Amendment No. 4 to Development Agreement for Panther Instrument System



 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 240.24b-2. 

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 – ANALYSIS AND
PROTOTYPE
	  	 	3	  
	 3.3.  MILESTONE 2 – [...***...]
	  	 	4	  
	 3.4.  MILESTONE 3 – DEVELOPMENT OF PANTHER
SYSTEM SOFTWARE AND FIRMWARE WITH V&V
	  	 	4	  
		
	 4.      PROJECT MANAGEMENT
	  	 	4	  
		
	 4.1.  TEAM DESCRIPTION
	  	 	4	  
	 4.2.  PROJECT SCHEDULE
	  	 	5	  
	 4.3.  PROJECT COSTS
	  	 	5	  
		
	 5.      TERMS AND CONDITIONS
	  	 	7	  


  

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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:

 Panther Project Software Development Plan, P10233-0108 

Panther Software Architecture Description, P10233-0035 
 Blood Bank Panther Instrument [...***...]SRS, P10233-TBD 
  

	3.1.	HIGH LEVEL REQUIREMENTS 

  

	 	•	 	 [...***...] 


  

	 	•	 	 [...***...] 


  

	 	•	 	 [...***...] 


  

	 	•	 	 [...***...] 


  

	 	•	 	 [...***...] 


  

	 	•	 	 [...***...] 


  

	 	•	 	 [...***...] 


  

	 	•	 	 [...***...] 


  

	 	•	 	 [...***...] 


  

	3.2.	MILESTONE 1 – ANALYSIS AND PROTOTYPE 


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 an initial project payment upon signing the project agreement. 

  

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	3.3.	MILESTONE 2 – [...***...] 


Milestone 2 includes [...***...]. Milestone 1 is scheduled to be an initial project payment upon signing the project agreement. Milestone 2 is
scheduled to be completed [...***...]. 
  

	3.4.	MILESTONE 3 – DEVELOPMENT OF PANTHER SYSTEM SOFTWARE AND FIRMWARE WITH V&V 

 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 the Panther Software Development Plan, P10233-0108 
  

	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
	  	 During the development approximately [...***...] FTEs including:
 [...***...]
 [...***...]
 [...***...]
	  	 Implementation of the software development, integration and unit testing.
 Main Responsibilities:
 [...***...]
 [...***...]
 [...***...]
 [...***...]
 [...***...]



  

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	 Gen-Probe Software Development
	  	During the development phase approximately [...***...] FTEs	  	 Implementation of the software development, integration and unit testing.
 Main Responsibility:
 [...***...]

			
	 Stratec Verification Management and Team
	  	Approximately [...***...] FTEs during the verification phase	  	 Verification including

Software test protocols
 Software test
execution
 Software test reports

			
	 Gen-Probe Validation Management and Team
	  	Approximately [...***...] FTEs during the validation phase	  	 Validation master plan

Validation summary report
 Validation
management


  

	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 – Analysis and Prototype
	  	 	[...***...]	  
	 Milestone 2 – [...***...]
	  	 	[...***...]	  
	 Milestone 3 – Development of panther system Software and firmware with verification and validation (summary verification
report)
	  	 	[...***...]	  

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

 

	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. 

  

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	 Phase
	  	 Cost

	 Milestone 1 – Analysis and Prototype
	  	[...***...]
	 Milestone 2 – [... ***... ]
	  	[...***...]
	 Milestone 3 – Development of panther system Software and firmware with verification and validation (summary verification
report)
	  	[...***...]
	 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. 

  
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 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 
 Bernd M.
Steidle 
 Member, Board of Management, Marketing and Sales 
 +49 7082 7916 65 
 b.steidle@stratec-biomedical.de 

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

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

[...***...] 
  

					
	 	 	 	  	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	  	 	5	  


  
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	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 the “Multiple Program Software Release Schedule [...***...]. 
  

	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 [...***...]
	  	 	 
	 Receiving PO [...***...]
	  	 	[...***...]	  
	 Implementation for Internal release [...***...]
	  	 	[...***...]	  
	 Complete Verification of [...***...]
	  	 	[...***...]	  


  

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