exv10w4






Exhibit 10.4




***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. 3 TO

DEVELOPMENT AGREEMENT

FOR PANTHER INSTRUMENT SYSTEM




     This Amendment No. 3 (“Amendment No. 3”) 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. 3, 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 software for use with real time assays on the Panther Instrument, on
the terms and conditions more fully set forth in the Gen-Probe Statement of Work attached
hereto as Exhibit 3A and in the STRATEC Proposal attached hereto as Exhibit 3B. Exhibit 3A
and Exhibit 3B are incorporated into this Amendment No. 3 by reference as though fully set
forth. In the event of any conflict between Exhibit 3A and Exhibit 3B, Exhibit 3A shall
control.
	 
	2.	 	All capitalized terms used but not defined in this Amendment No. 3 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. 3.
	 
	5.	 	This Amendment No. 3 is effective on the Amendment Effective Date.










 









 











     IN WITNESS WHEREOF, the Parties have executed this Amendment No. 3 by their duly authorized
representatives.



	 	 	 	 	 	 	 

	 
	 	 	 	 	 	 
	Gen-Probe Incorporated

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

     Brad Blake

	 	 	 	/s/ Marcus Wolfinger
 

     Marcus Wolfinger
	 	 
	Vice President, Instrument Systems

	 	 	 	CEO, Stratec	 	 











2









 








EXHIBIT A




Gen-Probe Statement of Work



 









 





PANTHER

Real-Time Statement of Work

Revision: A

January 31, 2011




Presented By:

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

Gen-Probe Incorporated

10210 Genetic Center Drive

San Diego, CA 92131

(858) 410-8000





 




			
	***	 	Confidential Treatment Requested





 









 






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 —[...****...]
	 	 	4	 
	3.3. Milestone 2 — [...***...]
	 	 	5	 
	3.4. Milestone 3 — [...***...]
	 	 	5	 
	3.5. Milestone 4 — [...***...]
	 	 	5	 
	3.6. Milestone 5 — [...***...]
	 	 	5	 
	 
	 	 	 	 
	4. PROJECT MANAGEMENT
	 	 	5	 
	4.1. Team Description
	 	 	6	 
	4.2. Project Schedule
	 	 	7	 
	4.3. Project Costs
	 	 	8	 
	 
	 	 	 	 
	5. TERMS AND CONDITIONS
	 	 	9	 








 




			
	***	 	Confidential Treatment Requested




2









 











2. Project Overview and Scope


Stratec Biomedical Systems shall provide software and firmware services for the
prototyping/analysis, design, implementation, and testing of adding the Real-Time Assay
functionality to the PANTHER platform. Hardware is specifically excluded from this Statement of
Work.





3. Tasks


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




[...***...]



     [...***...]



     [...***...]



     [...***...]



     [...***...]



     [...***...]



     [...***...]



     [...***...]



     [...***...]



     [...***...]



     [...***...]



     [...***...]



     3.1. HIGH LEVEL REQUIREMENTS



Milestone 1 [...***...]





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






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







 




			
	***	 	Confidential Treatment Requested





3









 






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





Milestone 2 [...****...]





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





Milestone 3 [...***...]





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





     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. This also includes [...***...]








 




			
	***	 	Confidential Treatment Requested





4









 




[...***...]. Milestone 1 is scheduled to be [...***...].



     3.3. MILESTONE 2 — [...****...]


Milestone 2 includes any initial database and firmware architectural changes that are needed to
support the Real Time Assay architecture. Software functionality shall include [...***...].
Milestone 2 is scheduled to be completed [...***...].




     3.4. MILESTONE 3 — [...***...]


Milestone 3 includes all software for Real Time Assay on Panther feature complete implementation to
firmware, workflows, reports design, and LIS support; create/update verification protocols and
software. 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 [...***...].




     3.5. MILESTONE 4 — [...***...]


Milestone 4 includes addressing any issues identified in Milestone 3. Milestone 4 includes
[...***...].




     3.6. MILESTONE 5 — [...***...]


Milestone 5 includes addressing any issues identified in Milestone 4. Milestone 5 also includes
[...***...]. Milestone 5 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
[...***...]






 




			
	***	 	Confidential Treatment Requested





5









 





     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

	 	[...***...]

[...***...]

[...***...]

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


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

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

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


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

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

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

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

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

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

[...***...]

[...***...]








 




			
	***	 	Confidential Treatment Requested





6









 





     4.2. PROJECT SCHEDULE


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




	 	 	 
	Milestone	 	Date
	Milestone 1 —[...****...]

	 	[...***...]
	Milestone 2 — [...***...]

	 	[...***...]
	Milestone 3 — [...***...]

	 	[...***...]
	Milestone 4 — [...***...]

	 	[...***...]
	Milestone 5 — [...***...]

	 	[...***...]






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








 




			
	***	 	Confidential Treatment Requested





7









 





     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.





	 	 	 	 	 
	 	 	Payment to Stratec	 	Payment to Stratec
	Phase	 	AG	 	USA
	Milestone 1 — [...****...]
	 	$[...***...]	 	[...***...]
	Milestone 2 — [...***...]
	 	$[...***...]	 	[...***...]
	Milestone 3 — [...***...]
	 	$[...***...]	 	[...***...]
	Milestone 4 — [...***...]
	 	$[...***...]	 	[...***...]
	Milestone 5 — [...***...]
	 	$[...***...]	 	[...***...]
	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.









 




			
	***	 	Confidential Treatment Requested










8









 




4.3.2. Terms and Conditions




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










9









 








EXHIBIT B




STRATEC Proposal








 









 








Panther




Instrument System




SW Implementation for Real-Time Panther




Company name and address




Stratec Biomedical Systems AG

Gewerbestr. 37

75217 Birkenfeld



Germany




Contact persons




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

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

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

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




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

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

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

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

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




2010-12-20




	 	 	 

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

	 	DATE








 




			
	***	 	Confidential Treatment Requested





1









 





	 	 	 	 	 	 	 

	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	 








 




			
	***	 	Confidential Treatment Requested





2









 






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 the continued implementation of
the Real-time Panther SW requirements summarized from [...****...] and provided
2010-12-16. In this document the instrument for the continued development is named the “Real-Time
Panther”.



To date it is not clear how many hardware changes (if any) will be needed to support the Real-Time
assays on the current diagnostic Instrument. Hardware development tasks to the current diagnostic
Instrument are not subject to this proposal.



Note: chapter 4 was updated to clarify the involvement of [...***...]. (2011-01-20)






 




			
	***	 	Confidential Treatment Requested





3









 






2. Proposed Solution for Real-Time Panther


2.1. STRATEGY



The instrumentation platform for general diagnostic application is defined in the PRD and includes
the high level SW requirements. According to these requirements the Real-Time Panther
[...****...].



With this understanding no hardware / module modification is considered in the scope of this
development.



With software version 3.2.0.6 the majority of the features for Real-Time functionality to fulfill
PRD rev. D. have been implemented under Stratec responsibility. [...***...].



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



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.



The verification group at Stratec will continue in its current composition [...***...].
In addition Stratec will improve the administrative support for [...***...].



SW development includes:





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




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




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




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




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




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




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




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




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




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


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



Basic database functions have been planned and implemented under the work statement No. 1
(Incremental Change for Blood Screening), in addition [...****...] will be implemented
under [...***...] work statement. For the specific Real-Time DM functions such as [...***...] the
implementation is covered under this development.






 




			
	***	 	Confidential Treatment Requested





4









 






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 [...***...]. However, in case
of any scheduling conflict [...***...].



Specific details are provided in [...***...].
The development is scheduled to be feature complete [...***...].





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 entire Stratec SW development resources for Panther will continue their services [...***...].



In particular are these:



- [...***...] fulltime resources provided by [...***...]

- [...***...] fulltime resources provided by [...***...]

- [...***...] fulltime resource provided by [...***...]

- [...***...] fulltime resources provided by [...***...]

- [...***...] fulltime resource for [...***...]

- [...***...] continues as fulltime resource for the Stratec team till [...***...].



In addition Stratec is requesting [...***...]. The cost for [...***...] are not under the scope of
this proposal an shall be covered by Gen-Probe separately.



Further needs of [...***...] will be handled in a way, that [...***...].
Gen-Probe agrees to provide [...***...] access to the Gen-Probe facility and a reasonable place to
work for the entire scope of the [...***...] development. He will be located at San Diego area and
be employed by Stratec Biomedical US.









 




			
	***	 	Confidential Treatment Requested





5









 





5. Milestone Payments



	 	 	 	 	 
	 	 	Stratec Biomed.	 	Stratec Biomed.
	Development of Real-Time Panther Software	 	AG	 	US
	[...****...]

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

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

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

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

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

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

	 	 	 	[...***...]








 




			
	***	 	Confidential Treatment Requested






6