exv10w5






Exhibit 10.5




***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406




AMENDMENT NO. 4 TO

DEVELOPMENT AGREEMENT

FOR PANTHER INSTRUMENT SYSTEM




     This Amendment No. 4 (“Amendment No. 4”) is entered into effective as of February 1, 2011
(“Amendment Effective Date”) pursuant to and amending the “Development Agreement for Panther
Instrument” (the “Agreement”) between Gen-Probe Incorporated, a Delaware corporation (“Gen-Probe”),
and STRATEC Biomedical Systems AG (“STRATEC”) (collectively, “Parties”).



RECITALS




     STRATEC and Gen-Probe entered into a Development Agreement for Panther Instrument System
having an effective date of 22 November 2006 (“Agreement”), which has been previously amended in
writing by the Parties.




	 	 	The Parties now wish to further amend the Agreement.





     NOW, THEREFORE, in consideration of the mutual obligations in this Amendment No. 4, the
Parties agree as follows:



TERMS





	1.	 	The Agreement is hereby further amended to include additional services by STRATEC for the
design and development of [...***...], on the terms and
conditions more fully set forth in the Gen-Probe Statement of Work attached hereto as Exhibit
4A and in the STRATEC Proposal attached hereto as Exhibit 4B. Exhibit 4A and Exhibit 4B are
incorporated into this Amendment No. 4 by reference as though fully set forth. In the event
of any conflict between Exhibit 4A and Exhibit 4B, Exhibit 4A shall control.






	2.	 	All capitalized terms used but not defined in this Amendment No. 4 will have the respective
meaning given to them in the Agreement.






	3.	 	All other terms and conditions of the Agreement, as amended, shall remain in full force and
effect.






	4.	 	Facsimile signatures are deemed equivalent to original signatures for purposes of this
Amendment No. 4.






	5.	 	This Amendment No. 4 is effective on the Amendment Effective Date.






 


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     IN WITNESS WHEREOF, the Parties have executed this Amendment No. 4 by their duly authorized
representatives.



	 	 	 

	Gen-Probe Incorporated

	 	STRATEC Biomedical Systems AG
	 
	 	 
	/s/ Brad Blake May 6, 2011

	 	/s/ Marcus Wolfinger 2011/05/17
	 

	 	 
	Brad Blake

	 	     Marcus Wolfinger
	Vice President, Instrument Systems

	 	CEO, Stratec







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EXHIBIT A




Gen-Probe Statement of Work













 





PANTHER

[...***...] Statement of Work

Revision: A

January 31, 2011




Presented By:

[...***...]

Gen-Probe Incorporated

10210 Genetic Center Drive

San Diego, CA 92131

(858) 410-8000




 


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1. Table of Contents




	 	 	 	 	 

	1. TABLE OF CONTENTS
	 	 	2	 
	 
	 	 	 	 
	2. PROJECT OVERVIEW AND SCOPE
	 	 	3	 
	 
	 	 	 	 
	3. TASKS
	 	 	3	 
	3.1. High Level Requirements
	 	 	3	 
	3.2. MileStone 1 — [...***...]
	 	 	3	 
	3.3. Milestone 2 —  [...***...]
	 	 	4	 
	3.4. Milestone 3 —  [...***...]
	 	 	4	 
	 
	 	 	 	 
	4. PROJECT MANAGEMENT
	 	 	4	 
	 
	 	 	 	 
	4.1. Team Description
	 	 	4	 
	4.2. Project Schedule
	 	 	5	 
	4.3. Project Costs
	 	 	6	 
	 
	 	 	 	 
	5. TERMS AND CONDITIONS
	 	 	0	 







 


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2. Project Overview and Scope



Stratec Biomedical Systems shall provide services for the prototyping/analysis, design,
implementation, and testing of adding [...***...] to the PANTHER platform.




3. Tasks



This section provides an overview of the tasks to be completed for the prototyping/analysis,
design, implementation and validation of [...***...] to the PANTHER platform. For a detailed
description of the objectives, tasks, and deliverables please see the following documents:




[...***...]



[...***...]



[...***...]




3.1. HIGH LEVEL REQUIREMENTS



•      [...***...]



•      [...***...]



•      [...***...]



•      [...***...]



•      [...***...]



•      [...***...]



•      [...***...]



•      [...***...]



•      [...***...]




3.2. MILESTONE 1 — [...***...]



Milestone 1 includes project kick off and updating of required project documents including the
project management plan, requirements documents, key configuration management, software testing,
and defect tracking plans. Milestone 1 is scheduled to be [...***...].





 


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3.3. MILESTONE 2 — [...***...]



Milestone 2 includes [...***...]. Milestone 1 is scheduled to be [...***...]. Milestone 2 is
scheduled to be completed [...***...].




3.4. MILESTONE 3 — [...***...]



Milestone 3 includes [...***...]. Milestone 3 also includes design review and documentation
updates. Milestone 3 includes addressing any issues identified in Milestone 2, executing UIT,
informal verification, update design documents, and preparing the software for formal verification
and validation. Milestone 3 is scheduled to be feature complete [...***...].




4. Project Management



This section contains the approach Gen-Probe and Stratec will use to complete the project.
Included is a description of the team members, project strategy or development plan, quality
processes, schedule, and estimated costs. A more detailed project summary can be found in
[...***...]




4.1. TEAM DESCRIPTION




     * Indicates 100% Project Commitment. Project Commitment defined as allocation for working on
projects. Some managers will have other functional and design review responsibilities.



	 	 	 	 	 
	Role	 	Resources	 	Responsibility
	Software Core Team Lead 

Technical Lead PC SW

	 	[...***...]

[...***...]
	 	Software team/project
management, consultant
to technical lead and
primary liaison with
Project Management and
requirements
	 
	 	 	 	 
	Stratec Software Development

	 	[...***...]

[...***...]

[...***...]

[...***...]
	 	Implementation of the
software development,
integration and unit
testing.
	 
	 	 	 	 
	 

	 	 	 	Main Responsibilities:
	 

	 	 	 	[...***...]






 


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	Role	 	Resources	 	Responsibility
	 

	 	 	 	[...***...].
	 
	 	 	 	 
	Gen-Probe Software Development

	 	 	 	Implementation of the
software development,
integration and unit
testing. 




Main Responsibility:
	 

	 	 	 	[...***...].
	 
	 	 	 	 
	Stratec Verification
Management and Team

	 	[...***...]
	 	[...***...]

[...***...]

[...***...]

[...***...]
	 
	 	 	 	 
	Gen-Probe Validation
Management and Team

	 	[...***...]
	 	[...***...]

[...***...]

[...***...]






4.2. PROJECT SCHEDULE





  This section contains an overview of the estimated proposed project schedule. The schedule
provides resources, durations, and task order.





	 	 	 	 	 
	 	 	 	 	 
	Milestone
	 	 	Dates	 
	Milestone 1 — [...***...]
	 	 	[...***...]	 
	Milestone 2 — [...***...]
	 	 	[...***...]	 
	Milestone 3 — [...***...]
	 	 	[...***...]	 







	 	 	For more details on the project schedule please see [...***...] Project Schedule.






 


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4.3. PROJECT COSTS





	 	 	Stratec Biomedical will perform the tasks outlined in this work statement on a set Milestone
basis. The following table summarizes estimated projected cost required to complete these
tasks.





	 	 	 	 	 
	Phase	 	Cost	 
	Milestone 1 — [...***...]
	 	 	[...***...]	 
	Milestone 2 — [...***...]
	 	 	[...***...]	 
	Milestone 3 — [...***...]
	 	 	[...***...]	 
	Total
	 	 	[...***...]	 







	 		
	 	 	4.3.1. Project Assumptions




This section lists the assumptions that have been made in preparing this work statement.





	 	•	 	This work statement is based on the best information available at the time it was
written.
	 
	 	•	 	Gen-Probe will provide timely responses to requests for design inputs for supporting
information.
	 
	 	•	 	Stratec and Gen-Probe will each appoint a single point of contact for the management of
this project.
	 
	 	•	 	Gen-Probe will make appropriate personnel available to Stratec engineers for questions
and reviews.
	 
	 	•	 	Stratec will make appropriate personnel available to Gen-Probe engineers for questions
and reviews.
	 
	 	•	 	Project priorities can change due to circumstances such as urgent improvements needed to
support commercial instruments, additional customer features or increased complexity of
implementation. Mutual agreement from Program Managers from both parties can adjust the
deliverables for interim milestones without altering the Work Statement.






 


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5. Terms and Conditions





	 	 	See Development Agreement for Panther Instrument System for terms and
conditions.
















 








EXHIBIT B




STRATEC Proposal













 





Panther




Instrument System




[...***...] Blood Bank Utilization




Company name and address




Stratec Biomedical Systems AG

Gewerbestr. 37

75217 Birkenfeld




Germany




Contact persons




[...***...]

[...***...]

[...***...]

[...***...]




[...***...]

[...***...]

[...***...]

[...***...]

[...***...]




2010-12-08




			
	 	 	 
	< [...***...] PROGRAM MANAGER>
	 	DATE





 


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	1 OVERVIEW
	 	 	3	 
	 
	 	 	 	 
	2 PROPOSED SOLUTION FOR BLOOD BANK UTILIZATION
	 	 	4	 
	 
	 	 	 	 
	2.1 Strategy
	 	 	4	 
	 
	 	 	 	 
	2.2 Development and Design Services
	 	 	4	 
	 
	 	 	 	 
	3 TIMELINE
	 	 	5	 
	 
	 	 	 	 
	3.1 SW development
	 	 	5	 
	 
	 	 	 	 
	4 DEVELOPMENT AND DESIGN TEAM
	 	 	5	 
	 
	 	 	 	 
	5 MILESTONE PAYMENTS
	 	 	6	 
















 





     1. Overview


Stratec develops for Gen-Probe a low- to mid-volume instrument named “Panther”, for current
and future molecular diagnostic assays.



In accordance with this development Stratec was requested to quote a modification of said
instrument for performing current and future blood bank assays (Request for Quotation dated
2009-08-26). In this document the instrument for the blood bank market is named the “Blood Bank
Panther”.



The general approach for this project is to [...***...].
With work statement No. 1 effective December 03, 2009 the development of the Incremental Change for
Blood Screening was amended to the Development Agreement for the Panther Instrument.



In conjunction with the above Stratec was also requested to provide a Proposal for the development
of [...***...].



Both instruments shall be considered a Gen-Probe Inc. exclusive product and Gen-Probe will remain
the legal manufacturer.



 


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2. Proposed Solution for Blood Bank Utilization




2.1. STRATEGY



The instrumentation platform for blood bank application is defined in the PRD and the PRD feature
summary (attachment A and B of the Request for Quotation).In addition [...***...].



According to these requirements the Blood Bank Panther [...***...].
With this understanding no hardware / module modification is considered in the scope of this
development.



However, [...***...].




2.2. DEVELOPMENT AND DESIGN SERVICES



The responsibilities and development services as defined in the Panther development plan dated
2007-06-13 and related documents remain unchanged,
resources and split of tasks between the development sites will be according to the Panther SW
development plan dated 2009-09-25.




SW development includes:



 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]

 —  [...***...]



The overall cost of the development is USD [...***...].



Lower level database functions have been planned and implemented under the work statement No. 1
(Incremental Change for Blood Screening), in addition [...***...] will be implemented under this
development.




 


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3. Timeline




3.1. SW DEVELOPMENT



As agreed with Gen-Probe the development of the diagnostic Panther has the highest priority.



The team will use its best effort to implement the items needed for the Blood Bank Panther in
conjunction with the SW implementation of the other Panther SW lines. However, in case of any
scheduling conflict [...***...].



Specific details are provided in [...***...].




4. Development and Design Team



The development and design team remains the same as for the Panther development.
The majority of the tasks and responsibilities for the software development will be shared between
the different sites according to the SW Development Plan dated 2009-09-25.



Stratec has already added [...***...].




5. Milestone Payments




     Development of Blood Bank Panther [...***...]



	 	 	 	 	 

	[...***...]
	 	 	[...***...]	%
	[...***...]
	 	 	[...***...]	%
	[...***...]
	 	 	[...***...]	%






 


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