EXHIBIT 10.19
INTERNATIONAL DISTRIBUTION AGREEMENT
BETWEEN
CARDIOGENESIS CORPORATION
AND
BOSTON SCIENTIFIC CORPORATION
JANUARY 22, 1997
**CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT. CONFIDENTIAL PORTIONS (DESIGNATED BY [ ** ]) HAVE BEEN OMITTED FROM THE PUBLIC FILING AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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TABLE OF CONTENTS
Page BACKGROUND 1
TERMS AND CONDITIONS 1
1. DEFINITIONS.....................................................................................................1
1.1 Definitions Relating to Financial Matters.............................................................1
1.1.1 "dollars" or "$"............................................................................1
1.1.2 [ ** ]....................................................................1
1.1.3 "Average Sales Price" or "ASP"..............................................................1
1.1.4 "BSC Gross Margin"..........................................................................2
1.1.5 "Company Hardware Unit Cost"................................................................2
1.1.6 "Self-Covered Warranty Costs"...............................................................2
1.2 Definitions Relating to Technology....................................................................3
1.2.1 "Designated Use"............................................................................3
1.2.2 "TMR".......................................................................................3
1.2.3 "ITMR"(TM)..................................................................................3
1.2.4 "TTMR"(TM)..................................................................................3
1.2.5 "PMR"(TM)...................................................................................3
1.3 Definitions Relating to Products......................................................................3
1.3.1 "Hardware Unit" or "Hardware Units".........................................................3
1.3.2 "Disposable" or "Disposables"...............................................................3
1.3.3 "System"....................................................................................3
1.3.4 "Parts".....................................................................................3
1.3.5 "Products"..................................................................................4
1.3.6 "Other Products"............................................................................4
1.3.7 "End-User"..................................................................................4
1.3.8 "Existing Third-Party End-User".............................................................4
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1.4 Definitions Relating to Term of This Agreement........................................................4
1.4.1 "Contract Year".............................................................................4
1.4.2 "European Regulatory Approval Date".........................................................4
1.5 Definitions Relating to Territory.....................................................................4
1.5.1 "Territory".................................................................................4
1.5.2 "Europe"....................................................................................5
1.5.3 "EU"........................................................................................5
1.5.4 "Japan".....................................................................................5
1.5.5 "ROW".......................................................................................5
2. EXCLUSIVE DISTRIBUTORSHIP.......................................................................................5
2.1 Distribution Rights...................................................................................5
2.1.1 Grant of Rights.............................................................................5
2.1.2 Co-Marketing Rights.........................................................................5
2.2 Certain Provisions With Respect to Software...........................................................6
2.3 Placement of Products By The Company For Research
or Investigational Purposes...........................................................................6
2.4 Transition With Respect To Certain Third Party Sales..................................................6
2.5 No Competing Products.................................................................................8
2.6 Appointment by BSC of Subdistributors.................................................................8
2.7 [ ** ]..............................................................................8
2.8 Lease and Rentals.....................................................................................9
2.9 Other Products........................................................................................9
3. TRADEMARKS AND TRADENAMES; PROTECTION OF THE COMPANY'S
PROPRIETARY RIGHTS. 9
3.1. No Rights Granted Except As Provided Herein...........................................................9
3.2 Assistance ...........................................................................................9
4. NO ALTERATION OF PRODUCTS OR LABELING; ADAPTATION OF
PRODUCTS FOR LOCAL MARKETS; LABELING...........................................................................10
4.1 No Alteration Of Products or Labeling................................................................10
4.2 Adaptation Of Products For Local Markets.............................................................10
4.3 Labeling 10
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5. INSTALLATION AND SET-UP; TRAINING AND TECHNICAL SUPPORT;
REPAIR AND SERVICE..11
5.1 Installation and Set-Up..............................................................................11
5.2 Training and Technical Support.......................................................................11
5.2.1 BSC and BSC's Subdistributors..............................................................11
5.2.2 End-Users..................................................................................11
5.3 Non-Warranty Repair; Technical Support...............................................................11
5.4 Warranty Repair And Service..........................................................................11
6. CE MARK AND ISO 9001 CERTIFICATION; REGULATORY
APPROVALS; COMPLIANCE; INSPECTION; CHANGES TO
PRODUCTS; CERTAIN GOALS OF THE COMPANY.........................................................................12
6.1 CE Mark and ISO 9001 Certification...................................................................12
6.2 Regulatory Approvals.................................................................................12
6.2.1 Europe.....................................................................................12
6.2.2 Japan......................................................................................12
6.2.3 ROW........................................................................................13
6.3 Compliance...........................................................................................13
6.4 Changes to Products..................................................................................13
7. CERTAIN BSC RESPONSIBILITIES WITH RESPECT TO MARKETING.........................................................14
7.1 Marketing Support And Related Matters................................................................14
7.2 Marketing Materials................................................................................ 14
8. [ ** ].......................................................................................15
8.1 [ ** ].......................................................................................15
8.1.1 [ ** ]...................................................................15
8.1.2 [ ** ]...................................................................15
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8.2 Milestones...........................................................................................16
8.3 [ ** ].............................................................................17
9. PURCHASE ORDERS................................................................................................17
9.1 Monthly Estimates....................................................................................17
9.2 Cancellation By BSC..................................................................................17
9.3 Failure of The Company to Timely Deliver.............................................................18
9.4 Sale Terms...........................................................................................18
9.5 Failure of BSC To Make Payment.......................................................................18
10. SHIPMENT.......................................................................................................18
10.1 Shipment.............................................................................................18
10.2 Title and Risk of Loss...............................................................................18
10.3 Partial Delivery.....................................................................................18
10.4 Delivery Schedule; Delays; Allocation................................................................19
10.5 Export/Import License................................................................................19
10.6 Inspection Of Shipments By BSC.......................................................................19
11. PRICES AND PAYMENT.............................................................................................20
11.1 Hardware Unit Transfer Price to BSC..................................................................20
11.1.1 Hardware Unit Transfer Price Generally.....................................................20
11.1.2 Hardware Unit Transfer Price For [ ** ]..................................20
11.1.3 Effect on Hardware Unit Transfer Price of Increases
in Company Hardware Unit Cost..............................................................20
11.1.4 Effect on Hardware Unit Transfer Price of Decreases
in Company Hardware Unit Cost..............................................................20
11.1.5 Lease and Rentals of Hardware Units........................................................20
11.2 Disposables Transfer Price to BSC....................................................................20
11.2.1 Disposables Transfer Price.................................................................21
11.2.2 Minimum Pricing............................................................................21
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11.3 Initial Disposables ASP's and Initial Hardware Unit Transfer Price;
[ ** ] ASP Report; Adjustment of Hardware Unit Transfer Price
and Disposables Transfer Price For Changed ASP's; Exchange Rates.....................................21
11.3.1 Initial Disposables ASP's and Initial Hardware Unit
Transfer Price.............................................................................21
11.3.2 [ ** ] ASP Report; Disposables ASP's and Hardware
Unit ASP's.................................................................................21
11.3.3 Adjustment of Hardware Unit Transfer Price and
Disposables Transfer Price For Changed ASP's...............................................22
11.3.4 Cash Adjustment For Differences in ASP.....................................................22
11.3.5 Proration and Effect of Termination or Expiration..........................................22
11.3.6 Exchange Rates.............................................................................22
11.4 Price to BSC For Parts...............................................................................23
11.5 Taxes, Tariffs, And Related Fees.....................................................................23
11.6 Payment Terms........................................................................................23
11.6.1 Cash or Letter of Credit Payment...........................................................23
11.6.1.1 Cash Payment.....................................................................23
11.6.1.2 Letter of Credit Payment.........................................................23
11.6.2 Credit Terms; Security Interest............................................................24
11.6.3 Interest...................................................................................24
11.6.4 Acceleration of Due Dates In The Event of BSC Breach.......................................24
11.7 Offsets ...........................................................................................24
12. RECORDS RETENTION; COMPLIANCE CERTIFICATES.....................................................................25
12.1 Records Retention....................................................................................25
12.2 Compliance Certificates.............................................................................25
12.2.1 BSC Compliance Certificate.................................................................25
12.2.2 Company Compliance Certificate.............................................................25
12.2.3 [ ** ]...................................................................26
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13. TERM OF AGREEMENT AND TERMINATION..............................................................................26
13.1 Term ...........................................................................................26
13.1.1 Europe.....................................................................................26
13.1.2 Japan......................................................................................26
13.1.3 ROW........................................................................................26
13.2 Termination..........................................................................................26
13.2.1 Termination By Either Party For Insolvency, Etc.
Of Other Party.............................................................................26
13.2.2 Termination By The Company For BSC's Material Breach.......................................27
13.2.3 Termination By BSC for the Company's Material Breach;
Certain Other Voluntary Termination Rights of BSC..........................................27
13.2.3.1 Company Material Breach..........................................................27
13.2.3.2 Certain Other Voluntary Termination Rights of BSC................................27
13.2.4 Termination By Certain Successors to The Company...........................................27
13.3 Effect of Expiration or Termination..................................................................28
13.3.1 Orders After Expiration or Termination; Continuing Purchases...............................28
13.3.2 No Releases As To Payment..................................................................29
13.3.3 Disposition of Leases and Rentals Upon Expiration
or Termination.............................................................................29
13.3.4 Return of Materials........................................................................29
13.3.5 No Continuing Rights.......................................................................29
13.3.6 Registrations; Regulatory Approval Costs...................................................29
13.4 Certain Transitional Support To The Company By BSC...................................................30
13.5 Limitation of Liability..............................................................................30
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14. WARRANTY AND LIMITATION OF REMEDIES............................................................................30
14.1 Warranties...........................................................................................30
14.2 Limitation As To The Company's Warranty On Products..................................................31
14.3 Disclaimer of Warranties.............................................................................31
14.4 Prohibition on Warranties By BSC to Any Third Party..................................................31
14.5 Limited Liability....................................................................................31
14.5.1 Limitation of The Company's Liability......................................................31
14.5.2 BSC Acknowledgment.........................................................................31
15. INTELLECTUAL PROPERTY INFRINGEMENT; PRODUCT LIABILITY;
INDEMNIFICATION AND LIMITATIONS................................................................................32
15.1 Indemnification Provisions...........................................................................32
15.1.1 Indemnification of BSC By The Company For
Intellectual Property Claims...............................................................32
15.1.2 No Combination Claims; No Indirect Or Similar Damages......................................33
15.1.3 Limitation.................................................................................33
15.1.4 Discontinuance of Product Sales............................................................33
15.2 Indemnification of BSC By The Company For Product Liability And
Breach Of Representation Claims......................................................................33
15.3 Indemnification of The Company By BSC................................................................34
15.4 Relative Fault.......................................................................................34
15.5 General Limitations of Liability.....................................................................34
16. INSURANCE..................................................................................................... 34
17. PRODUCT COMPLAINTS; REGULATORY COMPLIANCE; RECALLS.............................................................35
17.1 Product Complaints...................................................................................35
17.2 Regulatory Compliance................................................................................35
17.3 Recalls ...........................................................................................35
17.3.1 Procedure..................................................................................35
17.3.2 Recall Requested by BSC....................................................................36
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18. CONFIDENTIAL INFORMATION.......................................................................................36
18.1 Protection of Confidential Information of The Other Party............................................36
18.2 Non-Use of Confidential Information of The Other Party...............................................36
18.3 Other Agreements.....................................................................................37
18.4 Press Releases.......................................................................................37
19. DISPUTE RESOLUTION.............................................................................................37
19.1 General..............................................................................................37
19.2 Applicable Law; Disclosure...........................................................................37
19.3 Arbitrator Decisions.................................................................................37
19.4 Award of Arbitrators.................................................................................37
20. MISCELLANEOUS..................................................................................................38
20.1 No Agency............................................................................................38
20.2 [ ** ].............................................................................38
20.3 Force Majeure........................................................................................38
20.4 Notices..............................................................................................38
20.5 Entire Contract......................................................................................39
20.6 Waivers; Amendments..................................................................................39
20.7 Assignability........................................................................................39
20.8 Severability.........................................................................................39
20.9 U.N. Convention Excluded.............................................................................39
20.10 Applicable Law and Forum Selection...................................................................40
20.11 Survival.............................................................................................40
20.12 Equitable Relief.....................................................................................40
20.12 Counterparts.........................................................................................40
EXHIBIT A DESCRIPTION OF DISPOSABLES AND HARDWARE UNITS EXHIBIT B COUNTRIES IN EUROPE
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