EX-10.30






Exhibit 10.30

***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.




FUTURE BLOOD SCREENING ASSAY-




ULTRIO 2 ADDENDUM




AMENDING




AGREEMENT ENTERED INTO AS OF JUNE 11, 1998




BY AND BETWEEN




GEN-PROBE INCORPORATED




AND




NOVARTIS VACCINES & DIAGNOSTICS, INC.









 









 











	 	 	 	 	 
	1.
Definitions
	 	 	1	 
	 
	1.1 Agreement
	 	 	1	 
	 
	1.2 Binder
	 	 	1	 
	 
	1.3 Budget
	 	 	2	 
	 
	1.4 Completion Date
	 	 	2	 
	 
	1.5 FTE Labor Rate
	 	 	2	 
	 
	1.6 Interim Events
	 	 	2	 
	 
	1.7 Marketing Evaluation
	 	 	2	 
	 
	1.8 Material Modification
	 	 	2	 
	 
	1.9 Non-material Modification
	 	 	2	 
	 
	1.10 Product Requirements Document (or “PRD”)
	 	 	2	 
	 
	1.11 Project Management
	 	 	2	 
	 
	1.12 Resource Plan
	 	 	3	 
	 
	1.13 Software Requirements Specifications (or “SRS”)
	 	 	3	 
	 
	1.14 Timeline
	 	 	3	 
	 
	1.15 Ultrio 2 Assay Product
	 	 	3	 
	 
	1.16 Ultrio 2 Development Costs
	 	 	3	 
	 
	1.17 Ultrio 2 Development Program
	 	 	3	 
	 
	2. Ultrio 2 Development Program
	 	 	3	 
	 
	2.1 Objective
	 	 	3	 
	 
	2.2 General Conduct of Development
	 	 	3	 
	 
	2.3 No Guarantee
	 	 	4	 
	 
	2.4 Project Management
	 	 	4	 
	 
	2.4.1 Principles of Project Management
	 	 	4	 
	 
	2.4.2 Project Manager
	 	 	4	 





i 









 






	 	 	 	 	 
	2.4.3 Gen-Probe Project Manager’s Responsibilities
	 	 	5	 
	 
	2.4.4 Meetings of the Supervisory Board
	 	 	5	 
	 
	2.5 Development Responsibilities
	 	 	6	 
	 
	2.5.1 Principal Responsibility; General Statement
	 	 	6	 
	 
	2.5.2 Shared Responsibility
	 	 	6	 
	 
	2.5.3 Principal and Shared Responsibility; Specific Allocation
	 	 	6	 
	 
	2.5.4 Regulatory/Licensure
	 	 	7	 
	 
	2.5.5 Disagreements
	 	 	7	 
	 
	3. Modifications
	 	 	7	 
	 
	3.1 Ultrio 2 Development Program Definition
	 	 	7	 
	 
	3.2 Modifications
	 	 	8	 
	 
	3.2.1 Request for Modifications
	 	 	8	 
	 
	3.2.2 Non-Material Modifications
	 	 	8	 
	 
	3.3 Material Modifications
	 	 	8	 
	 
	3.3.1 Request for Material Modifications
	 	 	8	 
	 
	3.3.2 Initial Analysis of Impact of Proposed Material Modification
	 	 	8	 
	 
	3.3.3 Preparation of Modified Ultrio 2 Development Program
	 	 	9	 
	 
	3.3.4 Acceptance of Modified Ultrio 2 Development Program
	 	 	9	 
	 
	3.3.5 Effective Date of Modified Ultrio 2 Development Program
	 	 	9	 
	 
	3.4 Notice of Significant Changes
	 	 	10	 
	 
	4. Changes to Ultrio 2 Assay Product after Completion Date
	 	 	10	 
	 
	4.1 Process
	 	 	10	 
	 
	4.2 Additional Work under Addendum
	 	 	10	 
	 
	5. Ultrio 2 Development Costs
	 	 	10	 
	 
	5.1 [...***...] Ultrio 2 Development Costs
	 	 	10	 
	 
	5.2 Definition and Calculation of Ultrio 2 Development Costs
	 	 	11	 
	 
	5.2.1 Ultrio 2 Development Costs; FTE Labor Rate
	 	 	11	 






 




			
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	5.2.2 Comparison with Resource Plan
	 	 	12	 
	 
	5.2.3 Methodology
	 	 	12	 
	 
	5.3 Payment of Ultrio 2 Development Costs
	 	 	13	 
	 
	5.3.1 Accrued Ultrio 2 Development Costs
	 	 	13	 
	 
	5.3.2 [...***...] Budgeted Payments
	 	 	13	 
	 
	5.3.3 [...***...] True-Up Payments
	 	 	13	 
	 
	5.3.4 Invoices
	 	 	13	 
	 
	5.4 Dispute
	 	 	14	 
	 
	5.5 Right to Audit and Verify
	 	 	14	 
	 
	6. Manufacturing and Commercialization
	 	 	14	 
	 
	6.1 Definitions Relevant to Manufacturing and Commercialization Obligation
	 	 	14	 
	 
	6.1.1 Applicable Purchase Price
	 	 	14	 
	 
	6.1.2 Transfer Price
	 	 	14	 
	 
	6.1.3 Manufacturing Cost
	 	 	14	 
	 
	6.1.4 Rare Reagents
	 	 	14	 
	 
	6.2 Right to Audit and Verify
	 	 	14	 
	 
	6.3 Quality Arrangements
	 	 	14	 
	 
	6.4 Non-Commercial Products
	 	 	15	 
	 
	6.5 Commercialization Budget
	 	 	15	 
	 
	7. License Grants
	 	 	16	 
	 
	8. Addendum Effective Date; Term; Termination
	 	 	16	 
	 
	8.1 Term of Ultrio 2 Addendum
	 	 	16	 
	 
	8.2 Termination for Breach
	 	 	16	 
	 
	  8.2.1 Default
	 	 	16	 
	 
	  8.2.2 Right to Cure Event of Default
	 	 	17	 






 




			
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	8.2.3 Effect of Termination for Breach
	 	 	17	 
	 
	8.3 Termination by Both Parties
	 	 	18	 
	 
	8.3.1 Vote to Terminate
	 	 	18	 
	 
	8.3.2 Effect of Notice Period on Termination by Both Parties
	 	 	18	 
	 
	8.3.3 Effect of Termination by Both Parties
	 	 	18	 
	 
	8.4 Termination by Either Party; Unilateral Withdrawal from Ultrio 2 Development Program
	 	 	18	 
	 
	8.5 Continuance of Ultrio 2 Development Program following Unilateral Withdrawal or Termination
	 	 	19	 
	 
	8.5.1 Election
	 	 	19	 
	 
	8.5.2 Funding and Conduct of Development
	 	 	19	 
	 
	8.5.3 Reimbursement of Development Costs
	 	 	19	 
	 
	8.5.4 Control of the Program upon Unilateral Funding
	 	 	21	 
	 
	8.5.5 Rights under Agreement
	 	 	21	 
	 
	9. Escalation
	 	 	21	 
	 
	9.1 Escalation Process
	 	 	21	 
	 
	9.2 Remedies in Event of Default
	 	 	21	 
	 
	9.3 Survival
	 	 	21	 
	 
	10. No Other Amendment
	 	 	22	 
	 
	11. Counterparts
	 	 	22	 







iv 









 








Future Blood Screening Assay-




ULTRIO 2 ADDENDUM




     This Future Blood Screening Assay — Ultrio 2 Addendum (the “Ultrio 2 Addendum”) is entered
into, effective as of October 1, 2008 (the “Addendum Effective Date”) pursuant to and amending that
certain Agreement entered into as of June 11, 1998 (the “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 Novartis Vaccines & Diagnostics, Inc., a Delaware
corporation (“Novartis”; and collectively with Gen-Probe, the “parties”) with a place of business
at 4560 Horton Street, Emeryville, CA 94608.



Recitals




     A. Prior to April 19, 2006, the legal name of Novartis Vaccines and Diagnostics, Inc. was
Chiron Corporation.



     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 Future Blood Screening Assays to
be conducted by the Blood Screening Instruments.



     C. The parties have discussed the proposed development of an enhanced triplex TMA assay for
the detection of human immunodeficiency virus Type 1 (HIV), hepatitis C virus (HCV), and/or
hepatitis B virus (HBV), on both the enhanced semi-automated instrument system (“eSAS”) (referred
to in the Agreement as the Leader/Magnetic Separation Instrument) and on the fully-automated TIGRIS
instrument, which assay would fall within the definition of a “Future Blood Screening Assay” set
forth in Section 1.30 of the Agreement (the “Ultrio 2 Assay”).



     E. By this Ultrio 2 Addendum, the parties desire to include the Ultrio 2 Assay to be conducted
by one or more of the Blood Screening Instruments within the scope of the provisions of the
Agreement, as clarified and amended by the terms and conditions more particularly described in this
Ultrio 2 Addendum.



Agreement




     NOW,
THEREFORE, for and in consideration of the mutual covenants and agreements set forth in this Ultrio 2 Addendum, the parties agree as follows:



1. Definitions. All capitalized terms used but not defined in this Ultrio 2 Addendum shall
have the meanings set forth in the Agreement.




     1.1 Agreement shall mean the June 11, 1998 Collaboration Agreement, as amended in the
manner described in Recital A.



     1.2 Binder means that certain three-ring binder, with one or more volumes, entitled “Ultrio
2 Development Program for the Ultrio 2 Assay Product (Gen-Probe/Novartis Ultrio 2 Development
Addendum, dated as of xxx) Binder,” in which certain documents, materials or other items
incorporated into this Ultrio 2 Addendum by reference are kept. The original Binder and an
additional volume of the Binder, labeled “Amendments to Ultrio 2 Development Program” and
reflecting any changes,



1









 







modifications or amendments to the Binder, are maintained by and located at the premises of
Gen-Probe. A copy of the original Binder, and a copy of the additional volume of the Binder, each
signed by both parties, shall be maintained by and located at the premises of Novartis.



     1.3 Budget means the budgeted Ultrio 2 Development Costs of the Ultrio 2 Development
Program. The Budget shall include the estimated cost of the Ultrio 2 Development Program on a
monthly basis through the end of the Ultrio 2 Development Program. The approved Budget is
described in the Binder under the heading “Budget”, and may be amended from time to time under the
provisions of Section 3 below.



     1.4 Completion Date means [...***...].



     1.5 FTE Labor Rate is defined in Section 5.2.1.



     1.6 Interim Events means such events of material significance to the Ultrio 2
Development Program as are mutually agreed to by both parties and set forth with specificity and
identified as an “Interim Event” on the Timeline, as such Interim Events may be modified, pursuant
to the change procedures set forth in Section 3 of this Ultrio 2 Addendum.



     1.7 Marketing Evaluation means a limited-duration evaluation of the performance of the
Ultrio 2 Assay Product in a customer’s or potential customer’s laboratory setting, primarily for
the purposes of customer familiarization and on-site demonstration of assay performance. Data
generated in the course of a Market Evaluation is not required for and will not be used for any
regulatory submission, or for the release of any blood product or diagnostic purpose.



     1.8 Material Modification means a change or amendment to the Ultrio 2 Development
Program that materially affects the requirements set forth in the then-current Product Requirements
Document, Software Requirement Specifications, Resource Plan or Budget, or that materially modifies
an Interim Event set forth in the Timeline.



     1.9 Non-material Modification means a change or amendment to the Ultrio 2 Development
Program other than a Material Modification. Written agreement among members of Project Management
that a modification is a “Non-material Modification” hereunder as described in Section 3.2 below
shall be conclusive.



     1.10 Product Requirements Document (or “PRD”) means the requirement specifications for
the Ultrio 2 Assay Product, and includes as a component thereof the Software Requirements
Specifications. The initial Product Requirements Document is described in the Binder, under the
heading “Product Requirements Document (PRD, Revision 2007-05-25)“and may be amended from time to
time under the provisions of Section 3 below. Novartis shall have primary responsibility for
obtaining customer input for use in drafting requirements, communicating that Input, and ensuring
that customer requirements are addressed in the PRD.



     1.11 Project Management is defined in Section 2.4.1.





 




			
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2









 










     1.12 Resource Plan means the description of (i) a party’s personnel to be allocated to
the Ultrio 2 Development Program, including the name of the specific personnel or the qualification
or grade of unidentified personnel, and dedicated amount of time and periods for the commitment of
such personnel required for the Ultrio 2 Development Program, and (ii) equipment, tools, software,
or other special items, the purchase, license or leasing of which is specifically required for use
by such personnel to support the Ultrio 2 Development Program. The initial Resource Plan is
described in the Binder, under the heading “Resource Plan,” and may be amended from time to time
under the provisions of Section 3 below.



     1.13 Software Requirements Specifications (or “SRS”) means the specifications for the
software component of the Ultrio 2 Development Program. The initial Software Requirements
Specifications are described in the Binder, under the heading “Software Requirements Specifications
(SRS, Revision C, dated xxx),” and may be amended from time to time under the provisions of Section
3 below.



     1.14 Timeline means the overall development timeline as developed and maintained by
the Program Manager.



     1.15 Ultrio 2 Assay Product is defined on Schedule 1.16 and expressly excludes any
products or instruments in the Clinical Diagnostic Field.



     1.16 Ultrio 2 Development Costs means, with respect to this Ultrio 2 Addendum only,
the development costs defined in Section 5 hereof.



     1.17 Ultrio 2 Development Program means the statement of work for the development of
the Ultrio 2 Assay Product, including any required instrument modifications or validations, under
the terms of this Ultrio 2 Addendum, as such development program is described in the Binder, and
consists of (i) the Product Requirements Document, (ii) the Software Requirements Specifications,
(iv) the Resource Plan included within the Budget, and (v) the Budget.



2. Ultrio 2 Development Program.




     2.1 Objective. Subject to the terms of the Agreement, as amended by this Ultrio 2
Addendum, the parties each shall conduct their respective obligations under the Ultrio 2
Development Program as established in accordance with the terms hereof, and shall conduct such
clinical trials and apply for and endeavor to obtain such regulatory approvals as necessary or
appropriate to make and sell the Ultrio 2 Assay Product for use in the Blood Screening Field. The
Development Program will be limited to development of the Ultrio 2 Assay Product for sale outside
the United States, unless and until the Supervisory Board approves a specific development plan and
budget for the United States and a written amendment reflecting such agreement is signed by the
parties.



     2.2 General Conduct of Development. The parties shall conduct their respective
obligations under the Ultrio 2 Development Program in compliance in all material respects with all
requirements of applicable laws and regulations and all applicable good laboratory, clinical and
manufacturing practices. In addition, the parties each shall proceed diligently with their
respective obligations under the Ultrio 2 Development Program and shall use their respective
Commercially Reasonable Efforts to achieve the objectives of the Ultrio 2 Development Program
efficiently and expeditiously. The parties each shall allocate such personnel, equipment,
facilities and other resources to the Ultrio 2 Development Program to carry out their respective
obligations and to accomplish the objectives thereof, all as is more particularly described in the
Ultrio 2 Development Program, as amended from time to time during the term of this



3









 




Ultrio 2 Addendum (in accordance with the provisions of Section 3). Each party shall have the right
to consult with the other party regarding the Ultrio 2 Development Program and the obligation to
reasonably consider the other party’s advice.




     2.3 No Guarantee. While each party agrees to use Commercially Reasonable Efforts to
achieve the objectives described in the Ultrio 2 Development Program (as amended from time to time
during the term of this Ultrio 2 Addendum (in accordance with the provisions of Section 3)
efficiently and expeditiously, the parties understand that they have embarked on a development
program whose outcome is uncertain. The parties further understand that the Ultrio 2 Development
Program is subject to a number of variables that are inherent to the development process and that
there is a possibility that the parties may fail to successfully complete the development of the
Ultrio 2 Assay Product, even though each party exercises Commercially Reasonable Efforts and
commits the resources described in the Ultrio 2 Development Program. Neither party will be in
breach of its obligations to the other hereunder and such party shall be deemed to have exercised
Commercially Reasonable Efforts, so long as such party shall have committed the resources described
in the Ultrio 2 Development Program, even if such resources fail to successfully complete the
development of the Ultrio 2 Assay Product, or to complete the development of the Ultrio 2 Assay
Product in accordance with the Timeline or for the amounts described in the Budget or to the
specifications set forth in the PRD or the SRS. The payment of Ultrio 2 Development Costs between
the parties shall be due and payable without respect to the achievement of any particular
deliverable specified in the Ultrio 2 Development Program.



     2.4 Project Management.



          2.4.1 Principles of Project Management. The parties agree that in the process of
exercising their responsibilities, the Project Team (led by the Gen-Probe Project Manager as set
forth herein) should have routine access to such information needed to assess progress under and
costs of the Ultrio 2 Development Program and that team members from each party shall be invited to
participate in team meetings, and have access to team meeting minutes, except to the extent the
Gen-Probe Project Manager determines in their reasonable discretion that any such meetings or
minutes contain confidential, proprietary information of Gen-Probe. In such cases, the Gen-Probe
Project Manager shall (i) determine whether the Novartis team members can attend all or a portion
of such meeting, (ii) provide a copy of the meeting minutes to Novartis team members for the
activity with such confidential, proprietary information redacted, and (iii) to the extent that
such minutes had proprietary or confidential information redacted, inform the appropriate Novartis
team members of the general nature of any decisions made at such meeting which affect the Timeline,
Budget or Interim Events; provided, however that the Gen-Probe Project Manager may only redact
information comprising Gen-Probe intellectual property and know how or confidential business
issues. Team members will have access to non-confidential and non-proprietary information of the
other party necessary to perform their responsibilities under the Ultrio 2 Development Program,
including those listed under Section 2.4.4. Confidentiality will be maintained in accordance with
Section 8.1 of the Agreement, and disclosure of any information under this Section 2.4.1 shall be
governed by that certain Confidentiality and Joint Interest Agreement, by and between the parties,
dated as of October 30, 2001.




          2.4.2 Project Manager. The project associated with development of the Ultrio 2 Assay
Product will be managed under a Project Manager appointed by Gen-Probe, whose responsibilities are
described in Section 2.4.3. The Ultrio 2 Development Program will be managed by a Project Manager
appointed by Gen-Probe. As of the Addendum Effective Date, the Project Manager shall be
[...***...]. Any change by Gen-Probe of the Project Manager must be approved by the Supervisory
Board, which approval shall not be unreasonably withheld.





 




			
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          2.4.3 Gen-Probe Project Manager’s Responsibilities. The Gen-Probe Project Manager
shall be responsible for the following activities, together with such other activities as the
parties may agree:




               (a) Managing all matters relating to the Ultrio 2 Development Program under this Ultrio 2
Addendum, including each party’s respective responsibilities and contributions and receiving
reports from the project team;



               (b) Providing written monthly progress reports to the parties and presenting status reports to
the Supervisory Board in accordance with Section 2.4.4 below;



               (c) Submitting and receiving the reports, materials and documents required to be delivered
under this Ultrio 2 Addendum;



               (d) Overseeing the process of proposing, and submitting to the parties, any proposed
modifications to the Product Requirements Document, Software Requirement Specifications, Resource
Plan or Budget, and in the event the parties cannot agree, presenting the same to the Supervisory
Board in an objective and neutral manner; Project Manager has responsibility for documenting
changes to scope — all requests to Supervisory Board must include impact to latest business case,
as well as impact to current timeline and budget.



               (e) Arranging any meetings to be held between the parties and participating, to the extent the
Project Manager deems appropriate, in meetings of the project team;



               (f) Maintaining, for record keeping purposes, a log book or notes containing summaries and
dates of all material communications and deliveries between the parties of which the Project
Manager is aware, consistent with the parties’ protocol for such sharing of confidential
information set forth in that certain Confidentiality and Joint Interest Agreement, by and between
the parties, dated as of xxx;



               (g) Implementing appropriate practices and procedures to manage the progress under this Ultrio
2 Addendum;



               (h) Fostering good communication among the project team and between the parties. It is
intended by the parties that both parties share in the information concerning the progress made in
the Ultrio 2 Development Program and the cause of any delays. It is expected that Novartis will
make recommendations to the Gen-Probe Project Manager for preferred paths when substantial delays
are identified and multiple paths forward are identified. Understanding that it takes time for
information to flow up the chain of command, the Gen-Probe Project Manager will inform Novartis of
delays and progress on resolution as soon as it becomes available to him/her; and



               (i) It is understood that both companies hold proprietary trade secret know-how and processes
regarding their respective technologies that are not necessarily shared as part of this Agreement.
On occasion it may occur that a full understanding of difficulties in the progress of development
may require a detailed understanding of this proprietary know-how and processes. Each party will
endeavor to appraise the other of the outcomes and consequences of these difficulties, while
protecting the confidentiality of the information.



          2.4.4 Meetings of the Supervisory Board. The Supervisory Board shall meet from time to time
during the term of this Ultrio 2 Addendum, but not less frequently than once each calendar



5









 






quarter during the term hereof. Not less frequently than quarterly, a regular agenda item at the
regularly scheduled Supervisory Board meeting shall be to receive a report from the Project Manager
and conduct a review of the Ultrio 2 Development Program to assess progress of the development and
the potential for commercialization of the Ultrio 2 Assay Product.




     2.5 Development Responsibilities.



          2.5.1 Principal Responsibility; General Statement. The parties’ intention is the
smooth and efficient conduct of development, and the parties desire by this Section 2.5 to provide
guiding principles by which day-to-day decisions may be made by the responsible party and by which
the approval process more particularly described in Section 3 below shall be governed. The parties
intend that the Ultrio 2 Assay Product development will be conducted primarily and principally by
Gen-Probe. Section 2.5.3 below specifies the development activities that will be the primary
responsibility of Novartis. The party to whom principal responsibility is allocated in this Section
2.5 has the power to make day-to-day decisions regarding matters within the area of such
responsibility, consistent with the overall Ultrio 2 Development Program. The parties’ obligations
with respect to certain warehousing and shipping are subject to Amendment No. 3.




          2.5.2 Shared Responsibility. Gen-Probe and Novartis have entered into that certain
Definitive Written Settlement Agreement, dated December 5, 2001. Section 2(a) of the Definitive
Written Settlement Agreement incorporates by reference the provisions of the Short Form Agreement
(attached as Exhibit A to the Definitive Written Settlement Agreement). The parties hereby
expressly incorporate the provisions of Sections F.5 and F.6 of the Short Form Agreement between
the parties, dated, into this Ultrio 2 Addendum, and agree that the provisions of Sections F.5 and
F.6 of the Short Form Agreement will govern the relationship between the parties for the purpose of
the Ultrio 2 Assay Product in connection with the subject matters addressed in those provisions.




          2.5.3 Principal and Shared Responsibility; Specific Allocation. Without limiting the
general statements set forth in Sections 2.5.1 and 2.5.2, the parties agree to allocate specific
responsibility as follows:




	 	 	 	 	 
	Function	 	Principal Responsibility	 	Shared Responsibility
	[...***...]

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

	 	Gen-Probe	 	 
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

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

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

	 	Gen-Probe	 	 
	[...***...]

	 	Gen-Probe*	 	 
	[...***...]

	 	Gen-Probe*	 	 
	[...***...]

	 	Gen-Probe*	 	 
	[...***...]

	 	 	 	Gen-Probe/Novartis
	[...***...]

	 	 	 	Gen-Probe/Novartis
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

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

	 	Gen-Probe	 	 






 




			
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	Function	 	Principal Responsibility	 	Shared Responsibility
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

	 	Gen-Probe	 	 
	[...***...]

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

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

	 	Novartis for tiers 1 and 2;
Gen-Probe for tier 3
	 	Gen-Probe/Novartis








 




			
	*	 	Novartis shall have reasonable input into [...***...].





          2.5.4 Regulatory/Licensure. Pursuant to [...***...]. All disagreements on
regulatory/licensure issues shall be addressed by the Supervisory Board and, if necessary, by
implementation of the escalation procedure described in Article 13 of the Agreement, excluding
arbitration. For issues that cannot be resolved through such procedures, Gen-Probe’s Chief
Executive Officer shall have the right to make a final decision.




          2.5.5  Disagreements. It is recognized that the project team may disagree on
approaches for aspects of the project. Even though one party has the principal responsibility for
development in the functional area described in Section 2.5, disagreements that cannot be resolved
by the Gen-Probe Project Manager may be brought to the Supervisory Board. However, work will
proceed in accordance with the choice of the principally responsible party, while being discussed
at the Supervisory Board. In the event that the parties do not agree at the Supervisory Board
level, the party with principal responsibility may continue to proceed per its best judgment. If a
disagreement arises in a functional area for which responsibility is shared and resolution cannot
be achieved at the Supervisory Board, except as to Regulatory/Licensure Strategy which shall be
governed by Section 2.5.4 above, work shall be suspended in such functional area until a resolution
is reached through Article 13 of the Agreement, including arbitration.



3. Modifications.




     3.1 Ultrio 2 Development Program Definition. The parties have prepared and agreed
upon an Ultrio 2 Development Program, as described in the Binder. The Ultrio 2 Development Program,
as described in the Binder, will govern the rights and responsibilities of the parties until
changed in accordance with the provisions hereof. The parties recognize and anticipate that
additional clarification and refinement of the Ultrio 2 Development Program, including changes, if
any, necessary to reflect accepted delays in, or increases in costs of, development, will be
required as development proceeds. The parties intend that this Ultrio 2 Addendum establish a
process by which the parties will amend the Ultrio 2 Development Program, in accordance with the
terms described in this Section 3.





 




			
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     3.2 Modifications.



          3.2.1 Request for Modifications. Either party may propose either Material or
Non-material Modifications to any part of the Ultrio 2 Development Program from time to time during
the term of this Ultrio 2 Addendum, including without limitation a request for a change to the FTE
Labor Rate, as defined in Section 5.2.1. The process applicable to any such proposed modifications
shall be as described in this Section 3. Changes, modifications or improvements to the Ultrio 2
Assay Product, after the Completion Date, and the parties’ obligations and rights with respect
thereto, are governed by the provisions of Section 4 below. The Project Manager, and under his or
her supervision, the project team, will review any proposed modification to the Ultrio 2
Development Program. Any modification which (i) reflects an increase in the actual Ultrio 2
Development Costs incurred that, when aggregated with all previously authorized modifications, of
greater than [...***...] over the Development Costs reflected in the original Budget approved in
effect as of the date this Ultrio 2 Addendum was executed by the parties, or (ii) contains a
proposal to alter any Interim Event as compared to the most recently approved Timeline shall be
deemed to be a Material Modification. The Supervisory Board shall review requested changes and
make a determination with respect to whether such requested modifications are Material or
Non-material Modifications. If the Supervisory Board has met and consulted without resolution,
then either party may, in its discretion, determine that the parties have reached an impasse with
respect thereto and implement the escalation procedure described in Article 13 of the Agreement to
resolve such impasse.




          3.2.2 Non-Material Modifications. Unless changes to the specifications described in
Section 3.2.1 constitute a Material Modification, any Non-Material Modifications shall be reported
in the monthly summary progress reports pursuant to Section 2.4.4 and shall not be subject to the
approval process described in Section 3.3.




     3.3 Material Modifications.



          3.3.1 Request for Material Modifications. In the event that one party desires to
request a Material Modification to the Ultrio 2 Development Program from time to time during the
term hereof, such party (the “requesting party”) shall submit to the other party such request in
writing, in sufficient detail to enable the other party (the “receiving party”) to evaluate the
request. Without limiting the foregoing, the requesting party shall prepare a revised draft
version of the Budget, reflecting any changes necessary to fully implement the requested Material
Modification to the Ultrio 2 Development Program. Requests for Material Modification shall include
an analysis of the probable impact to the latest business case for the Ultrio 2 Assay Product, as
well as an analysis of the impact to current timeline and budget.




          3.3.2 Initial Analysis of Impact of Proposed Material Modification. Promptly upon
receipt of such request, but in any event not more than [...***...] thereafter, the parties
shall conduct a preliminary analysis of the impact that the requested Material Modification would
have, including without limitation the impact any such proposed Material Modification would have on
the Budget and/or the Timeline, and shall meet and conduct an analysis of the impact of such
Material Modification on the potential profitability of the Ultrio 2 Assay Product. Should either
party conclude, in its reasonable discretion, that the potential [...***...] by any proposed change
to the Ultrio 2 Development Program requested in accordance with this Section 3.3, such party may
elect to terminate participation in the Ultrio 2 Development Program under the provisions of
Section 8.4.






 




			
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          3.3.3 Preparation of Modified Ultrio 2 Development Program. Unless the parties terminate
the Ultrio 2 Development Program for convenience under Section 8.3 below or a party terminates on
unilateral withdrawal under Section 8.4 below, promptly upon completion of the review and analysis
under Section 3.3.2, Gen-Probe and Novartis shall complete and deliver to the Supervisory Board
revisions to the Product Requirements Document, Software Requirements Specification, Resource Plan
or Budget, as applicable, responsive to the request for acceptance by the parties under Section
3.3.5 below. Costs incurred by Gen-Probe and Novartis to prepare such response to the request
shall be included in Ultrio 2 Development Costs hereunder.




          3.3.4 Acceptance of Modified Ultrio 2 Development Program.




               (a) Unless the parties terminate the Ultrio 2 Development Program for convenience under
Section 8.3 below or a party terminates on unilateral withdrawal under Section 8.4 below, the
parties shall promptly, but not later than [...***...] after preparation by the parties of a
modified Ultrio 2 Development Program under Section 3.3.3 meet and consult with respect to the
proposed modified Ultrio 2 Development Program. No modified Ultrio 2 Development Program shall be
effective unless approved by the Supervisory Board.



               (b) If the Supervisory Board approves a modified Ultrio 2 Development Program, then the
parties shall thereafter finalize such modified Ultrio 2 Development Program, using the provisions
of this Section 3.3.5(b), as follows:



                    (i) Each party shall, within [...***...] following completion of the consultation and review
under paragraph (a), deliver to the other party either a written approval of the proposed modified
Ultrio 2 Development Program or a detailed written statement specifying the basis for rejection.
Approval shall not be unreasonably withheld. The requesting party may, in response to a rejection,
revise the proposed modified Ultrio 2 Development Program to reflect the discussions of the
parties, and redeliver the revised proposed modified Ultrio 2 Development Program for further
review, until the parties agree upon the Material Modification. Either party may, in its
discretion and with notice to the other party, determine that the parties have reached an impasse
with respect to any proposed Material Modification and deliver the request to the Supervisory Board
for determination.



                    (ii) If a party delivers the request to the Supervisory Board for determination, the
Supervisory Board shall promptly, but not later than the later of (i) [...***...] after
receipt of a requested modified Ultrio 2 Development Program, or (ii) [...***...], meet and discuss
the proposed Material Modification to Ultrio 2 Development Program.



                    (iii) If the Supervisory Board has met and consulted without resolution, then either party
may, in its discretion, determine that the parties have reached an impasse with respect to any
proposed modification and implement the escalation procedure described in Article 13 of the
Agreement to resolve such impasse. Notwithstanding anything to the contrary in this Ultrio 2
Addendum or the Agreement, all Material Modifications, whether agreed or determined through
arbitration, shall be finally determined and documented in accordance with this Section 3.3. Where
one party has rejected a proposed modified Ultrio 2 Development Program, the sole question to be
presented in any arbitration is whether that party unreasonably withheld its approval.



          3.3.5 Effective Date of Modified Ultrio 2 Development Program. At such time as the parties
(or, if applicable, the Supervisory Board) shall have accepted a modified Ultrio 2 Development
Program incorporating a Material Modification, or any portion thereof, the parties shall evidence
such






 




			
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agreement by initialing the revised Product Requirements Document, Software Requirements
Specification, Resource Plan or Budget, as applicable. The Ultrio 2 Development Program as so
modified and approved shall constitute the Ultrio 2 Development Program hereunder and be
incorporated by reference into this Ultrio 2 Addendum, and shall supersede the preceding Ultrio 2
Development Program, or applicable portions thereof, for all purposes. In order to evidence their
agreement to the revised Ultrio 2 Development Program, the parties shall include it in an
additional volume of the Binder, labeled “Amendments to Ultrio 2 Development Program,” in which all
amendments and modifications to the Ultrio 2 Development Program will be kept.




     3.4 Notice of Significant Changes. Each party will give [...***...] notice to the
other party prior to any proposal of a significant reduction or increase in resources from the
then-current Resource Plan in order to allow the parties time to divert resources either to or from
the Ultrio 2 Development Program. Any significant changes to the Budget or the Resource Plan shall
be effective only upon the expiration of [...***...] from the delivery of such notice, unless the
parties both agree to a shorter period of time in writing.


4. Changes to Ultrio 2 Assay Product after Completion Date.




     4.1 Process. Notwithstanding the provisions of Section 3, the parties recognize that
from time to time during the term hereof the market may demand or regulatory changes may require
that special enhancements or modifications be made to the Ultrio 2 Assay Product, and that either
party may desire to adopt such changes. From and after the Completion Date, each party will notify
the Supervisory Board promptly upon receipt of a request from a customer, or upon identification of
regulatory changes that may require the parties to implement any enhancement, modification or other
change to the Ultrio 2 Assay Product. The Supervisory Board shall promptly, but not later than the
latter of (i) [...***...] after receipt from a party of such request for such changes to the Ultrio
2 Assay Product, or (ii) [...***...], meet and consult with respect to such requested change. The
Supervisory Board shall decide (i) whether the requested changes should be implemented; and (ii)
whether the requested changes can be implemented under the terms of this Ultrio 2 Addendum or are
significant enough to warrant a new Development Program under the terms of Article 3 of the
Agreement, in which case the parties shall use the process more particularly described in Section
3.2 of the Agreement.



     4.2 Additional Work under Addendum. If the Supervisory Board determines that the
changes are sufficiently minor that they can be implemented under this Ultrio 2 Addendum, then the
parties shall implement the process more particularly described in Section 3.3 above, and the
Supervisory Board may approve a new Ultrio 2 Development Program, consisting of a new modified
Product Requirements Document, Software Requirements Specifications, Resource Plan and Budget, for
the purpose of developing such changes. Notwithstanding the foregoing, nothing herein shall
obligate either party to conduct development work after the Completion Date with respect to the
Ultrio 2 Assay Product, without regard to whether the other party indicates a willingness to pay
some portion or the entire costs of such development.


5. Ultrio 2 Development Costs.




     5.1 [...***...] Ultrio 2 Development Costs. [...***...] Ultrio 2 Development Costs,
as defined in and subject to Section 5.2 below. Such costs shall be payable as described in
Section 5.3 herein. The Budget has been prepared for the purpose of permitting the parties to plan
for Ultrio 2 Development Program expenditures related to Ultrio 2 Development Costs hereunder and
represents the parties’ best estimate of such Ultrio 2





 




			
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Development Costs, but does not represent a “fixed price maximum” or other guaranteed maximum
cost of the development required for the Ultrio 2 Development Program. Marketing Evaluations are
outside the scope of Development Costs [...***...], Gen-Probe will not unreasonably withhold
support of Marketing Evaluations.




     5.2 Definition and Calculation of Ultrio 2 Development Costs: “Ultrio 2 Development
Cost” with respect to the Ultrio 2 Development Program means the fully-burdened cost of conducting
the research and development (including clinical trials and domestic and international regulatory
submissions) of the Ultrio 2 Assay Product, and shall include (i) the reasonable cost of all
quantities of raw materials, intermediates and finished goods necessary for the manufacture of such
quantities of the Ultrio 2 Assay Product utilized during the Ultrio 2 Development Program, and (ii)
the reasonable cost of such quantities of the Ultrio 2 Assay Product that are manufactured for, but
not utilized during, the Ultrio 2 Development Program, that are not sold nor retained for research
and/or development or other internal purpose and are scrapped due to product expiration; provided,
however that internal costs and costs payable to Third Parties for clinical trials shall not be
included within “Ultrio 2 Development Costs” until such internal costs and costs payable to Third
Parties exceed the Duplex/eSAS Clinical Trial Costs, as set forth in Sections F.1 and F.4 of the
Short Form Agreement. “Ultrio 2 Development Costs” shall include any direct costs incurred in
modification of the eSAS and Tigris instruments hardware and software as required for purposes of
enabling the instruments to perform the Ultrio 2 Assay Product. In the event the modified TIGRIS
instrument does not meet PRD requirements for MTBF, if both parties agree to proceed with the
development program then the Supervisory Board will decide how to address the burden of instrument
costs attributable to the Ultrio 2 modifications. Costs will be calculated in accordance with
United States generally accepted accounting principles, consistently applied (“U.S. GAAP”), or as
otherwise mutually agreed in writing between the parties.



          5.2.1 Ultrio 2 Development Costs; FTE Labor Rate.




               (a) In lieu of accounting specifically for and receiving direct reimbursement for certain
Ultrio 2 Development Costs, the parties have agreed to include reimbursement for those certain
categories of Ultrio 2 Development Costs within an agreed-upon labor rate for full time equivalent
personnel (the “FTE Labor Rate”). Those categories of “Ultrio 2 Development Costs” included within
the FTE Labor Rate are those costs more particularly described on Schedule 5, in paragraph 2
entitled “Ultrio 2 Development Costs included within FTE Labor Rate”. Neither party shall be
reimbursed separately for Ultrio 2 Development Costs included within FTE Labor Rate. Those
categories of “Ultrio 2 Development Costs” not included within the FTE Labor Rate are those costs
more particularly described on Schedule 5, in paragraph 3 entitled “Ultrio 2 Development Costs not
included within FTE Labor Rate”. Each party shall be reimbursed separately for Ultrio 2
Development Costs not included within FTE Labor Rate.



               (b) The FTE Labor Rate in effect as of the Addendum Effective Date is set forth in paragraph 1
on the attached Schedule 5, and is included in the Resource Plan and reflected in the Budget. Each
year the parties will evaluate and re-set a FTE Labor Rate for the Budget for the new calendar year
based on the parties’ budgets for the then-current calendar year and consistent with the
requirements of Section 5.2.1(d) below. In the event the parties shall not have agreed upon a new
FTE Labor Rate before commencement of a calendar year, the parties shall use the rate in effect
during the immediately preceding calendar year for billing purposes, subject to “true-up” (using
the same methodology as described in Section 5.2.1(e) below) at such time as the FTE Labor Rate for
the then-current calendar year has been agreed.





 




			
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               (c) In addition to the annual reset described in Section 5.2.1(b) above, either party shall have
the right to request a change in the FTE Labor Rate reflected on the attached Schedule 5 to be
applied on a prospective basis under the approval process set forth in Section 3. Acceptance of
such request for modification shall be governed by Section 3.3.4 of this Ultrio 2 Addendum.



               (d) In addition to the foregoing, throughout the term of this Ultrio 2 Addendum:



                         (i) each party shall have the same FTE Labor Rate applicable to it as is applied to the other
party, subject to any agreed modifications; and



                         (ii) in the event either party requests a modification to the FTE Labor Rate hereunder, the
modified FTE Labor Rate shall be calculated using the same methodology as that used to calculate
the FTE Labor Rate in effect as of the Addendum Effective Date. The methodology used to calculate
the FTE Labor Rate in effect as of the Addendum Effective Date is described on the attached
Schedule 5.2.3, entitled “Ultrio 2 Development Costs Calculation Methodology”.



               (e) In the event aggregate actual Ultrio 2 Development Costs that are reimbursed through the
FTE Labor Rate exceeded, or fell short of, the agreed FTE Labor Rate reflected in the Budget (as
agreed to in accordance with the provisions of Section 5.2.1(b) above) for such calendar year, the
parties will “true-up” such reimbursement annually in accordance with this Section 5.2.1(e). On or
before [...***...] of each year during the term hereof, each Gen-Probe will calculate and deliver
to Novartis an accounting of the actual expenditures made by Gen-Probe for those costs more
particularly described on Schedule 5, in paragraph 2 entitled “Ultrio 2 Development Costs included
within FTE Labor Rate” and compare them to the amounts reimbursed through the FTE Labor Rate in
such year. Each party will have until [...***...] in which to meet and agree upon a final FTE
Labor Rate for such year (the “Final FTE Labor Rate”) which more closely approximates the actual
labor rate experienced by each party. If necessary Novartis will travel to Gen-Probe in order to
complete the review in these timeframes. Each party shall have the same Final FTE Labor Rate
applicable to it as is applied to the other party, subject to any agreed modifications. If the
parties disagree on a Final FTE Labor Rate, such disagreement shall be addressed by the Supervisory
Board and, if necessary, by implementation of the escalation procedure described in Article 13 of
the Agreement, excluding arbitration. In the event that one party received less than the Final FTE
Labor Rate, such party shall be entitled to receive from the other party an amount equal to
[...***...] of the difference between the actual Ultrio 2 Development Costs included within the FTE
Labor Rate and the reimbursed Ultrio 2 Development Costs included within the FTE Labor Rate;
similarly, in the event that one party received more than the Final FTE Labor Rate, such party
shall be required to reimburse the other party in an amount equal to [...***...] of the difference
between the actual Ultrio 2 Development Costs included within the FTE Labor Rate and the reimbursed
Ultrio 2 Development Costs included within the FTE Labor Rate.



               (f) Ultrio 2 Development Costs not included within the FTE Labor Rate shall be budgeted and
trued-up under the same terms as the FTE Labor Rate. This includes all scrap (for example:
finished goods, sub-assemblies, TIGRIS parts and ancillaries) manufactured/procured for the Ultrio
2 program but not consumed. Translation costs will be paid by Novartis and then applied to the
Monthly True Up Payment per 5.3.3.



          5.2.2 Comparison with Resource Plan. The planned resources, and the associated costs,
will be broken out on a monthly basis and analyzed against the Resource Plan and reflected in the
Budget.




          5.2.3 Methodology. Attached hereto as Schedule 5.2.3 is a detailed methodology for
the calculation of the Ultrio 2 Development Costs, including costs
reimbursed through the FTE Labor rate






 




			
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and significant external costs, as defined in this Section 5.2. The parties shall use such
methodology for the purpose of invoicing and payment more particularly described in Section 5.3
below.




     5.3 Payment of Ultrio 2 Development Costs. In addition to the provisions of Article 7
of the Agreement, the parties agree as follows:



          5.3.1 Accrued Ultrio 2 Development Costs. Each party has already incurred, prior to
the date of execution of this Ultrio 2 Addendum, certain Ultrio 2 Development Costs. To the extent
that one party has paid more than its [...***...] share of the aggregate Ultrio 2 Development Costs
incurred prior to and until the date of execution of this Ultrio 2 Addendum, the other party will
reimburse such party for [...***...] the difference between the Ultrio 2 Development Costs paid by
that party and [...***...] of the aggregate Ultrio 2 Development Costs incurred prior to and until
the date of execution of this Ultrio 2 Addendum. Attached to this Ultrio 2 Addendum as Schedule
5.3.1 is a summary of the Ultrio 2 Development Costs incurred by the parties prior to the execution
of this Ultrio 2 Addendum.




          5.3.2 [...***...] Budgeted Payments. Each party’s [...***...] share of Ultrio 2
Development Costs will be [...***...] in an amount equal to the amount reflected in Budget
[...***...]. The Budget sets forth the parties’ anticipated expenditures and FTE Labor amounts for
Ultrio 2 Development Costs [...***...] during the term of the Ultrio 2 Development Program in the
line item entitled “Total Project Gen-Probe” and “Total Project Novartis,” respectively. The line
items entitled “Gen-Probe Payment to Novartis” and “Novartis Payment to Gen-Probe” in the Budget
identify (i) the amount by which Novartis and Gen-Probe, respectively, are anticipated to incur
Ultrio 2 Development Costs in excess of their respective [...***...] share (the “negative delta”),
and (ii) the party who is required to make the reimbursement payment. [...***...] during the term
of the Ultrio 2 Development Program, Gen-Probe will invoice Novartis the amount of such negative
delta net of any credits or additional charges against amounts previously paid that have been
agreed to by the Project Management prior to the date on which Gen-Probe rendered the invoice.
Attached hereto as Schedule 5.3.2 is an example of this payment methodology.




          5.3.3 [...***...] True-Up Payments. At the end of [...***...], each party will
calculate the actual FTE Labor hours expended on the Ultrio 2 development Program during
[...***...]. The Project Manager will review these actual FTE Labor hours compare them to the
Budget for the applicable [...***...]. In the event that one party expended more than [...***...]
of actual FTE Labor hours or Ultrio 2 Development Costs not included in the FTE Labor hours during
[...***...], taking into account all payments made under Section 5.3.2, the parties shall calculate
the cost of such negative delta using the agreed FTE Labor Rate and Gen-Probe will adjust the next
invoice issued to Novartis in the amount of such credit or additional charge on or before the
expiration of [...***...] after the end of the applicable [...***...]. Attached hereto as Schedule
5.3.3 is an example of this true-up methodology.




          5.3.4 Invoices. Each party will invoice the other for the amounts described in this
Section 5.3 and all invoices will be due and payable [...***...] from the date of the invoice. In
the event payment is not received within such period, the delinquent party shall pay a service
charge if billed, equal to the amount overdue multiplied by [...***...], but not exceeding the
maximum allowable rate.






 




			
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     5.4 Dispute. Neither party shall unilaterally invoice the other in advance for more than
the amount reflected in the then-current Budget in a given period nor withhold payments of the
amount reflected in the then-current Budget. Either party may, in its discretion, determine that
the parties have reached an impasse with respect to a particular Budget item, the invoicing or
payment of same, and implement the escalation procedure described in Article 13 of the Agreement to
resolve such impasse. Notwithstanding the foregoing, neither party may withhold payment of
[...***...] budgeted payments under Section 5.3.2, cease development work or otherwise impede the
progress of the Ultrio 2 Development Program by reason of such dispute.



     5.5 Right to Audit and Verify. Each party is entitled to review, evaluate, and in its
discretion independently verify the basis of and actual expenditures incurred by the other party
for which such party requests reimbursement as Ultrio 2 Development Costs hereunder, in accordance
with the provisions of Section 7.3 of the Agreement, including without limitation actual
expenditures after the Addendum Effective Date but prior to the execution of this Ultrio 2
Addendum.


6. Manufacturing and Commercialization.




     6.1 Definitions Relevant to Manufacturing and Commercialization Obligation. The
parties intend that the Ultrio 2 Assay Product falls within the following provisions of the
Agreement:



          6.1.1 Applicable Purchase Price. As used in the Agreement, the “Applicable Purchase
Price” applicable to the Ultrio 2 Assay Product is as set forth in Section 1.2.1 of the Agreement.
The parties acknowledge that the Ultrio 2 Assay Product is a Future Blood Screening Assay which
includes as a constituent element an assay for HCV (other than those sold pursuant to Sections
3.1.4(b) or 3.6 of the Agreement), for which the provisions of Section 1.2.1 of the Agreement
describes the “Applicable Purchase Price”, as determined from time to time during the term of the
Agreement. Notwithstanding section 3.2.7(b) of the Agreement, the Applicable Purchase Price for
the Ultrio 2 Assay Product in the territory will never be less than [...***...].




          6.1.2 Transfer Price. The “Transfer Price” applicable to the Ultrio 2 Assay Product
is set forth in Section 1.58.2 of the Agreement except that the Transfer Price for Ultrio 2 Assay
Product from conformance or development lots that is transferred to Third Parties in the Territory
for use in the Blood Screening Field shall reflect and be adjusted if and to the extent that the
costs of manufacture of such conformance or development lots is included as part of the Ultrio 2
Development Costs. The Transfer Price will never be less than the Manufacturing Cost for the
Ultrio 2 Assay Product. The second sentence of Section 1.58.2 is deleted in its entirety, and
replaced with the following:




     “The Transfer Price, based on this objective, shall never be less than [...***...].”



          6.1.3 Manufacturing Cost. The “Manufacturing Cost” for the Ultrio 2 Assay Product
shall be calculated as defined in Schedule 6.1.3.




          6.1.4 Rare Reagents. The Ultrio 2 Assay Product is a Future Blood Screening Assay
which incorporates substantial Rare Reagents, as defined in Section 1.51 of the Agreement.




     6.2 Right to Audit and Verify. Novartis is entitled to review, evaluate, and in its
discretion independently verify the basis of Gen-Probe’s Manufacturing Cost using an independent
third party, in accordance with the provisions of Section 7.3 of the Agreement



     6.3 Quality Arrangements. The parties have previously adopted Amended and Restated
Supplemental Agreement No. 1 (Quality Agreement), effective as of March 1, 2006 (the “Quality





 




			
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Agreement”). The Quality Agreement shall govern the parties’ quality roles and responsibilities
with respect to the Ultrio 2 Assay Product.




     6.4 Non-Commercial Products.



          6.4.1 If any portion of the notebook, development, clinical or conformance lots of the Ultrio
2 Assay Product manufactured for the Ultrio 2 Development Program is sold to a Third Party for use
outside the United States or utilized by Novartis or Gen-Probe in a research or development program
other than the Ultrio 2 Development Program, including without limitation research studies or
marketing studies performed in support of commercialization of the Ultrio 2 Assay Product, or the
development and clinical trials for the Tigris instrument, the party selling or utilizing such
Ultrio 2 Assay Product shall reimburse the Ultrio 2 Development Program to the extent that the
program was charged for the materials.




          6.4.2
Section 6.10 of the Original Agreement is amended to add the following as new subsection (b), applicable to the Ultrio 2 Assay Product only:





“(b) Gen-Probe agrees to provide to Novartis reasonable quantities of the Ultrio 2 Assay
Product manufactured by Gen-Probe for uses other than sale to customers, including without
limitation research studies, marketing studies, internal research and development, and
troubleshooting (all for Novartis’s use only in direct furtherance of the express purposes
of this Agreement and without any implied license for any purpose other than such express
purposes), to the extent such Products are specifically ordered by Novartis for such
purposes (“Non-commercial Ultrio 2 Assay Products”). The entire compensation to Gen-Probe
for Non-commercial Products shall be not greater [...***...], as determined by reference to
Gen-Probe’s customary and ordinary accounting practices. The quantities of Non-commercial
Ultrio 2 Assay Products ordered by Novartis as well as quantities of Ultrio 2 Assay Products
consumed by Gen-Probe for all purposes other than the Ultrio 2 Assay Development Program
shall be subject to review by the Supervisory Board.”



     6.5 Commercialization Budget.



               (a) For the purpose of determining “commercialization costs” (to be reimbursed to Novartis as
permitted in Section 8.5 of the Agreement), Novartis shall submit to Gen-Probe a commercialization
budget, promptly following any termination of this Ultrio 2 Addendum for breach in accordance with
Section 8.2 or an unilateral withdrawal by a party in accordance with Section 8.4, and the timely
election by a Continuing Party to continue the Ultrio 2 Development Program, as described in this
Section 6.4.



               (b) Novartis shall submit to Gen-Probe a commercialization budget, setting forth the programs
and anticipated costs, including applicable costs and overhead for internal sales, marketing,
distribution, training, technical support, instrument service and field service engineering,
product support, quality assurance, regulatory affairs and clinical affairs all as required to
commercialize the Ultrio 2 Assay. Such commercialization budget shall also include out-of pocket
costs associated with each such program and initiative plus costs associated with any third party
support and allocated costs of instrumentation on a per unit or other reasonable allocation method
applicable to the commercialization of the Ultrio 2 Assay Product. The detail and basis provided in
the proposed budget shall be commensurate with the information supplied by Gen-Probe to support Gen-Probe’s calculation of
Manufacturing Cost.



               (c) Gen-Probe will deliver to Novartis either a written acceptance of the proposed
commercialization budget or a detailed written statement specifying the basis for rejection.





 




			
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Novartis may, in response to a rejection, revise the proposed commercialization budget to reflect
the discussions of the parties, and redeliver the revised commercialization budget for further
review, until the parties agree upon the final commercialization budget. Either party may, in its
discretion and with notice to the other party, determine that the parties have reached an impasse
with respect to the proposed commercialization budget and deliver a request to the Supervisory
Board for determination.




               (d) If a party delivers the request to the Supervisory Board for determination of the
commercialization budget, the Supervisory Board shall promptly, but not later than the later of (i)
[...***...] after receipt of the request, or (ii) [...***...], meet and discuss the proposed
commercialization budget.



               (e) If the Supervisory Board has met and consulted without resolution, then either party may,
in its discretion, determine that the parties have reached an impasse with respect to the proposed
commercialization budget and implement the escalation procedure described in Article 13 of the
Agreement to resolve such impasse.



               (f) Labeling: Labeling will indicate that the Product was “Developed by Gen-Probe, in
collaboration with Chiron a Novartis business”


7. License Grants.



The grant of licenses for the purpose of conducting the Ultrio 2 Development Program shall be
governed by Sections 3.2.6 and Section 9 of the Agreement. Novartis agrees that Gen-Probe shall be
[...***...].



8. Addendum Effective Date; Term; Termination.




     8.1 Term of Ultrio 2 Addendum. This Ultrio 2 Addendum shall become effective on the
Addendum Effective Date and shall continue in effect through the Blood Screening Term (as
determined without consideration of this Addendum), unless sooner terminated in accordance with the
provisions hereof. Neither execution of this Addendum nor development and sale of the Ultrio 2
Assay Product for any market (including the United States, if agreed by the parties in accordance
with Section 2.1) shall extend the Blood Screening Term as otherwise computed under Section 1.7 of
the Agreement without consideration of such Ultrio 2 Assay Product, and subsection (b) of Section
1.7 shall not apply to the Ultrio 2 Assay Product. Termination of this Ultrio 2 Addendum shall be
governed by the terms of this Section 8 and termination of the Agreement is governed by Section
11.2 of the Agreement.



     8.2 Termination for Breach.



          8.2.1 Default. Either party (the “nondefaulting party”) has the right, upon written
notice to the other party (the “defaulting party”), to terminate the Ultrio 2 Development Program,
upon






 




			
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the occurrence of any of the following events of default and the expiration of any applicable
period of time for cure:




               (a) if a party fails to make a payment required under Sections 5.3.2 or 5.3.3 hereunder;



               (b) if a party invoices for amounts using expenditures not falling within the definition of
Ultrio 2 Development Costs or not included within the Budget.



               (c) if a party fails to exercise Commercially Reasonable Efforts to commit the resources
described in the Ultrio 2 Development Program or to exercise Commercially Reasonable Efforts
achieve the objectives of the Ultrio 2 Development Program; provided, however, that the failure to
successfully complete the development of the Ultrio 2 Assay Product, or to complete the development
of the Ultrio 2 Assay Product on the Timeline or for the amounts described in the Budget or to the
specifications set forth in the PRD or the SRS shall not be deemed to be a breach of this Ultrio 2
Addendum; and



               (d) if a party defaults under the Agreement which default results in the termination of the
Agreement.



          8.2.2 Right to Cure Event of Default. Upon the occurrence of any event of default
entitling a party to terminate this Ultrio 2 Addendum, the non-defaulting party may send notice of
event of default, specifying in reasonable detail the nature of the default, to the defaulting
party. The defaulting party will have [...***...] following the date of receipt of such notice
within which to cure the breach or event of default. Failure to cure the default within such time
period will result in termination of the Ultrio 2 Development Program without further notice by the
non-defaulting party, unless such non-defaulting party extends the cure period by written notice or
withdraws the default notice. (The expiration of the period for such right to cure without cure,
extension or withdrawal of the default notice is referred to as the “effective date of
termination”.)




          8.2.3 Effect of Termination for Breach. Upon a termination of this Ultrio 2 Addendum
for default under this Section 8.2:




               (a) Subject to the rights of the parties under Section 9.3, the Ultrio 2 Development Program
shall be terminated.



               (b) The non-defaulting party’s rights under the Agreement shall remain in full force and
effect unchanged.



               (c) The defaulting party’s rights under the Agreement with respect to all Products, other than
the Ultrio 2 Assay Product, shall remain in full force and effect unchanged.



               (d) The defaulting party’s rights under the Agreement with respect to the Ultrio 2 Assay
Product shall terminate and be of no further force and effect. The defaulting party may not
undertake a development substantially similar to the Ultrio 2 Development Program with any other
party for a period of [...***...] from the date of termination.



               (e) The defaulting party shall pay, to the other party, in addition to any other rights or
remedies available to the nondefaulting party at law or equity, promptly upon receipt of an invoice
therefore, an amount equal to (i) [...***...],





 




			
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(ii) [...***...], and (iii) [...***...].




     8.3 Termination by Both Parties.



          8.3.1 Vote to Terminate. The Supervisory Board, by unanimous vote, has the right,
upon three (3) months written notice to both parties, to terminate the Ultrio 2 Development Program
and by extension this Ultrio 2 Addendum.




          8.3.2 Effect of Notice Period on Termination by Both Parties. During the notice
period as set forth in Section 8.3.1, the provisions for reimbursement of a party’s development
efforts in accordance with the then-current Budget continue in force and effect, unless the party
faced with reduction agrees that it can displace employees to other activities in a shorter time.
The parties agree that each party shall attempt to minimize costs during the notice period. During
the notice period, the parties shall continue to perform their respective obligations under the
Ultrio 2 Development Program, unless otherwise agreed by the parties in writing. Upon the
expiration of the notice period (and the effective date of termination under Section 8.2 or the
effective date of withdrawal under Section 8.4 of the Ultrio 2 Development Program), each party
shall pay, promptly upon receipt of an invoice therefor, to the other party an amount equal to (i)
all Ultrio 2 Development Costs accrued to date in the terminated Ultrio 2 Development Program for
which an invoice has been rendered and (ii) all Ultrio 2 Development Costs not yet invoiced but
incurred in the terminated Ultrio 2 Development Program, whether or not disputed, as set forth in
the approved Budget.




          8.3.3 Effect of Termination by Both Parties. Upon any termination of the Ultrio 2
Development Program under this Section 8.3, the parties shall have such rights on termination as
shall be unanimously agreed by the Supervisory Board as part of the decision to terminate for
convenience.




     8.4 Termination by Either Party; Unilateral Withdrawal from Ultrio 2 Development
Program. Either party (referred to for convenience as the “withdrawing party”) may elect to
terminate this Ultrio 2 Addendum under this Section 8.4 on the following basis without further
cause:



               (a) The withdrawing party concludes in its reasonable discretion that the potential for
[...***...] by any proposed change to the Ultrio 2 Development Program requested in accordance with
Section 3.3 above; or



               (b) The withdrawing party receives a request for a Material Modification of the Ultrio 2
Development Program as determined in accordance with Section 3.2.1; or



               (c) The parties have failed to achieve one or more of the Interim Events.


The withdrawing party may terminate this Ultrio 2 Addendum under this Section 8.4 upon the
provision to the other party (referred to for convenience as the “non-withdrawing party”) of
[...***...] prior written notice, specifying in reasonable detail the basis on which the
withdrawing party is unilaterally terminating this Ultrio 2 Addendum. (The notice of intent to
withdraw described in this Section 8.4 is referred to for convenience as the “withdrawal notice”;
and a date which is [...***...] later is referred to for convenience as the “effective date of
withdrawal”).






 




			
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     8.5 Continuance of Ultrio 2 Development Program following Unilateral Withdrawal or
Termination.



          8.5.1 Election. Following any termination of this Ultrio 2 Addendum for breach in
accordance with Section 8.2 or an unilateral withdrawal by a party in accordance with Section 8.4,
the non-defaulting party (under Section 8.2) or the non-withdrawing party (under Section 8.4)
(referred to for convenience as the “Continuing Party”) may elect to continue the Ultrio 2
Development Program by providing written notice to the other party on or before the effective date
of termination under Section 8.2 or the effective date of withdrawal under Section 8.4.




          8.5.2 Funding and Conduct of Development.




               (a) If a Continuing Party elects pursuant to this Section 8.5 to continue funding the Ultrio 2
Development Program, such Continuing Party shall be solely responsible for the current funding of
all Ultrio 2 Development Costs from and after the effective date of termination under Section 8.2
or the effective date of withdrawal under Section 8.4, subject to the right to reimbursement more
particularly described below.



               (b) In addition to Section 8.5.2(a), if the Continuing Party is Novartis, Novartis shall pay
Gen-Probe [...***...]. Such amount shall be payable in accordance with the provisions of Section
5.3, including without limitation monthly payment against Budget and monthly true-up payments.
Novartis shall be entitled to reimbursement of such amounts paid in accordance with the provisions
of Section 8.5.3 below. In the event, however, that Novartis shall elect to cease the development,
marketing and sale of the Ultrio 2 Assay Product prior to the effective commercialization thereof,
then Novartis shall pay Gen-Probe an additional amount equal to [...***...] of the total aggregate
Ultrio 2 Development Costs (meeting the definition and calculated as described in Section 5.2)
incurred by Gen-Probe from and after the effective date of termination for breach under Section 8.2
or the date of receipt from Gen-Probe of the withdrawal notice delivered pursuant to Section 8.4 of
the Ultrio 2 Addendum, which additional amount the parties agree will compensate Gen-Probe for the
resources committed by Gen-Probe to the Ultrio 2 Development Program which did not result in an
effectively commercialized Ultrio 2 Assay Product. Novartis shall pay such additional amount
promptly upon ceasing such development, as permitted under Section 3.2.1(c) of the Agreement.



               (c) In addition to Section 8.5.2(a), if the Continuing Party is Gen-Probe, in the event that
Gen-Probe shall elect to cease the development, marketing and sale of the Ultrio 2 Assay Product
prior to the effective commercialization thereof, then Gen-Probe shall pay Novartis an additional
amount equal to [...***...] of the total aggregate commercialization costs incurred by Novartis as
approved in the commercialization budget under Section 6.4 to be incurred prior to the effective
commercialization of the Ultrio 2 Assay Product. Gen-Probe shall pay such additional amount
promptly upon ceasing such development, as permitted under Section 3.2.1(c) of the Agreement.



     8.5.3 Reimbursement of Development Costs. The party electing to continue development
under the terms of Section 8.5 shall be deemed to be the party who “wishes to develop the Future
Blood Screening Assay” described in Section 3.2.1(c) of the Agreement. The provisions of Section
3.2.1(c) and the provisions of Section 3.2.3(b)(i) of the Agreement shall govern the rights and
obligations of the parties from and after the effective date of termination under Section 8.2 or
the





 




			
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effective date of withdrawal under Section 8.4 of the Ultrio 2 Development Program as a joint
development program under this Ultrio 2 Addendum, except Section 3.2.1(b) of the Agreement shall be
deleted in its entirety, and replaced with the following.




     “b. In the case of a Future Blood Screening Product which is funded by one party
pursuant to Section 3.2.1(c) of the Agreement and Section 8.5 of the Ultrio 2 Addendum, such
party shall be solely responsible for all Development Costs of such Future Blood Screening
Assay and be entitled to reimbursement of the portion of the total Development Costs
incurred after the effective date of termination under Section 8.2 or the effective date of
withdrawal under Section 8.4, as the case may be (the “Post-Withdrawal Development Costs”),
as follows:




     i. If the funding party is Gen-Probe, Novartis shall (A) [...***...]; (B) [...***...];
(C) [...***...]; (D) [...***...]; and (F) [...***...]. Thereafter, Net Sales shall be paid
as provided under Section 3.2.7 of the Agreement.




          ii. If the funding party is Novartis, Novartis shall pay to Gen-Probe the [...***...],
then Novartis shall (A) first, [...***...]; (B) second, [...***...]; (C) third, [...***...];
(D) fourth, [...***...]; and (E) fifth, [...***...].





 




			
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[...***...]. Thereafter, Net Sales shall be paid as provided under Section 3.2.7 of
the Agreement.




          iii. The parties agree that the funding party is entitled to a preferential return on
the Post-Withdrawal Development Costs incurred by the funding party, as a reasonable return
for the additional risk incurred by the funding party, in an amount equal [...***...] on the
Post-Withdrawal Development Costs actually incurred by the funding party from the date
incurred until the date on which such Post-Withdrawal Development Costs are reimbursed from
Ultrio 2 Assay Product revenues pursuant to Section 3.2.1(b)(i) above or Section
3.2.1(b)(ii) above, as applicable.”



          8.5.4 Control of the Program upon Unilateral Funding. The Continuing Party shall have
the right to appoint the Project Manager from and after the effective date of termination under
Section 8.2 or the effective date of withdrawal under Section 8.4. The Continuing Party shall have
the right to make such Material Modifications to the Ultrio 2 Development Program that it deems
necessary or prudent in its reasonable discretion, without the acceptance of the other party as
otherwise required under Section 3.3.4 of this Ultrio 2 Addendum. Notwithstanding the above, the
Continuing Party shall remain obligated to provide the other party with a copy of the Ultrio 2
Development Program, and all notice and reporting obligations set forth herein shall remain in full
force and effect.




          8.5.5 Rights under Agreement. Except as expressly modified by this Section 8.5, the
parties shall retain all rights and obligations allocated pursuant to Section 3.2 of the Agreement.
Without limiting the foregoing, without respect to which party is the Continuing Party, Gen-Probe
shall have the exclusive right and obligation to conduct the development work and to manufacture
the Ultrio 2 Assay Product; Novartis shall have the exclusive right to promote, market and sell the
Ultrio 2 Assay Product and the parties shall have their respective rights under Section 3.2.8 of
the Agreement, all as is more particularly described in the Agreement unaffected in any way by the
withdrawal from the Ultrio 2 Development Program.



9. Escalation.




     9.1 Escalation Process. Prior to implementing the arbitration process more
particularly described in Article 13 of the Agreement, the parties agree to escalate any dispute
first to a discussion between responsible managers, and if they cannot agree, then to the
Supervisory Board. However the parties explicitly acknowledge that in the event of the need for an
urgent decision the party with primary responsibility will proceed to make the decision, and
implement. It is agreed that the party with primary responsibility will make all reasonable and
timely efforts to inform the other party of the issue requiring decision, particularly where the
issue is one of some consequence.



     9.2 Remedies in Event of Default. Neither party shall be entitled to exercise any
remedy otherwise available to it at law or in equity unless and until such party shall have
provided the other party with notice of such event of default, reasonably specifying the nature of
the default, and any applicable period of time for cure thereof shall have expired without cure,
and the procedures defined in Article 13 of the Agreement shall have been first exhausted.



     9.3 Survival. Upon a termination of this Ultrio 2 Addendum, the following provisions
of this Ultrio 2 Addendum shall survive such termination: Sections 2.3, 2.4.1, 8, 9, and 10 and
all rights under Section 5.3.3 that have accrued as of the date of termination.





 




			
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10. No Other Amendment. Except as expressly set forth in this Ultrio 2 Addendum, all other
terms and conditions of the Agreement, the parties’ Definitive Written Settlement Agreement, dated
December 5, 2001, and the Short Form Agreement, dated November 16, 2001, are hereby ratified and
shall continue in full force and effect. In the event of a conflict between the terms of this
Ultrio 2 Addendum and the Agreement, the terms of this Ultrio 2 Addendum shall control. The
provisions of this Ultrio 2 Addendum are intended to, and hereby, supersede any provisions in the
Definitive Written Settlement Agreement entered into by and between the parties, dated December 5,
2001, and the Short Form Agreement entered into by and between the parties, dated November 16,
2001, on the same subject matter.



11. Counterparts. This Ultrio 2 Addendum may be executed in counterparts, each of such
shall be deemed an original, and all of which together shall constitute one and same instrument.




     IN WITNESS WHEREOF, the parties have caused this Ultrio 2 Addendum to be executed and the
persons signing below warrant that they are duly authorized to sign for and on behalf of the
respective parties.



	 	 	 	 	 	 	 	 	 	 	 
	GEN-PROBE INCORPORATED, 

a Delaware corporation	 	 	 	NOVARTIS VACCINES & DIAGNOSTICS, INC.,
a
Delaware corporation	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Henry L. Nordhoff
 

Henry L. Nordhoff
	 	 	 	By:
	 	/s/ Gene W. Walther
 

Gene W. Walther
	 	 
	Its:

	 	Chief Executive Officer
	 	 	 	Its:
	 	Head, Diagnostics	 	 
	Date:

	 	October 15, 2008
	 	 	 	Date:
	 	October 17, 2008	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	By:
	 	/s/ Joerg Reinhardt	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	Joerg Reinhardt	 	 
	 

	 	 	 	 	 	Its:
	 	Chief Executive Officer	 	 
	 

	 	 	 	 	 	Date:
	 	October 20, 2008	 	 






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Schedule 1.16.




Description of Ultrio 2 Assay Product



The Ultrio 2 triplex assay is an in-vitro nucleic acid amplification test for the qualitative
detection of human immunodeficiency virus Type 1 (HIV-1) RNA, hepatitis B virus (HBV) DNA, and/or
hepatitis C virus (HCV) RNA in human plasma for use in the Blood Screening Field. The Ultrio 2
triplex assay will not discriminate between HIV-1, HBV and HCV infection. The Ultrio 2 assay is to
be developed to run initially on both the enhanced semi-automated instrument (eSAS) and the Tigris
instrument.



HIV-1, HBV and HCV discriminatory Probe reagents are in -vitro nucleic acid amplification tests for
the qualitative detection of the specified virus and are provided with the Ultrio 2 triplex assay
as part of the Ultrio 2 Assay Product for use in discriminating between HIV-1, HBV and HCV in
plasma following a positive result from the Ultrio 2 triplex assay.



For purposes of the foregoing Addendum, all of the Ultrio 2 triplex assay and the associated
discriminatory probe reagents are included within the definition of the “Ultrio 2 Assay Product.”




     [...***...]





 




			
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Schedule 5

Ultrio 2 Development Costs



1. Reimbursable FTE Rate. Budget rates for future years will be based on [...***...] per FTE per
calendar year until finalized each year per section 5.2.1. Future calendar year FTE billing rates
will be agreed to based on future annual budgets. In the absence of agreement, the FTE billing
rate will be the then current billing rate subject to true-up once new rates have been agreed.



2. Ultrio 2 Development Costs included within FTE Labor Rate. Ultrio 2 Development Costs included
within FTE Labor Rate consist of all attributable costs associated with the development of the
Ultrio 2 Assay Product and modifications to associated instrument system platforms (but excluding
Tigris instruments) that may be required for such Ultrio 2 Assay Product (calculated in accordance
with United States generally accepted accounting principles, or as otherwise mutually agreed in
writing between the parties) incurred prior to the Completion Date and includes pilot development;
validation studies necessary for product and process licensure; clinical studies; licensing
activities; and the manufacture and ultimate disposition of conformance lots of material,
calculated as follows:




               (a) Shared development costs include: research and development associated with the Ultrio 2
Development Program; clinical studies; validation exclusively associated with the particular
analyte; development lots; document preparation specific to the development; modifications to the
enhanced semi-automated instrument (eSAS) or the TIGRIS instrument and/or its ancillaries.



               (b) The planned resources, and the associated costs, will be broken out on a [...***...] basis
and analyzed against the Resource Plan and reflected in the Budget;



               (c) Salaried staff costs included within the Budget will be adjusted to reflect actual staff
costs. Salary information may be aggregated to protect the identity of individuals. This salary
information will be verifiable on a need to know basis to a select number of personnel from each
company;



               (d) Cost for wage laborers plus the applicable overhead charge for such labor (calculated at
the rates and charges described in Section 5.2.1) paid to personnel described in the Resource Plan,
including the Ultrio 2 Development Program project manager and personnel engaged to perform QA
testing for the Ultrio 2 Development Program;



               (e) Costs for engineering prototypes and manufacturing pilot modules required for the Ultrio 2
Development Program;



               (f) Costs of inventory consumed in the Ultrio 2 Development Program, including raw material,
intermediates and finished goods, and conformance lots, whether reject or not, that arise from the
Ultrio 2 Development Program or are necessary to support the Ultrio 2 Development Program, and
scrap material, including raw materials and development materials that arise from the Ultrio 2
Development Program but excluding Ultrio 2 Assay Product and scrap materials used strictly for
internal research purposes or consumed in development programs other than the Ultrio 2 Development
Program; Material such as finished goods, sub-assemblies, ancillaries and TIGRIS parts not used
during development but created as part of the program are classified as scrap not included in FTE
rate but to be split during true up process.



               (g) Costs for conformance product documentation;





 




			
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               (h) Costs for courier and mail service fees for delivery of items between Gen-Probe and
Novartis;



               (i) Costs of travel, lodging and reasonable per diem expenses for employee and consultants of
Gen-Probe or Novartis incurred in furtherance of their activities hereunder, providing training or
participating on the Supervisory Board to the extent such costs are not included within the
overhead charge applicable to labor costs;



               (j) Costs of foreign registrations, marketing studies to support registration, and market
research costs necessary to better define requirements or to support national decision-making;



               (k) Such other categories as the parties may agree from time to time using the approval
process described in Section 0.



               (l) All budgeted expenses of Departments directly involved with the Ultrio 2 Development
Program



               (m) Appropriate portions of budgeted costs of departments indirectly involved in the Ultrio 2
Development Program.


3. Ultrio 2 Development Costs not included within FTE Labor Rate.




               (a) Cost of conformance lot materials consumed in performance of Ultrio 2 Development Product
or clinical trials.



               (b) Significant Third Party consultant charges (i.e. CRO, regulatory expertise, etc.) to the
extent not captured within the FTE rates in Item 2 above.



               (c) Tooling changes required to support enhanced semi-automated instrument (eSAS) or TIGRIS
modifications are not included in FTE rate and will be split during the true up process.




 









 








Schedule 5.2.3




Ultrio 2 Development Costs Calculation Methodology




 









 





[...***...]






 




			
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[...***...]






 




			
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[...***...]






 




			
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[...***...]






 




			
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Schedule 5.3.1




Accrued Ultrio 2 Development Costs



The parties acknowledge and agree that development costs for the calendar years 2006 and 2007 have
previously been trued-up between the parties and that no payment is due from either party to the
other in connection with the development program conducted during those years not withstanding both
parties right to audit and verify pursuant to Section 5.5.



The parties further acknowledge and agree that they will meet and negotiate in good faith with
respect to development costs incurred during calendar year 2008 prior to execution of the foregoing
agreement and any payment due from one party to the other pursuant to Section 5.3.1 shall be made
promptly.





 









 








Schedule 5.3.2




[...***...] Budgeted Payments




     The party with the negative delta shall submit to the other party, on or before the end of the
[...***...] during the term of the Ultrio 2 Development Program, an invoice setting forth the
amount of the delta. In addition, any party owed by other an excess adjustment shall submit to the
other party, on or before the end of the [...***...] during the term of the Ultrio 2 Development
Program, an invoice setting forth the amount of the excess adjustment, providing reasonable detail
for any Ultrio 2 Development Costs not previously invoiced and requesting payment of [...***...] of
the total amount. Ultrio 2 Development Costs by the invoicing party incurred to date and not yet
reimbursed as provided herein, providing reasonable detail for any Ultrio 2 Development Costs not
previously invoiced and requesting payment of 50% of the total amount. Each party shall pay on or
before the date specified therefore in the invoice an amount equal to the lesser of (i) the Ultrio
2 Development Costs reflected on the invoice submitted to such party on account of such payment
(together with amounts reflected on earlier invoices not previously reimbursed) or (ii) the amount
of the payment described on the attached budget. To the extent that a reimbursement payment is
inadequate to cover the total Ultrio 2 Development Costs incurred to date by a party, then each
party shall carry over the balance to the next subsequent payment(s) until finally reimbursed in
full.



     By way of example, and using hypothetical dollars for actual expenditures, the calculation
would operate as follows:



[...***...]





 




			
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Schedule 5.3.3




[...***...] True-Up Payments

(sample methodology)




     By way of example, and using hypothetical dollars for actual expenditures, the calculation
would operate as follows: (true-up payment due to Novartis in this case):


[...***...]






 




			
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