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MODIFIED BLOOD SCREENING INSTRUMENT ? eSAS 2 ADDENDUM AMENDING AGREEMENT ENTERED INTO AS OF JUNE 11, 1998

Addendum or Modifications

MODIFIED BLOOD SCREENING INSTRUMENT ?
eSAS 2 ADDENDUM
AMENDING
AGREEMENT ENTERED INTO AS OF JUNE 11, 1998

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CHIRON CORP | GEN-PROBE INCORPORATED,

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Title: MODIFIED BLOOD SCREENING INSTRUMENT ? eSAS 2 ADDENDUM AMENDING AGREEMENT ENTERED INTO AS OF JUNE 11, 1998
Date: 5/6/2005
Industry: BIOTRX     Sector: HEALTH

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Exhibit 10.331

 

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.

 

 

MODIFIED BLOOD SCREENING INSTRUMENT –

eSAS 2 ADDENDUM

 

AMENDING

 

AGREEMENT ENTERED INTO AS OF JUNE 11, 1998

 

BY AND BETWEEN

 

GEN-PROBE INCORPORATED, A DELAWARE CORPORATION

 

AND

 

CHIRON CORPORATION

 

effective as of January 1, 2002

 



 

TABLE OF CONTENTS

 

1.

Definitions

 

 

1.1

Agreement

 

 

1.2

Binder

 

 

1.3

Budget

 

 

1.4

eSAS 2 Instrument

 

 

1.5

eSAS 2 Development Costs

 

 

1.6

eSAS 2 Development Program

 

 

1.7

eSAS 2 Addendum Term

 

 

1.8

FTE Labor Rate

 

 

1.9

Material Modification

 

 

1.10

Non-material Modification

 

 

1.11

Product Requirements Document

 

 

1.12

Resource Plan

 

 

1.13

Software Requirements Specifications

 

 

1.14

Technical Plan

 

 

1.15

Timeline

 

2.

eSAS 2 Development Program

 

 

2.1

Objective

 

 

2.2

General Conduct of Development

 

 

2.3

No Liability if Commercially Reasonable Efforts Are Expended

 

 

2.4

Project Management

 

 

 

2.4.1

Principles of Project Management

 

 

 

2.4.2

Project Manager

 

 

 

2.4.3

Project Manager’s Responsibilities

 

 

 

2.4.4

Project Leaders

 

 

 

2.4.5

Reports

 

 

 

2.4.6

Meetings of the Supervisory Board

 

 

2.5

Development Responsibilities

 

 

 

2.5.1

Principal Responsibility; General Statement

 

 

 

2.5.2

Regulatory/Licensure

 

 

 

2.5.3

Project Leader Disagreements

 

3.

Modifications

 

 

3.1

eSAS 2 Development Program Definition

 

 

 

3.1.1

[***] Modules

 

 

 

3.1.2

[***] Modules

 

 

3.2

Modifications

 

 

 

3.2.1

Request for Modifications

 

 

 

3.2.2

Monthly Progress Reports

 

 

3.3

Material Modifications

 

 

 

3.3.1

Request for Material Modifications

 

 

 

3.3.2

Initial Analysis of Impact of Proposed Material Modification

 

 

 

3.3.3

Preparation of Modified eSAS 2 Development Program

 

 

 

3.3.4

Acceptance of Modified eSAS 2 Development Program

 

 

 

3.3.5

Effective Date of Modified eSAS 2 Development Program

 

 

3.4

Notice of Significant Changes

 

4.

Changes to eSAS 2 Instrument after Completion Date

 

 

i



 

5.

eSAS 2 Development Costs

 

 

5.1

[***] to pay Development Costs

 

 

5.2

Definition and Calculation of eSAS 2 Development Costs

 

 

 

5.2.1

eSAS 2 Development Costs; FTE Labor Rate

 

 

 

5.2.2

Comparison with Resource Plan

 

 

 

5.2.3

Methodology

 

 

5.3

Payment of eSAS 2 Development Costs

 

 

 

5.3.1

Accrued eSAS 2 Development Costs

 

 

 

5.3.2

Monthly Notices; Payments

 

 

 

5.3.3

Invoices

 

 

5.4

Reimbursement of eSAS 2 Development Costs

 

6.

Manufacturing and Commercialization

 

 

6.1

eSAS 2 Instrument Manufacturing Costs

 

 

6.2

Rights to Manufacture and Sell

 

 

 

6.2.1

Blood Screening Field

 

 

 

6.2.2

Clinical Diagnostic Field

 

 

 

6.2.3

Right to Acquire All Rights to Manufacture and Commercialize

 

 

6.3

Consideration on eSAS 2 Instrument Sales

 

 

6.4

Authorization Letter

 

7.

Ownership; License Grant

 

 

7.1

Ownership

 

 

7.2

License Grant

 

 

7.3

[***] Immunity

 

8.

Addendum Effective Date; Term; Termination

 

 

8.1

Term of eSAS 2 Addendum

 

 

8.2

Termination for Breach

 

 

 

8.2.1

Default

 

 

 

8.2.2

Right to Cure Event of Default

 

 

 

8.2.3

Effect of Termination for Breach

 

 

8.3

Termination by Chiron

 

 

8.4

Continuance of eSAS 2 Development Program following Termination

 

 

 

8.4.1

Election

 

 

 

8.4.2

Funding and Conduct of Development

 

 

 

8.4.3

Reimbursement of Development Costs

 

 

 

8.4.4

Control of the Program upon Unilateral Funding

 

 

 

8.4.5

Rights under Agreement

 

9.

Escalation

 

 

9.1

Escalation Process

 

 

9.2

Remedies in Event of Default

 

 

9.3

Survival

 

10.

No Other Amendment

 

11.

Counterparts

 

 



 

CONFIDENTIAL

 

REDACTED VERSION

 

 

MODIFIED BLOOD SCREENING INSTRUMENT –

eSAS 2 ADDENDUM

 

This Modified Blood Screening Instrument — eSAS 2 Addendum (“eSAS 2 Addendum”) is entered into, effective as of January 1, 2002 (“Addendum Effective Date”) pursuant to and amending that certain Agreement entered into as of June 11, 1998 (“Agreement”) by and between Gen-Probe Incorporated, a Delaware corporation (“Gen-Probe”) with a principal place of business at 10210 Genetic Center Drive, San Diego CA 92121, and Chiron Corporation, a Delaware corporation (“Chiron;” Chiron and Gen-Probe each is individually referred to as  “Party” and collectively are referred to as the “Parties”) with a place of business at 4560 Horton Street, Emeryville, CA 94608.

 

Recitals

 

A.                                   The Parties entered into the Agreement as of June 11, 1998.  The Agreement was amended by the following: (i) June 11, 1998 Supplemental letter agreement, (ii) June 26, 1998 Addendum to Collaboration Agreement, (iii) June 30, 1998 Supplemental letter agreement, (iv) June 30, 1998 Consent, (v) December 7, 1999 Amendment to Collaboration Agreement, (vi) February 1, 2000 Amendment No. 2 to Collaboration Agreement, (vii) June 7, 2001 Supplemental agreement no. 1  (Customer training and Support), (viii) October 30, 2001 Confidentiality and Joint Interest Agreement, (ix) April 1, 2002 Amendment No. 3 (warehousing and shipping), (x) the Short Form Agreement dated November 16, 2001 and the Definitive Written Settlement Agreement dated December 5, 2001, (xi) the Future Blood Screening Assay – Ultrio Addendum dated as of January 1, 2002 (the “Ultrio Development Addendum”), (xii) March 5, 2003 Amendment No. 4 (Milestone for Ultrio on Tigris); (xiii) the Future Blood Screening Assay – WNV Addendum dated as of June 1, 2003 (the “Ultrio Development Addendum”) and (xiv) January 1, 2004 Amendment No. 5 (Applicable Purchase Price).

 

B.                                     In the Agreement, the Parties agreed to discuss, during the term thereof, the selection and establishment of one or more Development Programs for one or more Blood Screening Instruments.

 

C.                                     The Parties have discussed the proposed development of an eSAS 2 Instrument system, consisting of the following multiple modules: (i) a front end pipettor; (ii) an automated reagent addition station; (iii) an automated target capture bay; (iv) an automated incubation module; and (v) a data management to track sample and system interactions to meet customer demands of throughput and automation required for pooled donor screening by NAT.

 

D.                                    The Parties intend that the development of each module in the eSAS 2 Instrument system will provide improved automation or replacement of current aging or obsolete instrument components with newer technology, all without [***] the assay sensitivity or specificity; subject to all the terms and conditions of this eSAS 2 Addendum, the Parties will agree that each such module within the eSAS 2 Instrument system will be a modification to a “Blood Screening Instrument”, as provided in Section 3.3.7 of the Agreement.

 

E.                                      By this eSAS 2 Addendum, the Parties desire to provide for the development of the eSAS 2 Instrument by Chiron pursuant to the Agreement, as clarified and amended by the terms and conditions more particularly described in this eSAS 2 Addendum.

 

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Agreement