Exhibit 10.1
Fourth Services Addendum — Advanced Care
Enhanced Product
Dated with effect from 14 May, 2009
This Services Addendum (Fourth Services Addendum) to the Master Services and
Supply Agreement dated 29 October 2007 as amended and restated on 14 May 2009
between LifeScan, Inc., Universal Biosensors Pty Ltd and Universal Biosensors,
Inc. (Master Agreement) is entered into by and between LifeScan, Inc., a
Californian corporation of 1000 Gibraltar Drive, Milpitas, CA 95035-6312, USA
(LifeScan), Universal Biosensors Pty Ltd ACN 098 234 309, a company incorporated
in Victoria, Australia of 1 Corporate Avenue, Rowville, Victoria 3178, Australia
(UBS) and Universal Biosensors, Inc., a Delaware corporation having its
registered office at c/o Corporation Service Company 2711 Centerville Road,
Suite 400, Wilmington, Delaware 19808 USA (UBI).
The parties agree that this Fourth Services Addendum is to be attached to, and
form part of the Master Agreement. In relation to the matters addressed in this
Fourth Services Addendum, each of LifeScan, UBS and UBI agree to be bound by all
of the terms and conditions of the Master Agreement including without limitation
Sections 10.3 (Manner of Performing the Services) and 11.4 (Audit Rights) and
each party makes the representations and warranties set forth in the Master
Agreement expressed to be made by LifeScan, UBS or UBI, as the case
may be.
All capitalized terms used in this Fourth Services Addendum and not otherwise
defined herein shall have the meaning ascribed to such terms in the Master
Agreement (including all Service Addendums and Product Addendums).
Background
LifeScan wishes for UBS to provide Services in connection with the feasibility,
development, validation, and launch and post launch support, of a Product
intended for the advanced care setting, and meeting the Product Specification to
be set forth in functional specification quality management system MER003 (ACEP
Product Specifications) as such Product Specifications may be modified from time
to time in accordance with clause 5.3 of the Master Agreement (Advanced Care
Enhanced Product or ACEP). The parties agree that the ACEP Product
Specifications shall conform with the Target ACEP Product Specifications profile
set forth in Annexure A hereto (Annexure A). The ACEP shall constitute a
“Product” for purposes of the Master Agreement.
The Services shall be performed as generally set forth in the attached Scope of
Work, and as otherwise agreed by the Joint Steering Committee.

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The Services will be undertaken in phases, generally feasibility, development,
validation and launch and post launch support, or as may be mutually agreed from
time to time.
In consideration of the mutual promises, covenants and agreements below and in
the Master Agreement, the parties further agree as follows:
1. Services
As more fully set forth in the attached Scope of Work, UBS will undertake the
Services required to assess the feasibility of, develop, validate, and provide
launch and post launch support of, the ACEP. Unless agreed otherwise, in seeking
to develop the ACEP, it is anticipated that UBS will use the Initial Product as
its development base and will ascertain whether the Initial Product (as defined
in the Master Agreement) can be modified to meet the ACEP Product Specifications
.
At or prior to the conclusion of the feasibility review, the parties will
complete a Product Addendum for the ACEP as provided by Clause 5.2 of the Master
Agreement. For purposes of clarification, it is anticipated the parties may
amend the Services and Scope of Work and any applicable Product Addendums from
time to time. Any amendments will be discussed by the Joint Steering Committee
and mutually agreed upon by the parties and no such amendment will be effective
until it is reduced to writing and signed by an authorized officer of each
party. Notwithstanding the prior sentence, if LifeScan determines an amendment
of the Services or the Scope of Work or Addendums are required for safety or
quality reasons, UBS will use good faith efforts to agree to the amendment.
Amendments to the ACEP Product Specifications are to be made in accordance with
clause 5.3 of the Master Agreement.
UBS shall provide written reports of its progress in performing the Services as
provided by Clause 13.2 of the Master Agreement. The Parties agree that due to
the inherently uncertain nature of research and development activities, the
actual outcomes and results of the Services cannot be assured.
2. Consideration
UBS will provide the Joint Steering Committee with its proposed pricing for the
Services from time to time for approval. The pricing will include any specific
capital items needed to perform the Services. Such items may include laboratory
equipment or equipment for manufacturing.

The cost of Services undertaken shall not exceed the approved pricing without
the prior written approval of the LifeScan representative on the Joint Steering
Committee (such approved exception, an Exception). UBS will not be required to
provide any Services for which the Parties have been unable to agree on pricing
with respect to necessary capital equipment and those applicable Services or in
circumstances where there has been a change of scope in the Services and an
Exception is not approved. Unless provided for in approved pricing, UBS shall
not incur any non-cancelable

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commitments in excess of US$50,000 without the approval of the LifeScan
representative on the Joint Steering Committee.
Unless otherwise agreed in writing, funding for the Services will be through the
payments made by LifeScan pursuant to the Development and Research Agreement
between the Parties, dated 1 April 2002, as amended (Development Agreement). To
the extent that LifeScan makes any such payments under the Development Agreement
for the ACEP before Services to be performed hereunder are rendered, such
payment will be credited toward future performance of the Services.
Whilesover the funding for the Services related to the ACEP is being provided
under the Development Agreement, the performance by UBS under this Fourth
Services Addendum, will satisfy any corresponding requirements that UBS has with
regard to the ACEP under the Development Agreement. It is the parties intention
that LifeScan’s payment obligations with regard to the activities set out in
this Fourth Services Addendum shall be no greater than those set forth in the
Development Agreement, and that UBS shall not be obligated to undertake any
activity related to the ACEP that may be required by the Development Agreement,
if it has performed any substantially similar activity pursuant to this Fourth
Services Addendum.
Whilesover the funding for the Services is being provided through the amounts to
be paid under the Development Agreement, payments will be made by LifeScan in
accordance with the terms of the Development Agreement.
3. Term of Fourth Services Addendum
This Fourth Services Addendum shall be taken to commence on the date of this
Fourth Services and shall continue until terminated by LifeScan by providing
30 days prior written notice, or upon termination of the Master Agreement in
accordance with its terms. Further, the Parties will determine at the completion
of each phase (i.e. feasibility, development, validation, launch and post launch
support) whether or not to continue to the next phase of activities under this
Fourth Services Addendum, provided this Fourth Services Addendum would terminate
unless both parties mutually agree to continue with the relevant next stage of
Services.
4. Termination
In the event that this Fourth Services Addendum is terminated, LifeScan must pay
(i) any fees and charges incurred prior to termination; and (b) any fees and
charges for any non cancellable commitments entered into by UBS prior to
termination, provided such fees and charges are in accordance with the approved
pricing or any Exception.
Executed as an agreement by the duly authorized representative of each Party as
of the date first written above.

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Executed by LifeScan, Inc.
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Name      
 
               
 
         
 
Title    

             
Executed by Universal Biosensors Pty Ltd
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Company Secretary/Director
     
 
Director    
 
             
 
Name of Company Secretary/Director (print)
     
 
Name of Director (print)    

                   
Executed by Universal Biosensors, Inc.
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Name      
 
               
 
         
 
Title    

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Advanced Care Enhanced Product
Scope of Work
Feasibility

  1.   Determine and execute a body of work to ascertain what changes are needed
to meet the ACEP Product Specification target profile set forth in Annexure A.  
  2.   Develop a definitive Functional Specification to conform with the Target
ACEP Product Specifications profile set forth in Annexure A, in accordance
clause 5.3 of the Master Agreement.     3.   Execute a body of work to determine
a formulation to incorporate in feasibility lots. 4. Define and execute a body
of work to determine a strip differentiation mechanism.     5.   *[REDACTED]    
6.   *[REDACTED]     7.   *[REDACTED]     8.   Commence a first stability study
from the first feasibility lots.     9.   Complete and test final algorithm as
determined by the Data Management Team.     10.   *[REDACTED]     11.   Lab link
changed where necessary and validated.     12.   Host feasibility review
toll-gate when 4 week stability data from second feasibility lots is available
(assuming stability dating is gating; otherwise as agreed).

Development and Validation

  13.   Complete strip Operational Qualification. 14. Complete strip Performance
Qualification.     15.   Complete UBS portion of DVT as mutually agreed by Data
Management Team     16.   Complete stability report to agreed real-time time
point.     17.   Complete UBS Quality Management Systems requirements, including
toll gates.     18.   Complete UBS portion of regulatory submission
deliverables.     19.   Complete transfer into production and production
readiness tasks.

 

*   Confidential portion has been omitted and has been filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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Launch and Post Launch

  20.   Assist in the assessment of data from the field and use the data to
decide methods for adapting process and control methodology to improve ACEP
performance.     21.   Specify and control ACEP component performance and
requirements. Manage or assist in the qualification and approval of all changes
to suppliers and materials for ACEP.     22.   Identify, validate and implement
cost reductions and process improvement in manufacturing the ACEP.     23.  
Assist on a mutually agreed basis so that LFS may obtain supply agreements with
suppliers of components comprising the ACEP.     24.   Investigate causes of
customer complaints with the ACEP referred to UBS by LifeScan.     25.   Assist
on a mutually agreed basis to implement design changes to the ACEP

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Annexure A
Target Advanced Care Enhanced Product (ACEP) Product Specifications Profile
*[REDACTED 6 Pages]
 

*   Confidential portion has been omitted and has been filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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