EXHIBIT 10.41
MARKETING AND DISTRIBUTION
AGREEMENT
BY AND BETWEEN
ABBOTT LABORATORIES
AND
DIGENE CORPORATION
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
TABLE OF CONTENTS
ARTICLE 1. - DEFINITIONS......................................................3
1.1 "Affiliate"......................................................3
1.2 "Africa".........................................................3
1.3 "Amplified Reimbursement"........................................3
1.4 "Analyte"........................................................4
1.5 "AUP"............................................................4
1.6 "Base Sales".....................................................4
1.7 "Book Value".....................................................4
1.8 "Business Day"...................................................4
1.9 "Calendar Quarter"...............................................4
1.10 "Certificate of Analysis"........................................4
1.11 "Change of Control"..............................................5
1.12 "CMV"............................................................5
1.13 "CMV Territory"..................................................5
1.14 "Confidential Information".......................................5
1.15 "Contract Year"..................................................6
1.16 "CT/GC"..........................................................6
1.17 "CT/GC Clearance"................................................7
1.18 "CT/GC Non-U.S. AUP".............................................7
1.19 "CT/GC Products".................................................7
1.20 "CT/GC U.S. AUP".................................................7
1.21 "CT/GC Specifications"...........................................8
1.22 "CT/GC Territory"................................................8
1.23 "Delivered "and "Delivery".......................................8
1.24 "Designated Country".............................................8
1.25 "Digene Equipment"...............................................8
1.26 "Digene Products"................................................9
1.27 "Digene Trademarks"..............................................9
1.28 "Distributor"....................................................9
1.29 "Distributor Territories"........................................9
1.30 "Distribution Agreement".........................................9
1.31 "Effective Date".................................................9
1.32 "Equipment"......................................................9
1.33 "Europe".........................................................9
1.34 "FDA"............................................................9
1.35 "Field"..........................................................9
1.36 "Fully Burdened Manufacturing Cost".............................10
1.37 "HBV"...........................................................10
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.38 "HBV AUP".......................................................10
1.39 "HBV Products"..................................................11
1.40 "HBV Specifications"............................................11
1.41 "HBV Territory".................................................11
1.42 "HPV"...........................................................11
1.43 "HPV AUP".......................................................11
1.44 "HPV Products"..................................................12
1.45 "HPV Specifications"............................................12
1.46 "HPV Territory".................................................12
1.47 "Hybrid Capture(R) Technology"..................................12
1.48 "Hybrid Capture for Digene Products"............................12
1.49 "Improvement"...................................................12
1.50 "Incremental Sales".............................................13
1.51 "Initial Term"..................................................13
1.52 "Innovation"....................................................13
1.53 "Middle East"...................................................13
1.54 "Minimum Transfer Price"........................................13
1.55 "Murex Entities"................................................14
1.56 "Net Sales".....................................................14
1.57 "Non-Amplified Reimbursement"...................................15
1.58 "Non-proprietary Equipment".....................................15
1.59 "Other Products"................................................15
1.60 "Other Product Specifications"..................................15
1.61 "Party".........................................................15
1.62 "Patents".......................................................16
1.63 "Product".......................................................16
1.64 "Product Accessories"...........................................16
1.65 "Purchase Price"................................................16
1.66 "Recall"........................................................16
1.67 "SHARP".........................................................16
1.68 "SHARP Territory"...............................................16
1.69 "Shipped Products"..............................................16
1.70 "Specifications"................................................16
1.71 "Term"..........................................................16
1.72 "Territory".....................................................16
1.73 "Third Party"...................................................17
1.74 "Trade".........................................................17
1.75 "Trade Secrets".................................................17
1.76 "Transition Period".............................................17
1.77 "United States".................................................17
1.78 "Validation Protocols"..........................................17
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.79 "Warranty Period"...............................................17
1.80 "Work With".....................................................18
1.81 "Year 2000 Compliant"...........................................18
ARTICLE 2. - APPOINTMENT TO MARKET AND DISTRIBUTE.............................18
2.1 Exclusive Appointment for CT/GC..................................18
2.2 Exclusive Appointment for HBV....................................19
2.3 Exclusive Appointment for HPV....................................19
2.4 Additional Territories...........................................20
2.5 Noncompetition...................................................21
2.6 Trade Costs......................................................21
2.7 Selling Price....................................................21
2.8 Contracting Rights...............................................22
2.9 Distributor Territories..........................................22
2.10 Non-Exclusive Appointment for Equipment..........................23
ARTICLE 3. - MARKETING AND PROMOTION..........................................23
3.1 Abbott's General Marketing and Promotion Responsibilities........23
3.2 Digene's General Promotional Responsibilities....................24
3.3 Development of Promotional and Marketing Materials...............24
3.4 Marketing Plans..................................................24
3.5 Sales Reports....................................................25
3.6 Support..........................................................26
3.7 Product Samples..................................................26
3.8 Marketing Steering Committee.....................................26
ARTICLE 4. - SALES PERFORMANCE THRESHOLDS.....................................27
4.1 Net Sales Thresholds for CT/GC...................................27
4.2 Net Sales Thresholds for HBV.....................................29
4.3 Net Sales Thresholds for HPV.....................................31
4.4 Exercise of Rights...............................................34
4.5 Wind-down Activities.............................................34
4.6 Factors Affecting Net Sales......................................35
ARTICLE 5. - MANUFACTURE AND SUPPLY...........................................35
5.1 Supply...........................................................35
5.2 Forecasting......................................................39
5.3 Orders...........................................................40
5.4 Failure to Supply Product........................................41
5.5 Failure to Supply Digene Equipment...............................43
5.6 Supply Allocation................................................44
5.7 Ordering Processing..............................................44
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.8 Safety Stock.....................................................44
5.9 Hazardous Classification Labeling................................44
ARTICLE 6. - PRICE AND TERMS..................................................45
6.1 Purchase Price for Equipment.....................................45
6.2 Product Transfer Price...........................................46
6.3 Minimum Transfer Price...........................................47
6.4 Year-End Reconciliation..........................................47
6.5 Royalty Obligations..............................................48
6.6 Payment Terms....................................................48
6.7 Foreign Exchange.................................................48
ARTICLE 7. - SHIPMENT AND DELIVERY............................................49
7.1 Shipment.........................................................49
7.2 Delivery.........................................................49
7.3 Export Licenses: Import Certificates; Customs and
Regulatory Approval for Delivery of Shipped Products
Outside the United States........................................49
7.4 Title and Risk of Loss...........................................50
7.5 Taxes............................................................50
7.6 Certificate of Analysis..........................................50
ARTICLE 8. - ACCEPTANCE OF SHIPPED PRODUCT; INSPECTION OF
MANUFACTURING FACILITY...........................................51
8.1 Digene Testing...................................................51
8.2 Abbott Testing...................................................51
8.3 Abbott Inspection................................................53
ARTICLE 9. - REGULATORY COMPLIANCE AND MEDICAL COMPLAINTS.....................53
9.1 No Modification..................................................53
9.2 Regulatory Compliance............................................53
9.3 Customer Complaints..............................................54
ARTICLE 10. - RECALL OR WITHDRAWAL............................................55
10.1 Event of Recall and Withdrawal...................................55
10.2 Expense of Recall................................................55
ARTICLE 11. - BOOKS AND RECORDS...............................................56
11.1 Examination Rights...............................................56
11.2 Reconciliation of Underpayment or Overcharge.....................56
11.3 Costs of Examination.............................................57
ARTICLE 12. - PATENTS AND TRADEMARKS..........................................57
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
12.1 Trademark License...............................................57
12.2 Trademark Ownership.............................................58
12.3 Infringement....................................................59
12.4 Possible Removal From Market....................................59
12.5 Third Party Claims for Infringement.............................60
12.6 Co-Labeled Product..............................................60
12.7 Limitation of Liability.........................................60
ARTICLE 13. - REPRESENTATIONS AND WARRANTIES..................................61
13.1 Digene Representations and Warranties...........................61
13.2 Replacement or Repair...........................................62
13.3 Third Party Distributors........................................63
13.4 Limitation on Warranties........................................63
13.5 Patent Representations and Warranties...........................63
13.6 General Representations and Warranties..........................64
ARTICLE 14. - GENERAL INDEMNIFICATION.........................................64
14.1 Digene Indemnification..........................................64
14.2 Abbott Indemnification..........................................65
14.3 Cooperation.....................................................65
14.4 Insurance.......................................................65
ARTICLE 15. TERM AND TERMINATION..............................................66
15.1 Term............................................................66
15.2 Termination for Cause...........................................66
15.3 Termination By Digene For Abbott's Failure to
Achieve Net Sales Thresholds....................................67
15.4 Termination By Abbott for Change of Control.....................68
15.5 Partial Termination By Digene For Abbott's Failure
to Market in Particular Country.................................69
15.6 Continuation of Force Majeure...................................70
15.7 Accrued Obligations.............................................70
15.8 Additional Remedies for Breach..................................70
ARTICLE 16. - CONSEQUENCES OF TERMINATION.....................................71
16.1 Buy-out of Equipment and Inventory..............................71
16.2 Termination Fee.................................................71
16.3 Residual Payments...............................................72
ARTICLE 17. - CONFIDENTIALITY AND PUBLIC ANNOUNCEMENTS........................72
17.1 Confidentiality.................................................72
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
17.2 Handling of Trade Secrets.......................................73
17.3 Confidential Treatment..........................................73
17.4 Public Announcements............................................74
ARTICLE 18. - FORCE MAJEURE..................................................74
ARTICLE 19. - IMPROVEMENTS, INNOVATIONS, DIGENE PRODUCTS;
DEVELOPMENT PROJECTS............................................75
19.1 First Right of Negotiation......................................75
19.3 Third Party Licenses............................................78
19.4 Determination of Improvements or Innovations....................78
19.5 [*****].........................................................80
19.6 Development Projects............................................80
19.7 Testing Service Rights..........................................82
19.8 R&D Expenses....................................................82
19.9 Products Outside the Scope of the Agreement.....................82
ARTICLE 20. - TRANSFER, MODIFICATION OR TERMINATION OF OBLIGATIONS
UNDER THE MUREX AGREEMENTS......................................82
20.1 General.........................................................82
20.2 Distribution of HBV.............................................83
20.3 Distribution of HPV.............................................83
20.4 Distribution of CMV.............................................83
20.5 Distribution of SHARP Signal System Products....................84
20.6 Murex-Only Labeled Products.....................................85
20.7 Continuing Obligations Under the Murex Agreements...............86
20.8 Transition Period...............................................87
20.9 Termination of the Murex Agreements.............................90
ARTICLE 21. - MISCELLANEOUS...................................................92
21.1 Relationship of the Parties.....................................92
21.2 Successors and Assignment.......................................92
21.3 Binding Effect..................................................92
21.4 Entire Agreement................................................93
21.5 Governing Law...................................................93
21.6 Dispute Resolution..............................................93
21.7 Notices.........................................................93
21.8 Severability....................................................94
21.9 Interpretation..................................................95
21.10 Amendments......................................................95
21.11 Waiver..........................................................95
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
21.12 Survival........................................................95
21.13 Headings........................................................96
21.14 Counterparts....................................................96
21.15 Mutual Drafting.................................................96
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
MARKETING AND DISTRIBUTION AGREEMENT
THIS AGREEMENT is made, as of the Effective Date, by and between Abbott Laboratories, an Illinois corporation having its principal place of business at 100 Abbott Park Road, Abbott Park, Illinois 60064-6400 ("Abbott"), and Digene Corporation, a Delaware corporation having its principal place of business at 9000 Virginia Manor Road, Beltsville, Maryland 20705 ("Digene").
WITNESSETH:
WHEREAS, Digene is engaged in the development, manufacture, marketing and distribution of medical diagnostic products;
WHEREAS, Digene has entered into: (i) a Distribution Agreement with Murex Diagnostics Corporation dated August 1, 1997; (ii) an Agency and Sales Representation Agreement with Murex Diagnostics Corporation dated February 1, 1997; (iii) a Customer Transfer Agreement with Murex Diagnostics Corporation dated February 1, 1997; (iv) an Escrow Agreement dated February 1, 1997 among Digene, Murex Diagnostics Corporation and Reid & Priest LLP; (v) a Distribution Agreement with Murex Biotech Limited dated February 28, 1996, as amended February 1, 1997; (vi) a Development and License Agreement with International Murex Technologies Corporation dated May 31, 1994 (and the related escrow agreement); (vii) a letter agreement dated May 31, 1994 with International Murex Technologies Limited; (viii) a Development and License Agreement with International Murex Technologies Corporation dated
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
April 14, 1993 (and the related escrow agreement); and (ix) a Distribution Agreement with International Murex Technologies Corporation dated May 19, 1992, as amended on May 26, 1993 and April 4, 1996, (collectively the "Murex Agreements") for the distribution and development of certain Digene products (Murex Biotech Limited, Murex Diagnostics Corporation and International Murex Technologies Limited were at all relevant times subsidiaries or affiliates of International Murex Technologies Corporation and together with International Murex Technologies Corporation are hereinafter referred to as "Murex");
WHEREAS, on or about April 17, 1998, Abbott acquired International Murex Technologies Corporation pursuant to an Acquisition Agreement dated March 13, 1998, and as a result thereof, assumed the obligations of Murex under the Murex Agreements;
WHEREAS, Digene desires to transfer certain obligations under the Murex Agreements to Abbott, to enter into a new distribution arrangement with Abbott regarding the development, manufacture, marketing and distribution of certain of its products in certain territories in the world and, in connection therewith, to terminate the Murex Agreements;
WHEREAS, Digene and Abbott wish to collaborate to expand the development and utilization of certain Digene products;
WHEREAS, Abbott, through its Diagnostics Division ("ADD"), is engaged in the development, manufacture, marketing and distribution of medical diagnostic products;
WHEREAS, Abbott desires to accept the transfer of certain obligations under the Murex Agreements, to enter into a new distribution arrangement with Digene regarding the
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
development, manufacture, marketing and distribution of certain Digene products and, in connection therewith, to terminate the Murex Agreements; and
WHEREAS, in accordance with the terms and conditions hereof, Digene is willing to appoint Abbott as a distributor of certain Digene products in certain territories, and Abbott is willing to accept such appointment.
NOW THEREFORE, in consideration of the mutual covenants and agreements contained herein, and upon the terms and subject to conditions set forth below, Abbott and Digene hereby agree as follows:
ARTICLE 1. - DEFINITIONS
The following words and phrases, when used herein with initial capital letters, shall have the meanings set forth or referenced below:
1.1 "Affiliate" shall mean, with respect to each Party (as hereinafter defined), any legal entity which is, directly or indirectly, controlling, controlled by or under common control with such Party. For purposes of this definition, a Party shall be deemed to control another entity if it owns or controls, directly or indirectly, more than fifty percent (50%) of the voting equity of the other entity (or other comparable ownership interest for an entity other than a corporation).
1.2 "Africa" shall mean those countries and territories set forth on Schedule 1.2.
1.3 "Amplified Reimbursement" shall mean reimbursement under the Medicare/Medicaid CPT code for reimbursement as an amplified assay, which as of the Effective Date (as hereinafter defined) is 87491 (CT) and 87591 (GC).
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.4 "Analyte" shall mean an individual compound, nucleic acid or fragment thereof, bacteria, virus, fungus, mycoplasm or other substance which is the target of quantitative or qualitative measurement.
1.5 "AUP" shall mean average unit selling price.
1.6 "Base Sales" shall mean the Net Sales (as hereinafter defined) in calendar year 1998 of each Product (as hereinafter defined) sold by Digene and its Affiliates in the same Territory (as hereinafter defined) in which Abbott and its Affiliates are granted distribution rights hereunder with respect to such Product, as set forth on Schedule 1.6.
1.7 "Book Value" shall mean the Purchase Price (as hereinafter defined) of the Digene Equipment (as hereinafter defined), less accumulated depreciation on a straight-line basis for four (4) years with $0.00 residual value, in accordance with generally accepted accounting principles in the United States (as hereinafter defined) ("GAAP"), consistently applied.
1.8 "Business Day" means any day other than a day which is a Saturday or Sunday or other day on which commercial banks in Ne ...
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