Document:

exv10w1

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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	Executed by Universal Biosensors, Inc.

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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.

			
	 	 	 
	Advanced Care Enhanced Product (Execution)	 	Page | 7exv10w2

Exhibit 10.2

Fifth Amendment to the Development and Research Agreement

Amendment Effective Date: May 14, 2009

This fifth amendment (Amendment) to the Development and Research Agreement dated 1 April 2002 is by
and among LifeScan, Inc., Universal Biosensors Pty Ltd and Universal Biosensors, Inc. as amended by
four letter agreements dated March 31, 2004, December 21, 2004, December 7, 2005 and June 1, 2005,
respectively (Development Agreement).

The parties agree to hereby add UBS as a party to the Development Agreement and the parties to the
Development Agreement shall be 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 of having its registered office at c/o
Corporation Service Company 2711 Centerville Road, Suite 400, Wilmington, Delaware 19808 USA (UBI).

The Parties wish to amend the Development Agreement in the manner set out in this Amendment to
clarify certain matters which have arisen since the Development Agreement was signed.

This Amendment is to take effect upon execution by the Parties and is to operate and be interpreted
according to the provisions of the Development Agreement.

In consideration of the mutual promises, covenants and agreements set forth in this Amendment and
in the Development Agreement, the Parties agree as follows:

Amendments

	 	1.	 	Paragraph 1.8 of the Development Agreement is deleted and replaced with the
following:
	 
	 	 	 	“1.8 Program” means the annual list of research and development projects created by
UNIVERSAL BIOSENSORS for the Steering Committee in accordance with Section 2.1(a).”
	 
	 	2.	 	Paragraph 2.1(a) of the Development Agreement is deleted and replaced with the
following:

	 	“(a)	 	 Effective immediately and prior to December in each year for the following year
during the term of this Agreement, UNIVERSAL BIOSENSORS shall prepare an annual
list of research and development projects including work plans and cost estimates
for UNIVERSAL BIOSENSORS to work on during the calendar year or

			
	 	 	 
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	 	 	 	part thereof and submit it to the Steering Committee. The Steering Committee
shall review and determine which projects are to be funded during that calendar
year. Notwithstanding the definition in Section 1.8 or Exhibit B, the funded
projects shall become the Program for such calendar year or part thereof.”

	 	3.	 	The parties agree to delete paragraph 2.2 to the Development Agreement and replace it
with the following:

	 	“(a) 	 	Supervision of the Program shall be provided by the Joint
Steering Committee as defined in that certain Amended and Restated Master
Services and Supply Agreement between the parties dated 29 October 2007 (the
“Master Agreement”) and that any references to the Steering Committee in this
Development Agreement shall be deemed to refer to the Joint Steering
Committee in the Master Agreement.
	 
	 	(b)	 	For clarification the parties agree the establishment,
composition and decision making provisions for the Joint Steering Committee
in Article 4 of the Master Agreement shall also apply to and govern the
Steering Committee in this Development Agreement.”

	 	4.	 	The parties agree to delete paragraph 4.1 to the Development Agreement and replace it
with the following:

	 	“4.1(a) 	 	In the period from April 1, 2009 until December 31, 2009, LIFESCAN shall make
payments to UNIVERSAL BIOSENSORS in the amount of US$250,000 (two hundred and fifty
thousand US dollars) per calendar quarter with the payment to be made within 30 days
of the beginning of each quarter. LIFESCAN agrees it will fund during the calendar
year commencing January 1, 2010, an amount that is to be determined in its discretion,
and that is between US$5,000,000 (five million US dollars) and US$9,000,000 (nine
million US dollars) depending on the Program recommended by the Joint Steering
Committee. Unless otherwise agreed, payment will be made in equal quarterly tranches
within 30 days of the beginning of each quarter. In subsequent years during the term
of this Development Agreement, the Steering Committee will recommend the Program and a
funding level for each party based on the success of the Initial Product and
consistent with LIFESCAN’s strategic and financial interests for such year.
	 
	 	(b)	 	Notwithstanding the foregoing, in the event: (i) the Milestone (defined in
the Master Agreement) for the Initial Product has not been achieved before January 1,
2010, then LifeScan shall fund US$4,000,000 (four million US dollars) to UNIVERSAL
BIOSENSORS within 30 days to prepay the Program; and (ii) the Milestone for the
Initial Product has not been achieved before April 1, 2010, then LIFESCAN shall fund
an additional US$4,000,000 (four million US dollars) to

			
	 	 	 
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	 	 	 	UNIVERSAL BIOSENSORS within 30 days to prepay the Program for 2010. For
clarification, UNIVERSAL BIOSENSORS agrees that if LIFESCAN has paid the payments
in paragraph (i) and/or (ii) above, they shall be credited toward the funding in
paragraph (a) above for development research due to UNIVERSAL BIOSENSORS in 2010.
	 
	 	(c)	 	For clarification, UNIVERSAL BIOSENSORS agrees that any amounts paid to it by
LIFESCAN in this Section 4.1 shall be dedicated solely to the Program and/or a Product
and cannot be used for any other projects of UNIVERSAL BIOSENSORS without the prior
written consent of LIFESCAN.
	 
	 	(d)	 	At the direction of UNIVERSAL BIOSENSORS, payments under this clause 4.1 may
be made to Universal Biosensors Pty Limited, recognizing that the research and
development activities under this Agreement will be conducted by Universal Biosensors
Pty. Limited. UNIVERSAL BIOSENSORS shall notify LifeScan of the party to which
payment shall be made within 15 days of the date any payment is due.”

	 	5.	 	The parties agree to delete Exhibit B and Exhibit E in their entirety and in each
case replace with a notation “[Intentionally left blank].”

			
	 	 	 
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The Parties agree that all other provisions in the Development Agreement remain unchanged and
effective.

Executed as a deed by the duly authorized representative of each Party as of the date first written
above.

	 	 	 	 	 	 	 	 	 
	Executed by LifeScan, Inc.

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	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,

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[Execution Page for Fifth Amendment to the Development Agreement]

			
	 	 	 
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