on
April 13, 2005 (the “ Second Loan
”).
WHEREAS, the
parties hereto desire to make certain representations, warranties
and agreements in connection with the Merger and also to prescribe
various conditions to the Merger.
NOW, THEREFORE, in
consideration of the premises and the representations, warranties,
covenants and agreements herein contained, and intending to be
legally bound hereby, the Company, Parent, Merger Subsidiary, the
Principal Stockholders and the Stockholders’ Representative
hereby agree as follows:
ARTICLE 1
THE MERGER; CONVERSION OF SHARES
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1.1
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The Merger . At the Effective Time (as defined
below) and upon the terms and subject to the conditions of this
Agreement and in accordance with the Delaware General Corporation
Law (the “ DGCL ”), Merger Subsidiary shall be
merged with and into the Company, and, following the merger, the
Company shall continue as the surviving corporation (the “
Surviving Corporation ”), the separate corporate
existence of Merger Subsidiary shall cease and the Surviving
Corporation shall continue to be governed by the laws of the State
of Delaware (the “ Merger ”).
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1.2
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Effective Time
. Subject to the terms
and conditions set forth in this Agreement, on the Closing Date (as
defined below) the Company and Merger Subsidiary will file, or
cause to be filed, with the Secretary of State of the State of
Delaware a Certificate of Merger, in the form as required by, and
executed and acknowledged in accordance with, the applicable
provisions of the DGCL, and substantially in the form attached
hereto as Exhibit A (the “ Certificate of
Merger ”). The Merger shall become effective at 3 p.m.
Central Standard Time on the date the Certificate of Merger is
filed or, if agreed to by the
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Parent and the Company, such later
date or time set forth in the Certificate of Merger (the “
Effective Time ”).
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1.3
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Closing of the Merger
. Unless this Agreement
shall have been terminated and the transactions contemplated herein
abandoned pursuant to Article 7 hereof, the closing of the
Merger (the “ Closing ”) will take place on a
date (the “ Closing Date ”) to be specified by
Parent and the Company which shall be no later than the second
business day after satisfaction or waiver of the latest to occur of
the conditions set forth in Articles 5 and 6 (other than delivery
of items to be delivered at the Closing and other than those
conditions that by their nature are to be satisfied at the Closing,
it being understood that the occurrence of the Closing shall remain
subject to the delivery of such items and the satisfaction or
waiver of such conditions at the Closing), at 10:00 a.m.,
local time, at the offices of Oppenheimer, Wolff & Donnelly
LLP, 45 South Seventh Street, Suite 3400, Minneapolis,
Minnesota 55402, unless another time, date, place or manner (e.g.,
by facsimile exchange of signature pages with originals to follow
by overnight delivery) is agreed to by the parties hereto. The
parties will use commercially reasonable efforts to consummate the
Closing as soon as the closing conditions in Articles 5 and 6 are
satisfied or waived; provided , however , that in no
event shall the Closing occur later than the Termination Date. If
the Closing has not occurred by the fiftieth (50
th
) day after the Company
has delivered a right of first refusal notice to Conceptus pursuant
to Section 5.1 of the Settlement and License Agreement, Parent
shall advance the Company an additional $300,000 on the fifty-first
(51 st ) day to cover the costs and
expenses of the Company’s operations through Closing (the
“ Supplemental Advance ”).
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1.4
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Effects of the Merger
. The Merger shall have
the effects set forth in the DGCL. Without limiting the generality
of the foregoing and subject thereto, at the Effective Time all the
properties, rights, privileges, powers and franchises of the
Company and Merger Subsidiary shall vest in the Surviving
Corporation and all debts, liabilities and duties of the Company
and Merger Subsidiary shall become the debts, liabilities and
duties of the Surviving Corporation.
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1.5
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Certificate of Incorporation of the
Surviving Corporation . The form of Certificate of
Incorporation of Merger Subsidiary, as amended, attached hereto as
Exhibit B , shall be the Certificate of Incorporation
of the Surviving Corporation until thereafter further amended in
accordance with Applicable Law, except that the name of the
Surviving Corporation shall be Ovion Inc.
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1.6
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Bylaws of the Surviving
Corporation .
The Bylaws of Merger Subsidiary as in effect immediately prior to
the Effective Time shall be the Bylaws of the Surviving Corporation
until thereafter amended in accordance with Applicable Law, except
that the name of the Surviving Corporation shall be Ovion
Inc.
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1.7
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Directors and Officers of the
Surviving Corporation . The directors and officers of
Merger Subsidiary immediately prior to the Effective Time shall be
the directors and officers respectively, of the Surviving
Corporation until their respective successors shall be duly elected
and qualified.
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2
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1.8
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Initial Merger
Consideration . Subject to Section 1.11
(Dissenting Shares) and Section 8.6 (Right of Set-Off), Parent
shall pay for all of the Company Common Stock, Company Preferred
Stock, Company Stock Options and Company Warrants issued and
outstanding immediately prior to the Effective Time the
consideration set forth in this Section 1.8 as
follows:
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(a)
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Parent shall advance Three Hundred
Thousand Dollars ($300,000) as a third loan to fund the ongoing
operation of the Company (the “ Third Loan ”
and, together with the First Loan and the Second Loan, the “
Loans ”) upon execution of this Agreement, unless
Parent has previously advanced the Third Loan to the
Company.
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(b)
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At
Closing, Parent shall pay Ten Million Dollars ($10,000,000) (the
“ Initial Payment ”), plus or minus, as the case
may be, the Purchase Price Adjustment, if any (as defined in
section 1.8(c)) (as so adjusted, the “ Initial Merger
Consideration ”), which shall be paid by Parent to the
Persons and in the amounts as follows: (x) One Million Dollars
($1,000,000) (the “ Escrow Funds ”) to the
Escrow Agent to be held in escrow to secure any indemnification
obligation of the Stockholders under Section 8.2; (y) Two
Hundred Eighty Thousand Five Hundred Dollars ($280,500), in the
aggregate, to the persons and in the amounts as set forth in
Section 2.5 of the Disclosure Schedule, in partial repayment
of the Bridge Loans; and (z) the balance of the Initial Merger
Consideration, less any withholding described in 4.11(g), in
accordance with the terms of the Payment Agreement (such balance
payable to the Stockholders at Closing is sometimes referred to
herein as the “ Net Initial Merger Consideration
”). The Escrow Funds shall not be distributed to the
Stockholders until twelve (12) months after the Effective Time
and shall only be distributed in accordance with the terms and
conditions of the Escrow Agreement. In the event that Parent shall
have perfected, prior to the expiration of such twelve- (12-) month
period, a claim for indemnification pursuant to Section 8.4,
the Stockholders’ Representative and the Parent shall
endeavor in good faith to determine a reasonable estimate of the
maximum amount of such claim and shall instruct the Escrow Agent to
deliver any excess amount of Escrow Funds to the Payment Agent for
distribution to the Stockholders in accordance with the Escrow
Agreement.
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(c)
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The
Initial Payment shall be adjusted (the “ Purchase Price
Adjustment ”) as follows: (A) decreased by
(i) the amount of the Loans; (ii) the amount of
consideration that would have been payable to Dissenting
Stockholders (as defined below) if they had not perfected their
rights as Dissenting Stockholders; (iii) the amount, if any,
by which Transaction Expenses exceed $150,000; (iv) any
amounts paid prior to Closing in settlement of the Musket
Litigation; (v) the Supplemental Advance, if any; and
(vi) the aggregate amount of the employee bonuses payable at
Closing, as set forth in Section 2.8(j) of the Disclosure
Schedule; and (B) increased by (i) the Closing Capital
and (ii) that portion of the Supplemental Advance, if any,
that the Company spends on operations in the ordinary course of
business, consistent in nature and amount with past practice, after
having spent all other cash resources available to the Company
following
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3
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advancement by Parent of the Third
Loan. “ Closing Capital ” shall mean the amount
of cash on hand as of the Closing, excluding amounts received from
the exercise of options and warrants, if any; provided ,
however , that the Company continues to pay its liabilities
and make cash disbursements through the Closing in the ordinary
course of business, consistent in timing, nature and amount with
past practice.
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(d)
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Not
less than three (3) business days prior to the Closing, the
Company shall prepare and deliver to Parent a good faith written
estimate of the Initial Merger Consideration, setting forth, in
reasonable detail, a calculation of the estimated: (i) Purchase
Price Adjustment, including estimated Transaction Expenses; and
(ii) Closing Capital.
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1.9
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Contingent Merger
Consideration . As additional consideration for
the Merger and subject to the conditions set forth in this
Section 1.9, Section 1.11 (Dissenting Shares),
Section 4.11(g) (Tax Withholding) and Section 8.6 (Right
of Set-Off), Parent shall make the following additional payments
(collectively, the “ Contingent Merger Consideration
” and, together with the Initial Merger Consideration, the
“ Merger Consideration ”) to the Payment Agent
for distribution to those Stockholders who are not otherwise
Dissenting Stockholders:
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(a)
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If
the Company or Parent (i) receives IDE approval from the U.S.
Food and Drug Administration (the “ FDA ”) to
conduct a clinical trial of the Product, and (ii) commences an
FDA-approved pivotal clinical trial with respect to the Product as
demonstrated by the first successful placement of the Product in
both ostia using flexible hysteroscopy (the “ Clinical
Trial ”) (the “ First Milestone ”),
Parent shall pay an additional Five Million Dollars ($5,000,000),
less (i) the Legal Advance Funds, if any, advanced to the
Company pursuant to Section 4.12, (ii) the amounts owed
under the Bridge Loans on the First Milestone within fifteen
(15) days of completing the First Milestone and (iii) the
aggregate amount of the employee bonuses payable at the First
Milestone, as set forth in Section 2.8(j) of the Disclosure
Schedule;
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(b)
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If
the Company or Parent completes enrollment of and placement of the
Product in the minimum number of patients in the Clinical Trial
required for a PMA submission (the “ Second Milestone
”), Parent shall pay an additional Five Million Dollars
($5,000,000), less (i) the amounts owed under the Bridge Loans
on the Second Milestone within fifteen (15) days of completing
the Second Milestone and (ii) the aggregate amount of the
employee bonuses payable at the Second Milestone, as set forth in
Section 2.8(j) of the Disclosure Schedule;
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(c)
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If
the Company or Parent receives PMA approval, including but not
limited to final labeling, from the FDA to market the Product for
female sterilization (the “ Third Milestone ”
and the date such approval is received, the “ PMA-Approval
Date ”), Parent shall pay an additional Ten Million
Dollars ($10,000,000) within fifteen (15) days of completing
the Third Milestone; and
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4
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(d)
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After the Third Milestone is
successfully completed, Parent will pay an amount equal to one
times Net Sales of the Product for the twelve- (12-) month period
(the “ Final Contingent Payment ” and, together
with the First Milestone, the Second Milestone and the Third
Milestone, the “ Milestones ”) beginning on the
later of: (A) the first fiscal quarter of Parent commencing
more than six (6) months after the PMA-Approval Date or
(B) January 1, 2008 (in either case, the “
Contingent Period ”).
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(i)
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If
one or more of the Interference Requests have resulted in the U.S.
Patent and Trademark Office declaring an interference that is
pending at the end of the Contingent Period, Parent may pay all or
a portion of the Final Contingent Payment, if any, to the Escrow
Agent in an amount not to exceed the Maximum Interference
Liability, minus any amounts previously set-off with respect to one
or more of the Interference Requests (the “ Additional
Escrow Funds ”) until final resolution of such
interference.
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(ii)
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In
the event of a catastrophic event, such as a war, terrorist attack,
tornado, earthquake, or similar extraordinary event, or an FDA
inspection, shutdown, or recall that causes the manufacturing of
the Product to be suspended for five days or more and such
suspension results in Parent being unable to fill orders for the
Product, the Contingent Period shall be extended for the period of
time that Parent is unable to fill orders for the
Product.
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(e)
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Parent shall deliver to the
Stockholders’ Representative, no later than sixty
(60) days following the last day of the Contingent Period, a
statement with reasonable detail reflecting Parent’s
calculation of Net Sales for the Contingent Period (the “
Contingent Calculation ”). The Stockholders’
Representative shall not distribute these statements to any Person
other than such advisors and consultants as may be necessary to
assist the Stockholders’ Representative in reviewing the
Contingent Calculation and any accompanying information. The
Contingent Calculation will be deemed to be accepted by the
Stockholders’ Representative and shall be conclusive for
purposes of determining the Contingent Calculation, unless the
Stockholders’ Representative shall have delivered to Parent
within fifteen (15) days following delivery of the Contingent
Calculation a written statement objecting to any of the information
contained in the Contingent Calculation, specifying in reasonable
detail the amount in dispute and accompanied by detailed schedules
and work papers providing reasonable support for such
determination. With respect to any undisputed portion of the
Contingent Calculation (the “ Undisputed Contingent
Amount ”), Parent shall pay fifty percent (50%) of such
Undisputed Contingent Amount (the “ Initial Contingent
Payment Amount ”) to the Payment Agent for distribution
to the Stockholders pursuant to Section 1.9(g).
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(f)
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The
Stockholders’ Representative may cause an audit to be made of
those books and records of Parent and the Surviving Corporation
that are reasonably necessary
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to
review and audit the information delivered pursuant to
Section 1.9(e) and created in connection with the Contingent
Calculation. Any such audit shall be conducted only by an
independent certified accountant selected by the
Stockholders’ Representative and reasonably acceptable to
Parent, after prior written notice to Parent, and shall be
conducted during regular business hours at Parent’s offices
and in such a manner so as not to interfere with Parent’s
normal business activities. Parent agrees to permit such
accountants, during normal business hours, to have reasonable
access to, and to examine and make copies of, those books and
records of Parent and the Surviving Corporation that are reasonably
necessary to review and audit the Contingent Calculation. Neither
the Stockholders’ Representative nor such auditors will have
the right to review or audit any other books and records of Parent.
In no event shall more than one audit be conducted, nor shall the
records supporting any statements be audited more than once for the
same purpose. In the event any such audit reveals any discrepancy
less than five percent (5%) of the Net Sales for the period
audited, the Stockholders shall pay for the reasonable third party
costs and expenses of such audit. In the event any such audit
reveals any discrepancy greater than or equal to five percent (5%)
of the Net Sales for the period audited, Parent shall pay for the
reasonable third party costs and expenses of such audit. The
determination of the auditors with respect to the Contingent
Calculation (the “ Final Contingent Calculation
”) shall be final and binding upon the parties
hereto.
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(g)
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Subject to Section 8.6, within
fifteen (15) days following final determination of the
Contingent Calculation pursuant to Section 1.9(e) or 1.9(f),
Parent shall pay to the Payment Agent for distribution to the
Stockholders an amount equal to either (i) the Contingent
Calculation, in the case in which no dispute has arisen in
connection with the Contingent Calculation or (ii) the amount
obtained by subtracting (A) the Initial Contingent Payment
Amount from (B) the Final Contingent Calculation.
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1.10
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Cancellation and Conversion of
Company Securities at the Effective Time . On or prior to Closing, all
outstanding shares of Company Preferred Stock shall be converted
into Company Common Stock in accordance with the Company’s
Certificate of Incorporation and Applicable Law. As of the
Effective Time, by virtue of the Merger and without any action on
the part of any holder of any share of capital stock of the Company
or Merger Subsidiary:
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(a)
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Subject to the terms and conditions
hereof, each share of Company Common Stock issued and outstanding
immediately prior to the Effective Time (other than
(i) Company Common Stock held in the Company’s treasury,
(ii) Company Common Stock held at the Effective Time by
Parent, Merger Subsidiary or any Affiliate of Parent, and (iii)
Dissenting Shares) shall automatically be converted into the right
to receive Merger Consideration in cash, payable to the holders
thereof upon surrender of the Certificates (as defined in
Section 1.12(a) below) in accordance with their Percentage
Interest, as set forth in Schedule 1.10 .
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(b)
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Each Company Stock Option and each
Company Warrant that is outstanding immediately prior to the
Effective Time, whether or not vested or exercisable, shall,
effective immediately prior to the Effective Time, be cancelled and
the holder of such Company Stock Option or Company Warrant, as
applicable, shall have the right to receive the Merger
Consideration minus the exercise price for such Company Stock
Option or Company Warrant, that is due such holder based on the
number of shares vested or exercisable as of the Effective Time, in
accordance with their Percentage Interest, as set forth in
Schedule 1.10 . Except as otherwise agreed to in
writing by the parties hereto, the Company Stock Option Plans and
any other plan, program or arrangement providing for the issuance
or grant of any interest in respect of the capital stock of the
Company shall terminate as of the Effective Time, and the Company
shall ensure that following the Effective Time no holder of a
Company Stock Option or Company Warrant shall have any right
thereunder to acquire any equity securities of the Company, Parent
or Merger Subsidiary.
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(c)
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Each share of the common stock, par
value $.01 per share, of Merger Subsidiary (“ Merger
Subsidiary Common Stock ”), issued and outstanding at the
Effective Time of the Merger shall be converted into one
(1) share of common stock, par value $0.01 per share, of the
Surviving Corporation (“ Surviving Corporation Common
Stock ”).
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(d)
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Each share of Company Common Stock
held in the treasury of the Company and each share of Company
Common Stock held by Parent, Merger Subsidiary or any Affiliate of
Parent, Merger Subsidiary or the Company immediately prior to the
Effective Time will, by virtue of the Merger and without any action
on the part of Merger Subsidiary, the Company or the holder
thereof, be canceled, retired and cease to exist without payment of
any consideration therefore and without any conversion
thereof.
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(e)
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At
least three days prior to Closing, the Company shall prepare and
deliver to Parent Schedule 1.10 .
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(a)
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Notwithstanding any provision of
this Agreement to the contrary, any shares of Company Capital Stock
issued and outstanding immediately prior to the Effective Time that
are held by any holder of shares of Company Capital Stock that has
not voted in favor of the Merger (if entitled to vote) and has
properly exercised and perfected appraisal rights in accordance
with either Section 262 et. seq. of the DGCL or Section 1300
et seq. of the California Corporations Code (the “ CCC
”) (such holders are referred to as “ Dissenting
Stockholders ” and such shares are referred to as “
Dissenting Shares ”) will not be converted into the
right to receive the Merger Consideration, but will become entitled
to the right to receive such consideration as may be determined to
be due to the holders of such Dissenting Shares pursuant to the
DGCL or the CCC); provided , however , that any
holder of Dissenting Shares who will have failed to perfect or who
effectively will have
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withdrawn or lost such rights of
appraisal under the DGCL or the CCC will forfeit the right to
appraisal of such shares of Company Capital Stock, and such shares
of Company Capital Stock will no longer be Dissenting Shares and,
as of the Effective Time, will be deemed to have been converted
into the right to receive the Merger Consideration.
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(b)
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The
Company will give Parent and Merger Subsidiary prompt notice of any
written demands for appraisal, withdrawals of demands for appraisal
and any other related instruments received by the Company and,
Parent will have the right to participate in all negotiations and
proceedings with respect to such demands. Prior to the Effective
Time, the Company will not, except with the prior written consent
of Parent, which consent shall not be unreasonably withheld,
delayed or conditioned, make any payment with respect to, or settle
or offer to settle, any such demands. Notwithstanding anything to
the contrary in this Section 1.11 if (i) the Merger is
terminated, rescinded or abandoned or (ii) if the Stockholders
revoke the authority to effect the Merger, then the right of any
Stockholder to be paid the fair value of such Stockholder’s
shares of Company Capital Stock will cease. The Surviving
Corporation will comply with all obligations of the DGCL and CCC
with respect to Dissenting Stockholders.
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1.12
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Escrow Procedure; Exchange of
Certificates .
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(a)
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U.S. Bank National Association or
such other bank as the parties may agree shall act as the payment
agent (in such capacity, the “ Payment Agent ”),
pursuant to a payment agreement to be entered into between the
Company and the Payment Agent (the “ Payment Agreement
”), and escrow agent (in such capacity, the “ Escrow
Agent ”), pursuant to the Escrow Agreement, for the
benefit of the holders of Company Common Stock and Company
Preferred Stock for the purpose of paying the Merger Consideration
upon surrender of certificates which immediately prior to the
Effective Time represented Company Common Stock or Company
Preferred Stock (in either case, the “ Certificates
”).
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(b)
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At
the Closing, Parent shall deposit, or shall cause to be deposited,
with the Payment Agent pursuant to the Payment Agreement, for the
benefit of the Stockholders, cash in U.S. dollars in an amount
equal to the Net Initial Merger Consideration.
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(c)
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To
the extent that sums are released by the Payment Agent or the
Escrow Agent to the Stockholders or the Parent in accordance with
this Agreement or the Escrow Agreement, any accumulated interest
shall be distributed in accordance with the Payment Agreement or
the Escrow Agreement, as the case may be.
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(d)
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As
soon as reasonably practicable after the Effective Time, the
Payment Agent shall mail to each holder of record of Certificates:
(i) a letter of transmittal (which shall specify that delivery
shall be effected, and risk of loss and title to the Certificates
shall pass, only upon delivery of the Certificates to the Payment
Agent and shall be in such form and have such other provisions as
Parent and the
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8
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Company may reasonably specify) and
(ii) instructions for use in effecting the surrender of the
Certificates in exchange for a cash payment of the proper Merger
Consideration when and if it becomes payable under this Agreement.
Upon surrender of a Certificate for cancellation to the Payment
Agent, together with such letter of transmittal, duly executed, the
holder of such Certificate shall be entitled to receive in exchange
therefor by check or wire transfer, as the case may be, an amount
equal to the proper Merger Consideration when and if it becomes
payable under this Agreement, and the Certificate so surrendered
shall forthwith be canceled. No interest shall be paid or accrued
on any Merger Consideration upon the surrender of any Certificates.
In the event of a transfer of ownership of Company Common Stock or
Company Preferred Stock which is not registered in the transfer
records of the Company, payment of the proper Merger Consideration
when and if it becomes payable under this Agreement may be paid to
a transferee if the Certificate representing such Company Common
Stock or Company Preferred Stock, as applicable, is presented to
the Payment Agent, accompanied by all documents that the Payment
Agent may require to evidence and effect such transfer and by
evidence that any applicable stock transfer or other taxes required
as a result of such payment to a Person other than the registered
holder of such shares have been paid. Until surrendered and
exchanged as contemplated by this Section 1.12, each
Certificate shall be deemed at any time after the Effective Time to
represent only the right to receive upon such surrender an amount
equal to the proper Merger Consideration when and if it becomes
payable under this Agreement.
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(e)
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In
the event that any Certificate shall have been lost, stolen or
destroyed, the Payment Agent will, upon the making of an affidavit
of that fact by the holder claiming such Certificate to have been
lost, stolen or destroyed, pay the proper Merger Consideration as
would be required pursuant to this Agreement but for the failure to
deliver such Certificate to the Payment Agent; provided ,
however , that the Surviving Corporation may, in its
discretion and as a condition precedent to the issuance thereof,
require the owner of such lost, stolen or destroyed Certificate to
deliver a bond in such sum as it may reasonably direct as indemnity
against any claim that may be made against the Surviving
Corporation with respect to the Certificate alleged to have been
lost, stolen or destroyed.
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(f)
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The
Merger Consideration paid upon the surrender of Certificates for
exchange of Company Common Stock and Company Preferred Stock in
accordance with the terms hereof shall be deemed to have been paid
in full satisfaction of all rights pertaining to such Company
Common Stock and Company Preferred Stock. After the Effective Time,
there shall be no further registration of transfers on the stock
transfer books of the Surviving Corporation of the Company Common
Stock or Company Preferred Stock that were outstanding immediately
prior to the Effective Time. If, after the Effective Time,
Certificates are presented to the Surviving Corporation for any
reason, they shall be canceled and exchanged as provided in this
Article 1, except as otherwise provided by Applicable
Law.
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9
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(g)
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Notwithstanding
Section 1.12(d), neither the Surviving Corporation nor Parent
shall be liable to any holder of Company Common Stock or Company
Preferred Stock for any Merger Consideration delivered to a public
official pursuant to any applicable abandoned property, escheat or
similar law.
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(h)
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To
the extent permitted by Applicable Law, any amounts of Merger
Consideration, including any Escrow Funds, Additional Escrow Funds
and any Set-Off Amounts pursuant to Section 8.6, remaining
unclaimed by any holder of Company Common Stock or Company
Preferred Stock at the time the Escrow Agreement and Payment
Agreement are terminated in accordance with their respective terms
(or such earlier date immediately prior to such time as such
amounts would otherwise escheat to or become property of any
governmental entity) shall be delivered to Parent and shall become
the property of the Parent, subject to the rights of any such
Stockholder to claim such amounts from Parent.
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ARTICLE 2
REPRESENTATIONS AND WARRANTIES OF THE COMPANY AND THE PRINCIPAL
STOCKHOLDERS
As
a material inducement to Parent and Merger Subsidiary to enter into
this Agreement, with the understanding that Parent and Merger
Subsidiary will be relying thereon in consummating the transactions
contemplated hereunder, the Company and the Principal Stockholders,
jointly and severally, hereby represent and warrant to Parent and
Merger Subsidiary that except as set forth in the Disclosure
Schedule delivered by the Company to Parent and Merger Subsidiary
on the date hereof (the “ Disclosure Schedule ”)
the statements contained in this Article 2 are true and
correct. The Disclosure Schedule is arranged in sections
corresponding to the sections and subsections of this
Article 2, and disclosure in one section of the Disclosure
Schedule shall constitute disclosure for all sections of the
Disclosure Schedule only to the extent to which the applicability
of such disclosure is reasonably apparent.
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2.1
|
Corporate Organization and
Power . The
Company is a corporation duly organized, validly existing and in
good standing under the laws of its jurisdiction of incorporation,
and has all requisite corporate power and authority, and all
governmental licenses, governmental authorizations, governmental
consents and governmental approvals, required to carry on its
business as now conducted and to own, lease and operate the assets
and properties of the Company as now owned, leased and operated,
except for any such governmental licenses, governmental
authorizations, governmental consents and governmental approvals
the failure to have would not have a Material Adverse Effect on the
Company. The Company is duly qualified or licensed to do business
as a foreign corporation and is in good standing in every
jurisdiction in which the character or location of its properties
and assets owned, leased or operated by the Company or the nature
of the business conducted by the Company requires such
qualification or licensing, except where the failure to be so
qualified, licensed or in good standing in such other jurisdiction
would not, individually or in the aggregate, have a Material
Adverse Effect on the Company. The Company has heretofore delivered
to Parent complete and accurate copies of its Certificate of
Incorporation and Bylaws, as currently in effect. The
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Disclosure Schedule contains a list
of all jurisdictions in which the Company is qualified or licensed
to do business.
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2.2
|
Subsidiaries . The Company does not have and has
never had any subsidiaries. The Company does not own or control or
have any capital, equity, partnership, participation or other
ownership interest in any corporation, partnership, joint venture
or other business association or entity.
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2.3
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Authorization
. The Company has the
full corporate power and authority to enter into this Agreement
and, subject to obtaining the necessary approval of its
stockholders with respect to the Merger, to carry out the
transactions contemplated herein. The Board of Directors of the
Company have taken, and prior to the Closing the Stockholders will
have taken, all action required by law, the Company’s
Certificate of Incorporation and Bylaws and otherwise to duly and
validly authorize and approve the execution, delivery and
performance by the Company of this Agreement and the consummation
by the Company of the transactions contemplated herein and no other
corporate proceedings on the part of the Company are, or will be,
necessary to authorize this Agreement or to consummate the
transactions contemplated hereby. The affirmative vote of holders
of at least: (a) a majority of the outstanding
shares
of Company Capital Stock, voting together as a class; (b) a
majority of the outstanding
shares
of Company Preferred Stock, voting separately as a class, and
(c) a majority of the outstanding shares of Company Common
Stock, voting separately as a class, are the only votes of the
holders of any class or series of the Company’s capital stock
necessary to approve and adopt this Agreement and to consummate the
Merger. This Agreement has been, and the agreements, if any,
required by Article 5 will be, duly and validly executed and
delivered by the Company and constitutes the legal, valid and
binding obligations of the Company, enforceable against it in
accordance with their terms, subject to laws of general application
relating to bankruptcy, insolvency, reorganization, moratorium or
other similar laws affecting creditors’ rights generally and
rules of law governing specific performance, injunctive relief or
other equitable remedies.
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2.4
|
Capitalization of the
Company . The
authorized capital stock of the Company consists of
(a) 15,000,000 shares of Company Common Stock, 3,140,955
shares of which are issued and outstanding; and (b) 5,000,000
shares of Company Preferred Stock, 321,795 shares of which are
issued and outstanding and convertible into 321,795 shares of
Company Common Stock. All of the issued and outstanding shares of
Company Capital Stock are duly authorized, validly issued, fully
paid, nonassessable and free of preemptive rights. All issued and
outstanding
shares
of Company Capital Stock are owned (of record) solely by the
Stockholders in the exact amounts as set forth in the Disclosure
Schedule. There are 500,000 shares of Company Common Stock reserved
for future issuance pursuant to Company Stock Plans, including
347,500 shares subject to outstanding Company Stock Options, and
106,983 shares of Company Preferred Stock subject to outstanding
Company Warrants. There are no other outstanding (w) shares of
capital stock or other voting securities of the Company,
(x) securities of the Company convertible into or exchangeable
for shares of capital stock or voting securities of the Company,
(y) options, warrants, conversion privileges, contracts,
understandings, agreements or other rights to purchase or acquire
from the Company, and, no obligations of the Company to issue,
any
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11
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capital stock, voting securities or
securities convertible into or exchangeable for capital stock or
voting securities of the Company, and (z) equity equivalent
interests in the ownership or earnings of the Company or other
similar rights (collectively, “ Company Securities
”). There are no outstanding obligations of the Company to
repurchase, redeem or otherwise acquire any Company Securities.
Except as contemplated under Section 2.35, there are no
stockholder agreements, voting trusts or other agreements or
understandings to which the Company is a party or by which it is
bound relating to the voting or registration of any shares of
capital stock of the Company.
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2.5
|
Non-Contravention
. Neither the execution,
delivery and performance by the Company of this Agreement nor the
consummation of the transactions contemplated herein will (a)
contravene or conflict with the Certificate of Incorporation or
Bylaws of the Company, (b) contravene or conflict with or
constitute a violation of any provision of any Applicable Law
binding upon or applicable to the Company, or any of the
Company’s assets; (c) result in the creation or
imposition of any Lien on any of the Company’s assets, other
than Permitted Liens or (d) be in conflict with, constitute
(with or without due notice or lapse of time or both) a default
under, result in the loss of any material benefit under, or give
rise to any right of termination, cancellation, increased payments
or acceleration under any terms, conditions or provisions of any
note, bond, lease, mortgage, indenture, license, contract,
franchise, permit, instrument or other agreement or obligation to
which the Company is a party, or by which any of their respective
properties or assets may be bound, except in the case of clause
(b) where such conflicts or other occurrences could not
reasonably be expected to have, individually or in the aggregate, a
Material Adverse Effect.
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2.6
|
Consents and Approvals
. No consent, approval,
order or authorization of or from, or registration, notification,
declaration or filing with (hereinafter sometimes separately
referred to as a “ Consent ” and sometimes
collectively as “ Consents ”) any individual or
entity, including without limitation any Governmental Authority or
Person, is required in connection with the execution, delivery or
performance of this Agreement by the Company or the consummation by
the Company of the transactions contemplated herein, other than the
requirements of the DGCL for filing of appropriate documents to
effect the Merger. The Company is the “acquired person”
within the meaning of Rule 801.2(b) promulgated pursuant to
the HSR Act and does not within the meaning of Rule 801.1 of
the HSR Act directly or indirectly control (as defined in
Rule 801.1(b)) any entities, trusts, partnerships or other
business organizations. The Company had total assets as of the date
of its last regularly prepared balance sheet (as determined in
accordance with Rule 801.11 of the HSR Act) of less than Ten
Million Seven Hundred Thousand Dollars ($10,700,000) and annual net
sales for its most recent fiscal year (as determined in accordance
with Rule 801.11 of the HSR Act) of less than Ten Million
Seven Hundred Thousand Dollars ($10,700,000). There are no facts
relating to the identity or circumstances of the Company that would
prevent or materially delay obtaining any of the
Consents.
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12
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2.7
|
Financial Statements; Undisclosed
Liabilities.
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(a)
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The
Company has delivered to Parent true, correct and complete copies
of the unaudited balance sheet, as of April 30, 2005 of the
Company (the “ Latest Balance Sheet ”) and the
unaudited statements of income, stockholders’ equity and cash
flows of the Company for the three-month period ended
April 30, 2005 (such statements of income, stockholders’
equity and cash flows and the Latest Balance Sheet being herein
referred to as the “ Latest Financial Statements
”). The Latest Financial Statements are based upon the
information contained in the books and records of the Company and
fairly and accurately present the financial condition of the
Company as of the dates thereof and results of operations for the
periods referred to therein. The Latest Financial Statements have
been prepared in accordance with the income tax basis of accounting
consistently applied.
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(b)
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All
accounts, books and ledgers related to the business of the Company
are properly and accurately kept, are complete in all material
respects, and there are no material inaccuracies or discrepancies
of any kind contained or reflected therein. The Company does not
have any of its records, systems, controls, data, or information
recorded, stored, maintained, operated or otherwise wholly or
partly dependent upon or held by any means (including any
electronic, mechanical or photographic process, whether
computerized or not) which (including all means of access thereto
and therefrom) are not under the exclusive ownership (excluding
licensed software programs) and direct control of the
Company.
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(c)
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Except as and to the extent
reflected in the Latest Balance Sheet, the Company has no
liabilities or obligations (whether accrued, absolute, contingent,
unliquidated or otherwise, whether due or to become due, whether
known or unknown, and regardless of when asserted) arising out of
transactions or events heretofore entered into, or any action or
inaction, or any state of facts existing, with respect to or based
upon transactions or events heretofore occurring, except
liabilities of not more than $150,000 in the aggregate that have
arisen after the date of the Latest Balance Sheet in the ordinary
course of business, consistent with past custom and practice (none
of which is a liability for breach of contract, breach of warranty,
violation of Applicable Law, tort, infringement, claim or
lawsuit).
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2.8
|
Absence of Certain
Changes .
Except as otherwise authorized by this Agreement, since
December 31, 2004, the Company has owned and operated its
assets, properties and businesses in the ordinary course of
business and consistent with past practice and there has not
been:
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(a)
|
any
change, effect, event, occurrence, state of facts or development
that individually or in the aggregate, has had or could reasonably
be expected to have a Material Adverse Effect;
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13
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(b)
|
any
declaration, setting aside or payment of any dividend or other
distribution with respect to any shares of capital stock of the
Company, or any repurchase, redemption or other acquisition by the
Company (other than any wholly-owned subsidiary) of any outstanding
shares of capital stock or other equity or debt securities of, or
other ownership interests in, the Company;
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(c)
|
any
split, combination or reclassification of any of its capital
stock;
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(d)
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any
amendment of any provision of the Certificate of Incorporation,
Bylaws or other governing documents of, or of any material term of
any outstanding security issued by, the Company;
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(e)
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any
incurrence, assumption or guarantee by the Company of any
indebtedness for borrowed money;
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(f)
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any
change in any method of accounting or accounting practice by the
Company;
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(g)
|
issuance of any equity or debt
securities of the Company other than pursuant to the Company Stock
Option Plans, Company Stock Options or Company Warrants in the
ordinary course of business and consistent with past
practice;
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(h)
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acquisition or disposition of assets
material to the Company, taken as a whole, except for sales of
inventory in the ordinary course of business consistent with past
practice, any acquisition or disposition of capital stock of any
third party, or any merger or consolidation with any third party,
by the Company;
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(i)
|
any
creation or assumption by the Company of any Lien except for
Permitted Liens;
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(j)
|
any
individual capital expenditure (or series of related capital
expenditures) either involving more than Ten Thousand Dollars
($10,000) or outside the ordinary course of business;
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(k)
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any
material damage, destruction or loss (whether or not covered by
insurance) from fire or other casualty to its tangible
property;
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(l)
|
any
material increase in the base salary of any officer or employee of
the Company;
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(m)
|
any
adoption, amendment, modification, or termination of any bonus,
profit-sharing, incentive, severance or other similar plan for the
benefit of any of its directors, officers or employees except as
required by Applicable Law;
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(n)
|
entry by the Company into any joint
venture, partnership or similar agreement with any
person;
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(o)
|
any
filing of any amended Tax Return, settlement of any Tax claim or
assessment relating to the Company, payment of any estimated Taxes
in excess of $10,000,
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14
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change in method of Tax accounting,
or consent to the extension or waiver of the limitations period
applicable to any claim or assessment with respect to Taxes;
or
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(p)
|
any
authorization of, or commitment or agreement to take any of, the
foregoing actions except as otherwise permitted by this
Agreement.
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2.9
|
Assets and Properties
.
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(a)
|
The
Company has good and valid right, title and interest in and to or,
in the case of leased properties or properties held under license,
good and valid leasehold or license interests in, all of its assets
and properties, including, but not limited to, all of the
machinery, equipment, terminals, computers, vehicles, and all other
assets and properties (real, personal or mixed, tangible or
intangible) reflected in the Latest Balance Sheet and all of the
assets purchased or otherwise acquired since the date of the Latest
Balance Sheet, except those assets and properties disposed of in
the ordinary course of business after the date of the Latest
Balance Sheet. The Company holds title to each such property and
asset free and clear of all Liens, except Permitted
Liens.
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(b)
|
The
(i) current use and operation of all real property is in
compliance with all Applicable Laws (including without limitation
laws relating to parking, zoning and land use) and public and
private covenants and restrictions except where non-compliance
would not be reasonably likely to have a Material Adverse Effect on
the Company, (ii) Company has not received written notice of
noncompliance with any Applicable Laws and (iii) utilities,
access and parking, if any, for each such real property are
adequate for the current use and operation of each such real
property. There are no zoning, building code, occupancy restriction
or other land-use regulation proceedings or any proposed change in
any Applicable Laws, which could materially detrimentally affect
the use or operation by the Company of any real property, nor has
the Company received any written notice of any special assessment
proceedings affecting the real property, or applied for any change
to the zoning or land use status of the real property. The Company
has obtained all licenses, permits, approvals, easements and rights
of way (and all such items are currently in full force and effect)
required from any Governmental Authority having jurisdiction over
each real property or from private parties for the current use and
operation of each real property except where the failure to obtain
such licenses, permits, approvals, easements and rights of way
would not be reasonably likely to have a Material Adverse Effect on
the Company. Neither the Company, nor any Subsidiary is a foreign
person, as the term foreign person is defined in Section 1445(f)(3)
of the Code.
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2.10
|
Manufacturing and Marketing
Rights . The
Company has not granted rights to manufacture, produce, assemble,
license, market, or sell the Product to any other person and is not
bound by any agreement that affects the Company’s exclusive
right to develop, manufacture, assemble, distribute, market or sell
the Product.
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15
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2.11
|
FDA and Regulatory
Matters .
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(a)
|
The
Company has obtained all necessary and applicable approvals,
clearances, authorizations, licenses and registrations required by
United States or foreign governments or government agencies, to
permit the design, development, pre-clinical and clinical testing,
manufacture, labeling, and distribution of its products in
jurisdictions where it currently conducts such activities with
respect to each product, but excluding Environmental Permits which
are addressed in Section 2.22 below (collectively, the “
Company Licenses ”). The Company is in compliance in
all material respects with the terms and conditions of each Company
License. The Company is in compliance in all material respects with
all Applicable Laws regarding registration, license, certification
for each site at which a product is manufactured, labeled, or
distributed. To the extent any product has been exported from the
United States, the Company has exported such product in compliance
in all material respects with Applicable Laws. All manufacturing
operations performed by or on behalf of the Company have been and
are being conducted in all material respects in compliance with the
Quality Systems regulations of the FDA and, to the extent
applicable to the Company, counterpart regulations in the European
Union and all other countries where compliance is required. All
non-clinical laboratory studies of products sponsored by the
Company and intended to be submitted to regulatory authorities in
support of regulatory clearance or approval, have been and are
being conducted in compliance in all material respects with the
FDA’s good Laboratory Practice for Non-Clinical Studies
regulations (21 CFR Part 58) in the United States and, to the
extent applicable to the Company, counterpart regulations in the
European Union and all other countries. The Company is in
compliance in all material respects with all applicable reporting
requirements for all Company Licenses or plant registrations
including, but not limited to, applicable adverse event reporting
requirements in the United States and outside of the United States
under Applicable Law. The Disclosure Schedule sets forth a list of
all Company Licenses.
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(b)
|
The
Company is in compliance in all material respects with all FDA and
non-United States equivalent agencies and other Applicable Laws
relating to the maintenance, compilation and filing of reports,
including medical device reports, with regard to the
Company’s products. The Disclosure Schedule sets forth a list
of all applicable adverse event reports related to the Products,
including any report filed under 21 CFR §
812.150(b).
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(c)
|
Neither the Company nor any
Subsidiary has received any written notice or other written
communication from the FDA or any other Governmental Authority
alleging any violation of Applicable Law by the Company.
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(d)
|
There have been no recalls, field
notifications or seizures ordered or adverse regulatory actions
taken or, to the Company’s Knowledge, threatened by the FDA
or any other Governmental Authority with respect to any of the
Company’s products, including any facilities where any such
products are produced,
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processed, packaged or stored, and
neither the Company nor any Subsidiary has within the last three
years, either voluntarily or at the request of any Governmental
Authority, initiated or participated in a recall of any
product.
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(e)
|
The
Company and each Subsidiary have conducted all of their clinical
trials with reasonable care and in all material respects in
accordance with all Applicable Laws and the stated protocols for
such clinical trials.
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(f)
|
All
filings with and submissions to the FDA and any corollary entity in
any other jurisdiction made by the Company with regard to the
Company’s products, were true, accurate and complete in all
material respects as of the date made, and, to the extent required
to be updated, as so updated remain true, accurate and complete in
all material respects as of the date hereof, and do not materially
misstate any of the statements or information included therein, or
omit to state a material fact necessary to make the statements
therein not misleading.
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2.12
|
Reimbursement/Billing
.
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(a)
|
The
Company is neither a provider nor a supplier under Medicare,
Medicaid or any other government-sponsored health care program
(collectively, “ Government Programs ”), and
does not bill any Government Program or third party payor for its
products.
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(b)
|
There is no pending, nor to the
knowledge of Company, threatened, proceeding or investigation under
any Government Program involving the Company.
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(c)
|
To
Company’s actual knowledge, the Company has not arranged with
or contracted with (by employment or otherwise) any person who is
excluded from participation in any Government Program for the
provision of items or services for which payment may be made under
any such Government Program. None of the officers, directors, or
managing employees (as such term is defined in 42 U.S.C. §
1320a-5(b)) of the Company, has been excluded from any Government
Program or been subject to sanction pursuant to 42 U.S.C. §
1320a-7a or 1320a-8 or been convicted of a crime described at 42
U.S.C. § 1320a-7b.
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(d)
|
Neither the Company, any director,
officer or employee of the Company, nor any agent acting on behalf
of or for the benefit of any of the foregoing, has directly or
indirectly in connection with the Company: (i) offered or paid
any remuneration, in cash or in kind, to or made any financial
arrangements with, any past, present or potential customers, past
or present suppliers, patients, contractors or employees of third
party payors or Government Programs in order to obtain business or
payments from such persons other than in the ordinary course of
business; (ii) given or agreed to give, any gift or gratuitous
payment of any kind, nature or description (whether in money,
property or services) to any customer or potential customer,
supplier or potential supplier, contractor, third party payor or
any other person other than in connection with promotional or
entertainment activities in the ordinary course of business and in
compliance with the
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17
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Company’s compliance program;
or (iii) made any false entries on any of the Company’s
books or records for any purpose prohibited by Applicable
Law.
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(e)
|
Neither the Company, nor any
director, officer or employee of the Company is a party to any
contract to provide services, lease space or lease equipment to the
Company with any physician, health care facility, hospital or other
person who is in a position to make or influence referrals to the
Company where such contract or provision of services or space is
prohibited by Applicable Law.
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2.13
|
Compliance with Applicable
Laws . The
Company, and each of its officers, directors, agents and employees
have complied in all material respects with all Applicable Laws,
including, but not limited to, Applicable Laws relating to
Government Programs and to billing and health care fraud (including
the federal Anti-Kickback Law, 42 U.S.C. §1320a-7b, the Stark
I and II Laws, 42 U.S.C. §1395nn, as amended, and the False
Claims Act, 31 U.S.C. §3729 et seq . and any
regulations related thereto, as well as with any similar state
statutes). To the Company’s Knowledge, no claims have been
filed against the Company alleging a violation of any Applicable
Law. The Company is not a “covered entity” or a
“business associate” within the meaning of the HIPAA
Privacy Regulations.
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2.14
|
Government Inspections
. The Company
(i) is not a party to a Corporate Integrity Agreement with the
Office of the Inspector General of the Department of Health and
Human Services, (ii) has no reporting obligations pursuant to
any settlement agreement entered into with any governmental body,
(iii) to the Company’s Knowledge, has not been the
subject of any Government Program investigation conducted by any
governmental body, (iv) has not been a defendant in any qui
tam /False Claims Act litigation (other than by reason of an
unsealed complaint of which the Company has no knowledge), and
(v) has not been served with or received any search warrant,
subpoena, civil investigation demand, contact letter, or to the
Company’s Knowledge, telephone or personal contact by or from
any governmental body.
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2.15
|
Permits . The Disclosure Schedule sets forth
all approvals, authorizations, certificates, consents, licenses,
orders and permits and other similar authorizations of all
Governmental Authorities (and all other Persons) that are necessary
for the Company to conduct its business and own and operate its
properties, but excluding Environmental Permits which are addressed
in Section 2.22 below (the “ Permits ”).
Each Permit is valid and in full force and effect and none of the
Permits will be terminated, revoked, modified or become terminable
or impaired in any respect for any reason, except as would not have
a Material Adverse Effect on the Company. The Company has conducted
its business in compliance with all material terms and conditions
of the Permits. The term Permits shall not include any Company
License as defined in Section 2.11.
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2.16
|
Inventories . All inventories of the Company
reflected in the Latest Balance Sheet (a) to the
Company’s Knowledge, conform to the material specifications
established therefor, and (b) to the Company’s
Knowledge, have been manufactured in material compliance with all
Applicable Laws. The quantities of all inventories, materials and
supplies of the Company are not obsolete, damaged, slow-moving,
defective or excessive and the present
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18
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quantities of all inventory,
materials and supplies of the Company are reasonable in the present
circumstances of the business of the Company, as a whole, as
currently conducted, except for items that are obsolete or below
standard quality, all of which are immaterial to the overall
financial condition of the Company, taken as a whole, and have been
adequately allowed for in the Latest Balance Sheet.
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2.17
|
Litigation . There are no (a) actions,
suits, claims, hearings, arbitrations, proceedings (public or
private) or governmental investigations that have been brought by
any Governmental Authority or any other Person against the Company
or any officer, employee or director of the Company in their
capacity as such (collectively, “ Proceedings
”), nor any investigations or reviews by any Governmental
Authority against or affecting the Company, pending or, to the
Company’s Knowledge, threatened, against or by the Company or
any of their assets or which seek to enjoin or rescind the
transactions contemplated by this Agreement; and (b) existing
orders, judgments or decrees of any Governmental Authority naming
the Company as an affected party or otherwise affecting any of the
assets or the business of the Company.
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(a)
|
The
Disclosure Schedule lists the following Contracts of the Company
(collectively, the “ Scheduled Contracts
”):
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(i)
|
Each Contract providing for the
lease of real property by the Company or which is used by Company
in connection with the operation of its business.
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(ii)
|
Each Contract relating to all
machinery, tools, equipment, motor vehicles, rolling stock and
other tangible personal property (other than inventory and
supplies) owned, leased or used by the Company, except for items
having remaining payments of less than $10,000 which do not, in the
aggregate, have remaining payments of more than $25,000 or having a
remaining term of longer than six (6) months or that are not
cancelable by the Company in its discretion and without penalty
upon notice of sixty (60) days or less.
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(iii)
|
Each Contract to which the Company
is a party that would reasonably be expected to involve payments by
or to the Company in excess of $25,000, or would have a Material
Adverse Effect.
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(iv)
|
All
Contracts relating to, or evidences of, or guarantees of, or
providing security for, indebtedness or the deferred purchase price
of property (whether incurred, assumed, guaranteed or secured by
any asset).
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(v)
|
Each independent sales
representative or distribution agreement, supply agreement or
similar Contract relating to or providing for the marketing or
manufacturing of the Company’s products.
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19
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(vi)
|
Each consulting, development, joint
development, research and development, regulatory or similar
Contract relating to development of the Company’s products or
Intellectual Property and each Contract under which the Company has
granted or obtained a license to Intellectual Property, other than
commercial software licenses.
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(vii)
|
All
acquisition, partnership, joint venture, teaming arrangements or
other similar Contracts.
|
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(viii)
|
Any
Contract under which the Company has agreed not to compete or has
granted to a third party an exclusive right that restricts or
otherwise adversely affects the ability of the Company to conduct
its business.
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(ix)
|
All
Benefit Plans.
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(x)
|
All
Contracts with any “disqualified individual” (as
defined in Section 280G(c) of the Code) which contains any
severance or termination pay liabilities which would result in a
disallowance of the deduction for any “excess parachute
payment” (as defined in Section 280G(b)(l) of the Code)
under Section 280G of the Code.
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(xi)
|
Every Contract between the Company
and any of the Company’s officers, directors or more than 5%
stockholders, or any entity in which any of the Company’s
officers, directors or more than 5% stockholders has a greater than
2% equity interest.
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(xii)
|
All
Contracts for clinical or marketing trials relating to the
Company’s products and all Contracts with physicians,
hospitals or other healthcare providers, or other scientific or
medical advisors.
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(xiii)
|
All
Contracts not identified in clause (xii) which relate to the
Company’s compliance with or obligation to comply with the
requirements of the HIPAA Privacy Regulations, including without
limitation all business associate agreements, subcontractor
agreements, confidentiality agreements and similar
contracts.
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(b)
|
The
Company has delivered to Parent true and correct copies (or
summaries, in the case of any oral Contracts) of all such Scheduled
Contracts. None of the Scheduled Contracts contain a provision
requiring the consent of any party with respect to the consummation
of the transaction contemplated herein. No notice of default
arising under any Scheduled Contract has been delivered to or by
the Company. Each Scheduled Contract is a legal, valid and binding
obligation of the Company and each other party thereto, enforceable
against each such party thereto in accordance with its terms,
except as may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting
creditors’ rights generally and subject to general principles
of equity, and neither the Company, nor, to the Company’s
Knowledge, the other party thereto, is in breach, violation or
default thereunder. The Company is not a party to and is
not
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20
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bound by any contract, agreement or
instrument that currently has or would have a Material Adverse
Effect.
|
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(a)
|
None of the Company, or any other
ERISA Affiliate sponsors, maintains, contributes to, is required to
contribute to or has or could have any liability of any nature,
whether known or unknown, direct or indirect, fixed or contingent,
with respect to, any Pension Plan, including, without limitation,
any such plan that is excluded from coverage by Section 4 of
ERISA or is a “Multiemployer Plan” within the meaning
of Section 3(37) or 4001(a)(3) of ERISA. To the
Company’s Knowledge, each such Pension Plan that is a
Multiemployer Plan has been operated in all material respects in
accordance with its terms and in compliance in all material
respects with the applicable provisions of ERISA, the Code and
other Applicable Law. Each such other Pension Plan has been
operated in all material respects in accordance with its terms and
in compliance in all material respects with the applicable
provisions of ERISA, the Code and all other Applicable Law. All
Pension Plans which the Company operates as plans that are
qualified under the provisions of Section 401(a) of the Code
satisfy in form and operation all applicable qualification
requirements and has not received in the preceding seven
(7) years or committed to receive a transfer of assets and/or
liabilities or spin-off from another plan, except transfers, which
qualify as transfers from eligible rollover distributions within
the meaning of Code Section 402(c)(4). None of the Company,
any Subsidiary or any other ERISA Affiliate has sponsored,
maintained or contributed to any Pension Plan which, during the
preceding seven (7) years, has been terminated, including by
way of merger with or into another Pension Plan.
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(b)
|
No
Pension Plan is now nor has ever been “top-heavy”
pursuant to Section 416 of the Code.
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(c)
|
The
Disclosure Schedule sets forth the name of each ERISA
Affiliate.
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(d)
|
None of the Company, any Subsidiary
or any other ERISA Affiliate has or could have any liability of any
nature, whether known or unknown, direct or indirect, fixed or
contingent, to any Pension Plan, the Pension Benefit Guaranty
Corporation or any other person, arising directly or indirectly
under Title IV of ERISA other than liability pursuant to
Section 4007 for premiums which are not yet due (without
regard to any waiver). No “reportable event,” within
the meaning of Section 4043 of ERISA, has occurred with
respect to any Pension Plan subject to Title IV of ERISA. None of
the Company, any Subsidiary or any other ERISA Affiliate has ceased
operations at any facility or withdrawn from any Company Pension
Plan in a manner which could subject the Company, any Subsidiary or
any other ERISA Affiliate to liability under Section 4062(e), 4063
or 4064 of ERISA. None of the Company, any
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21
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Subsidiary or any other ERISA
Affiliate maintains, contributes to or has participated in or
agreed to participate in any Pension Plan that is a Multiemployer
Plan. None of the Company, any Subsidiary or any other ERISA
Affiliate has been a party to a sale of assets to which
Section 4204 of ERISA applied with respect to which it could
incur any withdrawal liability (including any contingent or
secondary withdrawal liability) to any Multiemployer Plan. None of
the Company, any Subsidiary or any other ERISA Affiliate has
incurred, or has experienced an event that will, within the ensuing
twelve (12) months, result in, a “complete
withdrawal” or “partial withdrawal,” as such
terms are defined respectively in Sections 4203 and 4205 of
ERISA, with respect to a Pension Plan which is a Multiemployer
Plan, and nothing has occurred that could result in such a complete
or partial withdrawal. None of the Company, any Subsidiary or any
other ERISA Affiliate has incurred a decline in contributions to
any Multiemployer Plan such that, if the current rate of
contributions continues, a seventy percent (70%) decline in
contributions (as defined in Section 4205 of ERISA) will occur
within the next three (3) plan years.
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(e)
|
None of the Company, any Subsidiary
or any other ERISA Affiliate sponsors, maintains, contributes to,
is required to contribute to, or has or could have any liability of
any nature, whether known or unknown, direct or indirect, fixed or
contingent, with respect to any Welfare Plan, whether insured or
otherwise, including, without limitation, any such plan that is a
Multiemployer Plan within the meaning of Section 3(37) of
ERISA. To the Company’s Knowledge, each such Welfare Plan
that is a Multiemployer Plan has been operated in all material
respects in accordance with its terms and in compliance in all
material respects with applicable provisions of ERISA, the Code and
other Applicable Law. Each such other Welfare Plan has been
operated in all material respects in accordance with its terms and
in compliance in all material respects with the applicable
provisions of ERISA, the Code and all other Applicable Law.
Benefits under each Welfare Plan are fully insured by an insurance
company unrelated to the Company, any Subsidiary or any other ERISA
Affiliate. No insurance policy or contract requires or permits
retroactive increase in premiums or payments due thereunder. None
of the Company, any Subsidiary or any other ERISA Affiliate has
established or contributed to, is required to contribute to or has
or could have any liability of any nature, whether known or
unknown, direct or indirect, fixed or contingent, with respect to
any “voluntary employees’ beneficiary
association” within the meaning of Section 501(c)(9) of
the Code, “welfare benefit fund” within the meaning of
Section 419 of the Code, “qualified asset account”
within the meaning of Section 419A of the Code or “multiple
employer welfare arrangement” within the meaning of
Section 3(40) of ERISA. No Welfare Plan that is a
Multiemployer Plan imposes any post-withdrawal liability or
contribution obligations upon the Company or any ERISA Affiliate.
None of the Company, any Subsidiary or any other ERISA Affiliate
maintains, contributes to or has or could have any liability of any
nature, whether known or unknown, direct or indirect, fixed or
contingent, with respect to medical, health, life or other welfare
benefits for present or future terminated employees or their
spouses or dependents other than as required by Part 6 of
Subtitle B of Title I of ERISA or any comparable state
law.
|
22
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|
(f)
|
None of the Company, any Subsidiary
or any other ERISA Affiliate is a party to, maintains, contributes
to, is required to contribute to or has or could have any liability
of any nature, whether known or unknown, direct or indirect, fixed
or contingent, with respect to any Compensation Plan. Each
Compensation Plan has been operated in all material respects in
accordance with its terms and in compliance in all material
respects with the applicable provisions of all Applicable
Law.
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(g)
|
There are no facts or circumstances
which could, directly or indirectly, subject the Company, any
Subsidiary or any other ERISA Affiliate to any (i) excise tax
or other liability under Chapters 43, 46 or 47 of Subtitle D of the
Code, (ii) penalty tax or other liability under
Chapter 68 of Subtitle F of the Code or (iii) civil
penalty, damages or other liabilities arising under
Section 502 of ERISA.
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(h)
|
Full payment has been made of all
amounts which the Company, any Subsidiary or any other ERISA
Affiliate is required, under Applicable Law, the terms of any
Benefit Plan, or any agreement relating to any Benefit Plan, to
have paid as a contribution, premium or other remittance thereto or
benefit thereunder. Each Pension Plan that is subject to the
minimum funding standards of Section 412 of the Code and/or
Section 302 of ERISA meets those standards and has not
incurred any accumulated funding deficiency within the meaning of
Section 412 or 418B of the Code or Section 302 of ERISA
and no waiver of any minimum funding requirements has been applied
for or obtained with respect to any Pension Plan. The Company, the
Subsidiaries and each other ERISA Affiliate has made adequate
provisions for reserves or accruals in accordance with GAAP to meet
contribution, benefit or funding obligations arising under
Applicable Law or the terms of any Benefit Plan or related
agreement. There will be no change on or before Closing Date in the
operation of any Benefit Plan or any documents with respect thereto
which will result in an increase in the benefit liabilities under
such Benefit Plans, except as may be required by law.
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(i)
|
The
Company and each other ERISA Affiliate has timely complied in all
material respects with all reporting and disclosure obligations
with respect to the Benefit Plans imposed by the Code, ERISA or
other Applicable Law.
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(j)
|
There are no pending or, to the
Company’s Knowledge, threatened audits, investigations,
claims, suits, grievances or other proceedings, and there are no
facts that could give rise thereto, involving, directly or
indirectly, any Benefit Plan, or any rights or benefits thereunder,
other than the ordinary and usual claims for benefits by
participants, dependents or beneficiaries.
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(k)
|
The
transactions contemplated herein do not result in any payment
(whether of severance pay or otherwise), forgiveness of debt,
distribution, increase in benefits, obligation to fund, or the
acceleration of accrual, vesting, funding or payment of any
contribution or benefit under any Benefit Plan.
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(l)
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No
employer other than the Company and/or an ERISA Affiliate is
permitted to participate or participates in the Benefit Plans. No
leased employees (as defined in Section 414(n) of the Code) or
independent contractors are eligible for, or participate in, any
Benefit Plans.
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(m)
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No
action or omission of the Company, any Subsidiary or any other
ERISA Affiliate or any director, officer, employee, or agent
thereof in any way restricts, impairs or prohibits the Parent, the
Company, any Subsidiary, any other ERISA Affiliate or any successor
from amending, merging, or terminating any Benefit Plan in
accordance with the express terms of any such plan and Applicable
Law.
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(n)
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The
Disclosure Schedule lists each Benefit Plan and the Company has
delivered to the Parent true and complete copies of all Benefit
Plan documents and related trust agreements or other agreements or
contracts evidencing any funding vehicle with respect thereto,
including all amendments. The Company has delivered to the Parent
true and complete copies of: (i) the three most recent annual
reports on Treasury Form 5500, including all schedules and
attachments thereto, with respect to any Benefit Plan for which
such a report is required; (ii) the three (3) most recent
actuarial reports with respect to any Pension Plan that is a
“defined benefit plan” within the meaning of Section
414(j) of the Code; (iii) the form of summary plan
description, including any summary of material modifications
thereto or other modifications communicated to participants,
currently in effect with respect to each Benefit Plan;
(iv) the most recent determination letter with respect to each
Pension Plan intended to qualify under Section 401(a) of the Code
and the full and complete application therefor submitted to the
Internal Revenue Service; and (v) all professional opinions,
material internal memoranda, material correspondence with
regulatory authorities and administrative policies, manuals,
interpretations and the like with respect to each Benefit
Plan.
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(o)
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The
Disclosure Schedule lists each Benefit Plan that is or may be, in
whole or in part, subject to Section 409A of the Code (each
such plan or part thereof, a “ Section 409A Benefit
Plan ”). Except as set forth in the Disclosure Schedule,
to the Company’s Knowledge: (a) each Section 409A
Benefit Plan complies in form with Section 409A of the Code,
and (b) no service provider under any Section 409A
Benefit Plan is subject to the additional income tax under
Section 409A of the Code.
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(p)
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The
Disclosure Schedule lists and the Company has delivered to the
Parent true and correct copies of the Welfare Plan documents
establishing compliance with the HIPAA Privacy Regulations,
including appointment of a privacy official, its Notice of HIPAA
Privacy Practices, privacy policies and procedures, and the plan
administrator’s group health plan document amendment
certification.
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(q)
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The
Company has properly determined and timely collected and reported
all Federal Insurance Contribution Act (“ FICA
”) taxes imposed under Sections 3101 and 3111 of the
Code on remuneration for employment that constitutes
“wages”
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within the meaning of Section
3121(a) of the Code, including amounts deferred under nonqualified
deferred compensation plans, agreements or arrangements.
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2.20
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Labor and Employment
Matters .
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(a)
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The
Disclosure Schedule sets forth a list of the current employees,
officers and directors of the Company. The Company has previously
delivered to Parent a complete and accurate list of all current
employees, officers and directors of the Company that includes
their base salaries and bonus. All employees of the Company are
employed on an “at-will” basis. The Disclosure Schedule
identifies all employees who are currently on leave for any reason
or receiving disability or workers’ compensation or any other
similar type of benefit from the Company.
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(b)
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The
Company is and has been in compliance in all material respects with
all Applicable Laws respecting employment and employment practices,
terms and conditions of employment and wages and hours, including
without limitation any such Applicable Laws respecting employment
discrimination and occupational safety and health requirements, and
has not and is not engaged in any unfair labor practice. There is
no unfair labor practice complaint against the Company pending or,
to the Company’s Knowledge, threatened before the National
Labor Relations Board or any other comparable Governmental
Authority. There is no labor strike, dispute, slowdown or stoppage
actually pending or, to the Company’s Knowledge, threatened
against or directly affecting the Company. No labor representation
question exists respecting the employees of the Company and there
is not pending or, to the Company’s Knowledge, threatened any
activity intended or likely to result in a labor representation
vote respecting the employees of the Company. No grievance or any
arbitration proceeding arising out of or under collective
bargaining agreements is pending and no claims therefor exist or,
to the Company’s Knowledge, have been threatened. No
collective bargaining agreement is binding and in force against the
Company or currently being negotiated by the Company. The Company
has not experienced any significant work stoppage or other
significant labor difficulty. The Company is not delinquent in
payments to any persons for any wages, salaries, commissions,
bonuses or other direct or indirect compensation for any services
performed by them or amounts required to be reimbursed to such
persons, including without limitation any amounts due under any
Benefit Plan. Upon termination of the employment of any person,
neither the Company, Parent nor any subsidiary of Parent will, by
reason of any agreement or understanding to which the Company is a
party, be liable to any of such persons for so-called
“severance pay” or any other payments. Within the
twelve-month period prior to the date hereof there has not been any
expression of intention to the Company by any officer or key
employee to terminate such employment.
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(c)
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All
individuals who are performing or have performed services for the
Company or any of its Affiliates and who are or were classified by
the Company or any of its Affiliates as “independent
contractors” qualify for such classification under Section
530 of the Revenue Act of 1978 or Section 1706 of the Tax
Reform Act
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of 1986, as
applicable, and such individuals are not entitled to any benefits
under the Benefit Plans maintained by the Company.
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2.21
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Intellectual Property
.
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(a)
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Except for Intellectual Property
relating to commercial off-the-shelf software, the Disclosure
Schedule lists all Intellectual Property that is registered with,
has been applied for, or has been issued by the U.S. Patent and
Trademark Office or a corresponding foreign governmental or public
authority and all Intellectual Property that: (i) is owned by,
licensed to or otherwise controlled by the Company; (ii) is
used in, developed for use in, or, to the Company’s
Knowledge, necessary to the conduct of its business as now
conducted; or (iii) has been licensed to or from third
parties. The Company has delivered or made available to Parent
complete and accurate copies of correspondence, litigation
documents, agreements, file histories and office actions relating
to the patents and patent applications listed in the Disclosure
Schedule. Each item of Intellectual Property owned or used by the
Company immediately prior to the Effective Time hereunder will be
owned or available for use by the Parent on identical terms and
conditions immediately after the Effective Time.
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(b)
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The
Company owns, free and clear of any Lien (other than Permitted
Liens), and possesses all right, title and interest, or holds a
valid license, in and to all Intellectual Property, and has taken
all reasonable action to protect the Intellectual Property. To the
Company’s Knowledge, all patents included in the Intellectual
Property are valid and enforceable. To the Company’s
Knowledge, the Intellectual Property owned or licensed by the
Company constitutes all the intellectual property necessary to the
conduct of the business of the Company as it is currently
conducted. There are no royalties, fees, honoraria or other
payments payable by the Company to any Person by reason of the
ownership, development, modification, use, license, sublicense,
sale, distribution or other disposition of the Intellectual
Property other than salaries and sales commissions paid to
employees and sales agents in the ordinary course of business. The
Company has taken all reasonable security measures to protect the
secrecy, confidentiality and value of the Intellectual
Property.
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(c)
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The
Disclosure Schedule lists the Internet domain names included in the
Intellectual Property. The Company is the registrant and sole legal
and beneficial owner of the Internet domain names included in the
Intellectual Property, free and clear of all Liens. The Company is
the registered owner of the trademarks underlying each of the
domain names included in the Intellectual Property. The Company is
not aware of any pending or threatened actions, suits, claims,
litigation or proceedings relating to the domain names included in
the Intellectual Property. The Company has operated the websites
identified in the Disclosure Schedule.
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(d)
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All
personnel, including employees, agents, consultants and
contractors, who have contributed to or participated in the
conception or development, or both, of
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the
Intellectual Property on behalf of the Company and all officers and
technical employees of the Company either (i) have been a
party to “work-for-hire” arrangements or agreements
with the Company in accordance with applicable federal and state
law that has accorded the Company full, effective, sole, exclusive
and original ownership of all tangible and intangible property
thereby arising, or (ii) have executed appropriate instruments
of assignment in favor of the Company as assignee that have
conveyed to the Company effective, sole and exclusive ownership of
all tangible and intangible property arising thereby.
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(e)
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To
the Company’s Knowledge, the conduct of the Company’s
businesses has not infringed, misappropria
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