� Deacons
Exhibit
10.35
� Deacons
***Sections
3.3(2), 3.3(3), 3.3(7), 3.3(8) and 4.1, Schedule 1 and Annexures A and B in
their entirety have been omitted pursuant to a request for confidential
treatment and have been filed separately with the U.S. Securities and Exchange
Commission.
Dated
October 25, 2007
Manufacturing
and development agreement
Parties
MiniFAB
(Aust) Pty Ltd
ACN 100
768 474
OcuSense,
Inc.
Contact
Xxxxxxx X'Xxxx
Partner
Xxxxx 00,
XXXX Xxxxx, 000 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 0000
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Telephone:
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x00
(0)0 0000 0000
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Email:
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xxxxxxx.xxxxx@xxxxxxx.xxx.xx
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Website:
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xxx.xxxxxxx.xxx.xx
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Our
ref:
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2626784
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Contents | ||
1.
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Definitions
and interpretation
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1
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2.
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Development
of the First Product
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6
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3.
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Supply
of Products
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6
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4.
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Price
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13
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5.
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Development
of New Products
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14
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6.
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OcuSense
Licence
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18
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7.
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Obligations
of MiniFAB
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20
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8.
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Meeting
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20
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9.
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Payment
and invoicing
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21
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10.
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Amendments
to Specifications
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21
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11.
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Registrations,
safety and Product liability
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22
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12.
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Insurance
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23
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13.
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Warranties
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23
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14.
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Third
party licensors and contractors; Technology Transfer.
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23
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15.
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Term,
breach and termination
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26
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16.
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Liability
and indemnity
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27
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17.
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Goods
and services tax
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29
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18.
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Confidentiality
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29
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19.
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Disputes
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31
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20.
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Force
Majeure
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33
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21.
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Notices
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33
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22.
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General
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34
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Schedule
1 First Product
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36
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Schedule
2 Form of Development Order
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37
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Manufacturing and Development
Agreement dated October 25, 2007
Parties
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MiniFAB (Aust) Pty Ltd
ACN 100 768 474
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of 0 Xxx
Xxxxxxxxx, Xxxxx Xxxxxxxx, Xxxxxxxx 0000, Xxxxxxxxx (MiniFAB)
OcuSense,
Inc.
of 00000
Xxxx Xxxxx Xx., Xxxxx 000, Xxx Xxxxx, XX 00000,
U.S.A.
(OcuSense)
Introduction
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A.
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MiniFAB
is a micro-nano-bio company that offers customised manufacturing
and advanced product development
services.
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B.
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OcuSense
is an in-vitro diagnostics company that is developing and desires to
commercialise a proprietary tear testing platform, TearLab™, capable of
accurately and rapidly diagnosing various eye diseases at the
point-of-care.
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C.
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MiniFAB
and OcuSense are parties to that certain development agreement for a tear
collection interface (“TCI”) device comprised of
Terms of Business and the Project Proposal for Project Tear-Sense (Stage
0), each dated 17 November 2006 (collectively, the "Development
Agreement").
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D.
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OcuSense
wishes to acquire the services of MiniFAB in the manufacture and
supply of the TCI Device developed under the Development
Agreement, as well as potential development and manufacture of other TCI
Devices, and MiniFAB has agreed to provide such services, on the terms of
this Agreement.
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It
is agreed
1.
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Definitions
and interpretation
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1.1
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Definitions
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In this
Agreement:
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(1)
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Agreement means this
document, including any schedule or annexure to
it;
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(2)
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Annual Production
Capacity means, in respect of each Product, the
quantity
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of
the Product that MiniFAB is reasonably capable of manufacturing each year,
and as varied in accordance with clause 3.5. The Annual Production
Capacity for the First Product is specified in Schedule 1 and the Annual
Production Capacity for the New Products is to be agreed between the
parties pursuant to clause 5.8;
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(3)
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Business Day means a day
that is not a Saturday, Sunday or any other day which is a public holiday
or a bank holiday in Melbourne,
Australia;
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(4)
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cGMP means current Good
Manufacturing Practices, as established by
the FDA;
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(5)
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Commencement Date means
October 19, 2007;
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(6)
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Commercially Reasonable
Efforts means the exercise of such efforts and commitment of
such resources by MiniFAB as would be expended on, or committed by MiniFAB
for, a comparable development or manufacturing program of a similar scope
and at a similar stage in development or product lifecycle, comparable
profit margin and potential, competitive landscape, and risk profile, in
each case with due regard to the nature of efforts and cost required for
such development or manufacturing and taking into account payments made by
OcuSense, or obligated to be made by OcuSense, under this
Agreement;
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(7)
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Confidential Information
of a party means any Information (and all tangible and intangible
embodiments thereof of any kind whatsoever) provided by that party or its
Representatives to the other party or its Representatives whether provided
orally or in any form and is marked, identified as or otherwise
acknowledged to be confidential at the time of disclosure to the other
party; provided, however, that information, data and results generated by
MiniFAB under the Development Agreement, or in the course of performing
activities under this Agreement, that relate to OcuSense's technology or
to the development of Products or prototypes thereof shall be deemed the
Confidential Information of
OcuSense;
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(8)
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Default Rate means 10%
per annum;
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(9)
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Delivery Point means the
premises of MiniFAB located at 0 Xxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxx,
XXXXXXXXX;
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(10)
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Development Expenses
means all costs and expenses incurred by MiniFAB for the development
of a New Product as more particularly described in clause 5.5(1)(a),
but does not include the capital expenditures referred to in clause 5.5(1)(b);
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(11)
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Development Order means
a document substantially in the form set out in Schedule 2 executed
by or on behalf of MiniFAB and OcuSense which details a New Product
to be developed by MiniFAB in accordance with clause
5;
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(12)
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Development Request has
the meaning given in clause 5.2;
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(13)
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EXW means "ex works",
according to the Incoterms 2000 published by the International
Chamber of Commerce (ICC) as amended from time to
time;
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(14)
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FDA means the United
States Food and Drug
Administration;
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(15)
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First Product means the
TCI Device developed under the Development Agreement, together with
the capsule and applicable packaging, all as further described in Schedule
1;
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(16)
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Force Majeure means any
cause which is not within the reasonable control of the party affected by
it including, but not limited to, acts of God, war declared or undeclared,
civil disturbance, acts or omissions of government or other competent
authority, fire, lightning, explosion or flood, but excludes any cause due
to lack of demand or market success for the
Products;
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(17)
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Governmental Agency
means any court, administrative agency or commission or other
governmental agency, body or instrumentality, domestic or
foreign;
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(18)
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Information means any
information or know-how pertaining to, or in the possession or
control of, a party including, but not limited to,
information concerning its business, systems, technology and afairs,
such as:
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(a)
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financial,
technological, strategic or business information, concepts, plans,
strategies, directions or
systems;
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(b)
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research,
development, operational, legal, marketing or accounting information,
concepts, plans, strategies, directions or
systems;
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(c)
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technology,
source and object codes for computer sofware, intellectual property
rights and technical and historical information relating
thereto;
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(d)
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customer
and supplier information; and
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(e)
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information
relating to the Products;
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(19)
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Insolvency Event in the
context of a person means:
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(a)
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a
receiver, receiver and manager, official manager,
trustee, administrator, other controller (as defined in the Corporations Xxx
0000 (Cth)) or similar official is appointed, or steps are
taken for such appointment, over any of the equipment or undertaking
of the person;
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(b)
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the
person is or becomes unable to pay its debts when they are due or is
or becomes unable to pay its debts within the meaning of the Corporations Xxx
0000 (Cth) or is presumed to be insolvent under the Corporations Xxx
0000 (Cth);
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(c)
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the
person ceases or threatens to cease to carry on business;
or
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(d)
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an
application or order is made for the liquidation of the person or a resolution
is passed or any steps are taken to liquidate or pass a resolution for the
liquidation of the person otherwise than for the purpose of an
amalgamation or
reconstruction;
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(20)
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Intellectual Property
means any copyright, design (whether registered or unregistered),
trademark (whether registered or unregistered), patent or patent
application or invention, circuit layout, know-how, confidential
information (whether such information is in writing or recorded in any
other form) and other proprietary or personal rights arising from
intellectual activity in the business, industrial, scientific or artistic
fields;
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(21)
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Supply Start Date has
the meaning given in clause 3.2(2);
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(22)
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Loss means any loss,
damage, cost, interest, expense, fee, penalty, fine, forfeiture,
assessment, demand, liability or damages incurred by a person to the
extent resulting from any action, suit, claim, proceeding or cause of
action brought against such party by a third
party.
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(23)
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Minimum Orders means, in
respect of each Product, the minimum quantity of Product that
OcuSense must purchase from MiniFAB during a specified period. The
Minimum Orders are specified in clause
3.3(7);
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(24)
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New Products means any
TCI Devices developed pursuant to this Agreement and any other goods
that the parties agree are New Products. For the avoidance of doubt,
New Products do not include the First
Product;
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(25)
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OcuSense IP has the meaning
given in clause 6.1;
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(26)
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Price means, in respect
of each Product, the price payable by OcuSense to MiniFAB for the
supply of that Product, inclusive of all packaging, labelling and all
other handling charges (other than the freight
costs);
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(27)
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Products means the First
Product and any New Products;
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(28)
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Prototype First Product
means a pre-production prototype of the First Product conforming to
the First Product Requirement Definitions, and mayinclude prototype units
of the First Product at different stages of development (such
as, for example, alpha prototypes and beta
prototypes).
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(29)
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Purchase Order has the
meaning given in clause 3.4;
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(30)
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Quarter means a period
of three months commencing on 1 January, 1 April, 1 July or 1
October;
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(31)
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R&D Services means
those development services for New Products as specified in clause
5.1;
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(32)
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Registrations means all
registrations or approvals required from the relevant Regulatory
Authority or Authorities for the export, import, storage,
promotion, supply, sale or other distribution in the of the
Products;
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(33)
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Regulatory Authority
means any Governmental Agency having responsibility for the
regulation of, oversight of or whose approval is required for
the manufacture, marketing, sale or supply of the Products or the
facilities in which it is
manufactured;
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(34)
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Regulatory Requirements
means, collectively:
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(a)
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all
laws and regulations and any and all other requirements of the FDA or
any other Regulatory Authority that are mandatory to the manufacture,
packaging, labelling, storage, handling and shipment of the Products by
MiniFAB and, subject to clause 2.1, includes cGMP;
and
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(b)
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all
standards set by the International Organization for Standardization (ISO)
that are mandatory to the manufacture, packaging, labelling, storage,
handling and shipment of the Products by MiniFAB, including without
limitation ISO 13485:2003 (Medical Devices Quality Management System), ISO
10993-1 (Biocompatibility), ISO 10993-5 (Biocompatibility: Cytotoxicity),
and ISO 10993-10 (Biocompatibility: Sensitization and Irritation), but
excludes
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(c)
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any
law, regulation, requirement or standards that apply to the design,
trials, marketing, sales or supply of the Products (and which do not also
apply to the manufacture of Products and/or to MiniFAB's supply to
OcuSense hereunder);
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(35)
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Representative of a
party means the employees, directors, agents or advisors of that
party;
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(36)
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Requirement Definitions
means, with respect to any Product, the written documentation guiding
MiniFAB's development of such Product, including detailed requirement
definitions for such Product, as agreed by the parties. The initial
Requirement Definitions for the First Product have been agreed by the
parties as of the Commencement Date. The Requirement Definitions may be
modified from time to time by mutual agreement of OcuSense and MiniFAB in
the course of development work for such Product, and MiniFAB agrees to use
Commercially Reasonable Efforts to accommodate changes to the Requirement
Definitions as OcuSense may from time to time
request;
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(37)
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Second Product means the
first New Product developed pursuant to this Agreement, which the parties
intend to be a TCI Device similar to the First Product, provided that such
product would be designed to measure either (i) a marker other than
osmolarity, or (ii) both osmolarity and one other additional
marker;
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(38)
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Specifications means,
with respect to any Product, the definitive written documentation
guiding MiniFAB's manufacture, packaging, labelling, storage and handling
of such Product, prepared and agreed in accordance with clause 3.1; in
each case, and as modified from time to time by mutual agreement of
OcuSense and MiniFAB in accordance with clause
10;
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(39)
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Successful Completion
has the meaning provided in clause
5.10;
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(40)
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TCI Device means any tear
collection interface device or any microfluidicbased
device;
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(41)
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Technical Agreement
means the technical agreement entered into between MiniFAB and OcuSense
with respect to each Product, as may be amended from time to time, which
specifies their respective responsibilities for quality control and
quality assurance and related activities and qualifications with respect
to the applicable Product. The Technical Agreement for the First Product
shall be entered into concurrently with this Agreement. Mutually agreed
Technical Agreements for other Products shall be entered into prior to
commercial manufacture and supply of such
Products;
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(42)
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Term means the term of
this Agreement, including any extended term underclause 15.1;
and
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(43)
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Wholesale Price of a
Product at a particular time means the highest wholesale price at
which OcuSense has sold such Product to third parties during the
previous 3 months period.
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1.2
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Interpretation
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(1)
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Reference
to:
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(a)
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one
gender includes the others;
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(b)
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a
person includes a body corporate;
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(c)
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a
party includes the party's executors, administrators, successors
and permitted assigns;
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(d)
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a
statute, regulation, code or other law or a provision of any of
them includes:
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(i)
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any
amendment or replacement of it; and
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(ii)
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another
regulation or other statutory instrument made under it, or
made under it as amended or replaced;
and
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(e)
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dollars
means Australian dollars unless otherwise
stated.
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(2)
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"Including"
and similar expressions are not words of
limitation.
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(3)
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Where
a capitalized word or expression is given a particular meaning,
other parts of speech and grammatical forms of that capitalized word
or expression have a corresponding
meaning.
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(4)
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Headings
and any table of contents or index are for convenience only and do not
form part of this Agreement or affect its
interpretation.
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(5)
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A
provision of this Agreement must not be construed to the disadvantage of a
party merely because that party was responsible for the preparation of the
Agreement or the inclusion of the provision in the
Agreement.
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(6)
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If
an act must be done on a specified day which is not a Business Day, it
must be done instead on the next Business
Day.
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1.3
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Parties
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(1)
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If
a party consists of more than 1 person, this Agreement binds each of
them separately and any 2 or more of them
jointly.
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(2)
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An
obligation, representation or warranty in favour of more than 1 person is
for the benefit of them separately and
jointly.
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(3)
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A
party which is a trustee is bound both personally and in its capacity as
a trustee.
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2.
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Development
of the First Product
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2.1
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Regulatory approvals and
exemptions
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As
between the parties, OcuSense shall be responsible, in its discretion, for
activities in seeking Registrations and other regulatory approvals from
applicable Regulatory Authorities with respect to Products (including any CLIA
waiver from the FDA in respect of the FDA 510(k) application for the OcuSense
system which uses the Products developed under this Agreement).
2.2
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Design Development
completed
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The
parties agree that the development of the design for the First Product has
been completed, and the Requirement Definitions of the First Product are as
annexed to Annexure A.
2.3
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Prototype Acceptance
Testing
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(1)
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The
parties agree that MiniFAB has manufactured and supplied to OcuSense
sufficient units of the Alpha Prototype First Product for the purposes of
testing on or about 26 July 2007, and that prior to the Commencement Date,
OcuSense has tested such units to determine whether the Alpha Prototype
First Product is as described in "Design Specification Stage 1 Work
package
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1.1 Final
Report", and has generated and provided MiniFAB with feedback regarding areas of
improvement with respect to the First Product, to be addressed by MiniFAB prior
to manufacturing and supplying OcuSense with the Beta Prototype First
Product.
(2)
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The
parties acknowledge that, as of the Commencement Date, manufacture, supply
and testing of units of the Beta Prototype First Product has not yet
occurred, and further acknowledge that the terms and conditions of the
Development Agreement continue to apply with respect to such
activities.
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(3)
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MiniFAB
will, in accordance with its obligations under the
Development Agreement, develop and optimise its manufacturing process
such that MiniFAB can manufacture the First Product to meet the
Minimum Orders of the First
Product.
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3.
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Supply
of Products
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3.1
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Specifications
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(1)
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The
initial Specifications for the First Product have been agreed by the
parties prior to execution of this Agreement. Promptly after
OcuSense's Acceptance of a New Product as set forth in clause 5.9, MiniFAB
shall prepare, on the basis of the most recent Requirement Definitions for
such New Product, and provide to OcuSense for approval, the definitive
Specifications for the applicable Product, for MiniFAB's use to
manufacture, package, label, store and handle the applicable
Product.
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(2)
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OcuSense
will review the Specifications submitted by MiniFAB under
clause 3.1(1) and may request amendments or modifications to the
Specifications if:
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(a)
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the
Specifications are inconsistent with the Requirement
Definitions;
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(b)
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the
Specifications are inconsistent with the Regulatory
Requirements;
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(c)
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the
requirements of the Specifications are unreasonable or uncommercial
having regard to the Price or proposed Price of the relevant Product;
or
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(d)
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the
requirements of the Specifications are unrelated to the
Product.
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(3)
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MiniFAB
must act reasonably and accommodate any requests for amendment to the
Specifications made by OcuSense under clause
3.1(2).
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(4)
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OcuSense
must accept the Specifications when it is satisfied that the
Specifications are consistent with the Requirement Definitions and the
Regulatory Requirements, and are reasonable and commercial having regard
to the Price or proposed Price of the relevant
Product.
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(5)
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The
parties agree that the definitive Specifications for the First Product are
set forth in Annexure B.
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(6)
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The
Specifications for any Product may be modified or amended by mutual
written agreement of the Parties. In the event that OcuSense requests
changes to the Specifications for reasons other than those set forth in
clause 3.1(2) above, MiniFAB agrees to use Commercially Reasonable Efforts
to accommodate such requested
changes.
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3.2
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Capital investments and Supply
Start Date
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(1)
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MiniFAB
will:
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(a)
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in
respect of the First Product - from the Commencement Date;
and
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(b)
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in
respect of each New Product - in accordance with the project
plan specified in the Development Order for that New
Product,
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use
Commercially Reasonable Eforts to acquire, construct or develop such plant,
equipment, raw materials, labour, utilities and capital improvements as are
necessary to manufacture the Product to meet the Minimum Orders of that Product.
MiniFAB shall set up the manufacturing process, manufacture the Products, and
assemble and package the Products, all in accordance with the Specifications and
all Regulatory Requirements. MiniFAB shall label the Products with such labels,
tradenames, and trademarks as directed by OcuSense.
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(2)
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MiniFAB
will notify OcuSense when MiniFAB reasonably believes that it has the
necessary plant and equipment to manufacture a particular Product to meet
the Minimum Orders of that Product. Promptly following such notification
by MiniFAB, the parties shall mutually agree on and set the date (Supply Start Date for
that Product) on which OcuSense may begin placing binding Purchase Orders
for that Product pursuant to clause
3.4.
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(3)
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It
is the intention of the parties that the Supply Start Date for the First
Product shall take place no later than March 15, 2008 (the initial "Cut-Off Date"). If the
Supply Start Date for the First Product has not taken place on or prior to
the Cut-Off Date, then, provided that MiniFAB has used Commercially
Reasonable Efforts to meet the Cut-Off Date, the parties
will:
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(a)
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meet
and discuss the reasons for the
failure;
|
(b)
|
negotiate
a mutually agreed remedy plan to address the reasons for the failure;
and
|
(c)
|
acting
reasonably, agree on a revised Cut-Off Date, subject to clause 3.2(4)
.
|
MiniFAB
must implement the remedy plan and use Commercially Reasonable Efforts to meet
the revised Cut-Off Date.
|
(4)
|
The
procedures described in clause 3.2(3) will apply for at least two times,
but the revised Cut-Off Date shall not be later than sixty (60) days
following the initial Cut-Off Date specified in clause 3.2(3), above. If
MiniFAB fails to meet the Cut-Off Date for the third time, then OcuSense
may immediately terminate this Agreement, which shall be effective upon
written notice to MiniFAB.
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3.3
|
Supply and Purchase
Obligations
|
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(1)
|
MiniFAB
shall manufacture the Products exclusively for OcuSense; and MiniFAB
shall sell the Products exclusively to OcuSense or its designee; and
MiniFAB shall not otherwise manufacture, sell, or distribute the Products
to any third party. MiniFAB acknowledges that OcuSense may manufacture
Products itself and/or engage one or more third parties in addition to
MiniFAB to supply the Products to
OcuSense.
|
***Section
3.3(2) and 3.3(3) in their entirety have been omitted pursuant to a request for
confidential treatment and have been filed separately with the U.S. Securities
and Exchange Commission.
|
(4)
|
MiniFAB
hereby acknowledges that OcuSense needs to obtain a reliable supply of the
Products that meets certain quality, quantity and timing requirements, and
agrees to comply with the following Supply
Requirements:
|
(a)
|
subject
to clause 3.2(3), ensure that the Supply Start Date for the First Product
occurs on or prior to the Cut-Off
Date;
|
(b)
|
ensure
that the Supply Start Date for the Second Product occurs on or prior to
the applicable cut-off date as specified in the Development Order for the
Second Product;
|
(c)
|
ensure
that each batch of Product are in full compliance with the Specifications
(including without limitation any failure rates specified therein), the
Technical Agreement, and the Regulatory Requirements;
and
|
(d)
|
ensure
that, for each 3 month period, at least 95% of shipments of Products are
delivered by the delivery date required under clause
3.6.
|
|
(5)
|
If
MiniFAB fails to comply with the Supply Requirements then, subject
to clause 3.3(6):
|
(a)
|
MiniFAB
must provide OcuSense with the reasons for
the non-compliance;
|
(b)
|
the
parties must meet and discuss the reasons given by
MiniFAB;
|
(c)
|
the
parties must, acting reasonably, negotiate a mutually agreed remedy
plan to address the reasons for the non-compliance;
and
|
(d)
|
MiniFAB
must implement the agreed remedy
plan.
|
(6)
|
If
MiniFAB fails to comply with the same Supply Requirement again within
a period of 3 months after the first non-compliance, then MiniFAB is
deemed to have committed a material breach of this Agreement for the
purposes of clause 15.2(1).
|
***Section
3.3(7) and 3.3(8) in their entirety have been omitted pursuant to a request for
confidential treatment and have been filed separately with the U.S. Securities
and Exchange Commission.
(9)
|
OcuSense
shall have no purchase obligations under this Agreement, except as
expressly set forth in this clause 3.3. For the avoidance of doubt,
subject to clauses 3.3(2), 3.3(7) and 3.3(8), OcuSense shall have the
right to engage any third party to manufacture and supply any
Products.
|
3.4
|
Forecast and
ordering
|
|
(1)
|
Not
less than 3 months prior to the Supply Start Date for a Product and on
or before the 1st date of each calendar month thereafter, OcuSense
must submit to MiniFAB a non-binding forecast of the quantity of each of
the Products that OcuSense expects to purchase in each of the 3rd through
the 6th month following the month for which the forecast is due (e.g., the
forecast due on January 1, 2010 would contain a forecast for April through
June of 2010).
|
|
(2)
|
OcuSense
must order the Products 45 days prior to their requested deliverydates (as
determined in accordance with clause 3.6) by sending binding written
purchase orders to MiniFAB stating the Product, unit quantities and any
other information reasonably required by MiniFAB from time to time (Purchase Orders).
OcuSense may begin placing Purchase Orders for any particular Product
commencing with the Supply Start Date for that Product. OcuSense shall use
reasonable endeavours to ensure that the quantities of Products set forth
in its Purchase Orders are consistent with the then-current
forecast.
|
|
(3)
|
A
Purchase Order constitutes an irrevocable offer made by OcuSense to
MiniFAB for the supply of the Products specified in the Purchase Order on
the terms and conditions of this Agreement. Once received by MiniFAB, the
Purchase Order is firm and may not be cancelled or modified without
MiniFAB's prior written consent.
|
|
(4)
|
Subject
to clauses 3.4(5) or 3.5, MiniFAB must accept a Purchase Order if the
quantity of the Product the subject of the Purchase Order is between 80%
and 150% of the most recent forecast. In addition, MiniFAB agrees to use
Commercially Reasonable Efforts to accept and satisfy Purchase Orders
exceeding 150% of the most recent forecast. In the event that OcuSense
places a Purchase Order that exceeds 150% of the most recent forecast,
MiniFAB shall (i) accept the Purchase Order with respect to quantities at
least equal to 150% of the most recent Purchase Order, and (ii) notify
OcuSense in writing of those quantities (if any) exceeding 150% of the
most recent forecast with respect to which MiniFAB is rejecting the
Purchase Order.
|
|
(5)
|
If
MiniFAB believes, on reasonable grounds, that a Purchaser Order is
materially incorrect or, to the extent a Purchase Order exceeds 150% of
forecast amounts, it is not capable of satisfying the Purchase Order with
respect to excess amounts so ordered, then MiniFAB may reject the Purchase
Order and must notify OcuSense as soon as possible. If MiniFAB does not
reject to a Purchaser Order within 5 Business Days of receipt of the
Purchase Order, then MiniFAB is deemed to have accepted the Purchaser
Order. Any rejection by MiniFAB of a Purchase Order that is not provided
for in this clause 3.4(5) or 3.5 is deemed to be a material breach of this
Agreement for the purposes of clause
15.2(1).
|
3.5
|
Annual Production
Capacity
|
(1)
|
Despite
clause 3.4(4), MiniFAB may, in its absolute discretion, refuse
to accept any Purchase Order for a particular Product if the Purchase
Order would require MiniFAB to exceed the Annual Production Capacity of
that Product during that year.
|
|
(2)
|
The
parties may, from time to time, vary the Annual Production Capacity of a
particular Product by agreement in writing. If OcuSense requests MiniFAB
to increase the Annual Product Capacity, the parties shall promptly confer
and discuss such matter in good faith, and MiniFAB shall endeavor to
inform OcuSense within thirty (30) days whether MiniFAB will agree to the
requested increase in the Annual Production
Capacity.
|
3.6
|
Delivery
|
MiniFAB
will manufacture and deliver the Products EXW (Incoterms 2000) the Delivery
Point within 45 days afer the date of Purchase Order, unless the Purchase Order
specifies a later delivery date. MiniFAB shall pay pre-pay all freight,
insurance charges, taxes, import and export duties, inspection fees and other
charges applicable to the transport and delivery of the Products, and add all
such charges to invoices to OcuSense as a separate line item at pass-through
cost.MiniFAB shall use such shipping method and carrier, and shall provide such
carrier with such shipping instructions, as specified by OcuSense. In the even
that any two or more consecutive shipments ordered by OcuSense in accordance
with clause 3.4 are delivered more than five (5) business days after the
delivery date indicated in the first sentence of this clause 3.6, then OcuSense
shall be entitled to a thirty percent (30%) discount on the Price of the actual
Products in such shipments which were not actually delivered by the required
delivery date. The parties acknowledge and agree that such discount is
independent of, and without prejudice to, other applicable remedies that may be
available to OcuSense for failures of MiniFAB to supply Products
in accordance with this Agreement.
3.7
|
Inspection and Nonconforming
Goods
|
(1)
|
OcuSense
must inspect the Products within 14 days after delivery (or
such longer time as provided in the Technical Agreement) and must
accept the Products if they meet the Specifications, the requirements
of the Technical Agreement, and the Regulatory Requirements. If OcuSense
fails to object in writing within the applicable period, then OcuSense
must accept the delivered Products. OcuSense may reject the delivered
Products only if the Products fail to meet the Specifications, the
requirements of the Technical Agreement,and/or the Regulatory
Requirements. If OcuSense rejects the delivered Products, OcuSense must
provide MiniFAB in writing the reasons for the rejection and the
reasonably available evidence to substantiate those reasons.
|
(2)
|
If OcuSense rejects the
relevant Product, then MiniFAB shall promptly supply conforming
replacement Products as soon as possible, whether or not MiniFAB agrees
that OcuSense properly rejected such Products. MiniFAB agrees to notify
OcuSense in writing if such replacement Products will not be shipped
within five (5) business days.
|
(3)
|
If
OcuSense properly rejected the original Products, then OcuSense's payment
for the rejected Products shall be deemed payment for the replacement
Products. If OcuSense was not entitled to reject the original Products,
then OcuSense shall pay for both the rejected Products and the replacement
Products.
|
(4)
|
If
the parties disagree whether OcuSense properly rejected the original
Products, then the parties shall refer such matter to a mutually
acceptable, independent testing laboratory (the Testing Lab) to
determine whether such Products were properly rejected. The fees and costs
of the Testing Lab shall be borne by OcuSense if the Testing Lab
determines that the Products were improperly rejected and by MiniFAB if
the Testing Lab determines that the Products were properly rejected. If
the Testing Lab is unable to determine whether the rejected Products met
the Specifications, the requirements of the Technical Agreement or the
Regulatory Requirements, then either party may submit the matter to the
dispute resolution process in clause
19.
|
(5)
|
OcuSense
may withhold payment for any rejected Products (and only the rejected
Products) until:
|
(a)
|
MiniFAB
re-delivers conforming Products, or
|
(b)
|
the
Testing Lab or dispute resolution process determines that
the Products rejected by OcuSense met the Specifications,
the requirements of the Technical Agreement and the
Regulatory Requirements.
|
3.8
|
Technical
Agreements
|
MiniFAB
and OcuSense shall enter into a Technical Agreement with respect to the First
Product promptly following (and no later than sixty (60) days after) the
Commencement Date, and the manufacture, production and supply of the First
Product shall be conducted in accordance with such Technical Agreement. The
parties shall enter into a Technical Agreement with respect to each New Product
promptly following agreement upon the applicable Requirement Definitions, and no
later than ninety (90) days prior to the applicable Supply Start Date for such
New Product. MiniFAB and OcuSense shall determine in good faith those
subcontractors (if any) performing any manufacturing activities with respect to
Products with whom OcuSense shall enter into separate written technical or
quality agreements. Technical Agreement will address matters such as shelf life,
storage, release requirements, facility registrations, recordkeeping, retention
and review of documentation, annual product review, shipping products only upon
release, and the like, which are not addressed in this Agreement.
3.9
|
Quality
Control
|
MiniFAB
shall conduct all quality control testing of the Products supplied hereunder
prior to shipment in accordance with the Technical Agreements and applicable
Laws. MiniFAB shall, and shall cause its subcontractors to, retain records and
samples of Products relating to such testing, and samples (identified by batch
number) of Products supplied to OcuSense, in each case in conditions and for
times as required by applicable Law (collectively, "Shipment Samples"), and
shall provide OcuSense with reasonable access to the Shipment Samples for
testing and other purposes on OcuSense's request. If OcuSense conducts quality
control testing of Products supplied
hereunder afer delivery thereof to OcuSense, OcuSense shall also use the same
analytical methodology as used by MiniFAB. Upon written request from OcuSense,
MiniFAB shall provide a reasonably detailed description of the analytical
methodology used by MiniFAB for quality control testing of the
Products.
4.
|
Price
|
***Section
4.1 has been omitted in its entirety pursuant to a request for confidential
treatment and has been filed separately with the U.S. Securities and Exchange
Commission.
4.2
|
Price
revisions
|
(1)
|
When
the Minimum Orders requirement for the Second Product has
been satisfied, the parties will meet and discuss any revision to the
Price of the Second Product, with the intent that the price will be
adjusted as mutually agreed by the parties to
reflect:
|
(a)
|
the
fact that the initial capital expenses incurred by MiniFAB have
been amortised;
|
(b)
|
any
further capital expenses incurred by MiniFAB to meet expected demand;
and
|
(c)
|
any
cost savings and efficiency improvements (which will be
shared equally unless otherwise agreed between the
parties).
|
(2)
|
The
parties agree to act reasonably when negotiating the revision to the
Price of the Second
Product.
|
5.
|
Development
of New Products
|
5.1
|
R&D Services
|
|
(1)
|
R&D
Services for New Products include:
|
(a)
|
project
management services relating to the development of the
New Product;
|
(b)
|
assisting
OcuSense in the development, validation and finalisation of the
Requirement Definitions for the New
Product;
|
(c)
|
assisting
OcuSense in the development, validation and finalisation of the
Specifications for the New Product;
|
(d)
|
using
Commercially Reasonable Efforts to develop processes, methodology and
technology to manufacture the New Product;
|
(e)
|
using
Commercially Reasonable Efforts to evaluate and recommend appropriate
technology necessary to manufacture the New
Product;
|
(f)
|
using
Commercially Reasonable Efforts to develop and construct plant and
equipment necessary to manufacture the New Product;
and
|
(g)
|
such
other services as specified in a Development
Order.
|
(2)
|
R&D
Services exclude:
|
(a)
|
the
initial formulation of and research on the Requirement
Definitions for the New
Product;
|
(b)
|
carrying
out experiments, clinical tests or other validation methodologies in
relation to the New Product;
|
(c)
|
preparations
or filings relating to obtaining Registration for the
New Product;
|
(d)
|
sales,
distribution, marketing or public release of the New
Product;
|
(e)
|
patent
review; and
|
(f)
|
legal
or other professional advisory
services.
|
5.2
|
Request for
development
|
(1)
|
OcuSense
may, from time to time, request MiniFAB in writing to provide
R&D Services to develop a New Product (Development
Request).
|
(2)
|
Subject
to clause 5.2(4), if and when OcuSense elects, in its discretion,
to develop a Second Product, OcuSense agrees that it will provide an
opportunity for MiniFAB to provide the R&D Services with respect to
the Second Product, as follows:
|
(a)
|
OcuSense
shall provide a written Development Request for the Second Product
pursuant to clauses 5.2(1) and
5.2(3);
|
(b)
|
the
parties shall discuss in good faith the anticipated activities
under the Development Request and capabilities required to perform
such activities;
|
(c)
|
if
MiniFAB does not wish to undertake to perform the applicable R&D
Services for the Second Product, MiniFAB agrees to promptly notify
OcuSense in writing;
|
(d)
|
if
MiniFAB wishes to perform the applicable R&D Activities for the Second
Product, MiniFAB shall propose the financial terms under which it is
willing to undertake the R&D Services specified in the Development
Request; and
|
(e)
|
if
MiniFAB has appropriate capability to perform such R&D Activities for
the Second Product as set forth in the Development Request, and offers to
perform such activities on financial terms that are at least as favorable
to OcuSense as other bids for conducting such R&D Services OcuSense
receives from third parties with capability of performing such R&D
Services, then OcuSense shall engage MiniFAB for the conduct of such
R&D Services for the Second Product. In such event, the parties shall
prepare and sign a mutually agreed written Development Order, which shall
set forth the activities to be conducted, timelines, deliverables,
financial terms, and other mutually agreed terms and conditions regarding
such R&D Services. Such Development Order shall be consistent with the
intellectual property provisions and other applicable terms and conditions
of this Agreement.
|
Subject
to the foregoing, OcuSense may engage any other person to provide R&D
Services and OcuSense shall have no obligation to offer to MiniFAB the
opportunity, or to engage MiniFAB, to perform any R&D Services. For clarity,
OcuSense shall not be obligated to engage MiniFAB to perform R&D Services
for any New Product other than the Second Product.
(3)
|
A
Development Request must include:
|
(a)
|
a
detailed description of the New
Product;
|
(b)
|
draft
Requirement Definitions for the New Product;
and
|
(c)
|
a
draft project plan including a proposed
timetable.
|
(4)
|
MiniFAB
will consider a Development Request and notify OcuSense in
writing whether or not MiniFAB accepts the Development Request within
20 Business Days of receipt of the request. If MiniFAB fails to respond
within that time period, then it is deemed to have rejected the
Development Request. To avoid doubt, MiniFAB is not required to provide
any reason for rejecting a Development Request. It is understood that the
Development Request is intended as an opportunity for the parties to
negotiate terms and conditions on which MiniFAB may conduct the applicable
R&D Services for OcuSense. Accordingly, (i) MiniFAB shall not be
obligated to accept any Development Request, and (ii) except as expressly
set forth in clause 5.2(2)(e) with respect to the Second Product, OcuSense
shall not be obligated to engage MiniFAB to conduct R&D Services.
Without limiting the foregoing, if MiniFAB rejects (or is deemed to have
rejected) the Development Request for the Second Product, then despite
clause 5.2(2), OcuSense may engage another service provider to provide
R&D Services in respect of that Development Request. OcuSense shall
have no obligation to offer to MiniFAB any further opportunity, or to
engage MiniFAB, to perform any R&D Services except as expressly set
forth under clause 5.2(2).
|
5.3
|
Development
Order
|
|
(1)
|
If
MiniFAB accepts a Development Request,
then:
|
(a)
|
MiniFAB
will provide OcuSense with a revised draft project plan. including
proposed milestones and payment milestones;
and
|
(b)
|
the
parties must meet within 20 Business Days of the acceptance to meet and
discuss the Development Request with the intent to finalise a Development
Order.
|
|
(2)
|
The
parties will act reasonably in negotiating the terms of the
Development Order.
|
|
(3)
|
To
avoid doubt, neither party is bound by a Development Request,
a Development Order or any obligations to develop a New Product until
the relevant Development Order is signed by both
parties.
|
5.4
|
Provision of R&D
Services
|
|
(1)
|
MiniFAB
will provide the R&D Services in accordance with the
relevant Development Order in a diligent and ethical manner, with due
care and skill and to a high professional standard, in accordance with
this Agreement, and all applicable Regulatory
Requirements.
|
|
(2)
|
MiniFAB
will use Commercially Reasonable Efforts to meet any milestones agreed in
the relevant Development Order. Each Development Order may specify the
agreed-upon remedies that shall apply for any failure by MiniFAB to meet
such milestones, or otherwise fail to perform the R&D Services in
accordance with clause 5.4(1).
|
5.5
|
Responsibilities of each
party
|
|
(1)
|
MiniFAB
is responsible for and will bear the costs and expenses
associated with:
|
(a)
|
the
provision of the R&D Services in accordance with the relevant
Development Order (Development Expenses);
and
|
(b)
|
the
construction and acquisition of any plant and equipment and other related
capital expenditures relating to the R&D
Services.
|
(2)
|
OcuSense
will develop, validate and finalise the Requirement Definitions and the
Specifications of the New Product in consultation with MiniFAB. MiniFAB
will assist OcuSense in accordance with the R&D
Services.
|
(3)
|
OcuSense
is solely responsible for and will bear all costs and
expenses associated with all activities relating to the research and
development of the New Product that are not expressly included as
part of R&D Services or that are expressly excluded from the
R&D Services.
|
5.6
|
Ownership of Requirement
Definitions and
Specifications
|
The
Requirement Definitions and the Specifications of any Product and all
Intellectual Property rights relating to any Product, the Requirement
Definitions and the Specifications therefor are and will remain to be owned
solely by OcuSense. MiniFAB hereby assigns all Intellectual Property subsisting
in the foregoing to OcuSense.
5.7
|
Payment for R&D
Services
|
OcuSense
will pay MiniFAB for the provision of the R&D Services in accordance with
payment milestones specified in. the relevant Development Order.
5.8
|
Other matters relating to
Development Order
|
Prior to
the Successful Completion of a New Product, the parties will meet and negotiate
(acting reasonably) the following items relating to the New
Product:
(1)
|
the
Price for the New Product (provided that the Price for the Second
Product is set in accordance with clause
4.1(2));
|
(2)
|
the
percentage applicable to calculating the amount payable under clause
3.3(8)(c)
|
(3)
|
the
Minimum Orders requirement for the New Product, if any (provided
that the Minimum Order for the Second Product is set in accordance
with clause 3.3(7)(c)); and
|
(4)
|
the
Annual Production Capacity for the New
Product.
|
5.9
|
Prototype
Acceptance Testing
|
|
(1)
|
If
required under the relevant Development Order, the parties will
conduct acceptance testing of the New Product in accordance with this
clause 5.9.
|
|
(2)
|
Promptly
upon completion of the development of the New Product, MiniFAB shall
manufacture and supply to OcuSense a reasonable number of prototype units
for the purposes of OcuSense's testing and evaluation, together with such
documentation (including without limitation the QA test report), materials
and equipment reasonably necessary for OcuSense to perform testing and
evaluation of the prototype. It is understood that the mutually agreed
Development Order may provide for the supply and testing of multiple sets
of prototype units for the New Product at different stages of development
(such as, for example, alpha prototypes and beta
prototypes).
|
|
(3)
|
OcuSense
may reject the prototype of the New Product only if it does not conform to
the Requirement Definitions. OcuSense must accept the prototype of the New
Product if it conforms to the Requirement
Definitions.
|
|
(4)
|
If
OcuSense rejects the prototype then OcuSense must notify MiniFAB of the
reasons for such rejection and MiniFAB will have thirty (30) days to cure
such defect or non-conformance or dispute Ocusense's rejection pursuant to
the dispute resolution process under clause 19. OcuSense may require
MiniFAB to resubmit revised prototype units to OcuSense for testing and
evaluation until the prototype fully conforms to the Requirement
Definitions of the Product.
|
|
(5)
|
Upon
OcuSense's acceptance of the New Product (“Acceptance”),
OcuSense shall promptly inform MiniFAB in
writing.
|
5.10
|
Successful
Completion
|
Successful
Completion in relation to a New Product means:
(1)
|
if
the relevant Development Order provides a definition - the
meaning ascribed to that term in the Development Order;
or
|
(2)
|
the
Acceptance of a New Product by OcuSense, as such term is defined
in clause 5.9.
|
|
5.11
|
Discontinuance - Unable to
finalise Requirement
Definitions
|
If the
parties are unable to finalise the Requirement Definitions for the New Products
by the deadline specified in the relevant Development Order (or after a
reasonable time if no such deadline is specified), then either party may
discontinue the relevant Development Order by notifying the other party in
writing, in which case OcuSense will be solely responsible for all Development
Expenses incurred up to that point in time and any other unavoidable costs
reasonably incurred by MiniFAB in connection with the
discontinuance.
|
5.12
|
Discontinuance -
OcuSense
|
OcuSense
may discontinue the development of any New Product at any time upon written
notice, in which case MiniFAB will invoice, and OcuSense must pay, all
outstanding amounts that are payable in accordance with the payment milestones
specified in the Development Order for the R&D Services actually rendered by
MiniFAB prior to the termination of the relevant Development Order. It is
understood and agreed that any R&D Services with respect to the Second
Product and any other New Product will be undertaken in reasonable stages in
order to provide OcuSense an opportunity to evaluate the results of the R&D
Services in each such stage and to determine whether OcuSense, in its
discretion, wishes to cease development of the Second Product or other New
Product. In the event that OcuSense unilaterally discontinues development of the
Second Product and terminates the corresponding R&D Services (other than as
a result of MiniFAB's inability or unwillingness to conduct such R&D
Services, or as set forth in clause 15.2) prior to MiniFAB's shipment of beta
prototypes, then OcuSense agrees that it will provide an opportunity for MiniFAB
to provide the R&D Services with respect to development of its next
subsequent New Product (excluding any New Products then already under contract
for development by third parties) as set forth in clause 5.2(2), subject to the
terms of clause 5.2(4).
|
6.
|
OcuSense
Licence
|
|
6.1
|
Limited
licence
|
(1)
|
Subject
to the terms and conditions of this Agreement, OcuSense grants
to MiniFAB during the Term a limited, royalty free, non-exclusive
licence (without the right to sublicense) under any Intellectual Property,
know-how and technical information owned (or licensed with the right to
sublicense) by OcuSense relating to the development or manufacture of the
Products (OcuSense
IP) to use OcuSense IP to perform MiniFAB's obligations under this
Agreement (OcuSense
Licence).
|
(2)
|
MiniFAB
may only use OcuSense IP to the extent necessary or desirable
to develop and manufacture the Products and New Products or
otherwise necessary for the purposes of this
Agreement.
|
6.2
|
Provision of OcuSense IP
materials
|
OcuSense
will provide or otherwise make available all information and materials relating
to the OcuSense IP known to or possessed by OcuSense that are reasonably
necessary to enable MiniFAB to perform its obligations under this
Agreement.
|
6.3
|
Ownership of OcuSense IP and Improvements to
OcuSense IP
|
All
OcuSense IP, and all improvements to OcuSense IP, including any
modifications and developments made thereto by MiniFAB shall be the sole
property of OcuSense and MiniFAB hereby assigns to OcuSense its entire right,
title and interest therein. Such improvements, modifications and developments
will be included in OcuSense IP and covered by the OcuSense Licence. All
injection moulds directed to the Products, and all rights in and to such
injection moulds, shall be owned by OcuSense and part of the OcuSense IP.
MiniFAB will cooperate with OcuSense in good faith to assist OcuSense in such
manner as OcuSense may reasonably request if such moulds are required to be
duplicated, but may otherwise retain them whilst MiniFAB has an obligation to
continue to manufacture the relevant Product. All OcuSense IP shall be
treated by MiniFAB as Confidential Information of OcuSense. MiniFAB shall
promptly disclose to OcuSense all improvements, modifications and developments
to OcuSense IP made or conceived by or on behalf of MiniFAB, and provide
OcuSense with copies of all information available to MiniFAB regarding such
improvements, modifications and developments. To the extent any of the rights
that the parties intend to be assigned by MiniFAB to OcuSense (as set forth in
clause 5.6 and this clause 6.3) cannot be assigned by MiniFAB to OcuSense,
MiniFAB hereby grants to OcuSense an exclusive, royalty-free, transferable,
irrevocable, worldwide license (with rights to sublicense through multiple tiers
of sub-licensees) to practice such non-assignable rights, title and interest. To
the extent any of such rights can be neither assigned nor licensed by MiniFAB to
OcuSense, MiniFAB hereby irrevocably waives and agrees never to assert such
non-assignable and non-licensable rights, title and interest against OcuSense or
any of OcuSense's licensees or successors in interest to such non-assignable and
non-licensable rights.
|
6.4
|
IP Warranties and
indemnity
|
(1)
|
OcuSense
warrants that OcuSense has the right and authority to grant MiniFAB
the OcuSense Licence.
|
(2)
|
OcuSense
shall indemnify and at all times holds harmless MiniFAB against any Losses
resulting from a third person's claim against MiniFAB alleging that the
use of OcuSense IP by MiniFAB constitutes an infringement of any
Intellectual Property of that third person; provided, however, that
OcuSense shall not be obligated to indemnify MiniFAB, and MiniFAB shall
indemnify and at all times hold harmless OcuSense against any such Losses
(i.e., Loses arising from third party claims of infringement), to the
extent the alleged infringement results from any modifications and
developments made to OcuSense IP by MiniFAB other than in accordance with
instructions contained in any
Specifications.
|
6.5
|
Termination of
licence
|
The
OcuSense Licence terminates automatically upon the termination or expiry of
this Agreement for any reason.
|
6.6
|
Infringement and protection of
OcuSense IP
|
OcuSense
is solely responsible for the protection, defence and maintenance of
the OcuSense IP. However, MiniFAB will promptly notify OcuSense if
MiniFAB is aware of any infringement of the OcuSense IP by any third
person.
|
7.
|
Obligations
of MiniFAB
|
|
7.1
|
Cooperation with
OcuSense
|
MiniFAB
will (a) provide OcuSense with analytical and manufacturing documentation,
internal progress reports, regulatory compliance files and quality assurance
files, and other relevant information as requested by OcuSense regarding quality
control for the Products supplied under this Agreement, (b) reasonably cooperate
with OcuSense in responding to all requests for information from customers and
the relevant Regulatory Authorities having jurisdiction to make such requests,
and (c) on a quarterly basis, prepare and submit to OcuSense a production
capacity development plan addressing MiniFAB's efforts to increase production
capacity to meet OcuSense's forecasts, and participate in a review thereof with
OcuSense. OcuSense must bear any reasonable pre-approved out-of-pocket costs
incurred by MiniFAB pursuant to this clause 7.1. If OcuSense refuses to
pre-approve any such reasonable costs described in the preceding sentence on
request by MiniFAB, then MiniFAB is released from its obligations under this
clause 7.1 in respect of the obligations that are subject of, and to the extent
subject of, those costs that OcuSense refused to pre-approve.
|
7.2
|
Regulatory
licences
|
MiniFAB
must at its own cost obtain and comply with all necessary licences, consents,
permits and regulations which may from time to time be required by the relevant
Regulatory Authorities in Australia to carry out its development and
manufacturing services under this Agreement. Without limiting the generality of
the foregoing, prior to commencing the manufacture of the First Product, MiniFAB
shall be certified to meet ISO 13485 for manufacturing. OcuSense is responsible
for obtaining
all Registrations and approvals for the export of the Products from Australia or
supply of the Products anywhere in the world.
|
7.3
|
Batch
records
|
Without
limiting the generality of clause 7.1, on a monthly basis, MiniFAB must
retain and furnish to OcuSense for analysis by OcuSense's Quality
Department:
(1)
|
samples
of each batch of Products manufactured under this Agreement;
and
|
(2)
|
batch
production and quality control
records,
|
to the
extent required by the Specifications and all applicable Regulatory
Requirements.
|
7.4
|
Facility
Audits
|
OcuSense
shall have the right, during normal business hours and upon reasonable notice,
to audit MiniFAB's facility at which the Products are manufactured for
compliance with the Specifications, the Regulatory Requirements, and the terms
and conditions of this Agreement. MiniFAB shall give OcuSense prior written
notice (whenever reasonably feasible) of any Governmental Agency inspection of
the MiniFAB facility, and MiniFAB shall permit a representative of OcuSense to
be present at such inspection. MiniFAB shall promptly provide to OcuSense copies
of all notices, correspondence and other materials delivered to or received from
the Governmental Agency regarding such MiniFAB facility or the
Products.
|
8.
|
Meeting
|
|
8.1
|
During
the Term, the parties will endeavour to meet at least every 6 months to
discuss and review the state of the relationship between
them. Each party must ensure that at least one of its senior
representatives attend each meeting. Any meeting may be
teleconferenced.
|
|
8.2
|
Each
party will alternate to organise the meeting. The party responsible
for organising the meeting must prepare a formal agenda prior to the
meeting and organise formal minutes to be taken and distributed to all
attendees after the meeting takes place. Each party may provide its
suggest agenda items. The compulsory topics for the agenda are as
follows:
|
(1)
|
review
of previous minutes; and
|
(2)
|
progress
of any development and
registration.
|
|
9.
|
Payment
and invoicing
|
|
9.1
|
Invoice
|
(1)
|
In
relation to the supply of Products, MiniFAB will invoice OcuSense on
a monthly in arrears basis.
|
(2)
|
In
relation to the provision of R&D Services, MiniFAB will invoice
OcuSense in accordance with the Development Agreement for the First
Product and the payment milestone specified in the relevant Development
Order for New Products.
|
|
9.2
|
Payment
|
OcuSense
must pay all undisputed invoices within 40 days after receipt of the
invoice or, if later, within 40 days after delivery of the relevant
Products to the Delivery Point.
|
9.3
|
Interest
|
If
OcuSense fails to pay an amount on the due date for any undisputed
payment, OcuSense must pay MiniFAB interest at the Default Rate on that
amount, calculated and payable monthly, computed from the due date until
the amount is paid in full.
|
10.
|
Amendments
to Specifications
|
|
10.1
|
Compliance with Regulatory
Requirements
|
In the
event that OcuSense or MiniFAB becomes aware of any changes or any pending
changes in any applicable Regulatory Requirements which could affect the
manufacture of a Product, OcuSense or MiniFAB, as applicable must promptly
notify the other party in writing of any such change or proposed change and the
Specifications of that Product must then, if necessary be amended by mutual
written agreement of the parties. Such change will become effective and binding
on MiniFAB from a date agreed by the parties. Costs and expenses reasonably
incurred by MiniFAB to implement the amendments to the Specifications required
under this clause 10.1 may be reflected in the Price of Products as set forth in
clause 10.3.
10.2
|
Voluntary
changes
|
Either
party may suggest changes in the Specifications of any of the Products by
notifying the other party in writing in reasonable detail of such suggested
changes. The parties must negotiate in good faith with a view to agreeing to the
same and who will bear the cost of the same. If the parties agree in writing
upon the suggested changes, including the lead-time for implementing such
changes, the Specifications must be amended accordingly, and any such change
will become effective and binding on MiniFAB from a date agreed by the parties.
Notwithstanding the foregoing, OcuSense shall not be obligated to agree to any
change to Specifications proposed by MiniFAB.
10.3
|
Cost of amendments to
Specifications or changes in Regulatory
Requirements
|
Unless
otherwise agreed by the parties, it is understood that the Price of
applicable Products will be adjusted up or down by an amount equal to the
increase or decrease in
MiniFAB's costs (as determined by the parties' mutually agreed cost model, which
shall not include amounts allocable to other products or to facilities or
equipment not utilized for Products) as a result of changes in Regulatory
Requirements and/or changes in the Specifications. Subject to clauses 10.1 and
10.2, OcuSense is responsible for all pre-approved reasonable out-of-pocket
costs and expenses incurred by MiniFAB to implement any changes to the
Specifications under this clause 10. It is understood and agreed that if
OcuSense pays for the purchase of capital equipment under this clause 10.3, then
(i) OcuSense shall be the owner of such equipment, (ii) such equipment shall not
be used in the manufacture or testing of any products other than Products, and
(iii) and the parties shall reasonably cooperate to execute and file such
documents as are reasonably required to evidence and protect OcuSense's
ownership interest in such equipment. In the event MiniFAB proposes an upward
adjustment in the Price of any Product under this clause 10.3, OcuSense shall
have the right, at its sole cost, to designate an independent accounting firm
reasonably acceptable to MiniFAB to audit MiniFAB's books and records to verify
the amount of the cost increase claimed by MiniFAB to determine the rights of
the parties as described above in this clause 10.3.
|
11.
|
Registrations,
safety and Product liability
|
|
11.1
|
Registrations of
Products
|
OcuSense
is responsible for the sales, marketing and distribution of the Products,
and is
also responsible for:
(1)
|
obtaining
all necessary Registrations for the Products;
and
|
(2)
|
maintaining
records of all sales of Product sufficient to adequately administer a
recall, market withdrawal or correction for such period as is required
under applicable regulations.
|
MiniFAB
agrees to maintain all applicable records relating to the manufacture of the
Products supplied hereunder for a period of 5 years after the Product is
supplied hereunder, as more particularly set forth in the Technical Agreement.
Thereafter, MiniFAB shall notify OcuSense in writing before destroying any such
records and, if requested by OcuSense, agrees to transfer all such records to
OcuSense or its designee at OcuSense's expense.
11.2
|
Adverse
events
|
OcuSense
must promptly disclose to MiniFAB during the Term any information it acquires
which relates to the safety of the Product, including, inter alia, all side
effects, injury, toxicity or sensitivity reactions including unexpected or
increased incidence and severity thereof. All such information will be treated
as Confidential Information of OcuSense.
11.3
|
Notification of
defects
|
In the
event that MiniFAB becomes aware of any defect in the Product it will
immediately
notify OcuSense in writing and provide it with a full disclosure of the
defect or
non-compliance.
11.4
|
Recalls
|
(1)
|
The
parties each must notify the other promptly and in writing if any Product
is requested or required to be the subject of a recall, market
withdrawal or correction (Recall).
|
(2)
|
OcuSense
is solely responsible for the handling and disposition of any
Recall and will assume all regulatory responsibility for such
matters, including responsibility for all communications with the
relevant Governmental Agencies. MiniFAB shall diligently cooperate
with OcuSense in the administration of any
recall.
|
(3)
|
If
a Recall is due to a non compliance with the Specifications or
the Regulatory Requirements of the Product that is caused by the
fault MiniFAB then MiniFAB will bear the reasonable cost of the
Recall. In all other cases OcuSense is solely responsible for the
cost of the Recall.
|
12.
|
Insurance
|
12.1
|
Required Insurance from
MiniFAB
|
MiniFAB
must take out prior to the Cut-Off Date, and thereafter maintain during
the Term:
(1)
|
all
insurances required by law, including workers compensation insurance in
accordance
with relevant law; and
|
(2)
|
public
liability insurance for an amount of not less than A$5 Million per claim
and
in the aggregate.
|
12.2
|
Required Insurance from
OcuSense
|
OcuSense
must take out prior to the Cut-Off Date, and thereafter maintain during
the Term:
|
(1)
|
all
insurances required by law, including workers compensation insurance
in accordance with relevant law;
and
|
|
(2)
|
product
liability insurance for an amount of not less than US$5 Million
per claim in the aggregate.
|
12.3
|
Evidence of
insurance
|
Each
party must, if reasonably requested by the other party, provide the other party
with
evidence that the each insurance required to be taken out by the party pursuant
to this
clause 12 exists and is current.
13.
|
Warranties
|
13.1
|
Product
warranties
|
MiniFAB
warrants that (a) the Products manufactured by MiniFAB under this Agreement will
comply with the Specifications of the Products and shall be free from defects in
material and workmanship, and (b) MiniFAB's facility for manufacture of Products
shall be maintained and operated in compliance with all applicable Regulatory
Requirements, and all Products shall be manufactured, packaged, labelled,
stored, handled, and shipped by MiniFAB in compliance with all applicable
Regulatory Requirements and the applicable Technical Agreement.
14.
|
Third
party licensors and contractors; Technology
Transfer
|
14.1
|
Sub-Contractors
|
Except
with respect to laser ablation and etching and injection molding activities,
which activities shall be conducted at MiniFAB's facilities unless otherwise
agreed by the parties, MiniFAB may engage sub-contractors to perform MiniFAB's
obligations under this Agreement upon express prior written consent of OcuSense,
which consent shall not be unreasonably withheld. Without limitation, it is
agreed that if OcuSense is not comfortable that a proposed sub-contractor has
the requisite capabilities and that such proposed sub-contractor will protect
OcuSense's intellectual property rights and that such proposed sub-contractor
will comply with the terms and conditions set forth in this Agreement (including
assignment of intellectual property), or if such proposed sub-contractor is
involved in the manufacture, development or commercialization of products
competing with the Products, then it shall be reasonable for OcuSense to
withhold approval of such proposed subcontractor. The appointment of
sub-contractors shall not affect or diminish MiniFAB's responsibilities and
obligations under this Agreement, and MiniFAB shall ensure the compliance of
each such subcontractor with the confidentiality obligations and other
obligations of MiniFAB set forth in this Agreement. If OcuSense engages a third
party to manufacture the Products, it will impose similar restrictions to the
foregoing on that third party.
14.2
|
Cooperation with
Sensortec
|
MiniFAB
acknowledges that OcuSense has entered into that certain development and option
agreement with Sensortec Limited (“Sensortec”), pursuant to
which Sensortec may provide certain services and a license with respect to
certain of its technology, in each case pertaining to the manufacture of the
Products. MiniFAB agrees that upon request of OcuSense, MiniFAB shall coordinate
its activities under this Agreement with Sensortec, as may be necessary or
useful for MiniFAB's and Sensortec's performance of their respective
obligations to OcuSense regarding the Product. Upon request of MiniFAB, OcuSense
shall act as a liaison between MiniFAB and Sensortec to facilitate productive
cooperation between them.
14.3
|
Non exclusive
arrangement
|
Nothing
in clause 14.2 prevents either party from contracting with Sensortec
independently for purposes unrelated to this Agreement.
14.4
|
Evaluation and licensing of
other third party technology
|
If the
parties agree or MiniFAB recommends (pursuant to the provision of R&D
Services) that a particular technology is necessary to manufacture any New
Product, then OcuSense will evaluate such recommendation, and if OcuSense
determines in its sole discretion that licensing of such technology is
desirable, OcuSense will be solely responsible for procuring (at its own cost
and expenses) the requisite licences from the owner of that technology for the
purposes of including the relevant technology in the New Product.
14.5
|
Technology Ownership and
Licensing; Technology
Transfer
|
(1)
|
OcuSense
shall retain ownership of any pre-existing intellectual property rights in
materials and information provided by OcuSense to MiniFAB for use by
MiniFAB for the purposes of undertaking activities under this Agreement.
MiniFAB shall retain ownership of any pre-existing intellectual property
rights in materials, information, tools and methodologies provided by
MiniFAB for the purposes of undertaking activities under this Agreement
(and any improvements to them, except to the extent that those
improvements comprise patented or unpatented intellectual property owned
or controlled by OcuSense or that have application in the field of
measuring osmolarity or osmolality of, or other characteristic of or any
biomarker in, human tear fluid) (collectively, "MiniFAB Background IP")
and MiniFAB hereby grants OcuSense a worldwide, non-exclusive,
royalty-free license (with the right to grant and authorize sublicenses)
to make, have made, use, offer for sale, sell and otherwise exploit
MiniFAB Background IP as may be required to make, have made, use, offer
for sale, sell and otherwise exploit Licensed Products or incorporated
into processes or procedures for manufacturing or testing Licensed
Products. As used herein, "Licensed Product" means
any article, item, product, equipment, process, data, report or other
deliverable designed or developed in whole or part for OcuSense by MiniFAB
under the Development Agreement or this Agreement, whether or not such
development or design is completed or successfully meets intended
criteria, including without limitation the First Product, Second Product
and any other New Products developed in whole or part under the
Development Agreement or in R&D Services performed by MiniFAB under
this Agreement.
|
(2)
|
Subject
to clause 14.5(1) and the requirement for OcuSense to pay MiniFAB all
outstanding fees and charges due to MiniFAB, MiniFAB agrees to assign and
hereby assigns to OcuSense all right, title and interest in and to any
trade dress, trademarks and design registrations or design patents, and
any inventions, whether patentable or not, and any other discoveries,
trade secrets or know-how which:
|
(a)
|
are
embodied in a Licensed Product; and
|
(b)
|
were
made, developed, conceived or first reduced to practice by or for MiniFAB
as a direct result of MiniFAB undertaking activities under the Development
Agreement or this Agreement
|
along
with all patents, copyrights, and any other intellectual property rights
therein, including the right to apply for and maintain the rights described in
this clause 14.5(2) in all countries worldwide (such rights comprising the 'Project IP') and MiniFAB
will (at the OcuSense's request and cost) do those things that may be reasonably
necessary to effect the registration of such intellectual property. OcuSense
must provide to MiniFAB full details (including copies of all relevant
documentation) of any application for registration (whether as a registered
patent, a registered design or otherwise) of the Project IP or any part of
it.
(3)
|
At
any time during the term of this Agreement, or in the event of
any termination of this Agreement, OcuSense shall have the right to
require MiniFAB:
|
(a)
|
to
provide all reasonable assistance as requested by OcuSense, including
without limitation transfer of technology, materials, information
and documentation, to enable OcuSense to manufacture the
Products internally or to secure the production and supply of the Products
by a third party contractor (whether or not all or part of such
technology, materials, information and documentation falls within the
MiniFAB Background IP owned by MiniFAB);
and
|
(b)
|
to
provide OcuSense with the consultancy services of all key engineering
personnel of MiniFAB to effect or support such transfer of technology
and/or the license to MiniFAB Background
IP.
|
OcuSense
shall pay MiniFAB for the time spent by MiniFAB's key personnel in conducting
such technology transfer activities as may be requested by OcuSense, at
MiniFAB's reasonable and customary rates for similar consultancy, and shall
reimburse MiniFAB's out-of-pocket expenses incurred in conducting such
technology transfer.
(4)
|
All
MiniFAB Background IP shall be treated by OcuSense and its sublicensees
and their third party manufacturers as Confidential Information of
MiniFAB; provided, however, that (i) OcuSense may disclose the
MiniFAB Background IP to actual and potential investors,
sublicensees, advisors and/or contract manufacturers of Licensed
Products, in each case under reasonable and customary terms of
confidentiality; and (ii) OcuSense and its sublicensees and contract
manufacturers may disclose such information as is reasonably
necessary in seeking regulatory approvals in connection with the
manufacture, clinical development, use or commercialization of
Licensed Products. For clarity, this clause 14.5(4) shall not be construed
to prevent the use of MiniFAB Background IP in under authority of the
license set forth in clause 14.5(1)
above.
|
(5)
|
This
clause 14.5 will survive termination of this
Agreement.
|
15.
|
Term,
breach and termination
|
15.1
|
Term
|
(1)
|
This
Agreement commences on the Commencement Date and continues for an
initial period of ten (10) years after the Commencement
Date.
|
(2)
|
This
Agreement shall automatically renew for additional terms of three
(3) years
each, unless either party provides the other party with a written notice
of non-renewal
at least 180 days prior to the scheduled expiration of the then
current
term.
|
15.2
|
Termination for
cause
|
Notwithstanding
clause 15.1, either party may terminate this Agreement effective immediately
upon the giving of written notice to the other party (Defaulting Party)
if:
(1)
|
the
Defaulting Party commits a material breach of this Agreement and fails to
correct the breach within 30 days after written notice to do
so;
|
(2)
|
the
Defaulting Party fails to carry out any material provision of this
Agreement and the failure is not capable of remedy;
and/or
|
(3)
|
an
Insolvency Event occurs in relation to the Defaulting
Party.
|
In the
event that OcuSense is entitled to terminate this Agreement under clause 15.2(1)
or 15.2(2) above and the applicable default or breach relates to the R&D
Services under one or more Development Orders, OcuSense may, in its discretion,
elect to terminate such Development Orders without terminating this Agreement
with respect to manufacture and supply of Products.
15.3
|
Effect of
termination
|
(1)
|
Upon
termination or expiry of this Agreement for any reason other than
for material breach by MiniFAB or due to an Insolvency Event in
relation to OcuSense, MiniFAB will complete the delivery of all
outstanding Purchase Orders.
|
(2)
|
Upon
termination of this Agreement for material breach by
MiniFAB, OcuSense may elect to cause MiniFAB to complete the delivery
of all outstanding Purchase Orders or to cancel any or all
outstanding Purchase Orders (in whole or in
part).
|
(3)
|
Upon
termination or expiry of this Agreement for any
reason
|
(a)
|
OcuSense
must pay all outstanding undisputed invoices for allcompleted
Purchase Orders;
|
(b)
|
all
Development Orders are deemed to be discontinued
and:
|
(i)
|
if
this Agreement is terminated under clause 15.2 and MiniFAB is the
Defaulting Party, then MiniFAB will be responsible for
all Development Expenses incurred;
and
|
(ii)
|
if
this Agreement is terminated for any other reason, then OcuSense must
pay MiniFAB all Development Expenses incurred and any other
unavoidable costs incurred by MiniFAB in connection with the
termination, as set forth in clause 5.12;
and
|
(c)
|
each
party must immediately return the Confidential Information of
the other party to the other
party.
|
(4)
|
Except
as provided in clause 15.4, termination is without prejudice to
the rights of either party for any prior
breach.
|
15.4
|
Termination
Fee
|
(1)
|
If
this Agreement is terminated for any reason, other than where MiniFAB
is the Defaulting Party, and the Minimum Orders requirements set
forth in clause 3.3(7) have not been satisfied on or before the effective
date of termination (other than as a result of the inability or failure of
MiniFAB to timely supply conforming Products in quantities ordered by
OcuSense), then OcuSense shall be deemed to have failed to meet the
Minimum Orders requirement, and shall pay MiniFAB the amounts specified in
clause 3.3(8) (Termination Fee);
provided, however, the Termination Fee shall not include any amounts with
respect to Minimum Orders requirements for Second Products as set forth in
clause 3.3(7)(c) and 3.3(8)(c) unless such termination is effective after
the date MiniFAB notifies OcuSense pursuant to clause 3.2(2) that MiniFAB
has put in place the necessary plant and equipment to manufacture the
Second Product to meet the Minimum Orders of that
Product.
|
(2)
|
The
parties acknowledge and agree that (i) the Termination Fee is a genuine
pre-estimate of the anticipated loss or damage which would be suffered by
MiniFAB as a result of the early termination of this Agreement, (ii) the
agreed upon Termination Fee shall be in lieu of any actual or alleged
damages, losses or harm to MiniFAB resulting from such Termination and/or
from any failure of OcuSense to order or purchase Products from MiniFAB
under this Agreement (Termination Losses), and
(iii) MiniFAB waives its right to seek recovery or reimbursement of all
Termination Losses other than the Termination
Fee.
|
15.5
|
Survival
|
All
clauses that by their nature survive expiration or termination of this Agreement
will remain in force. For the avoidance of doubt, clauses 1, 5.6, 6.3,
6.4(2), 11.1, 11.4, 13, 14.5, 15, 16, 17, 18, 19, 21 and 22 survive
termination.
16.
|
Liability
and indemnity
|
16.1
|
Indemnity by
OcuSense
|
OcuSense
shall indemnify MiniFAB and its Representatives against all Lossesincurred
by them as result of claims by third persons against MiniFAB arising directly
or
indirectly as a result of:
(1)
|
any
grossly negligent, unlawful, fraudulent or wilful misconduct committed
byOcuSense
or its Representatives in the performance of this
Agreement;
|
(2)
|
the
marketing, promotion, sale or supply of the Product by OcuSense;
or
|
(3)
|
OcuSense's failure
to obtain, maintain or comply in any respect with any Registrations,
|
except,
in each case, to the extent Losses result from any event described
in clause 16.2.
16.2
|
Indemnity by
MiniFAB
|
MiniFAB
shall indemnify OcuSense and its Representatives against all Losses incurred by
them as a result of claims by third persons against OcuSense arising directly or
indirectly, to the extent resulting from:
(1)
|
any
grossly negligent, unlawful, fraudulent or wilful misconduct committed by
MiniFAB or its Representatives in the performance of this
Agreement;
|
(2)
|
any
manufacturing defect in any Product supplied by MiniFAB to OcuSense, or
any failure of any such Product to conform to the Specifications or the
Regulatory Requirements therefor;
or
|
(3)
|
MiniFAB's
failure to obtain and maintain all necessary governmental permits for the
development and manufacture of Products
hereunder.
|
16.3
|
General provisions applicable
to indemnities
|
A party
(the "Indemnitee") that intends to claim indemnification under this clause 16
shall promptly notify the other party (the "Indemnitor") of any claim, demand,
action or other proceeding for which the Indemnitee intends to claim such
indemnification. The Indemnitor shall have the right to assume and control the
defense thereof with counsel selected by the Indemnitor; provided, however, that
the Indemnitee shall have the right to retain its own counsel to participate in
the defense, subject to Indemnitor's right to control the defense. The indemnity
obligations under this clause 16 shall not apply to amounts paid in settlement
of any Loss if such settlement is effected without the prior express written
consent of the Indemnitor, which consent shall not be unreasonably withheld or
delayed. The failure to deliver notice to the Indemnitor within a reasonable
time after notice of any relevant claim, or the commencement of any such action
or other proceeding shall not relieve such Indemnitor of all liability to the
Indemnitee under this clause 16 with respect thereto, but if such failure is
prejudicial to the Indemnitor's ability to defend such claim, and if such
prejudice results in Losses that otherwise would likely have been avoided or
reduced if timely notice had been given, then the Indemnitor shall be relieved
of said part of the Losses. The Indemnitor may not settle or otherwise consent
to an adverse judgment in any such claim, that diminishes the rights or
interests of the Indemnitee without the prior express written consent of the
Indemnitee, which consent shall not be unreasonably withheld or delayed (it
being understood that no consent by the Indemnitee is required for the
Indemnitor to obtain a full release of all claims by a third person against an
Indemnitee in exchange solely for the payment of a settlement amount by
Indemnitor). The Indemnitee, its employees and agents, shall reasonably
cooperate with the Indemnitor and its legal representatives in the investigation
of any claim covered by this clause 16. The indemnities contained in this clause
16 do not negate the obligation of the party having the benefit of such
indemnity to mitigate its losses; and are continuing obligations on each party,
separate and independent of any other obligation.
16.4
|
No consequential
damages
|
Except
for any liability under clause 18 or the indemnity provided under clauses 16.1
or 16.2, to the extent permitted by law, neither party will be liable to the
other party in any circumstances for any special, incidental, punitive,
exemplary, consequential or any other indirect loss or damage, or in any event
for any loss of revenue, loss of production, loss of profit or loss of
data.
17.
|
Goods
and services tax
|
17.1
|
In
this clause 17:
|
(1)
|
GST means GST as
defined in A New Tax System (Goods and Services Tax) Xxx
0000 as amended (GST
Act) or any replacement or other relevant legislation and
regulations;
|
(2)
|
words
or expressions used in this clause which have a particular meaning
in the
GST
law (as defined in the GST Act, and also including any
applicable legislative
determinations and Australian Taxation Office public rulings) have
the
same meaning, unless the context otherwise
requires;
|
(3)
|
any reference to GST payable
by a party includes any corresponding GST payable by the representative
member of any GST group of which that party is a
member;
|
(4)
|
any
reference to an input tax credit entitlement by a party includes
any corresponding
input tax credit entitlement by the representative member of any GST group
of which that party is a member;
and
|
(5)
|
if
the GST law treats part of a supply as a separate supply for the purpose
of determining
whether GST is payable on that part of the supply or for the purpose
of determining the tax period to which that part of the supply is
attributable,
such part of the supply is to be treated as a separate
supply.
|
17.2
|
Unless
GST is expressly included, the consideration to be paid or provided under
any other clause of this Agreement for any supply made under or in
connection with this Agreement does not include
GST.
|
17.3
|
To
the extent that any supply made under or in connection with this Agreement
is a taxable supply, the GST exclusive consideration otherwise to be paid
or provided for that taxable supply is increased by the amount of any GST
payable in respect of that taxable supply and that amount must be paid at
the same time and in the same manner as the GST exclusive consideration is
otherwise to be paid or provided. A party's right to payment under this
clause is subject to a valid tax invoice being delivered to the recipient
of the taxable supply.
|
17.4
|
To
the extent that one party is required to reimburse or indemnify another
party for aloss, cost or expense incurred by that other party, that loss,
cost or expense does notinclude any amount in respect of GST for which
that other party is entitled to claim aninput tax
credit.
|
18.
|
Confidentiality
|
18.1
|
Prohibited
acts
|
Neither
party may, without the other party's prior written consent, copy or disclose or
cause to be copied or disclosed any Confidential Information of the other party
other than to the extent that such Confidential Information must be
disclosed:
(1)
|
to
the party's sub-contractors, employees, legal advisers, auditors,
investors or other consultants in order for this Agreement to be
performed, provided that the recipients of the information undertake in
writing to the party to keep that information strictly confidential;
or
|
(2)
|
to
Regulatory Authorities as required to obtain or maintain any
regulatory approvals.
|
18.2
|
Permitted
uses
|
Each
party may only make use of Confidential Information of the other party to
the extent necessary to enable the party to perform its obligations or
exercise its rights under this Agreement.
18.3
|
Excluded
information
|
For the
purposes of this clause, Confidential Information does not include
any information which the receiving party can establish:
(1)
|
was
in the public domain when it was disclosed to the receiving
party;
|
(2)
|
becomes,
after being disclosed to the receiving party, part of the
public domain, except through disclosure contrary to this
Agreement;
|
(3)
|
was
already in the receiving party's possession when it was disclosed to the
receiving party and was not otherwise acquired from the other party
directly or indirectly; or
|
(4)
|
was
lawfully disclosed to the receiving party by a third party having the
unrestricted legal right to disclose that information without requiring
the maintenance of confidentiality.
|
Prior to
making a disclosure of information which the receiving party alleges is no
longer or never was Confidential Information by virtue of falling within one of
the above exceptions, the receiving party must give to the other party 10
Business Days notice of the proposed disclosure and the reasons for the
exception applying.
18.4
|
Compulsory
disclosures
|
The
obligations of confidentiality in this clause do not apply to a receiving party
where the receiving party is required under the lawful compulsion of any court,
tribunal, authority or regulatory body to disclose any Confidential Information
of the other party. Provided that before a party discloses any Confidential
Information pursuant to the foregoing it must provide the other party with
reasonable notice to enable it to seek a protective court order or other remedy
in respect of the Confidential Information, and it must provide the other party
with all assistance and co operation which the other party considers necessary
to obtain such protective court order or other remedy.
|
18.5
|
Protection of
information
|
Each
party must notify the other party in writing immediately upon the discovery of
any apparent unauthorised use or disclosure of any Confidential Information and
take all reasonable steps to enforce the confidentiality obligations imposed or
required to be imposed by this clause 18 including diligently prosecuting at its
cost any breach or threatened breach of any such confidentiality obligations by
any person to whom it has disclosed or allowed access to the Confidential
Information or at the other party's option making all reasonable efforts to
assist the other party to help regain possession of the Confidential Information
and prevent any further unauthorised disclosure or use.
|
18.6
|
Confidentiality of
agreement
|
The
parties must maintain absolute confidentiality concerning the existence and
subject matter of this Agreement and no public announcement or communication
relating to the negotiations of the parties or the existence, subject matter or
terms of this Agreement may be made or authorised by a party without the prior
written approval of the other party except that the following disclosures may be
made in relation to this Agreement:
(1)
|
by
either party to its sub-contractors, employees, auditors,
consultants, professional advisers, bankers, financial advisers,
financiers, investors and potential investors upon those persons
undertaking to keep confidential any information so disclosed;
or
|
(2)
|
to
comply with any applicable law or requirement of any
Governmental Agency or of any public stock exchange on which shares
of the disclosing party are
listed.
|
18.7
|
Return of Confidential
Information
|
Each
party agrees that on termination or expiration of this Agreement it will deliver
to that other party any and all materials containing or embodying that other
party's Confidential Information and any copies thereof; provided that each
party shall be entitled to retain one (1) copy of the other party's Confidential
Information, to be kept at such party's legal files for use solely for the
purpose of ensuring continued compliance with the terms of this
Agreement.
19.
|
Disputes
|
19.1
|
Attempt to
Settle
|
If a
dispute arises between the parties in connection with this Agreement then the
parties must use all reasonable endeavours acting in good faith to settle the
dispute as soon as practicable.
19.2
|
Limitations on Court
Proceedings
|
A party
must not commence court proceedings in relation to a dispute arising in
connection with this Agreement until it has exhausted the procedures in this
clause 19, unless the party seeks urgent interlocutory relief.
19.3
|
Disputes relating to
Product
|
If the
dispute relates to whether or not a particular Product meets the Specifications
and the Regulatory Requirements, then the parties must submit the dispute to an
independent laboratory, which will act as an expert in determining whether or
not the Product meets the Specifications and the Regulatory Requirements;
provided, however, that if it is not technically feasible to make such
independent laboratory determination in connection with a particular dispute
(e.g., if insufficient number of samples of a relevant batch of Products is
available), then such dispute shall be determined by arbitration under clause
19.5
19.4
|
Other
disputes
|
If a
dispute does not relate to whether or not a particular Product meets the
Specifications and the Regulatory Requirements and the parties are unable in
good faith to settle the dispute within 20 Business Days after the dispute
arose, then either party may submit the matter to arbitration under clause
19.5.
19.5
|
Arbitration
|
(1)
|
If
any dispute arises under, or in connection with, this Agreement and/or any
Development
Order, or in connection with any breach or alleged breach of this
Agreement or any Development Order, and such matter is not resolved
pursuant to clause 19.1 or 19.3 or by other agreement of the parties, such
matter shall be finally resolved through binding arbitration as set forth
in this clause 19.5. Either party may initiate arbitration of such a
matter, and the party initiating arbitration of such dispute must give to
the other party or parties to the dispute notice specifying the dispute
and requiring its resolution under this clause 19.5 (Notice of Dispute). Such
Notice of Dispute shall be given in accordance with the arbitration rules
specified under this clause
19.5.
|
(2)
|
Each
such dispute is by this clause 19.5 referred to binding arbitration for
final resolution. The arbitration must be conducted
in:
|
(a)
|
Melbourne,
Australia if the Notice of Dispute is given by
OcuSense; and
|
(b)
|
San
Diego California, USA, if the Notice of Dispute is given
by MiniFAB.
|
(3)
|
If
the parties have not agreed upon the arbitrator within 7 days after the
Notice of Dispute is given, the arbitrator is the person appointed by the
Chair of the Victorian Chapter of the Institute of Arbitrators and
Mediators Australia (Principal Appointor) or
the Principal Appointor's nominee, acting on the request of any party to
the dispute.
|
(4)
|
The
arbitrator must not be a present or former member, officer, employee or
agent of a party to the dispute or a person who has acted as a mediator or
advised any party in connection with the
dispute.
|
(5)
|
The
arbitration shall be conducted in accordance with the then-current rules
of the International Centre for Dispute Resolution by one (1) arbitrator
appointed in accordance with such rules. The arbitrator shall determine
what discovery will be permitted, consistent with the goal of limiting the
cost and time which the parties must expend for discovery; provided the
arbitrator shall permit such discovery as the arbitrator deems necessary
to permit an equitable resolution of the dispute. The arbitrator shall not
order or require discovery against either party of a type or scope that is
not permitted against the other party. The costs of the arbitration,
including administrative and arbitrators' fees, shall be shared equally by
the parties, and each party shall bear its own costs and attorneys' and
witness' fees incurred in connection with the arbitration. Any arbitration
subject to this Article shall be completed within one (1) year from the
filing of notice of a request for such arbitration. No punitive damages
may be granted by the arbitrator. The arbitration proceedings and the
decision shall not be made public without the joint consent of the
parties, and each party shall maintain the confidentiality of such
proceedings and decision unless otherwise permitted by the other party,
except to the extent (and solely to the extent) either party is required
to disclose such information by applicable securities or other laws. The
parties agree that the decision shall be the sole, exclusive and binding
remedy between them regarding any and all disputes, controversies, claims
and counterclaims presented to the arbitrator. Any award may be entered in
a court of competent jurisdiction for a judicial recognition of the
decision and applicable orders of enforcement, and either party may apply
to any court of competent jurisdiction for appropriate temporary
injunctive relief pending resolution of any arbitration proceeding. The
arbitrator shall provide a written arbitration award setting forth the
arbitrator's findings on material questions of law and of fact, including
references to the evidence on which the findings of fact were based. Each
party may be represented by a qualified legal practitioner or other
representative.
|
(6)
|
This
clause 19.5 applies even where the Agreement is otherwise void
or voidable.
|
19.6
|
Continuing
Obligations
|
19.7
|
Except
as specifically provided in this Agreement, the parties must continue
to perform their obligations under this Agreement despite the
existence of a dispute or any steps being taken under this clause
19.
|
20.
|
Force
Majeure
|
20.1
|
Party not
liable
|
Where a
party is required under this Agreement to perform an obligation or do any act or
thing by a designated time or date (Obligation), the party is not
liable for any delay in performing or for failure to perform an Obligation where
the delay or failure arises from Force Majeure and that party has complied with
this clause.
20.2
|
Notice of Force
Majeure
|
A party
who claims Force Majeure must:
(1)
|
give
the other party prompt notice of the Force Majeure with reasonably full
particulars and an estimate of the extent and duration of its delay in
performance, or inability to perform;
and
|
(2)
|
use
all possible diligence to resume normal performance of the delayed
obligations as quickly as possible.
|
20.3
|
Termination in case of Force
Majeure
|
If the
delay continues beyond 30 days after the notice given under clause 20.2, the
parties must meet to discuss in good faith a mutually satisfactory resolution of
the problem and, if unable to achieve such a resolution within a further 60
days, either party may elect to terminate this Agreement by 30 days prior
written notice to the other.
21.
|
Notices
|
21.1
|
A
notice or other communication connected with this Agreement (Notice) has
no legal effect unless it is in
writing.
|
21.2
|
In
addition to any other method of service provided by law, the Notice may
be:
|
(1)
|
sent
by prepaid post to the address of the addressee set out in this
Agreement or subsequently
notified;
|
(2)
|
sent
by facsimile to the facsimile number of the
addressee;
|
(3)
|
sent
via email to the email address of the addressee;
or
|
(4)
|
delivered
at the address of the addressee set out in this Agreement or subsequently
notified.
|
21.3
|
If
the Notice is sent or delivered in a manner provided by clause 21.2, it
must be treated as given to and received by the party to which it is
addressed:
|
(1)
|
if
sent by facsimile or email, on the next Business Day at the place of
receipt, unless a transmission failure notice is received by the
sender; or
|
(2)
|
if
sent by post or otherwise, upon receipt by the
addressee.
|
21.4
|
Despite
clause 21.3(1):
|
(1)
|
a
facsimile is not treated as given or received unless at the end of
the transmission the sender's facsimile machine issues a report
confirming the transmission of the number of pages in the
Notice;
|
(2)
|
a
facsimile is not treated as given or received if it is not received in
full and in legible
form and the addressee notifies the sender of that fact by the close of
the
Business Day on which it would otherwise be treated as given and
received.
|
22.
|
General
|
22.1
|
Further
assurance
|
Each
party must promptly at its own cost do all things (including executing and if
necessary delivering all documents) necessary or desirable to give full effect
to this Agreement, to the extent commercially reasonable to do so.
22.2
|
Entire
understanding
|
This
Agreement is the entire agreement and understanding between the parties on
everything connected with the subject matter of this Agreement and supersedes
any prior agreement or understanding on anything connected with that subject
matter. Notwithstanding the foregoing, the Development Agreement continues to
govern the development of the First Product; provided, however, that in the
event of a conflict between any provision of the Development Agreement and any
provision of this Agreement, the relevant provision of this Agreement shall
govern.
22.3
|
Variation
|
An
amendment or variation to this Agreement is not effective unless it is in
writing and signed by the parties.
22.4
|
Waiver
|
A party's
failure or delay to exercise a power or right does not operate as a waiver of
that
power or right. The exercise of a power or right does not preclude either its
exercise
in the future or the exercise of any other power or right. A waiver is not
effective
unless it is in writing. Waiver of a power or right is effective only in respect
of the
specific instance to which it relates and for the specific purpose for which it
is given.
22.5
|
Costs and
outlays
|
Each
party must pay its own costs and outlays connected with the
negotiation, preparation and execution of this Agreement.
22.6
|
Governing law and
jurisdiction
|
This
Agreement shall be governed and construed in accordance with the laws of
England,
United Kingdom.
[Signature
page follows]
Executed
as an agreement.
Executed
by MiniFAB (Aust) Pty
Ltd
ACN 100
768 474 in accordance with
section
127 of the
Corporations Xxx
0000:
/s/
Xxxxxxx Xxxxxxxxx
|
/s/
Xxxx Xxxxxx
|
Director/company
secretary
|
Director
|
Xxxxxxx Xxxxxxxxx
|
Xxxx Xxxxxx
|
Name
of director/company secretary
|
Name
of director
|
(BLOCK
LETTERS)
|
(BLOCK
LETTERS)
|
Signed
for and on behalf of
OcuSense, Inc. by its
authorised
representative
in the presence of:
/s/
Xxxxxxx Xxxxx
|
/s/
Xxxx Xxxxxx
|
Signature
of witness
|
Signature
of authorised representative
|
Xxxxxxx Xxxxx
|
XXXX XXXXXX,
CEO
|
Name
of witness
|
Name
of authorised representative
|
(BLOCK
LETTERS)
|
(BLOCK
LETTERS)
|
Address
of witness
00000
Xxxx Xxxxx Xx. #000
Xxx
Xxxxx, XX 00000
U.S.A.
***Schedule
1 in its entirety has been omitted pursuant to a request for confidential
treatment and has been filed separately with the U.S. Securities and Exchange
Commission.
Schedule
2
Form
of Development Order
Development
Order made between MiniFAB and OcuSense pursuant to the Manufacturing and
Development Agreement dated ###
Date of
Development Order
1.
|
Description of New
Product
|
###
|
2.
|
Draft New Product Development
Requirements
|
#Insert
draft#
|
3.
|
Estimated Development
Expenses
|
###
|
4.
|
Project
Plan
|
#Please
insert a project plan for carrying out the development.#
|
5.
|
Development Milestones and
Payments (if not included in the Project
Plan)
|
#Each
payment milestone should specify the amount payable and when it is payable.
Other payment terms (if any) should be specified.#
|
6.
|
Successful
Completion
|
#Please
insert criteria for Successful Completion. If this is left blank, then the
default provisions in clause 5.10 will apply.#
|
7.
|
Other
terms
|
#Insert
any other applicable terms relevant to the development of the new
product.#
MiniFAB
and OcuSense agree that MiniFAB will provide the R&D Services pursuant to
the Manufacturing and Development Agreement between the parties to develop the
New Product as detailed in this Development Order.
Signed
for and on behalf of MiniFAB
Signed
for and on behalf of OcuSense
***Annexures A
and B in their entirety have been omitted pursuant to a request for confidential
treatment and have been filed separately with the U.S. Securities and Exchange
Commission.