EXHIBIT 10.29
CONFIDENTIAL
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DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
BY AND BETWEEN
THIRD WAVE TECHNOLOGIES, INC.
AND
ACLARA BIOSCIENCES, INC.
DATED OCTOBER 24, 2001
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Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [ * ]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
CONFIDENTIAL
TABLE OF CONTENTS
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ARTICLE 1 DEFINITIONS2
1.1. "ACLARA COMPONENT" ..................................... 2
1.2. "ACLARA MARKS" ......................................... 2
1.3. "ACLARA PARTNER" ....................................... 2
1.4. "ACLARA TECHNOLOGY" .................................... 2
1.5. "AFFILIATE" ............................................ 2
1.6. "APPROVED PRODUCT" ..................................... 3
1.7. "[ * ] INSTRUMENT" ..................................... 3
1.8. "CLEAVASE ENZYME" ...................................... 3
1.9. "COLLABORATION PRODUCT" ................................ 3
1.10. "COMMERCIAL LAUNCH" .................................... 3
1.11. "COMMERCIALIZATION COSTS" .............................. 3
1.12. "COMMERCIALIZING PARTY" ................................ 4
1.13. "COMMERCIALIZATION PLAN AND BUDGET" .................... 4
1.14. "COMMERCIALIZATION TEAM LEADER" ........................ 4
1.15. "CONTROLLED AFFILIATE" ................................. 4
1.16. "COVER" ................................................ 4
1.17. "CUSTOMER" ............................................. 4
1.18. "DEVELOPMENT COMMITTEE" ................................ 4
1.19. "DEVELOPMENT COSTS" .................................... 4
1.20. "DEVELOPMENT PERSONNEL" ................................ 4
1.21. "DEVELOPMENT PLAN AND BUDGET" .......................... 4
1.22. "DEVELOPMENT PROGRAM" .................................. 5
1.23. "DEVELOPMENT RATE" ..................................... 5
1.24. "DEVELOPMENT TERM" ..................................... 5
1.25. [ * ] .................................................. 5
1.26. "EARLY ACCESS PROGRAM" ................................. 5
1.27. "ETAG PRODUCT" ......................................... 5
1.28. "ETAG SIGNAL PROBE" .................................... 5
1.29. "EXCLUSIVE CONTROL" .................................... 5
1.30. "EXCLUSIVE TARGET ROYALTY" ............................. 5
1.31. "FIELD" ................................................ 5
1.32. "FINANCE SUB-COMMITTEE" ................................ 6
1.33. "FTE" OR "FULL-TIME EQUIVALENT" ........................ 6
1.34. "GAAP" ................................................. 6
1.35. "GENOTYPING APPLICATIONS" .............................. 6
1.36. "INTELLECTUAL PROPERTY RIGHTS" ......................... 6
1.37. "INTELLECTUAL PROPERTY SUB-COMMITTEE" .................. 6
1.38. "INVADER PROBE" ........................................ 6
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1.39. "INVADER REACTION" ..................................... 6
1.40. "JOINT DISTRIBUTOR" .................................... 6
1.41. "JOINT MARK" ........................................... 6
1.42. "JOINT PRODUCT FORECAST" ............................... 7
1.43. "JOINT STEERING COMMITTEE" ............................. 7
1.44. "LICENSABLE" ........................................... 7
1.45. "MANUFACTURING COSTS" .................................. 7
1.46. "MANUFACTURING PARTY" .................................. 7
1.47. "MARKETING DISTRIBUTOR" ................................ 8
1.48. [ * ] .................................................. 8
1.49. "MILESTONE" ............................................ 8
1.50. "MULTI-TARGET ANALYSIS" ................................ 8
1.51. "MULTI-TARGET ETAG PROBE SET" .......................... 8
1.52. "NET SALES" ............................................ 8
1.53. "NON-COMMERCIALIZING PARTY" ............................ 9
1.54. "NON-EXCLUSIVE CONTROL" ................................ 9
1.55. "NON-EXCLUSIVE TARGET ROYALTY" ......................... 9
1.56. "NON-HYBRIDIZING REGION" ............................... 9
1.57. "PATENT RIGHTS" ........................................ 9
1.58. "PRIMARY PROBE" ........................................ 9
1.59. "PROJECT LEADER" ....................................... 10
1.60. "PROPRIETARY TARGET ROYALTY" ........................... 10
1.61. [ * ] .................................................. 10
1.62. "SALES GOAL" ........................................... 10
1.63. "SOFTWARE" ............................................. 10
1.64. "SPECIFICATIONS" ....................................... 10
1.65. "TARGET" ............................................... 11
1.66. "TARGET FEES" .......................................... 11
1.67. "TECHNOLOGY" ........................................... 11
1.68. "TWT TECHNOLOGY" ....................................... 11
1.69. "TWT MARKS" ............................................ 11
1.70. "VALID CLAIM" .......................................... 11
ARTICLE 2 DEVELOPMENT PROCEDURES ......................................... 12
2.1. PROJECT LEADERS ........................................ 12
2.2. DEVELOPMENT COMMITTEE .................................. 13
ARTICLE 3 DEVELOPMENT PLAN AND BUDGET .................................... 14
3.1. GENERAL ................................................ 14
3.2. CONTENTS ............................................... 15
3.3. PERIODIC REVIEWS ....................................... 15
3.4. DEVELOPMENT PRIORITIES ................................. 15
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3.5. EXPANSION OF THE FIELD ................................. 15
ARTICLE 4 DEVELOPMENT PROGRAM ............................................ 15
4.1. DEVELOPMENT PROGRAM .................................... 15
4.2. [ * ] INSTRUMENTS ...................................... 16
4.3. PROPRIETARY TARGETS .................................... 16
4.4. CHANGES ................................................ 18
4.5. EXTENSION OF MILESTONE DATES ........................... 18
4.6. DEVELOPMENT REPORTS AND RECORDS ........................ 18
4.7. DEVELOPMENT TERM ....................................... 19
4.8. DEVELOPMENT PROGRAM LICENSES ........................... 19
4.9. THIRD PARTY TECHNOLOGY ................................. 19
4.10. AGREEMENTS WITH EMPLOYEES AND SUBCONTRACTORS ........... 20
4.11. VISITING PERSONNEL ..................................... 20
4.12. EQUIPMENT OWNERSHIP .................................... 20
ARTICLE 5 FUNDING OF DEVELOPMENT PROGRAM ................................. 20
5.1. FUNDING ................................................ 20
5.2. DEVELOPMENT RATE ....................................... 20
5.3. OTHER APPROVED DEVELOPMENT COSTS ....................... 21
5.4. PAYMENT ................................................ 21
5.5. EXCESS COSTS ........................................... 21
5.6. RECONCILIATION ......................................... 22
ARTICLE 6 JOINT STEERING COMMITTEE AND COMMERCIALIZATION PLAN
AND BUDGET ..................................................... 22
6.1. GENERAL ................................................ 22
6.2. COMMERCIALIZATION TEAM LEADER .......................... 22
6.3. [INTENTIONALLY OMITTED] ................................ 23
6.4. JOINT STEERING COMMITTEE ............................... 23
6.5. FINANCE SUB-COMMITTEE .................................. 25
6.6. COMMERCIALIZATION PLAN AND BUDGET ...................... 25
6.7. FUNDING OF COMMERCIALIZATION ACTIVITIES ................ 27
6.8. JOINT PRODUCT FORECASTS AND ORDERS ..................... 29
ARTICLE 7 COMMERCIALIZATION .............................................. 29
7.1. GENERAL RESPONSIBILITIES ............................... 29
7.2. SALES GOALS ............................................ 30
7.3. COMMERCIAL LAUNCH ...................................... 30
7.4. MARKETING AND DISTRIBUTION BY TWT ...................... 30
7.5. MARKETING AND DISTRIBUTION BY ACLARA ................... 31
7.6. INDIRECT DISTRIBUTION .................................. 31
7.7. NO OTHER DISTRIBUTION RIGHTS ........................... 32
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7.8. PRODUCT CONFIGURATIONS ................................. 32
7.9. MARKETING MATERIALS AND PRESENTATIONS .................. 32
7.10. CUSTOMER AGREEMENTS .................................... 32
7.11. THIRD PARTY PATENTS .................................... 33
7.12. PACKAGING AND LABELING ................................. 33
7.13. CUSTOMER RESTRICTIONS .................................. 34
7.14. CUSTOMER SUPPORT AND WARRANTIES ........................ 34
7.15. INTERNAL USE ........................................... 34
ARTICLE 8 COMMERCIALIZATION ECONOMICS .................................... 35
8.1. INITIAL PAYMENTS ....................................... 35
8.2. ACCOUNTING DEFINITIONS ................................. 35
8.3. ACCOUNTING BASED ON SALES .............................. 36
8.4. PROPRIETARY TARGET ROYALTIES ........................... 37
8.5. PROPRIETARY TARGET OFFSETS ............................. 38
8.6. BUNDLING ............................................... 39
8.7. OTHER THIRD PARTY ROYALTIES ............................ 39
ARTICLE 9 TRADEMARKS AND BRANDING ........................................ 39
9.1. JOINT MARKS ............................................ 39
9.2. CO-BRANDING ............................................ 40
ARTICLE 10 MANUFACTURING ................................................. 42
10.1. LICENSES ............................................... 42
10.2. RESTRICTIONS ........................................... 42
10.3. RESPONSIBILITIES ....................................... 42
10.4. ECONOMICS .............................................. 43
10.5. PRODUCT CHANGES ........................................ 43
ARTICLE 11 SUPPLY OF ACLARA COMPONENTS ................................... 44
11.1. TERMS AND CONDITIONS ................................... 44
11.2. SUPPLY ................................................. 44
11.3. FORECASTS .............................................. 44
11.4. ORDERS ................................................. 45
11.5. COMPENSATION ........................................... 45
11.6. DELIVERY ............................................... 45
11.7. INVOICING .............................................. 46
11.8. QUALITY AND QUALITY CONTROL ............................ 46
11.9. INSPECTION/REJECTION ................................... 46
11.10. PRODUCT WARRANTY ....................................... 47
11.11. SHORTAGE OF SUPPLY OF ACLARA COMPONENTS ................ 47
11.12. THIRD PARTY CONTRACTORS ................................ 50
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ARTICLE 12 SUPPLY OF APPROVED PRODUCTS ................................... 50
12.1. TERMS AND CONDITIONS ................................... 50
12.2. SUPPLY ................................................. 50
12.3. FORECASTS .............................................. 51
12.4. ORDERS ................................................. 52
12.5. CONSIDERATION .......................................... 52
12.6. DELIVERY ............................................... 53
12.7. INVOICING .............................................. 53
12.8. QUALITY AND QUALITY CONTROL ............................ 53
12.9. INSPECTION/REJECTION ................................... 53
12.10. PRODUCT WARRANTY ....................................... 54
12.11. SHORTAGE OF SUPPLY OF APPROVED PRODUCTS ................ 54
12.12. THIRD PARTY CONTRACTORS ................................ 58
ARTICLE 13 PAYMENTS; REPORTS; RECORDS .................................... 59
13.1. RECONCILIATION ......................................... 59
13.2. INITIAL PAYMENT UPON MANUFACTURE OF APPROVED
PRODUCTS ............................................... 59
13.3. SUPPLY OF ACLARA COMPONENTS AND APPROVED PRODUCTS
TO TWT ................................................. 59
13.4. SUPPLY OF CLEAVASE ENZYME AND APPROVED PRODUCTS
TO ACLARA .............................................. 59
13.5. PAYMENTS FOR INTERNAL USE BY THE MANUFACTURING
PARTY .................................................. 59
13.6. PAYMENT METHOD ......................................... 60
13.7. CURRENCY CONVERSION .................................... 60
13.8. RECORDS; INSPECTION .................................... 60
13.9. TAXES .................................................. 61
ARTICLE 14 INTELLECTUAL PROPERTY ......................................... 62
14.1. OWNERSHIP .............................................. 62
14.2. PROSECUTION OF SOLELY OWNED PATENT RIGHTS .............. 64
14.3. PROSECUTION OF JOINTLY OWNED PATENT RIGHTS ............. 64
ARTICLE 15 CONFIDENTIALITY ............................................... 66
15.1. CONFIDENTIAL INFORMATION ............................... 66
15.2. PERMITTED USE AND DISCLOSURE ........................... 67
15.3. CONFIDENTIAL TERMS/PUBLICITY ........................... 67
15.4. PROPRIETARY MARKINGS ................................... 67
ARTICLE 16 REPRESENTATIONS, WARRANTIES, AND DISCLAIMERS .................. 68
16.1. GENERAL ................................................ 68
16.2. BY TWT ................................................. 68
16.3. BY ACLARA .............................................. 68
16.4. DISCLAIMERS ............................................ 68
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ARTICLE 17 INDEMNIFICATION ............................................... 69
17.1. INDEMNIFICATION OF TWT ................................. 69
17.2. INDEMNIFICATION OF ACLARA .............................. 70
17.3. PROCEDURE .............................................. 70
ARTICLE 18 DISPUTE RESOLUTION ............................................ 71
18.1. DISPUTES ............................................... 71
18.2. FULL ARBITRATION ....................................... 71
18.3. SHORT FORM ARBITRATION ................................. 72
18.4. COMMERCIALIZATION PLAN AND BUDGET DISPUTE
RESOLUTION ............................................. 73
ARTICLE 19 TERM AND TERMINATION .......................................... 74
19.1. TERM ................................................... 74
19.2. NO APPROVAL FOR COMMERCIAL LAUNCH ...................... 74
19.3. TERMINATION FOR CAUSE .................................. 74
19.4. [INTENTIONALLY OMITTED] ................................ 75
19.5. EFFECT OF TERMINATION .................................. 75 ARTICLE 20 GENERAL ....................................................... 80
20.1. NO OTHER RIGHTS ........................................ 80
20.2. GOVERNING LAW AND JURISDICTION ......................... 80
20.3. ASSIGNMENT ............................................. 80
20.4. INDEPENDENT CONTRACTORS ................................ 81
20.5. FORCE MAJEURE .......................................... 81
20.6. NOTICES ................................................ 81
20.7. COMPLIANCE WITH LAWS ................................... 82
20.8. ARTICLE AND SECTION HEADINGS, LANGUAGE AND
CONSTRUCTION ........................................... 82
20.9. MODIFICATION AND WAIVER ................................ 82
20.10. SEVERABILITY ........................................... 83
20.11. ENTIRE AGREEMENT ....................................... 83
20.12. FURTHER ASSURANCES ..................................... 83
20.13. BANKRUPTCY ............................................. 84
20.14. COUNTERPARTS ........................................... 84
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CONFIDENTIAL
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Development and Commercialization Agreement (the "AGREEMENT"), effective as of October 24, 2001 (the "EFFECTIVE DATE"), is made by and between Third Wave Technologies, Inc., a Delaware corporation, having a place of business at 502 S. Rosa Road, Madison, WI 53719 ("TWT"), and ACLARA BioSciences, Inc., a Delaware corporation, having a place of business at 1288 Pear Avenue, Mountain View, CA 94043 ("ACLARA") (each a "PARTY;" together the "PARTIES").
BACKGROUND
A. TWT has technology and intellectual property for, among other things, genetic analysis, including test kits, components, and other products and services based upon its proprietary Invader(R) platform, and is in the business of manufacturing and commercializing such products, components and services.
B. Similarly, ACLARA has technology and intellectual property for, among other things, genetic analysis and biopharmaceutical research, including products and components based upon ACLARA's proprietary eTag(TM) technology.
C. On the terms and conditions set forth below, ACLARA and TWT desire to collaborate to develop and commercialize assay kits for use on [ * ] instruments commercially available from third parties to perform simultaneous multiple gene expression and/or genotyping assays, each assay testing for a unique analyte, using ACLARA's eTag(TM) technology in TWT's Invader(R) platform.
D. Additionally, TWT has built up significant manufacturing capacities and capabilities for assay kits which the Parties intend to utilize, to the extent mutually agreed, to manufacture the co-developed assay products hereunder, all on the terms and conditions set forth below.
E. The Parties acknowledge that the arrangement set forth in this Agreement is intended to make available to customers a wider range and variety of products than would have been available in the time frames contemplated herein in the absence of the collaboration between the Parties.
NOW, THEREFORE, for and in consideration of the covenants, conditions and undertakings hereinafter set forth, TWT and ACLARA each agree as follows:
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[ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
CONFIDENTIAL
ARTICLE 1
DEFINITIONS
As used in this Agreement, the following terms shall have the meanings indicated:
1.1. "ACLARA COMPONENT" shall mean an ACLARA Precursor in a [ * ]. As used herein, "ACLARA Precursors" shall mean [ * ].
1.2. "ACLARA MARKS" shall mean the trademarks, trade names, and logos of ACLARA set forth in Exhibit 1.2, as amended by ACLARA from time to time in accordance with this Agreement. ACLARA uses "eTag" as a trademark of ACLARA, but such term is printed in this Agreement without the (TM) mark for convenience.
1.3. "ACLARA PARTNER" shall mean a non-Affiliate third party entity that ACLARA has proposed to TWT in writing be authorized by TWT to distribute Approved Products under this Agreement concurrently with the distribution, as authorized by ACLARA, of [ * ].
1.4. "ACLARA TECHNOLOGY" shall mean the ACLARA Patents and ACLARA Technical Information.
1.4.1 "ACLARA PATENTS" shall mean all Patent Rights owned or Licensable by ACLARA or its Controlled Affiliates during the term of this Agreement which would, absent a license or other authorization from the owner of such Patent Rights, be infringed by the composition, manufacture, sale, use, importation, or other exploitation of an Approved Product (or any component thereof).
1.4.2 "ACLARA TECHNICAL INFORMATION" shall mean all Technology disclosed by ACLARA directly to TWT during the term of this Agreement to the extent it relates to the composition, manufacture, sale, use, importation, or other exploitation of an Approved Product, and trade secret rights to the extent embodied in such Technology that are proprietary to or Licensable by ACLARA or its Controlled Affiliates.
1.5. "AFFILIATE" shall mean any entity which controls, is controlled by or is under common control with the applicable entity for so long as such control exists. For purposes of this definition, "control" shall mean beneficial ownership of fifty percent (50%) or more of the shares of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority). A "CONTROLLED AFFILIATE" shall mean an entity that is controlled by a Party to this Agreement.
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[ * ] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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CONFIDENTIAL
1.6. "APPROVED PRODUCT" shall mean a Collaboration Product for which the Parties have agreed in writing upon a Specification and that is developed by the Parties under this Agreement, which Collaboration Product (i) consists of a Multi-Target eTag Probe Set, Cleavase Enzyme, and appropriate buffers, all as specified in the Specification for such Collaboration Product and (ii) is designed and intended for use to perform the particular Multi-Target Analysis, producing the resulting eTag Products, using a [ * ] Instrument, each as set forth in such Specifications. For clarity, each Approved Product shall be limited to, and include, [ * ] as set forth in such Specifications. Notwithstanding anything to the contrary, Approved Product shall not mean any [ * ]t.
1.7. "[ * ] INSTRUMENT" shall mean any instrument, other than a [ * ] on samples which is generally commercially available from a third party during the term of this Agreement and which is suitable for use to separate in the same solution multiple products by molecular weight and charge, including those resultant eTag Products that arise from performing multiple genotyping and/or gene expression analyses simultaneously in such a solution, and is suitable for detecting and/or quantifying each of such multiple eTag Products. [ * ] Instrument shall include the instruments identified in Exhibit 1.7.
1.8. "CLEAVASE ENZYME" shall mean any enzyme that (A) has the ability to recognize the structure formed by the hybridization of an Invader Probe and a Primary Probe to their cognate Target sequ ...
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