CONTRACT MANUFACTURING AGREEMENT
Exhibit
10.2
The undersigned,
Medtech
Products Inc., a
company organized and existing under the laws of the State of Delaware, USA,
having its principal place of business at 00 Xxxxx Xxxxxxxx, Xxxxxxxxx, Xxx
Xxxx
00000, together with any affiliate thereof, hereinafter called “Medtech”;
And
PHARMASPRAY
B.V., a
company organised and existing under the laws of the Netherlands, having its
domicile at Xxxxxxxxxxx 00 (0000 ML) Veendam, hereinafter called “Pharmaspray”.
Sometimes
hereinafter
jointly referred to as the “Parties”
or separately as the “Party”.
WHEREAS:
A.
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Medtech
is the owner
of all Intellectual Property Rights relating to the Product (as defined
in
Clause 1) for the USA, Canada and
certain other countries and
is to be considered the Specification Holder of the
Product;
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B.
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Pharmaspray
is an
aerosol manufacturer filling aerosol cans with cosmetic and medical
products;
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C.
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The
Products sold by
Medtech are subject to ISO-13485 Standard and GMP 820
standard;
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D.
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Pharmaspray
operates
in accordance with ISO-9001:2000
Standard;
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E.
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The
Parties wish to
(co)operate in accordance with ISO-13485 Standard, ISO-9001:2000
Standard,
the Quality Manual (as defined in Clause 1) and the instructions
of
Medtech as specified in the Schedule(s) which form part of this Agreement;
and
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F.
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The
Parties now wish
to formalize this Agreement as a “Turn-Key Agreement” in which they will
include all their agreements with respect to the Procurement Services,
Production Services, Packaging Services, Logistic Services and other
services provided by Pharmaspray to
Medtech.
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NOW
THEREFORE THE PARTIES AGREE AS FOLLOWS:
1.
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Definitions
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1.1.
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The
term “Acceptance
of the Materials” shall mean the point in time at which the Materials (as
defined hereafter) are physically handed over to or become under
the
control and care of Pharmaspray in order to manufacture and package
the
Products.
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1.2.
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The
term “Agreement”
shall mean this document including the Quality Manual and all (further)
Schedules and annexes hereto and thereto, each as amended from time
to
time by the Parties upon mutual written
agreement.
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1.3.
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The
term
“Commencement Date” shall mean October 5,
2007.
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1.4.
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The
term "Delivery
of the Products" shall mean the point in time at which the Products
(as
defined hereafter) are delivered to Medtech or the designated agent
or
distributor of Medtech. Unless otherwise specified in writing, Delivery
of
Products shall occur ex works (EXW, incoterms 2000) in
Veendam.
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1.5.
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The
Term “Force
Majeure” shall mean those circumstances which are unforeseeable and beyond
the reasonable control of each of the Parties and which prevent the
total
or partial carrying out of any obligation by a party under this Agreement,
such as acts or regulations or decrees of any government (de facto
or de
jure), natural phenomena, such as earthquakes and floods, fires,
riots,
shipwrecks, freight embargoes or other circumstances whether similar
or
dissimilar to those enumerated
above.
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1.6.
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The
term
“Intellectual Property Rights” shall mean any and all intellectual
property rights, good will, know-how and other intangibles relating
to the
Product and its packaging including (but not limited to) national
and
international patents, trade name(s) and
trademark(s).
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1.7.
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The
term “Logistic
Services” shall mean all services provided by Pharmaspray as from the
beginning of the manufacture of the Product until the physical delivery
of
the Product to Medtech, Medtech's distributors, agents or other
destinations, including the storage and the arranging of
transport.
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1.8.
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The
term “Materials”
shall mean all semi fabrics, ingredients, spare parts, and packaging
material necessary to assemble the
Product.
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1.9.
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The
term "Mold"
shall mean the mold purchased by Pharmaspray from NPK Products B.V.
on or
about May 1, 2007 for use by Pharmaspray in the manufacture of the
Product.
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1.10.
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The
term “Packaging
Services” shall mean the packaging of the Product(s) (as defined
hereafter) by Pharmaspray according
to the
Quality Manual (as defined hereafter) and other specific
instructions of Medtech.
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1.11.
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The
term
“Procurement Services” shall mean the various acts of identifying,
qualifying, ordering and obtaining via Purchase Orders or other means
those Materials necessary or appropriate to the production of Products
until such Materials are physically delivered to Pharmaspray. In
performing Procurement Services, Pharmaspray shall act for its own
account
and not as agent for Medtech.
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1.12.
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The
term “Product”
shall mean a consumer product composed and/or manufactured on behalf
of
Medtech bearing the Compound W Freeze Off® or other trademarks owned by
Medtech and used for the cryogenic treatment of warts, skin tags
or other
lesions in humans, according to Medtech’s specifications as described in
Schedule
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1. | |
1.13.
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The
term “Production
Services” shall mean the manufacture of the Product, including production,
assembly, filling and labelling of the aerosol cans by Pharmaspray
as
instructed by Medtech in accordance with the terms of this Agreement
and
the Quality Manual.
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1.14.
|
The
term “Purchase
Order” shall mean a written instruction to provide the Procurement
Services, Production Services, Packaging Services and Logistics Services,
which instruction is prepared by Medtech and directed to Pharmaspray
and
includes specific instruction as to the delivery of the
Product.
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1.15.
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The
term “Quality
Manual” shall mean the Quality Agreement attached hereto as Schedule 4, as
it may be subsequently amended, revised or replaced upon mutual written
agreement.
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1.16.
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The
term “Schedule”
shall mean any schedule to this Agreement, including any amendment
thereto.
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1.17.
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The
term “Storage
Location” shall mean the warehouse located at Xxxxxxxxxxx 00 and Cereslaan
9 (9641 ML) Veendam unless otherwise agreed by the Parties in writing.
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1.18.
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The
term “Supplier”
shall mean suppliers designated or appointed by Pharmaspray, subject
to
approval by Medtech, as described – non limitative – in Schedule
2.
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1.19.
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The
term “Turn-Key
Agreement” shall mean an understanding between the Parties acknowledging
the assumption of all responsibility by Pharmaspray for
all Procurement Services, Production Services, Packaging
Services, Logistics Services and other services necessary or appropriate
to the fulfilment of Purchase Orders for the Product except as otherwise
provided in this Agreement.
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In
as far as
applicable in the context of the Agreement, terms defined in the
singular
shall include the plural and vice versa.
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2.
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Procurement,
Production, Packaging and Logistic
Services
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2.1.
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On
the terms and
conditions of the Agreement, Medtech hereby appoints Pharmaspray
and
Pharmaspray hereby accepts such appointment to provide the Procurement
Services, Production Services, Packaging Services and the Logistic
Services during the term of the Agreement in a manner befitting a
careful
contractor, excepting only as provided
herein.
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2.2.
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Without
limiting the
(general) obligations of the contracting Parties under this Agreement,
the
Parties shall provide mutual assistance and shall co-operate with
each
other and with third parties in order to ensure that the quality
of the
Procurement, Production, Packaging and Logistics Services are maintained
and that the Parties' expectations in entering into this Agreement
are
fulfilled; in particular, Pharmaspray represents that it has such
resources necessary to fulfil its obligations and that it shall be
pro-active in resolving any problems. Medtech shall
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promptly
inform Pharmaspray of all changes in its Compound W Freeze
Off® business which may impact on the performance of the Production
Services under this
Agreement.
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2.3.
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Pharmaspray
shall
provide the Procurement services, Production Services, Packaging
Services
and Logistics Services in accordance with the applicable ISO standards,
the Quality Manual and Schedules, any (other) specific instructions
of
Medtech and any further mandatory national and international
specifications, as applicable from time to
time.
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2.4.
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Medtech
will provide
Pharmaspray every month with a twelve month rolling sales forecast
for the
Products. The forecast for the three month period immediately following
the issuance of the forecast shall be converted into Purchase Orders
from
Medtech to Pharmaspray, which Purchase Orders shall be deemed
binding.
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2.5.
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If
Pharmaspray
incurs costs directly based upon Medtech’s forecast for the next three
months, and Medtech does not issue a Purchase Order related to those
costs
within six months after the applicable month, Pharmaspray may charge
such
costs to Medtech.
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2.6.
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Pharmaspray
will
source the Materials mentioned in Schedule 2 from Suppliers approved
by
Medtech. Pharmaspray will manage a minimum amount of safety stock,
with
the minimum amount to be determined by the Parties. To the
extent any safety stock agreed by the Parties and maintained by
Pharmaspray becomes obsolete due solely to the actions of Medtech,
Medtech
shall be obligated to reimburse Pharmaspray for its actual cost to
purchase such safety stock.
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2.7.
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Pharmaspray
is
responsible for the delivery of the Materials required for the manufacture
or production of the Product to Pharmaspray’s
premises.
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2.8.
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Subject
to clause
7.3 and 7.5 and the provisions of Section 9, Pharmaspray is responsible
for the compliance of the Materials with the applicable ISO standards
and
any further national and international specifications applicable
from time
to time at the moment of Acceptance of the Materials. Pharmaspray
shall
check such compliance, in as far as visually observable, at the Acceptance
of the Materials.
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2.9.
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Pharmaspray
shall
deliver the Products related to a specific written order of Medtech
to the
distributors or agents of Medtech within four (4) weeks upon such
order,
provided that Pharmaspray has received the sales forecast the specific
order is based upon, in due time.
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2.10.
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Medtech
is allowed
to conduct regularly scheduled quality audits of both the production
process and the Product at Pharmaspray’s premises at any reasonable time
after receipt of written notice from Medtech of its intent in advance.
Pharmaspray may require its representative to be present and that
such
visit is under the condition that the internal rules of Pharmaspray
or the
Storage Location are being complied with. Medtech will be responsible
for
all associated costs of such quality audits. Medtech shall have the
right
to reject Products that do not meet the Product Specifications set
forth
in Schedule 1, the Quality Manual or other specific instructions
of
Medtech. Reasonable efforts will be made to salvage usable portions
of any
batch should a sampling of Products not be in compliance with the
Product
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Specifications set forth in Schedule 1, the Quality Manual or other specific instructions of Medtech. | |
2.11.
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Pharmaspray
shall
provide Medtech with updates on its business operations as specified
in
the Quality Manual.
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2.12.
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Pharmaspray
shall
keep an adequate administration of deliveries to Medtech’s distributors or
agents. Pharmaspray shall provide copies of all shipping documents
to
Medtech in case of re-calls, whatever the cause for such re-calls
may
be.
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2.13.
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Each
Party shall,
upon execution of this Agreement, appoint one of its employees to
be a
relationship manager responsible for liaison between the
Parties. The relationship managers shall conference not less
than quarterly and meet in person not less than annually to coordinate
the
production activities, handle purchase orders, track assembly progress
and
any packaging work, movement of Product, deliveries, sales status
and the
current status of the business relationship and manage issues that
have
arisen.
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2.14.
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Conveyance
and
delivery of the Products shall occur ex works (EXW) in Veendam, unless
otherwise agreed between the Parties in
writing.
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2.15.
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Medtech
is and shall
at all times remain the owner of the Intellectual Property Rights
to the
Product in the United States, Canada and certain other countries
where it
owns Intellectual Property Rights. No license of whatever nature
in
relation to any Intellectual Property Rights is granted by Medtech
to
Pharmaspray. Pharmaspray shall have the obligation to obtain
and maintain all governmental licenses, permits or approvals necessary
to
manufacture the Product at its facility in
Veendam.
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3.
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Packaging
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3.1.
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Pharmaspray
will
package the Product according to the Quality Manual and other specific
instructions of Medtech.
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3.2.
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Pharmaspray
has
acquired the Mold as described in clause 1.9 above. The acquirement
costs
were and will be borne by
Pharmaspray.
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4.
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Transport
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4.1.
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Medtech
is
responsible for transport of delivered Products from the premises
of
Pharmaspray at Veendam to her distributors, agents or (other) final
destinations. The Parties agree that Pharmaspray shall organize this
transport under the authority of and on expense of Medtech, thus
acting as
representative of Medtech.
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4.2.
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Medtech
shall
designate the carrier(s)/transporter(s) to be involved in transportation
of delivered Products. Pharmaspray, as representative of Medtech,
will
contract these carriers/transporters; Medtech being the contractant
of the
carrier/transporter.
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4.3.
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All
costs of
transport taking place after delivery, charged to Pharmaspray, will
be
charged on to Medtech. Pharmaspray will provide Medtech with copies
of the
transport invoices the on-charging is based
upon.
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4.4.
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After
delivery (ex
works) of the Products has taken place, Pharmaspray is neither responsible
nor liable for the acts and omissions of carriers/transporters that
are
contracted by Pharmaspray on behalf of Medtech.
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Loading, stowage and discharging |
4.5.
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The
obligation of
(un)loading, stowage and discharging the Materials and/or the Products
and
the liability for any damage to and/or loss of the Materials and/or
Products caused by (un)loading, stowage and/or discharging the Materials
and/or the Products rests with Pharmaspray, until delivery of the
Products
to Medtech defined in clause 2.14.
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4.6.
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Any
stipulation,
condition, reservation or exemption as to responsibility and/or liability
of Pharmaspray for loss of and/or damage to the Materials and/or
the
Products, occurring during loading on, stowing, and subsequently
to the
discharging from the means of carriage in which the Materials and/or
the
Products are (to be) carried (before delivery to Medtech), shall
be null
and void unless with prior written consent of
Medtech.
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4.7.
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Pharmaspray
shall at
all times load, stow and discharge the Materials and the Products
in
accordance with the applicable provisions of the Quality Manual and
the
specific instructions of Medtech.
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5.
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Independent
and other Subcontractors of
Pharmaspray
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5.1.
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Pharmaspray
is
entitled to contract and instruct (independent) subcontractors and/or
auxiliary persons for the manufacturing, packaging, and storage of
the
Product, subject to the reasonable written consent of Medtech and
subject
to reasonable assurance that all confidential and proprietary information
of Medtech will be safeguarded.
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5.2.
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Pharmaspray
shall be
responsible and liable for the acts and omissions of its employees,
servants, (independent) subcontractors, agents, suppliers and other
persons whose services it uses for the performance of its obligations
under this Agreement, as if such acts and omissions were its own,
cases of
Force Majeure excepted.
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6.
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Rates,
Charges and Payment Terms
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6.1.
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All
rates, costs and
expenses with respect to the production and packaging and storage
services
shall be charged and invoiced by Pharmaspray to Medtech on a weekly
basis
and in conformity with the provisions set down in Schedule 3 regarding
the
rates and charges. The prices set out on Schedule 3 shall be fixed
prices
for the term of this Agreement; provided, however, Pharmaspray shall
be
entitled to pass on to Medtech in the first quarter of each calendar
year,
by mutual written agreement, any significant net increase in prices
charged by third parties in connection with Pharmaspray's services
provided (including any increase in prices
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for
raw
materials). In the event of a demonstrable price-increase of
one or more Materials exceeding 5%, Pharmaspray shall also during
the calendar year be entitled to pass on to Medtech this
price-increase in consultation with
Medtech.
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6.2.
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Invoices
shall be
issued and expressed in Euros and payment shall be made in Euros
to a
Dutch bank account of Pharmaspray. If, at the request of Pharmaspray,
any
costs, duties and the like involved with payment shall be paid by
Medtech
in another currency and/or a foreign bank account, the costs for
such
payment shall be borne by
Pharmaspray.
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6.3.
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Any
objections to
the invoice Medtech has received from Pharmaspray shall be made by
Medtech
in writing within sixty (60) days from the invoice date. If no objections
are made within 60 days from the invoice date, the invoice shall
be
binding on both Parties.
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6.4.
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Medtech
shall pay
the invoiced amounts within sixty (60) days counting from the invoice
date. Medtech shall only be allowed to pay at a later date with prior
written consent of Pharmaspray. If Medtech pays the invoice
within eight (8) days of the invoice date, Medtech shall be entitled
to
receive a credit equal to 3% of the total amount of the invoice,
except of
the costs of transport organized on behalf of Medtech as mentioned
in
clause 4.3
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6.5.
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Any
payment to be
made by either Party under this Agreement shall be made in
full without set-off, restriction, condition or deduction for or on
account in any counterclaim.
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6.6.
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Any
and all
outstanding payments of Medtech due to Pharmaspray shall become
immediately payable (opeisbaar)
if Medtech is declared bankrupt or in moratorium of payments, discontinues
its business or if its business is
liquidated.
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6.7.
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If
Medtech does not
pay the amount due within the agreed time, Medtech shall be legally
held
to be in default and shall be liable to pay interest equal to the
Dutch
statutory interest rate plus 4% over the entire invoice amount, commencing
on the due date of the invoice, until the actual date of payment.
Medtech
is liable to pay any and all judicial and/or extra-judicial costs
for debt
collection by Pharmaspray.
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6.8.
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To
the extent that
Product produced and delivered by Pharmaspray are for sale and use
in the
United States, Canada or anywhere else outside The Netherlands, no
VAT tax
shall be included in the invoice.
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6.9.
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The
Parties agree
that the prices, rates and charges appearing in Schedule 3 have been
established for purposes of this Agreement with mutual implicit
assumptions in cost of goods sold (“COGS”) and exchange rates between the
U.S. dollar and the Euro. To the extent that fluctuations in exchange
rates occur such that there is a variance of more than 10% in any
twelve
month period in the effective exchange rate, the Parties agree to
meet and
to negotiate in good faith to achieve an equitable and commercially
viable
accommodation. Increases in COGS not primarily related to exchange
rates
shall be subject to annual review, and to the extent reasonably applicable
shall be modulated by published cost-of-living
indexes.
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7.
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Warranties
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7.1.
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Subject
to clause
7.3 and 7.5, Pharmaspray represents and warrants that the performance
of
the Production Services shall be in compliance with the Product
Specifications set forth in Schedule 1, the Quality Manual and any
other
provisions of this Agreement, cases of Force Majeure
excepted.
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7.2.
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Subject
to clauses
7.3, Pharmaspray represents and warrants that she shall assemble
the
Products in complete and correct state and in compliance with the
Product
Specifications set forth in Schedule 1, the Quality Manual and any
other
provisions of this Agreement, cases of Force Majeure
excepted.
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7.3.
|
The
representation
and warranty mentioned in clause 7.1 and 7.2 do not apply to defects
in
the Product caused by defects in Materials delivered to Pharmaspray
by Suppliers if the Materials are accompanied by a certificate
of analysis conforming with the Specifications and all approval procedures
and criteria required by the Quality Manual are met. The representation
and warranty does not apply to texts/artwork edited or provided by
Medtech.
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7.4.
|
The
Parties
represent and warrant that, during this Agreement and after termination
and completion of this Agreement, except as may be required by judicial
process or the regulatory requirements of governmental authority
having
jurisdiction over the Parties and/or Products, they shall keep
confidential any information whatsoever regarding the Materials,
the
Products, the contents of this Agreement, and the Quality Manual
and
Schedules and not provide any third party with such confidential
information unless with prior written consent of the other
Party.
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7.5.
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The
Parties agree
that the existing design of the Product is the responsibility of
Medtech
as specification holder. The responsibility of Pharmaspray is to
insure
that production of the Product is in all respects in conformance
with
specifications and applicable regulatory requirements. The warranties
of
Pharmaspray shall be viewed in all respects as limited by this Section
7.5.
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8. | Insurance |
8.1
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Both
Parties shall
on request provide the other Party with periodic evidence of satisfactory
product liability insurance coverage for the
Products.
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9.
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Liability
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9.1.
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Pharmaspray
shall be
liable for any and all damages and costs suffered by Medtech as a
consequence of Pharmaspray's non-performance (“tekortkoming
in de nakoming”) of its obligations under the Agreement, including
but not limited to the warranties granted by Pharmaspray pursuant
to
clause 7.1 and 7.2 of this Agreement, cases of Force Majeure excepted.
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9.2.
|
Except
as set forth
in Section 7.5, Pharmaspray shall be responsible for damage, defects,
non-delivery or late delivery caused by Materials from Suppliers.
Notwithstanding the foregoing, Pharmaspray is not liable for damage,
defects, non-delivery or late delivery caused by the design of the
Product, the formula(s), the package or instructions, prescribed
by
Medtech and/or shortcomings caused by Medtech.
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9.3.
|
As
to arranging for
transport of Products on behalf of Medtech after delivery ex works
has
taken place, Pharmaspray is only liable for her own acts and omissions;
Pharmaspray is not to be considered the insurance carrier or shipper.
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9.4.
|
The
Parties agree
that Pharmaspray’s liability is in any case limited to the greater of (1)
the invoiced value of the Products for that specific order; or (2)
the
maximum amount Pharmaspray’s insurance company will compensate for in that
particular case provided that Pharmaspray has arranged and maintained
for
sufficient insurance coverage or could reasonably expected to arrange
for,
and maintain a certain level of insurance coverage, considering the
standard practice in the industry, in accordance with this Agreement.
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9.5.
|
Only
Medtech shall
be responsible and liable for the content of artwork, consumer
instructions and label copy. Pharmaspray is not responsible or liable
for
the content of consumer instructions, artwork and label copies and
any
(other) texts on the Products, including the Product package. Pharmaspray
shall only be responsible for assuring that only artwork provided
by or
approved by Medtech is accurately utilized.
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9.6.
|
Medtech
shall be
liable for any and all material damages and costs suffered by Pharmaspray
as a consequence of a defect (or defects) in Materials delivered
by
Medtech or defect(s) in texts/artwork edited or provided by Medtech.
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9.7.
|
Neither
of the
Parties shall be liable in case of Force Majeure.
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9.8.
|
Claims
of either
party against the other expire in accordance with the provisions
of the
Dutch Civil Code. Shorter expiration dates are not valid, unless
with
prior written consent of the other Party.
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10. | Indemnifications |
10.1.
|
Subject
to the
provisions of Sections 7.3, 7.5 and 9, Pharmaspray will hold harmless
and
indemnify Medtech from and in regard to any and all claims by third
parties in connection to the performance by Pharmaspray of the production
and packaging services such as, but not limited to, claims originating
from defectiveness of the Products and/or the Materials required
for the
Products and the production process, cases of Force Majeure excepted.
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10.2.
|
Medtech
will hold
harmless and indemnify Pharmaspray from and in regard to any and
all
claims by third parties other than Suppliers, originating from
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|
1. |
defects
in the
texts/artwork edited, approved or provided by Medtech, or
|
|
2. |
the
design of the
Product, formula(s), component parts packaging or instructions provided,
prescribed or designed by Medtech or Medtech’s predecessors in interest.
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11. | Exclusivity |
11.1.
|
During
the term of
this Agreement, Pharmaspray shall not provide any services whatsoever
to
third parties in relation to aerosol products similar to or in any
way
competing with the Product in the United States, Canada and Mexico.
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11.2.
|
During
the term of
this Agreement, Medtech shall purchase the Product only and exclusively
from Pharmaspray.
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12. | Duration and Termination |
12.1.
|
This
Agreement shall
become effective for an initial period of three years, starting from
the
Commencement Date. This Agreement may be renewed for additional three
year
periods upon the mutual written consent of the Parties no later than
six
months prior to the then applicable expiration date.
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12.2.
|
Each
of the Parties
has the right to terminate this Agreement with immediate effect by
giving
written notice if any of the following events shall occur:
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|
a.
|
the
other party
breaches any of the terms of this Agreement and fails to remedy such
breach within thirty (30) days after written notice requiring to
do so,
unless such breach or failure does not justify this with its consequences
in view of its minor importance;
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b.
|
the
other party
files a petition for moratorium of payments with the competent court
or is
granted a moratorium of payments;
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c.
|
the
other party
files a petition for bankruptcy with the competent court or is declared
bankrupt; or
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d.
|
the
board of
directors of the other party resolves to dissolve or liquidate its
company.
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12.3.
|
In
case of
termination of the Agreement pursuant to Clause 12.2, the terminating
Party is entitled to receive full compensation for any and all direct
damage suffered by it as a result of the termination and/or, in the
case
of the event stated under Clause 12.2 sub a., any damage suffered
as a
result of such breach.
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12.4.
|
In
deviation of
Clause 12.1, Medtech may terminate this Agreement with immediate
effect by
giving written notice, without any compensation or damages whatsoever
to
Pharmaspray, if Pharmaspray becomes owned or controlled by or associates
with or merges with a producer who provides production services to
competitors of the Product.
|
13. | Completion after termination |
13.1.
|
Upon
termination of
the Agreement, Medtech is obliged to take delivery of the Materials
and
(semi) Products still in the possession and/or under the control
of
|
Pharmaspray on the expiration date of the Agreement or, in case of termination with immediate effect, within 2 weeks upon such termination, after payment of all outstanding amounts to Pharmaspray. Pharmaspray and Medtech shall mutually agree as to the allocation of costs incurred for raw materials, labels and packaging; provided, that, in the event Medtech terminates this Agreement for any reason other than as set forth in Sections 12.2 and 12.4 hereof, Medtech shall be obligated to purchase from Pharmaspray, at Pharmaspray’s actual cost, any safety stock agreed between Medtech and Pharmaspray; and provided further, that, notwithstanding the foregoing, any breaching Party shall be fully responsible for such costs (including, without limitation, safety stock maintained by Pharmaspray). Medtech shall have the right, but not the obligation, to purchase any finished Products being held in Pharmaspray’s inventory for which no Purchase Orders have been submitted. | |
13.2.
|
If
Medtech
terminates this Agreement prior to purchasing eight million (8,000,000)
units of the Product from Pharmaspray, Medtech shall purchase the
Mold
from Pharmaspray in an amount equal to 250,000 Euros (the purchase
price
for the Mold) multiplied by a fraction the numerator of which is
the
Shortfall Amount (as defined below) and the denominator of which
is
8,000,000. The “Shortfall Amount” shall equal eight million (8,000,000)
units less the number of units of the Product purchased by Medtech
hereunder through the termination date. Upon Medtech’s
purchasing eight million (8,000,000) units of the Product from
Pharmaspray, Pharmaspray shall promptly transfer title to the Mold
to
Medtech.
|
Should the Mold be utilized by Pharmaspray for purposes other than the manufacture of the Product hereunder, the acquisition cost of the Mold to Medtech shall be reduced proportionately to the additional use. |
14. | No Rescission |
14.1
|
The
Parties herewith
expressly waive the right to rescind the Agreement pursuant to Article
265
of Book 6, Dutch Civil Code.
|
15. | Miscellaneous |
15.1.
|
Changes
in the Quality Manual. Subject to the written consent of
Pharmaspray which shall not be unreasonably withheld, delayed or
conditioned, Medtech reserves the right to amend or adapt the Quality
Manual and Schedules to changes in the aforementioned regulation
and
legislation and / or to the introduction of new regulations and /
or
legislation regarding the quality requirements of the Product from
time to
time.
|
15.2.
|
Successors
and Assignments. This Agreement is binding on and for the benefit
of both Parties and their successors and permitted assignees. Neither
Party may assign (its rights under) this Agreement without the prior
written consent of the other party. Pharmaspray shall have no rights
in
the Materials and / or Products of Medtech and may not and shall
not
attempt to assign any interests, either real or presumed, to the
Materials
and /or (Semi) Products of Medtech.
|
15.3.
|
Entire
Agreement. This Agreement represents the entire agreement of the
Parties with respect to its subject matter, and supersedes all prior
proposals, agreements, memoranda and / or understandings with respect
to
this Agreement or its subject matter between Medtech and Xxxxxxx
USA B.V.
and Pharmaspray B.V. Any future representation, agreement, understanding
or waiver will only be binding if in writing and signed by the Party
sought to be bound.
|
15.4.
|
Schedules
and Annexes. Each schedule, annex and / or the applicable
provisions of the Quality Manual will become part of and subject
to this
Agreement upon signature and date by both Parties.
|
15.5.
|
Waivers.
Either Party’s failure strictly to enforce any provision of this Agreement
will not be construed as a waiver of that provision or as excusing
the
other Party from future performance.
|
15.6.
|
Notices.
All notices required or permitted under this Agreement shall be in
writing
unless otherwise indicated in this Agreement. The notifying Party
shall
send the written notice to the address of the other Party as shown
at the
beginning of this Agreement and/or any other address as agreed upon
by the
receiving Party. Sent notices will only be effective upon actual
receipt
by the other Party.
|
15.7.
|
Electronic
Mail. The Parties agree that day-to-day communication can also
be
by electronic mail (e-mail). Sent e-mail messages will only be effective
upon actual receipt by the other Party. Notwithstanding the preceding
passages, any message, notice and /or document relating to modification
and/or which affects the effect of this Agreement shall only have
binding
effect if in writing (not being electronic mail and/or other electronic
documents) and with written consent of the Parties.
|
15.8.
|
Confidentiality.
Each Party shall, during this Agreement and after termination and
completion of this Agreement, keep confidential any information whatsoever
regarding the business of the other Party and not provide any third
party
with such confidential information unless with prior written consent
of
the other Party, except as may be reasonably required by judicial
process
or compliance with applicable governmental and regulatory requirements.
|
15.9.
|
Mandatory
Law. This Agreement shall only take effect to the extent that
its
provisions are not contrary to any provision of mandatory (national
and /
or international) law. Any provision of this Agreement being contrary
to
any provision of mandatory law or otherwise being null and void does
not
effect the validity of the other provisions of this Agreement.
|
15.10.
|
General
Terms and Conditions. The applicability of any general terms and
conditions of the contracting Parties, other than those which are
expressly and with written consent of both Parties declared applicable
to
the relationship between Medtech and Pharmaspray under this Agreement,
is
hereby expressly excluded.
|
15.11.
|
Changes
to the Agreement. Provisions that deviate from this Agreement can
be invoked by both Parties only if and to the extent that these provisions
are accepted by both Parties in writing.
|
15.12.
|
Severability.
If any term or condition of this Agreement is null and void or will
become
null and void during the course of this Agreement, the validity and
effectiveness of all other terms and conditions shall not be impaired
thereby. All terms and conditions of this Agreement are separable.
|
16. | Applicable law and jurisdiction |
16.1.
|
This
Agreement is
exclusively governed and construed by Dutch law, as will all disputes
that
may arise from this Agreement. All legal concepts to which reference
is
made in this Agreement are Dutch legal concepts.
|
|
All
disputes,
arising in connection with the present Agreement or further contracts
and
/ or agreements resulting here from, which cannot be settled amicably,
shall be settled by the competent Court of Groningen, The Netherlands,
notwithstanding higher appeals.
|
[Remainder
of page
intentionally left blank]
This
agreement was signed with duplicate originals in Irvington, New York on December
21, 2007.
/s/ Xxxxx X. Xxxxxxxx | /s/ Xxx Xxxxxx | ||||
Medtech Products Inc. | Pharmaspray B.V. | ||||
By: Xxxxx X. Xxxxxxxx | By: Xxx Xxxxxx | ||||
Treasurer | Managing Director |
Schedules
|
Schedule 1 | Product Definitions and Specification |
Schedule 2 | Suppliers and Materials |
Schedule 3 | Prices, Rates and Charges |
Schedule 4 | Quality Manual |