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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT 10.41
MARKETING AND DISTRIBUTION
AGREEMENT
BY AND BETWEEN
XXXXXX LABORATORIES
AND
DIGENE CORPORATION
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TABLE OF CONTENTS
ARTICLE 1. - DEFINITIONS......................................................3
1.1 "Affiliate"......................................................3
1.2 "Africa".........................................................3
1.3 "Amplified Reimbursement"........................................4
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"...............................................5
1.10 "Certificate of Analysis"........................................5
1.11 "Change of Control"..............................................5
1.12 "CMV"............................................................5
1.13 "CMV Territory"..................................................5
1.14 "Confidential Information".......................................6
1.15 "Contract Year"..................................................7
1.16 "CT/GC"..........................................................7
1.17 "CT/GC Clearance"................................................7
1.18 "CT/GC Non-U.S. AUP".............................................7
1.19 "CT/GC Products".................................................8
1.20 "CT/GC U.S. AUP".................................................8
1.21 "CT/GC Specifications"...........................................9
1.22 "CT/GC Territory"................................................9
1.23 "Delivered "and "Delivery".......................................9
1.24 "Designated Country".............................................9
1.25 "Digene Equipment"...............................................9
1.26 "Digene Products"................................................9
1.27 "Digene Trademarks"..............................................9
1.28 "Distributor"....................................................9
1.29 "Distributor Territories".......................................10
1.30 "Distribution Agreement"........................................10
1.31 "Effective Date"................................................10
1.32 "Equipment".....................................................10
1.33 "Europe"........................................................10
1.34 "FDA"...........................................................10
1.35 "Field".........................................................10
1.36 "Fully Burdened Manufacturing Cost".............................10
1.37 "HBV"...........................................................10
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1.38 "HBV AUP".......................................................11
1.39 "HBV Products"..................................................11
1.40 "HBV Specifications"............................................11
1.41 "HBV Territory".................................................12
1.42 "HPV"...........................................................12
1.43 "HPV AUP".......................................................12
1.44 "HPV Products"..................................................12
1.45 "HPV Specifications"............................................13
1.46 "HPV Territory".................................................13
1.47 "Hybrid Capture(R) Technology"..................................13
1.48 "Hybrid Capture for Digene Products"............................13
1.49 "Improvement"...................................................13
1.50 "Incremental Sales".............................................14
1.51 "Initial Term"..................................................14
1.52 "Innovation"....................................................14
1.53 "Middle East"...................................................14
1.54 "Minimum Transfer Price"........................................14
1.55 "Murex Entities"................................................15
1.56 "Net Sales".....................................................15
1.57 "Non-Amplified Reimbursement"...................................16
1.58 "Non-proprietary Equipment".....................................16
1.59 "Other Products"................................................16
1.60 "Other Product Specifications"..................................16
1.61 "Party".........................................................17
1.62 "Patents".......................................................17
1.63 "Product".......................................................17
1.64 "Product Accessories"...........................................17
1.65 "Purchase Price"................................................17
1.66 "Recall"........................................................17
1.67 "SHARP".........................................................17
1.68 "SHARP Territory"...............................................17
1.69 "Shipped Products"..............................................17
1.70 "Specifications"................................................17
1.71 "Term"..........................................................17
1.72 "Territory".....................................................18
1.73 "Third Party"...................................................18
1.74 "Trade".........................................................18
1.75 "Trade Secrets".................................................18
1.76 "Transition Period".............................................18
1.77 "United States".................................................18
1.78 "Validation Protocols"..........................................19
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1.79 "Warranty Period"...............................................19
1.80 "Work With".....................................................19
1.81 "Year 2000 Compliant"...........................................19
ARTICLE 2. - APPOINTMENT TO MARKET AND DISTRIBUTE.............................20
2.1 Exclusive Appointment for CT/GC..................................20
2.2 Exclusive Appointment for HBV....................................20
2.3 Exclusive Appointment for HPV....................................21
2.4 Additional Territories...........................................21
2.5 Noncompetition...................................................22
2.6 Trade Costs......................................................23
2.7 Selling Price....................................................23
2.8 Contracting Rights...............................................23
2.9 Distributor Territories..........................................23
2.10 Non-Exclusive Appointment for Equipment..........................24
ARTICLE 3. - MARKETING AND PROMOTION..........................................25
3.1 Xxxxxx'x General Marketing and Promotion Responsibilities........25
3.2 Digene's General Promotional Responsibilities....................25
3.3 Development of Promotional and Marketing Materials...............26
3.4 Marketing Plans..................................................26
3.5 Sales Reports....................................................27
3.6 Support..........................................................28
3.7 Product Samples..................................................28
3.8 Marketing Steering Committee.....................................28
ARTICLE 4. - SALES PERFORMANCE THRESHOLDS.....................................29
4.1 Net Sales Thresholds for CT/GC...................................29
4.2 Net Sales Thresholds for HBV.....................................32
4.3 Net Sales Thresholds for HPV.....................................34
4.4 Exercise of Rights...............................................37
4.5 Wind-down Activities.............................................37
4.6 Factors Affecting Net Sales......................................38
ARTICLE 5. - MANUFACTURE AND SUPPLY...........................................38
5.1 Supply...........................................................38
5.2 Forecasting......................................................43
5.3 Orders...........................................................44
5.4 Failure to Supply Product........................................44
5.5 Failure to Supply Digene Equipment...............................47
5.6 Supply Allocation................................................48
5.7 Ordering Processing..............................................48
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5.8 Safety Stock.....................................................48
5.9 Hazardous Classification Labeling................................49
ARTICLE 6. - PRICE AND TERMS..................................................49
6.1 Purchase Price for Equipment.....................................49
6.2 Product Transfer Price...........................................51
6.3 Minimum Transfer Price...........................................52
6.4 Year-End Reconciliation..........................................52
6.5 Royalty Obligations..............................................52
6.6 Payment Terms....................................................53
6.7 Foreign Exchange.................................................53
ARTICLE 7. - SHIPMENT AND DELIVERY............................................53
7.1 Shipment.........................................................53
7.2 Delivery.........................................................54
7.3 Export Licenses: Import Certificates; Customs and
Regulatory Approval for Delivery of Shipped Products
Outside the United States........................................54
7.4 Title and Risk of Loss...........................................55
7.5 Taxes............................................................55
7.6 Certificate of Analysis..........................................55
ARTICLE 8. - ACCEPTANCE OF SHIPPED PRODUCT; INSPECTION OF
MANUFACTURING FACILITY...........................................55
8.1 Digene Testing...................................................55
8.2 Abbott Testing...................................................56
8.3 Abbott Inspection................................................58
ARTICLE 9. - REGULATORY COMPLIANCE AND MEDICAL COMPLAINTS.....................58
9.1 No Modification..................................................58
9.2 Regulatory Compliance............................................58
9.3 Customer Complaints..............................................59
ARTICLE 10. - RECALL OR WITHDRAWAL............................................59
10.1 Event of Recall and Withdrawal...................................59
10.2 Expense of Recall................................................60
ARTICLE 11. - BOOKS AND RECORDS...............................................60
11.1 Examination Rights...............................................60
11.2 Reconciliation of Underpayment or Overcharge.....................61
11.3 Costs of Examination.............................................62
ARTICLE 12. - PATENTS AND TRADEMARKS..........................................62
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12.1 Trademark License...............................................62
12.2 Trademark Ownership.............................................63
12.3 Infringement....................................................64
12.4 Possible Removal From Market....................................64
12.5 Third Party Claims for Infringement.............................65
12.6 Co-Labeled Product..............................................65
12.7 Limitation of Liability.........................................65
ARTICLE 13. - REPRESENTATIONS AND WARRANTIES..................................66
13.1 Digene Representations and Warranties...........................66
13.2 Replacement or Repair...........................................67
13.3 Third Party Distributors........................................68
13.4 Limitation on Warranties........................................68
13.5 Patent Representations and Warranties...........................68
13.6 General Representations and Warranties..........................69
ARTICLE 14. - GENERAL INDEMNIFICATION.........................................70
14.1 Digene Indemnification..........................................70
14.2 Abbott Indemnification..........................................70
14.3 Cooperation.....................................................71
14.4 Insurance.......................................................71
ARTICLE 15. TERM AND TERMINATION..............................................71
15.1 Term............................................................71
15.2 Termination for Cause...........................................72
15.3 Termination By Digene For Xxxxxx'x Failure to
Achieve Net Sales Thresholds....................................73
15.4 Termination By Abbott for Change of Control.....................73
15.5 Partial Termination By Digene For Xxxxxx'x Failure
to Market in Particular Country.................................74
15.6 Continuation of Force Majeure...................................76
15.7 Accrued Obligations.............................................76
15.8 Additional Remedies for Breach..................................76
ARTICLE 16. - CONSEQUENCES OF TERMINATION.....................................76
16.1 Buy-out of Equipment and Inventory..............................76
16.2 Termination Fee.................................................77
16.3 Residual Payments...............................................77
ARTICLE 17. - CONFIDENTIALITY AND PUBLIC ANNOUNCEMENTS........................78
17.1 Confidentiality.................................................78
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17.2 Handling of Trade Secrets.......................................78
17.3 Confidential Treatment..........................................79
17.4 Public Announcements............................................79
ARTICLE 18. - FORCE MAJEURE..................................................80
ARTICLE 19. - IMPROVEMENTS, INNOVATIONS, DIGENE PRODUCTS;
DEVELOPMENT PROJECTS............................................81
19.1 First Right of Negotiation......................................81
19.3 Third Party Licenses............................................84
19.4 Determination of Improvements or Innovations....................84
19.5 [*****].........................................................86
19.6 Development Projects............................................86
19.7 Testing Service Rights..........................................88
19.8 R&D Expenses....................................................88
19.9 Products Outside the Scope of the Agreement.....................88
ARTICLE 20. - TRANSFER, MODIFICATION OR TERMINATION OF OBLIGATIONS
UNDER THE MUREX AGREEMENTS......................................88
20.1 General.........................................................89
20.2 Distribution of HBV.............................................89
20.3 Distribution of HPV.............................................89
20.4 Distribution of CMV.............................................89
20.5 Distribution of SHARP Signal System Products....................90
20.6 Murex-Only Labeled Products.....................................92
20.7 Continuing Obligations Under the Murex Agreements...............92
20.8 Transition Period...............................................93
20.9 Termination of the Murex Agreements.............................97
ARTICLE 21. - MISCELLANEOUS...................................................98
21.1 Relationship of the Parties.....................................98
21.2 Successors and Assignment.......................................98
21.3 Binding Effect..................................................99
21.4 Entire Agreement................................................99
21.5 Governing Law...................................................99
21.6 Dispute Resolution.............................................100
21.7 Notices........................................................100
21.8 Severability...................................................101
21.9 Interpretation.................................................101
21.10 Amendments.....................................................102
21.11 Waiver.........................................................102
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21.12 Survival.......................................................102
21.13 Headings.......................................................102
21.14 Counterparts...................................................103
21.15 Mutual Drafting................................................103
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MARKETING AND DISTRIBUTION AGREEMENT
THIS AGREEMENT is made, as of the Effective Date, by and between Xxxxxx
Laboratories, an Illinois corporation having its principal place of business at
000 Xxxxxx Xxxx Xxxx, Xxxxxx Xxxx, Xxxxxxxx 00000-0000 ("Abbott"), and Digene
Corporation, a Delaware corporation having its principal place of business at
0000 Xxxxxxxx Xxxxx Xxxx, Xxxxxxxxxx, Xxxxxxxx 00000 ("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 Xxxx & 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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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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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).
3
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
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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 New York, New York are
authorized or required to remain closed.
1.9 "Calendar Quarter" shall mean a period of three (3) consecutive
calendar months commencing on January 1, April 1, July 1 or October 1 of any
Contract Year (as hereinafter defined).
1.10 "Certificate of Analysis" shall mean finished goods test results
accompanying the release of Products.
4
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.11 "Change of Control" shall mean: (a) the consolidation or merger of
Digene or any Affiliate of Digene holding or controlling a majority of the
assets relating to the business of Digene which is the subject of this
Agreement, with or into any Third Party (as hereinafter defined); (b) the
assignment, sale, transfer, lease or other disposition of all or substantially
all of the assets of Digene and its Affiliates taken as a whole; or (c) the
acquisition by any Third Party or group of Third Parties acting in concert, of
beneficial ownership (within the meaning of Rule 13d-3 of the Securities and
Exchange Commission ("SEC") under the Securities Exchange Act of 1934, as
amended) of shares of voting stock of Digene, the result of which in the case
of any transaction described in clauses (a), (b) and (c) above is that
immediately after the transaction the shareholders of Digene immediately before
the transaction own less than fifty percent (50%) of the outstanding shares of
the surviving corporation in a transaction specified in clause (a) above or the
acquiror in a transaction specified in clause (b) or (c) above.
1.12 "CMV" shall have the meaning set forth in Section 20.4.
1.13 "CMV Territory" shall mean Europe (as hereinafter defined), the
Middle East (as hereinafter defined) and Africa.
1.14 "Confidential Information" shall mean any and all technical data,
information, materials and other know-how, including Trade Secrets (as
hereinafter defined), presently owned by or developed by or licensed to, or on
behalf of, Digene or Abbott which relates to the development, manufacture,
promotion, marketing, distribution, sale or use of (a) any Product or Digene
Products, (b) any Improvement (as hereinafter defined) or Innovation (as
hereinafter defined), (c) any Digene Equipment, (d) a development project
described in Article 19 during the
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Term (as hereinafter defined), (e) any Abbott products, and (f) any
information, including financial data, relating to the business of either of
the Parties and/or of their Affiliates, which a Party and/or its Affiliates
discloses to the other Party and/or its Affiliates in writing and identifies as
being confidential, or if disclosed orally, visually or through some other
media, is identified as confidential at the time of disclosure and is
summarized in writing within thirty (30) days of such disclosure and identified
as confidential, except any portion thereof which:
(a) is known to the receiving Party and/or its Affiliates at the time
of the disclosure, as evidenced by its written records;
(b) is disclosed to the receiving Party and/or its Affiliates by a
Third Party having a legal right to do so;
(c) becomes patented, published or otherwise part of the public
domain through no fault of the receiving Party and/or its Affiliates; or
(d) is independently developed by or for the receiving Party and/or
its Affiliates without use of Confidential Information disclosed
hereunder, as evidenced by its written records.
1.15 "Contract Year" shall mean a calendar year during the Term, except
that the first Contract Year shall begin on the Effective Date and shall end on
December 31, 1999.
1.16 "CT/GC" shall mean Digene's diagnostic assay utilizing Hybrid
Capture(R) Technology (as hereinafter defined) designed to detect the presence
of gonorrhea and/or chlamydia in a sample in accordance with the CT/GC
Specifications (as hereinafter defined),
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including any Improvements thereto (except as provided in Section 19.2),
consisting of the CT/GC Products (as hereinafter defined).
1.17 "CT/GC Clearance" shall have the meaning set forth in Section 4.1.
1.18 "CT/GC Non-U.S. AUP" shall mean (a) for the purpose of payment of the
transfer price under Section 6.2(a), (i) in the first Contract Year, the amount
set forth on Schedule 1.18 and (ii) for each subsequent Contract Year, the Net
Sales of each CT/GC Product sold by Abbott and its Affiliates in the CT/GC
Territory (as hereinafter defined), excluding the United States, during the
first nine (9) months of the immediately preceding Contract Year, divided by
the number of units of each such CT/GC Product sold by Abbott and its
Affiliates in the CT/GC Territory, excluding the United States, during the
first nine (9) months of the immediately preceding Contract Year, which
calculation shall be provided to Digene by written notice from Abbott no later
than December 1 of such immediately preceding Contract Year, and (b) for the
purposes of year-end reconciliation under Section 6.4 the Net Sales of CT/GC
sold by Abbott and its Affiliates in the CT/GC Territory, excluding the United
States, during the immediately preceding Contract Year divided by the number of
units of each such CT/GC Product sold by Abbott and its Affiliates in the CT/GC
Territory, excluding the United States, during the immediately preceding
Contract Year.
1.19 "CT/GC Products" shall mean each of the CT/GC products listed by part
number on Schedule 1.19.
1.20 "CT/GC U.S. AUP" shall mean (a) for the purpose of payment of the
transfer price under Section 6.2(b), (i) in the first Contract Year, the amount
set forth on Schedule 1.20
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and (ii) for each subsequent Contract Year, the Net Sales of each CT/GC Product
sold by Abbott and its Affiliates in the United States during the first nine
(9) months of the immediately preceding Contract Year, divided by the number of
units of each such CT/GC Product sold by Abbott and its Affiliates in the
United States during the first nine (9) months of the immediately preceding
Contract Year, which calculation shall be provided to Digene by written notice
from Abbott no later than December 1 of such immediately preceding Contract
Year, and (b) for the purposes of year-end reconciliation under Section 6.4 the
Net Sales of CT/GC sold by Abbott and its Affiliates in the United States
during the immediately preceding Contract Year divided by the number of units
of each such CT/GC Product sold by Abbott and its Affiliates in the United
States during the immediately preceding Contract Year.
1.21 "CT/GC Specifications" shall mean the characteristics of CT/GC set
forth on Schedule 1.21 as such specifications may be amended from time to time
pursuant to Section 21.10.
1.22 "CT/GC Territory" shall mean the United States, Europe, the Middle
East and Africa, as may be amended in accordance with Sections 2.4 or 15.5.
1.23 "Delivered "and "Delivery" shall have the meanings ascribed to them
in Section 7.1.
1.24 "Designated Country" shall mean a country in the Territory to which
Shipped Products (as hereinafter defined) shall be delivered.
1.25 "Digene Equipment" shall mean the DML 2000 Luminometers, DCR 1 Tube
Luminometers and other system equipment listed on Schedule 1.25.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.26 "Digene Products" shall mean all existing and new products
principally utilizing Hybrid Capture for Digene Products (as hereinafter
defined), including any Improvements thereto sold or to be sold by Digene in
the Field other than Products and Other Products.
1.27 "Digene Trademarks" shall mean the trademarks of Digene as set forth
on Schedule 1.27.
1.28 "Distributor" shall mean a Third Party with whom Digene has a
Distribution Agreement (as hereinafter defined) in effect on the Effective Date
in the Territory for Products as set forth on Schedule 1.28.
1.29 "Distributor Territories" shall mean those countries identified on
Schedule 1.29, as may be amended from time to time in accordance with the
provisions of Section 2.9.
1.30 "Distribution Agreement" shall mean each agreement between Digene and
any Distributor for the development, manufacture, marketing and/or distribution
of Products in the Territory, as set forth on Schedule 1.30.
1.31 "Effective Date" shall mean the date on which the last Party
executes this Agreement.
1.32 "Equipment" shall mean Digene Equipment and Non-proprietary Equipment
(as hereinafter defined).
1.33 "Europe" shall mean those countries and territories listed on
Schedule 1.33.
1.34 "FDA" shall mean the United States Food and Drug Administration and
any successor agency thereto.
1.35 "Field" shall mean the in vitro human diagnostic market.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.36 "Fully Burdened Manufacturing Cost" shall mean the cost of goods
produced, including direct labor, direct materials and allocable manufacturing
overhead incurred in the manufacture of the Products and the purchase and
packaging of Digene Equipment, all determined in accordance with generally
accepted industry standards and GAAP, consistently applied.
1.37 "HBV" shall mean Digene's diagnostic assay utilizing Hybrid Capture
Technology designed to detect the presence of Hepatitis B Virus in a sample in
accordance with the HBV Specifications (as hereinafter defined), including any
Improvements thereto (except as provided in Section 19.2), consisting of the
HBV Products (as hereinafter defined).
1.38 "HBV AUP" shall mean (a) for the purpose of payment of the transfer
price under Section 6.2(c), (i) in the first Contract Year, the amount set
forth on Schedule 1.38 and (ii) for each subsequent Contract Year, the Net
Sales of each HBV Product sold by Abbott and its Affiliates in the HBV
Territory (as hereinafter defined) during the first nine (9) months of the
immediately preceding Contract Year, divided by the number of units of each
such HBV Product sold by Abbott and its Affiliates in the HBV Territory during
the first nine (9) months of the immediately preceding Contract Year, which
calculation shall be provided to Digene by written notice from Abbott no later
than December 1 of such immediately preceding contract year, and (b) for the
purposes of year-end reconciliation under Section 6.4 the Net Sales of HBV sold
by Abbott and its Affiliates in the HBV Territory during the previous Contract
Year, divided by the number of units of each such HBV Product sold by Abbott
and its Affiliates in the HBV Territory during the immediately preceding
Contract Year.
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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.
1.39 "HBV Products" shall mean each of the HBV products listed by part
number on Schedule 1.39.
1.40 "HBV Specifications" shall mean the characteristics of HBV set forth
on Schedule 1.40, as such specifications may be amended from time to time
pursuant to Section 21.10.
1.41 "HBV Territory" shall mean Europe, the Middle East and Africa, as may
be amended in accordance with Sections 2.4 or 15.5.
1.42 "HPV" shall mean Digene's diagnostic assay utilizing Hybrid Capture
Technology designed to detect the presence of Human Papillomavirus in a sample
in accordance with the HPV Specifications (as hereinafter defined), including
any Improvements thereto (except as provided in Section 19.2), consisting of
HPV Products (as hereinafter defined).
1.43 "HPV AUP" shall mean (a) for the purpose of payment of the transfer
price under Section 6.2(d), (i) in the first Contract Year, the amount set
forth on Schedule 1.43 and (ii) for each subsequent Contract Year, the Net
Sales of each such HPV Product sold by Abbott and its Affiliates in the HPV
Territory (as hereinafter defined) during the first nine (9) months of the
immediately preceding Contract Year, divided by the number of units of each
such HPV Product sold by Abbott and its Affiliates in the HPV Territory during
the first nine (9) months of the immediately preceding Contract Year, which
calculation shall be provided to Digene by written notice from Abbott no later
than December 1 of such immediately preceding Contract Year, and (b) for the
purposes of year-end reconciliation under Section 6.4 the Net Sales of HPV sold
by Abbott and its Affiliates in the HPV Territory during the previous Contract
Year, divided by 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.
number of units of each such HPV Product sold by Abbott and its Affiliates in
the HPV Territory during the immediately preceding Contract Year.
1.44 "HPV Products" shall mean each of the HPV products listed by part
number on Schedule 1.44.
1.45 "HPV Specifications" shall mean the characteristics of HPV set forth
on Schedule 1.45, as such specifications may be amended from time to time
pursuant to Section 21.10.
1.46 "HPV Territory" shall mean Europe, the Middle East and Africa, as may
be amended in accordance with Sections 2.4 or 15.5.
1.47 "Hybrid Capture(R) Technology" shall mean the [***********************
********************************************************************************
*******************************************************************************]
1.48 "Hybrid Capture for Digene Products" shall mean the methods for
performing Hybrid Capture I and Hybrid Capture II assays in coated tube and
96-well microplates for nucleic acid sequences that involve antibody
recognition of double-stranded sequences and which is claimed by the Patents.
1.49 "Improvement" shall mean any improvement, modification or adjustment
of or to any Product or Digene Product, as the case may be, which provides no
recognized or a moderate, but not significant, benefit to customers in terms of
the testing method, performance and/or automation. Examples of Improvements
include, but are not limited to, the following: [*******************************
********************************************************************************
********************************************************************************
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
********************************************************************************
********************************************************************************
********************************************************************************
*******************************************************************************]
1.50 "Incremental Sales" shall mean the Net Sales of a Product or
Products in the twelve (12) months preceding a Change in Control in excess of
Base Sales of such Product or Products.
1.51 "Initial Term" shall mean the period beginning on the Effective Date
and ending, with respect to CT/GC on December 31 of the fifth full Contract
Year after CT/GC Clearance and, with respect to HBV and HPV, on December 31,
2003.
1.52 "Innovation" shall mean any significant development, improvement,
modification or adjustment of or to any Product which results in a technology
restatement or a unique competitive advantage which provides significant
customer benefit in terms of the testing method, performance and/or automation.
Examples of Innovations include, but are not limited to, the following: [*******
********************************************************************************
*******************************************************************************]
1.53 "Middle East" shall mean those countries and territories set forth on
Schedule 1.53.
1.54 "Minimum Transfer Price" shall mean the minimum price Digene shall
invoice Abbott and its Affiliates for any Product as set forth on Schedule
1.54.
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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.
1.55 "Murex Entities" shall mean Murex Diagnostic Corporation, Murex
Biotech Limited, International Murex Technologies Corporation, International
Murex Technologies Limited and any Murex Affiliate obligated to perform
activities pursuant to any of the Murex Agreements.
1.56 "Net Sales" shall mean the total of the gross amount billed or
invoiced to Third Parties for the sale of a Product in the Field, less:
(a) rebates granted and allowances, trade, quantity or cash discounts
actually allowed and taken.
(b) retroactive price reductions imposed by government authorities;
(c) fees, commissions or rebates lawfully paid pursuant to contracts
with group purchasing organizations;
(d) amounts actually repaid a Third Party by reason of rejection or
return of defective Product; and
(e) upcharges paid by Third Parties as part of a reagent agreement
plan or similar arrangement;
provided, however, that if any Product is sold by Abbott or its Affiliates in
combination with other components which have commercial utility other than use
in combination with such Product (together, a "Combination Product"), Net Sales
of such Product shall be the gross invoiced price of such Combination Product
billed to customers by Abbott or its Affiliates, less the allowances and
adjustment referred to above, multiplied by the fraction A/(A+B), where A is
the gross selling price of the Product sold separately during the period in
question, and B is 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.
gross selling price of such other components sold separately during the period
in question; provided, further, that if any Combination Product is sold by
Abbott or its Affiliates and the gross selling price for the Product or such
other components is not determinable, then the gross amount billed or invoiced
to Third Parties for the sale of such Product shall be deemed to be an amount
equal to the percentage of the gross sales price, less the allowances and
adjustments referred to above, for the Combination Product which is equal to
the percentage of the fair market value of the Product and such other
components in the Combination Product represented by the fair market value of
the Product.
1.57 "Non-Amplified Reimbursement" shall mean reimbursement under the
Medicare/Medicaid CPT code for reimbursement as a non-amplified assay, which as
of the Effective Date is 87490 (CT) and 87590 (GC).
1.58 "Non-proprietary Equipment" shall mean the equipment available for
purchase from Third Parties, as set forth on Schedule 1.58, which is utilized
in connection with Digene Equipment, and which has been specified and validated
under the Validation Protocol (as hereinafter defined) for use in connection
with Products.
1.59 "Other Products" shall mean CMV and SHARP(TM) (as hereinafter
defined).
1.60 "Other Product Specifications" shall mean the characteristics of CMV
or SHARP, as the case may be, set forth on Schedule 1.60, as such
specifications may be amended from time to time pursuant to Section 21.10.
1.61 "Party" shall mean Digene or Abbott, and "Parties" shall mean Digene
and Abbott.
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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.
1.62 "Patents" shall mean the patents and patent applications (including
any patents that issue based upon such patent applications) set forth on
Schedule 1.62.
1.63 "Product" shall mean CT/GC, HBV and HPV, or any combination of the
foregoing, including the Product Accessories (as hereinafter defined), manuals,
labeling, packaging and package inserts thereto.
1.64 "Product Accessories" shall mean proprietary sample collection
devices, reagents, and/or other consumables that may be used in connection with
Products, as set forth on Schedule 1.64.
1.65 "Purchase Price" shall mean the price for Equipment purchased by
Abbott and its Affiliates from Digene hereunder, more fully described in
Section 6.1.
1.66 "Recall" shall have the meaning set forth in Section 10.1.
1.67 "SHARP" shall have the meaning set forth in Section 20.5.
1.68 "SHARP Territory" shall mean Europe, the Middle East and Africa.
1.69 "Shipped Products" shall have the meaning set forth in Section 7.1.
1.70 "Specifications" shall mean collectively the CT/GC Specifications,
the HBV Specifications and the HPV Specifications.
1.71 "Term" shall mean the Initial Term and any extensions thereto, unless
otherwise terminated earlier in accordance with the terms and conditions of
Article 15.
1.72 "Territory" shall mean collectively the CT/GC Territory, the HBV
Territory and the HPV Territory, as may be amended in accordance with Sections
2.4 or 15.5.
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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.
1.73 "Third Party" shall mean a natural person, corporation, partnership,
trust, joint venture, governmental authority or other legal entity or
organization other than the Parties and/or their Affiliates.
1.74 "Trade" shall mean potential customers, including, without
limitation, hospitals, physician office laboratories, reference laboratories,
alternate site facilities and group purchasing organizations, but shall not
include a Distributor during the term of such Distributor's Distribution
Agreement.
1.75 "Trade Secrets" shall mean the technical or non-technical data,
formulae, patterns, compilations, programs, devices, methods, techniques,
drawings, processes, financial data, financial plans, marketing plans, product
plans and the like, owned or licensed by a Party and/or its Affiliates: (a)
from which a Party and/or its Affiliates derives actual or potential economic
value by being held in secrecy and not known by Third Parties who are not under
an obligation of confidentiality with respect thereto; or (b) which gives such
Party an actual or potential advantage over Third Party competitors who do not
know or use it.
1.76 "Transition Period" shall have the meaning set forth in Section 20.8.
1.77 "United States" shall mean the fifty (50) states of the United
States, including its territories and possessions and the District of Columbia
and Puerto Rico.
1.78 "Validation Protocols" shall mean the Validation Protocols set forth
on Schedule 3.6.
1.79 "Warranty Period" shall have the meaning ascribed to it in Section
13.1(b).
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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.
1.80 "Work With" shall mean to provide reasonable assistance, to consult,
to offer advice and to take other reasonable steps designed to help resolve
technical or quality or customer problems and to provide a professional,
unified image to customers, and timely cooperation in the execution of
distribution, sales, marketing and promotion programs or the adjustments of any
Net Sales thresholds under this Agreement; provided, however, that "Work With"
shall not mean incurring any capital expenditures or incurring any expenses
other than direct salary, travel and accommodation costs of Abbott or Digene
employees, as the case may be. For the purposes of this definition, a failure
to "Work With" shall include a habitual neglect or failure to perform the
activities outlined in this Agreement over a commercially reasonable period of
time or failure to act in good faith, on a timely basis at the request of the
other Party. A failure to "Work With" shall be a material breach for the
purposes of Section 15.2.
1.81 "Year 2000 Compliant" shall mean having no lesser functionality with
respect to records containing dates before or after January 1, 2000, than
previously with respect to dates prior to January 1, 2000.
ARTICLE 2. - APPOINTMENT TO MARKET AND DISTRIBUTE
2.1 Exclusive Appointment for CT/GC. Subject to the terms and conditions
of this Agreement, Digene hereby appoints Abbott and its Affiliates for the
Term as Digene's exclusive distributor, subject to the rights of existing
Distributors, of CT/GC in the CT/GC Territory for use in the Field and Abbott
hereby accepts such appointment. As part of such appointment under this Section
2.1, Abbott shall have the right to appoint sub-distributors in those countries
or
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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.
territories in the CT/GC Territory in which Abbott generally uses
sub-distributors to distribute Xxxxxx diagnostic products. As exclusive
distributor hereunder, Abbott and its Affiliates shall have the sole and
exclusive right, subject to the rights of existing Distributors, to market,
promote, sell and distribute CT/GC in the CT/GC Territory for use in the Field,
which right shall operate to exclude all others, including Digene, its
Affiliates and all Third Parties.
2.2 Exclusive Appointment for HBV. Subject to the terms and conditions of
this Agreement, Digene hereby appoints Abbott and its Affiliates for the Term
as the exclusive distributor, subject to the rights of existing Distributors,
of HBV in the HBV Territory for use in the Field and Abbott hereby accepts such
appointment. As part of such appointment under this Section 2.2, Abbott shall
have the right to appoint sub-distributors in those countries or territories in
the HBV Territory in which Abbott generally uses sub-distributors to distribute
Xxxxxx diagnostic products. As exclusive distributor hereunder, Abbott and its
Affiliates shall have the sole and exclusive right, subject to the rights of
existing Distributors, to market, promote, sell and distribute HBV in the HBV
Territory for use in the Field, which right shall operate to exclude all
others, including Digene, its Affiliates and all Third Parties.
2.3 Exclusive Appointment for HPV. Subject to the terms and conditions of
this Agreement, Digene hereby appoints Abbott and its Affiliates for the Term
as the exclusive distributor, subject to the rights of existing Distributors,
of HPV in the HPV Territory for use in the Field and Abbott hereby accepts such
appointment. As part of such appointment under this Section 2.3, Abbott shall
have the right to appoint sub-distributors in those countries or territories in
the HPV Territory in which Abbott generally uses sub-distributors to distribute
Abbott
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
diagnostic products. As exclusive distributor hereunder, Abbott and its
Affiliates shall have the sole and exclusive right, subject to the rights of
existing Distributors, to market, promote, sell and distribute HPV in the HPV
Territory for use in the Field, which right shall operate to exclude all
others, including Digene, its Affiliates and all Third Parties.
2.4 Additional Territories. Promptly after the Effective Date, but no
later than December 31, 1999, the Parties shall commence good faith exclusive
negotiations to expand the territories covered by this Agreement with respect
to each Product subject to any existing agreements between Digene and a Third
Party; provided, however, that neither Party shall be obligated to enter into
such an arrangement after completing such good faith negotiations. In the event
that prior to December 31, 1999, Digene receives an unsolicited request from a
Third Party, which Digene desires to pursue, to negotiate or enter into an
agreement to market and distribute any Product in territories not covered by
this Agreement, Digene shall provide prompt written notice to Abbott with
respect to the Product and the territories for which it has received an
unsolicited request. Abbott shall provide written notice to Digene within ten
(10) Business Days of Xxxxxx'x receipt of Digene's notice of the unsolicited
request of whether it will commence good faith exclusive negotiations with
Digene regarding such Product and territories pursuant to this Section 2.4.
Such negotiations shall be deemed to commence on the date of Xxxxxx'x notice to
Digene. In the event that Abbott does not so notify Digene that it desires to
commence such negotiations, Digene may enter into negotiations and an agreement
with respect to such Product in such territories. In the event the Parties do
not enter into an expanded contractual relationship within sixty (60) days
after the commencement of good faith exclusive
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
negotiations, then, from the conclusion of such negotiations or the expiration
of such sixty (60) day period, whichever first occurs, until December 31, 2001,
Digene shall not enter into any distribution agreement with a Third Party with
respect to one or more Products in territories not covered by this Agreement,
the terms of which, when considered in their entirety, are materially more
favorable to the Third Party than the terms finally offered to or by Abbott in
such negotiations. Digene shall have no obligation under this Section 2.4 with
respect to any Product if Abbott is in material breach of this Agreement or if,
with respect to such Product, Xxxxxx'x distribution rights are non-exclusive or
have terminated.
2.5 Noncompetition. During the Term, Abbott and its Affiliates shall not,
directly or indirectly, promote, market, distribute or sell [*****************
*****************************************************************************
*******************************************************************************
*******************************************].
2.6 Trade Costs. Abbott and its Affiliates shall be responsible for
payment of all rebates, discounts, management fees, service allowances, credits
and taxes associated with the sale by Abbott or its Affiliates of Shipped
Products.
2.7 Selling Price. Abbott and its Affiliates shall, in their sole
discretion, determine the final sales price of Shipped Products sold by Abbott
and its Affiliates to the Trade; provided, however, that any discount to the
sales price of Products shall be consistent with the overall discounting policy
of Abbott in connection with the sale of its diagnostic products and, when
considered in relation to the percentage discount applicable to Xxxxxx
diagnostic products which
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
are sold together with or in connection with the Products, shall not materially
adversely affect Net Sales.
2.8 Contracting Rights. During the Term, Abbott and its Affiliates shall
have the exclusive right, subject to the Distribution Agreements, to contract
with the Trade for the sale of Products in the applicable Territory.
2.9 Distributor Territories. Digene shall terminate existing agreements,
arrangements and understandings regarding the distribution of Products with
Distributors in the Territory, unless such termination violates either the
terms of any such agreement, arrangement or understanding, any applicable law,
or both or such termination requires any payment by Digene. In such event,
Digene shall use commercially reasonable efforts to negotiate, at Digene's
cost, an arrangement whereby such agreement, arrangement or understanding (a)
is terminated, or (b) is converted to non-exclusive; provided, however, that
Digene shall have no obligations under this sentence if the cost of termination
or conversion is, in Digene's sole judgment, unreasonable. For the
non-exclusive Distributor Territories, a list of which is set forth on Schedule
1.30, Xxxxxx'x and its Affiliates' appointment hereunder shall be co-exclusive
for the applicable Products as of the Effective Date and shall remain
co-exclusive for such Products until termination of the applicable agreement,
arrangement or understanding with a Distributor, at which time, the Distributor
Territories that are subject to such agreement, arrangement or understanding
shall become part of the applicable Territory for such Products. For the
exclusive Distributor Territories, a list of which is set forth on Schedule
1.30, Abbott and its Affiliates shall have no rights to distribute the
applicable Products therein until termination of the applicable agreement,
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
arrangement or understanding with a Distributor, at which time, the Distributor
Territories that are subject to such agreement, arrangement or understanding
shall become part of the applicable Territory for such Products.
2.10 Non-Exclusive Appointment for Equipment. Subject to the terms and
conditions of this Agreement, Digene hereby appoints Abbott and its Affiliates
for the Term as the non-exclusive distributor of Equipment in the Territory for
use with respect to Products and in the CMV Territory with respect to CMV in
the Field and Abbott accepts such appointment. As part of such appointment
under this Section 2.10, Abbott shall have the right to appoint
sub-distributors in those countries or territories in the Territory in which
Abbott generally uses sub-distributors to distribute Xxxxxx diagnostic
products.
ARTICLE 3. - MARKETING AND PROMOTION
3.1 Xxxxxx'x General Marketing and Promotion Responsibilities. Xxxxxx
shall use commercially reasonable efforts to promote, market, sell and
distribute CT/GC, HBV, HPV, CMV, SHARP and Equipment in each country in the
CT/GC Territory, the HBV Territory, the HPV Territory, the CMV Territory and
the SHARP Territory, respectively, as the case may be. Such efforts may
include, but shall not be limited to, preparing collateral marketing materials,
conducting advertising, presenting educational seminars, participating in
customer visitations, displaying exhibits at trade shows and ensuring
representation and attendance at industry meetings, all of which shall be
performed in accordance with Xxxxxx'x usual and customary practices with regard
to other Xxxxxx-distributed diagnostic products of similar market potential.
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Xxxxxx shall, on an on-going basis, and at Xxxxxx'x cost, train and supervise
the appropriate personnel within the ADD sales force in the promotion and sale
of Shipped Products.
3.2 Digene's General Promotional Responsibilities. For the initial
training, Digene shall provide training personnel in such reasonable scope,
time and quantity as the Parties may mutually agree to train ADD's sales force.
In addition Digene, at Digene's cost, shall provide reasonable assistance to
Xxxxxx in the preparation of appropriate sales force training materials.
Further, Digene shall attend, at Digene's expense, major trade shows during the
Term, as mutually agreed by the Parties, to provide Xxxxxx with necessary
technical and Product and Other Product information support.
3.3 Development of Promotional and Marketing Materials. Promptly after
the Effective Date, Digene shall deliver to Xxxxxx copies of all promotional
and marketing materials owned or controlled by Digene to be used by Xxxxxx and
its Affiliates in the promotion and sale of Products and Other Products
hereunder. During the Term, Xxxxxx shall develop and prepare, at Xxxxxx'x sole
discretion and at its cost, promotional and marketing materials for use in its
sale of Shipped Products. Xxxxxx shall appropriately and with visual prominence
consistent with the use of its name, use Digene, Hybrid Capture, the names of
Products, Other Products and Digene Equipment and Digene Trademarks in all
promotional and marketing materials prepared for use in the sale of Shipped
Products.
3.4 Marketing Plans. Xxxxxx shall develop and prepare, at Xxxxxx'x sole
discretion and at its cost, all marketing plans for the promotion and sale of
Shipped Products; provided, however, that Xxxxxx shall provide to Digene prior
to implementation, any marketing plans
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
developed by Xxxxxx with respect to Products for Digene's review and comment
only. As part of such marketing plans, Xxxxxx and Digene shall mutually agree
to activities within such plans that shall be Digene's responsibility. The
marketing plans of Xxxxxx shall be considered Confidential Information. With
respect to marketing plans regarding HPV, Xxxxxx and Digene shall perform
marketing activities as follows:
(a) Digene shall be primarily responsible for marketing
activities directed toward obtaining governmental endorsement of HPV
testing, institutional reimbursement for use of the HPV test, and
maximizing consumer awareness and education of the benefits of HPV
testing, which activities shall be subject to the approval of Xxxxxx which
will not be unreasonably withheld. In performing such activities, Digene
shall exercise the same diligence and shall commit the same level of
effort as it does when it markets and promotes Digene Products and the
Products outside the HPV Territory;
(b) in addition to its overall marketing responsibilities, Xxxxxx
shall have the sole responsibility for marketing activities directed
toward obtaining laboratory endorsement and systematic use of HPV testing;
and
(c) Xxxxxx and Digene shall Work With each other in good faith and
use commercially reasonable efforts to promote HPV testing for primary
screening in the HPV Territory, subject to applicable regulatory approvals
and restrictions.
3.5 Sales Reports. Xxxxxx shall provide to Digene within forty-five (45)
days after each Calendar Quarter, a sales report reflecting the sales of
Products, by product part number and by country, by Xxxxxx and its Affiliates.
Each such report shall provide Net Sales dollars and
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
unit sales of Products, listed separately by product, by product part number
and by country, for that Calendar Quarter, and for that year-to-date. These
sales reports shall be considered Confidential Information.
3.6 Support. During the Term, Xxxxxx and its Affiliates and
subcontractors shall provide its customers purchasing Shipped Products with the
same level of training, support and service that Xxxxxx provides with respect
to other Xxxxxx-distributed diagnostic products it sells to the Trade. Xxxxxx
and its Affiliates shall use commercially reasonable efforts to instruct from
time to time all customers purchasing Products and Other Products to utilize
Equipment that has been specified and validated under the Validation Protocols
for Equipment used in connection with Products and Other Products. The
Validation Protocols shall be as set forth on Schedule 3.6.
3.7 Product Samples. During the Term, Digene shall make available to
Xxxxxx Products in such quantities as may be reasonably requested by Abbott and
its Affiliates and reasonably satisfactory to Digene, at [*****] price, to be
used by Xxxxxx and its Affiliates and sub-distributors to demonstrate and
sample the Products to the Trade in the Territory subject to reconciliation
under Section 6.4.
3.8 Marketing Steering Committee. Xxxxxx and Digene shall create a
Marketing Steering Committee which will be responsible for reviewing and
recommending general marketing and promotional responsibilities for Products
under this Article 3, recommending marketing plans and resolving operational
issues which may arise from time to time. The Marketing Steering Committee
shall consist of two (2) representatives from Xxxxxx and two (2)
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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.
representatives from Digene, as designated from time to time by each respective
Party. The Marketing Steering Committee shall meet in person or by telephone at
least twice per year. Either Party may replace one or both of its
representatives on the Marketing Steering Committee at any time after providing
five (5) Business Days written notice to the other Party. The members of the
Marketing Steering Committee shall Work With each other in good faith to
satisfy their responsibilities under this Section 3.8.
ARTICLE 4. - SALES PERFORMANCE THRESHOLDS
4.1 Net Sales Thresholds for CT/GC. As of the Effective Date, the FDA
has not cleared CT/GC for use in the United States. Until 510(k) clearance by
the FDA to market CT/GC (as filed with the FDA as of the Effective Date) in the
United States has been obtained, Digene is able to deliver CT/GC to Xxxxxx for
resale in the United States, and CT/GC meets the automation specifications set
forth on Schedule 4.1 and has been internally validated by Digene pursuant to
the Validation Protocols ("CT/GC Clearance"), Xxxxxx shall not be subject to
any Net Sales thresholds for CT/GC. Xxxxxx shall be subject to Net Sales
thresholds for CT/GC in the CT/GC Territory at the completion of the [********]
following the Contract Year in which CT/GC Clearance was obtained and
thereafter, as follows:
------------------------------------------------------------------------------------------------
CPT Code Net Sales in [***] Net Sales in [***] Net Sales in [***]
-------- ------------------ ------------------ ------------------
------------------------------------------------------------------------------------------------
Non-Amplified $[***] $[***] The greater of
Reimbursement $[***] or the Net
Sales in the [***]
------------------------------------------------------------------------------------------------
27
36
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.
------------------------------------------------------------------------------------------------
Amplified $[***] $[***] The greater of
Reimbursement $[***] or the Net
Sales in the [***]
------------------------------------------------------------------------------------------------
(a) Xxxxxx Achieves Thresholds. If Xxxxxx and its Affiliates achieve
each Net Sales threshold set forth above during the Term, this
Agreement shall be extended automatically on an exclusive basis with
respect to CT/GC in the CT/GC Territory for an additional Contract Year
and shall continue to be extended for an additional Contract Year for
each subsequent Contract Year in which the Net Sales threshold is
achieved. If Xxxxxx and its Affiliates do not have Net Sales in the
[******] following the Contract Year in which CT/GC Clearance was
obtained which meet the Net Sales threshold established for such
Contract Year or if after the Initial Term, Xxxxxx and its Affiliates
do not have Net Sales in any subsequent Contract Year which meet the
Net Sales threshold established for Contract Years after the Initial
Term, Digene, at its sole discretion, may elect, within one hundred and
twenty (120) days following the completion of such Contract Year, to
convert this Agreement [**********************************************
***********************] following the Contract Year in which the Net
Sales threshold was not achieved. [************************************
******************************************************************
******]. If Digene elects to so convert this Agreement, Digene shall
provide Xxxxxx with written notice of such election and such
[************************] shall become applicable immediately upon
Xxxxxx'x receipt of the notification.
28
37
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.
(b) Xxxxxx Fails to Achieve Thresholds. If Xxxxxx and its Affiliates
do not achieve the Net Sales threshold for CT/GC for the [******]
following the Contract Year in which CT/GC Clearance was obtained,
Digene, at its sole discretion, may elect, within one hundred and
twenty (120) days following the completion of such [******], to convert
this Agreement [**********************************************
******************************************] If Digene elects to so
convert this Agreement, Digene shall provide Xxxxxx with written notice
of such election and such [*************************] shall become
applicable immediately upon Xxxxxx'x receipt of notification.
[*********************************************************************
**********************************************************************
***********************].
At the expiration of the Term, if Xxxxxx was then [*************************],
Xxxxxx and Digene shall engage in a wind-down for a period of [******]
commencing at the expiration of the Term as more fully described in Section
4.5.
4.2 Net Sales Thresholds for HBV. During the Term, Xxxxxx shall be
subject to Net Sales thresholds for HBV at the completion of the [******] and
each subsequent Contract Year, if any, as follows:
------------------------------------------------------------------------------------------------
[********] [********] Each Contract Year
Following the[***]
------------------------------------------------------------------------------------------------
$[***] $[***] Actual Net Sales in
the [***]
------------------------------------------------------------------------------------------------
29
38
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.
(a) Xxxxxx Achieves Thresholds. If Xxxxxx and its Affiliates achieve
each Net Sales threshold set forth above during the Term, this
Agreement shall be extended automatically on an exclusive basis with
respect to HBV in the HBV Territory for [***************************]
and shall continue to be extended for [********************************
************************************************************************
***]. After the Initial Term, if Xxxxxx and its Affiliates do not have
Net Sales in any subsequent Contract Year which meets the Net Sales
threshold established for Contract Years after the Initial Term,
Digene, at its sole discretion, may elect, within one hundred and
twenty (120) days following the completion of such Contract Year, to
convert this Agreement [********************************************
**************************] following the Contract Year in which the Net
Sales threshold was not achieved. [********************************
****************************************************************************
****************************************************************************]
If Digene elects to so convert this Agreement, Digene shall provide Xxxxxx with
written notice of such election and such [******************************] shall
become applicable immediately upon Xxxxxx'x receipt of the notification.
(b) Xxxxxx Fails to Achieve Thresholds. If Xxxxxx and its Affiliates
do not achieve the Net Sales threshold for HBV for the [********],
Digene, at its sole discretion, may elect, within one hundred and
twenty (120) days following the completion of such [********], to
convert this Agreement [********************************************
******************************************] If Digene elects to so
convert
30
39
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.
this Agreement, Digene shall provide Xxxxxx with written notice of such
election and such [*************************] shall become applicable
immediately upon Xxxxxx'x receipt of the notification. In addition, if
Xxxxxx and its Affiliates do not achieve the Net Sales threshold for
HBV for the [********], and if Xxxxxx was then [************
***********], Digene, at its sole discretion and upon written notice to
Xxxxxx, may terminate this Agreement with respect to HBV only and
provide Xxxxxx with a wind-down period of [********] commencing at the
expiration of the Term, as more fully described in Section 4.5.
[********************************************************************
*****************************************************************************]
4.3 Net Sales Thresholds for HPV. During the Term, Xxxxxx shall be
subject to Net Sales thresholds for HPV at the completion of each of the
[********], inclusive, and each subsequent Contract Year, if any, as follows:
-----------------------------------------------------------------------------------------------
[***] [***] [***] [***]
-----------------------------------------------------------------------------------------------
$[***] $[***] $[***] $[***]
-----------------------------------------------------------------------------------------------
(a) Xxxxxx Achieves Thresholds. If Xxxxxx and its Affiliates achieve
the Net Sales thresholds set forth above for each of the [********],
this Agreement shall continue automatically after each such Contract
Year on an exclusive basis with respect to HPV in the HPV Territory for
an additional Contract Year. After the [********], the following shall
apply:
31
40
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.
(i) If Xxxxxx and its Affiliates have Net Sales of HPV in
the HPV Territory in the [********] of between [********] and
[********], Digene shall elect, at its sole discretion, either
to: [*********************************************************
**************************************************************
**************************************************************
**************************************************************
**************************************************************
**************************************************************
**************************************************************
*************************************************];
(ii) If Xxxxxx and its Affiliates have Net Sales of HPV in
the HPV Territory in the [********] of greater than [********]
but less than [********], Digene shall elect, at its sole
discretion, either to: [****************************************
****************************************************************
****************************************************************
****************************************************************
*************************************************************
************************************************************
************************************************************
*************************************************]; and
(iii) If Xxxxxx and its Affiliates have Net Sales of HPV in
the HPV Territory in the [********] of [********] or greater,
Xxxxxx, and not Digene, shall elect, at Xxxxxx'x sole
discretion, either to: [****************************
32
41
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.
****************************************************************
****************************************************************
****************************************************************
****************************************************************
***************************************************************
***************************************************************
*****************************************************
***********************]; provided, however, that in the event
Xxxxxx fails to notify Digene of its election within one hundred
twenty (120) days of the end of the [*****], Digene shall
provide Xxxxxx with prompt written notice of such failure and
Xxxxxx shall have thirty (30) days from receipt of such notice
to notify Digene in writing of Xxxxxx'x election under this
Section 4.3(a)(iii). If Xxxxxx fails to so notify Digene within
such thirty (30) day period, Digene may, at its sole discretion,
[*************************************************************
**************************************************************
**************************************************************
*******************************************************************************
*****************************************************************************];
(b) Xxxxxx Fails to Achieve Thresholds. If Xxxxxx and its
Affiliates do not achieve the Net Sales threshold for HPV for
any of the [*********], inclusive, Digene, at its sole
discretion, may elect, within one hundred and twenty (120) days
following the completion of each such Contract Year, to
[**************
33
42
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.
***********************************]. If Digene elects to
[************************] and Xxxxxx was then [************
************] Digene shall provide Xxxxxx with written notice of
such election and Xxxxxx and Digene shall engage in a wind-down
for a period of [*********] commencing at the expiration of the
Term, as more fully described in Section 4.5. [****************
*****************************************************************************].
4.4 Exercise of Rights. Digene shall have one hundred and twenty (120)
days from the date on which it is determined that Xxxxxx did not achieve a Net
Sales threshold set forth in this Article 4 to advise Xxxxxx in writing that
Digene is electing to assert the particular right associated with Xxxxxx'x
failure to achieve such Net Sales threshold. In the event Digene does not
provide Xxxxxx with such written election within the one hundred and twenty
(120)-day period, Digene shall be deemed to have waived such threshold
requirement and Digene shall be precluded from asserting Xxxxxx'x failure to
achieve such Net Sales threshold at any other time thereafter, except as
provided in Sections 15.4(b) and 19.2(b)(ii)(A).
4.5 Wind-down Activities. During a wind-down period Xxxxxx'x rights
shall convert to [***********************************************************
*******], and Digene and Xxxxxx shall continue to perform their respective
duties and be bound to their respective obligations hereunder with respect to
manufacturing, supplying, selling and distributing [************]. During such
wind-down period, Xxxxxx and its Affiliates shall only [***********************
**************************************************************************
***************************************************************************
*****************************************
34
43
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.
******************************************************************************
******************************************************************************
***********************************************************************
*****************************************************************************].
4.6 Factors Affecting Net Sales. In the event Xxxxxx'x Net Sales with
respect to any Product is materially adversely impacted as a result of: delays
in Digene obtaining CT/GC Clearance as contemplated by Section 4.1; changes in
reimbursement structure; Digene's failure to supply Abbott with Product in
accordance with the terms and conditions of Articles 5 or 18; Recalls; other
actions by regulatory authorities or by Digene as described in Section 12.4; or
any adverse change in the performance of the Product or failure to meet
Specifications, the Parties shall meet and negotiate in good faith an agreement
with respect to the appropriate downward adjustment to the applicable Net Sales
thresholds set forth above.
ARTICLE 5. - MANUFACTURE AND SUPPLY
5.1 Supply.
(a) Supply. Upon the terms and subject to the conditions of this
Agreement, Digene shall manufacture, or cause to be manufactured, and
provide to Xxxxxx such quantities of Products, Other Products and
Equipment as are consistent with the forecasting and ordering
provisions set forth in Sections 5.2 and 5.3.
(b) Labeling and Package Inserts. Digene, at its expense, shall
translate and modify each Product's, CMV's and Digene Equipment's
documentation and labeling into
35
44
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.
Spanish, Italian, French, and German and Xxxxxx shall be responsible
for translation into any other language so that such Products, CMV and
Digene Equipment comply with all local requirements for sale and
clinical use in each country or region of the applicable Territory.
Each Party shall assist the other Party with such translation at such
other Party's request. Further, subject to the requirements of
applicable law, Digene shall include on all Products a co-branded label
identifying Xxxxxx and Digene with equal prominence, which co-branded
label shall be reasonably satisfactory to both Parties.
(c) Registrations.
(i) Requirements. Digene shall own and hold and shall have
all right, title and interest in and to all registrations with
respect to Product and CMV that have been or will be filed in
the name of Digene. Digene, at its sole expense, except as
otherwise provided in this Section 5.1(c)(i) and as provided in
Section 19.6(b), shall be responsible for completing and
maintaining all documentation, including technical (e.g., the
international products master file) and all legal documentation
required for regulatory approvals for marketing Products and CMV
in the Territory and the CMV Territory, as the case may be. The
Parties shall Work With each other to complete such
registrations. To the extent a Designated Country requires
regulatory documentation necessary to market Products and CMV to
be filed in the name of a local Affiliate, Xxxxxx shall promptly
notify Digene in writing of Xxxxxx'x intent to seek such
registrations and, if Digene does not have or does not seek to
create such a local Affiliate, then
36
45
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.
Xxxxxx, at Xxxxxx'x sole expense, shall be responsible for
completing and maintaining all documentations, including
technical, and all legal documentation required for regulatory
approvals for marketing Products and CMV in such Designated
Country. Further, Xxxxxx shall own and hold and shall have all
right, title and interest in and to all registrations with
respect to Products and CMV that Xxxxxx paid for pursuant to the
immediately preceding sentence; provided, however, that Xxxxxx
shall not own or have any proprietary interest in or to any
Confidential Information disclosed by Digene hereunder with
respect to such registrations, unless otherwise agreed in
writing by the Parties. The Parties shall Work With each other
to prepare and submit all such regulatory filings in such
Designated Country.
(ii) Transfers. In the event Xxxxxx does not have exclusive
distribution rights with respect to a Product hereunder and
Digene desires to access and use any registrations obtained by
Xxxxxx under Section 5.1(c)(i) with respect to such Product or
CMV, Digene shall so advise Xxxxxx in writing. Promptly after
receipt of such request, Xxxxxx shall, to the extent permissible
under applicable law, provide Digene access and use of the
registrations requested by Digene, provided that Digene
reimburses Xxxxxx for Xxxxxx'x direct expense in obtaining such
registrations in accordance with the following formula: Digene
shall reimburse Xxxxxx at [********] of Xxxxxx'x direct expense,
and such reimbursement percentage shall be reduced in [********]
for each Contract Year in which such
37
46
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.
registrations are owned and held by Xxxxxx and in which Xxxxxx
retains any marketing and distribution rights hereunder
(excluding any wind-down periods described in Article 4) with
respect to the Products and/or CMV to which such registrations
apply; provided, however, that Digene shall only be obligated to
reimburse Xxxxxx for [**********************] determined pursuant
to such formula for any periods during which Xxxxxx'x rights to
such Product and/or CMV are [*************] hereunder. In the
event Xxxxxx does not have any marketing and distribution rights
hereunder with respect to a Product and/or CMV the registration
rights of which have been requested by Digene, Xxxxxx shall, to
the extent permissible under applicable law, transfer to Digene
all right, title and interest in and to such registrations.
(d) Changes. Digene shall notify Xxxxxx in writing of any
proposed changes in Digene's manufacturing process which affect fit,
form or function of Product or Other Product. Upon the request of
Xxxxxx, Digene shall provide to Xxxxxx representative samples of such
changed Product or Other Product in sufficient quantities for the sole
purpose of evaluating such proposed change in Digene's manufacturing
process. Upon such notice of any proposed change after receipt of such
representative samples, Xxxxxx may evaluate and communicate to Digene
its approval or disapproval of such change within forty-five (45) days
after the date of notice; provided, however, that Xxxxxx shall not
unreasonably withhold its approval of any such change. A failure to
notify by Xxxxxx within forty-five (45) days after the date of notice
by Digene shall be deemed to
38
47
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.
constitute Xxxxxx'x approval of such proposed change. Only upon
approval may Digene incorporate such change into the manufacturing
process. Digene shall be obligated only to notify Xxxxxx in writing of
any proposed material changes in Digene's manufacturing process which
do not affect fit, form or function of Product or Other Product but no
action by Xxxxxx shall be required in order for Digene to incorporate
such change.
(e) Certified Vendor. Digene shall use its reasonable
commercial efforts to become an Xxxxxx certified vendor within twelve
(12) months after the Effective Date.
(f) Special Provisions. Digene shall maintain stock of items
critical to the manufacture of Products and Other Products in
accordance with its standard operating procedure for ordering special
materials. Digene shall provide Xxxxxx notice of any change to such
standard operating procedure reasonably likely to affect the production
of Products or Other Products.
(g) Fully Burdened Manufacturing Costs Report. Digene shall
provide to Xxxxxx a written report reflecting a detailed analysis of
the Fully Burdened Manufacturing Costs for Products purchased on a cost
or cost-plus basis for the preceding Calendar Quarter and for Digene
Equipment purchased on a cost or cost-plus basis within forty-five (45)
days after each Contract Year for the preceding Contract Year. Further,
Digene shall advise Xxxxxx in writing sufficiently in advance of any
proposed change in Digene's accounting methodology and treatment so
that Xxxxxx can adjust its record-keeping accordingly to integrate such
change.
39
48
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.
5.2 Forecasting. Within thirty (30) days after the Effective Date, Xxxxxx
shall provide to Digene a written forecast of Xxxxxx and its Affiliates'
purchases of Product, Other Product and Equipment (listed separately) for the
first Contract Year. This forecast shall not be binding on either Party and
shall be used for planning purposes only. Further, on the Effective Date with
respect to the remainder of the first Calendar Quarter of the first Contract
Year, and then on or before the first day of each Calendar Quarter thereafter,
Xxxxxx shall provide to Digene a written rolling forecast estimating by month
Xxxxxx and its Affiliates' purchases of Product, Other Product and Equipment
(listed separately) for the following twelve (12)-month period. The quantity of
Product, Other Product and Equipment listed for the first three (3) months of
each forecast shall be a firm order, which is a guarantee of minimum orders to
be placed during the first three (3) months of each forecast and the remainder
of the forecast shall be used for planning purposes only. In the event Xxxxxx
and its Affiliates place firm orders during a Calendar Quarter that exceed the
amount of the firm order for such Calendar Quarter, Digene shall use its
commercially reasonable efforts to meet any such additional firm orders placed
by Xxxxxx or its Affiliates. Notwithstanding the preceding sentence, Digene
shall have no obligation to fill any additional firm orders to the extent such
additional firm orders exceed the quantities of Product, Other Product and
Equipment (listed separately) contained in the forecast by more than one
hundred fifty percent (150%).
5.3 Orders. All orders shall be placed on Xxxxxx purchase order forms,
which shall specify the quantity ordered, price, the requested delivery date
and any special shipping instructions or invoicing information. Except for the
terms specified in the purchase order in
40
49
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.
accordance with the preceding sentence, the terms and conditions of this
Agreement shall govern all purchases and supersede the general terms of any
purchase order, acknowledgment or invoice form.
5.4 Failure to Supply Product.
(a) In the event Digene is unable to supply Xxxxxx and its
Affiliates with Product (on a Product by Product basis): (i) in
accordance with Xxxxxx'x and its Affiliates' firm purchase orders
issued in accordance with Sections 5.2 and 5.3; (ii) as a result of an
uncured material breach by Digene of any covenant, representation or
warranty contained in this Agreement; or (iii) as a result of an event
of force majeure, Xxxxxx, subject to the terms and conditions of
Sections 5.4(b), 5.4(c) and 5.4(d), shall have the right to manufacture
or have manufactured for it any Product which supply is adversely
impacted as described above.
(b) Digene shall notify Xxxxxx in writing as soon as practicable
if Digene is unable or anticipates it will be unable to provide
sufficient quantities of Product as a result of a condition described
in Sections 5.4(a)(i)-(iii). Upon receipt of such notification, Xxxxxx
shall Work With Digene to resolve the failure to supply. If such
failure to supply has not been resolved in the reasonable good faith
judgment of Xxxxxx, which judgment shall not be unreasonably withheld,
within six (6) months from the date Xxxxxx received the notification
from Digene, Xxxxxx shall, on thirty (30) days written notice to
Digene, have the right to manufacture or have manufactured for it such
impacted Product.
41
50
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.
(c) In the event Xxxxxx exercises its right to manufacture or
have manufactured for it any Product pursuant to Section 5.4(b), (i)
Xxxxxx shall be obligated to pay to Digene an amount equal to
[********] of the [********] for the impacted Product which Xxxxxx
would have been obligated to pay had Digene continued to manufacture
such Product, until Digene resumes the manufacture of such Product
under Section 5.4(e), and (ii) Digene shall, solely for the period
during which Xxxxxx exercises its rights pursuant to Section 5.4(b),
transfer to Xxxxxx any rights, materials, know-how and documentation
necessary for the manufacture of such Product, if necessary, pursuant
to a fully paid temporary license until Digene resumes manufacture of
the impacted Product under Section 5.4(e). Xxxxxx shall use such
rights, materials, know-how and documentation only for the manufacture
of such Product in accordance with this Section 5.4 and not for any
other purpose.
(d) Notwithstanding the transfer to Xxxxxx of any rights,
materials, know-how, and documentation necessary for the manufacture of
any Product, Digene shall be permitted to cure any condition described
in Section 5.4(a)(i)-(iii). In the event Digene cures any inability to
supply Xxxxxx and its Affiliates with any Product at any time after
Xxxxxx'x exercise of its right to manufacture such Product, at Digene's
election, Xxxxxx shall return to Digene all rights, materials,
know-how, and documentation previously transferred pursuant to this
Section and Digene shall resume the manufacture of such Product. Any
rights, materials, know-how, and documentation transferred pursuant to
this Section shall be treated by Xxxxxx and/or its Affiliates as
Confidential Information.
42
51
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.
(e) If Digene elects to exercise its right to resume the
manufacture of such Product, Digene shall pay to Xxxxxx Xxxxxx'x direct
cost of capital after amortization and direct expenses for materials,
labor and direct allocable overhead for establishing the capability to
manufacture such Product and Xxxxxx shall transfer and convey to Digene
title to any equipment and other assets represented by such cost.
5.5 Failure to Supply Digene Equipment.
(a) In the event Digene is unable to supply Xxxxxx and its
Affiliates with Digene Equipment (on a product by product basis): (i) in
accordance with Xxxxxx'x and its Affiliates' firm purchase orders issued in
accordance with Sections 5.2 and 5.3; (ii) as a result of an uncured material
breach by Digene of any covenant, representation or warranty contained in this
Agreement; or (iii) as a result of an event of force majeure, Xxxxxx shall have
the right to purchase any equipment from Third Parties necessary to perform the
function(s) of Digene Equipment adversely impacted by this Section 5.5(a);
provided, however, that such equipment meets the Validation Protocols set forth
on Schedule 3.6.
(b) Digene shall notify Xxxxxx in writing as soon as practicable
if Digene is unable or anticipates it will be unable to provide sufficient
quantities of Digene Equipment as a result of a condition described in Sections
5.5(a)(i)-(iii). Upon receipt of such notification, Xxxxxx shall Work With
Digene to resolve the failure to supply. If such failure to supply has not been
resolved in the reasonable good faith judgment of Xxxxxx, which judgment shall
not be unreasonably withheld, within thirty (30) days from the date Xxxxxx
received the notification
43
52
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.
from Digene, Xxxxxx shall, on thirty (30) days written notice to Digene, have
the right to purchase equipment from Third Parties as provided in Section
5.5(a).
(c) If Digene elects to resume supply of Digene Equipment
adversely impacted by Section 5.5(a), Xxxxxx shall no longer have the right to
purchase equipment under Section 5.5(b), but Digene shall afford Xxxxxx a
commercially reasonably time frame in which to sell existing inventory of
alternative equipment purchased pursuant to Section 5.5(b).
5.6 Supply Allocation. In the event of a shortage of Product and/or CMV
during the Term, Digene shall allocate Product and CMV in a reasonable manner
so as to support Xxxxxx and its Affiliates as a supplier of Products and CMV,
and at a minimum, Digene shall allocate its manufacturing capability on a unit
basis such that Xxxxxx and its Affiliates receive the same percentage of
Digene's total output of Products and CMV as Xxxxxx and its Affiliates received
on average during the most recent six (6) months prior to the shortage.
5.7 Ordering Processing. Xxxxxx and its Affiliates shall have the sole
responsibility for solicitation and for receiving and processing orders for
Product from the Trade in the exclusive territories with respect to each
Product. Purchase orders for Products received by Digene from the Trade in such
territories shall be transferred immediately to Xxxxxx for handling and
invoicing. Digene shall promptly forward to Xxxxxx any order it receives during
the Term for Products from the Trade in the applicable Territory.
5.8 Safety Stock. Within thirty (30) days after the first Delivery of
each Product hereunder, Digene shall maintain a six (6) month safety stock of
the critical components (including, but not limited to, cell lines, antibodies,
calibrator and control stocks, and probe sets)
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
of each Product, based on the most recent twelve (12) month forecast provided
by Xxxxxx pursuant to Section 5.2. Digene shall rotate the safety stock with
each new manufacturing lot.
5.9 Hazardous Classification Labeling. To the extent required by
applicable law with respect to each Product, Other Product and Equipment,
Digene shall complete, subject to Xxxxxx'x prior written approval, which
approval shall not be unreasonably withheld, Product, Other Product and
Equipment analysis forms or, alternatively, Digene shall provide Xxxxxx with
access to all pertinent documentation with respect to each Product, Other
Product and Equipment, including, without limitation, composition, test results
or other relevant Product, Other Product and Equipment data, as deemed
necessary by Xxxxxx. Further, to the extent necessary, the Parties shall
address appropriate labeling matters.
5.10 Expiration Dating. Digene shall use commercially reasonable efforts
to extend to twelve (12) months the expiration dating on Products and CMV, if
applicable, delivered to Xxxxxx. Products and CMV shall have a minimum of six
(6) month expiration dating.
ARTICLE 6. - PRICE AND TERMS
6.1 Purchase Price for Equipment.
(a) Digene Equipment. Xxxxxx shall purchase from Digene all
Digene Equipment needed to implement and perform this Agreement at the
Purchase Price set forth on Schedule 6.1(a). Xxxxxx shall pay for such
Digene Equipment in accordance with Digene's standard payment terms,
which are net thirty (30) days.
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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.
(b) Existing Field Equipment. Xxxxxx shall purchase existing
field Equipment from Digene for the purchase price set forth on
Schedule 6.1(b), less accumulated depreciation for each item of
Equipment calculated since the date of shipment of such item by Digene.
Xxxxxx shall pay for such existing field Equipment within thirty (30)
days of the Effective Date. A list of such field Equipment is set forth
on Schedule 6.1(b).
(c) Non-proprietary Equipment. The Purchase Price for
Non-proprietary Equipment shall be as set forth on Schedule 6.1(c);
provided, however, that Xxxxxx and its Affiliates may, at their sole
cost and expense and at their sole discretion, purchase any
Non-proprietary Equipment directly from Third Parties; provided that
such Non-proprietary Equipment meets the Validation Protocols set forth
on Schedule 3.6.
(d) Equipment. To the extent Xxxxxx purchases Digene Equipment
listed on Schedule 6.1(a) and PC Monitor (Product Number 5050-1015) and
Inkjet Printer (Product Number 5050-1028A) from Digene, so that such
purchase constitutes a complete customer system, such Purchase Price
shall not [*************] per unit, adjusted for changes in the
Producer Price Index ("PPI") for in vitro diagnostic
substances-clinical chemistry products-standards and controls (Code
2835-115), as quoted by the U.S. Department of Labor, Bureau of Labor
Statistics (or any successor agency or index), from the PPI published
most recently prior to the Effective Date to the PPI published most
recently prior to the date of such purchase, provided that, in the
event and to the extent such adjustment cannot be passed on to
customers, the amount of 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.
adjustment or the portion thereof which cannot be passed on to
customers shall be reduced by [*************].
6.2 Product Transfer Price.
(a) Transfer Price of CT/GC Outside the United States. During the
Term, the transfer price of CT/GC with respect to sales outside the
United States shall be [******] of the CT/GC Non-U.S. AUP, subject to
[***************************************************].
(b) Transfer Price of CT/GC in the United States. During the
Term, the transfer price of CT/GC with respect to sales in the United
States shall be [******] of the CT/GC U.S. AUP, subject to [***********
***************************************].
(c) Transfer Price of HBV. During the Term, the transfer price of
HBV shall be [******] of the HBV AUP, subject to [********************
******************************].
(d) Transfer Price of HPV. During the Term, the transfer price of
HPV shall be [******] of the HPV AUP, subject to [********************
******************************].
(e) Purchase Price for Product Accessories. The purchase price
for Product Accessories is set forth on Schedule 1.64.
6.3 Minimum Transfer Price. Notwithstanding anything in this Article
6 or any other Section of this Agreement to the contrary, during the Term, the
transfer price for each Product shall be [*********************************
************************************].
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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.
6.4 Year-End Reconciliation. Within forty-five (45) days after the end
of each Contract Year, Xxxxxx and Digene shall reconcile, by product code, [***
*******************************************************************************
************************************]. In such reconciliation [*****************
*********************************************************************
********************************************************************]. The
calculations and results of such reconciliation shall be contained in a written
report submitted to Digene within thirty (30) days after the end of the
immediately preceding Contract Year. The Parties shall make any adjustments as
to overpayments or underpayments, if any, by credit or debit memo, as the case
may be, within fifteen (15) days after Digene's receipt of the report;
provided, however, any such adjustment in the final Contract Year shall be
handled by a check or wire transfer of the overpayment or underpayment to the
affected Party within thirty (30) days after the end of the final
reconciliation.
6.5 Royalty Obligations. Digene shall make, at Digene's sole cost and
expense, all royalty payments due to all relevant Third Parties as a result of
the manufacture, use, sale and importation of Products, Other Products and
Equipment in the affected territories.
6.6 Payment Terms. Digene shall invoice Xxxxxx or its Affiliates for
Products, Product Accessories, Product Samples, Other Products and Equipment
purchased hereunder. Xxxxxx shall pay such invoices in United States dollars
net thirty (30) days from the date of receipt of the invoice. In the event
Xxxxxx fails to make a payment when due, overdue payments shall bear interest
at the rate of one percent (1.0%) per month, or if lower, the highest rate
permitted by law, from the date due until paid.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
6.7 Foreign Exchange. All amounts referred to in this Agreement are
expressed in United States dollars. All payments under this Agreement shall be
made in United States dollars (or other legal currency of the United States).
If Xxxxxx, its Affiliates or its sub-distributors receive revenues from the
sales of Products in a currency other than United States dollars, Net Sales
with respect to such sales shall be converted into United States dollars at the
average exchange rate for such foreign currency calculated monthly by adding
the spot rate at the end of the month immediately prior to the date of sale and
the spot rate at the end of the current month in which such sale occurs divided
by two (2). Rates used shall be those available on Reuters at 9:00 a.m. CST on
the second to last business Day of the month, with the exception of November,
in which the last Business Day of the month shall be used.
ARTICLE 7. - SHIPMENT AND DELIVERY
7.1 Shipment. Delivery shall occur for Products, Other Products and
Equipment purchased from Digene ("Shipped Products") FOB Digene ("Delivery" or
"Delivered"). Unless otherwise agreed, freight charges for Shipped Products
Delivered will be invoiced directly to Xxxxxx by the carrier selected by Xxxxxx
in its sole discretion. Digene may make partial shipments of the Shipped
Products, subject to prompt filling of any resulting back order; provided,
however, that Xxxxxx shall not be responsible for any incremental freight
charges resulting from partial shipments.
7.2 Delivery. For Delivery of Shipped Products, Digene shall ship
Shipped Products ordered by Xxxxxx and its Affiliates in accordance with
shipping instructions provided by Xxxxxx.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
7.3 Export Licenses: Import Certificates; Customs and Regulatory
Approval for Delivery of Shipped Products Outside the United States.
(a) Xxxxxx'x Responsibilities. Xxxxxx, [************] shall: (i)
obtain any export license required by the country of manufacture to
export the Shipped Products to the Designated Country; (ii) obtain all
authorizations required to export the Shipped Products from the United
States or import the Shipped Products into the Designated Country;
(iii) obtain, if required, any import or export certificates and other
necessary permits or approvals required by any country from or through
which Shipped Products are to be shipped to Deliver the Shipped
Products to the Designated Country; and (iv) pay all applicable import
and custom duties, taxes and fees.
(b) Digene's Responsibilities. Digene shall take all reasonable
steps to cooperate with Xxxxxx in complying with any import, export or
custom regulations applicable to the Shipped Products, to the extent
consistent with applicable law, including filling out necessary
paperwork or reports to obtain any applicable waiver, exemption or
reduction of such duties in a timely manner.
7.4 Title and Risk of Loss. Title to and risk of loss Shipped
Products shall pass to Xxxxxx at the place and time of Delivery. Any loss or
damage to Shipped Products prior to Delivery shall be at Digene's risk.
7.5 Taxes. Any foreign, federal, state, county or local sales, use,
value-added or excise tax or similar charge, including customs and import
duties, or other tax assessment (other than that assessed against income),
license fee (other than royalties owed to Third Parties) or
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
other charge lawfully assessed or charged on the sale or transportation of
Shipped Products sold pursuant to this Agreement after Delivery to Xxxxxx shall
be paid by Xxxxxx.
7.6 Certificate of Analysis. Digene shall provide Xxxxxx with a
Certificate of Analysis with each lot of Products and Other Products sold to
Xxxxxx hereunder certifying compliance with the Specifications and Other
Product Specifications, respectively.
ARTICLE 8. - ACCEPTANCE OF SHIPPED PRODUCT; INSPECTION OF
MANUFACTURING FACILITY
8.1 Digene Testing. Digene shall inspect and test Shipped Products for
conformity to the Specifications or Other Product Specifications, as
applicable, in accordance with its normal quality assurance procedures as such
procedures may be amended from time to time prior to release to Xxxxxx and its
Affiliates. Digene shall notify Xxxxxx prior to any change in its quality
assurance procedures that reasonably may be expected to affect the quality of
the Shipped Product.
8.2 Xxxxxx Testing. All Shipped Products shall be subject to Xxxxxx'x or
its Affiliates' inspection and approval. At Xxxxxx'x request, Digene shall make
available to Xxxxxx up to four (4) kits per lot for each Product and Other
Product, free of charge, prior to the delivery of Products and Other Products,
to enable Xxxxxx to ensure that the Product or Other Product conforms to the
Specifications or Other Product Specifications, respectively. Xxxxxx or its
Affiliates shall, within ten (10) days after receipt of such Equipment or kits,
inspect and test such Equipment and kits and may reject any Shipped Product
which is:
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(a) not in compliance with the Specifications or Other Product
Specifications, as applicable;
(b) not in compliance with all manufacturing procedures,
in-process controls, testing, specifications and storage conditions, as
set forth in Digene's 510(k), or any foreign equivalent for Shipped
Products, or any subsequent amendments thereto;
(c) not manufactured in accordance with cGMPs with respect to
Products, Other Products and Digene Equipment;
(d) not conforming to instructions agreed upon by the Parties in
writing regarding packaging or transport;
(e) shipped in violation of any applicable statute,
administrative order or regulation;
(f) Recalled by any governmental agency or by Digene for reasons
for which Xxxxxx and its Affiliates are not at fault; or
(g) shipped by Digene with less than six (6) months dating with
respect to Products or CMV.
If Xxxxxx, or its Affiliates, as the case may be, reject any Shipped
Products, it shall give Digene written notice of such rejection within ten (10)
days testing period, accompanied by a written summary of the grounds for
rejection and any documentation of any testing performed by Xxxxxx, or its
Affiliates, as the case may be. Upon receipt of such notice, Digene may request
Xxxxxx, or its Affiliates, as the case may be, to return the rejected Shipped
Product, or samples thereof, for testing by Digene. Xxxxxx'x or its Affiliates'
rejection shall be final unless Digene
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
notifies Xxxxxx within thirty (30) days after the later of the receipt of the
rejection notice or the rejected Shipped Product, or samples thereof, that
Digene disagrees with Xxxxxx'x or its Affiliates' conclusions with respect to
the rejected Shipped Product. If the Parties are unable to resolve the dispute,
samples of the rejected Shipped Product shall be submitted to a mutually
acceptable independent testing laboratory for analysis. The results of the
independent testing laboratory shall be final and binding on the Parties. The
costs of the independent testing laboratory shall be paid by the Party against
whom the discrepancy is resolved. The Parties' inability to agree upon an
independent testing laboratory shall be resolved through the dispute resolution
procedures set forth in Section 21.6. All Products properly rejected by Xxxxxx
or its Affiliates pursuant to the terms and conditions of this Section 8.2 and
not otherwise replaced by Digene in a timely fashion to enable Xxxxxx and its
Affiliates to consummate the available sale to the Trade shall be included in
any calculation with respect to Net Sales thresholds as described in Article 4.
8.3 Xxxxxx Inspection. Digene shall permit Xxxxxx, upon reasonable
notice and during Digene's regular business hours, but no more often than once
in each Contract Year, access to those areas of Digene's manufacturing
facilities where the Products and Other Products are manufactured, tested,
packaged, stored, handled and shipped to verify Digene's compliance with its
obligations hereunder. The Device Master Record shall be available for review
by Xxxxxx on site at Digene's manufacturing facilities upon reasonable notice
from Xxxxxx.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ARTICLE 9. - REGULATORY COMPLIANCE AND MEDICAL COMPLAINTS
9.1 No Modification. Xxxxxx shall not modify, repackage, reformulate or
alter any Shipped Product, including its label, except with specific written
authorization from Digene.
9.2 Regulatory Compliance. Digene shall be responsible at Digene's
expense for all governmental and regulatory filings in the Territory for
Products, Digene Equipment and in the CMV Territory for CMV. All responses to
governmental agencies concerning the Products, Digene Equipment and CMV shall
be the sole responsibility of Digene, with reasonable assistance from Xxxxxx,
as requested by Digene. Digene shall provide Xxxxxx copies of all filings
and/or responses concerning the Products, Digene Equipment and CMV which occur
after the Effective Date. In the event Digene is unable to obtain or maintain
the requisite governmental approvals to enable Xxxxxx and its Affiliates to
sell Products in any such country in the Territory, Xxxxxx'x inability to meet
the Net Sales thresholds described in Article 4 shall be adjusted based on [***
************************************************************************
**************************************************************************
***********], to reflect the adverse impact to Xxxxxx due to the absence of
regulatory clearance.
9.3 Customer Complaints. In the event either Party receives a customer
complaint regarding Shipped Products, such Party shall promptly notify the
other of such complaint. If the Shipped Product giving rise to such complaint
was sold by Xxxxxx, its Affiliates or sub-distributors, then Xxxxxx shall
evaluate the complaint and promptly notify Digene in writing regarding such
evaluation. If Xxxxxx determines that such complaint is due to a matter that is
within Digene's responsibilities hereunder, then Digene, at Xxxxxx'x request
and Digene's
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
expense, shall assist Xxxxxx or its Affiliates in follow-up resolution of such
complaint. The Parties shall exchange on a confidential basis all pertinent
information regarding a customer complaint with respect to Products and
Equipment sold in the Territory, CMV sold in the CMV Territory and SHARP sold
in the SHARP Territory.
ARTICLE 10. - RECALL OR WITHDRAWAL
10.1 Event of Recall and Withdrawal. In the event: (a) any governmental
or regulatory authority in the Territory, CMV Territory or SHARP Territory
issues a request, directive or order that Shipped Product be recalled or
withdrawn, or such request, directive or order is imminent; (b) a court of
competent jurisdiction orders such recall or withdrawal; or (c) either Party
reasonably determines after consultation with the other that a recall or
withdrawal is necessary or advisable (each a "Recall"), the Parties shall take
all appropriate corrective action.
10.2 Expense of Recall. In the event a Recall results from any cause or
event arising from the manufacture, packaging, shipment of Shipped Products by
Digene or its Affiliates, or other cause or event attributable to Digene, its
Affiliates or Third Parties (excluding Third Parties in privity with Xxxxxx),
Digene shall be responsible for the expense of the Recall. In the event a
Recall results from any cause or event attributable to Xxxxxx, its Affiliates
or sub-distributors and arising from the marketing, promotion, sale or
distribution of Shipped Products by Xxxxxx, its Affiliates or sub-distributors,
or other cause or event attributable to Xxxxxx, its Affiliates or
sub-distributors, Xxxxxx shall be responsible for the expense of the Recall. In
each instance, the Parties shall cooperate to effectuate efficiently the
Recall. For purposes of this Agreement,
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Recall expenses shall include, without limitation, the expenses of notification
and destruction or return of the recalled or withdrawn Shipped Product and
Xxxxxx'x, its Affiliates' or sub-distributors' costs for the Shipped Products
recalled or withdrawn.
ARTICLE 11. - BOOKS AND RECORDS
11.1 Examination Rights. For a period of two (2) years following each
Contract Year, Xxxxxx and Digene each shall maintain proper books and records
in accordance with GAAP reflecting Net Sales, CT/GC Non-U.S. AUP, CT/GC U.S.
AUP, HBV AUP, HPV AUP, Minimum Transfer Price, transfer prices, Purchase Price,
Book Value and Fully Burdened Manufacturing Costs and other calculations
required by this Agreement, as appropriate. Upon thirty (30) days' prior
written notice to the other Party (but not more frequently than once in any
Contract Year, unless there is a dispute, then as frequently as is necessary),
a Party may examine the other Party's books and records relating to the matters
described herein, which shall be transferred to, if not already located at, the
other Party's principal place of business. The examining Party shall retain, at
its own expense, an independent certified public accountant not currently
engaged by the examining Party but reasonably acceptable to the other Party to
conduct the examination. The examination shall occur at the other Party's
principal place of business during its normal business hours for the sole
purpose of verifying the accuracy of such calculations. The independent
certified public accountant shall be required to execute a mutually acceptable
confidentiality agreement and shall report to both Parties its final
calculations, in addition to any discrepancy in the calculations made by the
Party whose books and records were
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
examined. Such examination rights may be exercised by the Parties only with
respect to books and records for the then current Contract Year and the
immediately preceding Contract Year.
11.2 Reconciliation of Underpayment or Overcharge. Within thirty (30)
days after completion of such examination, the Parties shall reconcile any
underpayment or overcharge, if any, by credit or debit memo; provided, however,
if such adjustment is to occur at the end of the final Contract Year, any
overpayment or underpayment shall be paid by check or wire transfer to the
affected Party within thirty (30) days after completion of the final
reconciliation.
11.3 Costs of Examination. The results of the independent examination
shall be subject to the alternative dispute resolution procedure in Section
21.6. The costs of the independent examination shall be paid by the Party whose
books and records were examined if the results of the independent examination
reflect a discrepancy from such books and records favorable to the Party
requesting the examination of greater than five percent (5%) with respect to
the calculation examined and otherwise such costs shall be paid by the Party
requesting the examination.
ARTICLE 12. - PATENTS AND TRADEMARKS
12.1 Trademark License. Digene hereby grants to Xxxxxx and its
Affiliates a nonexclusive license, with the right to sublicense, to use the
Digene Trademarks in the Field with respect to Products, Other Products and
Digene Equipment to market, promote, distribute and sell Products, Other
Products and Digene Equipment in the Territory, and the CMV Territory and the
SHARP Territory, respectively. On or before January 1 of each Contract Year,
Xxxxxx may
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
request a trademark report reflecting all applications by Digene for Digene
Trademarks and the status thereof. In addition, Digene shall, at its expense,
file new applications to register any or all of the Digene Trademarks in any or
all of the countries in the Territory, the CMV Territory and the SHARP
Territory, as may be reasonably requested by Xxxxxx. Xxxxxx shall give Digene
at least ninety (90) days' prior written notice before marketing, promoting,
selling or distributing any Product, Other Product or Digene Equipment under
the Digene Trademarks in any country not identified in the Digene Trademark
report. The Parties shall mutually agree on the trademark approach in any such
country, taking into consideration, among other things, the length of time
required to obtain trademark registration, laws relating to trademark use, the
existence of any conflicting trademark registrations, applications or uses and
the anticipated sales volumes of the relevant Products, Other Products or
Digene Equipment in such country. All representations of the Digene Trademarks
that Xxxxxx intends to use shall be consistent with written guidelines provided
to Xxxxxx by Digene or shall first be submitted to Digene for approval of
design, color and other details, which approval shall not be unreasonably
withheld or will be exact copies of those used by Digene. In addition, Xxxxxx
shall follow the written instructions issued by Digene from time to time for
the purpose of protecting the standards of quality established for the goods
and services sold under Digene Trademarks. Any use of an Xxxxxx trademark by
Digene shall be subject to Xxxxxx'x prior approval, which approval may be
withheld by Xxxxxx at Xxxxxx'x sole discretion.
12.2 Trademark Ownership. It is understood and agreed that Digene is the
sole and exclusive owner of all rights, title and interests in and to the
Digene Trademarks. Nothing
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
contained in this Agreement shall be construed as an assignment to Xxxxxx of
any rights, title or interests in the Digene Trademarks; it being understood
that all rights, title and interests relating to the Digene Trademarks are
expressly reserved by Digene, except for the rights being licensed hereunder.
12.3 Infringement. Each party shall notify the other Party of any
suspected infringements by Third Parties of the Digene Trademarks in the Field
or any patent or other proprietary right of Digene in the Field that may come
to such Party's attention. Digene shall have the initial right to determine
whether any action shall be taken on account of any such infringement, and
Digene shall have the right to employ counsel of its choosing and to direct the
handling of the litigation and any settlement thereof, at Digene's expense. In
the event Digene does not pursue such potential infringement within three (3)
months after notice of such potential infringement, Xxxxxx shall have the right
to take action on its own behalf, to employ counsel of its choosing and to
direct the handling of the litigation and any settlements thereof, at Xxxxxx'x
own expense. The Parties agree to cooperate with each other in maintaining,
protecting and defending the Digene Trademarks.
12.4 Possible Removal From Market. In the event that the manufacture,
use, sale or importation for sale of Product, Other Product or Digene Equipment
becomes, or, in the opinion of Digene or Xxxxxx, may become, the subject of any
claim, suit or proceeding for infringement or if the manufacture, use, sale or
importation for sale of the Product, Other Product or Digene Equipment is or,
in the opinion of Digene or Xxxxxx, is likely to be enjoined for infringement,
Digene shall, at its option and expense, do one (1) or more of the following:
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(a) obtain for Xxxxxx, its Affiliates and sub-distributors the
right to use, sell and import for sale the Product, Other Product or
Digene Equipment;
(b) modify the Product, Other Product or Digene Equipment so that
it becomes non-infringing or replace the Product, Other Product or
Digene Equipment with a non-infringing product while remaining in
compliance with Digene's published Specifications, or Other Product
Specifications in effect at the time; or
(c) require that Xxxxxx, its Affiliates and sub-distributors
cease to deliver the Product, Other Product or Digene Equipment in the
affected country.
In the event Digene does not perform (a) or (b) above, and such
nonperformance reduces Xxxxxx'x annual Net Sales for such Product by more than
[********], the Parties shall negotiate in good faith an agreement with respect
to [********************************************************************
********************************************].
12.5 Third Party Claims for Infringement. If a Third Party brings a
legal action or administrative proceeding against either or both of the Parties
alleging infringement by a Product, Other Product or Digene Equipment in the
Field in the Territory, the CMV Territory or the SHARP Territory, the Parties
agree that they shall confer in good faith to determine the most effective
means of cooperating to defend their sole and mutual interests.
12.6 Co-Labeled Product. Digene shall sell Products identified by an
Xxxxxx trademark or trade name only to Xxxxxx and its Affiliates or to an
Xxxxxx-appointed sub-distributor.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
12.7 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER
FOR ANY AMOUNTS REPRESENTING LOSS OF BUSINESS, OR INDIRECT, SPECIAL, EXEMPLARY,
CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING FROM THE PERFORMANCE OR
NONPERFORMANCE OF THIS AGREEMENT OR ANY ACTS OR OMISSIONS ASSOCIATED THEREWITH
OR RELATED TO THE USE OF ANY ITEMS OR SERVICES FURNISHED HEREUNDER, WHETHER THE
BASIS OF THE LIABILITY IS BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE AND
STRICT LIABILITY), STATUTORY OR ANY OTHER LEGAL THEORY. IN NO EVENT SHALL THIS
SECTION 12.7 BE DEEMED TO LIMIT LIABILITY FOR LOSS OF PROFITS UNDER THIS
AGREEMENT.
ARTICLE 13. - REPRESENTATIONS AND WARRANTIES
13.1 Digene Representations and Warranties. Digene represents and
warrants that all Products, Other Products and Digene Equipment delivered to
Xxxxxx hereunder shall be:
(a) manufactured in accordance with cGMPs, the Specifications or
Other Product Specifications, as applicable and, after December 31,
1999, ISO 9000 Series;
(b) free from defects in material and workmanship until one (1)
year after date of shipment for the Digene Equipment and/or the shelf
life for Products or Other Products having an expiration date (the
"Warranty Period");
(c) free and clear of any Third Party security interest, lien or
encumbrance;
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(d) manufactured in compliance with all applicable foreign,
federal, state and local laws and regulations in the location of
manufacture; and
(e) Year 2000 Compliant as of July 1, 1999 in accordance with the
following terms:
(i) all Products, Other Products and Digene Equipment that
operate on date data software and hardware; and
(ii) all mission critical hardware and software supplied by
Digene for Products, Other Products and Digene Equipment.
(f) Year 2000 Compliant as of December 1, 1999 with respect to
all mission critical hardware and software used in Digene's
manufacturing process for Products Other Products, and Digene
Equipment.
With respect to clauses (a), (b) and (d) of this Section 13.1, the
Parties acknowledge and agree that unless Digene fails to deliver Products,
Other Products or Digene Equipment consistently to Xxxxxx, at a mutually agreed
upon level, any Product, Other Product or Digene Equipment not conforming to
clauses (a), (b) and (d) of this Section 13.1 shall be handled in accordance
with Section 13.2 and shall not constitute a material breach of this Agreement.
13.2 Replacement or Repair. Digene, at its election, shall repair or
replace Products, Other Products or Digene Equipment returned during the
Warranty Period which fail to meet the warranty set forth in Section 13.1
("Defective Products"). Customers in the Territory, CMV Territory and SHARP
Territory shall return Defective Products to Xxxxxx, its Affiliates or
sub-distributors for return to Digene. Digene, at its election, shall accept
returned Defective
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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.
Products in accordance with the terms of Schedule 13.2 or Xxxxxx, at Digene's
request, shall dispose of such Defective Products appropriately. Digene shall
bear the cost of return shipment of Defective Products to Digene and the cost of
shipping repaired or replaced Defective Products to the customer or Xxxxxx, its
Affiliates or sub-distributors, as the case may be.
13.3 Third Party Distributors. Digene represents and warrants to Xxxxxx
that, except for Distributors, Xxxxxx and its Affiliates, and sub-distributors,
no Third Party has any right of distribution, marketing, promotion or any other
rights to sell Products in the applicable Territory.
13.4 Limitation on Warranties. DIGENE MAKES NO WARRANTIES REGARDING THE
PRODUCTS, OTHER PRODUCTS AND DIGENE EQUIPMENT OTHER THAN THE EXPRESS WARRANTIES
IN THIS ARTICLE AND THERE SHALL BE NO IMPLIED OR STATUTORY WARRANTIES, INCLUDING
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR
NON-INFRINGEMENT.
13.5 Patent Representations and Warranties.
(a) Digene represents and warrants to Xxxxxx as of the Effective
Date, that:
(i) to its knowledge, there are no Third Party patents,
trademarks or other proprietary rights which are valid and enforceable
and which would be infringed by making, having made, using, selling,
offering for sale or importing Products, Other Products and Digene
Equipment in the Territory, the CMV Territory or the SHARP Territory,
as applicable in accordance with the terms of this Agreement; and
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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.
(ii) to its knowledge, Digene is not, and as a result of the
execution and delivery of this Agreement or the performance of Digene
hereunder will not be in violation of or lose any rights pursuant to
any license, sublicense or agreement previously provided to a Third
Party.
13.6 General Representations and Warranties. Each Party represents and
warrants to the other Party as of the Effective Date as follows:
(a) it is a corporation duly organized and validly existing under the
laws of its state of incorporation;
(b) it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;
(c) the execution, delivery and performance by it of this Agreement
and its compliance with the terms and provisions hereof does not and will not
conflict with or result in a breach of any other agreement or relationship; and
(d) all mission critical hardware and software used in the
Performance of its duties and obligations hereunder shall be Year 2000 Complaint
no later than July 1, 1999, except, however that Digene's mission critical
hardware and software used in Digene's manufacturing process shall be Year 2000
Compliant no later than December 1, 1999.
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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.
ARTICLE 14. - GENERAL INDEMNIFICATION
14.1 Digene Indemnification. Digene shall indemnify, defend and hold Xxxxxx
and its Affiliates and their officers, directors, employees, and representatives
harmless from and against any and all claims, causes of action, suits,
proceedings, losses, damages, demands, fees, expenses, fines, penalties and
costs (including reasonable attorney's fees) arising out of, relating to or in
connection with: (a) the manufacture, shipment or use of Product, Other Product
or Digene Equipment; (b) the breach of Digene's warranties, representations or
covenants set forth in this Agreement or in the Murex Agreements as provided in
Article 20; (c) any Third Party patent infringement action against Xxxxxx and/or
its Affiliates relating to Products or Other Products; (d) the termination by
Digene of any distributor of Product in the Territory; and/or (e) the wrongful
or negligent acts or omissions on the part of Digene's employees, agents or
representatives.
14.2 Xxxxxx Indemnification. Xxxxxx shall indemnify, defend and hold Digene
and its Affiliates and their officers, directors, employees, and representatives
harmless from and against any and all claims, causes of action, suits,
proceedings, losses, damages, demands, fees, expenses, fines, penalties and
costs (including reasonable attorney's fees) arising out of, relating to or in
connection with: (a) the breach of Xxxxxx'x warranties, representations or
covenants set forth in this Agreement or in the Murex Agreements as provided in
Article 20; or (b) the wrongful or negligent acts or omissions on the part of
Xxxxxx'x employees, agents or representatives.
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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.
14.3 Cooperation. Each Party shall promptly notify the other Party of any
claim or potential claim covered by the indemnification provisions of this
Article 14 and shall include sufficient information to enable the other Party to
assess the facts. Each Party shall cooperate with the other Party in the defense
of all such claims. No settlement or compromise shall be binding on a Party
without such Party's prior written consent, which consent shall not be
unreasonably withheld or delayed.
14.4 Insurance. Digene shall procure and maintain during the Term
comprehensive commercial liability insurance, including contractual and products
liability coverage, in aggregate annual limits of Six Million Dollars
($6,000,000). Digene shall provide Xxxxxx with prompt written notice of any
notice of cancellation, modification or reduction of coverage under, such
policies. Digene shall cause Xxxxxx and its Affiliates to be named as additional
insureds on such policies and Digene policies shall be primary with respect to
any indemnification of Xxxxxx and its Affiliates hereunder.
ARTICLE 15. TERM AND TERMINATION
15.1 Term. Subject to early termination as set forth in this Article 15,
this Agreement shall begin on the Effective Date and shall continue until the
last day of the Initial Term. Thereafter, this Agreement, with respect to each
Product and Equipment, [**************************************************
*******************************] shall be extended automatically in accordance
with the terms and conditions of Article 4.
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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.
15.2 Termination for Cause.
(a) Either Party may terminate this Agreement for cause upon written
notice to the other Party in the event the other Party becomes insolvent or
makes an assignment for the benefit of its creditors, or upon appointment
of a trustee or receiver for the other Party of a material portion of its
assets, or upon filing of a voluntary petition against the other Party
under any bankruptcy or insolvency law, including Section 101 et seq.,
Title 11 of the United States Code (the "U.S. Bankruptcy Code"), or an
involuntary petition against the other Party under any bankruptcy or
insolvency law, including the U.S. Bankruptcy Code, which involuntary
petition remains undismissed or undischarged and in effect for a period of
ninety (90) days.
(b) Either Party may terminate this Agreement for cause (i) on a
Product by Product basis upon written notice to the other Party in the
event the other Party materially breaches this Agreement with respect to a
Product or Products, or (ii) in its entirety upon written notice to the
other Party in the event the other Party materially breaches this Agreement
with respect to all Products or with respect to terms which are not
specific as to Product and fails to cure such breach within sixty (60) days
after receipt of written notice of breach from the non-breaching Party, as
such cure period may be extended for such additional period as the
non-breaching Party reasonably determines that the breaching Party is
diligently pursuing a cure of such breach, to the extent such rights are
provided by Sections 4.2(b) or 4.3(b), as applicable.
15.3 Termination By Digene For Xxxxxx'x Failure to Achieve Net Sales
Thresholds. Digene shall have the right to terminate this Agreement with respect
to [*********************
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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.
************] if Xxxxxx fails to achieve the Net Sales thresholds [*************
*****************], and with respect to [********************************
[*******************] if Xxxxxx fails to achieve the Net Sales thresholds
[*****************************]. In the event of termination pursuant to this
Section 15.3, Xxxxxx and Digene shall continue to perform their obligations
hereunder [*********************************************************************
**********************************************].
15.4 Termination By Xxxxxx for Change of Control. Xxxxxx shall have the
right to terminate this Agreement [************************] prior written
notice to Digene in the event of a Change of Control of Digene wherein the
entity acquiring control of Digene is a material direct competitor of Xxxxxx.
Digene shall provide Xxxxxx written notice of any such Change of Control within
sixty (60) days thereafter. Xxxxxx shall provide written notification to Digene
of the exercise of its termination rights within sixty (60) days of receipt of
the notice of a Change of Control from Digene. The [*****************] period
set forth in this Section 15.4 shall commence on the date Digene receives
written notification of Xxxxxx'x exercise of rights under this Section.
Notwithstanding Xxxxxx'x right to terminate under this Section 15.4, the Parties
shall be obligated to the following:
(a) CT/GC Clearance. In the event a Change of Control giving Xxxxxx
the right to terminate hereunder occurs earlier than three (3) months prior
to the date of CT/GC Clearance, then Digene shall have the right within
sixty (60) days after CT/GC Clearance to terminate this Agreement with
respect to CT/GC and Equipment (provided
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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.
Xxxxxx does not then have rights to market and distribute [*************
*************************************************].
(b) [********************]. In the event a Change of Control giving
Xxxxxx the right to terminate hereunder occurs and, at the end of the most
recently completed Contract Year preceding such Change of Control, Xxxxxx
did not [***************************************************************
************************************************************************
***********************************************************************
*************************************] then Digene shall have [************
**********************************************************************
********************************************************************
*************************************************].
Digene shall only be obligated to provide Xxxxxx with a [*********] wind-down
under this Section if at the time of such Change of Control Xxxxxx was an
exclusive distributor for such Product.
15.5 Partial Termination By Digene For Xxxxxx'x Failure to Market in
Particular Country. In addition to its rights under Section 15.2, Section 15.3
and Section 15.4, Digene shall have the right, on sixty (60) days written
notice, to terminate Xxxxxx'x marketing and distribution rights with respect to
a Product and with respect to a country in the Territory if Xxxxxx fails, after
giving consideration to [*******************************************] to
meet its obligations [*****************] hereunder with respect to such Product
in such country and such failure has not been cured; provided, however, that if
Xxxxxx has recorded sales of such Product in such country,
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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.
Xxxxxx may initiate an alternative dispute resolution proceeding under Section
21.6 within such sixty (60) day period, in which event Digene's right to
terminate shall be determined by such proceeding. Solely for the purposes of
this Section 15.5, Abbott shall have sixty (60) days from the receipt of notice
from Digene under this Section 15.5 to cure any failure to meet obligations
[******************]. The partial termination of this Agreement with respect to
a Product and with respect to a country shall be without prejudice to any other
rights of the Parties hereunder. By way of example and for avoidance of doubt,
[******************************************************************************
********************************************************************************
*************************************************************************
********************************************************************************
*******************************************************************************
******************************************************************************
***********************************************].
15.6 Continuation of Force Majeure. Either Party may terminate this
Agreement in the event of force majeure event continues for one hundred eighty
(180) consecutive days and prevents a Party from materially performing its
obligations under this Agreement.
15.7 Accrued Obligations. Termination, expiration, cancellation or
abandonment of this Agreement through any means and for any reason shall not
relieve the Parties of any obligation accruing prior thereto and shall be
without prejudice to the rights and remedies of either Party with respect to any
antecedent breach of any of the provisions of this Agreement.
15.8 Additional Remedies for Breach. Notwithstanding the terms and
conditions of Section 15.2, neither Party shall be obligated to terminate this
Agreement in the event the other
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Party materially breaches this Agreement. The non-breaching Party shall have the
right to seek, in accordance with Section 21.6, other remedies available to it
at law and equity to recover for such breach, without having to terminate the
Agreement.
ARTICLE 16. - CONSEQUENCES OF TERMINATION
16.1 Buy-out of Equipment and Inventory.
(a) In the event of any termination or expiration of this Agreement,
except in the case of Xxxxxx'x non-performance, Digene shall, at Xxxxxx'x
option, within ninety (90) days after such termination or expiration, [***
********************************************************************
************************************************************************
***************************************************************************
**************************************************************************
******************************************************************].
(b) In the event of any termination of expiration of this Agreement
by reason of Xxxxxx'x non-performance, Digene may, at its option, within
ninety (90) days after such termination or expiration, [*****************
**********************************************************************
***************************************************************************
*********************************************************************
*********************************************************************
**********************************************************].
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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.
16.2 Termination Fee. In the event of termination of this Agreement by
Abbott pursuant to [************], Digene shall pay to Abbott upon the effective
date of such termination, [**************************************************
*************************************************].
16.3 Residual Payments. In the event of any termination of this Agreement
[***********************************************], and in consideration of
Abbott efforts in developing Product sales and goodwill during the Term, Digene
shall pay for [******] following the termination of this Agreement, a residual
to Abbott pursuant to [**************].
ARTICLE 17. - CONFIDENTIALITY AND PUBLIC ANNOUNCEMENTS
17.1 Confidentiality. The Parties acknowledge and agree that during the
Term, each of them and their Affiliates may exchange Confidential Information,
and the disclosure and use of any such Confidential Information shall be
governed by the provisions of this Article 17. Each Party shall use the
Confidential Information of the other Party only for the purpose of the
activities contemplated by this Agreement and may only disclose such
Confidential Information on a need to know basis for the purposes of this
Agreement to a Third Party or employee who is bound by a confidentiality
obligation similar to the terms of this Section 17.1. The Parties shall ensure
that their Affiliates and such Affiliates' officers, directors, employees,
representatives and agents shall keep all Confidential Information exchanged
hereunder confidential and treat such Confidential Information with the same
care as such Party would exercise in the handling of its own confidential or
proprietary information. Notwithstanding the foregoing, any Confidential
Information may be disclosed to the neutral in any alternative dispute
resolution proceeding
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
under Section 21.6, provided that such neutral executes a mutually acceptable
confidentiality agreement prior to the commencement of such proceeding. This
provision shall remain in effect for a period of five (5) years after
termination or expiration of this Agreement for all Confidential Information.
17.2 Handling of Trade Secrets. During the course of its performance
hereunder, a Party (the "Disclosing Party") may desire or be requested to
disclose Confidential Information to the other Party (the "Receiving Party"),
which the Disclosing Party considers a Trade Secret. In such event, the
Disclosing Party first shall inform the Receiving Party, on a non-confidential
basis, the general nature of the Trade Secret information. The Receiving Party
shall have ten (10) days to decide whether it wishes to have such Trade Secrets
disclosed to it and to inform the Disclosing Party in writing that it wishes to
receive such a disclosure. Any Trade Secrets so disclosed between the Parties
shall be marked "Trade Secret," and the Receiving Party shall not disclose or
use such Trade Secret for the Term and thereafter except as expressly permitted
under this Agreement. In the event the Disclosing Party discloses the Trade
Secrets to the Receiving Party without written approval of the Receiving Party
and/or without appropriately marking such information as "Trade Secret" that
Trade Secret shall be handled as Confidential Information under Section 17.1.
17.3 Confidential Treatment. Digene shall seek confidential treatment for
the terms and conditions of this Agreement to the fullest extent permitted by
the SEC and any other governmental agency or self-regulatory organization to
which Digene provides a copy of this Agreement, if at all. Prior to seeking
confidential treatment from the SEC or any other
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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.
governmental agency or self-regulatory organization for any such document,
Digene shall consult with Abbott and Xxxxxx'x counsel and provide them with a
reasonable opportunity to request the inclusion of specified provisions in any
request by Digene for confidential treatment.
17.4 Public Announcements. Neither Party shall make any public announcement
concerning this Agreement, nor make any public statement which includes the name
of the other Party or any of its Affiliates, or otherwise use the name of the
other Party or any of its Affiliates in any public statement or document without
the consent of the other Party, which consent shall not be unreasonably
withheld, except: (a) as may be required by law or judicial order, including
required disclosure under the Securities Act of 1933, as amended, the Securities
Exchange Act of 1934, as amended, any exchange on which either Party's equity
securities are listed, the National Association of Securities Dealers, Inc.
and/or its subsidiaries; (b) as may be contained in joint marketing materials,
presentations and related activities; (c) that Digene may provide general
information, including aggregate revenue information by region, on a periodic
basis and in response to inquiries; or (d) that either Party may include in a
subsequent public statement or document, information regarding this Agreement
which has already been approved by the other Party.
ARTICLE 18. - FORCE MAJEURE
Neither Party shall be held in breach of this Agreement for failure
to perform any of its obligations hereunder and, subject to the terms and
conditions of Section 15.6, the time required for performance shall be extended
for a period equal to the period of such delay, provided that
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
such delay has been caused by or is a result of any acts of God; acts of the
public enemy; civil strife; wars declared or undeclared; embargoes; labor
disputes, including strikes, lockouts, job actions or boycotts; fires;
explosions; floods; shortages of material or energy; events caused by reason of
laws or regulations or orders by any government, governmental agency or
instrumentality or by any other supervening unforeseeable circumstances beyond
the reasonable control of the Party so affected. The Party so affected shall:
(a) give prompt written notice to the other Party of the nature and date of
commencement of the force majeure event and its expected duration; and (b) use
its reasonable best efforts to relieve the effect of such cause as rapidly as
possible.
ARTICLE 19. - IMPROVEMENTS, INNOVATIONS, DIGENE PRODUCTS;
DEVELOPMENT PROJECTS
19.1 First Right of Negotiation. Digene hereby grants to Abbott the first
right of negotiation with regard to any transaction contemplated by Digene
whereby Digene, directly or indirectly, would itself, or would license, sell,
transfer, convey, assign to a Third Party or otherwise encumber any right, title
or interest of Digene to, sell, market, promote or distribute [*****************
*****************************************************************************
***************]; provided, however, that neither Party shall be obligated by
the grant of such right to enter into any arrangement after completing the good
faith negotiations described in this Section 19.1. In the event Digene
determines to undertake the foregoing itself or to solicit a proposal for the
foregoing, Digene first shall promptly provide exclusively to Abbott written
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
notice thereof, the scope thereof and [********************************]
involved. In the event Digene receives an unsolicited Third Party proposal with
respect to such a transaction and Digene intends to pursue negotiations with the
Third Party submitting such proposal, Digene shall promptly provide exclusively
to Abbott written notice of the fact that it has received such a proposal, the
scope thereof and [********************************] involved. Abbott shall have
[**********************] from receipt of any of such notices to advise Digene in
writing (the "Negotiation Notice") of whether Abbott shall negotiate with Digene
regarding [*********************************], as the case may be. If Abbott
elects to negotiate with Digene regarding [*********************************],
as the case may be, Abbott and Digene shall negotiate exclusively in good faith,
for up to [***************] after Digene receives the Negotiation Notice, a
definitive agreement reflecting the material terms of the license, sale,
marketing, promotion or distribution of [*********************************];
provided, however, that neither Party shall be obligated to enter into such an
arrangement after completing such good faith negotiations. If Abbott and Digene
are unable in good faith to reach a definitive agreement within the [**********
***] period, Digene may enter into negotiations and conclude with a Third Party
a definitive agreement of substantially similar scope and with respect to [****
*****************************], as the case may be, on terms which, when
considered in their entirety, are not materially less favorable to Digene than
those finally offered by or to Abbott or undertake the foregoing itself. In the
event that Abbott does not so notify Digene that it elects to negotiate such a
definitive agreement, Digene may undertake the foregoing itself or enter into
negotiations and an agreement with a Third Party with respect to [****
****************************] without any further obligations
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
with respect thereto under this Section 19.1. Digene shall have no obligations
under this Section 19.1 with respect to [***********************************
*****************************************************************************
*************************************************].
19.2 Restriction of Right to Improvements, Innovations and Digene Products.
(a) Improvements and Innovations. Digene shall have no obligation to
provide Abbott with [*************************************************
************************************************************************
*************************************************************************
*************************************************************************
*******************************************************************].
(b) [********] Digene shall have no obligation to provide
Abbott with first rights of negotiation to any [*************], as more
fully described in Section 19.1, upon the earlier of [*********************
**************************************************************************
*************************************************************************
**************************************************************************
***********************************************************************
********************************************************************];
provided, however, that if Digene's obligations under this sentence have
been terminated by reason of [**************************************
***************************************************************************
**************************************************************************
***
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
**********************************************************************
**************], Digene's obligations under Section 19.1 shall be restored
with respect to [********************************************************
***********************************************************************
*************************************************************************
*************] until or unless Digene shall otherwise be, or have been,
relieved of its obligations in accordance with this sentence.
19.3 Third Party Licenses. During the Term, Digene shall not license or
sublicense to a Third Party rights to a Product in the Field in the Territory,
provided that Abbott has [***********************************************
********].
19.4 Determination of Improvements or Innovations. The Parties shall
determine whether an improvement, modification or adjustment of or to a Product
is to be deemed an Improvement or an Innovation to such Product or whether an
improvement, modification or adjustment of or to a Digene Product is to be
deemed an Improvement to such Digene Product. Factors the Parties shall consider
in determining whether an improvement, modification or adjustment is an
Improvement or an Innovation to such Product or an Improvement to such Digene
Product, include, but are not limited to the following:[************************
********************************************************************************
*****************************************************************************].
In the event the Parties are unable to determine whether an improvement,
modification or adjustment of or to a Product is to be deemed an Improvement or
Innovation to such Product, or whether an improvement, modification or
adjustment of or to a Digene Product is to be deemed
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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.
an Improvement to such Digene Product, either Party may elect to conduct an
independent review of the dispute by impaneling an independent review board
comprised of four (4) opinion leaders in the industry, with each Party selecting
two (2) members thereof. If a Party elects to impanel an independent review
board, it shall provide the other Party with written notice of such election and
the Parties shall then select their respective members of such board. A hearing
on whether the particular improvement, modification or adjustment of or to a
Product is to be deemed an Improvement or Innovation to such Product, or whether
an improvement, modification or adjustment of or to a Digene Product is to be
deemed an Improvement to such Digene Product, shall be conducted within sixty
(60) days after receipt of the initial notice. Such hearing shall be held in the
presence of both Parties at a location to be mutually agreed to by the Parties
and shall be conducted over a period of no longer than eight (8) hours, with
each Party entitled to present for no longer than four (4) hours. The cost of
the hearing and of the members of the independent review board shall be shared
equally by the Parties. Any conclusions or recommendations offered by the
independent review board shall be advisory only, shall not be binding on either
Party and shall not be admissible in an alternative dispute resolution
proceeding under Section 21.6. Further, any such conclusions or recommendations
shall not be provided in writing. If after conducting the hearing with the
independent review board, the Parties remain unable to agree whether the
improvement, modification or adjustment is an Improvement or an Innovation to
such Product, or an Improvement to such Digene Product, then either Party may
seek final resolution of the dispute through the alternative dispute resolution
procedure under Section 21.6.
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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.
19.5 [*********]. Within one hundred and twenty (120) days following the
Effective Date, Abbott shall provide written notice to Digene as to whether [**
********************************************************************************
******************************************************************************
*********************************]. In the event Abbott so notifies Digene of
[***************************************************************************
****************************************************************************
******************************************************************************
************************]. In the event the Parties, after [********************
***********************************************************************
**************************************************************************
*****************************************************************]. In the event
Abbott does not so notify Digene or notifies Digene that it [******************
****************************************************************************]
19.6 Development Projects. Abbott shall [******************************
***] of the following development projects, subject to agreed upon milestones
and timeframe. Abbott shall promptly after the Effective Date, meet with Digene
and discuss a collaboration between the Parties to pursue [******************
**************************************************************************
******************************************************************************
****************************].
(a)[******************************************************************
***************************************************************************
***************************************************************************
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
***************************************************************************
***************************************************************************
***************************************************************************
***************************************************************************
***************************************************************************
***************************************************************************
***************************************************************************
***************************************************************************
************************************************************************].
(b)[******************************************************************
***************************************************************************
************************************************************************].
(c) [*****************************************************************
***************************************************************************
***************************************************************************
************************************************************************].
Once the Parties select [***********************************], the Parties shall
mutually prepare a project plan and milestone setting forth in detail the
expectation of the Parties.
19.7 Testing Service Rights. Digene hereby expressly reserves the right,
for its and its Affiliates, to sell or distribute all Products and Digene
Products as a product or as a testing service intended only for use in
functional genomics, pharmaceutical screening, or drug
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
discovery and development, including but not limited to therapeutics and
vaccines. In addition, Digene retains the right to supply all Products and
Digene Products for internal use by Digene and its Affiliates. For purposes of
clarification, products and testing services described in this Section 19.7
shall not include human in vitro diagnostic applications.
19.8 R&D Expenses. Except as otherwise provided in Section 19.6 or as
otherwise agreed, Digene shall be responsible, at its sole cost and expense for
the funding of [****************************************************************
***********************].
19.9 Products Outside the Scope of the Agreement. Except as provided in
Section 19.5, any rights of Digene to any product or Analyte which, with respect
to Products, does not principally utilize Hybrid Capture Technology and, with
respect to Digene Products, does not principally utilize Hybrid Capture for
Digene Products are outside the scope of this Agreement and Digene shall have no
obligation to negotiate with Abbott with respect to such rights for any country
in the world.
ARTICLE 20. - TRANSFER, MODIFICATION OR
TERMINATION OF OBLIGATIONS UNDER THE MUREX AGREEMENTS
20.1 General. The obligations of the Murex Entities and Digene under the
Murex Agreements shall, after the Effective Date, be transferred to, modified
(as applicable) and performed in accordance with the terms and provisions of
this Agreement, as set forth in this Article 20. Any obligations of the Murex
Entities and/or Digene under any of the Murex
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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.
Agreements, other than those described in this Article 20, shall be terminated
and of no further force and effect as of and after the Effective Date.
20.2 Distribution of HBV. Any distribution, marketing and/or manufacturing
activities of any of the Murex Entities under any of the Murex Agreements with
respect to HBV shall be transferred from such Murex Agreements and, after the
Effective Date, performed by Abbott and by Digene, as the case may be, in the
HBV Territory in accordance with the terms and provisions of this Agreement.
20.3 Distribution of HPV. Any distribution, marketing and/or manufacturing
activities of any of the Murex Entities under any of the Murex Agreements with
respect to HPV shall be transferred from such Murex Agreements and, after the
Effective Date, performed by Abbott and by Digene, as the case may be, in the
HPV Territory in accordance with the terms and provisions of this Agreement.
20.4 Distribution of CMV. The Parties shall transfer all obligations with
respect to the distribution of Digene products for the diagnosis of
cytomegalovirus set forth on Schedule 20.4 ("CMV") from all of the applicable
Murex Agreements to this Agreement, with such obligations to be performed as
follows. Subject to, and in accordance with the other terms and conditions of
this Agreement, Digene hereby appoints Abbott and its Affiliates for the Term as
a non-exclusive distributor of CMV in the CMV Territory for use in the Field,
and Abbott hereby accepts such appointment. As part of such appointment under
this Section 20.4, Abbott shall have the right to appoint sub-distributors in
those countries or territories in the CMV Territory in which Abbott generally
uses sub-distributors to distribute Xxxxxx diagnostic products. All CMV shall be
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
labeled identifying Digene only. Abbott shall not be required to meet any Net
Sales thresholds with respect to sales of CMV. Either Party shall be entitled to
terminate this non-exclusive distribution arrangement at any time by providing
to the other Party [******] written notice. The sales prices for the CMV shall
be determined as set forth in Section 2.7. During the Term, the transfer prices
of CMV shall be the price set forth on Schedule 20.4.
Notwithstanding the other provisions of this Section 20.4, the provisions
of Sections 2.4, 2.8, 2.9, 3.5, 3.8, 5.1(g), 5.4, 5.7 and 5.8 and Article 4
shall not apply to the marketing and distribution of CMV hereunder. In addition,
Digene and Abbott shall have no obligation under this Agreement or any of the
Murex Agreements for development activities with respect to products for the
diagnosis and/or treatment of CMV. Unless otherwise specified, however, all
other provisions of this Agreement shall apply to the marketing and distribution
of CMV.
20.5 Distribution of SHARP Signal System Products. The Parties shall
transfer all obligations with respect to the distribution of all Digene SHARP
Signal System products listed on Schedule 20.5 currently sold in the SHARP
Territory under the Murex Agreements ("SHARP") from all of the applicable Murex
Agreements to this Agreement, with such obligations to be performed as follows.
Subject to, and in accordance with the other terms and conditions of this
Agreement, Digene hereby appoints Abbott and its Affiliates for the Term as a
non-exclusive distributor of SHARP in the SHARP Territory for use in the Field,
and Abbott hereby accepts such appointment. As part of such appointment under
this Section 20.5, Abbott shall have the right to appoint sub-distributors in
those countries or territories in the SHARP
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Territory in which Abbott generally uses sub-distributors to distribute Xxxxxx
diagnostic products. All SHARP shall be labeled identifying Digene only. Abbott
shall not be required to meet any Net Sales thresholds with respect to sales of
SHARP. Either Party shall be entitled to terminate this non-exclusive
distribution arrangement at any time by providing to the other Party [******]
written notice. The sales prices for the SHARP shall be determined as set forth
in Section 2.7. During the Term, the transfer prices of SHARP shall be the price
set forth on Schedule 20.5.
Notwithstanding the other provisions of this Section 20.5, the provisions
of Sections 2.4, 2.8, 2.9, 3.5, 3.8, 5.1(b), 5.1(c), 5.1(g), 5.4, 5.5, 5.6, 5.7,
5.8 and 5.10 and Article 4 shall not apply to the marketing and distribution of
SHARP hereunder. In addition, Digene and Abbott shall have no obligation under
this Agreement or any of the Murex Agreements for development activities with
respect to the applications for SHARP. Unless otherwise specified, however, all
other provisions of this Agreement shall apply to the marketing and distribution
of SHARP.
20.6 Murex-Only Labeled Products. Pursuant to the Development and License
Agreement, dated as of April 14, 1993, between Digene and International Murex
Technologies Corporation and the 1994 Development and License Agreement dated as
of May 31, 1994, between Digene and International Murex Technologies
Corporation, Murex had the right to require Digene to provide Murex with
products developed under such agreements with labels designed by Murex. Pursuant
to such rights, Digene has provided CMV to Murex with Murex-only trade marks and
trade dress. Abbott, on behalf of itself and all Murex Entities and
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Affiliates, shall remove the requirement to label any such products, including
CMV, with any Murex identifier in the label or trade dress, and hereby
terminates the obligation of Digene to provide such Murex-only labeled products
pursuant to either Development and License Agreement.
20.7 Continuing Obligations Under the Murex Agreements.
(a) Confidentiality Provisions. As of the Effective Date, all
Confidential Information (as such term is defined in each of the Murex
Agreements) of either Digene or the applicable Murex Entity that relates, in any
way, to CMV, CT/GC, HBV, HPV or SHARP or any of the Equipment marketed,
distributed, sold, developed or manufactured in accordance with the terms of
this Agreement shall be treated as "Confidential Information" as defined in, and
exchanged under, this Agreement. The Parties shall protect the confidentiality
of, and abide by their respective non-disclosure obligations with respect to,
all such Confidential Information in accordance with the terms of Article 17 of
this Agreement. All Confidential Information of Digene or the applicable Murex
Entity not transferred to this Agreement pursuant to the foregoing shall
continue to be treated as Confidential Information of Digene and the applicable
Murex Entity in accordance with, and subject to the provisions of the applicable
Murex Agreement, including, without limitation, the provisions requiring Digene
(on behalf of itself and its Affiliates) and Abbott (regarding itself and its
Affiliates, including the Murex Entities) to continue to comply with the
confidentiality and non-disclosure obligations under the applicable Murex
Agreement for the time period specified in the applicable Murex Agreement
following the termination of such Murex Agreement. Nothing contained in this
Agreement shall be, or shall be
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deemed to be, a waiver by Digene or Abbott, or their respective Affiliates or
any of the Murex Entities of the confidentiality and non-disclosure obligations
set forth in each of the Murex Agreements.
(b) Indemnification Provisions. The indemnification provisions,
including the survival thereof, contained in the Murex Agreements shall continue
in full force and effect until terminated in accordance with the provisions of
each applicable Murex Agreement.
(c) Warranties. All warranties by Digene and/or its Affiliates in any
of the Murex Agreements shall apply to all products shipped by Digene or its
Affiliates to a Murex Entity or Abbott and/or its Affiliates prior to the
Effective Date.
20.8 Transition Period. For a period not to exceed one hundred eighty (180)
days from the Effective Date (the "Transition Period"), Digene and Abbott shall
Work With each other to transition the responsibilities and obligations under
the Murex Agreement to the responsibilities and obligations under this Agreement
in accordance with the following guidelines, which shall apply to all Products
and Other Products marketed, manufactured, sold and distributed hereunder:
(a) Marketing and Promotion. Abbott shall wind-down all marketing and
promotion efforts initiated under the Murex Agreements for products other than
the Products and Other Products and/or performed in areas of the world other
than the applicable Territory, the CMV Territory or the SHARP Territory within
the Transition Period. Thereafter, the provisions of Article 3 of this Agreement
shall supersede and replace all marketing and promotion obligations of the Murex
Entities set forth in any of the Murex Agreements.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) Selling Activities. As of the Effective Date, the forecasts, Net
Sales thresholds and requirements provisions as set forth in this Agreement
shall supersede and replace all forecasts, Net Sales thresholds and requirements
provisions as set forth in any of the Murex Agreements.
(c) Transfer Prices and Costs and Expenses. As of the Effective Date,
for all Product, Other Product and Equipment purchase orders that are placed
beginning after the Effective Date, the transfer prices and all provisions
related to costs and expenses, including, without limitation, the payment of
Trade costs, the determination of the selling price in the applicable Territory,
CMV Territory or SHARP Territory, as the case may be, costs of shipping, testing
and Recall, and the price and terms provisions set forth in Article 6 and
Article 20 of this Agreement shall supercede and replace all similar provisions
of any of the Murex Agreements. Any purchase orders relating to Product, Other
Product and Equipment sales to end-users or distributors or Murex Affiliates
initiated prior to or on the Effective Date shall be completed in accordance
with the provisions of the applicable Murex Agreement; provided, however, that
any Product, Other Product or Equipment sale transactions that cannot be
completed within the Transition Period (excluding receipt of payment) shall be
completed as expeditiously as possible in accordance with the provisions of this
Agreement.
(d) Customer Billing and Collection. Xxxxxx shall continue to perform
the customer billing, collection and Digene payment obligations of the Murex
Entities as set forth in any of the Murex Agreements for all Product, Other
Product and Equipment sales in the applicable Territory, CMV Territory or SHARP
Territory, as the case may be, initiated but not
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
completed prior to or on the Effective Date. After all such transactions have
been completed, the Parties shall cooperate with each other to terminate any
billing, collection and lock-box procedures established pursuant to the terms of
any of the Murex Agreements but not consistent with any similar terms of this
Agreement. Any purchase orders or sales performed in their entirety after the
Effective Date shall be handled in accordance with the provisions of this
Agreement.
(e) Wind-Down Activities. No wind-down provisions in any of the Murex
Agreements shall continue or be triggered.
(f) Equipment Buy-Out Provisions. The equipment buy-out obligations
under the Murex Agreements shall be handled in accordance with the provisions of
Section 6.1(b).
(g) Shipment and Delivery and Acceptance of Products and Other
Products. All shipments initiated prior to or on the Effective Date shall be
completed in accordance with the shipment, delivery and product acceptance terms
of the applicable Murex Agreement, but any shipments in the Territory, the CMV
Territory or the SHARP Territory after the Effective Date shall be performed in
accordance with the similar provisions of this Agreement.
(h) Consignment Inventory Storage Activities. The consignment
inventory holding obligations of the Murex Entities and Affiliates set forth in
Appendix A to the Agency and Sales Representation Agreement between Digene and
Murex Diagnostics Corporation shall continue until all consignment inventory of
Digene products has been depleted or discarded in accordance with the provisions
of such Murex Agreement.
(i) Financial Reconciliation.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
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(i) As of the Effective Date the Parties shall reconcile all payments
owed under any of the Murex Agreements and shall settle all outstanding
obligations in accordance with Schedule 20.8(i).
(ii) The Parties shall Work With each other during the Transition
Period to transfer all financial reporting, payment and accounting obligations
with respect to the sales of Products and Other Products in the Territory, the
CMV Territory or the SHARP Territory, as applicable, from the various systems
established pursuant to the Murex Agreements to the procedures and reporting
systems developed to comply with the provisions of this Agreement.
(j) Further Assurances. During the Transition Period, the Parties
shall Work With each other to amend this Agreement, in accordance with Section
21.10, to finalize Schedules 6.1(b) and 20.8(i) to update the information set
forth therein as of the Effective Date.
20.9 Termination of the Murex Agreements. Subject to the foregoing
provisions of this Article 20, each of Digene, on behalf of itself and its
Affiliates, and Abbott on behalf of itself, each Murex Entity and each Affiliate
of either Abbott or Murex hereby agrees that, as of the Effective Date, each of
the Murex Agreements shall be terminated and, except as set forth
herein, shall have no further force and effect. Without limiting the generality
of the foregoing sentence, Abbott and Digene shall have no further obligations
to each other under the Murex Agreements with respect to any: (a) marketing,
distribution or manufacture of any products and/or equipment as contemplated by
the Murex Agreements, other than as specifically set forth
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
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in this Agreement, including, without limitation, in any areas of the world
other than the Territory, the CMV Territory and the SHARP Territory; (b) product
or equipment development activities set forth in, or contemplated by, any of the
Murex Agreements; (c) indemnification obligations thereunder to the other Party
beyond the time periods described in this Article 20; and (d) payment and
related obligations other than those related to the transition activities
described in Section 20.8. All obligations of the parties thereto set forth in
the Murex Agreements for which similar provisions are set forth in this
Agreement, but not specifically mentioned in this Article 20 shall be governed,
with respect to the Products and Other Products and the Territory the CMV
Territory or the SHARP Territory, as applicable, to the extent applicable, by
such provisions of this Agreement (i.e., Recall, regulatory compliance, patent
and trademark protection, termination rights and consequences, new product
development efforts and miscellaneous provisions). Any provisions of the Murex
Agreements not covered by or contemplated by this Agreement shall be of no
further force and effect as of and after the Effective Date.
ARTICLE 21. - MISCELLANEOUS
21.1 Relationship of the Parties. The relationship of the Parties under
this Agreement is that of independent contractors. Nothing contained in this
Agreement shall be construed so as to constitute the Parties as partners, joint
venturers or agents of the other. Neither Party or its Affiliates has any
express or implied right or authority under this Agreement to assume or create
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any obligations or make any representations or warranties on behalf of or in the
name of the other Party or its Affiliates.
21.2 Successors and Assignment. Neither Party may assign its rights or
obligations under this Agreement without the prior written consent of the other
Party, which consent shall not be unreasonably withheld; provided, however, that
either Party may, without such consent, (a) assign this Agreement, in whole or
in part, to an Affiliate of such Party; (ii) designate one (1) or more of its
Affiliates to perform its obligations hereunder (in which case the designating
Party shall remain responsible for the performance of all of its obligations
hereunder); and (iii) assign any or all of its rights, interests or obligations
hereunder to any successor to the assignor in a merger or consolidation or any
other purchase of substantially all of the assets of the assignor. Any permitted
assignee shall assume all obligations of the its assignor under this Agreement.
No assignment shall relieve any Party of responsibility for the performance of
any obligation which such Party may have or incur hereunder.
21.3 Binding Effect. This Agreement shall be binding upon and inure to the
benefit of Abbott and those of its Affiliates which are acting or have acted as
a distributor hereunder and Digene and their respective successors and permitted
assigns. Abbott hereby guarantees the performance of all obligations hereunder
by all of its Affiliates which are acting or have acted as a distributor
hereunder.
21.4 Entire Agreement. This Agreement, including the Schedules, which are
incorporated herein by reference, set forth the entire understanding of the
Parties concerning the
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subject matter hereof and supersedes all written or oral prior agreements or
understandings with respect thereto.
21.5 Governing Law. This Agreement and the legal relations between
the Parties hereunder shall be construed, interpreted and governed by the laws
of the State of Illinois, without regard to its conflict of laws principles.
21.6 Dispute Resolution. Any controversy or claim arising out of or
relating to this Agreement, or the breach thereof, shall be resolved through the
alternative dispute resolution procedure described on Schedule 21.6; provided,
however, that this shall not prevent a Party from seeking and obtaining
injunctive relief in a court of competent jurisdiction.
21.7 Notices. All notices hereunder shall be in writing and shall
be: (a) delivered personally; (b) mailed by registered or certified mail;
postage prepaid; (c) sent by overnight courier; or (d) sent by facsimile or
express mail to the following addresses of the respective Parties:
If to Abbott: Xxxxxx Laboratories
Director, Acquisitions and Technology Assessment
D-9RK, Building AP6C
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx 00000-0000
Facsimile Number: (000) 000-0000
with copy to: Divisional Vice President
Domestic Legal Operations
X-000, Xxxxxxxx XX0X
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx 00000-0000
Facsimile Number: (000) 000-0000
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
If to Digene: Digene Corporation
Chief Executive Officer
0000 Xxxxxxxx Xxxxx Xxxx
Xxxxxxxxxx, Xxxxxxxx 00000
Facsimile Number: (000) 000-0000
with copy to: Xxxxxx Xxxxxxx, Xx.
Xxxxxxx Xxxxx Xxxxxxx & Xxxxxxxxx, LLP
0000 Xxxxxx Xxxxxx, 00xx Xxxxx
Xxxxxxxxxxxx, XX 00000-0000
Facsimile Number: (000) 000-0000
Notice shall be effective: (i) upon receipt if personally delivered; (ii) on the
third Business Day following the date of mailing if sent by registered or
certified mail; (iii) on the second Business Day following the date of delivery
to the express mail service if sent by express mail; and (iv) on the first
Business Day following the date of transmission or delivery to the overnight
courier if sent by facsimile or overnight courier. A Party may change its
address listed above by sending notice to the other Party.
21.8 Severability. If any provision of this Agreement for any reason shall
be held invalid, illegal or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect any other term or provision
hereof, and this Agreement shall be interpreted and construed as if such term or
provision, to the extent the same shall have been held to be invalid, illegal or
unenforceable, had never been contained herein.
21.9 Interpretation. When a reference is made in this Agreement to Sections
or Schedules, such references shall be to a Section of or Schedule to this
Agreement unless otherwise indicated. The words "include," "includes" and
"including" when used herein shall be deemed in each case to be followed by the
words "without limitation." The table of contents and
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headings contained in this Agreement have been inserted for convenience or
reference only and shall not be relied upon in construing this Agreement. Use of
any gender herein to refer to any person shall be deemed to comprehend
masculine, feminine, and neuter unless the context clearly requires otherwise.
21.10 Amendments. This Agreement may be amended at any time by a written
instrument executed by authorized representatives of both Parties. Any amendment
effective pursuant to this Section 21.10 shall be binding upon Abbott and those
of its Affiliates which are acting or have acted as a distributor hereunder and
Digene and their respective successors and permitted assigns.
21.11 Waiver. No waiver of any of the terms of this Agreement shall be
valid unless in writing and signed by authorized representatives of both
Parties. Failure by either Party to enforce any of its rights under this
Agreement shall not be construed as a waiver of such rights nor shall a waiver
by either Party in one or more instances be construed as constituting a
continuing waiver or as waiver in other instances.
21.12 Survival. Expiration or early termination of this Agreement shall not
relieve either Party of its obligations incurred prior to such expiration or
early termination. The following provisions shall survive expiration or early
termination of this Agreement: Article 1, the last sentence of Section 4.1(b),
the next to last sentence of Sections 4.2(b) and 4.3(b), Sections 4.5 and 6.4,
Article 10, Article 11, Article 13 (except Section 13.3) and Sections 14.1,
14.2, 14.3, 15.7, 16.1, 16.2, 16.3, 17.1, 17.2, 20.7, 21.5 and 21.6.
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21.13 Headings. The captions to the Articles and Sections in this Agreement
are inserted for convenience only and are not a part hereof.
21.14 Counterparts. This Agreement may be executed in two (2) original
counterparts, each of which shall be deemed an original, but both of which
together shall constitute one and the same instrument.
21.15 Mutual Drafting. This Agreement has been jointly drafted by Abbott
and Digene, and each provision hereof has been subject to the mutual
consultation, negotiation and agreement of the Parties and their respective
legal counsel and advisers and any rule of construction that a document shall be
interpreted or construed against the drafting party shall not be applicable.
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IN WITNESS WHEREOF, each Party has caused this Marketing and Distribution
Agreement to be executed on its behalf by its duly authorized officer as of the
Effective Date.
XXXXXX LABORATORIES DIGENE CORPORATION
By: /s/ Xxxxx X. Xxxxxxx By: /s/ Xxxx Xxxxx
-------------------------- --------------------------
Name: Xxxxx X. Xxxxxxx Name: Xxxx Xxxxx
Title: Corporate Vice President Title: President and Chief Executive
Diagnostic Products Officer
Research and Development
Date: May 7, 1999 Date: May 7, 1999
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LIST OF SCHEDULES
SCHEDULE 1.2 AFRICA
SCHEDULE 1.6 BASE SALES
SCHEDULE 1.18 CT/GC NON-U.S. AUP
SCHEDULE 1.19 CT/GC PRODUCTS
SCHEDULE 1.20 CT/GC U.S. AUP
SCHEDULE 1.21 CT/GC SPECIFICATIONS
SCHEDULE 1.25 DIGENE EQUIPMENT
SCHEDULE 1.27 DIGENE TRADEMARKS
SCHEDULE 1.28 DISTRIBUTORS
SCHEDULE 1.29 DISTRIBUTOR TERRITORIES
SCHEDULE 1.30 DISTRIBUTION AGREEMENTS
SCHEDULE 1.33 EUROPE
SCHEDULE 1.38 HBV AUP
SCHEDULE 1.39 HBV PRODUCTS
SCHEDULE 1.40 HBV SPECIFICATIONS
SCHEDULE 1.43 HPV AUP
SCHEDULE 1.44 HPV PRODUCTS
SCHEDULE 1.45 HPV SPECIFICATIONS
SCHEDULE 1.53 MIDDLE EAST
SCHEDULE 1.54 MINIMUM TRANSFER PRICE
SCHEDULE 1.58 NON-PROPRIETARY EQUIPMENT
SCHEDULE 1.60 OTHER PRODUCT SPECIFICATIONS
SCHEDULE 1.62 PATENTS
SCHEDULE 1.64 PRODUCT ACCESSORIES
SCHEDULE 3.6 VALIDATION PROTOCOLS
SCHEDULE 4.1 CT/GC AUTOMATION SPECIFICATIONS
SCHEDULE 6.1(a) PURCHASE PRICE FOR DIGENE EQUIPMENT
SCHEDULE 6.1(b) PURCHASE PRICE FOR EXISTING FIELD EQUIPMENT
SCHEDULE 6.1(c) PURCHASE PRICE FOR NON-PROPRIETARY EQUIPMENT
SCHEDULE 13.2 PRODUCT, OTHER PRODUCT AND EQUIPMENT REPLACEMENT OR
REPAIR
SCHEDULE 20.4 CMV
SCHEDULE 20.5 SHARP
SCHEDULE 20.8(i) FINANCIAL RECONCILIATION
SCHEDULE 21.6 ALTERNATIVE DISPUTE RESOLUTION
107
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.
SCHEDULE 1.2
AFRICA
All countries in the continent of Africa, excluding Algeria, Egypt, Morocco, The
Sudan and Tunisia
(which are to be included in Schedule 1.53)
108
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.
Schedule 1.6
Base Sales
TERRITORY CATEGORY SALES ($)
--------------------------------------------------------------------------------
EUROPE CT/GC [***]
--------------------------------------------------------------------------------
EUROPE HBV [***]
--------------------------------------------------------------------------------
EUROPE HPV [***]
--------------------------------------------------------------------------------
USA CT/GC [***]
--------------------------------------------------------------------------------
TOTAL [***]
--------------------------------------------------------------------------------
109
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.
SCHEDULE 1.18
CT/GC Non-U.S. AUP
DIGENE
ABBOTT CATALOG # CATALOG # DESCRIPTION QUANTITY AUP ($)
----------------------------------------------------------------------------------------------------------------------------------
2F72.01 5100-1400IVT Digene Sample Conversion Kit 100 ml [***]
----------------------------------------------------------------------------------------------------------------------------------
2F73.01 5100-1500IVT Digene Sample Conversion Kit 1 L [***]
----------------------------------------------------------------------------------------------------------------------------------
2F78.01 5130-1015IVT Digene Urine Prep Kit 96 Tests [***]
----------------------------------------------------------------------------------------------------------------------------------
2F79.01 5130-1096IVT Digene CT/GC Test 96 Tests [***]
----------------------------------------------------------------------------------------------------------------------------------
2F80.01 5130-1116IVT Digene CT/GC Test Panel 6 Samples [***]
----------------------------------------------------------------------------------------------------------------------------------
2F81.01 5135-1050IVT Digene CT-ID Test 96 Tests [***]
----------------------------------------------------------------------------------------------------------------------------------
2F82.01 5140-1000IVT Digene GC-ID Test 96 Tests [***]
----------------------------------------------------------------------------------------------------------------------------------
110
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.
Schedule 1.19
CT/GC Products
-------------------------------------------------------------------------------------------------------------------------------
ABBOTT DIGENE
CATALOG # CATALOG # DESCRIPTION QUANTITY
-------------------------------------------------------------------------------------------------------------------------------
2F72.01 5100-1400IVT Digene Sample Conversion Kit 100 ml
-------------------------------------------------------------------------------------------------------------------------------
2F73.01 5100-1500IVT Digene Sample Conversion Kit 1 L
-------------------------------------------------------------------------------------------------------------------------------
2F78.01 5130-1015IVT Digene Urine Prep Kit 96 Tests
-------------------------------------------------------------------------------------------------------------------------------
2F79.01 5130-1096IVT Digene CT/GC Test 96 Tests
-------------------------------------------------------------------------------------------------------------------------------
2F80.01 5130-1116IVT Digene CT/GC Test Panel 6 Samples
-------------------------------------------------------------------------------------------------------------------------------
2F81.01 5135-1050IVT Digene CT-ID Test 96 Tests
-------------------------------------------------------------------------------------------------------------------------------
2F82.01 5140-1000IVT Digene GC-ID Test 96 Tests
-------------------------------------------------------------------------------------------------------------------------------
111
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.
Schedule 1.20
CT/GC U.S. AUP
---------------------------------------------------------------------------------------------------------------------------------
AUP- ($) AUP- ($)
ABBOTT DIGENE AMPLIFIED NON-AMPLIFIED
CATALOG # CATALOG # DESCRIPTION QUANTITY REIMBURSEMENT. REIMBURSEMENT.
---------------------------------------------------------------------------------------------------------------------------------
2F72.01 5100-1400IVT Digene Sample Conversion Kit 100 ml [***] [***]
---------------------------------------------------------------------------------------------------------------------------------
2F73.01 5100-1500IVT Digene Sample Conversion Kit 1 L [***] [***]
---------------------------------------------------------------------------------------------------------------------------------
2F78.01 5130-1015IVT Digene Urine Prep Kit 96 Tests [***] [***]
---------------------------------------------------------------------------------------------------------------------------------
2F79.01 5130-1096IVT Digene CT/GC Test 96 Tests [***] [***]
---------------------------------------------------------------------------------------------------------------------------------
2F80.01 5130-1116IVT Digene CT/GC Test Panel 6 Samples [***] [***]
---------------------------------------------------------------------------------------------------------------------------------
2F81.01 5135-1050IVT Digene CT-ID Test 96 Tests [***] [***]
---------------------------------------------------------------------------------------------------------------------------------
2F82.01 5140-1000IVT Digene GC-ID Test 96 Tests [***] [***]
---------------------------------------------------------------------------------------------------------------------------------
112
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.
Schedule 1.21
CT/GC Specifications
General product description, intended use statement, general performance
characteristics and description of kit components as stated in the relevant
sections of the current, applicable product Package Inserts and Certificates of
Analysis as listed below:
Assay Digene Package Insert Certificate of Analysis
----------------------------------------------------------------------
CT/GC DNA Test L0990 06/97 L1350 12/98
(5130-1096 IVT)
----------------------------------------------------------------------
CT-ID DNA Test L0991 06/97 L1352 12/98
(5135-1050 IVT)
----------------------------------------------------------------------
GC-ID DNA Test L0992 06/97 L1351 12/98
(5140-1000 IVT)
----------------------------------------------------------------------
113
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.
Schedule 1.25
Digene Equipment
-----------------------------------------------------------------------------------------------------------
XXXXXX DIGENE DESCRIPTION QUANTITY
CATALOG # CATALOG #
-----------------------------------------------------------------------------------------------------------
3F62.01 4300-1010 CE DCR-1 Luminometer, 240 Volt (adaptable to 120 Volt) 1 Each
-----------------------------------------------------------------------------------------------------------
3F70.02 5000-1010 DML 2000 Luminometer 120 Volt 1 Each
-----------------------------------------------------------------------------------------------------------
3F70.03 5000-1020 DML 2000 Luminometer 240 Volt 1 Each
-----------------------------------------------------------------------------------------------------------
3F63.01 4300-1020 Rotary Shaker Assembly, 120 Volt 1 Each
-----------------------------------------------------------------------------------------------------------
3F63.02 4300-1025 Rotary Shaker Assembly, 240 Volt 1 Each
-----------------------------------------------------------------------------------------------------------
4F93.02 6000-2110 Rotary Shaker I, 120 Volt 1 Each
-----------------------------------------------------------------------------------------------------------
4F93.01 6000-2240 Rotary Shaker I, 240 Volt 1 Each
-----------------------------------------------------------------------------------------------------------
3F64.01 4300-1030 Rack Holder Shaker (Must be ordered with 4300-1020/1025) 1 Each
-----------------------------------------------------------------------------------------------------------
4F82.02 6000-1110 Microplate Heater I, 120 Volt 1 Each
-----------------------------------------------------------------------------------------------------------
4F82.01 6000-1240 Microplate Heater I, 220 Volt 1 Each
-----------------------------------------------------------------------------------------------------------
TBA 5050-xxxx HPV, CT/GC
-----------------------------------------------------------------------------------------------------------
HIV & HBV Software and Manuals ** 1 Each
-----------------------------------------------------------------------------------------------------------
TBA 5050-1024EN PC System American English* 1 Each
-----------------------------------------------------------------------------------------------------------
4F88.04 5050-1024FR PC System French * 1 Each
-----------------------------------------------------------------------------------------------------------
4F88.05 5050-1024GR PC System German * 1 Each
-----------------------------------------------------------------------------------------------------------
4F88.01 5050-1024IT PC System Italian * 1 Each
-----------------------------------------------------------------------------------------------------------
4F88.02 5050-1024SP PC System Spanish * 1 Each
-----------------------------------------------------------------------------------------------------------
4F88.03 5050-1024UK PC System English UK * 1 Each
-----------------------------------------------------------------------------------------------------------
*Includes: HP Brio CPU, Mouse, Language Specific Keyboard, Preloaded Software
(Language Specific Windows 95/Excel 97)
**Includes: HPV and CT/GC Software and Manuals (product part number 5050-1036
IVT) and HIV and HBV Software and Manuals (product part number 5050-1039 RUO).
114
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.
Schedule 1.27
Digene Trademarks
--------------------------------------------------------------------------------
XXXX REGISTRATION NUMBER REGISTRATION DATE
--------------------------------------------------------------------------------
SHARP SIGNAL 1,929,468 1/24/95
--------------------------------------------------------------------------------
DIGENE 1,958,407 2/27/96
--------------------------------------------------------------------------------
Digene Design Logo 1,958,406 2/27/96
--------------------------------------------------------------------------------
HYBRID CAPTURE 2,029,476 1/14/97
--------------------------------------------------------------------------------
115
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.
Schedule 1.28
Distributors
[*****************]
116
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.
Schedule 1.29
Distributor Territories
[*****]
117
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.
Schedule 1.30
Distribution Agreements
-----------------------------------------------------------------------------------
Company Name Contract Date Territory Product Comments
-----------------------------------------------------------------------------------
[***] [***] [***] [***] [***]
-----------------------------------------------------------------------------------
118
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.
Schedule 1.33
Europe
Albania
Andora
Austria
Baltic Republics: Xxxxxxx, Xxxxxx, Xxxxxxxxx
Xxxxxxx
Xxxxxxx
Xxxxxx
Xxxxxxxx
Commonwealth of Independent States
Croatia
Cyprus
Czech Republic
Denmark
Finland
France
Germany
Greece
Greenland
Hungary
Iceland
Ireland
Italy
Liechtenstein
Luxembourg
119
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.
Schedule 1.33 (cont'd)
Europe
Macedonia
Malta
Moldova
Monaco
Netherlands
Norway
Poland
Portugal
Romania
Russia
San Marino
Serbia
Slovenia
Slovakia
Spain
Sweden
Switzerland
Ukraine
United Kingdom
USSR - all former countries
Vatican City
Yugoslavia
120
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.
Schedule 1.38
HBV AUP
------------------------------------------------------------------------------------------------------------
XXXXXX CATALOG # DIGENE CATALOG # DESCRIPTION QUANTITY AUP ($)
------------------------------------------------------------------------------------------------------------
TBA 6110-1000 RUO Digene HBV Serum Training Panel 12 Samples [***]
------------------------------------------------------------------------------------------------------------
4F41.01 6110-1096 RUO Digene HBV DNA Test (Includes Kit and 96 Tests [***]
Positive Controls)
------------------------------------------------------------------------------------------------------------
4F39.01 6110-1097 RUO Digene HBV DNA Ultra Sensitive Kit 96 Tests [***]
(Includes Positive Controls & Ultra
Sensitive Controls)
------------------------------------------------------------------------------------------------------------
TBA 4402-0477 HBV Detection Reagent (Sent with Each [***]
4402-1060M)
------------------------------------------------------------------------------------------------------------
2F94.01 4402-1006M HBV DNA Test Panel 1 Set [***]
------------------------------------------------------------------------------------------------------------
8E16.01 4402-1060M HBV DNA Assay 60 Tests [***]
------------------------------------------------------------------------------------------------------------
121
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.
Schedule 1.39
HBV Products
----------------------------------------------------------------------------------------------
XXXXXX CATALOG # DIGENE CATALOG # DESCRIPTION QUANTITY
----------------------------------------------------------------------------------------------
TBA 6110-1000 RUO Digene HBV Serum Training Panel 12 Samples
----------------------------------------------------------------------------------------------
4F41.01 6110-1096 RUO Digene HBV DNA Test (Includes Kit and 96 Tests
Positive Controls)
----------------------------------------------------------------------------------------------
4F39.01 6110-1097 RUO Digene HBV DNA Ultra Sensitive Kit 96 Tests
(Includes Positive Controls & Ultra
Sensitive Controls)
----------------------------------------------------------------------------------------------
TBA 4402-0477 HBV Detection Reagent (Sent with Each
4402-1060M)
----------------------------------------------------------------------------------------------
2F94.01 4402-1006M HBV DNA Test Panel 1 Set
----------------------------------------------------------------------------------------------
8E16.01 4402-1060M HBV DNA Assay 60 Tests
----------------------------------------------------------------------------------------------
122
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.
Schedule 1.40
HBV Specifications
General product description, intended use statement, general performance
characteristics and description of kit components as stated in the relevant
sections of the current, applicable product Package Inserts and Certificates of
Analysis as listed below:
--------------------------------------------------------------------------------
Assay Digene Package Insert Certificate of Analysis
--------------------------------------------------------------------------------
HBV DNA Assay L0796 10/97 No reference number
4402-1060M
--------------------------------------------------------------------------------
HBV DNA Test L1183 10/98 L1339 03/99
(6110-1096RUO &
6110-1097RUO)
--------------------------------------------------------------------------------
123
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.
Schedule 1.43
HPV AUP
-----------------------------------------------------------------------------------------------------------
XXXXXX CATALOG# DIGENE CATALOG # DESCRIPTION QUANTITY AUP ($)
-----------------------------------------------------------------------------------------------------------
2F32.01 4401-1024 HPV DNA Test Panel 1 Set [***]
-----------------------------------------------------------------------------------------------------------
8E17.01 4401-1030UP HPV DNA Assay 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F74.01 5101-1024IVT Digene HPV Validation Panel 6 Samples [***]
-----------------------------------------------------------------------------------------------------------
2F75.01 5101-1042IVT HPV Validation Panel 36 Samples [***]
-----------------------------------------------------------------------------------------------------------
2F76.01 5101-1096IVT Digene HPV Test 96 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F33.01 4401-1016 HPV Type 16 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F34.01 4401-1018 HPV Type 18 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F35.01 4401-1031 HPV Type 31 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F36.01 4401-1033 HPV Type 33 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F37.01 4401-1035 HPV Type 35 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F38.01 4401-1042 HPV Type 42 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F39.01 4401-1043 HPV Type 43 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F40.01 4401-1044 HPV Type 44 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F41.01 4401-1045 HPV Type 45 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F42.01 4401-1051 HPV Type 51 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F43.01 4401-1052 HPV Type 52 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F44.01 4401-1056 HPV Type 56 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
2F45.01 4401-1611 HPV Type 6/11 60 Tests [***]
-----------------------------------------------------------------------------------------------------------
124
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.
Schedule 1.44
HPV Products
-----------------------------------------------------------------------------------------
XXXXXX CATALOG# DIGENE CATALOG # DESCRIPTION QUANTITY
-----------------------------------------------------------------------------------------
2F32.01 4401-1024 HPV DNA Test Panel 1 Set
-----------------------------------------------------------------------------------------
8E17.01 4401-1030UP HPV DNA Assay 60 Tests
-----------------------------------------------------------------------------------------
2F74.01 5101-1024IVT Digene HPV Validation Panel 6 Samples
-----------------------------------------------------------------------------------------
2F75.01 5101-1042IVT HPV Validation Panel 36 Samples
-----------------------------------------------------------------------------------------
2F76.01 5101-1096IVT Digene HPV Test 96 Tests
-----------------------------------------------------------------------------------------
2F33.01 4401-1016 HPV Type 16 60 Tests
-----------------------------------------------------------------------------------------
2F34.01 4401-1018 HPV Type 18 60 Tests
-----------------------------------------------------------------------------------------
2F35.01 4401-1031 HPV Type 31 60 Tests
-----------------------------------------------------------------------------------------
2F36.01 4401-1033 HPV Type 33 60 Tests
-----------------------------------------------------------------------------------------
2F37.01 4401-1035 HPV Type 35 60 Tests
-----------------------------------------------------------------------------------------
2F38.01 4401-1042 HPV Type 42 60 Tests
-----------------------------------------------------------------------------------------
2F39.01 4401-1043 HPV Type 43 60 Tests
-----------------------------------------------------------------------------------------
2F40.01 4401-1044 HPV Type 44 60 Tests
-----------------------------------------------------------------------------------------
2F41.01 4401-1045 HPV Type 45 60 Tests
-----------------------------------------------------------------------------------------
2F42.01 4401-1051 HPV Type 51 60 Tests
-----------------------------------------------------------------------------------------
2F43.01 4401-1052 HPV Type 52 60 Tests
-----------------------------------------------------------------------------------------
2F44.01 4401-1056 HPV Type 56 60 Tests
-----------------------------------------------------------------------------------------
2F45.01 4401-1611 HPV Type 6/11 60 Tests
-----------------------------------------------------------------------------------------
125
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.
Schedule 1.45
HPV Specifications
General product description, intended use statement, general performance
characteristics and description of kit components as stated in the relevant
sections of the current, applicable product Package Inserts and Certificates of
Analysis as listed below:
--------------------------------------------------------------------------------
Assay Digene Package Insert Certificate of Analysis
--------------------------------------------------------------------------------
HPV DNA Assay L0890 09/97 L1775
4401-1030
--------------------------------------------------------------------------------
HPV DNA Test L0893 06/97 L1460 12/98
(5101-1096)
--------------------------------------------------------------------------------
126
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.
Schedule 1.53
Middle East
Afghanistan
Algeria
Egypt
Iran
Iraq
Xxxxxx
Xxxxxx
Kuwait
Lebanon
Morocco
Oman
Qatar
Saudi Arabia
Syria
The Sudan
Tunisa
Turkey/Kurdistan
United Arab Emirates (UAE)
127
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.
Schedule 1.54
Minimum Transfer Price
--------------------------------------------------------------------------
Product Type Minimum Transfer Price
--------------------------------------------------------------------------
CT/GC [***]
[***]
[***]
--------------------------------------------------------------------------
HBV [***]
[***]
[***]
--------------------------------------------------------------------------
HPV [***]
[***]
[***]
--------------------------------------------------------------------------
*[************************************************************************
*****************************************************************************].
**Notwithstanding the calculation of the Minimum Transfer Price [*******
********] in no event shall the Minimum Transfer Price for any such Product be
greater than [********] of the actual transfer price of such Product at the
time of its first sale to Xxxxxx hereunder adjusted for changes in the PPI for
in vitro diagnostic substances-clinical chemistry products-standards and
controls (Code 2835-115), as quoted by the U.S. Department of Labor, Bureau of
Labor Statistics (or any successor agency or index), from the PPI published
most recently prior to such first sale to the PPI published most recently prior
to the date of the sale of such Product to which the Minimum Transfer Price is
applicable.
128
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.
Schedule 1.58
Non-proprietary Equipment
--------------------------------------------------------------------------------------------------
XXXXXX CATALOG # DIGENE CATALOG # DESCRIPTION QUANTITY
--------------------------------------------------------------------------------------------------
TBA 5050-1015 PC Monitor 1 Each
--------------------------------------------------------------------------------------------------
TBA 5050-1028A Inkjet Printer (Epson Stylus 640) 1 Each
--------------------------------------------------------------------------------------------------
XXX 0000-0000 Printer Cable 1 Each
--------------------------------------------------------------------------------------------------
TBA 4300-1013 DCR-1 Well Liner Assembly 1 Each
--------------------------------------------------------------------------------------------------
TBA 4301-1002 Decanting Racks 2/Pack
--------------------------------------------------------------------------------------------------
XXX 0000-0000 Specimen Tube Rack 1 Rack
--------------------------------------------------------------------------------------------------
TBA 4301-1012 DCR-1 Printer Paper 5 Rolls
--------------------------------------------------------------------------------------------------
TBA 4301-1500 Disposable Transfer Pipettes 500/Pack
--------------------------------------------------------------------------------------------------
2F84.01 4400-0296 Wash Buffer Pack 1 Pack
--------------------------------------------------------------------------------------------------
2F30.01 4400-1000 Luminometer Validation Reagents 1 Set
--------------------------------------------------------------------------------------------------
2F85.01 4500-1005 Sample Digestion Reagent 4 ml
--------------------------------------------------------------------------------------------------
3F73.01 5030-1010 Wash Apparatus 1 Unit
--------------------------------------------------------------------------------------------------
3F93.01 P0076 Hybridization Tube Caps, Green 1000/Bag
--------------------------------------------------------------------------------------------------
3F94.01 P0077 Hybridization Tube Caps, Red 1000/Bag
--------------------------------------------------------------------------------------------------
3F71.01 5015-1010 Specimen Collection Tube Rack 1 Each
--------------------------------------------------------------------------------------------------
3F72.01 5025-1010 EXPAND-4 Pipettor (includes Power Supply) 1 Each
--------------------------------------------------------------------------------------------------
3F72.02 5025-1015 EXPAND-4 Pipettor Stand 1 Each
--------------------------------------------------------------------------------------------------
3F72.04 5025-1021 Power Supply (Included with 5025-1010) 1 Each
--------------------------------------------------------------------------------------------------
3F75.01 5060-1001 MicroTubes 960/Pack
--------------------------------------------------------------------------------------------------
3F75.02 5065-1010 MicroTube Rack 1 Each
--------------------------------------------------------------------------------------------------
4F81.01 5070-1010 Plate Sealers 100/Pack
--------------------------------------------------------------------------------------------------
4F61.01 5075-1011 Extra Long Pipette Tips 720/Case
--------------------------------------------------------------------------------------------------
4F89.01 5080-1000 Screw Caps 1000/Bag
--------------------------------------------------------------------------------------------------
4F85.01 5090-1010 Disposable Reagent Reservoirs 100/Case
--------------------------------------------------------------------------------------------------
TBA 5100-0393 Wash Buffer (30x) 100 ml
--------------------------------------------------------------------------------------------------
4F87.01 5061-1001 1.5 ml Specimen Preparation Tubes with O-Ring 1000/Case
Screw Caps
--------------------------------------------------------------------------------------------------
4F86.01 5076-1011 Thin Tip Transfer Pipettes 2000/Case
--------------------------------------------------------------------------------------------------
4F81.02 6000-0319 HBV Plate Sealers 100/Box
--------------------------------------------------------------------------------------------------
4F79.01 6000-0904 HBV Absorbent Blotting Pad 3000/Case
--------------------------------------------------------------------------------------------------
4F80.01 6000-1203 HBV Hybridization Microplates 100/Box
--------------------------------------------------------------------------------------------------
129
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.
Schedule 1.60
Other Product Specifications
CMV
General product description, intended use statement, general performance
characteristics and description of kit components as stated in the relevant
sections of the current, applicable product Package Inserts and Certificates of
Analysis as listed below:
--------------------------------------------------------------------------------
Assay Digene Package Insert Certificate of Analysis
--------------------------------------------------------------------------------
CMV DNA Assay L0863 09/98 No reference number
(4403-2005, Murex
DP35)
--------------------------------------------------------------------------------
SHARP Specifications
SHARP Signal Assay (Digene Catalog No. 4600-1192 and Package Insert L0575
04/98)
Digene Internal QC Criteria:
When tested with a master Positive Control and RNA Probe, the absorbance at 450
nm should be greater than or equal to 0.60 after one hour substrate incubation.
Customer Criteria:
When tested with the Postive Control and RNA Probe from any Probe/Primer Kit,
the absorbance at 450 nm should be greater than or equal to 0.40 after one hour
substrate incubation.
SHARP Probe/Primer Kits
Digene Internal QC Criteria:
When the Postive Control and RNA Probe are tested with the SHARP Signal
Detection Kit, the absorbance at 450 nm should be greater than or equal to 0.60
after one hour substrate incubation.
Customer Criteria:
When the Positive Control and RNA Probe are tested with the SHARP Signal
Detection Kit, the absorbance at 450 nm should be greater than or equal to 0.40
after one hour substrate incubation.
130
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.
Schedule 1.62
Patents
------------------------------------------------------------------------------------------------
Application Filed Patent Issued Title Country
------------------------------------------------------------------------------------------------
[***] [***] [***] [****] [***] [***]
------------------------------------------------------------------------------------------------
131
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.
Schedule 1.64
Product Accessories
--------------------------------------------------------------------------------------------------------------
XXXXXX CATALOG # DIGENE CATALOG # DESCRIPTION QUANTITY COST ($)
--------------------------------------------------------------------------------------------------------------
2F71.01 5100-1050IVT Digene Cervical Sampler 50/Box [***]
--------------------------------------------------------------------------------------------------------------
8E33.01 4203-0020 Specimen Collection Kit 20 Kits, 1 Box [***]
--------------------------------------------------------------------------------------------------------------
2F29.01 4203-1030 STM 30 ml [***]
--------------------------------------------------------------------------------------------------------------
TBA 4203-1030S STM 1L [***]
--------------------------------------------------------------------------------------------------------------
132
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.
Schedule 3.6
Validation Protocols
Validation protocols will be as described in each Product, Other Product and
Equipment package insert.
133
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.
Schedule 4.1
CT/GC Automation Specifications
---------------------------------------------------------------------
Specification System Requirement
---------------------------------------------------------------------
[***] [***]
---------------------------------------------------------------------
134
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.
Schedule 4.1 (cont'd)
CT/GC Automation Specifications
---------------------------------------------------------------------
Specification System Requirement [***]
---------------------------------------------------------------------
---------------------------------------------------------------------
135
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.
SCHEDULE 6.1(a)
PURCHASE PRICE FOR DIGENE EQUIPMENT
----------------------------------------------------------------------------------------------------------------------
XXXXXX CATALOG # DIGENE CATALOG # DESCRIPTION QUANTITY COST ($)*
----------------------------------------------------------------------------------------------------------------------
3F62.01 4300-1010 CE DCR-1 LUMINOMETER, 240 VOLT (ADAPTABLE TO 1 EACH [***]
120 VOLT)
----------------------------------------------------------------------------------------------------------------------
3F70.02 5000-1010 DML 2000 Luminometer 120 Volt 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
3F70.03 5000-1020 DML 2000 Luminometer 240 Volt 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
3F63.01 4300-1020 Rotary Shaker Assembly, 120 Volt *** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
3F63.02 4300-1025 Rotary Shaker Assembly, 240 Volt *** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F93.02 6000-2110 Rotary Shaker I, 120 Volt *** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F93.02 6000-2110 Rotary Shaker I, 120 Volt *** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F93.01 6000-2240 Rotary Shaker I, 240 Volt *** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
TBA 4300-1030 Rack Holder Rotary Shaker (Must be ordered 1 Each [***]
with 4300-1020/1025)
----------------------------------------------------------------------------------------------------------------------
4F82.02 6000-1110 Microplate Heater I, 120 Volt *** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F82.01 6000-1240 Microplate Heater I, 220 Volt *** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
TBA 5050-xxxx HPV, CT/GC, HIV & HBV Software and Manuals 1 Each [***]
****
----------------------------------------------------------------------------------------------------------------------
TBA 5050-1024EN PC System American English** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F88.04 5050-1024FR PC System French ** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F88.05 5050-1024GR PC System German ** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F88.01 5050-1024IT PC System Italian ** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F88.02 5050-1024SP PC System Spanish ** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
4F88.03 5050-1024UK PC System English UK ** 1 Each [***]
----------------------------------------------------------------------------------------------------------------------
* All prices set forth in this column represent [***] Effective Date. All
purchases of Digene Equipment shall be either at [***], or with respect
to the items identified with ***, at [********]
**Includes: HP Brio CPU, Mouse, Language Specific Keyboard, Preloaded Software
(Language Specific Windows 95/Excel 97)
*** Price is [*******]
**** 5050-xxxx includes HPV and CT/GC Software and Manuals (product part number
5050-1036 IVT) and HIV and HBV Software and Manuals (product part number
5050-1039 RUO).
136
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.
Schedule 6.1(b)
Purchase Price for Existing Field Equipment
-------------------------------------------------------------------------
Description Data Grand Total
-------------------------------------------------------------------------
CABLE Price Ea [***]
---------------------------------------------------------
Quantity [***]
---------------------------------------------------------
Ext Price [***]
---------------------------------------------------------
Depreciation [***]
---------------------------------------------------------
Net Price [***]
-------------------------------------------------------------------------
DCR-1 Price Ea [***]
---------------------------------------------------------
Quantity [***]
---------------------------------------------------------
Ext Price [***]
---------------------------------------------------------
Depreciation [***]
---------------------------------------------------------
Net Price [***]
-------------------------------------------------------------------------
DML Price Ea [***]
---------------------------------------------------------
Quantity [***]
---------------------------------------------------------
Ext Price [***]
---------------------------------------------------------
Depreciation [***]
---------------------------------------------------------
Net Price [***]
-------------------------------------------------------------------------
MONITOR Price Ea [***]
---------------------------------------------------------
Quantity [***]
---------------------------------------------------------
Ext Price [***]
---------------------------------------------------------
Depreciation [***]
---------------------------------------------------------
Net Price [***]
-------------------------------------------------------------------------
PC Price Ea [***]
---------------------------------------------------------
Quantity [***]
---------------------------------------------------------
Ext Price [***]
---------------------------------------------------------
Depreciation [***]
---------------------------------------------------------
Net Price [***]
-------------------------------------------------------------------------
PIPETTOR Price Ea [***]
---------------------------------------------------------
Quantity [***]
---------------------------------------------------------
Ext Price [***]
---------------------------------------------------------
Depreciation [***]
---------------------------------------------------------
Net Price [***]
-------------------------------------------------------------------------
PRINTER Price Ea [***]
---------------------------------------------------------
Quantity [***]
---------------------------------------------------------
Ext Price [***]
---------------------------------------------------------
Depreciation [***]
---------------------------------------------------------
Net Price [***]
-------------------------------------------------------------------------
137
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.
Schedule 6.1(b) (con't)
Purchase Price for Existing Field Equipment
-----------------------------------------------------------------------------------
SHAKER Price Ea [***]
-----------------------------------------------------------
Quantity [***]
-----------------------------------------------------------
Ext Price [***]
-----------------------------------------------------------
Depreciation [***]
-----------------------------------------------------------
Net Price [***]
-----------------------------------------------------------------------------------
SOFTWARE Price Ea [***]
-----------------------------------------------------------
Quantity [***]
-----------------------------------------------------------
Ext Price [***]
-----------------------------------------------------------
Depreciation [***]
-----------------------------------------------------------
Net Price [***]
-----------------------------------------------------------------------------------
Total Ext Price [***]
-----------------------------------------------------------------------------------
Total Depreciation [***]
-----------------------------------------------------------------------------------
Total Net Price [***]
-----------------------------------------------------------------------------------
138
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.
Schedule 6.1(c)
Purchase Price for Non-proprietary Equipment
-----------------------------------------------------------------------------------------------------------------
XXXXXX CATALOG # DIGENE CATALOG # DESCRIPTION QUANTITY COST ($)
-----------------------------------------------------------------------------------------------------------------
TBA 5050-1015 PC Monitor 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
TBA 5050-1028A Inkjet Printer (Epson Stylus 640) 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
TBA 5050-1019 Printer Cable 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
TBA 4300-1013 DCR-1 Well Liner Assembly 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
TBA 4301-1002 Decanting Racks 2/Pack [***]
-----------------------------------------------------------------------------------------------------------------
TBA 4301-1003 Specimen Tube Rack 1 Rack [***]
-----------------------------------------------------------------------------------------------------------------
TBA 4301-1012 DCR-1 Printer Paper 5 Rolls [***]
-----------------------------------------------------------------------------------------------------------------
TBA 4301-1500 Disposable Transfer Pipettes 500/Pack [***]
-----------------------------------------------------------------------------------------------------------------
2F84.01 4400-0296 Wash Buffer Pack 1 Pack [***]
-----------------------------------------------------------------------------------------------------------------
2F30.01 4400-1000 Luminometer Validation Reagents 1 Set [***]
-----------------------------------------------------------------------------------------------------------------
2F85.01 4500-1005 Sample Digestion Reagent 4 ml [***]
-----------------------------------------------------------------------------------------------------------------
3F73.01 5030-1010 Wash Apparatus 1 Unit [***]
-----------------------------------------------------------------------------------------------------------------
3F93.01 P0076 Hybridization Tube Caps, Green 1000/Bag [***]
-----------------------------------------------------------------------------------------------------------------
3F94.01 P0077 Hybridization Tube Caps, Red 1000/Bag [***]
-----------------------------------------------------------------------------------------------------------------
3F71.01 5015-1010 Specimen Collection Tube Rack 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
3F72.01 5025-1010 EXPAND-4 Pipettor (includes Power Supply) 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
3F72.02 5025-1015 EXPAND-4 Pipettor Stand 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
3F72.04 5025-1021 Power Supply (Included with 5025-1010) 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
3F75.01 5060-1001 MicroTubes 960/Pack [***]
-----------------------------------------------------------------------------------------------------------------
3F75.02 5065-1010 MicroTube Rack 1 Each [***]
-----------------------------------------------------------------------------------------------------------------
4F81.01 5070-1010 Plate Sealers 100/Pack [***]
-----------------------------------------------------------------------------------------------------------------
4F61.01 5075-1011 Extra Long Pipette Tips 720/Case [***]
-----------------------------------------------------------------------------------------------------------------
4F89.01 5080-1000 Screw Caps 1000/Bag [***]
-----------------------------------------------------------------------------------------------------------------
4F85.01 5090-1010 Disposable Reagent Reservoirs 100/Case [***]
-----------------------------------------------------------------------------------------------------------------
TBA 5100-0393 Wash Buffer (30x) 100 ml [***]
-----------------------------------------------------------------------------------------------------------------
4F87.01 5061-1001 1.5 ml Specimen Preparation Tubes with O-Ring 1000/Case [***]
Screw Caps
-----------------------------------------------------------------------------------------------------------------
4F86.01 5076-1011 Thin Tip Transfer Pipettes 2000/Case [***]
-----------------------------------------------------------------------------------------------------------------
4F81.02 6000-0319 HBV Plate Sealers 100/Box [***]
-----------------------------------------------------------------------------------------------------------------
4F79.01 6000-0904 HBV Absorbent Blotting Pad 3000/Case [***]
-----------------------------------------------------------------------------------------------------------------
4F80.01 6000-1203 HBV Hybridization Microplates 100/Box [***]
-----------------------------------------------------------------------------------------------------------------
Schedule 13.2
PRODUCT, OTHER PRODUCT AND EQUIPMENT REPLACEMENT OR REPAIR
If Xxxxxx believes that a Product, Other Product or Equipment is a
Defective Product it shall so notify Digene in writing within sixty (60) days
of discovering the existence of such defect. Xxxxxx shall use commercially
reasonable efforts to provide to Digene a written report detailing the area(s)
of non-conformance within forty-five (45) days after providing Digene with the
initial notification. The Parties shall mutually determine if such Product,
Other Product or Equipment is a Defective Product and, if so, shall mutually
determine a time frame in which the Defective
139
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.
Product shall be either disposed of appropriately or packaged in accordance
with the appropriate international, national, state and local regulations for
return to Digene. Digene shall arrange for a shipping agent to collect, handle
and ship the Defective Product to a destination of Digene's choice and at
Digene's sole expense. Such collection shall occur during Xxxxxx'x normal
business hours.
140
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.
Schedule 20.4
CMV
---------------------------------------------------------------------------------------------------------
XXXXXX CATALOG # DIGENE CATALOG # DESCRIPTION QUANTITY COST ($)
---------------------------------------------------------------------------------------------------------
2F93.01 4400-0333 CMV Lysis Buffer 100 ml [***]
---------------------------------------------------------------------------------------------------------
8E19.01 4403-2005 CMV DNA Assay (Murex label) 60 Tests [***]
---------------------------------------------------------------------------------------------------------
2F92.01 4403-2006 CMV DNA Test Panel 1 Set [***]
---------------------------------------------------------------------------------------------------------
141
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Schedule 20.5
SHARP
----------------------------------------------------------------------------------------------------------------
XXXXXX CATALOG # DIGENE CATALOG # DESCRIPTION QUANTITY COST ($)
----------------------------------------------------------------------------------------------------------------
8E18.01 4600-1192 Sharp Signal System Assay 192 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F46.01 4600-1511 HBV Positive Control DNA 100 Microliters [***]
----------------------------------------------------------------------------------------------------------------
[***]
----------------------------------------------------------------------------------------------------------------
2F49.01 4600-1514 HIV Positive Control DNA 100 Microliters [***]
----------------------------------------------------------------------------------------------------------------
2F50.01 4600-1515 CMV Positive Control DNA 100 Microliters [***]
----------------------------------------------------------------------------------------------------------------
2F51.01 4600-1516 Mtb Positive Control DNA 100 Microliters [***]
----------------------------------------------------------------------------------------------------------------
2F86.01 4601-1100 HBV Probe Primer Set 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F54.01 4603-1100 HPV Probe Primer Set 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F88.01 4604-1145 HIV SK145/150 Probe Primer Set 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F87.01 4604-1380 HIV SK38/39 Probe Primer Set 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F89.01 4605-1100 CMV Probe Primer Set 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F56.01 4605-1101 Cytomegalovirus (CMV) 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F58.01 4606-1100 Mycobacterium TB 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F59.01 4607-1100 Herpes Simplex Virus 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F60.01 4608-1100 Varicella Zoster Virus 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F61.01 4609-1100 Human Herpes Virus 6 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F62.01 4610-1100 Xxxxxxx Xxxx Virus 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F63.01 4611-1100 Parvovirus B19 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F64.01 4620-1100 Borrelia burgdorderi, flagellin 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F65.01 4620-1101 Borrelia burgdorderi, OspA 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F66.01 4621-1100 Chlamydia Trachomatis 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F67.01 4630-1000 Toxoplasma gondii 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F67.01 4631-1100 Plasmodium flaciparum 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F69.01 4632-1100 Plasmodium vivax 210 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
2F70.01 4632-1101 Plasmodium vivax 247 100 Tests [***]
----------------------------------------------------------------------------------------------------------------
142
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.
Schedule 20.8(i)
Financial Reconciliation
Amounts due to (from) Digene as of March 31, 1999
Billed to Amount (USD)
--------- --------------
[******] $ [***]
Adjustments
-----------
Note offsets (9/30/98 & [***]
12/31/98)
Price adjustment on open equipment invoices [***]
----------------
Net amount due to Digene $ [***]
================
143
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.
Schedule 21.6
Alternative Dispute Resolution
The Parties recognize that a bona fide dispute as to certain matters may
arise from time to time during the term of this Agreement which relates to
either Party's rights and/or obligations. The terms of this Schedule 21.6 set
forth the procedures to be used in the alternative dispute resolution ("ADR")
process for resolving disputes between the Parties.
A Party initiating the ADR must first send written notice of the dispute to
the other Party for attempted resolution by good faith negotiation between their
respective presidents (or their equivalents) of the affected subsidiaries,
divisions, or business units within twenty-eight (28) days after such notice is
received (all references to "days" in this ADR provision are to calendar days).
If the matter is not resolved within such twenty-eight (28) day period, or
if the Parties fail to meet within such twenty-eight (28) day period, either
Party may initiate an ADR proceeding as provided herein. The Parties shall have
the right to be represented by counsel in such a proceeding.
22. To begin the ADR proceeding, a Party shall provide written notice (the
"ADR Notice") to the other Party of the issues to be resolved by ADR.
Within fourteen (14) days after its receipt of the ADR Notice, the other
Party may, by written notice to the Party providing the ADR Notice, add
additional issues to be resolved within the same ADR proceeding.
23. Within twenty-one (21) days following receipt of the ADR Notice, the
Parties shall select a mutually acceptable neutral individual to preside in
the resolution of any disputes in the ADR proceeding. If the Parties are
unable to agree on a mutually acceptable neutral within such period, either
Party may request the President of the CPR Institute for Dispute Resolution
("CPR"), 000 Xxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, to
select a neutral pursuant to the following procedures:
(a) The CPR shall submit to the Parties a list of not less than five
(5) candidates within fourteen (14) days after receipt of the request,
along with a Curriculum Vitae for each candidate. Each candidate shall
be independent and shall not be an employee, director or holder of one
percent (1%) or more of the outstanding equity securities of either
Party or any of their subsidiaries or affiliates or of any entity with
which either Party has a contractual or business relationship.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her
impartiality.
(c) Each Party shall number the candidates in order of preference
(with the number one (1) signifying the greatest preference and shall
deliver the list to the CPR within seven (7) days following receipt of
the list of candidates. If a Party believes a conflict of interest
exists regarding any of the candidates, that Party shall provide a
written explanation of the conflict to the CPR along with its list
showing its order of preference for the candidates. Any Party failing
to return a list of preferences on time shall be deemed to have no
order of preference.
(d) If the Parties collectively have identified fewer than three (3)
candidates deemed to have conflicts, the CPR immediately shall
designate as the neutral the candidate for whom the Parties
collectively have indicated the greatest preference. If a tie should
result between two candidates, the CPR may designate either candidate.
If the Parties collectively have identified three (3) or more
candidates deemed to have conflicts, the CPR shall review the
explanations regarding the conflicts and, it its sole discretion, may
either (i) immediately designate as the neutral the candidate for whom
the Parties collectively have indicated the greatest preference, or
(ii) issue a new list of not less than five (5) candidates, in which
case the procedures set forth in subparagraphs 2(a)-2(d) shall be
repeated until the neutral is selected.
24. No earlier than twenty-eight (28) days or later than fifty-six (56)
days after selection, the neutral shall hold a hearing to resolve each of
the issues identified by the Parties. The ADR proceeding shall take place
at a location agreed upon by the Parties. If the Parties cannot agree, the
neutral shall designate a location other than the principal place of
business of either Party or any of their subsidiaries or affiliates.
25. At least seven (7) days prior to the hearing, each Party shall submit,
in written form, the following to the other Party and the neutral:
(a) a copy of all exhibits on which such Party intends to rely in any
oral or written presentation to the neutral;
144
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.
(b) a list of any witnesses such Party intends to call at the
hearing, and a short summary of the anticipated testimony of each
witness;
(c) a proposed ruling on each issue to be resolved, together with a
request for a specific damage award or other remedy for each issue.
The proposed rulings and remedies shall not contain any recitation of
the facts or any legal arguments and shall not exceed one (1) page per
issue.
(d) a brief in support of such Party's proposed rulings and remedies,
provided that the brief shall not exceed twenty (20) pages. This page
limitation shall apply regardless of the number of issues raised in
the ADR proceeding.
Except as expressly set forth in subparagraphs 4(a) - 4(d), no discovery
shall be required or permitted by any means, including depositions,
interrogatories, requests for admissions, or production of documents.
26. The hearing shall be conducted on two (2) consecutive days and shall
be governed by the following rules:
(a) The hearing may be attended by one representative of each Party,
each Party's expert witnesses, if any, counsel and the neutral.
(b) Video conferencing shall be permissible at the discretion of the
neutral.
(c) Each Party shall be entitled to five (5) hours of hearing time to
present its case. The neutral shall determine whether each Party has
had the five (5) hours to which it is entitled.
(d) Each Party shall be entitled, but not required, to make an
opening statement, to present regular and rebuttal testimony,
documents or other evidence, to cross-examine witnesses, and to make a
closing argument. Cross-examination of witnesses shall occur
immediately after their direct testimony, and cross-examination time
shall be charged against the Party conducting the cross-examination.
(e) The Party initiating the ADR shall begin the hearing and, if it
chooses to make an opening statement, shall address not only issues it
raised but also any issues raised by the responding Party. The
responding Party, if it chooses to make an opening statement, also
shall address all issues raised in the ADR. Thereafter, the
presentation of regular and rebuttal testimony and documents, other
evidence, and closing arguments shall proceed in the same sequence.
(f) Except when testifying, witnesses, other than the Party
representatives and any expert witnesses, shall be excluded from the
hearing until closing arguments.
(g) Settlement negotiations, including any statements made therein,
shall not be admissible under any circumstances. Affidavits prepared
for purposes of the ADR hearing shall be admissible at the discretion
of the neutral, provided the affiant is available for purposes of
cross-examination. As to all other matters, the neutral shall have
sole discretion regarding the admissibility of any evidence.
27. Within seven (7) days following completion of the hearing, each Party
may submit to the other Party and the neutral a post-hearing brief in
support of its proposed rulings and remedies, provided that such brief
shall not contain or discuss any new evidence and shall not exceed ten (10)
pages. This page limitation shall apply regardless of the number of issues
raised in the ADR proceeding.
28. The neutral shall rule on each disputed issue within fourteen (14)
days following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the parties on each
disputed issue but may adopt one party's proposed rulings and remedies on
some issues and the other party's proposed rulings and remedies on other
issues. The neutral shall not issue any written opinion or otherwise
explain the basis of the ruling.
29. The neutral shall be paid a reasonable fee plus expenses. These fees
and expenses, along with the reasonable legal fees and expenses of the
prevailing Party (including all expert witness fees and expenses), the fees
and expenses of a court reporter, and any expenses for a hearing room,
shall be paid as follows:
(a) If the neutral rules in favor of one Party on all disputed issues
in the ADR, the losing Party shall pay 100% of such fees and expenses.
(b) If the neutral rules in favor of one Party on some issues and in
favor of the other Party on other issues, the neutral shall issue with
the rulings a written determination as to how such fees and expenses
shall be allocated between the Parties. The neutral shall allocate
fees and expenses in a way that bears a reasonable relationship to the
outcome
145
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.
of the ADR, with the Party prevailing on more issues, or on issues of
greater value or gravity, recovering a relatively larger share of its
legal fees and expenses.
30. The rulings of the neutral and the allocation of fees and expenses
shall be binding, non-reviewable, and non-appealable, and may be entered as
a final judgment in any court having jurisdiction.
31. Except as provided in paragraph 9 or as required by law, the existence
of the dispute, any settlement negotiations, the ADR hearing, any
submissions (including exhibits, testimony, proposed rulings, and briefs),
and the rulings shall be deemed Confidential Information, although the
rulings may be introduced in any subsequent ADR hearing relating to this
Agreement. The neutral shall have the authority to impose sanctions for
unauthorized disclosure of Confidential Information.
