exv10w3






Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



This Agreement is made on June 30, 2009
(“Execution Date”)




BETWEEN THE UNDERSIGNED:




UNILIFE MEDICAL SOLUTIONS LIMITED ABN 14 008 071 403, a
corporation existing and organized under
the laws of Australia, having its registered office at Suite 3, Level 11, 1 Chifley Square, Sydney
NSW 2000, Australia, represented by Mr Alan Shortall, Director, (hereafter referred to as
“UNILIFE”)



hereinafter collectively referred to as “UNILIFE”,




ON THE ONE PART,




AND:




SANOFI WINTHROP INDUSTRIE, a company existing and organized
under the laws of France, having its
registered office at 82, avenue Raspail, 94255 Gentilly, France, represented by Mr Philippe Luscan,
Chairman and Chief Executive Officer, and Mr Gérard Touratier, Chief Financial Officer, (hereafter
referred to as “SWIND”), acting on its behalf and on behalf of its Affiliates, and in particular
AVENTIS PHARMA S.A.



hereinafter referred to as “SWIND”,




ON THE OTHER PART,




WITNESSETH:




WHEREAS, AVENTIS PHARMA SA, and UNILIFE have signed on
respectively November 20th 2006
for AVENTIS PHARMA SA, and December 11, 2006, for UNILIFE a Memorandum of Understanding (“MOU”) in
order to allow AVENTIS PHARMA SA to evaluate certain ready to fill prototype syringes based
on/using UNILIFE’s safety syringe technology with a view to using the Ready to Fill Syringe Range
utilizing this technology for its pharmaceutical specialties.



WHEREAS, The Parties have completed an early technical
evaluation on UNILIFE Ready to Fill Syringes
technology based on the prototypes provided by UNILIFE to SWIND; to define the following steps of
their collaboration and allow SWIND an exclusive access to the UNILIFE Ready to Fill Syringe safety
syringe technology, they have in addition signed an agreement on June 30, 2008 as amended
(hereafter the “Exclusive Agreement”) and attached to the Agreement as Exhibit 1.


 


 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



WHEREAS, Under such Exclusive Agreement, the first step
of the collaboration between the Parties is
to negotiate and settle the final provisions of an industrialisation agreement for the Product
design, development and industrial scaling up of the Product, as such term is defined hereafter, by
UNILIFE.



WHEREAS, UNILIFE is willing to industrialize the Product for SWIND and its Affiliates.



NOW THEREFORE, in consideration of the premises and the
mutual covenants and agreements herein
contained, the Parties have agreed as follows:



ARTICLE 1 — DEFINITIONS




The following terms as used in this Industrialisation
Agreement shall have the meanings set forth
in this Article 1:




	1.1	 	“Affiliates” shall mean any company which, directly or indirectly,
controls or is controlled
or is under common control with a Party hereto, by means of ownership of more than fifty
percent (50%) of the voting stock or similar interest in said company.

	 
	1.2	 	“Agreement” shall mean this Industrialisation Agreement, including its
exhibits.

	 
	1.3	 	“Associate’’ has the meaning given to it in sections 11-17 of
the Australian Corporations
Act 2001 (Cth).

	 
	1.4	 	“Base Technology” of a Party shall mean any Intellectual Property Rights
existing and owned
by that Party and/or its Affiliates or agents on or before the Effective Date relating to the
RTFS technology or the Product and, for UNILIFE, includes the Patents.

	 
	1.5	 	“Business Day” shall mean any day which is not a Saturday, a Sunday or a
public holiday, in
France, in the United States and/or in Australia, as applicable to the performance of an
obligation under this Agreement by a Party in a particular country.

	 
	1.6	 	“Change of Control Event’’ shall mean:







	 	1.6.1	 	a takeover bid being made to the holders of UNILIFE shares which becomes
unconditional and will result in a single person or entity together with their
Associates owning 50% or more of the shares of UNILIFE;

	 
	 	1.6.2	 	through the acquisition of shares in UNILIFE a single person or entity
together with their Associates is able to determine the majority composition of the
Board of UNILIFE (“Board”); or





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	 	1.6.3	 	any other event which the Board determines, in its absolute discretion, to
be a change of control,







but, for the avoidance of doubt, a
‘Change of Control Event’ does not include, unless
otherwise determined by the Board, either an internal restructure of the UNILIFE group or a
transaction whereby the UNILIFE group is redomiciled by imposing a new parent company of
the UNILIFE group (including where such transaction is effected by a scheme of arrangement
under the Australian Corporations Act 2001 (Cth)). This exception to a “Change of Control
Event” includes a scheme of arrangement pursuant to which:




	 	(a)	 	a subsidiary of UNILIFE will become the new parent company of UNILIFE; or

	 
	 	(b)	 	the shareholders of UNILIFE on the record date of the scheme of arrangement
will be entitled to be issued shares equal to at least 50% of the issued ordinary
share capital of the new parent company of UNILIFE on the implementation date of the
scheme of arrangement.






1.7 “Change of Control Proposal” shall mean:




	 	1.7.1	 	any expression of interest, proposal or offer for a takeover bid, scheme of
arrangement, merger or amalgamation which would result in a single person or entity
together with their Associates owning 50% or more of the shares of UNILIFE;

	 
	 	1.7.2	 	any expression of interest, proposal or offer to acquire all or a
substantial part of the assets or business of UNILIFE; or

	 
	 	1.7.3	 	any expression of interest or proposal for UNILIFE to issue 25% or more of
its shares or other securities to a single person or entity or their Associates,







in each case which is recommended by the
Board of UNILIFE but, for the avoidance of
doubt, a ‘Change of Control Proposal’ does not, unless the Board determines otherwise,
include any expression of interest, proposal or offer in relation to or to effect either an
internal restructure of the UNILIFE group or a transaction whereby the UNILIFE group would
redomicile by imposing a new parent company of the UNILIFE group (including where such
transaction would be effected by a scheme of arrangement under the Australian Corporations
Act 2001 (Cth)). This exception to a “Change of Control Proposal” includes any expression
of interest, proposal or offer in relation to or to effect a scheme of arrangement pursuant
to which:




	 	(a)	 	a subsidiary of UNILIFE would become the new parent company of UNILIFE;
or







	 	(b)	 	the shareholders of UNILIFE on the record date of the scheme of arrangement
would be entitled to be issued shares equal to at least 50% of the issued ordinary
share capital of the new parent company of UNILIFE on the implementation date of the
scheme of arrangement.






 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.





	1.8	 	“COGs” shall mean costs of goods and includes all material, packaging,
inbound freight,
storage, inspection and handling costs prior to production, all employees related expenses
involved in the processing, qualification, testing and release of the Final Product,
sterilization, equipment depreciation, occupancy costs, utilities, supervisory labor,
maintenance, supplies and related support costs required to produce the Final Product.

	 
	1.9	 	“Co-Invention” shall mean an Invention (other than Base Technology or
Future Technology)
which is conceived, reduced to practice or created by the Parties together during the term of
this Agreement and which concerns the RTFS technology or the Product, even if any of the
conception, reduction to practice or creation of such Invention was started before the
Effective Date or continues after the term of this Agreement.

	 
	1.10	 	“Competing Product” means any syringe product with an integrated
retraction mechanism.

	 
	1.11	 	“Confidential Information” means information (wherever and in whatever
form it was obtained)
proprietary or confidential to a Party including:







	 	1.11.1	 	in relation to any of a Party’s (whenever it was obtained) or its
Affiliates’
business, operations or strategies;

	 
	 	1.11.2	 	the terms of this Agreement;

	 
	 	1.11.3	 	information designated as confidential by a Party;







	 	1.11.4	 	information acquired by the other Party solely by virtue of provisions of this
Agreement;

	 
	 	1.11.5	 	the Products, Intellectual Property Rights or other property of a Party or its
Affiliates; and

	 
	 	1.11.6	 	actual or prospective customers, clients or competitors of a Party or its
Affiliates.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	1.12	 	“Development Program” shall mean the detailed description of the
Industrialisation and
corresponding requirements, including the Milestones as set out in Exhibit 2 to this
Agreement.

	 
	1.13	 	“Effective Date” shall mean retroactively July 1st, 2008.

	 
	1.14	 	“Exclusive Agreement’’ has the meaning given to that term in
the recitals.

	 
	1.15	 	“Final Product” shall mean the Product produced once the Industrialisation
program is
completed.

	 
	1.16	 	“Future Technology” of a Party shall mean all Inventions (i) based
upon any Base
Technology or other background or pre-existing technology or Intellectual Property Rights of
that Party or (ii) relating to the RTFS technology or the Product which are conceived, reduced
to practice or created by that Party and/or its Affiliates or agents from and after the Effective Date
independently of the other Party. Future Technology may also comprise Inventions as
referred to hereabove whose conception, reduction to practice or the creation of which has
already started before the Effective Date and/or goes on after the term of this Agreement

	 
	1.17	 	“Good Distribution
Practices” or “GDP” means those practices
and standards which are part
of GMP and that require that medicinal products are consistently stored, transported and
handled under suitable condition as required by the product specification and that are set
forth in the European Union Guidelines on GDP of Medicinal Products for Human Use (94/C
63/03), and any subsequent or future revisions of such guidelines.

	 
	1.18	 	“Good Manufacturing
Practices” or “GMP” means those practices
laid down in international
guidelines and regulations such as the GMP rules of the World Health Organisation, the United
States Code of Federal Regulations (Title 21, Parts 210-211, as well as Parts 808, 812 and
820), and the European Union Guide to Good Manufacturing Practice including Annexes in the
Production of Pharmaceutical Products, and any subsequent or future revisions of such
guidelines and regulations.

	 
	1.19	 	“Harm” means any significant negative and unreasonable impact on
SWIND’s obligations or
benefits under this Agreement and/or its business (including where a competitor of SWIND (i)
becomes a subcontractor in respect of UNILIFE’s obligations under this Agreement or (ii)
together with its Associates, becomes an owner of 50% or more of the shares of UNILIFE) that
SWIND can establish to UNILIFE’s reasonable satisfaction will arise as a direct result of the
occurrence of the subcontracting or the Change of Control Event, as the case may be.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	1.20	 	“Industrialisation” shall mean the design development and
industrialisation program to be
performed by UNILIFE subject to and in accordance with the terms and conditions of this
Agreement in order that UNILIFE finalizes the RTFS design to ensure that it meets all
necessary requirements for medical devices, drug compatibility, filling processes and other
requirements as may be deemed necessary and provides to SWIND production quality products for
verification, validation and qualification purposes.

	 
	1.21	 	“Intellectual Property Rights” shall mean patents and patent applications,
know-how
(including, in particular, unpatented technical and other information such as, but without
prejudice to the generality of the foregoing, ideas, concepts, inventions, discoveries, data,
formulae, specifications, procedures, protocols, processes, results of experimentation or
tests), utility models, trademarks, design rights, copyrights and any other proprietary
rights, whether or not registered.

	 
	1.22	 	“Invention” shall mean any invention (whether patentable or
not) which may be used with the
RTFS technology or with, for or in relation to the Product or which arises from or in
connection with the performance of any Party’s obligations under this Agreement.

	 
	1.23	 	“Material
Obligation” means any obligation of a party under
this Agreement which,
considering the general nature of this Agreement as a whole, is of such importance to a Party
that it would not have entered into this Agreement unless substantial performance of that
obligation was assured and such was apparent to the other Party at the time of entering into
this Agreement. However, Material Obligation does not include obligations in relation to:







	 	(a)	 	accounting matters; or

	 
	 	(b)	 	any minor, procedural or administrative matter the breach of which does not
significantly reduce a Party’s benefits or significantly increase its obligations
under this Agreement.







	1.24	 	“Milestone” shall mean each one of the milestones identified in the
Development Program as
set forth in Exhibit 2.

	 
	1.25	 	“Party” shall mean UNILIFE or SWIND, as the case may be, and
“Parties” shall mean UNILIFE
and SWIND collectively.

	 
	1.26	 	“Patents” shall mean all international and national patent applications
relating to the
RTFS technology and, including the following international PCT (and corresponding non-PCT)
applications and any national patent or patent application derived therefrom or corresponding
thereto being numbers WO2006/119570, WO2006/108243, WO2004/082747, WO2005/072801, and
any Patent Rights arising out of or relating to such patents applications and relating to
the RTFS.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	1.27	 	“Patent Rights” shall mean patent applications or patents, author
certificates, inventor
certificates, utility certificates, improvement patents and models and certificates of
addition and all foreign counterparts of them of UNILIFE and includes any divisions, renewals,
continuations, continuations-in part, extensions, reissues, substitutions, confirmations,
registrations, revalidation or additions of or to them, as well as any supplementary
protection certificate in respect of them, relating to the RTFS.

	 
	1.28	 	“Product” shall mean the RTFS existing on the Effective Date for use
in/for the RTFS Market
and any variation in sizes or functionality as has been developed by UNILIFE and/or SWIND for
use in the RTFS Market prior to the present Agreement.

	 
	1.29	 	“Product Know-How” shall mean unpatented technical and other information
including, but
without prejudice to the generality of the foregoing, ideas, concepts, inventions,
discoveries, data, formulae, specifications procedures for experiments and tests and other
protocols, processes, results of experimentation and testing and assay protocols, relating
directly or indirectly to the Products and known to UNILIFE, of which UNILIFE is the
proprietor.

	 
	1.30	 	“RTFS” shall mean UNILIFE’s Ready to Fill Syringe safety syringe with
integrated auto and
controlled retraction intended to be supplied to pharmaceutical companies as a drug delivery
device.

	 
	1.31	 	“RTFS Market” shall mean the market for sterile syringe
products for use for ready to fill
or primary packaged drug delivery solutions.

	 
	1.32	 	“UNILIFE Intellectual Property” shall mean the Patents, Patent Rights and
Product Know-How
already existing on the Effective Date.






In this Agreement:



unless the context otherwise requires, all references to a
particular article or paragraph shall be
a reference to that article or paragraph in or to this Agreement as the same may be amended from
time to time pursuant to this Agreement;



headings are inserted for convenience only and shall be
ignored in construing this Agreement;




unless the contrary intention appears, words importing the
masculine gender shall include the
feminine and vice versa and words in the singular include the plural and vice versa;



unless the contrary intention appears, words denoting persons
shall include any individual,
partnership, company, corporation, joint venture, trust, association, organisation or other entity,
in each case whether or not having separate legal personality;


 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



reference to the words “include” or
“including” are to be construed without limitation to the
generality of the preceding words; and



reference to any statute or regulation includes any
modification or re-enactment of that statute or
regulation.



ARTICLE 2 — SCOPE OF THIS AGREEMENT





	2.1	 	SWIND hereby entrusts UNILIFE with, which in turn accepts, the performance of the
Industrialisation according to the terms and conditions set forth in this Agreement including
the Development Program, which is attached hereto as Exhibit 2.

	 
	2.2	 	The timetable and the Milestones for the Industrialisation of the Product are set
forth in
the Development Program. UNILIFE undertakes and warrants to carry out the Industrialisation in
accordance with the timetable and to use its best efforts to achieve the Milestones at the
dates set forth in Exhibit 2, unless a failure to do so is as a direct result of SWIND. In
such cases, both Parties shall discuss in good faith the consequences of said delay and the
way to resolve it. UNILIFE shall carry out its obligations under this Agreement with all due
care and skill and in accordance with all relevant legislation and
regulatory standards, including GMP and GDP, and quality standards such as ISO 13485.

	 
	2.3	 	The parties agree that the attached Exhibit 2 is a tentative Development
Program which
the parties undertake to finalize within sixty (60) Business Days of the Execution Date. If
the parties fail to finalize the Development Program within the sixty (60) Business Days, the
attached Exhibit 2 will be the final Development Program.






ARTICLE 3 — COLLABORATION BETWEEN THE
PARTIES





	3.1	 	UNILIFE and SWIND shall each designate an individual to be responsible for the
performance of
this Agreement (“Responsible Person”) and the individuals shall cooperate and consult with
each other on a reasonable basis and frequency in relation to the Industrialisation under this
Agreement. UNILIFE and SWIND shall appoint their respective Responsible Person plus two other
representatives each to a steering committee, which representatives shall jointly be referred
to as the “Steering Committee”. The Steering Committee shall meet regularly throughout the
course of the Agreement and, in any event, no less frequently than every six months. At such
meetings which, unless otherwise agreed, are to take place in an agreed form mutually
convenient to all the members of the Steering Committee (whether it be meetings in person,
over the telephone or otherwise), questions relating to the subject matter of this Agreement
shall be discussed to review the general implementation of this Agreement and to solve any
pending issues in relation thereto.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	3.2	 	The Responsible Persons of UNILIFE and SWIND will have exchanges of information on
the
Industrialisation on a reasonable basis, no less than [***]. In addition, UNILIFE will
submit to SWIND updates on the progress of the Industrialisation from time to time as agreed
between the Responsible Persons, but no less than [***], and will submit Milestone
final reports as provided in Exhibit 2 hereto within [***].







	3.3	 	For the performance of the Industrialisation, UNILIFE will use its own
premises.

	 
	3.4	 	UNILIFE shall itself exclusively determine the members of the team performing the
Industrialisation and undertakes to ensure that such members are appropriately qualified and
have the appropriate knowledge required for the proper performance of the Industrialisation.
UNILIFE will be fully liable for the supervision and monitoring of its agents and employees.
UNILIFE’s team performing the Industrialisation shall remain under UNILIFE’s sole control and
management.
SWIND will ensure that SWIND’s Responsible Person and all its key technical personnel are
reasonably available during the course of the Industrialisation.

	 
	3.5	 	Each Party shall promptly notify the other in writing of any pending processes,
methods,
specifications or manufacturing changes (hereafter the “Modification”) of which it becomes
aware or it is proposing during the Industrialisation. UNILIFE shall promptly provide SWIND
with an estimate of the cost changes — affecting in particular development costs and/or
supply prices — and the timing impacts arising from such Modification. UNILIFE and SWIND
shall evaluate together in good faith the benefit of such Modification and agree together on
the need to implement it or not. SWIND however retains the final right to decide within sixty
(60) Business Days whether to pay said costs to incorporate the Modification, or to refuse
said Modification. However, (i) neither Party shall be obliged to accept or implement any
Modification where the cost of such Modification to that Party is greater than the benefit of
such Modification to that Party, and (ii) neither Party shall withhold or delay acceptance of
any Modification where the cost of such Modification is nil or borne by the other Party. SWIND
shall not be responsible for the costs to incorporate a Modification resulting from any
failure of UNILIFE, in particular failure to achieve the desired features and functions
and/or, subject to this Article 3.5, to abide by the timetable as set forth in Exhibit 2. For
the avoidance of doubt, UNILIFE shall bear the portion of costs of any Modification it would
have decided to implement irrespective of the Industrialisation of the Products, in order to
maintain other products manufactured on its site. The parties acknowledge that the Development
Program and Milestones may be adjusted as a result of the time impacts of any accepted
Modification on such Milestones and the Development Program.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	3.6	 	UNILIFE acknowledges that SWIND shall independently support the Product
Industrialisation in
parallel in accordance with medical device procedures (FDA, MDD), i.e. SWIND shall own its own
design history file. To this purpose, UNILIFE shall provide SWIND with a copy of their design
development relevant documentation that constitutes UNILIFE’s design history file. UNILIFE
agrees that SWIND shall perform the Final Product design verification according to SWIND
documentation (Product design specification and design verification plan).







	3.7	 	UNILIFE agrees to take into account additional technical requirements coming from
SWIND
arising in the areas of human factor engineering, customer feedback, regulatory, marketing or
risk management during the development program up to the earlier of European and US regulatory
approval. The Development Program and the Milestones will be adjusted to accommodate any
delays caused by such process and the time impacts of any such additional technical
requirements.

	 
	3.8	 	UNILIFE acknowledges that SWIND shall, at SWIND’s sole expense, submit the
Final Product
for registration with health authorities worldwide and shall ensure that the Industrialisation
abides by the standards in this regard, such as ISO 13485, GMP and all applicable laws and
regulations. Furthermore, UNILIFE shall give SWIND access to all Industrialisation data and
agree to give SWIND all reasonable assistance that may be necessary for this purpose.

	 
	3.9	 	During the term of this Agreement UNILIFE will supply product (technical material)
to SWIND
from time to time as requested by SWIND for SWIND activities such as market research, user
evaluations, design evaluation testing, industrial trials etc at [***]. The estimated
total quantity for such activities sum up to a maximum of [***].






ARTICLE 4 — INVOICING — PAYMENTS





	4.1	 	The amounts set forth in Exhibit 2 for each Milestone will be invoiced by
UNILIFE to SWIND
upon [***]. For the avoidance of doubt, said amounts under the Agreement are exclusive
of any applicable taxes. SWIND agrees to pay up to a maximum of seventeen (17) million Euros,
exclusive of taxes, under this Agreement and the Development Program, but in no event will the
total amount invoiced by UNILIFE to SWIND under the Agreement exceed
seventeen (17) million Euros exclusive of taxes. Any additional cost in relation with the
completion of the Industrialisation that would exceed said amount will therefore be
exclusively borne by UNILIFE.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	4.2	 	UNILIFE will invoice and address the invoices in the name of SANOFI WINTHROP
INDUSTRIE,
Services Comptables, 20, avenue Raymond Aron, 92165 Antony Cedex, France. Any and all UNILIFE
invoices shall be paid by SWIND by bank transfer in Euros within thirty (30) days from the
invoice date.

	 
	4.3	 	Except with UNILIFE’s prior consent, all sums payable hereunder which are not
paid in
accordance with Article 4.2 shall bear interest at the rate per annum equal to EURIBOR for six
months deposits five (5) basis points from and including the day payment was due through and
including the day payment is made.

	 
	4.4	 	Withholding Tax. If SWIND is compelled by any law to make any tax deduction or
withholding
from any payment due to UNILIFE under this Agreement then SWIND must:







	 	4.4.1	 	make that deduction or withholding;

	 
	 	4.4.2	 	pay the full amount of the tax deduction or withholding in compliance with
the law;

	 
	 	4.4.3	 	promptly, and in any event within 30 days of the end of the month in which
that tax deduction or withholding is made, provide UNILIFE with a copy of the receipt
for each payment from the relevant governmental agency; and

	 
	 	4.4.4	 	Make the payment to UNILIFE net of withholding tax. However if UNILIFE is
able to provide documentation showing that it could not use the tax credit granted by
the tax treaty between Australia and France corresponding to withholding tax and that
consequently this tax credit is lost or is not able to be effectively used by Unilife
(ie actually offset against an actual tax liability of Unilife), then SWIND will make
an additional payment within a month of receiving such documentation by such amount
that, after deduction of the withholding tax referred to above, Unilife receives all
of the amount set out under
the relevant section of this Agreement applied on both the original payment and
the additional payment. Provided that, if UNILIFE can provide such documentation
prior to the relevant payment, SWIND will increase its payment as necessary to
ensure that UNILIFE receives the full amount which UNILIFE would have received if
no tax deduction or withholding had been made.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	4.5	 	The Parties agree that, notwithstanding clause 8.4 or any other provision of this
Agreement,
the Exclusive Agreement or any determination as to the nature of this Agreement or the
Exclusive Agreement by any authority, the payments made under the Exclusive Agreement and
against UNILIFE’s invoices dated 30 September 2008, 31 December 2008 and 31 March 2009 (“Prior
Payments”) were and the payments to be made under this Agreement are wholly for services
rendered or to secure the exclusivity of the supply of the Product, as the case may be. The
Parties agree that no part of such payments were or are to be in any way related to the
licensing of the UNILIFE Intellectual Property, other than to identify the Product the subject
of the Industrialisation and to allow the use of the relevant technology in the
Industrialisation in order and to enable the Parties to fulfil their obligations under this
Agreement.







	4.6	 	UNILIFE agrees to reimburse SWIND for any penalty tax imposed on SWIND prior to the
execution
of this Agreement by the French tax authority for failing to pay withholding tax on the Prior
Payments.






ARTICLE 5 — SUPPLY





	5.1	 	Subject to the full completion of the Industrialisation of the Product, the Parties
will
negotiate a supply agreement for the manufacture and purchase of the Final Product on a
commercial scale (“Supply Agreement”).

	 
	5.2	 	The Supply Agreement will, in addition to all usual matters for such agreements,
cover the
following matters:







	 	5.2.1	 	reflect the relevant terms of the Exclusive Agreement;

	 
	 	5.2.2	 	provide for SWIND and its Affiliates to exclusively purchase, subject only
to UNILIFE being able to meet demand, all ready-to-fill glass syringe products with an
integrated retraction mechanism for the RTFS Market from UNILIFE for the entire period
UNILIFE is required to provide the Final Product exclusively to SWIND or its
Affiliates;

	 
	 	5.2.3	 	provide for the pricing of units of the Final Product in accordance with
Article 5.4;

	 
	 	5.3.4	 	provide for the placing of orders for the Final Product by SWIND and its
Affiliates (including the process for placing orders, making payments and any times by
which any specified orders must be placed); and

	 
	 	5.2.5	 	subject to the prior written agreement of UNILIFE and under conditions to be
discussed and agreed upon in good faith between the Parties, provide that SWIND may be
able to appoint additional or alternative suppliers of the Final Product.







 


- 12 -












 




Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	5.3	 	Although the price of the Final Product, which will apply to all commercial orders
placed by
SWIND from the first commercial order placed, still needs to be negotiated and finalized and
set out in the Supply Agreement, the Parties agree nevertheless that such price of the Final
Product (excluding any Product supplied by UNILIFE to SWIND as contemplated under Article 3.9)
will [***].

	 
	5.4	 	Furthermore, the Parties agree that the suppliers for the pre-assembly components
may be
chosen, without limitation, from those listed in Exhibit 3.

	 
	5.5	 	Upon completion of the Industrialisation, UNILIFE shall on receipt of an order from
SWIND for
Final Products for:







	 	(i)	 	delivery over a 12 month period commencing, at the latest, 12 months after
the date the order is received (“Delivery Date”); and

	 
	 	(ii)	 	in total, with all other orders placed by SWIND for delivery during the 12
month period following the Delivery Date (“Relevant Period”), up to 30 % of UNILIFE’s
expected installed capacity for manufacture of the Final Product for the Relevant
Period (“Relevant Capacity”)







ensure that it is able to deliver such
order(s) in accordance with the agreed terms during
the Relevant Period, commencing no later than the Delivery Date.




	5.6	 	Any order(s) placed by SWIND for the Relevant Period which in total, together with
all other
SWIND’s orders to be delivered during the Relevant Period, exceed 30 % of the Relevant
Capacity will require a maximum of 24 months before the commencement of delivery.

	 
	5.7	 	For the avoidance of doubt, subject only to agreeing the terms of the supply, any
order
placed by SWIND pursuant to and in accordance with Article 5.6 that is within (in total with
all other SWIND orders to be delivered during the Relevant Period) 30% of UNILIFE’s actual
installed capacity for the Relevant Period must be supplied by UNILIFE.





 


 - 13 - 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



ARTICLE 6 — TERM AND TERMINATION





	6.1	 	This Agreement shall become effective as of the Effective Date and, unless otherwise
terminated as provided herein, shall remain in full force and effect until completion of
Industrialisation as described in Article 2 and more particularly set out in Exhibit 2,
following which it shall expire automatically.

	 
	6.2	 	Each Party shall have the right at any time during the period of this Agreement by
giving
written notice to the other party to terminate this Agreement forthwith in any of the
following events:







	 	6.2.1	 	if the other Party enters into either administration, receivership or
liquidation whether compulsory or voluntary otherwise than for the purposes of
amalgamation or reconstruction or entering into a composition with its creditors or
has a receiver appointed over all or the material part of its assets, provided and to
the extent that such termination is permitted pursuant to the applicable legislation
in the country of domicile of the relevant Party;

	 
	 	6.2.2	 	if a Party commits a breach of any Material Obligation which breach has not
been cured within thirty (30) business days following receipt of notice in writing
from the other Party detailing such breach (provided the breach is not the subject
of a dispute being dealt with pursuant to Article 15.2.2) or if a Party is
persistently in default of its other obligations having been repeatedly notified by
the other Party of its breaches under this Agreement and such, when taken together,
amount to a Material Obligation.







	6.3	 	Should the Industrialisation be terminated during any Milestone then, in addition to
any
other rights UNILIFE may have under this Agreement or at law, SWIND shall make a pro rata
payment to UNILIFE of the total sums due under Article 4.1 in respect of each uncompleted
Milestone(s) where UNILIFE has commenced work or committed itself such that it has incurred
its own irrecoverable liability. The pro rata payment shall be fairly determined taking into
consideration the amount of work or resources committed including an assessment of the number
of man hours worked or set aside for the Industrialisation and any stranded costs of UNILIFE.

	 
	6.4	 	If for technical or scientific reasons associated to the Industrialisation described
in
Exhibit 2 UNILIFE concludes that it cannot technically or scientifically or in any other way
perform the Industrialisation and is desirous to terminate this Agreement, the Parties shall
meet and discuss the difficulties and scientific and technical hurdles in an attempt to resolve such problems and
negotiate
in good faith the terms and conditions of the modifications to be made to the
Industrialisation when possible or, as the case may be, terminate the Industrialisation and
this Agreement. In such a case of termination, SWIND shall pay UNILIFE in full for all the
completed Milestones of the Industrialisation performed up to the date of termination and a
pro rata payment in respect of any uncompleted Milestone in accordance with Article 6.3.





 


 - 14 - 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	6.5	 	In the event that this Agreement is terminated by SWIND pursuant to
Article 6.2.1, 6.2.2 or
7.2 or by either Party pursuant to Article 6.4 then, save for each Parties’ ongoing
obligations pursuant to those Articles identified as surviving termination or expiry of this
Agreement, neither Party shall incur any future liability towards the other party other than
the payment by SWIND to UNILIFE in respect of Industrialisation performed up to and including
the day of such termination including for all completed Milestones and in accordance with
Article 6.3. UNILIFE will, on receipt of full payment of all sums due to
UNILIFE under this Agreement, transfer all work noted as deliverable to SWIND for all
completed Milestones covered by such payments. Such payment shall not occur in case of any
gross negligence or wilful misconduct of UNILIFE in performance of its obligations.

	 
	6.6	 	In the event UNILIFE can and does mitigate its loss under the termination of this
Agreement,
any savings made by UNILIFE shall be passed to SWIND in the form of a refund save that no
refund shall exceed the total sums received by UNILIFE from SWIND under this Article.

	 
	6.7	 	Termination of this Agreement for whatever reason shall not affect the accrued
rights of
either UNILIFE or SWIND arising under or out of this Agreement and all provisions which are
expressed to survive this Agreement and the provisions of Articles 8, 9, 11 and 15
(Confidentiality, Intellectual Property, Liability — Indemnities, Applicable law and
Jurisdiction) shall survive termination or expiry and remain in full force and effect. Article
5 shall survive expiry (but not termination) of this Agreement until execution of a Supply
Agreement, if any.

	 
	6.8	 	Subject to Articles 6.7 and 6.9 of this Agreement, termination of this Agreement for
whatever
reason (except for termination by SWIND pursuant to Article 6.2.1 and the expiry of this
Agreement) will automatically terminate the Exclusive Agreement.

	 
	6.9	 	If this Agreement is terminated by either party pursuant to Article 6.4 or by
SWIND pursuant
to Article 6.2.2 the Parties will, at SWIND’s request, negotiate in good faith how and on what
terms any of SWIND’s rights under the Exclusive Agreement may continue after the termination
of this Agreement.






ARTICLE 7 — CHANGE OF CONTROL 





	7.1	 	If UNILIFE agrees or proposes to agree the terms of a Change of Control Proposal
with a third
party:







	 	7.1.1	 	it must give SWIND written notice, within two Business Days of the terms of
the Change of Control Proposal being agreed or proposed to be agreed, of the terms of
the Change of Control Proposal (but, for the avoidance of doubt, not the identity of
the third party);

	 
	 	7.1.2	 	within five Business Days of receiving notice of the Change of Control
Proposal in accordance with Article 7.1.1, SWIND shall be entitled to make an offer
or a counter proposal to UNILIFE on at least equivalent terms to the Change of
Control Proposal (“Matching Offer”);





 


 - 15 - 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	 	7.1.3	 	if a Matching Offer is made under Article 7.1.2, in the absence of a
further Change of Control Proposal being made on improved terms, UNILIFE must accept
the Matching Offer and not pursue the Change of Control Proposal with the third
party; and

	 
	 	7.1.4	 	if the third party submits a revised Change of Control Proposal on improved
terms (“Increased Offer”) to UNILIFE prior to UNILIFE’s acceptance of the Matching
Offer, UNILIFE must serve a further written notice on SWIND in accordance with
Article 7.1.1 detailing the terms of the Increased Offer and SWIND will have a
further opportunity in accordance with Article 7.1.2 to make a further Matching Offer
to reflect the Increased Offer and the terms of Article 7.1.3 shall apply with
respect to the new Matching Offer.







	7.2	 	If a Change of Control Event occurs at any time during the term of this Agreement
which does
not involve SWIND or any Associate of SWIND obtaining control of UNILIFE under the Change of
Control Event and:







	 	7.2.1	 	which is not recommended by the Board of UNILIFE; or;

	 
	 	7.2.2	 	which will cause Harm to SWIND; or

	 
	 	7.2.3	 	under which the current CEO and director of UNILIFE (Mr Alan Shortall) is
not to continue in his current role as the CEO and as a director of UNILIFE for at
least two years after the Change of Control Event,

	 
	 	 	 	then:

	 
	 	7.2.4	 	UNILIFE must notify SWIND in writing within 5 Business Days of the
occurrence of the Change of Control Event; and

	 
	 	7.2.5	 	SWIND shall have the right, exercisable within ten Business Days of receipt
of a notice from UNILIFE under Article 7.2.1 or SWIND otherwise becoming aware of the
Change of Control Event, to terminate this Agreement with immediate effect by notice
in writing to UNILIFE.





 


 - 16 - 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



ARTICLE 8 — INTELLECTUAL PROPERTY 





	8.1	 	Each Party shall be and remain the exclusive owner of its (i) Base Technology
and (ii) Future
Technology and each Party shall have the exclusive right to maintain and prosecute these
rights. Each Party shall be solely responsible for the conduct and costs of filing,
prosecution and maintenance of patents and patent applications for its own Intellectual
Property Rights including, without limitation, for its Base Technology and Future Technology.

	 
	8.2	 	Subject to Articles 8.3 and 8.5, SWIND shall be the sole owner of any Co-Invention.
UNILIFE
is to assign to SWIND all its rights to any Co-Invention. SWIND shall be solely responsible
for the conduct of filing, prosecution and maintenance of any Intellectual Property Rights
arising from such Co-Invention, as is reasonably appropriate. UNILIFE is to support SWIND with
respect to the filing, prosecution and maintenance of the Intellectual Property Rights arising
from such Co-Inventions in good faith. The costs for filing, prosecution and maintenance of
any Intellectual Property Rights arising from
such Co-Inventions shall be solely borne by SWIND. If SWIND intends to give up any
Intellectual Property Rights arising from such Co-Invention, SWIND must first offer such
Intellectual Property Rights in writing to UNILIFE. If UNILIFE does not answer within 3
months in writing to SWIND that it intends to take over the Intellectual Property Rights
offered by SWIND at its own expenses, SWIND is entitled to give up such rights immediately,
as it deems appropriate. If UNILIFE does answer in writing within 3 months that it wishes
to take over the relevant Intellectual Property Rights (or any part of them), SWIND will do
all things necessary to transfer such rights to UNILIFE as quickly as possible and,
thereafter, UNILIFE will be solely responsible for such rights.

	 
	8.2	 	Use of Co-Inventions by SWIND. SWIND must not use any Co-Invention in
relation to or
for any glass Competing Product.

	 
	8.4	 	Licence from UNILIFE. UNILIFE hereby grants to SWIND and its Affiliates,
during the
term of this Agreement and solely for the purpose of and in order for SWIND to perform its
obligations under this Agreement, a royalty free, non-exclusive, worldwide licence for the
term of this Agreement to use and/or practice all UNILIFE-owned Intellectual Property Rights,
Base Technology, Future Technology and Inventions (including all information, documents and
tangible and intangible materials which result from the performance of the services under this
Agreement by UNILIFE) concerning the RTFS technology or the Product.

	 
	8.5	 	Licence from SWIND. Subject to Article 10, SWIND hereby grants to
UNILIFE and its
Affiliates a perpetual royalty-free, non-exclusive, worldwide licence to use and/or practice
all Co-Inventions. In addition SWIND hereby grants to UNILIFE and its Affiliates, during the
term of this Agreement for the purpose of the Industrialisation hereunder and otherwise to
perform its obligations hereunder, a royalty free, non-exclusive, worldwide licence and to
use and/or practice all SWIND-owned Intellectual Property Rights, Base Technology, Future
Technology and Inventions and all information, documents and tangible and intangible
materials provided by SWIND.





 


 - 17 - 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



ARTICLE 9 -LIABILITY - INDEMNITIES





	9.1	 	UNILIFE warrants that to the best of its knowledge, the UNILIFE Intellectual
Property is
valid, and that the marketing, sale or disposal of any Product and/or Final Product falling
within the scope of the UNILIFE Intellectual Property does not to the best of UNILIFE’s
knowledge infringe any third party Intellectual Property Rights. UNILIFE shall promptly inform
SWIND of any infringement, or improper or unlawful use of, or any change to the validity of
the UNILIFE Intellectual Property.

	 
	9.2	 	SWIND warrants that to the best of its knowledge SWIND’s Base Technology and
those Inventions
which are conceived, reduced to practice or created under this Agreement by SWIND and/or its
Affiliates or agents from and after the Effective Date are valid and such will not infringe
any third party’s Intellectual Property Rights. SWIND shall promptly inform UNILIFE of any
infringement, or improper or unlawful use of, or any change to the validity of SWIND’s Base
Technology and such Inventions.

	 
	9.3	 	Each Party (“Indemnifying Party”) shall indemnify and hold harmless the
other Party
(“Indemnified Party”) and its officers, employees and agents at all times in respect of any
and all losses, damages, costs and expenses suffered or incurred as a result of any
contractual, tortious or other claims or proceedings by third parties against Indemnified
Party arising out of the Indemnifying Party’s breach of this Agreement, including breach of
representations and warranties, violation of applicable law, negligence or wilful misconduct.

	 
	9.4	 	Neither Party shall be liable to the other in contract tort, negligence, breach of
statutory
duty or otherwise for any loss, damage, costs or expenses of any nature whatsoever incurred or
suffered by the other of an indirect or consequential nature, including any economic loss or
other loss of turnover, profits, business or goodwill.

	 
	9.5	 	Each Party’s aggregate liability to the other party under this Agreement for
any loss or
damage suffered by the other party as a result of breach of or in connection with this
Agreement, or in respect of any other liability in respect of the performance or
non-performance of the obligations covered by this Agreement, shall be limited to fifty
million (50,000,000) Euros.

	 
	9.6	 	The terms of this Article 9 shall survive expiration or termination of this
Agreement for
whatever reason.





 


 - 18 - 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



ARTICLE 10 — EXCLUSIVITY





	10.1	 	Should the Industrialisation process be delayed for any reason and outlast the
duration of
the Exclusive Licence or the Default Licence (as these terms are defined in the Exclusive
Agreement), whichever is applicable, the Parties agree that, provided that this Agreement has
not been terminated and the Supply Agreement has been executed, the exclusivity under the
Exclusive Agreement will be extended at least for the period needed to cover the full
completion of the Industrialisation.

	 
	10.2	 	In addition to the provisions relating to exclusivity in the Exclusive Agreement,
during the
term of the Exclusive Agreement (and any extension pursuant to Article 10.1) SWIND:







	 	10.2.1	 	will not, alone or through any Affiliate or third party arrangement, develop,
industrialise, commercialise, acquire, use or sell any glass Competing Product;

	 
	 	10.2.2	 	will not, alone or through any Affiliate or third party arrangement, develop,
industrialise, commercialise, acquire, use or sell any plastic Competing Product which
utilises or infringes any of the UNILIFE Intellectual Property or UNILIFE’s Future
Technology; and

	 
	 	10.2.3	 	may, subject to Articles 10.2.1, 10.2.2 and 10.3 develop, industrialise,
commercialise, acquire or use other technologies/products for the RTFS Market (“New
Product”).







	10.3	 	In respect of any proposed New Product, SWIND must:







	 	10.3.1	 	first establish whether the New Product is subject to any third party Intellectual
Property Rights or to other proprietary rights which prohibit or restrict the
manufacturing of the New Product (“Restrictive Proprietary Rights”);

	 
	 	10.3.2	 	if SWIND finds any Restrictive Proprietary Rights it must in good faith approach the
relevant third party(ies) which owns or control such Restrictive Proprietary Rights
and try to licence or obtain such other approval or consent for such Restrictive
Proprietary Rights for use by SWIND and UNILIFE on behalf of SWIND;

	 
	 	10.3.3	 	if SWIND is able to licence the Restrictive Proprietary Rights in accordance with
Article 10.3.2 then UNILIFE will be entitled to manufacture the New Product on
competitive terms to be agreed by the parties in good faith; or

	 
	 	10.3.4	 	if SWIND is unable to licence the Restrictive Proprietary Rights in accordance with
Article 10.3.2 then, on providing all necessary evidence to reasonably satisfy UNILIFE
that SWIND tried in good faith but failed to obtain such licence, SWIND may proceed
for the New Product with the third party(ies) that owns or controls the Restrictive
Proprietary Rights.






 


 - 19 - 









 




Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




ARTICLE 11 — CONFIDENTIALITY 





	11.1	 	Each Party acknowledges and agrees that while performing this Agreement it will be
exposed to
or be given Confidential Information of the other Party.

	 
	11.2	 	Each Party undertakes to maintain the secrecy of the Confidential Information of the
other
Party and to avoid any disclosure and/or use for a purpose other than performing this
Agreement and shall take no less care in respect of such Confidential Information than it
takes or should take regarding its own Confidential Information.

	 
	11.3	 	Each Party undertakes to make the Confidential Information of the other Party
available only
to its employees who have a direct need to have access to such information in order to perform
this Agreement and to take all reasonable steps necessary to ensure that such employees do not
disclose and/or use such Confidential Information of the other Party in a manner which is not
authorized under this Agreement.

	 
	11.4	 	The foregoing undertaking of confidentiality and non-use shall remain in full force
and
effect for a period of ten (10) years as of the Effective Date of this
Agreement, even if this Agreement is declared null and void for any reason, unless the
Confidential Information:







	 	11.4.1	 	was known to the public or was generally available to the public at the time of
disclosure of such Confidential Information;

	 
	 	11.4.2	 	becomes known to the public or is generally available to the public after the
disclosure of such Confidential Information, through no fault of the receiving Party
or of its employees;

	 
	 	11.4.3	 	is obtained lawfully from a third party without any restriction, provided that such
Confidential Information has not been acquired directly or indirectly by the third
party from the disclosing Party under an enforceable secrecy obligation;

	 
	 	11.4.4	 	can be established by a Party to have been in its possession before the time of
disclosure and was not acquired, directly or indirectly, from the other Party; or

	 
	 	11.4.5	 	can be established by a Party to have been developed by it independently of
Confidential Information received from the other Party.





 


 - 20 - 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	11.5	 	Should a Party require the assistance of third parties (subject to the other
Party’s prior
written approval) for the performance of the Agreement, these third parties will be subject to
the same conditions of confidentiality as the considered Party and will use the Confidential
Information only for the purpose of performing the Agreement.

	 
	 	 	In case of a breach of these obligations by said third parties, the Party which
required
their assistance shall remain responsible for them towards the other Party.

	 
	11.6	 	The restrictions on use and non-disclosure of Confidential Information shall not
apply where
the recipient Party is compelled to disclose the Confidential Information by reason of law or
order of a tribunal having competent jurisdiction over the Party. The disclosure is strictly
limited to what is legally required.

	 
	11.7	 	Upon expiry or prior termination of this Agreement, unless the Parties should decide
otherwise, each Party shall return to the other Party any and all written or recorded
Confidential Information of the other.

	 
	11.8	 	Except as strictly required by law, no press release or other public statements in
connection
with work performed under this Agreement intended for use in the public media, having or
containing any reference to SWIND or UNILIFE, shall be made by either Party without the prior
written approval of the other Party, which shall not be unreasonably withheld or delayed.






ARTICLE 12 — ASSIGNMENT — SUBCONTRACT



UNILIFE may subcontract, in whole or in part, the
Industrialisation provided that it (i) first
discusses such with SWIND and, in making its decision, takes into account all reasonable concerns
of SWIND and (ii) may not, without the prior written consent of SWIND, subcontract any part of the
Industrialisation so as to cause Harm to SWIND. UNILIFE may not otherwise assign, extend or
transfer any of its rights and obligations under this Agreement, without the express and prior
written consent of SWIND. Except to an Affiliate, SWIND may not assign, extend or transfer any of
its rights and obligations under this Agreement without the prior written consent of UNILIFE. Any
assignment, extension or transfer without the required consent and approval shall be null and void.
In case of subcontract, UNILIFE remains fully responsible for the proper performance of this
Agreement. SWIND may assign this Agreement to an Affiliate upon reasonable written notice to
UNILIFE.


 


 - 21 - 









 





Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



ARTICLE 13 — QUALITY — AUDIT





	13.1	 	UNILIFE undertakes to run the Industrialisation in compliance in particular with ISO
13485,
the Medical Devices Directive requirements (Council Directive 93/42/EEC of 14 June 1993, as
amended 2007/47/EC) and FDA regulation (GMP, 21CFR Part 820, GDP). Furthermore, both Parties
will agree on a regulatory plan which lists notably all relevant applicable standards,
guidelines etc.

	 
	13.2	 	SWIND or any third party appointed by SWIND (provided that said third party has
executed a
confidentiality agreement with UNILIFE with regard to any audit) will be allowed on no more
than two (2) occasions in any one calendar year, during the term of this Agreement during
normal office hours on giving reasonable notice to UNILIFE, to carry out a technical, design
development or quality assurance audit in the premises where the Industrialisation is
performed by UNILIFE.

	 
	13.3	 	UNILIFE undertakes to cooperate with and help SWIND, or any third party appointed by
SWIND,
for such audit.

	 
	13.4	 	Where any audit conducted reveals a breach of the Agreement by UNILIFE, UNILIFE will
undertake all efforts to resolve any issues notified during such audit.

	 
	13.5	 	UNILIFE shall immediately inform SWIND of any audit or notification by a regulatory
authority
that could have an impact in any manner on the Product and/or on this Agreement.






ARTICLE 14 — GENERAL PROVISIONS





	14.1	 	Entire agreement: The Exclusive Agreement, this Agreement and its attached Exhibits
contain
the entire agreement and understanding between the Parties with respect to the subject matter,
merge all prior discussions and negotiations between them and shall not be altered, amended or
construed by any previous or contemporaneous oral or written agreement.

	 
	 	 	Any amendment of or supplement to this Agreement (including changes to the Exhibits)
shall
only be by written instrument signed by both Parties. No modification, extension or
variation of this Agreement (or any document entered into pursuant to or in connection with
this Agreement) shall be valid unless it is in writing and signed by or on behalf of each
of the parties to this Agreement. For the avoidance of doubt, no modification or variation
of this Agreement shall be valid if made by e-mail.

	 
	 	 	Unless expressly so agreed, no modification or variation of this Agreement shall
constitute
or be construed as a general waiver of any provisions of this Agreement, nor shall it
affect any rights, obligations or liabilities under this Agreement which have already
accrued up to the date of such modification or waiver and the rights and obligations of the
parties under this Agreement shall remain in full force and effect, except and only to the
extent that they are so modified or varied.





 


 - 22 - 









 




Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	14.2	 	Waivers: A waiver of a breach or default under this Agreement shall not be a waiver
of any
other or subsequent breach or default. The failure or delay by either Party in enforcing
compliance with any term or condition of this Agreement shall not constitute waiver of such
term or condition, unless such term or condition is expressly waived in writing.

	 
	14.3	 	Force Majeure: Except for the failure to pay any money due under this Agreement,
neither
Party shall be held in breach of this Agreement by any reason of acts or omissions caused by
any Force Majeure event. A Force Majeure event shall mean an event which is the result of any
cause beyond the reasonable control of the concerned Party.

	 
	 	 	The affected Party shall use due diligence to remove any such causes and to resume
performance under this Agreement as soon as it is reasonably feasible. Either Party shall
notify in writing the other Party of any Force Majeure event which prevents such Party from
performing its obligations under this Agreement. In the event a Force Majeure situation
continues for more than 30 (thirty) days after notice is served, and is adversely effecting
the performance of this Agreement, each Party will have the right, on 15 (fifteen) days
advance written notice not to expire before the 30 (thirty) day period to terminate this
Agreement.

	 
	14.4	 	Hardship: Should any unforeseen event while not preventing either party from
performing any
of its obligations hereunder, cause either party inequitable hardship for the performance of
such obligations, and/or substantially affect the economic balance of the Agreement —
including unforeseen events leading to a substantial increase of the COGs per unit of the
Final Product —  and the party can demonstrate this by competent proof, then both parties
shall negotiate in good faith an equitable way to adapt this Agreement to the new
circumstances.

	 
	14.5	 	Each of UNILIFE and SWIND warrants and undertakes that it is able to enter into this
Agreement and is not restricted by any provisions of any agreements
of any nature which prevent it from carrying out this Agreement fully according to its
terms.

	 
	14.6	 	Separate Entities: Nothing in this Agreement shall constitute or be deemed to
constitute a
partnership between the Parties hereto or constitute or be deemed to constitute either Party
as an agent of the other for any purpose whatsoever, and neither Party shall have the
authority or power to bind the other Party, or to contract in the name of and create a
liability against the other Party in any way or for any purpose, unless explicitly instructed
in writing to do so.

	 
	14.7	 	Notices: All notices, reports and other writings which are required to be given or
submitted
pursuant to this Agreement shall be in writing and delivered personally or sent by
international courier service, or by confirmed facsimile transmission, to the addresses set
forth below or to such other address as a Party may from time to time notify to the other
Party. Any and all notices sent to the other Party in accordance with this Article shall
become effective as of receipt thereof by the other Party.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



SWIND:



To the attention of the Chief Executive Officer

Sanofi Winthrop Industrie

20, avenue Raymond Aron

92165 Antony Cedex

France

Telephone:+ 33 1 55 71 71 71

Facsimile: + 33 1 47 02 50 14




UNILIFE:




Alan Shortall

Unilife Medical Solutions Limited

633, Lowther Road

Lewisberry PA 17339

USA




Telephone: +1 717 938 9323

Facsimile: +1 717 938 9364




ARTICLE 15 — GOVERNING LAW — DISPUTES





	15.1	 	Governing Law: The Parties hereto agree that this Agreement, including without
limitation,
all transactions affected hereunder, its validity and enforceability and all relationships
between the Parties in this connection shall be construed under and be governed in all
respects by the laws of France.

	 
	15.2	 	Dispute:







	 	15.2.1	 	In the event of a dispute relating to any obligation of a Party that is not a
Material Obligation, the dispute shall be resolved in accordance with the dispute
resolution procedure set out in Exhibit 4.

	 
	 	15.2.2	 	In the event of a dispute relating to a Material Obligation of either Party or
otherwise relating to any question regarding the existence, validity or termination of
this Agreement (save for a disputes referred for resolution in accordance with Exhibit
4 pursuant to Article 15.2.1) (“Material Dispute”), the Material Dispute shall be
referred to the Steering Committee. If the Steering Committee does not resolve the
Material Dispute within a period of fourteen (14) days, the Material Dispute shall be
referred to the CEO of SWIND and the CEO of UNILIFE.





 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.




	 	 	 	If the CEOs fail to resolve the Material Dispute within 30 days of receipt of
the
written notice requesting the referral, the Parties hereby agree that such
Material Dispute shall exclusively submitted to and be settled by the courts of
Paris, France and courts of appeal there from and the Parties hereby submit to
such exclusive jurisdiction.







	15.3	 	In the event this Agreement, and any related document, should be translated from
English to
another language, the English version shall prevail in all respects in the case of any
discrepancy.






IN WITNESS WHEREOF, the Parties hereto have caused this
Agreement to be duly executed on the dates
indicated herein below.



Made in two (2) original copies




	 	 	 	 	 	 	 	 	 	 	 
	Antony, on June 29, 2009	 	 	 	Sydney, on	 	 	 	 
	 

	 	 	 	 	 	 	 	 

	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	SANOFI WINTHROP INDUSTRIE	 	 	 	UNILIFE	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Philippe Luscan
 

	 	 	 	By:
	 	/s/ Alan Shortall
 

	 	 
	 

	 	Name: Philippe LUSCAN
	 	 	 	 	 	Name: Alan SHORTALL	 	 
	 

	 	Title: Chairman and CEO
	 	 	 	 	 	Title:	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Gerald Touratier	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 

	 	Name: Gerard TOURATIER	 	 	 	 	 	 	 	 
	 

	 	Title: CFO	 	 	 	 	 	 	 	 






 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



Exhibit 2

Development Program




Exhibit 2.a Unilife Project Plan/ Development
Programme




[***]




Exhibit 2.b

Unilife Milestones




[***]




Exhibit 3

List of potential suppliers — Components




[***]


 


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Exhibit 10.3

CONFIDENTIAL TREATMENT

REQUESTED PURSUANT TO RULE 24b-2




Certain portions of this exhibit have been omitted pursuant
to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended. The omitted materials have been filed separately with the
Securities and Exchange Commission.



Exhibit 4

Dispute Resolution Procedure




In the event of a dispute between the Parties that is required
to be resolved by the Agreement
pursuant to the procedures of this Exhibit 4 the patties shall observe the following procedure:




	1.	 	The Parties shall make all reasonable efforts to resolve the dispute by amicable
negotiations.

	 
	2.	 	For factual matters related to the quality of Products, the Parties shall mutually
select an
independent laboratory to evaluate the materials. Such evaluation shall be binding on the
Parties only with respect to the factual determinations made in such evaluation.

	 
	3.	 	For factual matters related to GMP issues, the Parties shall mutually select an
independent
quality consultant to evaluate the issue. Such evaluation shall be binding on the Parties
only with respect to the factual determinations made in such evaluation.

	 
	4.	 	For factual matters related to an accounting matter, the Parties shall mutually
select an
independent certified accounting firm of international prominence in France to audit the
relevant books and records of the Parties related to such matters. Such audit shall be
binding on the Parties only with respect to the factual determinations made in such audit.

	 
	5.	 	The provisions of this Exhibit shall govern to finally resolve all disputes,
controversies
and claims between the Parties hereunder; provided, however, that the factual
determinations made pursuant to Sections 2, 3 and 4 of this Exhibit shall be final and binding
upon the Parties.

	 
	6.	 	No laboratory or quality consultant or accounting firm selected or acting pursuant
to this
Exhibit shall be deemed to be an arbitrator.

	 
	7.	 	Costs and expenses of any such laboratory or quality consultant or accounting firm
shall be
borne by the non-prevailing Party.







 


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