ULTRIO ADDENDUM AMENDING AGREEMENTAddendum or Modifications |
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Exhibit 10.329
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CONFIDENTIAL |
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REDACTED VERSION |
[***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
FUTURE BLOOD SCREENING ASSAY—
ULTRIO ADDENDUM
AMENDING
AGREEMENT ENTERED INTO AS OF JUNE 11, 1998
BY AND BETWEEN
GEN-PROBE INCORPORATED, A DELAWARE CORPORATION
AND
CHIRON CORPORATION
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Definitions |
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1.1 |
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Agreement |
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2 |
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1.2 |
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Binder |
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2 |
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1.3 |
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Budget |
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2 |
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1.4 |
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Completion Date |
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2 |
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1.5 |
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FTE Labor Rate |
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2 |
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1.6 |
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Interim Events |
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2 |
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1.7 |
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Material Modification |
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2 |
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1.8 |
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NIH Monies |
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2 |
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1.9 |
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Non-material Modification |
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2 |
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1.10 |
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Product Requirements Document |
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3 |
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1.11 |
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Project Management |
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3 |
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1.12 |
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Resource Plan |
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3 |
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1.13 |
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Software Requirements Specifications |
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3 |
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1.14 |
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Technical Plan |
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3 |
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1.15 |
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Timeline |
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3 |
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1.16 |
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Ultrio Assay Product |
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3 |
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1.17 |
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Ultrio Development Costs |
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3 |
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1.18 |
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Ultrio Development Program |
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3 |
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2. |
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Ultrio Development Program |
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3 |
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2.1 |
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Objective |
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3 |
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2.2 |
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General Conduct of Development |
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3 |
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2.3 |
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No Guarantee |
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4 |
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2.4 |
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Project Management |
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4 |
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2.4.1 Principles of Project Management |
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2.4.2 Project Manager |
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2.4.3 Project Manager's Responsibilities |
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2.4.4 Project Leaders |
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2.4.5 Reports |
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2.4.6 Meetings of the Supervisory Board |
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2.5 |
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Development Responsibilities |
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2.5.1 Principal Responsibility; General Statement |
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2.5.2 Shared Responsibility |
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2.5.3 Principal and Shared Responsibility; Specific Allocation |
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2.5.4 Regulatory/Licensure |
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2.5.5 Project Leader Disagreements |
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3. |
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Modifications |
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8 |
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3.1 |
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Ultrio Development Program Definition |
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8 |
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3.2 |
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Modifications |
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3.2.1 Request for Modifications |
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8 |
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3.2.2 Non-Material Modifications |
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8 |
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3.3 |
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Material Modifications |
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9 |
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3.3.1 Request for Material Modifications |
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9 |
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3.3.2 Initial Analysis of Impact of Proposed Material Modification |
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9 |
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3.3.3 Preparation of Modified Ultrio Development Program |
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3.3.4 Acceptance of Modified Ultrio Development Program |
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3.3.5 Effective Date of Modified Ultrio Development Program |
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3.4 |
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Notice of Significant Changes |
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10 |
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4. |
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Changes to Ultrio Assay Product after Completion Date |
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4.1 |
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Process |
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10 |
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4.2 |
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Additional Work under Addendum |
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11 |
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Ultrio Development Costs |
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5.1 |
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[***] Ultrio Development Costs and [***] |
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11 |
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5.2 |
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Definition and Calculation of Ultrio Development Costs; [***] |
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5.2.1 Ultrio Development Costs; FTE Labor Rate |
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5.2.2 Comparison with Resource Plan |
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5.2.3 Methodology |
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5.3 |
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Payment of Ultrio Development Costs |
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5.3.1 Accrued Ultrio Development Costs |
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5.3.2 [***] Budgeted Payments |
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5.3.3 [***] True-Up Payments |
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5.3.4 Invoices |
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5.4 |
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Dispute |
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5.5 |
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Right to Audit and Verify |
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6. |
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Manufacturing and Commercialization |
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6.1 |
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Definitions Relevant to Manufacturing and Commercialization Obligation |
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6.1.1 Applicable Purchase Price |
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6.1.2 Transfer Price |
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6.1.3 Manufacturing Cost |
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6.1.4 Rare Reagents |
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6.2 |
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Right to Audit and Verify |
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6.3 |
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Non-Commercial Products |
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6.4 |
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Commercialization Budget |
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7. |
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License Grants |
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8. |
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Addendum Effective Date; Term; Termination |
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8.1 |
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Term of Ultrio Addendum |
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8.2 |
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Termination for Breach |
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8.2.1 Default |
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8.2.2 Right to Cure Event of Default |
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8.2.3 Effect of Termination for Breach |
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8.3 |
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Termination by Both Parties |
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8.3.1 Vote to Terminate |
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8.3.2 Effect of Notice Period on Termination by Both Parties |
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8.3.3 Effect of Termination by Both Parties |
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8.4 |
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Termination by Either Party; Unilateral Withdrawal from Ultrio Development Program |
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