Exhibit 10.1


 


ASSET PURCHASE AGREEMENT


 


 


among


 


 


EDWARDS LIFESCIENCES LLC,

a Delaware limited liability
company, and


 


EDWARDS LIFESCIENCES A.G.,

a Swiss corporation,




and


 


C. R. BARD, INC.,


a New Jersey corporation, and


 


ANGIOMED GMBH & CO., MEDIZINTECHNIK
KG,

a German limited partnership


 


 


December 6, 2007


 





















 


Table of Contents


 


	
   

  	
   

  	
   

  	
  Page

  
	
   

  	
   

  	
   

  	
   

  
	
  1.

  	
  PLAN OF
  ACQUISITION

  	
   

  	
  1

  
	
   

  	
  1.1

  	
  Purchase and Sale of Transferred
  Assets

  	
   

  	
  1

  
	
   

  	
  1.2

  	
  Purchase Price and Adjustments

  	
   

  	
  8

  
	
   

  	
  1.3

  	
  Assumption of Liabilities.

  	
   

  	
  13

  
	
   

  	
  1.4

  	
  Taxes.

  	
   

  	
  14

  
	
   

  	
  1.5

  	
  Closing.

  	
   

  	
  16

  
	
   

  	
  1.6

  	
  Closing Deliverables.

  	
   

  	
  16

  
	
   

  	
  1.7

  	
  Accounts Receivable.

  	
   

  	
  17

  
	
   

  	
  1.8

  	
  Further Assurances.

  	
   

  	
  17

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.

  	
  REPRESENTATIONS
  AND WARRANTIES OF SELLERS

  	
   

  	
  18

  
	
   

  	
  2.1

  	
  Organization and Good Standing.

  	
   

  	
  18

  
	
   

  	
  2.2

  	
  Authority; Binding Effect.

  	
   

  	
  19

  
	
   

  	
  2.3

  	
  Consents.

  	
   

  	
  19

  
	
   

  	
  2.4

  	
  No Breach.

  	
   

  	
  19

  
	
   

  	
  2.5

  	
  Financial Information.

  	
   

  	
  20

  
	
   

  	
  2.6

  	
  Tax Liabilities.

  	
   

  	
  20

  
	
   

  	
  2.7

  	
  Litigation.

  	
   

  	
  20

  
	
   

  	
  2.8

  	
  Compliance With Laws.

  	
   

  	
  21

  
	
   

  	
  2.9

  	
  Title to Properties.

  	
   

  	
  23

  
	
   

  	
  2.10

  	
  Condition of Tangible Assets.

  	
   

  	
  23

  
	
   

  	
  2.11

  	
  Intellectual Property.

  	
   

  	
  24

  
	
   

  	
  2.12

  	
  [Intentionally Omitted]

  	
   

  	
  25

  
	
   

  	
  2.13

  	
  Labor Relations.

  	
   

  	
  25

  
	
   

  	
  2.14

  	
  Contracts.

  	
   

  	
  25

  
	
   

  	
  2.15

  	
  Inventory.

  	
   

  	
  27

  
	
   

  	
  2.16

  	
  Permits; Regulatory Matters.

  	
   

  	
  27

  
	
   

  	
  2.17

  	
  Absence of Certain Changes.

  	
   

  	
  28

  
	
   

  	
  2.18

  	
  No Brokers; Affiliate Transactions.

  	
   

  	
  28

  
	
   

  	
  2.19

  	
  Environmental Matters.

  	
   

  	
  28

  
	
   

  	
  2.20

  	
  Business Data; Product
  Specifications

  	
   

  	
  29

  
	
   

  	
  2.21

  	
  No Other Representations and
  Warranties

  	
   

  	
  29

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
  REPRESENTATIONS
  AND WARRANTIES OF BUYERS

  	
   

  	
  30

  
	
   

  	
  3.1

  	
  Organization and Good Standing

  	
   

  	
  30

  
	
   

  	
  3.2

  	
  Authority; Binding Effect

  	
   

  	
  30

  
	
   

  	
  3.3

  	
  Consents

  	
   

  	
  31

  
	
   

  	
  3.4

  	
  No Breach

  	
   

  	
  31

  
	
   

  	
  3.5

  	
  Capital Resources

  	
   

  	
  31

  
	
   

  	
  3.6

  	
  No Brokers

  	
   

  	
  31

  
	
   

  	
  3.7

  	
  No Other Representations and
  Warranties

  	
   

  	
  31

  



 


i





















 


	
  4.

  	
  COVENANTS
  OF SELLERS

  	
   

  	
  31

  
	
   

  	
  4.1

  	
  Interim Operation of Business

  	
   

  	
  31

  
	
   

  	
  4.2

  	
  Post-Closing Cooperation

  	
   

  	
  33

  
	
   

  	
  4.3

  	
  Full Access and Pre-Closing
  Cooperation

  	
   

  	
  33

  
	
   

  	
  4.4

  	
  Consents; Third Party Arrangements

  	
   

  	
  34

  
	
   

  	
  4.5

  	
  Non-Compete

  	
   

  	
  34

  
	
   

  	
  4.6

  	
  Inventory List; List of Acquired
  Contracts

  	
   

  	
  36

  
	
   

  	
  4.7

  	
  [Intentionally Omitted]

  	
   

  	
  36

  
	
   

  	
  4.8

  	
  FDA Regulatory Matters

  	
   

  	
  36

  
	
   

  	
  4.9

  	
  Transition of FDA Applications

  	
   

  	
  38

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
  COVENANTS
  OF BUYERS; MUTUAL COVENANTS

  	
   

  	
  39

  
	
   

  	
  5.1

  	
  Notice of Certain Events

  	
   

  	
  39

  
	
   

  	
  5.2

  	
  Regulatory Matters

  	
   

  	
  40

  
	
   

  	
  5.3

  	
  [Intentionally Omitted]

  	
   

  	
  40

  
	
   

  	
  5.4

  	
  Use of Names

  	
   

  	
  40

  
	
   

  	
  5.5

  	
  Records after Closing

  	
   

  	
  40

  
	
   

  	
  5.6

  	
  Certain Government Approvals

  	
   

  	
  41

  
	
   

  	
  5.7

  	
  Bulk Sales

  	
   

  	
  42

  
	
   

  	
  5.8

  	
  Confidentiality

  	
   

  	
  42

  
	
   

  	
  5.9

  	
  Product Liability

  	
   

  	
  42

  
	
   

  	
  5.10

  	
  Product Returns

  	
   

  	
  43

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
  COVENANTS RELATING TO EMPLOYEES

  	
   

  	
  43

  
	
   

  	
  6.1

  	
  Buyer’s Employment of Selected
  Business Employees

  	
   

  	
  43

  
	
   

  	
  6.2

  	
  Prior Service

  	
   

  	
  44

  
	
   

  	
  6.3

  	
  Participation by Transferred
  Employees in Buyers’ Benefit Plans

  	
   

  	
  44

  
	
   

  	
  6.4

  	
  Non-Solicitation

  	
   

  	
  44

  
	
   

  	
  6.5

  	
  No Transfer of Employment.

  	
   

  	
  45

  
	
   

  	
  6.6

  	
  WARN Act Compliance

  	
   

  	
  45

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
  CONDITIONS
  To closing

  	
   

  	
  46

  
	
   

  	
  7.1

  	
  Conditions to Each Party’s
  Obligations

  	
   

  	
  46

  
	
   

  	
  7.2

  	
  Conditions to Sellers’ Obligations

  	
   

  	
  46

  
	
   

  	
  7.3

  	
  Conditions to Buyers’ Obligations

  	
   

  	
  47

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.

  	
  INDEMNIFICATION
  AND CERTAIN REMEDIES

  	
   

  	
  47

  
	
   

  	
  8.1

  	
  Survival of Representations and
  Warranties

  	
   

  	
  47

  
	
   

  	
  8.2

  	
  Indemnification by Sellers

  	
   

  	
  48

  
	
   

  	
  8.3

  	
  Indemnification by Buyers

  	
   

  	
  51

  
	
   

  	
  8.4

  	
  Third-Party Claims

  	
   

  	
  52

  
	
   

  	
  8.5

  	
  Tax Benefits; Adjustments to
  Purchase Price

  	
   

  	
  53

  
	
   

  	
  8.6

  	
  Exclusive Remedy

  	
   

  	
  53

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  9.

  	
  TERMINATION
  AND ABANDONMENT

  	
   

  	
  54

  
	
   

  	
  9.1

  	
  Methods of Termination

  	
   

  	
  54

  
	
   

  	
  9.2

  	
  Termination Procedure and Effect

  	
   

  	
  54

  



 


ii





















 


	
  10.

  	
  MISCELLANEOUS

  	
   

  	
  54

  
	
   

  	
  10.1

  	
  Counterparts

  	
   

  	
  54

  
	
   

  	
  10.2

  	
  Notices

  	
   

  	
  54

  
	
   

  	
  10.3

  	
  Successors and Assigns

  	
   

  	
  55

  
	
   

  	
  10.4

  	
  Governing Law; Jurisdiction

  	
   

  	
  55

  
	
   

  	
  10.5

  	
  Amendment

  	
   

  	
  56

  
	
   

  	
  10.6

  	
  Entire Agreement

  	
   

  	
  56

  
	
   

  	
  10.7

  	
  Severability

  	
   

  	
  56

  
	
   

  	
  10.8

  	
  Specific Performance

  	
   

  	
  56

  
	
   

  	
  10.9

  	
  Publicity

  	
   

  	
  56

  
	
   

  	
  10.10

  	
  Interpretation

  	
   

  	
  57

  
	
   

  	
  10.11

  	
  Third Party Beneficiaries

  	
   

  	
  57

  
	
   

  	
  10.12

  	
  Knowledge Defined

  	
   

  	
  58

  
	
   

  	
  10.13

  	
  Expenses

  	
   

  	
  58

  
	
   

  	
  10.14

  	
  Damages

  	
   

  	
  58

  



 


	
  Annexes, Exhibits and Schedules:

  
	
   

  	
   

  
	
  Annex 1:

  	
  PMA Payments Milestones

  
	
  Annex 2:

  	
  Manufacturing Transfer Payment Milestone

  
	
   

  	
   

  
	
  Exhibit A:

  	
  Bill of Sale

  
	
  Exhibit B:

  	
  Cross License Agreement

  
	
  Exhibit C:

  	
  Transition Services Agreement

  
	
  Exhibit D:

  	
  Transition Supply Agreement

  
	
  Exhibit E:

  	
  Clinical Studies Agreement

  
	
  Exhibit F-1:

  	
  Disclosure Schedule

  
	
  Exhibit F-2:

  	
  Buyers’ Schedule

  
	
  Exhibit G-1:

  	
  US Seller Tax Certificate

  
	
  Exhibit G-2:

  	
  EU Seller Tax Certificate

  



 


iii





















 


Index of Defined Terms


 


	
  Term

  	
   

  	
  Section

  
	
   

  	
   

  	
   

  
	
  Accounting Methodologies

  	
   

  	
  1.2(b)(i)

  
	
  Acquired Contracts

  	
   

  	
  1.1(a)(x)

  
	
  Acquired IP Contracts

  	
   

  	
  1.1(a)(x)

  
	
  Agreement

  	
   

  	
  Preamble

  
	
  Allocation Disagreements

  	
   

  	
  1.2(f)(ii)

  
	
  Allocation Dispute Notice

  	
   

  	
  1.2(f)(ii)

  
	
  Allocation Methodology

  	
   

  	
  1.2(f)(ii)

  
	
  Ancillary Agreements

  	
   

  	
  1.6(j)

  
	
  Assigned IP Assets

  	
   

  	
  1.1(a)(iv)

  
	
  Assumed Obligations

  	
   

  	
  1.3(a)

  
	
  Business

  	
   

  	
  Recitals

  
	
  Business Data

  	
   

  	
  2.20(a)

  
	
  Business Employees

  	
   

  	
  6.1(a)

  
	
  Business Permits

  	
   

  	
  1.1(a)(vii)

  
	
  Buyer

  	
   

  	
  Preamble

  
	
  Buyer Allocation

  	
   

  	
  1.2(f)(ii)

  
	
  Buyer Consent

  	
   

  	
  3.3

  
	
  Buyer Indemnified Person

  	
   

  	
  8.2(a)

  
	
  Buyer Material Adverse Effect

  	
   

  	
  3.2

  
	
  Buyers

  	
   

  	
  Preamble

  
	
  Buyers’ Schedule

  	
   

  	
  3

  
	
  Claim

  	
   

  	
  2.7(a)

  
	
  Clinical Studies Agreement

  	
   

  	
  1.6(j)

  
	
  Closing

  	
   

  	
  1.5

  
	
  Closing Date

  	
   

  	
  1.5

  
	
  Closing Date Consideration

  	
   

  	
  1.2(a)(i)

  
	
  Closing Inventory Statement

  	
   

  	
  1.2(b)(iv)

  
	
  Closing Time

  	
   

  	
  1.5

  
	
  Code

  	
   

  	
  1.4(d)(i)

  
	
  Common Interest Agreement

  	
   

  	
  5.8

  
	
  Complaint System

  	
   

  	
  2.7(b)

  
	
  Confidentiality Agreement

  	
   

  	
  5.8

  
	
  Consent

  	
   

  	
  2.3

  
	
  Consignment Inventory Amount

  	
   

  	
  1.2(b)(i)(B)

  
	
  Contracts

  	
   

  	
  2.4

  
	
  Copyrights

  	
   

  	
  1.1(a)(iv)

  
	
  Covered Business

  	
   

  	
  4.5(a)(i)

  
	
  Cross License Agreement

  	
   

  	
  1.6(j)

  
	
  Current Inventory

  	
   

  	
  1.2(b)(i)

  
	
  Damages

  	
   

  	
  8.2(a)

  



 


iv





















 


	
  Term

  	
   

  	
  Section

  
	
   

  	
   

  	
   

  
	
  Deductible

  	
   

  	
  8.2(b)

  
	
  Directive

  	
   

  	
  2.8(b)

  
	
  Disclosure Schedule

  	
   

  	
  2

  
	
  Dispute Notice

  	
   

  	
  1.2(b)(v)

  
	
  Divestiture

  	
   

  	
  5.6(c)

  
	
  DMR

  	
   

  	
  1.1(a)(ix)

  
	
  DOJ

  	
   

  	
  5.6(b)

  
	
  Encumbrances

  	
   

  	
  1.1(a)

  
	
  Environmental Laws

  	
   

  	
  2.19(b)(i)

  
	
  ERISA

  	
   

  	
  1.1(a)(ix)

  
	
  Estimated Inventory Statement

  	
   

  	
  1.2(b)(i)

  
	
  EU Applications

  	
   

  	
  2.16(b)

  
	
  EU Buyer

  	
   

  	
  Preamble

  
	
  EU Law

  	
   

  	
  2.8(b)

  
	
  EU Seller

  	
   

  	
  Preamble

  
	
  EU Seller Tax Certificate

  	
   

  	
  1.6(k)

  
	
  Excluded Liabilities

  	
   

  	
  1.3(b)

  
	
  Excluded Taxes

  	
   

  	
  1.4(d)(ii)

  
	
  Extrusions

  	
   

  	
  Annex 2

  
	
  FD&C Act

  	
   

  	
  2.8(b)

  
	
  FDA Applications

  	
   

  	
  2.16(b)

  
	
  FDA Law

  	
   

  	
  2.8(b)

  
	
  FDA/EU Applications

  	
   

  	
  2.16(b)

  
	
  Final Inventory

  	
   

  	
  1.2(b)(vi)

  
	
  Final Purchase Price Allocation

  	
   

  	
  1.2(f)(i)

  
	
  Financial Information

  	
   

  	
  2.5

  
	
  FTC

  	
   

  	
  5.6(b)

  
	
  Governmental Entity

  	
   

  	
  1.1(a)(vii)

  
	
  HSR Act

  	
   

  	
  5.6(b)

  
	
  IDE

  	
   

  	
  4.8(b)

  
	
  Indemnitee

  	
   

  	
  8.4

  
	
  Indemnitor

  	
   

  	
  8.4

  
	
  Independent Firm

  	
   

  	
  1.2(b)(vi)

  
	
  Initial FDA Approval

  	
   

  	
  Annex 1

  
	
  Initial PMA Payment

  	
   

  	
  Annex 2, Annex 1

  
	
  Intellectual Property

  	
   

  	
  1.1(a)(iv)

  
	
  Inventory

  	
   

  	
  1.1(a)(ii)

  
	
  Inventory Amount

  	
   

  	
  1.2(b)(i)(A)

  
	
  Inventory Deficiency

  	
   

  	
  1.2(b)(ii)

  
	
  Inventory Excess

  	
   

  	
  1.2(b)(ii)

  
	
  IRBs

  	
   

  	
  4.8(b)

  
	
  Know-How

  	
   

  	
  1.1(a)(iv)

  



 


v





















 


	
  Term

  	
   

  	
  Section

  
	
   

  	
   

  	
   

  
	
  Law

  	
   

  	
  2.4

  
	
  Manufacturing Agreement

  	
   

  	
  1.1(a)(x)

  
	
  Manufacturing Protocols

  	
   

  	
  Annex 2

  
	
  Manufacturing Transfer Payments

  	
   

  	
  1.2(a)(iii)

  
	
  Material Adverse Effect

  	
   

  	
  2.1

  
	
  Material Contracts

  	
   

  	
  2.14(b), 2.14(b)

  
	
  Materials of Environmental Concern

  	
   

  	
  2.19(b)(ii)

  
	
  MCA

  	
   

  	
  5.8

  
	
  MDRs

  	
   

  	
  1.1(a)(ix)

  
	
  Notice Date

  	
   

  	
  1.2(b)(vi)

  
	
  Notice Period

  	
   

  	
  8.4(b)

  
	
  Order

  	
   

  	
  2.4

  
	
  parties

  	
   

  	
  Preamble

  
	
  party

  	
   

  	
  Preamble

  
	
  Patent Claim

  	
   

  	
  8.2(c)

  
	
  Patent Claim Notice

  	
   

  	
  8.2(c)(i)

  
	
  Patent Damages

  	
   

  	
  8.2(c)

  
	
  Patents

  	
   

  	
  1.1(a)(iv)

  
	
  Permits

  	
   

  	
  2.16(a)(ii)

  
	
  Permitted Encumbrances

  	
   

  	
  2.9(a)

  
	
  Plans

  	
   

  	
  1.1(b)(ix)

  
	
  PMA

  	
   

  	
  4.8(b)

  
	
  PMA Application

  	
   

  	
  4.8(b)

  
	
  PMA License

  	
   

  	
  4.9(d)

  
	
  PMA Payments

  	
   

  	
  1.2(a)(ii)

  
	
  Presentation Date

  	
   

  	
  1.2(f)(ii)

  
	
  Primarily Used in Business

  	
   

  	
  1.1(a)(xiv)

  
	
  Product Liability

  	
   

  	
  5.9

  
	
  Product Records

  	
   

  	
  1.1(a)(ix)

  
	
  Product Specifications

  	
   

  	
  1.1(a)(v)

  
	
  Products

  	
   

  	
  Recitals

  
	
  Proposed Adjustments

  	
   

  	
  1.2(b)(v)

  
	
  Purchase Price

  	
   

  	
  1.2(a)(iii)

  
	
  RESILIENT IDE

  	
   

  	
  4.8(b)

  
	
  Retained Names

  	
   

  	
  5.4(b)

  
	
  Secondary FDA Approval

  	
   

  	
  Annex 1

  
	
  Secondary PMA Payment

  	
   

  	
  Annex 1

  
	
  Seller

  	
   

  	
  Preamble

  
	
  Seller Business Combination Transaction

  	
   

  	
  4.5(b)

  
	
  Seller Indemnified Person

  	
   

  	
  8.3(a)

  
	
  Sellers

  	
   

  	
  Preamble

  
	
  Shared Contract

  	
   

  	
  1.1(d)

  



 


vi





















 


	
  Term

  	
   

  	
  Section

  
	
   

  	
   

  	
   

  
	
  Tangible Assets

  	
   

  	
  2.10

  
	
  Target Inventory

  	
   

  	
  1.2(b)(ii)

  
	
  Tax

  	
   

  	
  1.4(d)(iii)

  
	
  Tax Return

  	
   

  	
  1.4(d)(v)

  
	
  Taxes

  	
   

  	
  1.4(d)(iii)

  
	
  Taxing Authority

  	
   

  	
  1.4(d)(iv)

  
	
  Third-Party Claim

  	
   

  	
  8.4(a)

  
	
  Third-Party Claim Notice

  	
   

  	
  8.4(a)

  
	
  Thirdy Party Patent

  	
   

  	
  8.2(c)

  
	
  Trademarks

  	
   

  	
  1.1(a)(iv)

  
	
  Transactions

  	
   

  	
  Recitals

  
	
  Transfer Taxes

  	
   

  	
  1.4(b)

  
	
  Transferred Assets

  	
   

  	
  1.1(a)

  
	
  Transferred Employee

  	
   

  	
  6.1(b)

  
	
  Transition Services Agreement

  	
   

  	
  1.6(j)

  
	
  Transition Supply Agreement

  	
   

  	
  1.6(j)

  
	
  Treasury Regulations

  	
   

  	
  1.4(d)(vi)

  
	
  TSA Employees

  	
   

  	
  6.1(a)

  
	
  US Buyer

  	
   

  	
  Preamble

  
	
  US Seller

  	
   

  	
  Preamble

  
	
  US Seller Tax Certificate

  	
   

  	
  1.6(k)

  
	
  WARN

  	
   

  	
  2.13

  



 


vii




















 


ASSET PURCHASE AGREEMENT


 


THIS ASSET
PURCHASE AGREEMENT (this “Agreement”),
dated as of December 6, 2007, is made by and among EDWARDS LIFESCIENCES
LLC, a Delaware limited liability company (the “US Seller”),
EDWARDS LIFESCIENCES A.G., a Swiss corporation (the “EU Seller” and together with the US Seller, “Sellers” and each a “Seller”), C. R.
BARD, INC., a New Jersey corporation
(the “US Buyer”), and ANGIOMED GMBH &
CO., MEDIZINTECHNIK KG, a German limited partnership (the “EU Buyer” and together with the US Buyer, “Buyers” and each a “Buyer”). 
Buyers, on the one hand, and Sellers, on the other hand, are each
referred to herein as a “party”
and collectively as the “parties.”


 


RECITALS


 


WHEREAS, the Sellers and their
affiliates have established and maintain, and conduct, a business (the “Business”) that is engaged in the research and development,
design, manufacturing, marketing, distribution and sale of peripheral vascular
stents, which includes the following product lines of Sellers and their
affiliates (“Products”):  (i) self expanding stents; (ii) balloon
expanding stents; and (iii) delivery systems (including balloons and
catheters contained therein) associated with the foregoing products; and


 


WHEREAS, Sellers desire to sell
to Buyers, and Buyers desire to purchase from Sellers, all of the Transferred
Assets (as defined below), which do not include the Excluded Assets (as defined
below), and Buyers are willing to assume only the specified Assumed Obligations
(as defined below) of Sellers and will assume no other liabilities or
obligations, and the parties intend to consummate such sale and purchase and
the other transactions contemplated by this Agreement (collectively, the “Transactions”).


 


NOW, THEREFORE, in
consideration of the mutual covenants and consideration contained herein, the
parties hereto covenant and agree as follows:


 


1.                                      PLAN OF ACQUISITION


 


1.1          Purchase and
Sale of Transferred Assets


 


(a)           Transferred Assets.  Upon the terms and conditions set forth
herein and subject to Section 1.1(b), at the Closing, Sellers will
sell, assign, transfer, convey and deliver, or cause to be sold, assigned,
transferred, conveyed and delivered, to Buyers, and Buyers will buy, acquire
and take from Sellers or their affiliates, all of Sellers’ and their affiliates’
right, title and interest in and to the Transferred Assets (as defined below),
free and clear of all restrictions, liens, claims, mortgages, security
interests or other encumbrances of any kind (“Encumbrances”),
other than Permitted Encumbrances (as defined below).  “Transferred
Assets” means all of Sellers’ and their affiliates’ right, title and
interest in and to the following assets, properties, rights, goodwill and
claims of Sellers or their affiliates that relate to the Business or the
Products:


 

















 


(i)            all of the tangible personal property and equipment Primarily Used in the
Business, including the personal property and equipment listed on Schedule 1.1(a)(i);


 


(ii)           all finished goods inventory of the Business, excluding all inventories of raw
materials and work-in-process but including all finished goods inventory in
transit or held on consignment by any person, and any related packaging or
other materials or supplies that are, without duplication, (x) held for
sale by the Sellers or their affiliates on the Closing Date or (y) included
in the Closing Inventory Statement (collectively, the “Inventory”);


 


(iii)          all computer hardware, databases and
computer software Primarily Used in the Business, in each case, that are
specifically used in the manufacture of the Products, including the hardware,
databases and software listed on Schedule 1.1(a)(iii);


 


(iv)          all rights in and to the following U.S. and foreign intellectual property (the “Assigned IP Assets”): 
(A) all Patents (as defined below) Primarily Used in the Business,
including those Patents set forth in Schedule 1.1(a)(iv) but
specifically excluding those set forth on Schedule 1.1(b)(ii); (B) all Copyrights (as defined
below) Primarily Used in the Business, including those Copyrights set forth in Schedule 1.1(a)(iv);
(C) all Trademarks (as defined below) Primarily Used in the Business,
including those Trademarks set forth in Schedule 1.1(a)(iv); and (D) all
Know-How (as defined below) used exclusively in the Business or related
exclusively to any Product.  For the
avoidance of doubt, the Know-How in (D) above includes Product
Specifications (as defined below).  For
purposes of this Agreement, “Intellectual Property”
means and includes (1) patents (including applications, divisionals,
provisionals, continuations, continuations-in-part, re-examinations, reissues
or equivalent rights relating thereto, and their foreign counterparts),
industrial designs, utility models and equivalent rights (“Patents”),
(2) copyrights and copyrightable works (including software, systems,
documentation, graphics, research materials, lab books and reports, advertising
materials and website content) (“Copyrights”); (3) trade
names, brand names, trademarks, service marks, corporate names, logos, domain
names and other source indicators, and all of the goodwill associated with any
of the foregoing (“Trademarks”);
and (4) trade secrets, know-how, documents, drawings, procedures,
inventions, compositions of matter, technology, processes, methods and
formulae, confidential, proprietary or non-public information or materials in
any form or media, and all other intellectual or industrial property not
included in clauses (1) through (3) (“Know-How”);


 


(v)           all patterns, plans, designs, blueprints,
sketches, drawings, research data, formulae, compositions, chemical
formulations, design and other specifications, instructions for use, raw
material and component lists and specifications, manufacturing processes and
protocols, batch records, process descriptions and validations, procedures (including
quality testing and standard operating procedures), equipment requirements,
operating and other manuals, installation procedures and requirements,
installation/operation/performance qualification protocols, data (including
technical and computer data), records (including purchasing, regulatory
compliance, risk management 


 


2

















 


and research and development records),
environmental control documentation, product and process improvements,
proposals and related documentation, in each case, used exclusively in the
Business or related exclusively to any Product (“Product
Specifications”);


 


(vi)          all goodwill and other general intangible
properties and assets (other than Intellectual Property) that are Primarily Used
in the Business;


 


(vii)         except those Business Permits set forth on
Schedule 1.1(b)(xvii) and to the extent transferable and excluding all PMA
Applications, all approvals, licenses, permits, clearances, permissions,
exemptions, certifications, authorizations, consents of, or declarations,
registrations or filings with, any Federal, state, local, municipal, foreign or
multi-national governmental or regulatory authority, agency, commission, court
(including any arbitration panel), body or entity, or quasi-governmental,
self-regulatory organization, commission, body, authority or agency (each a “Governmental Entity”) (including all FDA Applications (as
defined below)) that are Primarily Used in the Business, including those listed
on Schedule 1.1(a)(vii) (“Business Permits”),
and all documentation specifically relating to all present and past Product
clinical trials;


 


(viii)        a list containing (A) the names and addresses, to the extent available,
of each person who purchased, during the period commencing on January 1,
2006 and ending on the date of this Agreement, any Products and (B) the
amount of Products purchased by each such person during such period;


 


(ix)           other than documents related to the PMA
Application for an SFA indication and to the extent transferable, all of the
following to the extent that they primarily relate to any existing Product (in
each case, whether such materials are evidenced in writing, electronically or
otherwise):  (A) all material
business records and all purchasing records and regulatory compliance records
(including each device master record (“DMR”) file); (B) all
regulatory correspondence; (C) all material records and all written
correspondence concerning the FDA Applications (together with all supporting
and background documentation); (D) submissions and reports to the FDA or
any notified body or competent authority (including all supporting and
background documentation); (E) manuals and procedures for assuring
compliance with FDA Law and EU Law (as those terms are defined hereunder), CE
technical files and all other records and materials necessary to comply with
FDA Law and EU Law or similar requirements of third party auditors; (F) all
data and information relating to nonclinical and clinical testing of Products,
including all records related to the CONTINUUM, ETAGIUSS, MELOPEE, ELODIE Phase
I and ELODIE Phase II studies; (G) risk management records; (H) supplier
and vendor lists; (I)  service provider lists; (J) promotional
literature and advertising materials with support data; (K) catalogs; (L) research
material; (M) design history files, complaints, medical device reports (“MDRs”); (N) correction and removal reports; (O) corrective
and preventive action reports, written memoranda or records documenting
decisions not to file a 510(k); (P) other product development records; and
(Q) all material business records, regulatory compliance records and
correspondence,


 


3

















 


research material, design history files and other product development
records related to past or current R&D projects (collectively, “Product Records”);


 


(x)            (A) the purchase orders and commitments of customers of the Business that are
outstanding and unfulfilled on the Closing Date, (B) the Manufacturing
Agreement by and among the US Seller and Admedes Schuessler GmbH, dated December 6,
2006 (the “Manufacturing Agreement”), (C) all
other Contracts that are Primarily Used in the Business, other than those
Contracts relating primarily to Intellectual Property and other than the “shared
contracts” set forth on Schedule 1.1(a)(x)(C) and (D) Contracts
Primarily Used in the Business and relating primarily to Intellectual Property,
including those Contracts set forth in Schedule 1.1(a)(x)(D) (the
“Acquired IP Contracts and
together with the Contracts described
in the foregoing sub-clauses (A) through (C) (other than
inventor assignments), collectively, the “Acquired Contracts”);


 


(xi)           to the extent transferable, (x) all warranties or guarantees by any
manufacturer or supplier to the extent related to any of the Transferred
Assets, and (y) all rights, claims, causes of action, rights of recovery,
rights to indemnification from third parties, refunds, deposits, rights of set
off, and rights of recoupment, in each case to the extent related to any of the
Transferred Assets or Assumed Obligations (as defined below) or Sellers’ or
their affiliates’ ownership, control or use thereof prior to the Closing Date,
including the right to recover all proceeds, settlements and damages therefrom;
provided that, to the extent that any item under sub-clauses (x) and
(y) above provides a right to make a claim against any third party and
relates to an Excluded Liability or a liability or obligation in respect of
which Sellers may be obligated to indemnify Buyers pursuant to this Agreement,
such item shall not be transferred to Buyers until the later to occur of (A) the
time at which Sellers no longer have any liability or obligation to indemnify
Buyers under Article 8 in respect thereof and (B) the expiration
of the eighteen (18) month survival period under Section 8.1;


 


(xii)          a schedule setting forth the current and
historical compensation and benefits coverage of Transferred Employees, and
historical sales rankings and sales data reports with respect to Transferred
Employees;


 


(xiii)         all prototypes and other assets exclusively
related to past or current R&D projects (including non-Biotronik PTA
balloons, covered peripheral stents and stent grafts (other than (A) devices or methods for the treatment of structural
heart disease or (B) devices or methods for the treatment of abdominal
aortic aneurysms or thoracic aortic aneurysms) in development); and


 


(xiv)        all other assets listed on Schedule 1.1(a)(xiv).


 


For all purposes of this Agreement, the defined phrase “Primarily Used In the Business” shall mean primarily
relating to, or used primarily or held for use primarily in or by, the Business
or in connection with the development of the existing Products.  Notwithstanding
anything herein to the contrary, Sellers shall retain possession of any
Transferred Assets


 


4

















 


reasonably necessary, as mutually agreed by
the parties, in connection with Sellers’ performance of their obligations under
the Ancillary Agreements (as defined below) and such Transferred Assets shall
be delivered to Buyers not at the Closing but as soon as reasonably practicable
after the earlier of (x) the date on which such Transferred Asset is no
longer reasonably necessary in connection with Sellers’ performance under the
Ancillary Agreements or (y) the expiration or termination of the relevant
Ancillary Agreements.  Furthermore,
notwithstanding anything herein to the contrary, Sellers shall not be precluded
from retaining copies of Transferred Assets that are documents (whether such
documents are evidenced in writing, electronically or otherwise) necessary for
retention in accordance with past practices for regulatory compliance or other
similar purposes, provided that all such material shall be held in confidence
in accordance with Section 5.8. 
Upon the transfer, and not prior thereto, of (i) the PMA
Application and the related Product Records pursuant to Section 4.8
and (ii) the RESILIENT IDE and the related Product Records pursuant to Section 4.9,
the PMA Application, RESLIENT IDE and the Product Records related to each shall
be deemed Transferred Assets.


 


(b)           Excluded Assets. 
Notwithstanding anything to
the contrary contained herein, Buyers shall not acquire any of Sellers’ and
their affiliates’ right, title or interest in and to any asset, property,
right, goodwill or claim,
except for the Transferred Assets.  The
assets, properties, rights, goodwill and claims of Sellers and their affiliates
that shall not be transferred hereunder are referred to herein as the “Excluded
Assets”, and, notwithstanding anything to the contrary contained herein, shall
include the following:


 


(i)            all inventories of raw materials and
work-in-process, as well as other tangible personal property and equipment set
forth on Schedule 1.1(b)(i)


 


(ii)           all Intellectual Property set forth on Schedule 1.1(b)(ii);


 


(iii)          any real property, whether owned or leased
(together with all easements, licenses, interests and all of the rights arising out of the ownership
thereof or appurtenant thereto and together with all buildings, structures,
facilities, fixtures and other improvements thereon);


 


(iv)          (A) all trade accounts receivable and other rights to
payment from customers of the Business and the full benefit of all security for
such accounts or rights to payment, including all trade accounts receivable
representing amounts receivable in respect of goods or products (including the
Products) shipped or sold or services rendered to customers of the Business on
or prior to the Closing Date, (B) all other accounts or notes receivable
of the Business and the full benefit of all security for such accounts or
notes, in each case, as of the Closing Date, and (C) any claim, remedy or
other right related to any of the foregoing, in each case, as of the Closing
Date;


 


(v)           other than the Transferred Assets listed in
Schedule 1.1(a)(iii), Sellers’ information systems, including hardware and software;


 


(vi)          the cash and cash equivalents, bank accounts and other depository accounts of
Sellers;


 


5

















 


(vii)         all insurance policies held by any Seller
or its affiliates and any refunds in connection with, and claims made against, such policies, and all claims,
rights and causes of action against any third party that relate to the Business
or any Transferred Assets, Excluded Assets or Excluded Liabilities (as defined
below);


 


(viii)        any Tax refunds, operating losses or credits of Sellers; provided
that any Tax refunds or credits attributable to the Business or the Transferred
Assets that relate to any taxable period or portion thereof, beginning after
the Closing Date, shall not constitute Excluded Assets;


 


(ix)           all rights in connection with, and assets held
with respect to, any “employee pension benefit plans” as defined in the
Employee Retirement Income Security Act of 1974, as amended (“ERISA”) or any “employee welfare benefit plans” as defined
in Section 3 of ERISA (collectively, “Plans”), in
each case maintained by any Seller or its affiliates;


 


(x)            any employment or consulting agreements;


 


(xi)           assets (including records, data and files),
rights or services used in connection with the finance, accounting, legal,
quality, regulatory, logistics, administrative, governance or other general
corporate functions of Sellers;


 


(xii)          all Contracts that are not Acquired Contracts or Acquired IP Contracts and all
Contracts set forth on Schedule 1.1(b)(xii);


 


(xiii)         all claims, demands, deposits, refunds,
rebates, causes of action, choses in action, rights of recovery, rights of
set-off and rights of recoupment to the extent relating to any of the Excluded
Assets or Excluded Liabilities
or as excluded pursuant to Section 1.1(a)(xi) hereof;


 


(xiv)        the company charter, qualifications to
conduct business as a foreign company, arrangements with registered agents
relating to foreign qualifications, taxpayer and other identification numbers,
seals, minute books, stock or security transfer books, shares of capital stock
or other equity securities,
certificates representing stock or other equity securities, and other documents
relating to the organization, maintenance and existence of Sellers or their
Affiliates;


 


(xv)         all personnel records and other records relating to the employees of the Business;


 


(xvi)        all rights of Sellers and Seller Indemnified Persons under this Agreement or any
Ancillary Agreement; and


 


(xvii)       all assets set forth on Schedule 1.1(b)(xvii).


 


(c)           Procedure for Acquired Contracts not Transferable.  Provided that all of the conditions to
Closing set forth in Article 7 shall have been satisfied or waived,
(i) if any 


 


6

















 


Acquired Contract is not
assignable or transferable to Buyers without the Consent (as defined below) of
any Governmental Entity or other third person (other than Sellers or their
affiliates), and (ii) such Consent has not been obtained at or prior to
the Closing, then this Agreement shall not constitute an assignment or transfer
thereof unless and until such Consent is obtained, and all liabilities related
to such Acquired Contract that would, but for the absence of such Consent,
constitute an Assumed Obligation shall not be assumed by Buyers hereunder,
unless and until (and effective only from the date) such Consent has been
obtained.  In such case, Sellers shall,
at their sole expense (except with respect to the obligations to be performed
by Buyers under the applicable Acquired Contract as provided herein
below):  (x) for a period of nine (9) months
following the Closing Date, continue to use commercially reasonable efforts to
obtain such Consent pursuant to Section 4.4(a) as soon as
practicable; (y) during the remaining term of such Acquired Contract, use
commercially reasonable efforts to provide Buyers as promptly as practicable
the benefits of such Acquired Contract to the same extent as if it had been
assigned and transferred to Buyers at and as of Closing; and (z) cooperate
in any commercially reasonable and lawful arrangement (including subleasing,
sublicensing or subcontracting arrangements) designed to provide such benefits
to Buyers to the same extent as if such Acquired Contract had been assigned and
transferred at and as of Closing.  To the
extent that Buyers are provided benefits of any Acquired Contract pursuant to
clauses (y) or (z) above (whether from Sellers or otherwise),
Buyers shall, to the extent permitted, use commercially reasonable efforts to
perform on behalf of Sellers, pursuant to and in accordance with such Acquired
Contract, and assume responsibility for, the obligations of Sellers that
correspond to the benefits of such Acquired Contract provided by Sellers to
Buyers.  Upon the receipt by Buyers or
Sellers following the Closing of the Consent of the applicable Governmental
Entity or third party to the assignment of an Acquired Contract not assigned at
Closing, such Acquired Contract shall, without any further action on the part
of Buyers or Sellers and without additional consideration, be deemed to have
been assigned by Sellers to Buyers and all related Assumed Obligations shall be
assumed by Buyers as of the date of the receipt of such Consent.


 


(d)           Procedure for Shared Contracts.  Sellers shall at their sole expense (except
with respect to the obligations to be performed by Buyers under the applicable
Shared Contract as provided herein below): 
(x) use commercially reasonable efforts to provide Buyers as
promptly as practicable the benefits of the relevant provisions of each
Contract listed on Schedule 1.1(a)(xi)(C) (“Shared
Contract”) during the remaining term of such Shared Contract to the
same extent as if such Shared Contract had been assigned and transferred to
Buyers at and as of Closing; and (y) cooperate in any commercially
reasonable and lawful arrangement (including subleasing, sublicensing or
subcontracting arrangements) designed to provide such benefits to Buyers to the
same extent as if such relevant provisions of such Shared Contract had been
assigned and transferred to Buyers at and as of Closing.  To the extent that Buyers are provided
benefits of any such Shared Contract pursuant to clauses (x) or (y) above
(whether from Sellers or otherwise), Buyers shall, to the extent permitted, use
commercially reasonable efforts to perform on behalf of Sellers pursuant to and
in accordance with such Shared Contract, and assume responsibility for, the
obligations of Sellers that correspond to the benefits of such Shared Contract
provided by Sellers to Buyers.


 


7

















 


1.2          Purchase
Price and Adjustments


 


(a)           Closing Date Consideration and Additional
Consideration.  Upon the terms
and subject to the conditions contained in this Agreement and in consideration
of the aforesaid sale, assignment, conveyance, transfer and delivery of the
Transferred Assets and further assurances by Sellers, and the assumption of the
Assumed Obligations by Buyers, subject to Section 1.2(b) and (c),
Buyers shall pay to Sellers the following amounts:


 


(i)            at the Closing, an aggregate amount in cash
equal to $74,249,958 (the “Closing Date
Consideration”);


 


(ii)           upon the achievement of the milestones set
forth on Annex 1, the additional consideration set forth on such
annex payable in accordance with such annex, which additional consideration
shall be in an aggregate amount up to $50,000,000 (the “PMA Payments”); and


 


(iii)          upon satisfaction of the condition set forth
on Annex 2, the additional consideration set forth on such annex
payable in accordance with such annex, which additional consideration shall be
in an aggregate amount equal to $15,000,000 (the “Manufacturing Transfer Payment”).


 


“Purchase Price” means the Closing Date
Consideration together with, if payable, the PMA Payments and the Manufacturing
Transfer Payments.


 


(b)           Price Adjustments Related to Inventory.  The Purchase Price payable under this
Agreement shall be adjusted upward or downward as follows:


 


(i)            Within five (5) business days prior to
the Closing Date, the US Seller shall deliver to Buyers a good faith estimate
of the statement of the Inventory of the Business as of the Closing Time (the “Estimated Inventory Statement”), which:


 


(A)          indicates
the aggregate value of the portion of such Inventory that is Current Inventory
(as defined below) (the “Inventory Amount”);
and


 


(B)           within
such Inventory, separately identifies those that are on consignment with third
parties, together with an indication of their aggregate value (the “Consignment Inventory Amount”) and their
value by customer location.


 


“Current Inventory” means all Inventory
excluding any obsolete or excess Inventory as determined in a manner consistent
with the historical accounting methods, policies and practices of the Business
as set forth on Schedule 1.2(b)(i)(A) (the “Accounting Methodologies”) and as reflected
in the calculation of the Target Inventory set forth on Schedule 1.2(b)(i)(B).  The Estimated Inventory Statement shall be
prepared using good faith estimates based on records of the Business.


 


(ii)           Based on the Inventory Amount in the
Estimated Inventory Statement, the Closing Date Consideration will be adjusted
as follows:  (x) if such Inventory
Amount is


 


8

















 


less than the Target Inventory (the amount of any such deficiency
referred to as the “Inventory Deficiency”),
the Closing Date Consideration shall be adjusted downward by the amount of the
Inventory Deficiency; (y) if such Inventory Amount is greater than the
Target Inventory (the amount of any such excess referred to as the “Inventory Excess”), the Closing Date
Consideration shall be adjusted upward by the amount of the Inventory Excess;
or (z) if such Inventory Amount is equal to the Target Inventory, there
shall be no adjustment made to the Closing Date Consideration.  The “Target
Inventory” is equal to $15,309,262, which has been calculated as set
forth on Schedule 1.2(b)(i)(B).


 


(iii)          Sellers shall order a physical count of
non-consignment Inventory to be conducted by its third-party warehouse
providers in the U.S. and Europe within five (5) business days of the
Closing Date.  Both Sellers and Buyers
shall have the right, but not the obligation, to attend and audit such physical
count.  Representatives of Sellers and
representatives of Buyers shall, together, conduct a physical inspection and
count of Inventory on consignment with third parties at twenty (20) randomly
selected customer locations in the U.S. and ten (10) randomly selected
customer locations in Europe where such consignment Inventory is located.  Sellers and Buyers shall mutually agree on
the randomly selected customer locations. 
Sellers shall extrapolate the results of such sampling of locations,
after making appropriate reconciling adjustments, to determine the Consignment
Inventory Amount.


 


(iv)          Within forty-five (45) calendar days after
the Closing Date, Sellers shall prepare and deliver to Buyers an unaudited
statement of the Inventory of the Business as of the Closing Time (the “Closing Inventory Statement”).  The Closing Inventory Statement shall be
prepared in the same manner as the statement of Target Inventory, based on the
Accounting Methodologies, and shall present fairly the Inventory of the
Business as of the Closing.  Buyers shall
provide to Sellers, and any person designated by Sellers, with access to the
books and records of the Business constituting Transferred Assets as may
reasonably be requested by Sellers to prepare the Closing Inventory Statement.


 


(v)           For forty-five (45) calendar days after
Buyers’ receipt of the Closing Inventory Statement, Buyers and their
representatives (including outside accountants) shall have the right to, at
their sole expense:  (A) review the
work papers, schedules, memoranda and other documents and information prepared
or reviewed by Sellers or their accountants or representatives in preparing the
Closing Inventory Statement, and communicate at mutually acceptable times with
the persons involved in the preparation of the Closing Inventory Statement; (B) conduct
physical inspections and samplings of any Inventory (including raw materials
and work-in-process held by Sellers in accordance with the Transition Supply Agreement),
wherever located, including samplings of finished goods which are on
consignment with third parties; and (C) advise Sellers in writing (a “Dispute Notice”) of any disagreement with
the Closing Inventory Statement, together with a written indication of any
adjustments (“Proposed Adjustments”)
which Buyers in good faith believe are necessary to be made to the Inventory
Amount or the Consignment Inventory Amount set forth therein, specifying in
each case the exact dollar amount of each adjustment and the basis for
requesting the Proposed Adjustments.  At


 


9

















 


the end of such period for delivery of a Dispute Notice, Buyers may not
introduce any additional disagreements with any item on the Closing Inventory
Statement, and any items in the Closing Inventory Statement that are not then
disputed in any Dispute Notice shall be deemed agreed by Sellers and Buyers and
shall be final and binding.  If Buyers
submit a Dispute Notice, Buyers and Sellers shall promptly meet and make a good
faith effort to resolve any disagreements between them concerning the Proposed
Adjustments, and if Sellers and Buyers reach agreement on the resolution of
such dispute, the Proposed Adjustments (with any changes agreed by the parties)
shall be final and binding.  If Buyers do
not submit any Dispute Notice within the forty-five (45) calendar day period
pursuant to this Section 1.2(b)(v), then the Closing Inventory
Statement shall be deemed the Final Inventory (as defined below).


 


(vi)          If any of the Proposed Adjustments in dispute
cannot be so resolved within twenty (20) calendar days after the date of the
Dispute Notice, the parties agree to promptly engage the services of a mutually
acceptable independent accounting firm that has not performed services for
either party or their affiliates within the three (3) calendar years prior
to such engagement (the “Independent Firm”)
to review and resolve all Proposed Adjustments on which the parties are unable
to agree.  The Independent Firm shall
only review disputed Proposed Adjustments and shall not have the ability to
review any items not in dispute in the Dispute Notice or otherwise previously
agreed by the parties.  Not later than
ten (10) calendar days after engaging the Independent Firm (the “Notice Date”), Buyers and Sellers each
shall present or cause to be presented to the Independent Firm in writing, and
the Independent Firm shall review and consider, their respective positions with
regard to the disputed Proposed Adjustments together with such supporting
documentation, calculation or written statements as either party may wish to
present, including documents generated by the parties during the physical
counts contemplated by paragraph (iii) above.  Sellers and Buyers shall use their respective
commercially reasonable efforts to cause the Independent Firm to render its
decisions on the disputed Proposed Adjustments as soon as it is reasonably
practicable but no later than thirty (30) calendar days after the Notice Date,
including by promptly complying with all reasonable requests of the Independent
Firm for information, papers, books, records and access to relevant personnel
and outside accountants of the parties. 
If a Proposed Adjustment to the Consignment Inventory Amount is in
dispute, the Independent Firm shall base its determination in such respect on
the review of relevant documents and discussions with customers holding
Inventory on consignment at the counted sites.  The determination of the Independent Firm
reached in accordance with this Section 1.2(b)(vi) shall be binding on the parties with respect to
changes, if any, to be made to the Proposed Adjustments.  The final Inventory Amount determined
pursuant to Sections 1.2(b)(v) and 1.2(b)(vi) is
referred to herein as the “Final Inventory.”  If Buyers
shall have submitted a Dispute Notice pursuant to Section 1.2(b)(v),
then the final Inventory Amount as agreed to by the parties or determined by
the Independent Firm shall be deemed the Final Inventory.


 


(vii)         In the event Buyers and Sellers submit any
unresolved disagreements to the Independent Firm for resolution as provided
herein, Buyers, on the one hand, and


 


10

















 


Sellers, on the other hand, shall share responsibility for the fees and
expenses of the Independent Firm as follows: 
(x) if the Independent Firm resolves all of the unresolved
disagreements in favor of either Sellers or Buyers, the other party shall be
responsible for all of the fees and expenses of the Independent Firm; or (y) if
the Independent Firm resolves certain of the unresolved disagreements in favor
of one party and the rest of the unresolved disagreements in favor of the other
party, each party shall be responsible for a proportionate amount of the fees
and expenses of the Independent Firm based on the dollar amount of the
unresolved disagreements resolved against such party compared to the total
dollar amount of all unresolved disagreements originally submitted to the
Independent Firm.


 


(viii)        Based on the Final Inventory, an adjustment
payment shall be calculated and paid as follows:  (i) if the Final Inventory shall be less
than the Inventory Amount set forth in the Estimated Inventory Statement,
Sellers shall pay to Buyers the absolute value of the difference between such
amounts; or (ii) if the Final Inventory shall be greater than the
Inventory Amount set forth in the Estimated Inventory Statement, Buyers shall
pay to Sellers the absolute value of the difference between such amounts.


 


(c)           Price Adjustment Related to Interim Sales Decline.  In the event that the total sales of the
Business in the United States for any consecutive three-month period between
the date of this Agreement and the Closing Date are less than $3,000,000 in the
aggregate, then the Purchase Price payable under this Agreement shall be
adjusted downward by an amount equal to $5,000,000.


 


(d)           Payment Method.  All payments under this Agreement will be
made by wire transfer of immediately available funds to such account as will be
specified by the party to receive such payment not less than two (2) business
days before the date the payment is to be made.


 


(e)           Release of Encumbrances.  At the Closing, Sellers shall deliver to
Buyers written evidence of full releases by third parties of any and all Encumbrances
(other than Permitted Encumbrances) against the Transferred Assets in a form
reasonably satisfactory to Buyers.


 


(f)            Allocation of Purchase Price; Individual Sales and
Purchases.


 


(i)            Sellers and Buyers agree that the Purchase
Price shall be allocated in accordance with the rules under Section 1060
of the Code and the Treasury Regulations promulgated thereunder.  Such allocation shall be determined as set
forth below (the “Final Purchase Price Allocation”). 
Sellers and Buyers agree to act in accordance with the computations and
allocations as determined pursuant to this Section 1.2(f) in
any relevant Tax Returns or filings, including any forms or reports required to
be filed pursuant to Section 1060 of the Code, the Treasury Regulations
promulgated thereunder or any provisions of Law (as defined below), and to
cooperate in the preparation of any such forms and to file such forms in the
manner required by applicable Law.


 


11

















 


(ii)           The parties acknowledge that they have
mutually prepared an  allocation
methodology schedule attached hereto as Schedule 1.2(f)(ii) (the
“Allocation Methodology”).  As soon as practicable, but no later than 10
calendar days after the Final Inventory has been determined pursuant to Section 1.2(b) hereof,
Buyers shall prepare and deliver to Sellers a schedule with their purchase
price allocation (the “Buyer Allocation”).  Such Buyer Allocation shall be prepared in
accordance with the Allocation Methodology. 
If Sellers have any good faith disagreement with the Buyer Allocation,
they shall advise Buyers in writing (an “Allocation
Dispute Notice”) of such disagreement within 30 calendar days of
receiving the Buyer Allocation, and such disagreement shall be resolved as set
forth below.  If Sellers shall not have
submitted any Allocation Dispute Notice to Buyers by the end of such 30-day
period, the Buyer Allocation shall be deemed the Final Purchase Price
Allocation.  If the disagreement(s) set
forth in the Allocation Dispute Notice (the “Allocation
Disagreements”) cannot be resolved within 30 calendar days after the
date of receipt of the Dispute Notice by Buyers, the parties agree to promptly
engage the services of an Independent Firm to review the Buyer Allocation and
resolve all such Allocation Disagreements. 
Not later than 15 calendar days after engaging the Independent Firm (the
“Presentation Date”), Buyers and
Sellers each shall present or cause to be presented to the Independent Firm in
writing, and the Independent Firm shall review and consider, their respective
positions with regard to the Allocation Disagreements.  Sellers and Buyers shall use their respective
commercially reasonable efforts to cause the Independent Firm to render its decisions
on the Allocation Disagreements as soon as it is reasonably practicable but no
later than thirty (30) calendar days after the Presentation Date, including by
promptly complying with all reasonable requests of the Independent Firm for
information, papers, books, records and access to relevant personnel and
outside accountants of the parties.  The determination of the Independent Firm
reached in accordance with this Section 1.2(f)(ii) shall be binding on the parties, and the purchase
price allocation so determined by the Independent Firm shall constitute the
Final Purchase Price Allocation.


 


(iii)          Sellers and Buyers shall follow and use such
allocation in all income, sales, registration and other Tax Returns, filings
and other related reports made by them to any Governmental Entities.  The parties shall make appropriate further
adjustments to the allocations in the Final Purchase Price Allocation schedule
to reflect any adjustments to the Purchase Price arising after preparation and
delivery to Sellers of the Buyer Allocation.


 


(g)           Withholding.  Buyers shall be entitled to deduct and
withhold or cause to be deducted and withheld from amounts otherwise payable to
any person pursuant to this Agreement such amounts as it is required to deduct
and withhold with respect to such payments under any provision of federal,
state, local or foreign Tax Law.  Any
amounts so deducted and withheld will be treated for all purposes of this
Agreement as having been paid to the person in respect of which such deduction
and withholding was made.


 


12

















 


1.3          Assumption
of Liabilities.


 


(a)           Limited Liabilities To Be Assumed.  As additional consideration for the purchase
of the Transferred Assets, effective immediately after the Closing Date, in
addition to the liabilities and obligations of Buyers under the Ancillary
Agreements, Buyers shall assume, perform and discharge the following
(collectively, the “Assumed Obligations”):


 


(i)            all liabilities and obligations accruing
from, arising out of or relating to the conduct or operation of the Business by
Buyers and their affiliates or the ownership or use of the Transferred Assets
by Buyers and their affiliates for the period following the Closing Date
(except to the extent such obligations or liabilities are the responsibility of
Sellers pursuant to this Agreement or any of the Ancillary Agreements,
including pursuant to Sellers’ indemnification obligations hereunder or
thereunder);


 


(ii)           all liabilities and obligations of the
Business arising under the Acquired Contracts that accrue from, arise out of or
relate to the period following the Closing Date, except liabilities and
obligations that arise from or relate to (A) defaults thereunder or
breaches thereof by Sellers or any of their affiliates on or prior to the
Closing or (B) events or conditions occurring prior to the Closing, which,
after notice or lapse of time or both, would constitute a default or breach by
Sellers or any of their affiliates);


 


(iii)          fifty percent (50%) of the Transfer Taxes;


 


(iv)          the patient follow up obligations with
respect to the CONTINUUM PMA post-approval study; and


 


(v)           all liabilities and obligations of Buyers
under this Agreement.


 


(b)           No Other Liabilities Assumed.  Except as expressly provided in this
Agreement and other than the Assumed Obligations, Buyers shall not assume and
shall not become liable to pay, perform or discharge any liabilities or
obligations of any kind or nature, whether known or unknown, contingent or
otherwise, arising at any time (the “Excluded
Liabilities”), and such Excluded Liabilities shall include the
following:


 


(i)            all liabilities and obligations with respect to
Sellers’ Plans or with respect to Sellers’ or their affiliates’ employment of (x) current
or former employees, officers, or directors of Sellers or their affiliates or (y) other
persons, including liability for:  (A) damages
(including reasonable out-of-pocket costs and fees incurred in connection with
any claims) or interest; (B) termination of employment, unemployment
payments, notice payments, severance (including with respect to Transferred
Employees); (C) wages, salary, commissions, bonuses, deferred
compensation, overtime and RTT time; (D) retention payments, benefits,
vacation payments, options, incentives, pensions, other benefit plans or
perquisites of any kind; (E) social security payments, payroll
withholdings and Taxes, workers’ compensation; (F) employment agreements,
consulting agreements, non-compete agreements, collective bargaining
agreements; (G) claims by Governmental Entities (including social plans,
pension plans, insurance plans, health


 


13

















 


plans or
similar organizations); (H) claims by, or in respect of, any persons who
are employees of Sellers or their affiliates on the Closing Date, or any former
employees of Sellers or their affiliates (other than a Transferred Employee)
who allege that they have become employees of Buyers or any of their affiliates
as a result of the sale of the Business pursuant to Article L 122-12 of
the French Labor Code or otherwise; in each case, arising out of the Closing or
otherwise in connection with or related to the Transactions, the operations of
Sellers’ or their affiliates’ other businesses, or the operation of the
Business on or prior to the Closing Date;


 


(ii)           all liabilities or obligations with respect
to any violations of any Law arising out of the activities, submissions,
statements or filings made by any Seller or its affiliates related to the PMA
Application and Sellers’ efforts to obtain either the Initial FDA Approval or
the Secondary FDA Approval, in each case, following the Closing Date and on or
prior to the date that the PMA Application, Initial FDA Approval and/or
Secondary FDA Approval is transferred to Buyers, as set forth in Section 4.9
hereunder;


 


(iii)          any liability or obligation of Sellers under,
or for costs and expenses in connection with the negotiation and execution of,
this Agreement or the Ancillary Agreements or the consummation of the
Transactions (in each case, other than as set forth in this Agreement);


 


(iv)          any liability or obligation of Sellers and
their affiliates under any Acquired Contract, to the extent not assumed by
Buyers pursuant to Section 1.3(a)(ii);


 


(v)           liabilities or obligations related to any
Excluded Asset;


 


(vi)          any liability or obligation for Excluded
Taxes (as defined below) and any liability or obligation for Transfer Taxes to
the extent Sellers are responsible for such Transfer Taxes pursuant to Section 1.4(b);


 


(vii)         all inter-company accounts between a Seller and
any of its affiliates; and


 


(viii)        all liabilities or obligations for money
borrowed or relating to any indebtedness or accounts payable of Sellers or
their affiliates (including the Business).


 


Sellers shall
remain solely and exclusively liable for the Excluded Liabilities.


 


1.4          Taxes.


 


(a)           Property Taxes and Assessments.  In the case of personal property Taxes and
special assessments relating to the Transferred Assets, Sellers shall be
responsible for and shall pay their pro rata portion of such Taxes allocable to
the period ending on the Closing Date, and Buyers shall be responsible for and
shall pay their pro rata portion of such Taxes allocable to the period after
the Closing Date.  Sellers and Buyers
shall cooperate in timely making all filings, returns, reports, and forms as
may be required to comply with the provisions of the relevant Tax Laws.  In the event that one of the parties pays
such Taxes attributable to a period for which the


 


14

















 


other party is responsible, the
other party shall promptly reimburse the paying party for its share of such
Taxes.


 


(b)           Transfer Taxes.  Sellers, on the one hand, and Buyers, on the
other hand, shall each bear and be responsible for fifty percent (50%) of the
amount of any sales, use, transfer, documentary, recording, gains and similar
Taxes and fees, and any deficiency, interest or penalty asserted with respect
thereof (collectively, “Transfer Taxes”)
arising out of the sale or transfer of the Transferred Assets pursuant to this
Agreement, and the parties shall cooperate as to the filing of all necessary
documentation with respect to such Transfer Taxes.


 


(c)           Taxes Generally.  Sellers shall pay all Excluded Taxes, and
Buyers shall pay all Taxes attributable to the operation of the Business or the
ownership of the Transferred Assets to the extent such Taxes are allocable to
any period after the Closing Date.


 


(d)           Definitions
Relating to Taxes.


 


(i)            “Code”
means the Internal Revenue Code of 1986, as amended.


 


(ii)           “Excluded
Taxes” means (i) all Taxes attributable to the Business or the
Transferred Assets that relate to any taxable period, or portion thereof,
ending at or before the Closing Date, and (ii) all Taxes of Sellers,
whether or not attributable to the Business or the Transferred Assets, and
whether or not arising from or related to the transactions contemplated by this
Agreement.


 


(iii)          “Tax”
or “Taxes” means all United States
federal, state, local, or foreign income, profits, estimated, franchise, gross
receipts, net receipts, capital, capital stock, net worth, sales, use,
withholding, turnover, goods and services, value added, ad valorem,
registration, general business, employment, social security, disability,
occupation, real property, personal property (tangible and intangible),
recording, stamp, transfer, conveyance, severance, production, excise,
emergency excise, alternative or add-on minimum, payroll, unemployment
insurance, premium, environmental, windfall profit, custom, duty, documentary,
information reporting, back-up withholding, and other taxes, withholdings,
duties, levies, imposts, license and registration fees, and other similar
charges and assessments (including all fines, penalties, and additions
attributable to or otherwise imposed on or with respect to any such taxes,
charges, fees, levies or other assessments, and all interest thereon and any
liability arising pursuant to the application of Treasury Regulation
section 1.1502-6 or any similar provision of any applicable state, local
or foreign Tax Law) imposed by or on behalf of any Taxing Authority.


 


(iv)          “Taxing
Authority” means any foreign, federal, state or local government,
political subdivision or Governmental Entity or regulatory authority, agency,
board, bureau, commission, instrumentality or court or quasi-governmental
authority, body, or instrumentalities exercising any authority to impose,
regulate or administer the imposition of Taxes.


 


15
















 


(v)           “Tax Return” means any return, statement,
report, filing, estimate, declaration, claim for refund, information return or
statement, or form, including in each case any amendments thereto, required to
be filed with any Taxing Authority by or with respect to Taxes.


 


(vi)          “Treasury Regulations” means the U.S.
treasury regulations promulgated pursuant to the Code.


 


1.5          Closing.  The
closing of the Transactions (the “Closing”) shall
take place at the offices of Simpson Thacher & Bartlett LLP, 425 Lexington
Avenue, New York, New York 10017, on any business day mutually agreed to by
Buyers and Sellers, within five (5) business days following the date all
conditions set forth in Article 7 of this Agreement are satisfied
(such date is referred to herein as the “Closing Date”
and, as used herein, 11:59 p.m. on the Closing Date shall be deemed to be
the “Closing Time”).  The parties intend, and shall use their
commercially reasonable efforts, to cause the Closing to occur as soon as
reasonably practicable after the date of this Agreement.


 


1.6          Closing Deliverables.  At
the Closing:


 


(a)           the US Seller shall deliver the Estimated
Inventory Statement to Buyers in accordance with Section 1.2(b)(i),
and Buyers shall deliver to Sellers the Closing Date Consideration in accordance
with Section 1.2(a) as adjusted pursuant to Section 1.2(b)(ii);


 


(b)           (i) each Seller shall deliver to
Buyers a Bill of Sale, or a comparable foreign law transfer instrument, and (ii) each
Seller shall deliver to Buyers, and each Buyer shall deliver to Sellers, an
Assignment and Assumption Agreement, or a comparable foreign law transfer
instrument, in each case duly executed by such Seller or Buyer, as the case may
be, in substantially the form attached hereto as Exhibit A, as the
case may be;


 


(c)           each Seller shall deliver to Buyers
one or more assignments for any Intellectual Property registrations and
applications included in the Assigned IP Assets in the form(s) provided to
such Seller by Buyers, provided that such form(s) shall be commercially reasonable
for the purpose of recordation at the applicable government agency or registry
in the applicable country or jurisdiction;


 


(d)           Sellers shall deliver to Buyers all
such deeds, endorsements, assignments, documents of title and other instruments
necessary to vest in Buyers good and marketable title to the Transferred Assets;


 


(e)           the US Seller shall deliver to Buyers
the certificate described in Section 7.3(a);


 


(f)            the US Buyer shall deliver to the US
Seller the certificate described in Section 7.2(a);


 


(g)           the US Seller shall deliver to
Buyers, and the US Buyer shall deliver to Sellers, an incumbency certificate of
each Seller or each Buyer, as the case may be, as to the person or


 


16

















 


persons authorized to execute
and deliver the documents contemplated in this Section 1.6 and any
other documents to be executed and delivered by such Seller or Buyer, as the
case may be, in connection with the Transactions and the specimen signatures of
such person or persons;


 


(h)           the US Seller shall deliver to Buyers
evidence of all Consents required at Closing pursuant to Section 7.3(b);


 


(i)            as more fully described in Section 1.2(d),
Sellers shall deliver written evidence of full releases by third parties of any
and all Encumbrances (other than Permitted Encumbrances) against the
Transferred Assets to Buyers in a form reasonably satisfactory to Buyers;


 


(j)            Sellers and Buyers shall execute and
deliver the Cross License Agreement in the form attached hereto as Exhibit B
(the “Cross License Agreement”), the
Transition Services Agreement in the form attached hereto as Exhibit C
(the “Transition Services Agreement”), the
Transition Supply Agreement in the form attached hereto as Exhibit D
(the “Transition Supply Agreement”) and the
Clinical Studies Agreement in the form attached hereto as Exhibit E
(the “Clinical Studies Agreement” and
together with the Bill of Sale, the Assignment and Assumption Agreement, the
Cross License Agreement, the Transition Services Agreement and the Transition
Supply Agreement, the “Ancillary Agreements”);


 


(k)           US Seller shall deliver to
Buyers a tax certificate (the “US Seller Tax Certificate”)
substantially in the form attached hereto as Exhibit G-1, duly
completed and executed by US Seller pursuant to section 1.1445-2(b)(2) of
the Treasury Regulations, certifying that US Seller is not a “foreign person”
within the meaning of Section 1445 of the Code.  EU Seller shall deliver to Buyers a tax
certificate (the “EU Seller Tax Certificate”)
substantially in the form attached hereto as Exhibit G-2, duly
completed and executed by EU Seller pursuant to section 1.1445-2(c)(1) of
the Treasury Regulations, certifying that EU Seller has not transferred any
property to Buyers that is a “United States real property interest” within the
meaning of Section 897 of the Code; and


 


(l)            each party shall execute and deliver
such other appropriate and customary certificates and documents as the other
party reasonably may request for the purpose of consummating the Transactions.


 


All actions
taken at the Closing shall be deemed to have been taken simultaneously at the
time the last of any such actions is taken or completed.


 


1.7          Accounts Receivable.  Any
amounts relating to accounts receivable arising on or prior to the Closing Date
in connection with the operation of the Business that are mistakenly paid to
Buyers shall be paid by Buyers to Sellers, and any amounts relating to accounts
receivable arising after the Closing Date in connection with the operation of
the Business that are mistakenly paid to Sellers shall be paid by Sellers to
Buyers.


 


1.8          Further Assurances.  After
the Closing, the parties hereto shall execute and deliver such additional
documents and take such additional actions as may reasonably be deemed necessary
or advisable by any party in order to consummate the Transactions and to vest
fully in


 


17

















 


Buyers title to and ownership of the Business
and the Transferred Assets (including, upon request by Buyers, assistance in
the collection or reduction to possession of any of the Transferred Assets and
payment or discharge of any Permitted Encumbrances on any of the Transferred Assets).


 


2.                                      REPRESENTATIONS AND WARRANTIES OF SELLERS


 


Each Seller, with respect to itself and the
Transferred Assets and Assumed Obligations owned or held by it prior to the
Closing, provides to each Buyer the representations and warranties contained in
this Article 2, as of the date of this Agreement and as of the
Closing, except as set forth in the disclosure schedule attached as Exhibit F-1
(the “Disclosure Schedule”).  The Disclosure Schedule is arranged to
cross-reference the numbered Sections of this Agreement to which disclosures
apply; provided that any disclosure included in the Disclosure Schedule
shall also be deemed to qualify and apply to any other Section of this Article 2
if it is reasonably apparent from the disclosure set forth in such Section of
the Disclosure Schedule that it applies to such other Section.  No reference to or disclosure of any item or
other matter in the Disclosure Schedule shall be construed as an admission or
indication that such item or other matter is material or that such item or
other matter is required to be referred to or disclosed in the Disclosure
Schedule.  No disclosure in the
Disclosure Schedule relating to any possible breach or violation of any
Contract or Law shall be construed as an admission or indication that any such
breach or violation occurred or exists.


 


2.1          Organization
and Good Standing.  Each Seller is duly
organized, validly existing and in good standing under the Laws of its
jurisdiction of incorporation or organization, and is in good standing to do
business as a foreign entity in all jurisdictions where failure to be in good standing
would reasonably be expected to result in a Material Adverse Effect.  As used in this Agreement, “Material Adverse Effect” means any event, circumstance,
occurrence, condition, development, change or effect that, individually or in
the aggregate with all other events, circumstances, occurrences, conditions, developments,
changes and effects:  (A) is or
would reasonably be expected to be materially adverse to the assets, rights,
properties, liabilities, operations, results of operations or financial condition
of the Business, other than any such event, circumstance, occurrence, condition,
development, change or effect to the extent resulting from or arising in
connection with (i) any change after the date of this Agreement in general
economic or financial market conditions, (ii) any change after the date of
this Agreement in GAAP or changes in Law (including Tax Laws or Tax regulations),
(iii) general changes or developments after the date of this Agreement in
the industry in which the Business is operated or in the medical devices
industry, (iv) the public announcement of this Agreement, including any
loss of sales in the United States or loss of employees or labor disputes or
employee strikes, slowdowns, job actions or work stoppages or labor union
activities (except that this clause (iv) shall not apply in respect
of Section 2.3 or 2.4), (v) any war, act of terrorism,
civil unrest, natural disasters, acts of God or similar events occurring after
the date of this Agreement, or (vi) any action by Sellers taken with the
consent or at the direction of Buyers or the compliance by Sellers with the
terms of this Agreement, except in each of the cases in clauses (i) through
(iii) and (v) to the extent any such changes have or would reasonably
be expected to have a disproportionate adverse effect on the Business as
compared to other businesses in the industry in which the Business is operated;
or (B) would reasonably be expected to prohibit or materially delay
Sellers’ ability to fulfill any


 


18

















 


of their respective material obligations
under this Agreement or the Ancillary Agreements or to consummate the
Transactions in accordance with this Agreement.


 


2.2          Authority; Binding
Effect.   Each Seller has the corporate or
limited liability company power and authority, and all Permits (as defined
below) required by any Governmental Entities or other authorities, to own,
lease and operate its assets and property and to carry on its business as now
being conducted, except as would not reasonably be expected to result in a
Material Adverse Effect.  Each Seller has
the requisite power and authority to execute, deliver and perform this
Agreement, the Ancillary Agreements and the other documents required to be
executed by it pursuant to this Agreement.  This Agreement, the Ancillary Agreements and
each of the other documents to be executed in connection with this Agreement
have been duly authorized, executed and delivered (or when executed, will be
duly executed and delivered) by each Seller and no other proceedings on the
part of any Seller (or its affiliates, directors or shareholders) are necessary
to authorize, consummate and perform this Agreement, the Ancillary Agreements,
the other documents to be executed in connection herewith or the
Transactions.  Assuming they constitute
the legal, valid and binding obligation of each Buyer, this Agreement, the
Ancillary Agreements and the other documents executed or to be executed in
connection with this Agreement are, or when executed and delivered will be, the
legal, valid and binding obligations of each Seller enforceable in accordance
with their terms, except as enforceability may be (a) limited by
bankruptcy, insolvency, reorganization, moratorium or similar Laws and (b) subject
to general principles of equity (regardless of whether such enforcement is considered in a
proceeding in equity or at law).


 


2.3          Consents.  Except as set forth in Section 2.3
of the Disclosure Schedule, there are no authorizations, consents, permits, waivers,
orders, licenses or approvals of, or declarations, registrations or filings
with, any Governmental Entity or any other third party or person (each, a “Consent”) that are required in connection with the
execution, delivery or performance by Sellers of this Agreement, the Ancillary
Agreements or the other agreements executed or to be executed by Sellers in
connection with this Agreement or the consummation by Sellers of the
Transactions, other than Consents the failure of which, individually or in the
aggregate, to obtain would not reasonably be expected to result in a Material
Adverse Effect or limit or materially adversely affect Buyers’ ability to (a) own
or use the Transferred Assets or (b) own and operate the Business
following the Closing.  Notwithstanding
the foregoing, certain Non-U.S. Contracts (as defined below) may require
Consent in connection with the execution, delivery or performance by Sellers of
this Agreement, the Ancillary Agreements or the other agreements executed or to
be executed by Sellers in connection with this Agreement or the consummation by
Sellers of the Transactions.  Such
Non-U.S. Contracts will be listed in a supplement to Section 2.3 of the
Disclosure Schedule after the date of this Agreement and on or prior to the
Closing Date.  As such, the
representations and warranties set forth in this Section 2.3 with
respect to such Non-U.S. Contracts will be true and correct only as of the
Closing Date and not as of the date of this Agreement.


 


2.4          No Breach.  Except as set forth in Section 2.4
of the Disclosure Schedule, the execution, delivery and performance of this
Agreement, the Ancillary Agreements and the other documents executed or to be
executed in connection herewith, and the consummation by Sellers of the
Transactions do not and will not, with or without notice or lapse of time or
both, violate,


 


19

















 


breach, conflict with,
constitute a default under, or permit the termination or the acceleration of
maturity or performance of, or result in the imposition of any Encumbrance upon
any property, right or asset of the Sellers or their respective affiliates
(including the Transferred Assets) or any of the Assumed Obligations pursuant
to:  (i) any provision of the
respective certificate of incorporation, certificate of formation, charter,
limited liability company agreement, bylaws or other similar organizational
documents of any Seller; (ii) any federal, state, local or foreign law,
statute, ordinance, rule, regulation, guidance or guideline (“Law”) or order, writ, judgment, injunction,
award or decree of any Governmental Entity (“Order”)
to which any Seller or their respective affiliates or any of their respective
assets, rights or properties or any of the Assumed Obligations are subject; or (iii) any
contract, agreement, license, commitment, lease, purchase order or other
instrument (including with customers, suppliers, distributors or employees),
note, bond, indenture, mortgage, deed of trust, loan, guarantee, security
agreement, pledge agreement or other evidence of indebtedness (collectively, “Contracts”) to which any Seller or their
respective affiliates is a party, by which any Seller or their respective
affiliates is bound, or to which any of the Transferred Assets, Assumed
Obligations or the Business is subject except, in the case of clause (ii) or
(iii) above, for any violations, conflicts, defaults, breaches,
terminations, accelerations or impositions that would not, individually or in
the aggregate, reasonably be expected to result in a Material Adverse Effect.


 


2.5          Financial Information.  The financial information set forth on Section 2.5
of the Disclosure Schedule (the “Financial Information”)
fairly presents, in all material respects, (i) the Inventory of the Business
as of September 30, 2007, (ii) the direct revenues of the Business
for the year ended December 31, 2006 and the ten (10) months ended October 31,
2007, and (iii) the actual gross profit of the Business for the year ended
December 31, 2006 and the ten (10) months ended October 31, 2007.
 The Inventory of the Business as of September 30,
2007 has been prepared in accordance with the Accounting Methodologies, and the
direct revenues and actual gross profit of the Business described above has
been prepared in accordance with Sellers’ historical management accounting
methods, consistently applied throughout such periods.


 


2.6          Tax Liabilities.  There are no Encumbrances on any Transferred Asset
imposed by any Taxing Authority and, to the knowledge of Sellers, there is no
proposal by any Taxing Authority to attach any such Encumbrances.


 


2.7          Litigation.


 


(a)           There is no material (i) suit,
claim (including warranty and product liability claims), action, complaint,
demand, litigation, arbitration, hearing, charge, notice, inquiry, review,
investigation or proceeding (collectively, a “Claim”)
or (ii) Order in effect, pending or asserted, or to the knowledge of
Sellers threatened, against any Seller or any of its affiliates with respect to
the Business, the Transferred Assets or the Assumed Obligations, or otherwise in
any material respect affecting the Business, the Transferred Assets or the
Assumed Obligations or the ability of Sellers to consummate the Transactions.


 


(b)           Sellers’ and their affiliates’
quality systems and records for complaint management and corrective and
preventive action and any other complaint handling system


 


20

















 


required by any other
Governmental Entity (“Complaint System”)
relating to the Products has been made available for review by Buyers and
contains, in all material respects, true, complete and correct records and
information about all Products.  The
records of Sellers and their affiliates relating to credits and allowances made
with respect to any Products have been made available for review by Buyers and
are true, complete and correct in all material respects.


 


(c)           Except as set forth in Section 2.7(c) of
the Disclosure Schedule, Sellers have made no material modifications to any
Product because of Claims concerning defects in such Product.  Except as set forth in Section 2.7(c) of
the Disclosure Schedule, since January 1, 2003, neither Sellers nor any of
their affiliates has been a defendant in any litigation involving product
liability or warranty claims, in each case with respect to the Products, and,
since such date, to the knowledge of Sellers, no such litigation has been threatened.


 


2.8          Compliance With Laws.


 


(a)           Each Seller and its affiliates is in
compliance with all Laws and Orders applicable to the Business, the Transferred
Assets and the Assumed Obligations and its own posted and internal policies
regarding privacy and personal information, except as would not reasonably be
expected to result in a Material Adverse Effect, and has not received any written
notification of any alleged failure or noncompliance with respect to the
foregoing.


 


(b)           Without limiting the generality of
the foregoing, except as set forth in Section 2.8(b) of the
Disclosure Schedule 2.8(b), Sellers and their affiliates have conducted and are
conducting the Business and have used and are using the Transferred Assets in
compliance in all material respects with the Federal Food, Drug, and Cosmetic
Act (the “FD&C Act”), 21 U.S.C. §301 et seq.,
and applicable regulations promulgated thereunder by the FDA (collectively, “FDA Law”) and European Union Directive 93/42 EEC, as amended
(the “Directive”), and applicable national
legislation of the European Union Member States (collectively, “EU Law”).  Each
Medical Device, as that term is defined in 21 U.S.C. § 321(h) (Section 201(h) of
the FD&C Act) or Article 1.2 of the Directive, that has been or is
being developed, manufactured, tested, packaged, labeled, distributed or
marketed by the Business, has been and is being developed manufactured, tested,
packaged, labeled, distributed or marketed by the Business in compliance in all
material respects with applicable Laws, including FDA Law or EU Law, including
those relating to:  (A) good
manufacturing practices, including quality systems requirements; (B) regulatory
approvals or clearances to market Medical Devices in the United States; (C) investigational
devices; (D) clinical studies and the protection of human subjects; (E) labeling;
(F) record keeping; and (G) filing of reports to the FDA or EU
competent authority.


 


(c)           Except as set forth in Section 2.8(c) of
the Disclosure Schedule, none of the Products have been recalled, whether
voluntarily or otherwise, or are or have been subject to device removals or
corrections required to be reported to the FDA or any other Governmental
Entity, and Sellers have not received notice, either completed or pending, of
any proceeding seeking a recall, removal, or corrective action of any Products.


 


21

















 


(d)           Neither Sellers nor their affiliates
nor any of their employees (or to the knowledge of Sellers, agents) have
knowingly made an untrue statement of material fact or fraudulent statement to
the FDA or any other Governmental Entity or notified body with respect to any
Product tested, manufactured, distributed, or sold by Sellers or their
affiliates, or failed to disclose a material fact required to be disclosed to
any Governmental Entity or notified body.


 


(e)           Sellers and their affiliates and
their officers, directors and employees (and to the knowledge of Sellers,
agents) have not, with respect to the Business: 
(A) been debarred or received notice of action or threat of action
with respect to debarment under the provisions of 21 U.S.C. §§ 335a,
335b, or 335c, 42 U.S.C. § 1320a-7, 45 C.F.R. Part 76 or any
equivalent provisions in any other jurisdiction; or (B) been subject to
any other enforcement action involving the FDA or similar Governmental Entity
in any other jurisdiction, including any suspension, consent decree, notice of
criminal investigation, indictment, sentencing memorandum, plea agreement,
court order or target or no-target letter, and none of the foregoing are
pending, asserted or, to the knowledge of Sellers, threatened against same.


 


(f)            Without limiting the generality of
the foregoing, each Seller and its affiliates are conducting the Business and
using the Transferred Assets, and have always conducted the Business and used
the Transferred Assets, in compliance with the Anti-Kickback Statute (42 U.S.C.
§ 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a),
the Stark Law (42 U.S.C. § 1395nn), the False Claims Act (31 U.S.C.
§ 3729 et seq.) and all of the regulations promulgated under all such
statutes.


 


(g)           To the extent applicable to the
Business and to the knowledge of Sellers:


 


(i)            each
Seller and each affiliate pays only reasonable travel and meal costs for health
care professionals receiving training sponsored by it, and each such health
care professional has a bona fide need for such training;


 


(ii)           (A) each
Seller and each affiliate provides educational grants to third party
educational sponsors only if such sponsors have a genuine educational purpose
or function and only when:  (x) the
educational gathering is primarily dedicated to promoting objective scientific
and educational activities and discourse; and (y) the training institution
or the conference sponsor selects the attending health care professionals who
are in training and (B) any meals sponsored or furnished by any Seller or
affiliate at a conference sponsored by a third party are of modest value;


 


(iii)          each
Seller and each affiliate pays consultants no more than fair market value for
their services, plus reasonable and actual expenses, and only purchases
services for which there is a commercially reasonable need that is identified
by the parties in advance;


 


(iv)          any
gift furnished by a Seller or an affiliate has never exceeded $100 and has
never been in the form of cash or a cash equivalent;


 


22

















 


(v)           all
grant making functions for each Seller and affiliate are separated from each
such entity’s sales and marketing functions; and


 


(vi)          all
price concessions offered or furnished by each Seller and affiliate to
purchasers comply with the discount safe harbor (42 C.F.R. § 1001.952(h)).


 


(h)           No Seller or affiliate has
established any reimbursement support program, such that payment for any
Product is contingent upon a purchaser’s receipt of payment from a third party
payer.  No Seller or affiliate furnishes
any coverage, coding, or billing advice to any health care professionals
regarding off-label indications of any Product.


 


(i)            Each Seller and each affiliate that
sells any Product has implemented a compliance plan, pursuant to which training
is furnished to all members of such Seller’s or affiliate’s sales force and
other personnel who have material contact with health care professionals on
behalf of Sellers or their affiliates.


 


(j)            To the knowledge of Sellers, there
is no pending proposed or final Medicare national or local coverage
determination that, if finalized, would restrict coverage for any of the
Products.


 


2.9          Title to Properties.


 


(a)           Sellers collectively have good, valid,
and marketable title to, or own, the Transferred Assets.  None of the Transferred Assets are subject to
any Encumbrances except:  (1) mechanics,
carriers, workers, repairs and other similar liens or encumbrances arising or
incurred in the ordinary course of business which are not material in aggregate
amount and which do not materially adversely affect the value or impair the use
of the property subject thereto, and (2) Encumbrances for Taxes that are
not yet due and payable (“Permitted
Encumbrances”).


 


(b)           Subject to obtaining the Consents set
forth in Section 2.3 of the Disclosure Schedule:  (i) Sellers have complete and
unrestricted power and the unqualified right to sell, transfer, convey, assign,
and deliver to Buyers; and (ii) assuming Buyers are bona fide purchasers, Buyers
shall hereby acquire, good, valid and marketable title to, or ownership of, the
Transferred Assets free and clear of all Encumbrances other than Permitted
Encumbrances.  Except as set forth in Section 2.9(b) of
the Disclosure Schedule and except for matters covered by Section 2.11,
the Transferred Assets, together with (x) assets, rights or services to be
provided to Buyers pursuant to the Ancillary Agreements, and (y) assets
(including records, data and files), rights or services used in connection with
the finance, accounting, legal, quality, regulatory, logistics, administrative,
governance or other general corporate functions of Sellers, constitute all of
the assets, rights and properties necessary for Buyers to operate and conduct the
Business as it was operated and conducted as of September 30, 2007, the
date of this Agreement and the Closing Date.


 


2.10        Condition
of Tangible Assets.  The assets, property,
equipment and other tangible property (“Tangible Assets”)
included in the Transferred Assets, whether owned or


 


23

















 


leased, have no material
defects, are in good condition and repair in all material respects, subject
only to ordinary wear and tear, and are usable in the Business as it was
operated and conducted as of September 30, 2007, the date of this
Agreement and the Closing Date.


 


2.11        Intellectual Property.


 


(a)           Section 2.11(a)(i)(A) and (B) of
the Disclosure Schedule identify, respectively, each Intellectual Property
registration and application included within the Assigned IP Assets and
licensed to Buyers pursuant to the Cross License Agreement.  Except as disclosed on Section 2.11(a)(ii) of
the Disclosure Schedule, all of the foregoing are subsisting and unexpired, and
to the knowledge of Sellers, valid and enforceable, and no action is due within
ninety (90) days after the date of this Agreement to maintain same.


 


(b)           (i) Sellers
and their affiliates own all of the material Intellectual Property included in
the Assigned IP Assets or licensed to Buyers pursuant to the Cross License
Agreement, free and clear of all Encumbrances (including any claims by current
or former employees or contractors) other than Permitted Encumbrances, and have
the right to transfer or license same to Buyers; (ii) except as set forth
in Section 2.11(b)(ii) of the Disclosure Schedule, no material Claim
or Order is pending or asserted, or to the knowledge of Sellers, threatened
(including “cease and desist” letters or invitations to enter into a patent
license) against any Seller or its affiliates:  (x) with respect to any material Intellectual
Property (including its ownership, use, validity or enforceability) included in
the Assigned IP Assets or licensed to Buyers pursuant to the Cross License
Agreement; or (y) with respect to the Intellectual Property of any Person
concerning the conduct of the Business as currently conducted and the
development of the existing Products; (iii) the conduct of the Business as
currently conducted and the development of the existing Products do not
infringe, misappropriate or violate, in any material respect, the Intellectual
Property (excluding Patents) of any Person, and to the knowledge of Sellers, no
person is infringing, misappropriating or violating any Assigned IP Assets or
any material Intellectual Property licensed to Buyers pursuant to the Cross
License Agreement; (iv) Sellers have taken
reasonable steps to protect, enforce and maintain the value and validity (and as applicable, secrecy) of any
material Assigned IP Assets and any material Intellectual Property
licensed to Buyers pursuant to the Cross License Agreement, have a commercially reasonable practice governing
the maintenance and access to their trade secrets or material
confidential information and, to the knowledge of Sellers, no material
violation of such policy has occurred; and (v) Sellers have a practice
requiring all persons who create, invent or contribute to items within the
Assigned IP Assets or material Intellectual Property licensed to Buyers
pursuant to the Cross License Agreement to execute an assignment agreement and,
to the knowledge of Sellers, no material violation of such practice has
occurred.


 


(c)           Schedule 1.1(a)(xi) sets
forth all Acquired IP Contracts, other than Contracts for off-the-shelf
software subject to a commercially available shrink or click wrap license
agreement.  Sellers have furnished or
made available to Buyers true and complete copies of all Acquired IP Contracts.


 


(d)           The Know-How included in the
Transferred Assets, together with the Know-How licensed to Buyers and their
controlled affiliates by Sellers and their controlled affiliates pursuant


 


24

















 


to the Cross License Agreement,
constitutes all of the Know-How necessary for Buyers to operate and conduct the
Business as it was operated and conducted as of September 30, 2007, the
date of this Agreement and the Closing Date.


 


(e)           Notwithstanding anything herein to
the contrary, except for the representations and warranties contained in this Section 2.11,
Sellers do not make any representation or warranty of any kind (whether
express, implied or otherwise) with respect to (i) the validity or
enforceability of the Intellectual Property included in the Assigned IP Assets
or the Intellectual Property licensed to Buyers pursuant to the Cross-License
Agreement or (ii) non-infringement of third party Intellectual Property.


 


2.12        [Intentionally Omitted]


 


2.13        Labor Relations.  Each
Seller and its affiliates (as relates to the Business or the employees of the
Business) is, and has been, in compliance in all material respects with the
Worker Adjustment and Retraining Notification Act of 1988 (“WARN”) and any similar applicable state or
local Laws.


 


2.14        Contracts.


 


(a)           Section 2.14(a) of
the Disclosure Schedule sets forth a list, as of the date of this Agreement, of
the following Contracts
(including summaries of oral agreements) to which any Seller or any of its
affiliates is a party or by which it or any of the Assets or the Assumed
Obligations is or may be bound or affected, in each case, that are material to
the operation or financial condition of the Business or are Acquired Contracts,
and further identifies which of such Contracts are not Acquired Contracts:


 


(i)            any
Contract that provides for either (x) payments to or by the Business of One
Hundred Thousand Dollars ($100,000) or more in any twelve-month period, or (ii) aggregate
payments to or by the Business of Five Hundred Thousand Dollars ($500,000) or
more (other than purchase orders or purchase commitments related to Sellers’ obligations
under the Transition Supply Agreement or the Transition Services Agreement,
except to the extent any such purchase orders or purchase commitments would
impose any obligations on the Business following termination of the Transition
Supply Agreement or the Transition Services Agreement);


 


(ii)           any material Contract relating to research and
development conducted or to be conducted related to the Business or any
Product, and all Contracts related to clinical trials;


 


(iii)          any
Contract that (A) prohibits or materially restricts the conduct or
operation of the Business or that would limit in any material respect the
freedom of Buyers or any of their affiliates to compete in any line of business
or with any person or in any geographical area or (B) requires the
referral of any business by Sellers or requires the Business to invest in any
third party or to make available investment or other business opportunities or
products or services on a priority, equal or exclusive basis;


 


25

















 


(iv)          any
material joint venture, partnership or similar agreement;


 


(v)           any
material Contract providing for or otherwise involving the payment or credit of
rebates, discounts or other consideration to customers of the Business;


 


(vi)          any
material consulting agreement relating to the Business, other than Contracts
with physician consultants set forth on Schedule 1.1(b)(xii);


 


(vii)         any
material lease of personal property, whether as lessor or lessee;


 


(viii)        any
material guaranty or suretyship, performance bond, indemnification or
contribution agreement, including any corporate or personal guarantee to
suppliers, sureties, banks or others; and


 


(ix)           any
Contract which is otherwise material to the conduct of the Business (or the
violation of which would, individually or in the aggregate, reasonably be
expected to result in a Material Adverse Effect).


 


(b)           Sellers have furnished or made
available, or will furnish or make available pursuant to Section 4.6(b),
to Buyers true and complete copies of all Contracts (or summaries of all oral
agreements) required to be listed in Section 2.14(a) of the
Disclosure Schedule (such Contracts, “Material
Contracts”).  Notwithstanding
the foregoing, certain non-U.S. Contracts (the “Non-U.S. Contracts”) are Material Contracts which are not
listed in Section 2.14(a) of the Disclosure Schedule as of the date
of this Agreement and which Sellers have not furnished or made available to
Buyers as of the date of this Agreement. 
The Non-U.S. Contracts will be listed in a supplement to Section 2.14(a) of
the Disclosure Schedule and provided to Buyers after the date of this Agreement
pursuant to Section 4.6.  As
such, the representations and warranties set forth in this Section 2.14
with respect to The Non-U.S. Contracts will be true and correct only as of the
Closing Date and not as of the date of this Agreement.  All Material Contracts are valid and legally
binding on and enforceable against the applicable Sellers and, to the knowledge
of Sellers, the counterparties thereto.  Each
Material Contract, subject to obtaining the applicable Consents, shall be
valid, binding and enforceable in all material respects immediately following
the consummation of the Transactions, assuming Buyers are, at such time, in
compliance with their obligations under such Material Contract.  There is no material dispute among, or material
breach alleged by any of, the parties to any Material Contract and no notice of
any penalty or liability has been delivered to Sellers with respect thereto.  To the knowledge of Sellers, none of the
suppliers, distributors or customers of the Business who is a party to a
Material Contract has refused, or communicated that it will refuse, to purchase,
distribute or supply goods or services in material amounts, as the case may be,
or has communicated that it will materially reduce amounts of goods or services
that it is willing to purchase from, or sell to, the Business or Buyers.  Sellers have not received any written notice from
any counterparty to a Material Contract of any material dispute, breach,
penalty, liability, refusal or other default or event that with or without
notice or lapse of time or both, would violate, breach, conflict with,
constitute a default under, or permit the termination or the acceleration of
maturity or performance of, or result in the imposition of any Encumbrance (other
than Permitted Encumbrances) upon any of the Transferred Assets or any of the
Assumed Obligations.


 


26

















 


2.15        Inventory.


 


Except with respect to obsolete or excess items
which have been reserved for in the Sellers’ Inventory reserves, the Inventory of
the Business consists of items in usable condition and saleable in the ordinary
course of the Business.


 


2.16        Permits; Regulatory
Matters.


 


(a)           Permits.


 


(i)            Schedule 1.1(a)(vii) sets
forth a true and complete list of all material Business Permits.


 


(ii)           Except
as set forth in Section 2.16(a)(ii) of the Disclosure Schedule and
except for Permits (as defined below) dictated by the location of the
facilities, there are no approvals, licenses, permits, clearances, permissions,
exemptions, certifications, authorizations, consents of, or declarations,
registrations or filings with, any Governmental Entity (“Permits”) which are required for the
operation of the Business as conducted in the ordinary course as of September 30,
2007, the date of this Agreement and the Closing Date that are not included in
the Business Permits, other than Permits the absence of which, individually or in
the aggregate, to maintain in effect or obtain would not reasonably be expected
to result in a Material Adverse Effect or materially adversely affect Buyers’
ability to own and operate the Transferred Assets or the Business following the
Closing.


 


(iii)          (x) Each
Business Permit is valid and in full force and effect in all material respects in every jurisdiction in which it is
required pursuant to applicable Laws; (y) the execution and delivery of
this Agreement and the Ancillary Agreements, and the consummation of the
Transactions will not result in any non-renewal, revocation, cancellation,
suspension or modification of any Business Permit, except as would not
reasonably be expected to result in a Material Adverse Effect; and (z) Sellers
are not in violation in any material respect of
any Business Permits, and no condition exists that with notice or lapse of time
or otherwise would constitute such a violation under the Business Permits.


 


(b)           FDA/EU
Applications.  Section 2.16(b) of
the Disclosure Schedule contains a list of all FDA/EU Applications that are
owned by Sellers and their affiliates and are Primarily Used in the
Business.  All of such FDA/EU
Applications are in good standing, subsisting, not abandoned, and are, to the
knowledge of Sellers, valid and enforceable. 
Except as set forth in Section 2.16(b) of the Disclosure
Schedule, no actions are due within ninety (90) days after the date hereof to
maintain any such FDA/EU Applications.  “FDA Applications” means all investigational
device applications, 510(k) premarket notifications, premarket approval
applications, supplemental premarket approval applications, master files, as
defined in 21 C.F.R. § 814.3, and all supplements or amendments
thereto, whether pending or approved or cleared by the FDA.  “EU
Applications” means all CE Marks, and any applications or
assessments to obtain marketing authorizations in the EU, whether pending or
approved or cleared by the


 


27

















 


applicable EU Governmental
Entities.  “FDA/EU Applications” means, collectively, the FDA Applications
and the EU Applications.


 


(c)           Except as identified in Section 2.16(c) of
the Disclosure Schedule, no Governmental Entity has issued any written notice,
warning letter, regulatory letter, untitled letter, Form FDA 483, or
other written communication or correspondence, or to the knowledge of Sellers,
any other communication or correspondence to Sellers or any of their
affiliates, (i) alleging that either the Business or the Transferred
Assets are or were, in any material respect, in violation of any Law applicable
to the research, development, testing, manufacturing, packaging, labeling,
marketing, distribution, sale or commercialization activities conducted by
Sellers or their affiliates with respect to the Business or the Transferred
Assets, or (ii) alleging that there are circumstances currently existing
which might reasonably be expected to lead to any loss of, refusal to renew or
refusal to approve any FDA/EU Application, FDA approval or material Business
Permit.


 


2.17        Absence of Certain Changes.  Except as set forth on Section 2.17 of
the Disclosure Schedule, since September 30, 2007, the Business has been
conducted only in the ordinary course and consistent with past practices in all
material respects.  Since December 31,
2006, Sellers have not suffered any change in the operations of the Business, results
of operations of the Business, Transferred Assets, Assumed Obligations or financial
condition of the Business, other than changes that, individually or in the
aggregate, have not resulted in and would not reasonably be expected to result
in a Material Adverse Effect.


 


2.18        No Brokers; Affiliate Transactions.


 


(a)           No agent, broker, finder or other
person or entity acting on behalf of Sellers or their affiliates will be
entitled to any broker’s, finder’s or similar fee or commission in connection
with the Transactions.


 


(b)           There are no Acquired Contracts between
a Seller (or any of its affiliates), on the one hand, and any affiliates of
such Seller , on the other hand.


 


2.19        Environmental Matters.


 


(a)           Except as, individually or in the
aggregate, would not reasonably be expected to result in a Material Adverse
Effect:  (i) the Business is in
compliance with all, and has not violated any, Environmental Laws applicable to
it; (ii) none of the Sellers or their affiliates has received any written notice
or claim asserting that the Business has violated any Environmental Laws, or
that any of the Sellers is liable or has any obligations to any Person as a
result of the presence or release of any Materials of Environmental Concern
relating to the Business, or indicating that there is any investigation of or
inquiry into the possibility of such a claim, and to Sellers’ knowledge there
is no basis for any such claim; and (iii) no Seller or any of their
affiliates is a party to any proceeding, investigation, or agreement concerning
Environmental Laws or the presence or release of any Materials of Environmental
Concern with respect to the Business. 
Sellers have provided to Buyers copies of all reports, assessments,
audits, and other similar documents, to the extent in the possession or control
of any of them, containing


 


28

















 


information material to the
Business regarding Environmental Laws or Materials of Environmental Concern.


 


(b)           For purposes of this Agreement, the
terms below shall have the meaning assigned:


 


(i)            “Environmental Laws” shall mean any and all
Laws (including common law) or Orders of the United States, any other nation,
and any state, local, municipal, or transnational authority, regulating,
relating to or imposing liability concerning pollution or protection of the
environment, or human health and safety as affected by exposure to Materials of
Environmental Concern; and


 


(ii)           “Materials of Environmental Concern” shall
mean any gasoline or petroleum (including crude oil or any fraction thereof) or
petroleum products, polychlorinated biphenyls, urea-formaldehyde insulation,
hazardous wastes, toxic substances, asbestos, pollutants, or contaminants
defined as such in, or regulated or that could reasonably be expected to result
in liability under, any applicable Environmental Law.


 


2.20        Business Data; Product
Specifications.


 


(a)           Section 2.20(a) of the Disclosure
Schedule provides a true, correct and complete list as of the date of this
Agreement of the following (the “Business
Data”):


 


(i)            any
sole sources of supply for any raw material, supply or component part required
or used in connection with any Product or in the Business;


 


(ii)           all
locations at which Transferred Assets that are Tangible Assets (other than
Inventory) are located (including locations owned or controlled by third
parties); and


 


(iii)          all
locations at which any Product clinical trials are being conducted.


 


(b)           With respect to any raw material,
supply or component part for which Sellers rely on a single source of supply,
to the knowledge of Sellers, there is no circumstance or condition that would,
after the Closing, reasonably be expected to cause Buyers not to be able to
obtain such items from such sole source suppliers on comparable terms and
conditions so as to operate and conduct the Business in substantially the same
manner as the Business was conducted and operated as of September 30,
2007, the date of this Agreement and the Closing Date.


 


(c)           The Product Specifications are
complete, current and accurate in all material respects, and include all documented
or tangibly evidenced data and know-how used by Sellers to manufacture the
Products before the Closing and are sufficient in detail and content to
identify and explain the designs, concepts and processes described therein.


 


2.21        No Other Representations and Warranties.  Except for the representations and warranties
contained in this Agreement or any schedule, annex, exhibit or document
delivered pursuant hereto, no Seller makes any representation or warranty of
any kind (whether express,


 


29

















 


implied or otherwise or whether
on behalf of itself or its affiliates), including with respect to the
Transferred Assets (including the value of any Transferred Asset), the Business
or otherwise with respect to any other information provided to Buyers,
including as to (a) the merchantability or fitness for any particular use
or purpose, (b) the operation of the Business by Buyers after the Closing,
or (c) the probable success or profitability of the ownership, use or
operation of the Transferred Assets by Buyers after the Closing.


 


3.                                      REPRESENTATIONS AND WARRANTIES OF BUYERS


 


Each Buyer,
with respect to itself, provides to each Seller the representations and
warranties contained in this Article 3, as of the date of this
Agreement and as of Closing except as set forth in the disclosure schedule attached
as Exhibit F-2  (the “Buyers’ Schedule”). 
The Buyers’ Schedule is arranged to cross-reference the numbered
Sections of this Agreement to which disclosures apply; provided that any
disclosure included in the Buyers’ Schedule shall also be deemed to qualify and
apply to any other Section of this Article 3 if it is
reasonably apparent from the disclosure set forth in such Section of the Buyer’s
Schedule that it applies to such other Section.  No reference to or disclosure of any item or
other matter in the Buyer’s Schedule shall be construed as an admission or
indication that such item or other matter is material or that such item or
other matter is required to be referred to or disclosed in the Buyer’s
Schedule.  No disclosure in the Buyer’s
Schedule relating to any possible breach or violation of any Contract or Law
shall be construed as an admission or indication that any such breach or
violation occurred or exists.


 


3.1          Organization and Good Standing.  Each Buyer is duly organized, validly
existing, and in good standing under the Laws of its jurisdiction of
incorporation or organization.


 


3.2          Authority; Binding Effect.  Each Buyer has the corporate or limited
partnership power and authority, and all Permits required by any Governmental Entities
or other authorities, to own, lease and operate its assets and property and to
carry on its business as now being conducted, except as would not reasonably be
expected to prohibit, impede or materially delay the consummation of the
Transactions by Buyers in accordance with this Agreement (a “Buyer Material Adverse Effect”).  Each Buyer has the requisite power and
authority to execute, deliver and perform this Agreement, the Ancillary
Agreements and the other documents required to be executed by it pursuant to
this Agreement.  This Agreement, the
Ancillary Agreements and each of the other documents to be executed in
connection with this Agreement have been duly authorized, executed and
delivered (or when executed, will be duly executed and delivered) by each Buyer
and no other proceedings on the part of any Buyer (or its affiliates, directors
or shareholders) are necessary to authorize, consummate and perform this
Agreement, the Ancillary Agreements, the other documents to be executed in
connection herewith or the Transactions.  Assuming they constitute the legal, valid and
binding obligation of each Seller, this Agreement, the Ancillary Agreements and
the other documents executed or to be executed in connection with this
Agreement are, or when executed and delivered will be, the legal, valid and
binding obligations of each Buyer enforceable in accordance with their terms,
except as enforceability may be (a) limited by bankruptcy, insolvency,
reorganization, moratorium or similar Laws and (b) subject to general
principles of equity (regardless of whether such enforcement is considered in a
proceeding in equity or at law).


 


30

















 


3.3          Consents.  Except as set forth in Section 3.3 of the
Buyers’ Schedule, there are no authorizations, consents, permits, orders,
licenses or approvals of, or declarations, registrations or filings with, any
Governmental Entity or any party to any material Contract to which any Buyer is
a party (each, a “Buyer  Consent”) that are required in connection with the
execution, delivery or performance by Buyers of this Agreement, the Ancillary
Agreements or the other agreements executed or to be executed by them in
connection with this Agreement or the consummation by Buyers of the
Transactions, other than Buyer Consents the failure of which, individually or
in the aggregate, to obtain would not reasonably be expected to result in a
Buyer Material Adverse Effect.


 


3.4          No Breach.  The execution, delivery and performance of
this Agreement, the Ancillary Agreements and the other documents executed or to
be executed in connection herewith and the consummation by Buyers of the
Transactions do not and will not, with or without notice or lapse of time or
both, violate, breach, conflict with, constitute a default under, or permit the
termination or the acceleration of maturity or performance of, or result in the
imposition of any Encumbrance upon any property, right or asset of Buyers or
their affiliates pursuant to (i) any provision of the articles of
incorporation or bylaws or other similar organizational documents of Buyers, (ii) any
Law or Order of any Governmental Entity to which any Buyer or their respective
affiliates or any of their respective assets, rights or properties are subject,
or (iii) any Contract to which any Buyer is a party, by which any Buyer is
bound, or to which any of Buyers’ assets, rights or properties are subject,
except, in the case of clause (ii) or (iii) above, for
violations, conflicts, defaults, breaches, terminations, accelerations or impositions
which would not, individually or in the aggregate, reasonably be expected to
result in a Buyer Material Adverse Effect.


 


3.5          Capital Resources.  Buyers have, and will have at the Closing,
sufficient cash to pay the Purchase Price and any other amounts payable by Buyers
in connection with the transactions contemplated by this Agreement.


 


3.6          No Brokers.  No agent, broker, finder or other person or
entity acting on behalf of Buyers or their affiliates will be entitled to any
broker’s, finder’s or similar fee or commission in connection with the
Transactions.


 


3.7          No Other Representations and
Warranties.  Except
for the representations and warranties contained in this Agreement or any
schedule, annex, exhibit or document delivered pursuant hereto, no Buyer makes
any representation or warranty of any kind (whether express, implied or
otherwise or whether on behalf of itself or its affiliates).


 


4.                                      COVENANTS OF SELLERS


 


4.1          Interim Operation of Business.  From the date of this Agreement through the Closing
Date, Sellers shall use commercially reasonable efforts to:  (i) cause the Business to be conducted in
the ordinary course of business, consistent with past practices, regular
customer service and business policies; (ii) maintain business and
accounting records of the Business in accordance with applicable Laws and in
substantially the same manner as presently maintained; (iii) comply in all
material respects with all Laws affecting the operation of the Business, the 


 


31

















 


Transferred
Assets and the Assumed Obligations, and pay Taxes of the Business that become
due and payable in the ordinary course; and (iv) preserve intact the Transferred
Assets, the business organization and goodwill of the Business and the
relationships of the Business with its customers, distributors, suppliers and
employees; provided, however, that in the event Sellers desire to
conduct the Business in a manner inconsistent with the foregoing, they may do
so with the prior written consent of Buyers (which consent shall not be
unreasonably withheld).  In addition to
the foregoing, except as otherwise required by this Agreement, Sellers will
not, and will cause their affiliates not to, do or permit to occur any of the
following with respect to the Business, the Transferred Assets or the Assumed
Obligations without the prior written consent of Buyers (which consent shall
not be unreasonably withheld):


 


(a)           sell, assign, transfer, lease,
license, sub-license, abandon, mortgage, encumber or otherwise dispose of (or
permit to lapse, expire or become abandoned) any Transferred Assets including
assets which are subject to the Cross License Agreement, except for
dispositions of immaterial or obsolete assets and sales of inventory, in each
case, in the ordinary course of business consistent with past practice;


 


(b)           incur or assume any obligations or
liabilities (fixed or contingent) relating to the Business or the Transferred
Assets, including the incurrence of indebtedness, guarantees or the making of
any loans, advances or capital contributions to, or investments in, any other
person, except unsecured current obligations and liabilities incurred in the
ordinary course of business consistent with past practice or those that will
not be Assumed Obligations;


 


(c)           fail to pay or satisfy any material
liabilities or obligation relating to the Transferred Assets or Assumed
Obligations, or alter in any material respect conduct, practices or policies
relating to the payment of accounts payable or collection of accounts
receivable in any way that would reasonably be expected to adversely affect in
any material respect the operation of the Business by Buyers after the Closing;


 


(d)           waive any rights or entitlements, or
settle or compromise, or permit any settlement or compromise of, any Claims
pending or threatened with respect to the Business, the Transferred Assets or
the Assumed Obligations, or to which the Business, any Transferred Assets or Assumed
Obligations are subject, in any case, that would reasonably be expected to
adversely affect in any material respect the operation of the Business by
Buyers after the Closing;


 


(e)           enter into, amend or modify in any
material respect, terminate, cancel or fail to renew any Material Contract,
except for amendments or modifications to Material Contracts to the extent
required for Sellers to comply with their obligations under Section 1.1(c),
Section 1.1(d), Section 4.4(b) or any Ancillary
Agreement (provided that, without the prior written consent by Buyers,
no such amendment or modification shall be made to any term or provision that
will apply to or bind Buyers or their affiliates, the Transferred Assets, the
Assumed Obligations or the Business on or after the Closing);


 


(f)            make any material changes in standard
sales terms and conditions;


 


32
















 


(g)                                 make
any change in accounting methods or principles applicable to the Business, the Transferred
Assets or the Assumed Obligations, except as required by changes in GAAP;


 


(h)                                 effect
or permit a “plant closing” or “mass layoff” as those terms are defined in WARN
without complying with the notice requirements and all other provisions of WARN
or take any similar action without complying with notice requirements and other
provisions of any similar applicable state or local Laws;


 


(i)                                     enter
into any commitment or transaction which, if effected before the date of this
Agreement, would constitute a material breach of the representations,
warranties or agreements contained in this Agreement, or take any action or
fail to take any action or, to the extent within Sellers’ control, permit to
occur any event that, individually or in the aggregate, would reasonably be
expected to result in a Material Adverse Effect; or


 


(j)                                     agree
or commit, whether in writing or otherwise, to do any of the foregoing.


 


4.2                               Post-Closing
Cooperation.  After Closing, Sellers
shall take all actions and execute all documents reasonably necessary to assist
Buyers or their designees, at Buyers’ request and expense, to secure, perfect
and record Buyers’ ownership of any Assigned IP Assets in all appropriate
government agencies and registries.  Upon a request from Buyers within two years after the
Closing Date, to the extent that any trade secrets or confidential information
included in the Assigned IP Assets (or licensed to Buyers pursuant to the Cross
License Agreement) are not delivered to Buyers in tangible or physical form
within the Transferred Assets, Sellers shall take reasonable efforts to obtain reasonable
disclosure to Buyers with respect thereto to be made by the applicable
then-current employees of Sellers, if any, within a reasonable time after such
request by Buyers.


 


4.3                               Full
Access and Pre-Closing Cooperation.  Prior
to the Closing, Sellers shall afford to Buyers, their counsel, accountants and
other representatives, access to the books, records, employees, suppliers,
distributors, customers and such other information of Sellers and their
affiliates relating in any way to the Business or the Transferred Assets in
order that Buyers may have reasonable opportunity to make such investigations (and
make such copies for its records) as they shall reasonably desire to make of
the affairs of Sellers relating to the Business or the Transferred Assets; and Sellers
will cause their officers and accountants to furnish such additional financial
and operating data and other information as Buyers shall, from time to time,
reasonably request, including correspondence with any Governmental Entity
related to the Business or any Product, business planning and integration
information as to customer bookings, sales backlog, distribution information,
and 2008 sales and marketing plans.  Any
such investigation shall be conducted at reasonable times, on reasonable prior
notice, and under reasonable circumstances. No investigation or findings of Buyers
shall diminish or affect the representations and warranties of Sellers
hereunder or relieve Sellers of any obligation hereunder.  Buyers and Sellers will use commercially
reasonable efforts after the date hereof and prior to Closing to develop an
arrangement that will facilitate the marketing and sale of Products by Buyers
or their affiliates in Europe as of Closing.


 


33

















 


4.4                               Consents;
Third Party Arrangements.


 


(a)                                  Sellers
shall use commercially reasonable efforts to obtain, prior to the Closing, all Consents
necessary for the consummation of the Transactions in a form reasonably
satisfactory to Buyers, including all Consents necessary for the assignment and
transfer to Buyers of the Acquired Contracts and the Consents described in Schedule 7.3(b).  All such Consents, waivers and approvals
shall be in writing and executed counterparts thereof shall be delivered to Buyers.
 All fees or costs (including attorney
fees) related to obtaining any Consent pursuant to this Section 4.4
shall be paid by Sellers, except that any fees or costs (including attorney
fees) related to obtaining Consents necessary for the assignment and transfer
to Buyers of the Manufacturing Agreement shall be shared equally by Buyers, on
the one hand, and Sellers, on the other hand. 
Notwithstanding the foregoing, no party shall be required to make any
payment to a third party in obtaining any Consent relating to Acquired
Contracts in excess of the aggregate amount set forth on Schedule 4.4(a).


 


(b)                                 To
the extent that the assignment of any Acquired Contract to Buyers pursuant to
this Agreement would reasonably be expected to prohibit, impede or materially
delay Sellers’ ability to fulfill their respective obligations under the
Ancillary Agreements, Sellers shall, at Sellers’ sole expense, use commercially
reasonable efforts to enter into any commercially reasonable and lawful
arrangement with any person who is a party to any such Acquired Contract as may
be necessary in order to ensure that, from and after the Closing, Sellers shall
have the ability to perform their obligations under the Ancillary
Agreements.  Sellers shall keep Buyers
apprised of the status of any discussions with third parties pursuant to this Section 4.4(b) on
a timely basis.


 


4.5                               Non-Compete.


 


(a)                                  In
order that Buyers may have and enjoy the full benefit of ownership of the
Business, Sellers agree that, for a period of three (3) years after the Closing
Date (with respect to European jurisdictions) and five (5) years after the
Closing Date (with respect to all other jurisdictions), neither Sellers nor any
of their affiliates will:


 


(i)                                     directly or
indirectly, either as principal, manager, agent, consultant, officer,
stockholder, partner, member, investor or lender or in any other capacity,
carry on, be engaged in or have any financial interest in, or willfully assist
any other person in engaging in, any business activity of the type carried out
by the Business as of the date of this Agreement or the Closing Date and the
development of peripheral PTA balloons, covered peripheral stents and stent
grafts (other than (A) devices
or methods for the treatment of structural heart disease or (B) devices or
methods for the treatment of abdominal aortic aneurysms or thoracic aortic
aneurysms) (the “Covered Business”);
provided, however, that nothing in this Section 4.5(a)(i) shall
be construed so as to preclude any of Sellers or their affiliates from
(x) enjoying the rights and performing its obligations in accordance with
the Contracts listed on Schedule 4.5(a)(i), (y) purchasing
debt or equity securities in any publicly or privately held company, provided
that Sellers’ or their affiliates’ beneficial ownership of any class of such
company’s securities does not exceed 5% of the outstanding securities of such
class, and such investment is solely


 


34

















 


passive and for investment purposes and Sellers do not exert any
influence over such company or otherwise directly or indirectly participate in
its management or operations, or (z) acquiring a business or an entity
whose ancillary business is the Covered Business, provided that (1) such
ancillary business does not represent fifty percent (50%) or more of the
revenues or consolidated assets of such acquired business or entity and (2) such
Covered Business is disposed of within twelve (12) months of acquisition; or


 


(ii)                                  directly or
indirectly take any action, or willfully assist any other person to take any
action, to call upon or solicit with respect to the Business, or divert, take
away or encourage to cease or reduce business, any customers, distributors or
suppliers of the Business, or make any attempt to do any of the foregoing; provided
that diversions, take aways, cessations or reductions in business of customers,
distributors or suppliers of the Business as a result of the operations of the
other businesses of Sellers and their affiliates in the ordinary course shall
not be deemed to constitute a breach of this clause (ii) so long as
Sellers are not in breach of the foregoing clause (i).


 


(b)                                 Nothing in this Section 4.5 shall
restrict the activities of any person or any of its affiliates that engages in
a Seller Business Combination Transaction; provided that the foregoing
shall not be construed to permit any Seller or any of its affiliates (or any
employees of any Seller or any of its affiliates) to participate or engage,
directly or indirectly, in any activity prohibited by the other provisions of
this Section 4.5 (it being understood that if any Seller merges or
consolidates with an unaffiliated person, the resulting merged or consolidated
person will not be subject to the terms of this Section 4.5, except
that the employees or assets (including subsidiaries) of such merged or
consolidated person which were employees or assets (including subsidiaries) of
such Seller or any of its subsidiaries immediately prior to such merger or
consolidation shall remain bound by this Section 4.5).  A “Seller
Business Combination Transaction” means any merger, acquisition,
consolidation or similar business combination transaction with the parent of
the US Seller pursuant to which the beneficial owners (as defined in Rule 13d-3
promulgated under the Securities Exchange Act of 1934, as amended) of the
outstanding common stock of such parent (and other outstanding voting
securities of such parent entitled to vote generally in the election of
directors of such parent, if any) immediately prior to the consummation of such
transaction do not upon such consummation beneficially own, solely in their
capacities as shareholders of the US Seller, at least fifty percent (50%) of
the outstanding common stock (and other outstanding voting securities entitled
to vote generally in the election of directors, if any) of the entity surviving
or resulting from the consummation of such transaction.


 


(c)                                  For
a period of three (3) years after the Closing Date, Sellers agree not to,
and to cause their affiliates not to, either on their own account or in
conjunction with or on behalf of any other person, directly or indirectly,
without the consent of Buyers, solicit for employment (other than through a
general advertisement or solicitation not aimed at a specific employee) or
employ any person then employed by Buyers or their affiliates in the Business.


 


(d)                                 Sellers agree that
this Section 4.5 is reasonable under the circumstances and is being
given in consideration for, and as an inducement to, the purchase of the
Business by Buyers.  Sellers and Buyers
agree that if in the opinion of any court of competent jurisdiction


 


35

















 


such restraint is not
reasonable in any respect, such court shall have the right, power and authority
to excise or modify such provision or provisions of this covenant as shall appear
not reasonable to the court and to enforce the remainder of the covenant as so
amended.  Sellers agree that any breach
of the covenants contained in this Section 4.5 would irreparably
injure Buyers, and accordingly Sellers agree that Buyers may pursue any remedy
they may have in law or in equity, including obtaining an injunction against
Sellers or their applicable affiliates from any court having jurisdiction over
the matter restraining any further violation of this Agreement.


 


4.6                               Inventory
List; List of Acquired Contracts.


 


(a)                                  As
soon as reasonably practicable, but no later than ten (10) business days
after the date of this Agreement, the US Seller will provide Buyers a true,
complete and correct list of Inventory items of the Business, including a separate
indication of the location at which any Inventory on consignment is located, as
of November 30, 2007.


 


(b)                                 No
later than twenty (20) business days following the date of this Agreement, the
US Seller will provide Buyers a true, complete and correct list and, upon
request of Buyers, copies of all Acquired Contracts (other than Acquired IP
Contracts) in effect as of the date of this Agreement, and no later than ten (10) business
days following the Closing, the US Seller will provide Buyers a true, complete
and correct updated list and, upon request of Buyers, copies of all Acquired
Contracts (other than Acquired IP Contracts) (provided that this
provision shall not be read to limit in any respect Section 1.1(a)(xi)).


 


4.7                               [Intentionally
Omitted]


 


4.8                               FDA
Regulatory Matters.


 


(a)                                  For
the period of one (1) year after the applicable date of transfer from
Sellers to Buyers of each of the FDA Applications as specified in Sections
4.8 and 4.9, Sellers shall, and shall cause their affiliates
to, assist Buyers, at Buyers expense, in: 
(i) disclosing and copying any relevant records and reports
received by Sellers after the transfer to Buyers of any FDA/EU Application that
are required to be made, maintained and reported pursuant to any applicable Law
in connection with such FDA/EU Application; and (ii) processing and
reporting complaints, service requests, adverse events, and device malfunctions
related to the Products that are the subject of such FDA/EU Applications, to
the extent required by applicable Laws.


 


(b)                                 During
the period between the date of this Agreement and the Closing Date, Sellers
shall, and shall cause their affiliates to: 
(i) make commercially reasonable efforts to obtain the Initial FDA
Approval and the Secondary FDA Approval, including the conduct and completion
of any additional testing required by the FDA; (ii) take all actions
necessary to continue the RESILIENT clinical study, in conformance with the
study protocols in the RESILIENT IDE, and any additional requirements imposed
by FDA or any relevant Institutional Review Boards (“IRBs”), and provide interim reports to Buyers, as requested by
Buyers; (iii) take all actions necessary and obtain any documentation
required to maintain the relevant FDA Applications and any amendments or
supplements thereto, including the original premarket approval (“PMA”) application filed on May 25,
2007 for the “Lifestent FlexStar System” and


 


36

















 


“FlexStar XL System” and
related PMA modules (the “PMA Application”)
and the Investigational Device Exemption (“IDE”)
#G040023 for the RESILIANT clinical study, and any supplements thereto (the “RESILIENT IDE”); and (iv) otherwise
comply with any Laws, including FDA Law and EU Law, with respect to all FDA/EU
Applications and any amendments or supplements thereto, including the PMA
Application and the RESILIENT IDE, and the Products.


 


(c)                                  Following
the Closing, Sellers shall, and shall cause their affiliates to, on behalf of
Buyers:  (i) subject to Sellers’
right to reasonably determine that it is not commercially reasonable to pursue
the Initial FDA Approval and/or the Secondary FDA Approval as set forth in Section 4.8(d) below,
take all actions necessary to obtain the Initial FDA Approval and the Secondary
FDA Approval, including the conduct and completion of any additional testing
required by the FDA; (ii) take all actions necessary to complete the
RESILIENT clinical study in conformance with the study protocols in the
RESILIENT IDE, and any additional requirements imposed by FDA or any relevant
IRBs, and provide interim reports to Buyers, as requested by Buyers; (iii) take
all actions necessary and obtain any documentation required to maintain the PMA
Application and any amendments or supplements thereto and the RESILIENT IDE;
and (iii) otherwise comply with any Laws, including FDA Law and EU Law,
with respect to the PMA Application and any amendments or supplements thereto
and the RESILIENT IDE.


 


(d)                                 Notwithstanding
Section 4.8(c) above, should Sellers, at any time after the
Closing, reasonably determine that it is not commercially reasonable to
continue to pursue the Initial FDA Approval and/or the Secondary FDA Approval,
Sellers shall notify Buyers of the same in writing, and upon receipt of such
notification, Buyers shall be entitled to assume and take control and ownership
of the PMA Application and any amendments or supplements thereto, including any
approvals received as of such date, and the approval process described
herein.  If Buyers elect to assume
control and ownership of the PMA Application or any amendments or supplements
thereto, in accordance with this Section 4.8(d), Sellers shall (i) assign,
transfer, convey and deliver the PMA Application and any amendments or
supplements thereto, including any approvals received as of such date, to
Buyers; (ii) at Buyers’ expense, take all actions necessary to effect the
transfer to Buyers of the PMA Application and any amendments or supplements
thereto (including any approvals received as of such date), including the
submission of notices and filings to the FDA and any other applicable
Governmental Entity regarding such transfer; (iii) take all actions
necessary to deliver the PMA Records to Buyers; and (iv) at Buyer’s
expense, make commercially reasonable efforts to continue to assist Buyers to
obtain such Initial FDA Approval and/or Secondary FDA Approval.


 


(e)                                  Upon
the earlier of (A) twelve (12) months after the receipt of the
Initial FDA Approval and (B) thirty (30) months after the Closing
Date, Buyers shall be entitled to assume and take control and ownership of the
PMA Application and any amendments or supplements thereto, including the
Initial FDA Approval and any other related approvals received as of such date; provided,
however, that, subject to Sellers’ right to reasonably determine that it
is not commercially reasonable to pursue the Secondary FDA Approval as set
forth in Section 4.8(d), Sellers shall continue to pursue the
Initial FDA Approval (if applicable) and the Secondary FDA Approval pursuant to
the requirements set forth in Section 4.8(c) above, and Buyers
shall reasonably cooperate with Sellers as necessary to (i) communicate
with FDA on matters related


 


37

















 


to the Initial FDA Approval (if
applicable) and the Secondary FDA Approval; (ii) submit to FDA any
regulatory filings associated with the Initial FDA Approval (if applicable) and
the Secondary FDA Approval.


 


(f)                                    Following
the Closing, Sellers shall, and shall cause their affiliates to, at Buyers’
request and expense, assist Buyers in the preparation of, and submit to FDA,
any manufacturing supplements to any FDA approval that results from the PMA
Application or any amendment or supplement thereto, including the Initial FDA
Approval, for the manufacture of Products at Buyers’ facilities.


 


(g)                                 At
Buyer’s election and expense and upon mutually agreed terms, Sellers shall
conduct a short-term clinical study  to
support a modification to the “Lifestent FlexStar System” and/or “FlexStar XL
System” to include the thumb-slide component or an expansion of the indications
for these systems as approved in the Initial FDA Approval and/or the Secondary
FDA Approval.


 


4.9                               Transition
of FDA Applications.


 


(a)                                  As
promptly as practicable following the Closing, but not later than thirty (30)
days following the Closing, Sellers shall, and shall cause their affiliates to,
take all actions necessary, at Buyers’ expense, to effect the transfer of all
510(k) FDA Applications included in Schedule 2.16(b).


 


(b)                                 Unless
already transferred under Section 4.8(d) or 4.8(e), as
promptly as practicable after the date that the Secondary FDA Approval is
granted, and in no case later than ten (10) business days after such date,
Sellers shall (i) assign, transfer, convey and deliver the Initial FDA Approval
and the Secondary FDA Approval to Buyers; (ii) take all actions necessary
to effect the transfer to Buyers of the Initial FDA Approval and the Secondary
FDA Approval, including the submission of notices and filings to the FDA and
any other applicable Governmental Entity regarding such transfer; and (iii) take
all actions necessary to deliver the PMA Records to Buyers.  Buyers shall pay all applicable FDA,
regulatory and government fees associated with the actions in this paragraph.


 


(c)                                  As
promptly as practicable after the date that the final RESILIENT study report is
issued, and in no case later than ten (10) business days after such date,
Sellers shall (i) assign, transfer, convey and deliver the RESILIENT IDE
to Buyers; (ii) take all actions necessary to effect the transfer to
Buyers of the RESILIENT IDE, including the submission of notices and filings to
the FDA and any other applicable Governmental Entity regarding such transfer;
and (iii) take all actions necessary to deliver the RESILIENT Records to
Buyers.


 


(d)                                 Sellers
hereby grant to Buyers, effective as of the Closing Date, an assignable,
exclusive, irrevocable, royalty-free, perpetual license (with the right to
sublicense) to manufacture, market, commercialize, sell or distribute the
Products under any FDA approval or clearance obtained by Sellers, including the
Initial FDA Approval and the Secondary FDA Approval, that results from the PMA
Application or any amendment or supplement thereto, or that otherwise includes
the Products that are the subject of the PMA Application (“PMA


 


38

















 


License”).  Sellers further agree, effective as of the
Closing Date, not to manufacture, market, commercialize, sell or distribute any
Products under such FDA approval or clearance, except as provided hereunder or
under the Ancillary Agreements, or as approved or requested in writing by
Buyers.  Buyers shall, and shall cause
their affiliates to, conduct all activities with respect to the PMA License in
conformance with applicable Laws, including FDA Law.  The PMA License provided for under this Section 4.9(d) shall
remain in effect until the Sellers transfer the applicable FDA approval or
clearance to Buyers, as provided in Sections 4.8(d), 4.8(e) and
4.9(b).


 


(e)                                  Notwithstanding
the foregoing, if Sellers determine that they are unable to complete the
RESILIENT clinical study, or if FDA or any other applicable Governmental Entity
requires that the RESILIENT clinical study be discontinued, Sellers shall take
all actions necessary to deliver to Buyers all Product Records relating to the
RESILIENT IDE, and Buyers shall be entitled to assume and take control of the
RESILIENT IDE; provided, however, that Sellers shall (i) ensure
that such termination or discontinuation is conducted in conformance with the
requirements of the RESILIENT IDE and (ii) provide written notice to
Buyers prior to effecting such termination or discontinuation.  If Buyers elect to assume control of the
RESILIENT IDE, in accordance with this Section 4.9(e), Sellers
shall (i) assign, transfer, convey and deliver the RESILIENT IDE to
Buyers; (ii) at Buyers’ expense take all actions necessary to effect the
transfer to Buyers of the RESILIENT IDE, including the submission of notices
and filings to the FDA and any other applicable Governmental Entity regarding
such transfer; (iii) take all actions necessary to deliver the RESILIENT
Records; (iv) at Buyer’s expense, assist Buyers to effect the transfer to
Buyers of the Excluded Clinical Contracts set forth in Section 1.1(b)(xii)
of the Disclosure Schedule; and (v) at Buyer’s expense, make commercially
reasonable efforts to continue to assist Buyers to address any FDA and/or IRB
concerns with respect to the RESILIENT clinical study.


 


5.                                      COVENANTS OF BUYERS; MUTUAL COVENANTS


 


5.1                               Notice of
Certain Events.


 


From time to
time prior to the Closing, Sellers and Buyers shall promptly advise each other
in writing of:  (i) any Material
Adverse Effect; (ii) the occurrence of any event of which such party
obtains knowledge which causes any of the representations and warranties made
by such party or the information included in any Schedule relating to the
representations of such party to be incomplete or inaccurate in any material
respect; (iii) the receipt of notice that any third party to any Acquired
Contracts is not likely to provide Consent to the assignment of such Acquired
Contract to Buyers pursuant to this Agreement; (iv) any notice or
communication from or correspondence with the FDA or any other Governmental
Entity in any way related to the Business; or (v) any notice or
communication asserting or threatening any Claim against such party or its
affiliates with respect to any Intellectual Property (including its ownership,
use validity or enforceability) included in the Assigned IP Assets or to be
licensed to Buyers pursuant to the Cross License Agreement.


 


39

















 


5.2                               Regulatory
Matters.


 


(a)                                  As
promptly as possible following the Closing, but not later than thirty (30) days
following the Closing, Sellers shall, and shall cause their affiliates to take
all actions necessary to effect the transfer of the relevant Business Permits
and Product Records to Buyers, including the submission of notices and filings
to any applicable Governmental Entity regarding such transfer.


 


(b)                                 During
the period between the date of this Agreement and the Closing Date, Sellers
shall, and shall cause their affiliates to:  (i) take all actions necessary and obtain
any documentation required to maintain the relevant Business Permits or to
obtain any further authorizations under any Laws; and (ii) take all
actions necessary to otherwise comply with any Laws with respect to all
Business Permits and the Products.


 


5.3                               [Intentionally
Omitted]


 


5.4                               Use of Names.


 


(a)                                  Subject
to Section 5.4(b), Buyers agree that neither they nor their
affiliates are licensed hereunder to use any Retained Names (as defined below),
including to identify their goods or services, after the Closing Date.


 


(b)                                 For
a period of two hundred seventy (270) days after the Closing Date and subject
to the requirements set forth in Section 5.4(c), Sellers shall license
to Buyers and their affiliates the right to use the Retained Names, on a
royalty-free, worldwide basis, in connection with their operation of the
Business in a manner consistent with past practice (including the distribution
of the Products (including labels and packaging) and advertising or other
product literature that bear the Retained Names).  Buyers may not use the Retained Names
thereafter, except in a non-trademark manner to describe the history of the
Business, as permitted by the “fair use” doctrine (or by the Trademark owner,
for any Retained Names owned by third parties) or as required by applicable
Law.  For two hundred seventy (270) days
after the Closing Date, Sellers and their affiliates shall display in the
locations within their websites that discuss the Business, a mutually-agreed
statement about this transaction and a mutually-agreed link to Buyers’
websites.  “Retained Names” means all Trademarks used in the Business as
of the Closing Date, except for the Trademarks included in the Assigned IP
Assets.


 


(c)                                  Buyers
shall as soon as reasonably practicable and in any event within two hundred
seventy (270) days following the Closing Date, remove or obliterate all
Retained Names from the Transferred Assets (other than legal documents and
other internal items that are not visible to the public).


 


5.5                               Records
after Closing.  For a period of six (6) years after the
Closing Date, Sellers and their respective representatives shall have
reasonable access to all of the books and records of the Business (including
any books and records relating to Taxes and Tax Returns of the Business), to
the extent that such access may reasonably be required by Sellers in connection
with matters relating to or affected by the operations of the Business prior to
the Closing Date, including Excluded Liabilities and Excluded Assets, the
preparation of Sellers’ financial reports 


 


40

















 


or Tax Returns,
any Tax audits, the defense or prosecution of litigation, and any other
reasonable need of Sellers to consult such books and records.  Such access shall be afforded by Buyers upon
receipt of reasonable advance notice and during normal business hours in a
manner so as to not interfere with the conduct of the Business.  Sellers shall be exclusively responsible for
any costs or expenses incurred by them pursuant to this Section 5.5.  If Buyers shall desire to dispose of any of
such books or records prior to the expiration of such six-year period, Buyers shall,
prior to such disposition, give Sellers a reasonable opportunity, at Sellers’
expense, to segregate and remove such books and records as Sellers may select.


 


5.6                               Certain
Government Approvals.


 


(a)                                  Upon
the terms and subject to the conditions herein, each of the parties hereto
agrees to use commercially reasonable efforts to take, or cause to be taken,
all reasonable actions and to do, or cause to be done, all reasonable things
necessary, proper or advisable to consummate as promptly as practicable the
Transactions, including using commercially reasonable efforts to cooperate to
effect all registrations and filings and submissions of information requested by
Governmental Entities in connection therewith necessary to enable it to
consummate the Transactions.  Each party
shall give the other party all information reasonably requested by such other
party pertaining to it and its subsidiaries and affiliates reasonably necessary
to enable such other party to take such actions, and in connection with the
Transactions the parties each shall file in a timely manner all reports and
documents required to be filed under any applicable Laws.  Sellers shall notify Buyers, and Buyers shall
notify Sellers, as the case may be, promptly of any material notice or other
communication from any Governmental Entity in connection with the Transactions
and from any person in relation to a Consent.


 


(b)                                 Without
limiting the generality of the foregoing, Buyers, on the one hand, and Sellers,
on the other hand, will as promptly as practicable, (i) but in no event
later than ten (10) business days following the execution and delivery of
this Agreement, file with the United States Federal Trade Commission (the “FTC”) and the United States Department of
Justice (the “DOJ”), and (ii) file
with the foreign competition authorities in each of the jurisdictions listed on
Schedule 5.6(b) to the extent required, the notification and
report form required for the Transactions, and any supplemental information
required in connection therewith, pursuant to the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 (the “HSR Act”)
and any foreign antitrust Laws, as applicable. 
Each party hereto represents and warrants that such notification and
report form and all such supplemental information submitted by such party or
its ultimate parent, and any additional supplemental information filed by such
party or its ultimate parent after the date of the original filing, will be in
substantial compliance with the requirements of the HSR Act.  Buyers and Sellers shall each furnish to the
other such necessary information and reasonable assistance as the other may
request in connection with its preparation of any filing or submission that is
necessary under the HSR Act and any applicable foreign antitrust Laws.  Sellers and Buyer shall keep each other
apprised of the status of any communications with, and inquiries or requests
for additional information from, the FTC or the DOJ, and shall use commercially
reasonable efforts to comply promptly with any such inquiry or request.  Sellers and Buyer will each use commercially
reasonable efforts to cause the expiration or early


 


41

















 


termination of the waiting
period required under the HSR Act as a condition to the purchase and sale of
the Transferred Assets.  Notwithstanding
anything herein to the contrary, all filing fees relating to any filing under
the HSR Act or any similar foreign antitrust Laws shall be borne by Buyers.


 


(c)                                  Notwithstanding
anything in this Agreement to the contrary, neither Buyers nor any of their
affiliates, shall be under any obligation to make proposals, execute or carry
out agreements or submit to orders providing for a Divestiture.  The term “Divestiture”
shall mean (i) the sale, license or other disposition or holding separate
(through the establishment of a trust or otherwise) of any assets (including
the Transferred Assets) or categories of assets of Buyers or any of their
affiliates, or (ii) the imposition of any limitation or restriction on the
ability of Buyers or any of their affiliates to freely conduct their business
(including the Business) or exercise full rights of ownership of such assets.


 


5.7                               Bulk
Sales.  The parties agree to waive
compliance with the provisions of the bulk sales or similar Laws of any
jurisdiction.


 


5.8                               Confidentiality.  The Mutual Confidentiality Agreement by and among
the US Seller and the US Buyer, dated as of September 6, 2007 (the “MCA”), and the Common Interest And Confidentiality
Agreement by and among the US Seller and the US Buyer, dated as of November 7,
2007 (the “Common Interest Agreement” and together
with the MCA, the “Confidentiality Agreements”)
shall continue to apply notwithstanding the execution of this Agreement.  Notwithstanding the foregoing, effective upon
the Closing, the confidentiality obligations of Buyers pursuant to the
Confidentiality Agreements and this Section 5.8 shall terminate
with respect to information held by Buyers and their affiliates contained
within the Transferred Assets and the Assumed Obligations.  Following the Closing, Sellers shall,
and shall cause their respective affiliates to, (i) maintain the
confidentiality of, and refrain from disclosing or using, any information of a
confidential nature relating to the Business, the Transferred Assets or the Assumed
Obligations, pursuant to the Confidentiality Agreements, and (ii) enforce
the confidentiality provisions in agreements (other than Acquired Contracts)
with employees, consultants and third parties covering information of a
confidential nature relating to the Business, the Transferred Assets or the Assumed
Obligations.


 


5.9                               Product Liability.  Each party shall be responsible for Product
Liability with respect to the Products as follows:


 


(a)                                  Sellers
shall be responsible for any and all Product Liability with respect to the
Products that were manufactured and sold or implanted on or prior to the
Closing Date, which shall be considered Excluded Liabilities for purposes of Article 8;


 


(b)                                 Buyers
shall be responsible for any and all Product Liability with respect to the
Products that were manufactured and sold or implanted after the Closing Date,
which shall be considered Assumed Obligations for purposes of Article 8;


 


(c)                                  if
a particular Product, with respect to which Product Liability arises, was
manufactured on or prior to the Closing Date but sold or implanted after the
Closing Date, then


 


42

















 


Sellers shall be responsible
for such Product Liability to the extent that such Product Liability is
attributable to a defect in the design, testing or manufacture of such Product,
and such Product Liability shall be considered an Excluded Liability for
purposes of Article 8; and


 


(d)                                 if
a particular Product, with respect to which Product Liability arises, was
manufactured on or prior to the Closing Date but sold or implanted after the
Closing Date, then Buyers shall be responsible for such Product Liability to
the extent that Sellers are not responsible for the same under the foregoing
clause (c), and such Product Liability shall be considered an Assumed Obligation
for purposes of Article 8.


 


With respect
to any Product Liability that a party is responsible for under this Section 5.9,
such party shall indemnify the other party in accordance with Article 8.  “Product Liability”
means Damages to the extent such arise out of a breach of any express or
implied product warranty, strict liability in tort, negligent manufacture of
product, negligent provision of services, product recall or any other written
allegation of liability or obligation arising from the design, manufacture,
testing, packaging, labeling (including instructions for use), advertising, marketing,
distribution or sale of any Product (whether for clinical trial purposes,
commercial use or otherwise), including any liability or obligation with
respect to any Product subject to a recall.


 


5.10                        Product
Returns.  In the event that, after the Closing, Buyers
accept for return or repurchase (other than pursuant to a Product recall that
is governed by Section 5.9) any Product manufactured before the
Closing due to a defect in the design, testing or manufacture of such Product
and provide a replacement therefor, Buyers shall provide written notice to
Sellers on a quarterly basis of any such returns or repurchases.  Provided that Sellers receive such written
notice within thirty (30) months after the Closing Date, Sellers shall promptly
reimburse (or cause their affiliates to reimburse) Buyers for the cost of such
replacement or repurchase; provided, however, that in no event
shall Sellers’ reimbursement obligation under this Section 5.10
exceed One Million Four Hundred Thousand Dollars ($1,400,000) in the
aggregate.  All other Products that
Buyers accept for return or repurchase shall be for the account of Buyers.


 


6.                                      COVENANTS RELATING TO EMPLOYEES


 


6.1                               Buyer’s
Employment of Selected Business Employees.


 


(a)                                  Employment by Buyer.  The employees of Sellers (i) listed on Schedule
6.1(a)(i) shall be referred to herein as “Business Employees” and (ii) the employees of Sellers
listed on Schedule 6.1(a)(ii) shall be referred to herein as “TSA Employees.”  Buyers may (in their sole discretion), for a
period commencing immediately after the date of this Agreement and ending on
the earlier of (x) the date that is sixty (60) days later and (y) the
date that is two (2) business days prior to the Closing Date, make an
offer of employment in writing to any of the Business Employees, to be
effective as of the Closing (but no earlier than the Closing).  Buyers may (in their sole discretion), for a
period commencing immediately after the date of this Agreement and ending on
the date of termination or expiration of the Transition Services Agreement and
Transition Supply Agreement, meet with and interview the TSA Employees but
shall not be permitted to make an offer of employment to any TSA Employees set
forth on Schedule 6.1(a)(iii) until the date that notice is
received from Buyers that each of the Transition


 


43

















 


Services Agreement and
Transition Supply Agreement will be terminating within sixty (60) days and such
offer shall only be effective upon the completion of the services under the
Transition Services Agreement or Transition Supply Agreement in the provision
of which such TSA Employee is engaged.  Notwithstanding
anything in the foregoing to the contrary, nothing in this Agreement shall
impose an obligation on any Buyer to offer employment to any employee of the
Sellers or offer any specified compensation or other benefits except to the
extent expressly provided herein.


 


(b)                                 Transferred Employees.  Each Business Employee and TSA Employee who accepts
an offer made under Section 6.1(a) and who becomes employed by
a Buyer (or any of its affiliates) shall be considered a “Transferred Employee” from and after his or
her employment by a Buyer (or any of its affiliates).


 


(c)                                  Cooperation by Sellers.  To facilitate the hiring by or on behalf of
Buyers (or one or more of their affiliates) of the Business Employees and TSA
Employees, Sellers shall, and shall cause their applicable affiliates to,
permit Buyers to meet and otherwise contact such employees during the time
periods set forth in Section 6.1(a); provided, however,
that Sellers and Buyers shall cooperate to ensure that such initial contact with
the Business Employees will be made, at the latest, twenty (20) business days
after the date hereof, and such initial and subsequent pre-Closing contacts
will be conducted at reasonable times and upon reasonable notice and at all
times in a manner that is reasonably acceptable to Sellers.


 


6.2                               Prior
Service.  Each Transferred Employee
shall be given full credit for all his or her service with Sellers and their
affiliates for purposes of (a) determining vesting and eligibility to
participate  under all of Buyers’ and
their applicable affiliates’ employee benefit plans, (b) calculating
severance benefits, and (c) calculating vacation benefits.  As soon as practicable, but in no event later
than five (5) business days from the date of request by Buyers, Sellers
shall prepare and provide to Buyers Schedule 6.2, which shall list
all periods of service with Sellers and their affiliates for each Business
Employee for whom information is requested by Buyers.


 


6.3                               Participation
by Transferred Employees in Buyers’ Benefit Plans.  Buyers shall, and shall cause their applicable
affiliates to, offer each Transferred Employee the opportunity to participate,
immediately after the Closing, in all of the employee benefit plans (of the
applicable Buyer or affiliate) for which each such Transferred Employee would
be eligible under the eligibility requirements for each such plan.  Each Transferred Employee will be covered
under the employee benefit plans of the applicable Buyer or affiliate that are
available to other employees of such Buyer or affiliate who are employed in
similar categories of employment, to the extent each such Transferred Employee
otherwise meets the eligibility requirements for each such plan.


 


6.4                               Non-Solicitation.  Except as provided in Section 6.1,
(a) With respect to any TSA Employee, until the earlier of (i) expiration
or termination of the Transition Services Agreement and the Transition Supply
Agreement and (ii) involuntary separation of employment other than as a
result of a breech of this Section 6.4 and (b) with respect to
any employee set forth on Schedule 6.4, until the earlier of (i) the
date that is five (5) years after the Closing Date and (ii) separation
of employment (other than as a result of a breach of this Section 6.4),
Buyers


 


44

















 


agree not to, and to cause
their affiliates not to, either on their own account or in conjunction with or
on behalf of any other person, directly or indirectly, without the consent of
Sellers, solicit for employment (other than through a general advertisement or
solicitation not aimed at a specific employee) or employ any such person.


 


6.5                               No
Transfer of Employment.


 


(a)                                  Sellers and Buyers agree that employees of
Sellers and their affiliates (other than the Transferred Employees) are not
intended to, by application of any applicable local law or otherwise, transfer
to Buyers as a result of the Transactions. Sellers and Buyers are
agreed that, wherever such a transfer could occur or be requested by any
employees of Sellers or any of their affiliates (other than the Transferred
Employees), they will contact such employees to avoid such transfer where
at all possible under the respective statutory provisions of the
jurisdiction governing the relevant employment relationship.  Both
Sellers and Buyers intend that all employees of Sellers and their affiliates
(other than the Transferred Employees) shall not become employees of Buyers or
any of their affiliates on or after the Closing Date irrespective of the
Transactions. To this end, Sellers shall perform all actions
and undertake all steps legally admissible in the respective
jurisdictions to ensure that such employees do not become employees of the
Buyers or any of their affiliates. 
Buyers and their affiliates covenant and agree not to hire or employ,
for a period of twelve (12) months after the Closing Date, any employees
domiciled in Europe that are terminated by Sellers or their affiliates.


 


(b)                                 In particular, Sellers shall, effective
as of the Closing Date, allocate any employees domiciled in the United
Kingdom to parts of Sellers’ business which do not form part of the
Transactions wherever such allocation or reassignment is legally
permissible. Where such allocation or reassignment to an excluded part of
Seller’s business is impermissible, Sellers shall use every effort to offer
to such UK employees, and procure that such employees
accept, contracts for continued employment with Sellers or any of their
affiliates on terms no less favorable than those in force immediately
prior to the Closing Date by entering into new employment agreements with such
employees.


 


(c)                                  If, for any reason whatsoever, any employee
of Sellers or any of their affiliates (other than the Transferred Employees)
should transfer to Buyers or any of their affiliates, Sellers shall indemnify
and hold harmless Buyers and their affiliates in respect of any cost
related to the termination of employment of any such employee provided that
Buyer takes commercially reasonable efforts to terminate such employee as soon
as practicable. This shall include all claims and payments defined as
Excluded Liabilities in Section 1.3(b) as well as any legal fees,
court costs or other such expenses which Buyers or their affiliates may
reasonably incur as a result of or in connection with the termination of
employment of any such employees provided that Buyer takes commercially
reasonable efforts to terminate such employees as soon as practicable.


 


6.6                               WARN
Act Compliance.  Sellers shall be
responsible for providing any required WARN Act notices or other notices
required by any similar applicable state or local laws and shall bear all costs
in connection with such obligations, if any, in connection with the
Transactions.


 


45

















 


7.                                      CONDITIONS TO CLOSING


 


7.1                               Conditions
to Each Party’s Obligations.


 


(a)                                  No Government Proceeding or Litigation.  No suit, action, investigation, inquiry, or
other proceeding by any Governmental Entity shall be pending which questions
the validity or legality of this Agreement or the Transactions.


 


(b)                                 No Injunction.  On the Closing Date, there shall be no
effective injunction, preliminary restraining order, or any Order of any nature
issued by a Governmental Entity directing that the Transactions not be
consummated as so provided.


 


(c)                                  Governmental and Regulatory Consents.  All Consents, approvals and authorizations
of, filings and registrations with, and notifications to (in each case, other
than antitrust filings), any Governmental Entity which are required for the
consummation of the Transactions shall have been obtained or made and shall be
in full force and effect.  All Consents,
approvals and authorizations or, filings and registrations with, and notifications
to, the relevant Governmental Entities with respect to antitrust filings in the
U.S. and in the jurisdictions listed on Schedule 5.6(b), which are
required for the consummation of the Transactions, shall have been obtained or
made and shall be in full force and effect, and all waiting periods applicable
thereto (including under the HSR Act and any applicable foreign antitrust Laws)
shall have expired.


 


7.2                               Conditions
to Sellers’ Obligations.  The obligations
of Sellers to consummate the Transactions shall be subject to the satisfaction,
at or before the Closing, of each of the following conditions, unless waived in
writing by US Seller on behalf of itself and the other Sellers:


 


(a)                                  Representations and Agreements.  (i) Each of the representations and
warranties made by Buyers herein (x) that are qualified or limited by
materiality (including Buyer Material Adverse Effect and the word material) shall
be true and correct when made, and on and as of the Closing Date with the same
effect as if such representations and warranties had been made on and as of the
Closing Date, except for those representations and warranties which speak as to
a specific date which shall be true and correct as of such date, and (y) that
are not so qualified or limited shall be true and correct in all material
respects when made, and on and as of the Closing Date with the same effect as
if such representations and warranties had been made on and as of the Closing
Date, except for those representations and warranties which speak as to a
specific date which shall be true and correct in all material respects as of
such date; (ii) Buyers shall have performed and complied in all material
respects with each of the agreements and covenants required to be performed or
complied with by Buyers on or prior to the Closing Date; and (iii) Sellers shall have received a certificate executed
by an executive officer of the US Buyer to the foregoing effect.


 


(b)                                 Ancillary Agreements.  Buyers shall have
executed and delivered the Bill of Sale, the Assignment and Assumption
Agreement, the Cross License Agreement, the Transition Services Agreement, the
Transition Supply Agreement and the Clinical Studies Agreement.


 


46
















 


7.3          Conditions to Buyers’ Obligations.  The obligations of Buyers to consummate the
Transactions shall be subject to the satisfaction, at or before the Closing, of
each of the following conditions, unless waived in writing by US Buyer on
behalf of itself and the other Buyers:


 


(a)           Representations
and Agreements.  (i) Each of the
representations and warranties made by Sellers herein (x) that are
qualified or limited by materiality (including Material Adverse Effect and the
word material) shall be true and correct when made, and on and as of the
Closing Date with the same effect as if such representations and warranties had
been made on and as of the Closing Date, except for those representations and
warranties which speak as to a specific date which shall be true and correct as
of such date, and (y) that are not so qualified or limited shall be true
and correct in all material respects when made, and on and as of the Closing
Date with the same effect as if such representations and warranties had been
made on and as of the Closing Date, except for those representations and
warranties which speak as to a specific date which shall be true and correct in
all material respects as of such date; (ii) Sellers shall have performed
and complied in all material respects with each of the agreements and covenants
required to be performed or complied with by Sellers on or prior to the Closing
Date; and (iii) Buyers shall have
received a certificate executed by an executive officer of the US Seller to the
foregoing effect.


 


(b)           Consents. 
Sellers shall have delivered to Buyers duly executed copies of all
Consents specified in Schedule 7.3(b), in a form reasonably
satisfactory to Buyers.


 


(c)           No
Material Adverse Effect.  No event, circumstance,
occurrence, condition, development, change or effect shall have occurred which,
individually or in the aggregate, has resulted in or would reasonably be
expected to result in a Material Adverse Effect.


 


(d)           Ancillary
Agreements.  Sellers shall have
executed and delivered the Bill of Sale, the Assignment and Assumption
Agreement, the Cross License Agreement, the Transition Services Agreement, the
Transition Supply Agreement and the Clinical Studies Agreement.


 


(e)           Third
Party Arrangements.  US Seller shall have
delivered an executed certificate that certifies Sellers have entered into the
necessary arrangements pursuant to Section 4.4(b) to fulfill their
respective obligations under the Ancillary Agreements.


 


8.                                      INDEMNIFICATION AND CERTAIN REMEDIES


 


8.1          Survival of Representations and Warranties.
 All
representations and warranties contained in this Agreement shall survive the
Closing for a period of eighteen (18) months from the Closing Date, at which
time all such representations and warranties will expire and terminate; provided
that the representations and warranties set forth in Section 2.6
(Tax Liabilities) shall survive until thirty (30) days after the expiration of
the applicable statutory period of limitations (giving effect to any waiver,
mitigation or extension thereof), at which time such representations and
warranties will expire; provided, further, that the
representations and warranties set forth in Section 2.1
(Organization and Good Standing), Section 2.2 (Authority; Binding
Effect), Section 2.9(a) (Title to Properties), Section 2.18(a) (No
Brokers), Section 3.1


 


47

















 


(Organization
and Good Standing), Section 3.2 (Authority; Binding Effect) or Section 3.6
(No Brokers) shall survive the Closing indefinitely; and provided, further,
that Section 2.8 (Compliance with Laws) shall survive until the
Initial FDA Approval is obtained solely for any liabilities or obligations with
respect to any violations of any Law arising out of the activities,
submissions, statements or filings made by any Seller or its affiliates, on or
prior to the Closing Date, related to the PMA Application or Sellers’ efforts
to obtain either the Initial FDA Approval or the Secondary FDA Approval.  Upon expiration and termination of a
representation or warranty as provided in the immediately preceding sentence,
no action or proceeding seeking damages or other relief for breach of any
thereof or for any misrepresentation or inaccuracy with respect thereto shall
be commenced thereafter, unless prior to such expiration and termination a
claim for indemnification with respect thereto shall have been made by written
notice given prior to such expiration and termination; provided, however,
that the foregoing shall not apply in the case or fraud or intentional
misrepresentation.


 


8.2          Indemnification by
Sellers.


 


(a)           Subject to the limitations set forth
in this Article 8, following the Closing, Sellers, jointly and
severally, shall indemnify Buyers and their affiliates and the officers,
directors, managers, employees, agents and representatives of each Buyer and
its affiliates (each, a “Buyer Indemnified
Person”) and hold them harmless from and against any loss,
liability, Claim, damage, Tax or expense (including reasonable legal fees and
expenses) (collectively, “Damages”)
suffered or incurred by the Buyer Indemnified Persons as a result of, arising
out of or relating to, any:


 


(i)            breach
of any representation or warranty made by Sellers contained in this Agreement,
the Disclosure Schedule, or the certificate delivered pursuant to Section 7.3(a) (determined
without giving effect to any “materiality” or “Material Adverse Effect”
qualification set forth therein);


 


(ii)           breach
of any covenant or obligation of any Seller contained in this Agreement; or


 


(iii)          Excluded
Liabilities.


 


(b)           Sellers will have no obligation to
indemnify the Buyer Indemnified Persons pursuant to Section 8.2(a)(i) in
respect of Damages arising from the breach of any representation or warranty
described therein unless the aggregate amount of all such Damages incurred or
suffered by the Buyer Indemnified Persons exceeds One Million Two Hundred Fifty
Thousand Dollars ($1,250,000), at which point Sellers will indemnify the Buyer
Indemnified Persons for all Damages suffered by them in excess of such
threshold (the “Deductible”) (provided
that the Deductible will not apply to claims for indemnification pursuant to Section 8.2(a)(i) in
respect of breaches of the representations and warranties set forth in Section 2.9(b) (Sufficiency
of Non-IP Assets) or Section 2.11(d) (Sufficiency of
Know-How)), and Sellers’ aggregate liability in respect of claims for
indemnification pursuant to Section 8.2(a)(i) will not in any
event exceed eleven percent (11%) of the Purchase Price actually received by
Sellers under Section 1.2 at the time of such indemnification
payment; provided that the foregoing limitations will not apply to


 


48

















 


(i) claims for
indemnification pursuant to Section 8.2(a)(i) in respect of
breaches of the representations and warranties set forth in Section 2.1
(Organization and Good Standing), Section 2.2 (Authority; Binding
Effect), Section 2.6 (Tax Liabilities), Section 2.9(a) (Title
to Properties) or Section 2.18(a) (No Brokers), or (ii) claims
based upon fraud or intentional misrepresentation by Sellers or their
affiliates.  The parties acknowledge and
agree that Buyers shall not be entitled to any rights of offset and shall not
be permitted to deduct any amounts claimed hereunder from any payments
otherwise required to be made by Buyers under this Agreement.


 


(c)           Patent
Liability and Indemnity; Exclusive Remedy.  Sellers, jointly and severally, shall
indemnify the Buyer Indemnified Persons in accordance with the provisions of
this Section 8.2(c) for any Patent Damages as a result of or
arising out of any Claim containing an allegation that the Products infringe a
Third Party Patent (as defined herein) (“Patent
Claim”).  “Patent Damages” shall mean monetary damages
(including, for the avoidance of doubt, royalty awards, accountings, lost
profits or other similar remedies under the patent Laws) actually paid by Buyer
Indemnified Persons (and not reimbursed by insurers, or by contribution or a
similar remedy) to a third party:  (A) on
any final Order after all appeals are exhausted or the time for all such
appeals has expired entered in respect of such a Patent Claim by a Governmental
Entity against a Buyer Indemnified Person; (B) for any settlements entered
into by a Buyer Indemnified Person as a result of or arising out of such a
Patent Claim; provided, however, that Sellers have consented in writing to such
settlement, such consent not to be unreasonably withheld, conditioned or
delayed; or (C) as a result of or arising out of any indemnification,
contribution, warranty or similar or equivalent claim by any contract
manufacturers, end-users, customers, suppliers or distributors of any Buyer
Indemnified Person, as a result of or arising out of any Patent Claim alleged
against any of them.  Patent Damages
shall not include any attorneys’ fees or costs, expert fees or costs, court
costs, sanctions or any other fees, costs or expenses of defense incurred by
the Buyer Indemnified Person (or the third parties in (C)) as a result of or
arising out of the defense of any Patent Claim. 
Solely for purposes of this Section 8.2(c), “Third Party Patent” means a patent issued,
not subject to a final, non-appealable adverse decision resulting from
reexamination or any final, non-appealable court decision of invalidity, as of
the Closing, excluding patents that are: 
(x) the subject of non-infringement opinions of outside counsel
that (i) are dated as of or prior to October 25, 2007; (ii) were
delivered or made available in writing to Buyers or their counsel on or prior
to November 25, 2007; and (iii) are signed as of or prior to the date
of this Agreement, or, with respect to opinions that are unsigned as of the
date of this Agreement, signed before the Closing Date; or (y) owned,
licensed or controlled by Buyers or their affiliates.


 


(i)            Sellers’
obligation to indemnify the Buyer Indemnified Persons in accordance with the
terms of this Section 8.2(c) is expressly conditional upon:


 


(A)          A written notice of a
Patent Claim first being received by a Buyer Indemnified Person after Closing
but in no event later than the second anniversary of the Closing Date;


 


(B)           Any Buyer notifying
Sellers in writing of a Patent Claim (“Patent
Claim Notice”) within
30 days of a Buyer Indemnified Person receiving such Patent


 


49

















 


Claim, unless and to the extent any delay thereafter does not
materially prejudice Sellers’ defense; provided, however, that Buyer
shall not be permitted to send any Patent Claim Notices to Sellers more than 60
days after the second anniversary of the Closing Date; and


 


(C)           In the event of
Patent Damages arising from a settlement, Sellers must have consented to such
Settlement, such consent not to be unreasonably withheld, conditioned or
delayed.


 


(ii)           Each
Buyer, with respect to itself, represents and warrants to Sellers that, to the
actual knowledge of the persons on Schedule 8.2(c)(ii), as of the
date of this Agreement and for the past three years prior to such date, such
Buyer has not received any written notice or any written threatened claim that
the conduct of such Buyer’s business infringes any Third Party Patent or patent
application covering stents, delivery systems for stents and/or the method of
insertion or implantation of stents.


 


(iii)          Buyers
(or, at Buyers’ election, the applicable Buyer Indemnified Person(s)) shall
have the sole right to control the defense of any Patent Claims at Buyers’
expense, and shall have the right to settle any such claim, provided that the
Buyer Indemnified Persons shall not enter into any settlement or pay any Patent
Damages that subjects Sellers to indemnification liability hereunder without
the Sellers’ prior consent, which consent shall not be unreasonably withheld,
conditioned or delayed.  Upon request,
Buyers (or the applicable Buyer Indemnified Person) shall promptly inform
Sellers of any material development in any Patent Claim hereunder; provided
that the parties shall cooperate in good faith to implement reasonable
arrangements designed to preserve any existing attorney-client privilege; provided,
further, that the Buyer Indemnified Person shall be entitled to withhold
information from Sellers if providing such information to Sellers would cause
the attorney-client privilege thereof to be waived and there is no method of
providing such information to Sellers in a manner which would not result in
such a waiver.  In the event of a Patent
Claim involving Patent Damages under Section 8.2(c)(C), if a Buyer
Indemnified Person does not have the information to provide to Sellers in
accordance with the preceding sentence, such Buyer Indemnified Person shall
reasonably cooperate with and assist Sellers to facilitate the third parties
identified in Section 8.2(c)(C) providing such information to
Sellers; provided that such third parties shall be entitled to withhold
such information from the Buyer Indemnified Person or from Sellers if providing
such information would cause the attorney-client privilege thereof to be waived
and there is no method of providing such information in a manner which would
not result in such a waiver.


 


(iv)          Sellers
have no obligation to indemnify the Buyer Indemnified Persons in accordance
with the terms of this Section 8.2(c) to the extent any Patent
Claim (or any Patent Damages arising therefrom) is based upon, in whole or in
part, any post-Closing modifications to the Products.  Nothing in this Section 8.2(c)(iv) shall
be deemed to modify the parties’ obligations under the Transition Supply
Agreement.


 


50

















 


(v)           For
purposes of this Section 8.2(c), Sellers’ obligation to indemnify
Buyer Indemnified Persons for Patent Damages is as follows:


 


	
  Patent Damages Paid By Buyer

  Indemnified Person

  	
   

  	
  Seller’s Reimbursement Percentage of 

  Patent Damages Paid

  	
   

  
	
  $0.01 to
  $30,000,000

  	
   

  	
  50%

  	
   

  
	
  Over
  $30,000,000

  	
   

  	
  0%

  	
   

  



 


By way of example and not as a
limitation:  If Buyer Indemnified Person(s) pay
Patent Damages of $15,000,000 for one or more Patent Claims, Sellers shall pay
such Buyer Indemnified Person(s) a total of $7,500,000 (that is, 50% of
the Patent Damages paid by such Buyer Indemnified Person(s) between $0.01
to $30,000,000).  If Buyer Indemnified
Person(s) pay Patent Damages in excess of $30,000,000 for one or more
Patent Claims, Sellers’ total indemnification obligation for Patent Claims
under this Section 8.2(c) and this Agreement shall be
$15,000,000 (50% of the Patent Damages up to $30,000,000 and 0% of all Patent
Damages over $30,000,000).


 


(vi)          Sellers shall indemnify the Buyer
Indemnified Persons for any Patent Damages for any sales reasonably identifiable
as damages on account of sales made prior to the Closing Date without regard to
the $15 million limitation set forth herein.


 


(vii)         The amounts set forth in this Section 8.2(c) are
cumulative, not per occurrence, and constitute Sellers’ full and complete
liability with respect to all Patent Claims as a result of or arising out of
this Agreement, the Products and the Business. 
It is the express and specific intention of the parties to this
Agreement that Sellers’ total liability on account of any and all Patent Claims
as a result of or arising out of this Agreement, the Products and the Business
be limited to no more than fifteen million dollars ($15,000,000) with respect
to Products sold after the Closing Date, plus, with respect to Products sold
before the Closing Date, the amounts set forth in Section 8.2(c)(vi),
if any.  This indemnity obligation and remedy are given to Buyer
Indemnified Persons solely for their benefit and there are no other third party
beneficiaries of this remedy.


 


8.3          Indemnification by
Buyers.


 


(a)           Subject to the limitations set forth
in this Article 8, following the Closing, Buyers shall indemnify
Sellers and their affiliates and the officers, directors, managers, employees,
agents and representatives of each Seller and its affiliates (each, a “Seller Indemnified Person”) and hold them
harmless from and against any Damages suffered or incurred by the Seller
Indemnified Persons as a result of, arising out of or relating to, any:


 


(i)            breach
of any representation or warranty made by Buyers contained in this Agreement,
the Buyers’ Schedule or the certificate delivered pursuant to Section 7.2(a)


 


51

















 


(determined
without giving effect to any “materiality” or “Buyer Material Adverse Effect”
qualification set forth therein);


 


(ii)           breach
of any covenant or obligation of any Buyer contained in this Agreement; or


 


(iii)          Assumed
Obligations.


 


(b)           Buyers will have no obligation to
indemnify the Seller Indemnified Persons pursuant to Section 8.3(a)(i) in
respect of Damages arising from the breach of any representation or warranty
described therein unless and until the aggregate amount of all such Damages
incurred or suffered by the Seller Indemnified Persons exceeds One Million Two
Hundred Fifty Thousand Dollars ($1,250,000) (at which point Buyers will
indemnify the Seller Indemnified Persons for all Damages suffered by them in
excess of such threshold), and the Buyers’ aggregate liability in respect of
claims for indemnification pursuant to Section 8.3(a)(i) will
not in any event exceed eleven percent (11%) of the Purchase Price actually
received by Sellers under Section 1.2 at the time of such
indemnification payment; provided that the foregoing limitations will
not apply to (i) claims for indemnification pursuant to Section 8.3(a)(i) in
respect of breaches of the representations and warranties set forth in Section 3.1
(Organization and Good Standing), Section 3.2 (Authority; Binding
Effect) or Section 3.6 (No Brokers) or (ii) claims based upon
fraud or intentional misrepresentation by Buyers or their affiliates.  The parties acknowledge and agree that
Sellers shall not be entitled to any rights of offset and shall not be
permitted to deduct any amounts claimed hereunder from any payments otherwise
required to be made by Sellers under this Agreement.


 


8.4          Third-Party Claims.  All claims for indemnification by a party
entitled to be indemnified under this Article 8 (an “Indemnitee”) by another party (an “Indemnitor”) shall be asserted and resolved
as follows:


 


(a)           If any claim or demand (other than
Patent Claims, which are governed by Section 8.2(c)) for which the
Indemnitee may claim indemnity pursuant to Section 8.2 or Section 8.3,
as the case may be, is asserted against or sought to be collected from the
Indemnitee by a third party (a “Third-Party
Claim”), then the Indemnitee shall give written notice thereof to
the Indemnitor as promptly as practicable following the receipt by the
Indemnitee of the Third-Party Claim (the “Third-Party
Claim Notice”); provided that the failure so to notify the
Indemnitor will not relieve the Indemnitor from any liability it may have to
the Indemnitee under this Article 8 unless, and then only to the
extent, the failure so to notify results in the loss of material rights or
defenses.


 


(b)           The Indemnitor shall have thirty (30)
days from the date on which the Third-Party Claim Notice is duly given (the “Notice Period”) to notify the Indemnitee
whether or not the Indemnitor desires, at its sole cost and expense, to defend
the Indemnitee against the Third-Party Claim with counsel of its choice
reasonably satisfactory to the Indemnitee.


 


(c)           If the Indemnitor notifies the
Indemnitee in writing within the Notice Period that it desires to defend the
Indemnitee against the Third-Party Claim, then (except as provided


 


52

















 


below) the Indemnitor shall
defend, at its sole cost and expense, the Indemnitee by appropriate
proceedings, shall use commercially reasonable efforts to settle or prosecute
the proceedings to a final conclusion in such a manner as to avoid the
Indemnitee becoming subject to any injunctive or other equitable order for
relief, and shall control the conduct of such defense.  The Indemnitor shall not be entitled to
assume the defense of any Third-Party Claim if the Third-Party Claim seeks any
relief other than money damages, including any type of injunctive or other
equitable relief.  If the Indemnitee
shall have reasonably concluded that there are legal defenses or rights
available to the Indemnitee that are in conflict with those available to the
Indemnitor, then the Indemnitee shall have the right to select one law firm (in
addition to local counsel) to act at the Indemnitor’s expense as separate
counsel, on behalf of the Indemnitee.  If
the Indemnitee desires to participate in, but not control, any other defense or
settlement, it may do so at its sole cost and expense (subject to the foregoing
sentence).  So long as the Indemnitor is
defending in good faith any such Third-Party Claim, the Indemnitee shall not
settle such Third-Party Claim without the consent of the Indemnitor, which
consent shall not be unreasonably withheld or delayed.


 


(d)           The Indemnitor will not consent to
the entry of any judgment or enter into any compromise or settlement with
respect to a Third-Party Claim without the prior written consent of the
Indemnitee (which consent shall not be unreasonably withheld or delayed).


 


(e)           If the Indemnitor fails to notify the
Indemnitee in writing within the Notice Period that the Indemnitor desires to
defend the Third-Party Claim, or if the Indemnitor gives such notice but fails
to prosecute vigorously and diligently or settle the Third-Party Claim, or if
the Indemnitee determines in good faith that there is a reasonable possibility
that a proceeding may affect it other than as a result of monetary damages for
which it would be entitled to indemnification hereunder, then the Indemnitee
will have the right to defend, at the sole cost and expense of the Indemnitor,
such Third-Party Claim to a final conclusion or to settle such Third-Party
Claim at the discretion of the Indemnitee (with the consent of the Indemnitor,
which consent will not be unreasonably withheld or delayed).  The Indemnitor may elect to participate in
such proceedings, negotiations or defense at any time at its own expense.  The Indemnitee will have full control of such
defense and proceedings, including (except as provided in the immediately
preceding sentence) any settlement thereof.


 


8.5          Tax Benefits; Adjustments to Purchase
Price. 
Indemnification payments under this Article 8 shall be paid
by the Indemnitor without reduction for any tax benefits available to the
Indemnitee.  All indemnification payments
paid to Buyers or Sellers pursuant to this Article 8 shall be
treated by the parties as an adjustment to the Purchase Price for income Tax
purposes, unless otherwise required by applicable Laws.


 


8.6          Exclusive Remedy.  Except as specifically set forth in this
Agreement, effective as of the Closing, in the absence of fraud or intentional
misrepresentation, each party waives, for itself and the applicable Indemnitee,
any rights and claims any Indemnitee may have against the applicable
Indemnitor, whether in law or equity, relating to this Agreement and the
transactions contemplated hereby.  After
the Closing, subject to the foregoing, this Article 8 will provide
the exclusive remedy for any breach of any representation, warranty, covenant
or other claim arising out of or relating to this Agreement.


 


53

















 


9.                                      TERMINATION AND ABANDONMENT


 


9.1          Methods of Termination.  This Agreement may be terminated at any time
prior to the Closing as follows:


 


(a)           by mutual consent of the parties to
this Agreement;


 


(b)           by either Buyers, on the one hand, or
Sellers, on the other hand, upon five (5) business days prior written
notice if the parties seeking to terminate are not then in material breach of
this Agreement and there has been a material breach of this Agreement by the
other parties which has not been cured prior to the earlier to occur of:  (i) thirty (30) days after written
notice of such breach has been given by the non-breaching parties and (ii) five
(5) business days prior to the End Date; or


 


(c)           by either Buyers, on the one hand, or
Sellers, on the other hand, upon written notice if the Closing has not occurred
on or before May 1, 2008; provided that the right to terminate this
Agreement under this Section 9.1(c) shall not be available to
a party whose failure to fulfill any of its obligations under this Agreement
has been the cause of, or results in, the failure of the Closing to occur.


 


9.2          Termination Procedure and Effect.  In the event of termination pursuant to this Article 9,
a written notice thereof shall forthwith be given by the terminating party to
the other party and the Transactions shall be abandoned without further
actions.  If the Transactions are
abandoned as provided herein, then:


 


(a)           the
Confidentiality Agreements shall survive the termination of this Agreement and
shall remain in full force according to their respective terms; and


 


(b)           all of the provisions of this
Agreement shall be of no further force and effect and the parties shall have no
further obligations hereunder, except that (i) the provisions of this Article 9,
Article 10 and Section 6.3 (Confidentiality) shall
survive such termination and (ii) each party shall retain its rights
against the other party with respect to any breach of this Agreement committed
prior to the termination or abandonment of the Transactions.


 


10.                               MISCELLANEOUS


 


10.1        Counterparts.  This Agreement may be executed in any number
of counterparts, each of which when so executed and delivered (including
delivery by facsimile transmission) shall be deemed an original, and such
counterparts together shall constitute only one original.


 


10.2        Notices.  All notices or other communications required
or permitted to be given hereunder shall be in writing and shall be delivered
by hand, or sent by telecopy, or sent, postage prepaid, by United States
registered, certified, or express mail, or reputable overnight courier service,
and shall be deemed given (i) if delivered by hand, when so delivered, or (ii) if
sent by telecopy, when received, or (iii) if sent by mail, three (3) business
days after mailing (two (2) 


54

















 


business days in the case of
express mail), or (iv) if sent by overnight courier service, one (1) business
day after delivery to such service, as follows:


 


	
  If to any Seller:

  	
  EDWARDS LIFESCIENCES LLC

  
	
   

  	
  c/o Edwards Lifesciences Corporation

  
	
   

  	
  Attn:     General
  Counsel

  
	
   

  	
  One Edwards Way

  
	
   

  	
  Irvine, California 92614

  
	
   

  	
  Fax: (949) 250-6868

  
	
   

  	
   

  
	
  Copies to:

  	
  GIBSON, DUNN & CRUTCHER LLP

  
	
   

  	
  Attn:     John M.
  Williams

  
	
   

  	
  3161 Michelson Drive, Suite 1200

  
	
   

  	
  Irvine, California 92612

  
	
   

  	
  Fax: (949) 451-4220

  
	
   

  	
   

  
	
  If to any Buyer:

  	
  C. R. BARD, INC.

  
	
   

  	
  Attn:     Office of the
  General Counsel

  
	
   

  	
  730 Central Avenue

  
	
   

  	
  Murray Hill, New Jersey 07974

  
	
   

  	
  Fax: (908) 277-8025

  
	
   

  	
   

  
	
  Copy to:

  	
  SIMPSON THACHER & BARTLETT LLP

  
	
   

  	
  Attn:    Kathryn King
  Sudol

  
	
   

  	
  425 Lexington Avenue

  
	
   

  	
  New York, New York 10017

  
	
   

  	
  Fax: (212) 455-2502

  



 


Any party hereto may change the
address to which notices and other communications are to be delivered or sent
by giving the other party notice in the manner herein set forth.


 


10.3        Successors and Assigns.  This Agreement and the rights,
interests, and obligations hereunder shall be binding upon and shall inure to
the benefit of the parties hereto and their respective successors and permitted
assigns, but neither this Agreement nor any of the rights, interests, or
obligations hereunder shall be assigned by any party without the prior written
consent of the other party hereto; provided that Buyers may assign their
rights, interests and obligations hereunder to any direct or indirect
wholly-owned subsidiary of the US Buyer upon written notice to Sellers; provided,
further, that any such assignment shall not relieve the assigning party
of its liabilities and obligations hereunder.


 


10.4        Governing Law;
Jurisdiction.


 


(a)           This Agreement shall be construed and
enforced in accordance with the Laws of the State of Delaware.


 


 


55

















 


(b)           Each of the parties hereto, (i) consents
to submit itself to the personal jurisdiction of the Court of Chancery of the
State of Delaware in the event any dispute arises out of this Agreement or any
of the Transactions, (ii) agrees that it will not attempt to deny or
defeat such personal jurisdiction by motion or other request for leave from any
such court, and irrevocably waives to the fullest extent permitted by
applicable Law any claim that (x) the suit, action or proceeding in such
court is brought in an inconvenient forum, (y) the venue of such suit,
action or proceeding is improper or (z) this Agreement, or the subject
mater hereof, may not be enforced in or by such courts, (iii) agrees that
it will not bring any action relating to this Agreement or any of the
Transactions in any court other than the Court of Chancery of the State of
Delaware, and (iv) waives any right to trial by jury with respect to any
action related to or arising out of this Agreement or any transaction
contemplated hereby.


 


10.5        Amendment.  This Agreement may be amended, modified, or
supplemented only by a written instrument executed by each party hereto.


 


10.6        Entire Agreement.  This Agreement, the Confidentiality Agreements, the Ancillary
Agreements, the exhibits, annexes and schedules hereto and thereto, and the
other documents executed and delivered or to be executed and delivered pursuant
hereto contain the complete agreement among the parties with respect to the
Transactions and supersede all prior oral or written agreements and
understandings among the parties with respect to the subject matter hereof.


 


10.7        Severability.  If any provision of this Agreement is held to
be illegal, invalid, or unenforceable, such provision shall be fully severable,
and this Agreement shall be construed and enforced as if such illegal, invalid,
or unenforceable provision were never a part hereof; the remaining provisions
hereof shall remain in full force and effect and shall not be affected by the
illegal, invalid, or unenforceable provision by its severance (except to the
extent such remaining provisions constitute obligations of another party to
this Agreement corresponding to the unenforceable provision); in lieu of such
illegal, invalid, or unenforceable provision, there shall be added
automatically as part of this Agreement, a provision as similar in its terms to
such illegal, invalid, or unenforceable provision as may be possible and be
legal, valid, and enforceable.


 


10.8        Specific Performance.  Each party’s obligations under this Agreement
are unique. If any party should default in its obligations under this Agreement,
the parties each acknowledge that it would be extremely impracticable to
measure the resulting damages; accordingly, the non-defaulting party, in
addition to any other available rights or remedies, may sue in equity for
specific performance, and the parties each expressly waive the defense that a
remedy in damages would be adequate, provided neither party shall be entitled
to recover punitive damages.


 


10.9        Publicity.  US Buyer and US Seller will promptly announce
the execution of this Agreement pursuant to separate press releases which will
have first been reviewed by the other party.  Each party will consider the comments of the
other but will not be required to incorporate such comments.


56

















 


10.10      Interpretation.  In this Agreement, the Disclosure Schedule,
the Buyers’ Schedule and any exhibit or annex hereto, or any other
document or instrument to be executed and delivered as contemplated herein:


 


(a)           words denoting the singular include
the plural and vice versa and words denoting any gender include all genders;


 


(b)           “including,” “includes,” “include” or
words of similar import shall be deemed to be accompanied by the words “without
limitation;”


 


(c)           “affiliate” has the meaning set forth
in Rule 12b-2 of the General Rules and Regulations under the
Securities Exchange Act of 1934, as amended;


 


(d)           “business day” means any day other
than a Saturday, Sunday, or a day that banks are required or permitted to close
in New York, New York;


 


(e)           “person” means an individual,
partnership, joint venture, corporation, limited liability company, trust,
unincorporated organization, government, Governmental Entity or other entity;


 


(f)            the use of headings is for
convenience of reference only and shall not affect the meaning or
interpretation of this Agreement;


 


(g)           when calculating the period of time
within which or following which any act is to be done or step taken, the date
that is the reference day in calculating such period shall be excluded and, if
the last day of such period is not a business day, the period shall end on the
next day that is a business day;


 


(h)           all dollar amounts are expressed in
United States funds, and all amounts payable hereunder shall be paid in United
States funds;


 


(i)            the words “hereof,” “hereby,” “herein,”
“hereunder” and similar terms in this Agreement refer to this Agreement as a
whole and not only to a particular Section in which such words appear; and


 


(j)            all references to statutes or
regulations are deemed to refer to such statutes and regulations as amended
from time to time or as superseded by comparable successor provisions.


 


10.11      Third Party Beneficiaries.  Except as expressly provided in Section 8.2
and Section 8.3 (it being understood that no distributor, customer,
supplier or end-user of Buyers, their affiliates or the Business shall have any
rights or remedies under this Agreement) this Agreement shall inure exclusively
to the benefit of and be binding upon the parties hereto and their respective
successors and permitted assigns, and nothing in this Agreement, express or
implied, is intended to confer upon any person (including, any Business
Employee or TSA Employee or any other employee, director or consultant under Article 6)
other than the parties hereto or their respective successors and permitted
assigns any rights, remedies, obligations or liabilities under or by reason of
this Agreement.


 


57

















 


10.12      Knowledge Defined.  As used in this Agreement, (a) the terms
“to the knowledge of Sellers” and similar terms shall mean the actual knowledge
of the individuals set forth in Schedule 10.12 and (b) the
terms “to the knowledge of Buyers” and similar terms shall mean the actual
knowledge of the individuals set forth in Section 10.12 of the Buyers’
Schedule.


 


10.13      Expenses.  Except as expressly set forth herein, each
party shall pay its own costs and expenses (including all legal, accounting and
other expenses incurred by itself and its affiliates) in connection with the
Transactions and this Agreement.


 


10.14      Damages.  EACH PARTY WAIVES ANY CLAIM TO, AND SHALL NOT
BE LIABLE (INCLUDING UNDER ARTICLE 8 OR OTHERWISE) FOR, ANY
PUNITIVE,  EXEMPLARY, MULTIPLIED,
INCIDENTAL, CONSEQUENTIAL, SPECIAL OR INDIRECT DAMAGES (INCLUDING BUSINESS
INTERRUPTION, LOSS OF FUTURE REVENUE, DIMINUTION IN VALUE, PROFITS OR INCOME,
OR LOSS OF BUSINESS REPUTATION OR OPPORTUNITY) FROM THE OTHER PARTIES (OR FROM
ANY AFFILIATE OF THE OTHER PARTIES).  FOR
THE AVOIDANCE OF DOUBT, THE FOREGOING SHALL NOT LIMIT A PARTY FROM SEEKING
INDEMNIFICATION UNDER ARTICLE 8 FROM THE OTHER PARTIES FOR
PUNITIVE, EXEMPLARY, MULTIPLIED, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR INDIRECT
DAMAGES (INCLUDING BUSINESS INTERRUPTION, LOSS OF FUTURE REVENUE, DIMINUTION IN
VALUE, PROFITS OR INCOME, OR LOSS OF BUSINESS REPUTATION OR OPPORTUNITY)
ASSERTED BY A THIRD PARTY.


 


[Signature page follows]


 


58

















 


IN WITNESS
WHEREOF, the parties hereto have executed this
Agreement as of the date first above written.


 


 


	
  SELLERS:

  	
   

  	
  BUYERS:

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  EDWARDS LIFESCIENCES LLC

  	
   

  	
  C. R. BARD, INC.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ John H. Kehl, Jr.

  	
   

  	
  By:

  	
  /s/ Robert L. Mellen

  
	
  Name: John H. Kehl, Jr.

  	
   

  	
  Name: Robert L. Mellen

  	
   

  
	
  Title: Corporate Vice President

  	
   

  	
  Title: VP Stratigic Planning and 

  	
   

  
	
   

  	
   

  	
  Business Development

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  EDWARDS LIFESCIENCES A.G. 

  	
   

  	
  ANGIOMED GMBH & CO.,

  	
   

  
	
   

  	
   

  	
  MEDIZINTECHNIK KG
  

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Patrick Verguet

  	
   

  	
   

  	
   

  	
   

  
	
  Name: Patrick Verguet

  	
   

  	
  By:

  	
   /s/ J.M. Spicer

  
	
  Title: CVP Europe

  	
   

  	
  Name: J.M. Spicer

  	
   

  
	
   

  	
   

  	
  Title: Managing Director

  	
   

  
									



 


 


[SIGNATURE PAGE TO ASSET PURCHASE AGREEMENT]