Document:

Consulting Agreement

 Exhibit 10.1 
 CONSULTING AGREEMENT 
 This Consulting Agreement (“Agreement”) is
made and entered into as of the 2nd day of November, 2011 and shall become effective on the 4th day of November, 2011 (the “Effective Date”), by and between VERMILLION, INC. (the “Company”) and Eric T. Fung
(“Consultant”). The Company desires to retain consultant as an independent contractor to perform consulting services for the Company, and Consultant is willing to perform such services, on terms set forth more fully below. In consideration
of the mutual promises contained herein, the parties hereto (the “Parties”) agree as follows: 
  

	 	1.	SERVICES AND CONSIDERATION 

 (a) Consultant shall serve as the Company’s Chief Medical Officer and a member of the Company’s Scientific Advisory Board. Consultant shall act as a medical advisor and perform the consulting
services as described in Exhibit A (the “Services”). 
 (b) The Company shall pay Consultant the compensation
set forth in Exhibit A for the performance of the Services. The Company shall also reimburse Consultant for approved reimbursable travel expenses incurred by Consultant in performing the Services pursuant to this Agreement, provided
Consultant receives written consent from an authorized agent of the Company prior to incurring any such expenses exceeding $100. Consultant (i) shall book any air travel authorized by the Company in economy or coach class and (ii) shall
book all such air travel and related accommodations through the Company’s authorized travel services provider. 
 (c)
Consultant shall submit all statements for Services and expenses on a monthly basis in a form approved by the Company. The Company shall pay each such statement fifteen (15) days after receipt. 

 

	 	2.	CONFIDENTIALITY 

(a) Definition. “Confidential Information” means any information, technical, data, trade secrets or know-how that the
Company considers to be confidential or proprietary including, but not limited to, research, product plans, products, services, suppliers, customer lists and customers, prices and costs, markets, software, developments, inventions, laboratory
notebooks, processes, formulas, technology, designs, drawings, engineering, hardware configuration information, marketing, licenses, finances, compensation packages, budgets or other business information disclosed by the Company either directly or
indirectly in writing, orally or by drawings or through Consultant’s allowed observation of parts or equipment, or through creation by consultant in the course of providing the Services during the term of this Agreement. Consultant also
understands that Confidential Information includes, but is not limited to, information pertaining to any aspects of the Company’s business that is either information not known by actual or potential competitors of the Company or is proprietary
information of the Company or its customers or suppliers, whether of a technical nature or otherwise. Further, Confidential Information, as defined herein, may include, but is not limited to, information disclosed to the Company by third parties.
Confidential Information does not include information that Consultant can establish: (i) was publicly known and made generally available in the public domain prior to the time of disclosure to Consultant by the Company;

 
(ii) becomes publicly known and made generally available after the disclosure to Consultant by the Company through no wrongful action or inaction of Consultant; (iii) is in the
possession of Consultant, without confidentiality restrictions, at the time of disclosure to Consultant by the Company as shown by Consultant’s files and records immediately prior to the time of disclosure; or (iv) has been approved for
release by the Company’s prior written authorization. 
 (b) Non-Use and Non-Disclosure. Consultant will not, during
or subsequent to the term of this Agreement, use the Company’s Confidential Information for any purpose whatsoever other than the performance of the Services on behalf of the Company. Consultant will not, during or subsequent to the term of
this Agreement, disclose the Company’s Confidential Information to any third party. Consultant shall not reverse engineer, disassemble or decompile any prototypes, software or other tangible objects, that embody the Company’s Confidential
Information. Consultant further agrees to take all reasonable precautions to prevent any unauthorized disclosure of such Confidential Information including, but not limited to, having each employee of Consultant, if any, with access to any
Confidential Information, execute a non-disclosure agreement containing provisions no less favorable to the Company and protective of Confidential Information unless Consultant has received prior written approval for such action from the Company;
and in such event, Consultant shall reproduce on any such approved copies, any of Company’s proprietary rights and confidentiality notices in the same manner in which such notices were set forth in or on the original. Consultant shall
immediately notify the Company in the event of any unauthorized use or disclosure of Confidential Information. 
 (c) Former
or Concurrent Employer’s Confidential Information. Consultant agrees that Consultant will not, during the term of this Agreement, improperly use, disclose, or induce the Company to use any proprietary information or secrets of any third
party. Consultant will not bring onto the premises of the Company unpublished document or proprietary information belonging to any third party. Consultant will indemnify the Company and hold it harmless from and against all claims, liabilities,
damages and expenses, including reasonable attorneys and costs of suit, arising out of or connection with any violation or claimed violation of a third party’s rights resulting in whole or in part from the Company’s use of the work product
of Consultant under this Agreement. 
 (d) Third Party Confidential Information. Consultant recognizes that the Company
has received and in the future will receive confidential or proprietary information of third parties subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes.
Consultant agrees that Consultant owes the Company and such third parties, during the terms of the Agreement and thereafter, a duty to hold all such confidential or proprietary information in the strictest confidence and not to disclose it to any
person, firm, corporation or other entity or to use it except as necessary in carrying out the Services for the Company consistent with the Company’s agreement with such third party. 

(e) Return of Materials. All documents and other tangible objects containing or representing Confidential Information and all
copies thereof that are in the possession of Consultant shall be and remain the property of the Company, and Consultant shall promptly return such Confidential Information and all copies thereof to the Company upon termination of this Agreement or
upon the Company’s earlier request. 

	 	3.	OWNERSHIP. 

 (a)
Assignment. Consultant agrees that all copyrightable material, notes, records, drawings, designs, inventions, improvements, developments, discoveries and trade secrets (collectively, “Inventions”) conceived, made or discovered by
Consultant, solely or in collaboration with others, during the period of this Agreement that relate in any manner to the business of the Company that Consultant may be directed to undertake, investigate or experiment with, or that Consultant may
become associated with in work, investigation or experimentation in the line of business of the Company in performing the Services hereunder, are the sole property of the Company. In addition, any Inventions made by Consultant that constitute
copyrightable subject matter shall be considered “works made for hire” as that term is defined in the United States Copyright Act. Consultant hereby assigns fully (and agrees to further assign or cause to be assigned, as necessary to
effect such full assignment) to the Company all Inventions and any copyrights, patents, or other intellectual property rights relating thereto. 
 (b) Further Assurances. Consultant agrees to assist the Company, or its designee, at the Company’s expense, in every proper way to secure the Company’s rights in the Inventions and any
copyrights, patents, or other intellectual property rights relating thereto in any and all countries, including in the disclosure to the Company of all pertinent information and data with respect thereto, the execution of all applications,
specifications, oaths, assignments and all other instruments that the Company shall deem necessary in order to apply for and obtain such rights and in order to assign and convey to the Company, its successors, assigns and nominees the sole and
exclusive right, title and interest in and to such Inventions, and any copyrights, patents, or other intellectual property rights relating thereto. Consultant further agrees that consultant’s obligation to execute or cause to be executed any
such instrument or papers, when it is in Consultant’s power to do so, shall continue after the termination of this Agreement. 
 (c) Pre-Existing Materials. Consultant agrees that if, in the course of performing the Services, Consultant incorporates into any Invention developed hereunder any invention, improvement,
development, concept, discovery or other proprietary information owned by Consultant or in which consultant has an interest (i) Consultant shall inform the company, in writing, before incorporating such invention, improvement, development,
concept, discovery or other proprietary information into any Invention; and (ii) the Company is hereby granted and shall have a nonexclusive, royalty-free, perpetual, irrevocable, worldwide transferable license (with the right to sublicense) to
make, have made, modify, use, sell and/or import such item as part of or in connection with such Invention. In addition, Consultant agrees that Consultant will promptly make full written disclosure to the company, will hold in trust for the sole
right and benefit of the Company, and hereby assigns to the Company, or its designees, all Consultant’s right, title and interest in and to any Inventions created within three years after the termination of this Agreement that are based upon or
derived from Confidential Information, and Consultant agrees that such Inventions are and shall be the sole and exclusive property of the Company. Nothing in the preceding sentence shall be construed to limit Consultant’s obligations under
Section 2 (“Confidentiality”) of this Agreement. Consultant shall not incorporate any invention, improvement development, concept, discovery or other proprietary information owned by any third party into any Invention without
Company’s prior written permission. 

 (d) Attorney in Fact. Consultant agrees that if the Company is unable, because of
Consultant’s unavailability, dissolution, mental or physical incapacity, or for any other reason, to secure Consultant’s signature to apply for or to pursue any application for any United States or foreign jurisdiction’s patents or
copyright registrations covering the Inventions assigned to the Company above, then Consultant hereby irrevocably designates and appoints the Company and its duly authorized officers and agents as Consultant’s agent and attorney in fact, to act
for and in consultant’s behalf and to execute and file any such applications and to do all other lawfully permitted acts to further the prosecution and issuance of patents, and copyright registrations with the same legal force and effect as if
executed by Consultant. 
  

	 	4.	NON-COMPETE AND NON-SOLICITATION 

 During the terms of Consultant’s engagement and for a period of three (3) years immediately following the termination or expiration of its engagement, consultant shall not directly or indirectly
(i) carry on any business or activity that competes directly or indirectly with the Company for a radius of fifth (50) miles from the present location of the Company in Austin, Texas; (ii) solicit or induce any employee or consultant
of the Company to quit their employment or cease doing business with the Company, or (iii) solicit any actual or potential customer of the Company for any business that competes directly or indirectly with the Company, unless Consultant is
specifically authorized to do (i), (ii) or (iii) with the prior written consent of the Company. Consultant acknowledges that the restrictions set forth in this Section 4 are reasonable and necessary for the proper fulfillment of its
consulting obligations. 
  

	 	5.	CONFLICTING OBLIGATIONS 

 Consultant certifies that Consultant has no outstanding agreement or obligation that is in conflict with any of the provision of this Agreement, or that would preclude Consultant from complying with the
provision hereof, and further certifies that consultant will not enter into any such conflicting agreement. 
  

	 	6.	TERM AND TERMINATION 

 (a) Term. This Agreement will commence on the Effective Date and will continue in full force and effect for an initial term of twelve (12) months. This Agreement may be renewed by the Parties,
by mutual written agreement. 
 (b) Termination. Either Party may termination this Agreement for any reason or no reason
upon giving thirty (30) days prior written notice thereof to the other Party. Any such notice shall be addressed to the other Party at the address shown below and shall be deemed given upon delivery if personally delivered, or forty-eight
(48) hours after deposited in the United States mail, postage prepaid, registered or certified mail, return receipt requested. Either Party may terminate immediately and without prior notice if the other Party is in breach of any material
provision of this Agreement, but such termination shall not preclude ay other legal or equitable remedy available to the terminating Party. 

 (c) Survival. Upon termination of this Agreement, all rights and duties of the
Parties toward each other shall cease except that: 
 (i) the Company shall be obliged to pay, within thirty (30) days of
the effective date of termination, any amounts owing to Consultant for expenses, if any, in accordance with the provision of Section 1 (“Services and Consideration”) hereof; and 

(ii) Sections 2 (“Confidentiality”), 3 (“Ownership”), 4 (“Non-Compete and Non-Solicitation”), 8
(“Independent Contractors”) and 10 (“Arbitration and Equitable Relief”) and such other provision that by their terms extend shall survive termination of this Agreement. 

 

	 	7.	ASSIGNMENT 

 Neither this
Agreement nor any right hereunder or interest herein may be assigned or transferred by Consultant without the express written consent of the Company. 
  

	 	8.	INDEPENDENT CONTRACTOR 

 The express intention of the Parties is that Consultant is an independent contractor to the Company hereunder. Nothing in this Agreement shall in any way be construed to constitute Consultant as an agent,
employee or representative of the Company, but Consultant shall perform the Services hereunder as an independent contractor. Consultant agrees to furnish (or reimburse the Company for) all tools and materials necessary to accomplish this Agreement,
and shall incur all expenses associated with performance without reimbursement from the Company, except as expressly provided herein. Consultant acknowledges and agrees that Consultant is obligated to report as income to all applicable taxing
authorities all compensation receive by Consultant pursuant to this Agreement, and Consultant agrees to and acknowledges the obligation to pay all self-employment and other taxes thereon. Consultant further agrees to indemnify and hold harmless the
Company and its directors, officers, and employees from and against all taxes, losses, damages, liabilities, costs and expenses, including attorney’s fees and other legal expenses, arising directly or indirectly from (i) any negligent,
reckless or intentionally wrongful act of Consultant or Consultant’s assistants, employees or agents, (ii) a determination by a court or agency that the Consultant is not an independent contractor, or (iii) any breach by the
Consultant or Consultant’s assistants, employees or agents of any of the covenants contained in this Agreement. 
  

	 	9.	BENEFITS 

Consultant acknowledges and agrees and the Parties’ intent hereunder is that Consultant receive no Company-sponsored benefits from
the Company either as a Consultant or an employee. Such benefits include, but are not limited to, paid vacation, sick leave, medical insurance, and 401(k) participation. If Consultant is reclassified by a state or federal agency or court as any
employee, the Company may elect to have Consultant become a reclassified employee, receiving no benefits except those mandated by state or federal law, even if by the terms of the Company’s standard benefit plans in effect at the time of such
reclassification Consultant would otherwise be eligible for such benefits. 

	 	10.	ARBITRATION AND EQUITABLE RELIEF 

 (a) Disputes. Except as provided in Section 10(d) below, the Company and Consultant agree that any dispute or controversy arising out of, relating to or in connection with the interpretation,
validity, construction, performance, breach or termination of this Agreement shall be settled by binding arbitration to be held in Austin, Texas in accordance with the Commercial Arbitration Rules, supplemented by the Supplemental Procedures for
Large Complex Disputes, of the American Arbitration Association as then in effect (the “Rules”). The arbitrator may grant injunctions or other relief in such disputes or controversy. The decision of the arbitrator shall be final,
conclusive and binding on the Parties to the arbitration. Judgment may be entered on the arbitrator’s decision in any court of competent jurisdiction. 
 (b) Consent to Personal Jurisdiction. The arbitrator(s) shall apply Texas law to the merits of any dispute or claim, without reference to conflicts of law rules. Consultant hereby consents to the
personal jurisdiction of the state and federal courts in Texas for any action or proceeding arising from or relating to this Agreement or relating to any arbitration in which the Parties are participants. 

(c) Equitable Relief. The Parties may apply to any court of competent jurisdiction for a temporary restraining order, preliminary
injunction, or other interim or conservatory relief, as necessary, without breach of this arbitration provision and without abridgment of the powers of the arbitrator. Consultant further agrees, for the purposes of this Section 10(c) and
Section 10(a) of this Agreement, that any breach of the covenants set forth in Sections 2 (“Confidentiality”), 3 (“Ownership”) and 4 (“Non-Compete and Non-Solicitation”) of this Agreement would cause the company
irreparable injury for which it would not have an adequate remedy at law. Accordingly, consultant agrees that if Consultant breaches Section 2 (“Confidentiality”), 3 (“Ownership”), or 4 (“Non-Compete and
Non-Solicitation”) of this Agreement, the Company will be entitled, in addition to any other right or remedy available, to temporary or preliminary equitable relief (including, but not limited to, a temporary restraining order or a preliminary
injunction) from a court of competent jurisdiction restraining such breach or threatened breach and final and permanent equitable relief (including, but not limited to, the granting of a permanent injunction and the ordering of specific performance)
from the arbitrator restraining such breach or threatened breach. 
 (d) Acknowledgment. CONSULTANT HAS READ AND
UNDERSTANDS SECTION 10 (“ARBITRATION AND EQUITABLE RELIEF”), WHICH DISCUSSES ARBITRATION. CONSULTANT UNDERSTANDS THAT BY SIGNING THIS AGREEMENT, CONSULTANT AGREES TO SUBMIT ANY CLAIMS ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS
AGREEMENT, OR THE INTERPRETATION, VALIDITY, CONSTRUCTION, PERFORMANCE, BREACH OR TERMINATION THEREOF, TO BINDING ARBITRATION, EXCEPT AS PROVIDED IN SECTION 10(c), AND THAT THIS ARBITRATION CLAUSE CONSTITUTES A WAIVER OF CONSULTANTS RIGHT TO A JURY
TRIAL AND RELATES TO THE RESOLUTION OF ALL DISPUTES RELATING TO ALL ASPECTS OF THE RELATIONSHIP BETWEEN THE PARTIES. 

	 	11.	GOVERNING LAW 

This Agreement shall be governed by the internal substantive laws, but not the choice of law rules, of the state of Texas. 

 

	 	12.	ENTIRE AGREEMENT 

This Agreement is the entire agreement of the Parties and supersedes any prior agreements between them, whether written or oral, with
respect to the subject matter hereof. No waiver, alteration, or modification of any of the provisions of this Agreement shall be binding unless in writing and signed by duly authorized representatives of the Parties hereto. 

 

	 	13.	ATTORNEY’S FEES 

 In any court action at law or equity that is brought by one of the Parties to enforce or interpret the provisions of this Agreement, the prevailing party will be entitled to reasonable attorney’s
fees, in addition to any other relief to which that party may be entitled. 
  

	 	14.	SEVERABILITY 

 If
one or more of the provisions in this Agreement are deemed void by law, then the remaining provisions will continue in full force and effect. 
  

	 	15.	TITLES AND SUBTITLES 

 The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement. 

IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of November 2, 2011. 

 

											
		 		 		 	 VERMILLION, INC.

Building Three, Suite 100
 Austin TX
78731

						
	By:	 	 /s/ Eric T. Fung
	 		 	By:	 	 /s/ Gail S. Page
	 	
	Name:	 	Eric T. Fung, M.D., Ph.D.	 		 	Name:	 	Gail S. Page	 	
	Title:	 	Consultant	 		 	Title:	 	Chief Executive Officer	 	

 Exhibit A 

 

	1.	Description of Services 

 Consultant shall be retained by the Company as its Chief Medical Officer and a member of the Company’s Scientific Advisory Board (“SAB”). As a member of the Company’s Scientific
Advisory Board, Consultant shall provide advice and recommendations with respect to the research, development and commercialization of the Company’s existing and future diagnostic tests, including, without limitation, OVA1, OVA2 and PAD tests.
Consultant shall provide any additional Services upon the Company’s request from time to time. 
  

	2.	Compensation 

 (a)
The Company shall pay Consultant for the Services provided as a member of the Company’s Scientific Advisory Board at the rate of $2,500 per quarter, prorated for any partial quarters. Such amount shall be payable to Consultant within thirty
(30) days after the end of each quarter (on a March 1 – February 28 fiscal agreement year). The Parties anticipate that Consultant will spend approximately four (4) business days each year (“Basic Service Days”)
during the term hereof in the performance of the Services as a member of the Company’s Scientific Advisory Board. 
 (b)
For any additional Services requested by the Company from time to time and performed by Consultant in excess of the Basic Service Days for Chief Medical Officer or other non-SAB duties, the Company shall pay Consultant at the rate of $145 per hour.
Such amount shall be payable within fifteen (15) days after the Company’s receipt of Consultant’s statement for such additional Services, pursuant to Section 1(b) of this Agreement. 

(c) The Company will reimburse Consultant for all approved reimbursable travel expenses pursuant to Section 1(b) of this Agreement.Amendment No. 3 to Development Agreement for Panther Instrument System

 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 240.24b-2. 

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	 		 	/s/ Marcus Wolfinger 
	Brad Blake	 		 	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 
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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 INITIAL AGREEMENT	  	 	5	  
		 	 3.3.
	 	MILESTONE 2 – SOFTWARE RELEASE FOR [...***...]	  	 	5	  
		 	 3.4.
	 	MILESTONE 3 – REAL TIME FEATURE COMPLETE SOFTWARE	  	 	5	  
		 	 3.5.
	 	MILESTONE 4 – REAL TIME V&V COMPLETE	  	 	5	  
		 	 3.6.
	 	MILESTONE 5 – REAL TIME PANTHER [...***...]	  	 	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	  

  

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	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: 
 Panther Project Software Development Plan, P10233-0108 

Panther Software Architecture Description, P10233-0035 
 Panther Product Requirements Document, P10233-0002 
 System Workflow SRS,
P10233-0235 
 User Interface SRS, P10233-0090 

Database SRS, P10233-0092 
 Event and Error Handling SRS, P10233-0083 
 Panther Instrument PRD
P10233-0002 
 Panther Instrument PSD, P10233-0003 

Security SRS, P10233-0248 
 Maintenance SRS, P10233-0243 
 Panther RT [...***...] SRS,
P10233-TBD 
  

	 	3.1.	HIGH LEVEL REQUIREMENTS 

 Milestone 1
Functionality 
  

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Milestone 2 Functionality 
  

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Milestone 3 Functionality 
  

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***Confidential Treatment Requested 
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	 	3.2.	MILESTONE 1 – ANALYSIS AND INITIAL AGREEMENT 

 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 [...***...] [.***.]. Milestone 1 is scheduled to be an initial project payment upon signing the project agreement and completing the functionality stated in the Milestone 1 functionality stated in 3.1.

  

	 	3.3.	MILESTONE 2 – SOFTWARE RELEASE FOR [...***...] 

 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 – REAL TIME FEATURE COMPLETE SOFTWARE 

 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 – REAL TIME V&V COMPLETE 

 Milestone 4 includes addressing any issues identified in Milestone 3. Milestone 4 includes completed functionality of the Real Time Assay on Panther software having verification and validation completed.
Milestone 4 is scheduled to be feature complete [.***.]. 
  

	 	3.6.	MILESTONE 5 – REAL TIME PANTHER [...***...] 

 Milestone 5 includes addressing any issues identified in Milestone 4. Milestone 5 also includes V&V for the final launch and Gen-Probe acceptance of Stratec Software Verification report
[...***...]. 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 the Panther Software Development Plan, P10233-0108 

  

***Confidential Treatment Requested 
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	 	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:
 [...***...]
 [...***...]

			
	Gen-Probe Software Development	  	 During the development 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 master plan

Verification summary report
 Verification
management
 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

  

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	 	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 – Analysis and Initial Agreement
	  	[...***...]
	 Milestone 2 – Software Release for [...***...]
	  	[...***...]
	 Milestone 3 – Real Time Feature Complete Software
	  	[...***...]
	 Milestone 4 – Real Time V&V Complete
	  	[...***...]
	 Milestone 5 – Acceptance of Summary Verification Report
	  	[...***...]

 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
	  	Payment to Stratec
AG	 	 	Payment to
Stratec USA	 
	 Milestone 1 – Analysis and Initial Agreement
	  	$	[...***...]	  	 	 	[...***...]	  
	 Milestone 2 – Software Release for [...***...]
	  	$	[...***...]	] 	 	 	[...***...]	  
	 Milestone 3 – Real Time Feature Complete Software
	  	$	[...***...]	  	 	 	[...***...]	  
	 Milestone 4 – Real Time V&V Complete
	  	$	[...***...]	  	 	 	[...***...]	  
	 Milestone 5 – Real Time Panther [...***...]
	  	$	[...***...]	  	 	 	[...***...]	  
		  	  
	  
	 	 	  
	  
	 
	 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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	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 
 Bernd M. Steidle

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

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

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

[...***...] 
  

							
		 		 	2010-12-20

  
  

 

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

  
 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) 

  
 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. 

  

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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
[...***...] However, in case of any scheduling conflict [...***...] 
 Specific details are provided in the “Multiple Program Software
Release Schedule dated [...***...]. 
 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 Stratec Biomedical [...***...] 

 

	 	•	 	 [...***...]fulltime resources provided by Stratec Biomedical [...***...] 

 

	 	•	 	 [...***...] fulltime resource provided by Stratec Biomedical [...***...] 

 

	 	•	 	 [...***...] fulltime resources provided by Stratec Biomedical [...***...] 

 

	 	•	 	 [...***...] 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. 

  

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	5.	Milestone Payments 

  

									
	 Development of Real-Time Panther Software
	  	Stratec Biomed.
AG	 	  	Stratec Biomed.
US	 
	 Receiving PO
	  	 	[...***...]	  	  	 	[...***...]	  
	 SW release for [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  
	 RT-Feature Complete
	  	 	[...***...]	  	  	 	[...***...]	  
	 VV complete of [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  
	 sum
	  	 	[...***...]	  	  	 	[...***...]	  
		  				  	  
	  
	 
	 total
	  				  	 	[...***...]	  
		  				  	  
	  
	 

  

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