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ULTRIO ADDENDUM AMENDING AGREEMENT

Addendum or Modifications

ULTRIO ADDENDUM AMENDING 
AGREEMENT
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CHIRON CORP | GEN-PROBE INCORPORATED

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Title: ULTRIO ADDENDUM AMENDING AGREEMENT
Date: 3/3/2004
Industry: BIOTRX     Sector: HEALTH

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Exhibit 10.329

CONFIDENTIAL

 

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


1.

 

Definitions

 

2

 

 

1.1

 

Agreement

 

2

 

 

1.2

 

Binder

 

2

 

 

1.3

 

Budget

 

2

 

 

1.4

 

Completion Date

 

2

 

 

1.5

 

FTE Labor Rate

 

2

 

 

1.6

 

Interim Events

 

2

 

 

1.7

 

Material Modification

 

2

 

 

1.8

 

NIH Monies

 

2

 

 

1.9

 

Non-material Modification

 

2

 

 

1.10

 

Product Requirements Document

 

3

 

 

1.11

 

Project Management

 

3

 

 

1.12

 

Resource Plan

 

3

 

 

1.13

 

Software Requirements Specifications

 

3

 

 

1.14

 

Technical Plan

 

3

 

 

1.15

 

Timeline

 

3

 

 

1.16

 

Ultrio Assay Product

 

3

 

 

1.17

 

Ultrio Development Costs

 

3

 

 

1.18

 

Ultrio Development Program

 

3

2.

 

Ultrio Development Program

 

3

 

 

2.1

 

Objective

 

3

 

 

2.2

 

General Conduct of Development

 

3

 

 

2.3

 

No Guarantee

 

4

 

 

2.4

 

Project Management

 

4

 

 

 

 

2.4.1    Principles of Project Management

 

4

 

 

 

 

2.4.2    Project Manager

 

5

 

 

 

 

2.4.3    Project Manager's Responsibilities

 

5

 

 

 

 

2.4.4    Project Leaders

 

6

 

 

 

 

2.4.5    Reports

 

6

 

 

 

 

2.4.6    Meetings of the Supervisory Board

 

6

 

 

2.5

 

Development Responsibilities

 

6

 

 

 

 

2.5.1    Principal Responsibility; General Statement

 

6

 

 

 

 

2.5.2    Shared Responsibility

 

6

 

 

 

 

2.5.3    Principal and Shared Responsibility; Specific Allocation

 

7

 

 

 

 

2.5.4    Regulatory/Licensure

 

7

 

 

 

 

2.5.5    Project Leader Disagreements

 

8

3.

 

Modifications

 

8

 

 

3.1

 

Ultrio Development Program Definition

 

8

 

 

3.2

 

Modifications

 

8

 

 

 

 

3.2.1    Request for Modifications

 

8

 

 

 

 

3.2.2    Non-Material Modifications

 

8

 

 

3.3

 

Material Modifications

 

9

 

 

 

 

3.3.1    Request for Material Modifications

 

9

 

 

 

 

3.3.2    Initial Analysis of Impact of Proposed Material Modification

 

9

 

 

 

 

3.3.3    Preparation of Modified Ultrio Development Program

 

9

 

 

 

 

3.3.4    Acceptance of Modified Ultrio Development Program

 

9

 

 

 

 

3.3.5    Effective Date of Modified Ultrio Development Program

 

10

 

 

3.4

 

Notice of Significant Changes

 

10

4.

 

Changes to Ultrio Assay Product after Completion Date

 

10

 

 

4.1

 

Process

 

10

 

 

4.2

 

Additional Work under Addendum

 

11

 

 

 

 

 

 

 

 

i


5.

 

Ultrio Development Costs

 

11

 

 

5.1

 

[***] Ultrio Development Costs and [***]

 

11

 

 

5.2

 

Definition and Calculation of Ultrio Development Costs; [***]

 

11

 

 

 

 

5.2.1    Ultrio Development Costs; FTE Labor Rate

 

11

 

 

 

 

5.2.2    Comparison with Resource Plan

 

13

 

 

 

 

5.2.3    Methodology

 

13

 

 

5.3

 

Payment of Ultrio Development Costs

 

13

 

 

 

 

5.3.1    Accrued Ultrio Development Costs

 

13

 

 

 

 

5.3.2    [***] Budgeted Payments

 

13

 

 

 

 

5.3.3    [***] True-Up Payments

 

13

 

 

 

 

5.3.4    Invoices

 

13

 

 

5.4

 

Dispute

 

14

 

 

5.5

 

Right to Audit and Verify

 

14

6.

 

Manufacturing and Commercialization

 

14

 

 

6.1

 

Definitions Relevant to Manufacturing and Commercialization Obligation

 

14

 

 

 

 

6.1.1    Applicable Purchase Price

 

14

 

 

 

 

6.1.2    Transfer Price

 

14

 

 

 

 

6.1.3    Manufacturing Cost

 

14

 

 

 

 

6.1.4    Rare Reagents

 

14

 

 

6.2

 

Right to Audit and Verify

 

14

 

 

6.3

 

Non-Commercial Products

 

15

 

 

6.4

 

Commercialization Budget

 

15

7.

 

License Grants

 

16

8.

 

Addendum Effective Date; Term; Termination

 

16

 

 

8.1

 

Term of Ultrio Addendum

 

16

 

 

8.2

 

Termination for Breach

 

16

 

 

 

 

8.2.1    Default

 

16

 

 

 

 

8.2.2    Right to Cure Event of Default

 

16

 

 

 

 

8.2.3    Effect of Termination for Breach

 

17

 

 

8.3

 

Termination by Both Parties

 

17

 

 

 

 

8.3.1    Vote to Terminate

 

17

 

 

 

 

8.3.2    Effect of Notice Period on Termination by Both Parties

 

17

 

 

 

 

8.3.3    Effect of Termination by Both Parties

 

17

 

 

8.4

 

Termination by Either Party; Unilateral Withdrawal from Ultrio Development Program

 

18