Supply Agreement
EXHIBIT
10.1
Supply
Agreement made effective this 3rd day of November, 2006 by and between Inverness
Medical Innovations, Inc., with offices at 00 Xxxxxx Xxxx, Xxxxx 000, Xxxxxxx,
XX 00000 on behalf of itself and its subsidiaries (“Inverness”) and Matritech,
Inc., a Delaware corporation with its principal place of business at 000 Xxxxxx
Xxxxxx, Xxxxxx, XX 00000 (“Matritech”) each “a Party” and together “the
Parties”.
Whereas,
the Parties are desirous of entering into arrangements for the supply to
Matritech of the NMP22®
BladderChek®
Test,
Now,
therefore, in consideration of the premises and for other good and valuable
consideration, the receipt and legal sufficiency of which are hereby
acknowledged, the Parties agree as follows:
1.0 Definitions
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1.1
Affiliate
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in
relation to a Party means any other entity which directly or indirectly
Controls is Controlled by or is under direct or indirect (e.g. through
an
intermediate subsidiary) common Control with that Party from time
to
time.
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1.2
Approved Custom
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Manufacturers
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means,
collectively, the entities listed on Schedule 6 hereof, as it may
be
amended in Writing from time to time by Inverness and
Matritech.
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1.3
Inverness/Approved
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Custom
Manufacturer
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Raw
Materials
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means
any and all raw materials supplied by Inverness or an Approved Custom
Manufacturer for incorporation into the Products.
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1.4
Biologicals
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means
all biological materials incorporated into the Products.
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1.5
Business Days
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means
any day excluding Saturday and Sunday or any public holidays in the
country where either Party is based.
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1.6
Control
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means
that an entity owns fifty percent (50%) or more of the voting shares
of a
second entity, and Control and Controlled shall be interpreted
accordingly.
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1.7
Effective Date
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means
the date set forth in the first sentence of this
Agreement.
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1.8
Firm Order
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has
the meaning given to it in clause 3.4, and refers to the first three
(3)
months of each Written forecast provided by Matritech to Inverness
and the
applicable Approved Custom Manufacturer.
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1.9
Force Majeure
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means,
in relation to a Party, any circumstance beyond the reasonable control
of
that Party; provided, however, that labor strife affecting a Party’s own
workforce or that of an Approved Custom Manufacturer, such as strikes,
lock-outs or other industrial actions, shall not constitute a Force
Majeure circumstance.
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1.10
Identified Confidential
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Information
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means
any information or data, regardless of whether it is in tangible
form,
disclosed by either Party (the “disclosing Party”) that the disclosing
Party has either marked as confidential or proprietary, or has identified
in Writing as confidential or proprietary within thirty (30) days
of
disclosure to the other Party (the “receiving Party”); provided,
however,
that reports and/or information related to a disclosing Party’s business
plans, strategies, technology, research and development, current
and
prospective customers, billing records, and products or services
shall be
deemed Identified Confidential Information of the disclosing Party
even if
not so marked or identified. Information will not be deemed Identified
Confidential Information hereunder if such information: (a) is known
to
the receiving Party prior to receipt from the disclosing Party directly
or
indirectly from a source other than one having an obligation of
confidentiality to the disclosing Party; (b) becomes known (independently
of disclosure by the disclosing Party) to the receiving Party directly
or
indirectly from a source other than one having an obligation of
confidentiality to the disclosing Party; (c) becomes publicly known
or
otherwise ceases to be secret or confidential, except through a breach
of
this Agreement by the receiving Party; or (d) is independently developed
by a receiving Party without reference to or use of the other Party’s
Identified Confidential Information.
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1.11
Intellectual
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Property
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means:-
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i)
copyrights, patents, database rights and rights in trademark designs,
know-how and confidential information (whether registered or
unregistered);
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ii)
applications for registration or the right to apply for registration
for
any of those rights; and
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iii)
all other intellectual property rights and the equivalent or similar
forms
of protection existing anywhere in the world.
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1.12
Inverness Patents
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means
those patents listed on Schedule 1.
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1.13
Matritech Raw
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Materials
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means
any and all raw materials supplied by Matritech for incorporation
into the
Products as set out in Schedule 5, as it may be amended from time
to time
by the Parties in Writing.
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1.14
Matritech Technology
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means
any Technology of Matritech relating to the Products existing as
of the
Effective Date and disclosed by Matritech to Inverness from time
to
time.
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1.15
New Technology
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means
any Technology and/or Intellectual Property developed by Inverness
or an
Approved Custom Manufacturer in
the manufacture of the Products and, for the avoidance of doubt,
not
including Matritech Technology.
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1.16
Price
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means
the price for the Product payable by Matritech to Inverness, which
may
vary depending on quantities ordered, calculated in accordance with
Schedule 2.
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1.17
Product Improvement
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means
any New Technology consisting of a development, enhancement or derivative
of the Product, but only to the extent that such technology is applicable
only to the Product.
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1.18
Products
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means
the products listed in Schedule 7, and subsequent versions thereof,
and
such additional products that the Parties may from time to time separately
agree in Writing shall be governed by the terms of this Agreement.
In the
case of such agreement, Schedule 7 shall be replaced with an updated
version including such additional products and Product shall mean
each
unit of those Products.
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1.19
Professional Field
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means all
channels of distribution resulting in the distribution of a Product
to (a)
licensed professional health-care providers (including hospitals,
physicians (acting as such), and licensed professional health-care
centers, (b) other third parties trained to administer and/or analyze
diagnostic test, and (c) professional diagnostic laboratories.
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1.20
Recall
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means
a recall or withdrawal of the Product and shall include any post-sale
warning regarding such Product;
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1.21
Receiving Points
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means
the premises designated by Matritech as the destination for each
order of
Products under Section 8.
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1.22
Specification
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means
the specifications for the Product set out in Schedule 3, as they
may be
amended from time to time under Section 6.0.
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1.23
Technology
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means
any methods, techniques, discoveries, inventions (whether patentable
or
not), formulae, formulations, technical and product specifications,
equipment descriptions, plans, layouts, drawings, computer programs,
assembly, quality control, installation and operating procedures,
operating manuals, technical and marketing information, designs,
data,
know-how and other information.
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1.24
Trademarks
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means
the registered trademarks of Matritech and pending trademark applications
related to the Product, which are listed in Schedule 4.
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1.25
Unit
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means
one item of the Product, e.g. one BladderChek Test.
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1.26
Valid Claim
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means,
with respect to a particular country, a claim of an issued patent
that (a)
has not lapsed or become abandoned, disclaimed, denied, revoked,
or
admitted to be invalid or unenforceable through reissue or disclaimer
or
otherwise in such country, and (b) has not been declared invalid
or
unenforceable by a court of competent jurisdiction or an administrative
agency for which there is no further right of appeal or for which
the
right of appeal is waived.
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1.27
Writing or Written
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means
any form of written communication and any other similar expression,
includes facsimile transmission and comparable means of communication,
but
not electronic mail.
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2.0 Roles
of the Parties
2.1 Matritech
will be the customer purchasing Products from Inverness. Inverness will be
a
contract manufacturer. Inverness represents and warrants that it owns controls,
or has licenses to the Inverness Patents. Certain Valid Claims of the Inverness
Patents may cover the Products. Inverness further represents and warrants that
the Inverness Patents include all of the patent rights in the lateral flow
area
(including issued patents and patent applications) owned, controlled, or
licensed by Inverness or its Affiliates that cover the Products as of the
Effective Date of this Agreement. The Inverness Patents are not being licensed
to Matritech. The Price contemplates the existence of the Inverness Patents.
Inverness may engage, as subcontract manufacturer, one or more Approved Custom
Manufacturers to have Products manufactured. Inverness will sell to Matritech
Products manufactured by Inverness or any such Approved Custom Manufacturer.
Such Products may only be resold, distributed and used in the Professional
Field
by Matritech and its resellers, distributors and end-customers. Subject to
the
terms and conditions of this Agreement (including without limitation this clause
2.1 and clause 5.4), Matritech may resell any such Product to Matritech’s
end-user customers, resellers and distributors (in any such case, only for
resale, distribution and use in the Professional Field), and such resales and
use by resellers are also contemplated in the Price. Matritech will notify
any
such reseller, distributor and end-customer in writing that Products may only
be
distributed for use in the Professional Field. Inverness covenants that
Inverness and its Affiliates shall not xxx or otherwise assert any claim or
counterclaim against Matritech, its Affiliates, or any of its or their
resellers, distributors or end-customers, to the extent based on a claim that
any such person or entity, with respect to such person’s or entity’s use,
distribution or sale of Products in accordance with the terms and conditions
of
this Agreement, infringes upon any Inverness Patent.
2.2 The
initial Approved Custom Manufacturers are listed on Schedule 6 hereof. If
Inverness elects to use an Approved Custom Manufacturer, Inverness agrees that
it will enter into, and maintain in full force and effect, agreements with
such
Approved Custom Manufacturers, for the duration of the Term of this Agreement,
covering the manufacture by such Approved Custom Manufacturer of the Products
for delivery to Matritech. To the extent that any Affiliate of an Approved
Custom Manufacturer is approved by Matritech (an “Approved Affiliate”), then
such Approved Affiliate(s) will also be an Approved Custom Manufacturer.
2.3 The
Parties shall meet at least once each year to review matters likely to be
relevant to the manufacture and sale of the Product.
3.0 Orders
for the Product.
3.1 Inverness
agrees to, or to cause one or more of the Approved Custom Manufacturers
to, deliver
to Matritech, in sufficient quantities to satisfy Matritech’s orders which are
made in accordance with the terms of this Agreement and on the delivery schedule
established in accordance with the terms of this Agreement, Product
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manufactured
by Inverness or such Approved Custom Manufacturer(s). Matritech
agrees to purchase from Inverness such volumes of the Products as Matritech
may
order from time to time in accordance with the provisions of this Agreement.
In
the event that Inverness elects to use an Approved Custom Manufacturer,
Matritech shall have the right with respect to each order of Products, to
express a preference for a particular Approved Custom Manufacturer to
manufacture the Products for Inverness to resell to Matritech pursuant to such
order, however, the ultimate designation of an Approved Custom Manufacturer
for
each order shall be at Inverness’ sole discretion.
3.2 Matritech
shall provide Inverness and the applicable Approved Custom Manufacturer with
a
Written forecast of its estimated monthly purchases of the Products for the
twelve (12) month period commencing with the calendar month following the month
in which such forecast is delivered to Inverness, the first three (3) months
of
which shall be binding on both Parties. Such forecasts shall represent
Matritech’s commercially reasonable, good-faith estimate of its Product
requirements from Inverness for such twelve (12) month period. Except
for the first three (3) months as described in the preceding sentence and except
as provided in clause 3.4, such forecasts are for the convenience of Inverness
and any applicable Approved Custom Manufacturer only, shall not constitute
firm
purchase or shipping orders and shall not be binding upon, or create any
obligation or liability with respect to, Matritech, Inverness or any applicable
Approved Custom Manufacturer.
3.3 Contemporaneously
with the execution of this Agreement, Matritech will deliver to Inverness or,
if
applicable, the applicable Approved Custom Manufacturer a sufficient quantity
of
Matritech Raw Materials to enable such Approved Custom Manufacturer to
manufacture quantities of the Product covered by at least the first four (4)
months of Matritech’s applicable forecast. Inverness will, or cause the
applicable Approved Custom Manufacturer to, advise Matritech in Writing from
time to time of the quantity of Matritech Raw Materials it has on hand and
Matritech will supply additional quantities of Matritech Raw Materials so that
Inverness or such Approved Custom Manufacturer always has an adequate supply
of
such Matritech Raw Materials to manufacture Product in accordance with this
Agreement.
3.4 At
the
time each Written forecast is delivered by Matritech to Inverness and the
applicable Approved Custom Manufacturer pursuant to clause 3.2, the first three
(3) months of such forecast (the “Firm Order Period”) shall be deemed a firm
order for the Product (a “Firm Order”), which Firm Order shall state actual
quantities and delivery dates for the Product for the Firm Order Period;
provided that no delivery date shall be earlier than [ ** ] days after the
date
of submission of that forecast. For purposes of clarification, after the first
forecast is delivered, the first month’s quantity in each subsequent forecast
shall not constitute a new Firm Order for that quantity, except to the extent
the quantity is increased as described in clause 3.5 hereof. Quantities of
Product delivered pursuant to a Firm Order shall not vary more than plus or
minus five percent (+/- 5%) of such Firm Order. Inverness shall, or shall cause
the applicable Approved Custom Manufacturer to, deliver the Product on the
delivery date specified by Matritech
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in
the
relevant Firm Order in accordance with the provisions of this clause 3.4 or
up
to ten (10) Business Days prior to or after such delivery date.
3.5 Once
a
Firm Order is submitted to Inverness and any applicable Approved Custom
Manufacturer with respect to any given Firm Order Period, Matritech may
reasonably revise that Firm Order by providing Written notice to Inverness
and
such Approved Custom Manufacturer; provided, however, that if the revised Firm
Order is for a larger quantity of Product, Inverness shall have [ ** ] days
from
the day of such revised Firm Order notice in which to deliver, or to have the
applicable Approved Custom Manufacturer deliver, the amount of Product that
is
in excess of the amount ordered by Matritech pursuant to the original Firm
Order. Notwithstanding the immediately preceding sentence, in the event
Matritech wishes to increase a Firm Order by greater than [ ** ], Inverness
is
only required to reasonable commercial efforts, or to cause the applicable
Approved Custom Manufacturer to make reasonable commercial efforts, to produce
such additional volume of Products for Matritech.
3.6 If
Matritech decreases the quantity set forth in Matritech’s Firm Orders, Matritech
shall be responsible for the reasonable cost of materials for the Product
purchased by Inverness or the applicable Approved Custom Manufacturer in
accordance with Matritech’s Firm Orders; provided, however, that Matritech shall
not be responsible for the reasonable cost of any materials that are or will
be
subsequently used by Inverness or the Approved Custom Manufacturer in respect
of
the Products. At Matritech’s option, Matritech may instruct Inverness to, or to
cause the applicable Approved Custom Manufacturer to, utilize such materials
in
the future supply of Product and Inverness agrees to follow any such
instruction. In addition, Inverness shall to use commercially reasonable efforts
to, or to cause the applicable Approved Custom Manufacturer to use commercially
reasonable efforts to, utilize such materials in the supply of product or in
the
manufacture of goods for third parties so as to minimize the amount of such
materials that remain unused.
Inverness shall advise, or shall direct the applicable Approved Custom
Manufacturer to advise, Matritech in Writing of the amount and cost of excess
materials resulting from Matritech’s decrease of Firm Orders that have not been
used in the future supply of Products or in the manufacture of goods for third
parties within ninety (90) days after the month for which the Firm Order is
decreased. Matritech shall have the right, at its option, to have the excess
material delivered to it or to another supplier of its choice.
3.7 Orders
for the Products shall be given by Matritech to Inverness and any applicable
Approved Custom Manufacturer in Writing, pursuant to a process to be mutually
defined by the Parties in consultation with any Approved Custom Manufacturers.
3.8 In
ordering and delivering Product, Matritech, Inverness and any applicable
Approved Custom Manufacturer may employ their standard forms, but nothing in
those forms shall be construed to modify or amend the terms of this Agreement,
and, in the case of any conflict herewith, the terms of this Agreement shall
control.
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3.9 In
partial consideration of sales of the Products, sales of the Products by
Inverness to Matritech under this Agreement shall be at the Price calculated
pursuant to Schedule 2 and shall be subject to credits as specified in such
Schedule.
3.10 Matritech
agrees with and undertakes to Inverness that it shall place orders with
Inverness for manufacture under this Agreement of a minimum quantity of Products
as set forth below, subject to performance by Inverness of its obligations
under
this Agreement:
| First 12 months (Year 1): | [ ** ] Units |
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Second
12 months (Year 2):
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[ ** ] Units |
Notwithstanding
the foregoing, if there is any shortfall in the number of units ordered by
Matritech in Year 1 of this Agreement, Matritech shall have the right to roll
that shortfall into Year 2 and order such Product during that period and any
Year 1 shortfall in orders shall not be deemed to be a breach of this Agreement.
After
the
second 12 months, no minimum order shall apply.
3.11 The
Approved Custom Manufacturers are as specified on Schedule 6 hereof, but the
Parties reserve the right to mutually agree in Writing to change such
designation from time to time. Inverness agrees to cooperate with Matritech
throughout the term of this Agreement to establish or develop alternate
subcontract manufacturers for the Product to ensure Matritech will have an
uninterrupted and adequate supply of Product.
4.0 Quality
of the Products
4.1 Inverness
warrants to Matritech that all Products supplied to Matritech under this
Agreement shall conform in all material respects to the Specification at the
time of delivery and over the shelf life of the Product specified in clause
4.7
below.
4.2 Matritech
may reject any of the Products which do not comply with clause 4.1 in accordance
with the processes described in clause 4.6.
4.3 For
the
purposes of assuring to Matritech the quality of the Products required under
this Agreement, Inverness shall, and shall cause each Approved Custom
Manufacturer to, permit the duly authorized representatives of Matritech, at
any
time during normal working hours and on reasonable notice, to inspect, at its
own expense, any premises of Inverness and/or the Approved Custom Manufacturer
where any of the Products are manufactured or stored by such party. Such
inspection shall only take place during the regular business hours of Inverness
or the Approved Custom Manufacturer, and in such a manner as not to interfere
unreasonably with the normal business activities
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of
Inverness or the Approved Custom Manufacturer. Such inspections shall not be
conducted hereunder more frequently than once every twelve (12) months,
provided, however, that in the event that an inspection reveals material
deficiencies in the Product, or customers have complained about specific quality
or performance issues, Matritech may require additional inspections in such
twelve (12) month period. Prior to commencing any such inspection, any
representative of Matritech that is not subject to a binding and enforceable
confidentiality agreement with Inverness or the Approved Custom Manufacturer
shall enter into an agreement with Inverness and/or the Approved Custom
Manufacturer which prohibits the disclosure of any information relating to
Inverness or the Approved Custom Manufacturer to any party, including Matritech,
except that such auditor may issue a report to Matritech, the sole purpose
of
which shall be to report to Matritech whether Inverness or the Approved Custom
Manufacturer is in compliance with the requirements of clause 4.1 above,
including a summary of and sufficient detail regarding the scope, quality,
and
methodology of such compliance or lack thereof.
4.4 Inverness
shall, or shall cause the applicable Approved Custom Manufacturer to, submit
to
Matritech for approval a minimum of [ ** ] samples of Product from each trial
production run. For the avoidance of doubt, Matritech shall pay for such samples
in accordance with Section 3 above. Inverness or the applicable Approved Custom
Manufacturer shall not commence any full production run until Matritech has
communicated its approval of the trial production run samples to Inverness
and
the applicable Approved Custom Manufacturer in Writing. Approval shall not
be
unreasonably withheld or delayed by Matritech. If Written approval takes more
than ten (10) Business Days, Inverness shall be deemed not to be in breach
of
any delivery obligations under this Agreement in respect of the Products
affected by such delay in approval. Once Matritech has advised Inverness and
the
applicable Approved Custom Manufacturer in Writing of its approval of the trial
production run samples, Inverness shall cause the full production run of the
Product to be manufactured and delivered to Matritech.
4.5 The
Parties will agree upon the quality control system which will be implemented
at
the premises of Inverness or the applicable Approved Custom Manufacturer prior
to the dispatch of the Products, whether from a trial production run or a full
production run. In the event of a change of Specification during the term of
this Agreement or a regulatory change which results in the need for a revised
quality control system, the Parties agree to cooperate in good faith to
determine the revised quality control system to be implemented at the premises
of Inverness or the applicable Approved Custom Manufacturer. Inverness agrees
to, or to cause the Approved Custom Manufacturer to, implement and utilize
the
quality control system, as it is agreed to from time to time.
4.6 In
the
event of any Products failing to comply with the warranty set forth in clause
4.1 above, Matritech shall notify Inverness and the applicable Approved Custom
Manufacturer in Writing of the failure as soon as reasonably practicable.
In
the
event that no such Written notice of warranty breach is given to Inverness
and
the
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applicable
Approved Custom Manufacturer within ten (10) Business Days of the receipt of
Product at the Receiving Point, then that shipment of Product shall be deemed
to
be accepted by Matritech, provided, however, that Matritech reserves the right
to revoke its acceptance and reject the Products if subsequent testing, to
occur
within thirty (30) calendar months after Matritech’s receipt of the Product at
the applicable Receiving Point, reveals that the Products fail to conform in
material respects with the Specification.
4.7 The
Parties agree that upon the Effective Date, the shelf life of the Products
shall
be [ ** ] and that any extension of the shelf life (and revision of the
Specification to a shelf life longer than [ ** ]) shall only be made in writing
during the term of this Agreement based upon accumulation of accelerated and/or
real time data related to the Products.
4.8 Matritech
shall inform Inverness and the applicable Approved Custom Manufacturer in
Writing of any claim relating to quantitative defects in shipments (shortfall
or
overage) of Product within thirty (30) days following actual receipt of such
shipments by Matritech at the Receiving Points, and Matritech shall provide
Inverness and the applicable Approved Custom Manufacturer with copies of any
appropriate documents relating to such quantitative defects that Matritech
has
in its possession. Inverness shall, or shall cause the applicable Approved
Custom Manufacturer to, provide Matritech with any quantities of such Product
missing as soon as reasonably possible after receipt of notice from Matritech.
Matritech shall only be obligated to pay for actual quantities of Product
received. Any claim for a quantitative defect which is not made within such
thirty (30) day period shall be deemed to have been waived by
Matritech.
4.9 In
the
event of any Product failing to comply with the warranty set forth in clause
4.1
above, Matritech shall have the option of requiring Inverness to provide
replacement Product manufactured by Inverness or the applicable Approved Custom
Manufacturer or to issue a credit for the amount of the Product supplied which
did not meet such warranty. In addition, Inverness shall pay Matritech the
reasonable cost of the Matritech Raw Materials which were incorporated into
the
rejected Product and the cost of all shipping, insurance and other charges
incurred by Matritech in connection with the transport of the Product failing
to
comply with the warranty set forth in clause 4.1 from Inverness or the
applicable Approved Custom Manufacturer to the Receiving Point. Matritech shall
notify Inverness and the applicable Approved Custom Manufacturer in Writing
of
its decision on whether it has elected either delivery of replacement Product
or
a credit within five (5) Business Days of notifying Inverness and the applicable
Approved Custom Manufacturer of the failure of any Product to comply with the
warranty set forth in clause 4.1 above.
4.10 Except
as
set forth in clauses 9.1, and this clause 4.10, Inverness’ and any Approved
Customer Manufacturer’s only liability in respect of Product that does not
comply with the warranty set forth in clause 4.1 above, or which is subject
to a
Recall as a result of the Product not conforming to this Specification or
applicable U.S. FDA regulations shall be set forth in clause 4.9 above.
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4.11 The
Parties acknowledge and agree that in the event any problems occur with either
the Matritech Raw Materials or the applicable Inverness/Approved Custom
Manufacturer Raw Materials, Matritech will work with Inverness or the applicable
Approved Custom Manufacturer and Inverness will, or will cause the applicable
Approved Custom Manufacturer to, work with Matritech to attempt to troubleshoot
any problems and in doing so such parties will act reasonably and in good faith.
The time to troubleshoot any problems will be at least thirty (30) days unless
the Parties agree to the contrary and during that 30 day period, no Party shall
argue that the other is in breach of the terms of this Agreement.
4.12 Matritech
will assist each Inverness and Approved Custom Manufacturer in defining
processes and procedures necessary to ensure compliance with all FDA
requirements for Good Manufacturing Practices. Inverness will, or will cause
each Approved Custom Manufacturer to, maintain a complete device history file
as
well as the records identified by Matritech including information regarding
quantities, lot numbers and shipping data for at least two years beyond the
expiration date of the Product. Inverness will deliver copies of all records
that are not, or are not deemed by the Approved Custom Manufacturer to be,
confidential for inclusion in a duplicate device history record.
4.13 Matritech
shall, from time to time during the period of manufacture of the Products and
at
the reasonable request of Inverness, consult with Inverness and any applicable
Approved Custom Manufacturer with respect to the process of manufacture of
the
Product.
4.14 Each
of
the Parties shall make available to the other Party and each Approved Custom
Manufacturer a senior manager who shall be responsible for liaising in
connection with the manufacture of the Product. Inverness shall cause each
Approved Custom Manufacturer to make available to Matritech a senior manager
who
shall be responsible for liaising in connection with the manufacture of the
Product.
4.15 EXCEPT
AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, INVERNESS MAKES NO OTHER
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS AND HEREBY
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, INCLUDING, WITHOUT
LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.
5.0 Manufacture
and Delivery of Products
5.1 Inverness
shall, or shall cause the applicable Approved Custom Manufacturer to, use
commercially reasonable efforts to manufacture sufficient stocks of the Products
to fulfil Inverness’ obligations under this Agreement.
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5.2 Matritech
shall provide Inverness or the applicable Approved Custom Manufacturer with
the
Matritech Raw Materials free of charge, and Inverness or the applicable Approved
Custom Manufacturer shall provide the Inverness/Approved Custom Manufacturer
Raw
Materials as part of the Price set forth in Schedule 2 hereof.
5.3 Inverness
shall, or shall cause the applicable Approved Custom Manufacturer to, arrange
for transport and insurance coverage of the Product from the premises of
Inverness or such applicable Approved Custom Manufacturer to the Receiving
Point
in accordance with the shipping method, carrier and other details, if any,
specified by Matritech. The costs of transport and insurance shall be included
in the price, except as provided in clause 4.9 hereof.
5.4 Title
to and
risk of loss of the Products shall pass from Inverness to Matritech once the
Products reach the Receiving Point. The Receiving Points shall be as set forth
on Schedule 8 hereof, which may be amended by mutual written agreement of the
Parties.
6.0 Product
Improvements; Modifications; Changes
6.1 Inverness
shall, or shall cause each Approved Custom Manufacturer to, promptly disclose
to
Matritech any Product Improvements developed in the course of Inverness or
such
Approved Custom Manufacturer’s manufacture of the Products. Matritech shall have
the right to submit a Written request to change the Specification to incorporate
the Product Improvements into the Product.
6.2 Whether
or not a Product Improvement exists, Matritech shall have the right to request
a
change to the Specification or to create a separate new Specification to be
applicable to some Products to be manufactured under the Agreement (each, a
“Change”). If Inverness agrees to proceed with the requested Change, the Change
will only be processed in accordance with a time frame agreed upon in Writing
and in advance by Inverness and Matritech.
6.3 The
Parties agree that, in the event Matritech requests a Change for any reason,
and
provided that Inverness agrees in Writing to proceed with such Change, the
Parties shall cooperate in good faith to attempt to mutually determine an
appropriate Price adjustment which will, when negotiated, be memorialized in
a
revised Schedule 2. Matritech shall be responsible for all such Price
adjustments resulting from each Change and for obtaining any regulatory
approvals that may be required as a result of each Change.
6.4 In
the
event of a Change, Matritech may require Inverness to, or to cause the Approved
Custom Manufacturer to, perform validation pilots prior to beginning production
of the revised Product. Notwithstanding the foregoing to the contrary, Inverness
shall not be required to, or to cause the Approved Custom Manufacturer to,
perform validation pilots of the revised Product until such time as the Parties
mutually agree in Writing on an equitable price for (a) Inverness’ or the
Approved Custom Manufacturer’s work on the pilots, taking into consideration
that the Product will not be
12
resold
by
Matritech, and (b) any resulting Product which may be ordered and manufactured
following successful completion of the validation pilots.
7.0 Price
of the Products
7.1 Subject
to the following provisions of this Section 7.0, the Price for each of the
Products paid by Matritech to Inverness shall be the Price reflected in or
calculated in accordance with Schedule 2. Inverness reserves the right to
increase prices once per year, at the beginning of each calendar year after
2007, with 30 days written notice. Price increases will be limited to no more
than [ ** ] or the percentage annual increase in PPI for in-vitro diagnostic
products for the immediately preceding calendar year period, which ever is
greater. Inverness owns or has a license to the Inverness Patents. Certain
Valid
Claims of the Inverness Patents may cover the Products. The Inverness Patents
are not being licensed to Matritech. The Price contemplates the existence of
the
Inverness Patents. Inverness and its Affiliates shall not xxx or otherwise
assert any claim or counterclaim against Matritech, its Affiliates, or any
of
its or their resellers, distributors or end-customers, to the extent based
on a
claim that any such person or entity, with respect to such person’s or entity’s
use, distribution or sale of Products prior to the Effective Date, infringed
upon any Inverness Patent.
7.2 The
Price
for the Products shall be inclusive of any costs of shipping packaging, carriage
and insurance of the Products.
7.3 Inverness
shall invoice Matritech by the 14th
(fourteenth) day of each month for the Price in respect of all deliveries of
the
Products made under this Agreement during the previous month, and Matritech
shall pay all undisputed sums for Products complying with the terms of this
Agreement in cleared funds to the bank nominated by Inverness within 30 (thirty)
days from the date on which each invoice is submitted by Inverness. If Matritech
is entitled to a credit under clause 4.9 above or Schedule 2 hereof, it may
apply the credit to amounts due from it to Inverness under this Agreement.
7.4 If
Matritech fails to pay any undisputed sum on the due date, then without
prejudice to clause 16.2:
| 7.4.1 |
the
unpaid amount shall bear interest from the due date until payment
is made
in full, both before and after any judgment, at [ ** ] per cent per
annum
over the rate quoted in the Wall Street Journal from time to time;
and
|
| 7.4.2 |
Inverness
shall be entitled to suspend deliveries of the Products until the
outstanding amount has been received by Inverness from
Matritech.
|
7.5 If
Matritech disputes the amount of any invoice received from Inverness, it shall
provide Inverness with Written notice of the dispute within ten (10) Business
Days of receipt of the invoice. The Parties agree that they shall diligently
attempt, in good
13
faith,
to
expeditiously resolve any dispute regarding the correct amount of the invoice.
If the dispute is not resolved within 30 days, any Party may resort to
appropriate dispute resolution processes.
8.0 Intellectual
Property and Trademarks
8.1 The
Parties agree that ownership of the Matritech Technology shall remain with
Matritech.
8.2 The
Parties acknowledge and agree that all Product Improvements shall be owned
by
Matritech. Inverness agrees to assign and does hereby assign the Product
Improvements along with all Intellectual Property in and to such Product
Improvements to Matritech. Inverness shall require all Approved Contract
Manufacturers contributing to the development of the Product Improvements to
have executed written instruments with Inverness, assigning all right title
and
interest in and to the Product Improvements and the Intellectual Property in
and
to such Product Improvements to Inverness.
8.3 Matritech
hereby grants, and will grant, to Inverness and any Approved Custom Manufacturer
non-exclusive, fully paid up, royalty-free license, under all of Matritech’s
Intellectual Property in, to and/or covering the Products and/or Product
Improvements, to perform all obligations under this Agreement.
8.4 Matritech
authorizes Inverness and any Approved Custom Manufacturer (as a subcontractor
of
Inverness) to apply the Trademarks listed in Schedule 4 to the Products for
the
purposes of performing its obligations under this Agreement.
8.5 Inverness
will provide Written notice to Matritech within five Business Days after any
loss of Inverness Patent rights by Inverness. Inverness agrees to provide
Matritech with prompt Written notice of the occurrence of any event that may
give rise to termination of any of rights of Inverness under the Inverness
Patent, as well as Written notice of any receipt by Inverness of paperwork
purporting to terminate any of its rights under the Inverness Patents.
9.0 Liability
and Indemnification
9.1 Inverness
shall indemnify and hold Matritech harmless from and against any and all third
party suits, actions, losses, obligations, deficiencies, liabilities, claims,
damages, cost and expense (including court costs and reasonable attorney fees)
(collectively, “Claims”) which arise out of, are caused by, relate to or result
or occur from or in connection with (a) the failure of any Product manufactured
by Inverness or an Approved Custom Manufacturer to comply with the warranty
set
forth in clause 4.1 above or (b) a claim that the manufacturing processes of
Inverness or any Approved Custom Manufacturer infringes or misappropriates
the
Intellectual Property of a third party. For purposes of clarity, a third party
is a party other than Inverness and Matritech.
14
9.2 Except
for liability which is contemplated by Section 9.1, Matritech agrees to
indemnify and hold Inverness and each Approved Custom Manufacturer harmless
from
and against any and all Claims which arise out of, are caused by, relate to
or
result or occur from or in connection with any and all Products and components
thereof, including, without limitation, all Biologicals, including without
limitation, Claims which arise out of, are caused by, relate to or result or
occur from or in connection with (i) the use and/or sale of the Products; and
(ii) any allegation that the Products infringe the Intellectual Property Rights
of a Third Party (except to the extent that such allegations concern a Claim
for
which Matritech is entitled to indemnification pursuant to clause 9.1)
9.3 If
a
Claim is made against either Party hereto and the Party against whom said Claim
is made intends to seek indemnification with respect thereto as set forth in
this Section 9.0, the indemnitee will promptly give Written notice to the
indemnifying Party of such Claim.
9.4 An
indemnifying Party may, but shall not be obligated to, take charge of the
defense (including any settlements) of such a Claim, provided however that
(a)
the indemnifying Party shall keep indemnitee informed of, and consult with
indemnitee in connection with the progress of such claim or settlement, (b)
the
indemnitee shall have the right to participate in such Claim or settlement
thereof with counsel selected by indemnitee at indemnitee’s expense and (c) the
indemnifying Party shall not have any right, without indemnitee’s Written
consent, to settle any such claim if such settlement would adversely affect
indemnitee.
10.0 Disclaimer
of Damages.
EXCEPT
FOR LIABILITY ARISING UNDER SECTION 9 ABOVE, NO PARTY SHALL BE LIABLE TO ANOTHER
PARTY UNDER THIS AGREEMENT FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTIAL, MULTIPLE
OR PUNITIVE DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER
OR
NOT FOR BREACH OF CONTRACT, NEGLIGENCE OR OTHERWISE AND WHETHER OR NOT THE
OTHER
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. THESE LIMITATIONS
SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED
REMEDY PROVIDED IN THIS AGREEMENT.
11.0 Recalls
11.1 Inverness
shall, and shall cause each Approved Custom Manufacturer to, comply and assist
with any Recall initiated by Matritech. Inverness may not initiate a Recall
if
Matritech objects to such Recall, except to the extent, in the reasonable
opinion of Inverness’ lawyers, Inverness is required to do so by applicable law
and/or regulatory requirements. Matritech shall comply and assist with any
such
Recalls initiated by Inverness. Except for where Inverness initiates a Recall
due to legal or regulatory requirements as described above, Matritech shall
have
sole responsibility for managing any Recall of the Product, provided that
Matritech shall consult with Inverness prior to initiating any Recall.
15
11.2 Except
as
required by applicable law and/or regulatory requirements, all communications
made in connection with any Recall shall come solely from Matritech, provided
that Matritech shall consult with Inverness prior to sending such a
communication and shall obtain Inverness’ Written acknowledgement prior to
dispatching the communication. In the case of any permitted communications
by
Inverness in connection with any Recall, Inverness will not send any such
communication without Matritech’s prior Written consent.
11.3 Upon
receiving from any authority having jurisdiction any direction to Recall any
Product from the market, the receiving Party shall immediately notify the other
Party in accordance with the terms hereof.
11.4 The
cost
of implementing any Recall shall be borne by Matritech except as provided in
clause 4.10 hereof.
12.0 Regulatory
Approval
12.1 As
among
the Parties, Matritech is solely responsible for obtaining regulatory approvals
and registrations of the Product in all regulatory jurisdictions in which the
Products are intended to be marketed and Matritech shall be the sole owner
of
such approvals and registrations.
12.2 Inverness
shall, and shall cause the Approved Custom Manufacturer to, provide Matritech
or, at the request of Matritech, any regulatory authority with any
documentation, data and other information relating to the Products that may
be
necessary for Matritech’s regulatory approval and maintenance efforts with
respect to the marketing of the Products. Matritech shall cooperate with
Inverness and any Approved Custom Manufacturer with respect to the submission
of
any such documentation, data and other information to any regulatory
authority.
13.0 Confidentiality
13.1 Except
in
accordance with the terms of this Agreement, neither Party shall, either during
the period of this Agreement or at any subsequent time, disclose to any other
person any Identified Confidential Information disclosed to it by the other
Party under this Agreement, and each Party shall use commercially reasonable
efforts, and in any event at least as rigorous as those it uses to protect
its
own confidential information, to keep the other Party’s Identified Confidential
Information confidential. In addition, Inverness shall cause each Approved
Custom Manufacturer to keep confidential and to refrain from disclosing any
Matritech Identified Confidential Information. Any Identified Confidential
Information of an Approved Custom Manufacturer shall be deemed Inverness’
Identified Confidential Information.
13.2 The
Identified Confidential Information of a disclosing Party may be disclosed
to:
16
| 13.2.1 |
any
employees of the receiving Party and any Affiliates of the receiving
Party
in question, or
|
| 13.2.2 |
any
governmental or other authority or regulatory body,
or
|
| 13.2.3 |
in
the case of disclosure of Matritech Identified Confidential Information
by
Inverness, any Approved Custom
Manufacturer,
|
but
only
to the extent necessary for the purposes of this Agreement or as required by
law, and subject in the case of disclosure under clause 13.2.1 and 13.2.3 to
the
Party in question first obtaining a Written undertaking from the entity to
whom
the disclosure is made to be bound to maintain the confidentiality of the
Information on terms at least as strict as the terms of this Agreement.
13.3 No
Party
shall use the name of another Party in any publication, press release or
advertising without the prior Written consent of the Party to be named.
Notwithstanding the foregoing sentence, any Party may make such regulatory
filings (and include such information therein) as it deems necessary or
appropriate to comply with stock exchange or Securities and Exchange Commission
rules and regulations or to comply with any court order or law.
14.0 Technology
Transfer
14.1 At
any
time during the term of this Agreement and upon the termination of this
Agreement for any reason, Inverness will at Matritech’s request (a) transfer, or
cause the applicable Approved Custom Manufacturer to undertake a transfer of,
the Product Improvements either to Matritech or to such third party as Matritech
shall specify and (b) use commercially reasonable efforts to, or cause the
applicable Approved Custom Manufacturer to use commercially reasonable efforts
to, promptly and accurately transfer the Product Improvements.
14.2 There
shall be no Technology transfer fee applicable to any transfer of the Product
Improvements, but Inverness, for itself or the applicable Approved Custom
Manufacturer, may request from Matritech reasonable compensation for the time
expended by its operations and/or technical personnel in undertaking the
transfer. If Inverness does request such reasonable compensation, Matritech
agrees to negotiate in good faith with Inverness to determine the amount of
such
compensation to be paid.
15.0 Force
Majeure
15.1 If
either
Party is affected by any Force Majeure circumstance, it shall promptly notify
the other Party of the nature and extent of the circumstance in
question.
15.2 Notwithstanding
any other provision of this Agreement, neither Party shall be deemed to be
in
breach of this Agreement, or otherwise be liable to the other Party, for
17
any
delay
in performance or the non-performance of any of its obligations under this
Agreement, to the extent that the delay or non-performance is due to any Force
Majeure circumstance of which it has notified the other Party, and the time
for
performance of that obligation shall be extended accordingly.
15.3 If
the
Force Majeure circumstance in question prevails for a continuous period in
excess of 30 days, the Parties shall enter into bona fide discussions with
a
view to alleviating its effects, or to agreeing on such alternative arrangements
as may be fair and reasonable. If no mutually satisfactory arrangement is agreed
upon within 15 days, either Party shall have the right to terminate this
Agreement. In the case of Inverness as a manufacturer, if the Force Majeure
circumstance is preventing Matritech from obtaining Product, Matritech shall
have the right to request that Inverness request that Inverness use an Approved
Custom Manufacturer for such manufacture. In the case of an Approved Custom
Manufacturer as a manufacturer, if the Force Majeure circumstance is preventing
Matritech from obtaining Product manufactured by a specific Approved Custom
Manufacturer, Matritech shall have the right to request that Inverness remove
that entity from the status of Approved Custom Manufacturer under this Agreement
and the right to request that Inverness substitute a different Approved Custom
Manufacturer. Inverness shall evaluate any such request, however, the ultimate
designation of an Approved Custom Manufacturer for each order and any
substitutions thereof shall be at the sole discretion of Inverness.
16.0 Duration
and Termination
16.1 This
Agreement shall come into force immediately on the Effective Date and, subject
to the following provisions of this Section 16.0, shall continue in force for
a
period of five (5) years. Thereafter, the Agreement shall renew automatically
for additional one (1) year periods, unless or until terminated by either Party
giving to the other Party at any time not less two hundred and seventy (270)
days Written notice to expire on or at any time after the end of the initial
period and/or applicable renewal period.
16.2 Inverness
shall be entitled forthwith to terminate this Agreement by giving Written notice
to the other Party if:
| 16.2.1 |
Matritech
commits any material breach of any of the provisions of this Agreement
and, in the case of such a breach which is capable of remedy, fails
to
remedy the breach within thirty (30) days after receipt of a Written
notice giving full particulars of the breach and requiring it to
be
remedied. In the case of such a breach which is not capable of remedy,
there will be no opportunity to remedy and this Agreement will terminate
upon receipt of such Written
notice;
|
| 16.2.2 |
Matritech
commits any breach of clause 3.10
above;
|
18
| 16.2.3 |
Matritech
shall be adjudicated bankrupt, goes into receivership or trusteeship,
makes a voluntary arrangement with its creditors or enters into any
similar proceeding of the same
nature;
|
| 16.2.4 |
Matritech
goes into liquidation (except for the purposes of an amalgamation,
reconstruction or other reorganization and in such manner that the
company
resulting from the reorganization effectively agrees to be bound
by or to
assume the obligations imposed on Matritech under this Agreement);
or
|
| 16.2.5 |
Matritech
ceases, or threatens to cease, to carry on
business.
|
16.3 Matritech
shall be entitled forthwith to terminate this Agreement by giving Written notice
to the other Party if:
| 16.3.1 |
Inverness
commits any material breach of any of the provisions of this Agreement
and, in the case of such a breach which is capable of remedy, fails
to
remedy the breach within thirty (30) days after receipt of a Written
notice giving full particulars of the breach and requiring it to
be
remedied. In the case of such a breach which is not capable of remedy,
there will be no opportunity to remedy and this Agreement will terminate
upon receipt of such Written
notice;
|
| 16.3.2 |
Inverness
shall be adjudicated bankrupt, goes into receivership or trusteeship,
makes a voluntary arrangement with its creditors or enters into any
similar proceeding of the same
nature;
|
| 16.3.3 |
Inverness
goes into liquidation (except for the purposes of an amalgamation,
reconstruction or other reorganization and in such manner that the
company
resulting from the reorganization effectively agrees to be bound
by or to
assume the obligations imposed on Inverness under this Agreement);
|
| 16.3.4 |
Inverness
ceases, or threatens to cease, to carry on business;
or
|
| 16.3.5 |
Inverness
loses rights to any of the Inverness
Patents.
|
16.4 As
an
alternative to termination of this Agreement in the event an Approved Custom
Manufacturer is the cause of the conduct that gives grounds for termination
under clauses 16.3.1 above, Matritech shall have the option of terminating
the
status of that Approved Custom Manufacturer and requesting the substitution
of
another Approved Custom Manufacturer in its place.
16.5 Any
waiver by either Party of a breach of any provision of this Agreement shall
not
be considered as a waiver of any subsequent breach of the same or any other
provision.
19
16.6 The
rights to terminate this Agreement given by this Section 16.0 shall not
prejudice any other right or remedy of either Party in respect of the breach
concerned (if any) or any other breach.
16.7 On
the
termination of this Agreement for any reason, Inverness shall, and if an
Approved Custom Manufacturer is manufacturing the applicable Product, shall
cause the applicable Approved Custom Manufacturer to:
|
16.8.1
|
cease
to manufacture the Products;
|
|
16.8.2
|
cease
to use any of the Trademarks;
|
|
16.8.3
|
destroy
any tangible copies of Matritech’s Identified Confidential Information;
and
|
|
16.8.4
|
promptly
return to Matritech all unused Matritech Raw
Materials.
|
16.9 On
the
termination of this Agreement for any reason, Inverness shall destroy any
tangible copies of the Matritech’s Identified Confidential
Information.
16.10 On
the
termination of this Agreement for any reason, Matritech shall destroy any
tangible copies of Inverness’ Identified Confidential
Information.
16.11 The
provisions of 4, 8, 9, 10, 13, 17, and 18 shall continue in force in accordance
with their terms, notwithstanding termination of this Agreement for any
reason.
17.0 Notices
and Service
17.1 Any
notice required or authorized by this Agreement may be given by hand delivery;
sent by certified or registered mail, return receipt requested; by facsimile
transmission providing a confirmation of transmission, or sent by an
internationally recognized courier service.
17.2 Any
notice delivered in hand shall be deemed given on the date of delivery. A notice
given by certified or registered mail which is not returned to the sender as
undelivered shall be deemed to have been given on the earlier of the date
reflected for delivery on the signed return receipt or the fifth day after
the
envelope containing it was so posted if the return receipt is undated. A notice
given by facsimile transmission shall be deemed given on the business day on
which the transmission was sent if the confirmation reflects that it was
successfully transmitted on or before 5:30 p.m. at the place of delivery (e.g.
Wales or Massachusetts) on a business day at the place of delivery, or otherwise
it shall be deemed delivered on the next business day. A notice given by
internationally recognized courier service shall be deemed given on the second
business day after depositing with the courier service.
20
17.3 All
notices concerning or arising out of this Agreement shall be addressed to the
Parties as follows:
| If to Matritech: |
Matritech,
Inc.
|
000
Xxxxxx Xxxxxx
Xxxxxx,
XX 00000 XXX
Attn.:
President
(000)
000-0000 (facsimile)
| If to Inverness: |
Inverness
Medical Innovations, Inc.
|
00
Xxxxxx
Xxxx, Xxxxx 000
Xxxxxxx,
XX 00000
Attn:
General Counsel’s office
(000)
000
0000 (facsimile)
or
to
such other officer at such other address as may be specified from time to time
by notice complying with the provisions hereof.
18.0 Miscellaneous
18.1 This
Agreement is personal to the Parties and neither of them may, without the
Written consent of the other, assign or transfer any of its rights, or
sub-contract or otherwise delegate (other than as provided herein with respect
to Approved Custom Manufacturers) any of its obligations, under this Agreement;
provided, however, that a Party may assign this Agreement to an entity or person
who acquires all or substantially all of its business (or segment, such as
Matritech’s NMP22 product line) by merger, sale of assets or otherwise.
Notwithstanding the foregoing, Matritech may not assign this Agreement to any
competitor of Inverness that sells bladder cancer detection products without
the
prior Written consent of Inverness, which consent may be withheld by Inverness
in its sole discretion. Any attempted assignment, delegation or transfer by
a
Party in violation hereof shall be null and void. Subject to the foregoing,
this
Agreement shall be binding on the parties and their successors and assigns.
18.2 The
relationship between the Parties established by this Agreement is that of
independent contractors, and nothing contained in this Agreement shall be
construed to (i) give either Party the power to direct and control the
day-to-day activities of the other Party, (ii) create a franchise, partnership,
agency, joint venture or employment relationship between the Parties, or (iii)
allow a Party to create or assume any obligation on behalf of the other Party
for any purpose whatsoever.
18.3 This
Agreement contains the entire agreement between the Parties with respect to
the
subject matter hereof, supersedes all previous agreements and undertakings
between the Parties, and may not be modified except by an instrument in Writing
signed by the duly authorized representatives of the Parties.
21
18.4 The
headings in this Agreement are for convenience only and shall not affect its
interpretation.
18.5 This
Agreement may be executed in two or more counterparts, each of which shall
be
deemed an original, but all of which together shall constitute one and the
same
instrument. This Agreement and any amendment or notice required or permitted
by
this Agreement, may also be executed via facsimile, which shall be deemed an
original.
18.6 If
any
provision of this Agreement is held by any court or other competent authority
to
be void or unenforceable in whole or part, the other provisions of this
Agreement and the remainder of the affected provisions shall continue to be
valid and enforceable.
18.7 This
Agreement shall be governed by and construed in all respects in accordance
with
the laws of the Commonwealth of Massachusetts without giving effect to its
conflicts of law principles. Each of the Parties consents to venue and
jurisdiction in any court of competent jurisdiction sitting within the
Commonwealth of Massachusetts.
In
witness whereof, the Parties hereto have executed this Agreement as of the
date
first above Written.
| Inverness Medical Innovations, Inc. | Matritech, Inc. |
| By: /s/ Xxx Xxxxxxxxx | By: /s/ Xxxxxxx X. Xxxxx |
| Its: CEO | Its: CEO |
| By: __/s/ Xxxx Warner___________ | |
| Its _ Asst. Sec’y____________ __ |
22
List
of Schedules
Schedule
1 - Inverness Patents
Schedule
2 - Price
Schedule
3 - Specification
Schedule
4 - Trade Marks
Schedule
5 - Matritech Raw Materials
Schedule
6 - Approved Custom Manufacturers
Schedule
7 - Products
Schedule
8 - Receiving Points
23
Schedule
1
Inverness
Patents
[
** ]
24
Schedule
2
Price
$[
** ]
per test, with devices packaged 24 to a box with 3-10 boxes per carton
25
Schedule
3
Specification
Schedule
3 - NMP22® BladderChek® Test Specification
| 1. |
Purpose
|
This
Specification is written to ensure the quality of the Matritech NMP22®
BladderChek® Test (Product) purchased from Inverness Medical and to ensure the
Product’s suitability for its intended xxx.xx described in its labeling. All
Product must conform to the Specification and all applicable US and foreign
regulations.
| 2. |
Definitions
|
| Test: |
Each
test consists of one test cassette, one transfer pipet, and one desiccant
pack sealed in a foil pouch.
|
| Test kit: |
Each
test kit consists of 24 BladderChek® Tests packed in a labeled
carton
with IFU and reorder reminder (2, non-CE, only).
|
In
achieving all specifications set forth below, the manufacturer must follow
and
conform to all procedures provided by Matritech, Inc. and must utilize the
materials and components provided and/or specified and approved by Matritech,
Inc.
[
** ]
| 7. |
Packing
and Shipping
|
| 7.1 |
Test
kits must be packaged in shippers so as to minimize product
damage. Shippers
must be received at the specified Receiving Point with no damage
to
the Product.
|
| 7.2 |
Product
must be shipped at [ ** ]°C to arrive at the specified Receiving Point
in
no more than [ ** ] calendar days.
|
| 8. |
Other
|
| 8.1 |
A
copy of the completed device history records must accompany the shipment
or
|
26
|
be
faxed or emailed separately if the shipment is intended for a Receiving
Point other
than Matritech, Newton, MA.
|
27
Schedule
4
Trade
Marks
Matritech
NMP22
BladderChek
NMP22
BladderChek
28
Schedule
5
Matritech
Raw Materials*
Test
line
antibody
Gold
conjugate
*Unless
provided by Inverness or an Approved Custom Manufacturer at the time of
execution of this agreement
29
Schedule
6
Approved
Custom Manufacturers
British
Biocell International Limited
Xxxxxx
Xxxx
Xx
Xxxx
Xxxxxx
Xxxxxxx,
XX00 0XX
Unotech
Diagnostics, Inc.
0000
Xxxxxxxxx Xxxxxx, Xxxxx 000
Xxx
Xxxxxxx, XX 00000
All
manufacturing subsidiaries of Inverness, including without limitation those
currently located in Bedford UK; Hangzhou, China; and Shanghai, China.
30
Schedule
7
Products
NMP22
BladderChek Test
31
Schedule
0
Xxxxxxxxx
Xxxxxx
Xxxxxxxxx,
Xxx., Xxxxxx, XX
Matritech
GmbH, Freiburg, Germany
32
