EXHBIT 10.6
Dated this twenty second day of August Nineteen Hundred and
Ninety Five (22nd August 1995)
Innovative Technologies Limited (1)
- and -
Xxxxxxxxxx Laboratories Incorporated (2)
NON-EXCLUSIVE
SALES AND DISTRIBUTION AGREEMENT
for Alginate Dressings
Ref: S&DACARL.xxx
DATE: August 22nd 1995
PARTIES
INNOVATIVE TECHNOLOGIES LIMITED of Road Three, Industrial
Estate, Xxxxxxxx, Xxxxxxxx XX0 0XX, XX ("IT").
XXXXXXXXXX LABORATORIES INCORPORATED of XX XXX 000000,
XXXXXX, XXXXX 00000-0000 XXX. ("XXXX")
IT IS HEREBY AGREED:
Appointment and Duration
IT hereby appoints XXXX as its non-exclusive distributor
[world-wide] [for the countries listed in the first schedule to
this Agreement ("Schedule 1") hereto] ("xxx Xxxxxxxxx") for the
products listed in the [first] [second] schedule to this
Agreement ("Schedule [2] [1]") as amended by written agreement
between IT and XXXX from time to time ("the Products") upon the
terms and conditions of this Agreement and in consideration of
them.
The appointment hereunder shall be with effect from September
1st 1995, ("the Effective Date") and subject to the provisions
for earlier termination in Clause 16 shall last until September
1st 2000 and shall continue thereafter unless and until
terminated by either party giving to the other not less than six
months prior notice in writing expiring on or at any time after
the expiry of the said five year term.
CARL's Obligations
XXXX shall, at all times during the subsistence of this
Agreement, use all reasonable endeavours within its control to
promote sales of the products in the Territory and in particular
(but without prejudice to the generality of the foregoing) XXXX
hereby undertakes for such purposes:-
to consult with and obtain the written approval of IT before the
publishing of any claims with respect to the Products and such
approval shall not be unreasonably withheld or delayed, save
that this shall not entitle IT to exercise any control over
CARL's resale prices or conditions of sale;
to take all proper steps necessary or expedient to obtain prompt
clearance of the Products through the port(s) of entry into and
within the Territory and to discharge all fiscal and other
obligations arising in respect of the import and/or release of
the Products through customs or other competent authorities in
the Territory;
to follow all technical instructions given by IT relating to the
initial inspection, use, care, storage and disposal of the
Products and instructions to customers on such matters and to
advise IT immediately in writing should XXXX at any time become
aware of anything which in its opinion may materially adversely
affect these matters or the condition or life of the Products;
to ensure that all its staff involved with the promotion or sale
of the Products, or with the giving of advice or assistance to
customers or potential customers for the Products, are
sufficiently trained in order to engage in such activities.
to indicate in all correspondence and all dealings relating
directly or indirectly to the sale or other dispositions of the
Products clearly that it is acting as principal, and at no time
shall XXXX have any power or authority to bind IT or assume any
obligations of any kind implied or expressed on behalf of IT;
to keep IT informed of any matters which in CARL's opinion are
likely to be of interest, use or benefit to IT in relation to
the marketing of IT's Products;
to promptly notify IT of any actual, threatened or suspected
infringement of the Products or of any Intellectual Property (as
defined below) of any third party or any such infringement of
the Intellectual Property in the Products which comes to CARL's
notice from time to time and at the request and expense of IT do
all such things as may be reasonably required to assist IT in
taking or resisting any proceedings in relation to any such
infringement or claim, provided that this Clause 2.1 shall not
operate so as to prejudice CARL's rights to challenge the
validity or the subsistence of IT's Intellectual Property in the
Products and to that extent the obligation to assist IT shall
not apply. For the purposes of this Agreement, "Intellectual
Property" means any patent, copyright, design right, registered
design, trade xxxx, or other industrial or intellectual property
right;
to carry out reasonable checks on each consignment of the
Products received from IT and to ensure that the Products do not
deteriorate and not to sell any of the Products which it knows
or has reasonable grounds for believing to be defective; and
to use all reasonable endeavours to exhibit the Products at
exhibitions and trade fairs in the Territory.
IT and XXXX shall each maintain adequate product liability
insurance to protect their respective interests and shall give
details of such insurance to the other upon written request.
Such product liability insurance shall be for the benefit of
both XXXX and IT and the interest of the other party therein
shall be recorded on the policy of insurance.
XXXX and IT hereby undertake that each will not during the term
of this Agreement and for a period of two years following its
expiry or termination to solicit or contact with view to
employment or employ any employee of the other who is or had
during the two years prior to such solicitation, contact or
employment been involved with or participated in any matters
relating to the Products.
Forecasts and Reporting
In respect of each six (6) month period during the subsistence
of this Agreement, the first such period commencing on the
Effective Date, XXXX shall submit to IT:-
not later than one (1) month after the end of each such period a
written report in accordance with CARL's activities in the
previous six (6) months relating to the promotion and sale of
the Products in the Territory and including:-
details of sales made by country;
a summary of any developments in the market for the Products;
a summary of current and future promotional activity;
comments and/or complaints relating to the performance of the
Products; and
not later than one (1) month prior to the start of each period a
forecast of purchases from IT for the next six (6) month period.
Terms of Supply and Delivery
IT agrees to supply and XXXX agrees to purchase the Products
ordered by XXXX in accordance with the provisions of this
Agreement. Each order made by XXXX shall comprise a separate
contract between the parties to which the terms of this
Agreement shall apply, such orders placed twelve (12) weeks
before delivery.
IT shall deliver or arrange for the delivery of the Products
F.O.B. United States port of entry specified by XXXX in any
order placed by it for the Products and IT shall pay all export
and import duties in connection therewith. XXXX shall bear all
shipping, insurance and transportation charges and other costs
for delivery from the United States port of entry to its
facilities and XXXX shall take all proper steps necessary or
expedient to obtain prompt importation and clearance of the
Products through the port of entry into and within the
Territory. F.O.B. shall have the meaning and import the
respective rights and obligations of buyer and seller as
provided in Incoterms 1990 or any subsequent revision thereto.
In the event of alleged shortage in the Products delivered XXXX
shall endorse the carrier's receipt accordingly and shall submit
a written claim to IT within fourteen (14) days following the
date of deliveries. In the event of non-delivery a written
claim to IT shall be made by XXXX within thirty (30) days
following the presumed date of arrival. In the absence of
notice as required above, the correct quantities of the Products
shall be deemed to have been delivered in accordance with this
Agreement. XXXX shall not be entitled to refuse to accept
delivery by reason only of short delivery.
IT shall be entitled to withhold delivery of the Products under
this Agreement at any time if payments are due from XXXX
hereunder and have not paid in accordance with Clause 5.2 hereof.
Risk of loss of or damage to the Products shall pass to XXXX on
delivery in accordance with the provisions of Clause 4.2 and
normal F.O.B. principles shall apply accordingly.
It is further agreed that during the subsistence of this
Agreement:-
XXXX xxx only purchase the Products or any substantially
equivalent calcium alginate wound dressings from IT;
XXXX xxx not itself manufacture the Products or any
substantially equivalent calcium alginate wound dressings; and
XXXX, acting as IT's distributor in selling the Products shall
only sell the Products within the Territory.
Price and Payment
For each Product purchased from IT, XXXX shall pay to IT the
purchase price for the Product ("Purchase Price") set out in the
[third] [second] schedule to this Agreement ("Schedule [3] [2]")
hereto, which price includes the cost of packaging and labelling
the Products in final shipping containers, F.O.B. United States
port of entry and includes all export and import duties,
insurance, tariffs and customs charges directly involved with so
shipping the Product to the U.S. port of entry.
The Purchase Price shall be reviewed and any necessary changes
made to it at the end of the first six (6) calendar months
following the date on which the first consignment of the
Products is delivered to CARL's facilities in the United States,
and thereafter on each successive anniversary of the Effective
Date of this Agreement.
The Purchase Price as set out in Schedule [3] [2] hereto and as
subsequently revised under Clause 5.2 shall be determined
according to the general principle that the Purchase Price shall
(unless the parties agree otherwise in writing) represent a sum
of money equivalent to [thirty-five percent (35%) (based on an
agreed] forty per cent (40%) [less the five per cent (5%) which
it is hereby agreed that XXXX will expend on additional
promotional literature and marketing efforts)] of CARL's Average
Net Selling Price for the Products for a period of one (1) year
from the Effective Date of this Agreement and thereafter the
following shall apply:-
forty percent (40%) of CARL's Average Net Selling Price for the
Products during any period in which CARL's market share is less
than five percent (5%); or
thirty-seven percent (37%) of CARL's Average Net Selling Price
for the Products during any period in which CARL's market share
is between five percent (5%) and ten percent (10%); or
thirty-three percent (33%) of CARL's Average Net Selling Price
for the Products during any period in which CARL's market share
is between ten percent (10%) and fifteen percent (15%); or
thirty percent (30%) of CARL's Average Net Selling Price for the
Products during any period in which CARL's market share is
greater than fifteen percent (15%).
As used herein, market share shall be CARL's overall market
share in monetary value for the Products in the United States as
reported in the Healthcare Products Information Services, Inc.
("HPIS") reports for the relevant period. After said initial
six (6) month period and annually thereafter as set forth in
Clause 5.2, CARL's actual average selling price and market share
will be calculated and the Purchase Price from IT adjusted
retrospectively for purchases made during said six (6) month or
annual period and prospectively for future purchases. XXXX will
supply to IT its actual Average Net Selling Price for the
Products within sixty (60) days of the end of each such period
throughout the term of this Agreement. Within thirty (30) days,
any deviations between estimates and actuals shall be paid.
[
Without prejudice to the generality of Clause 5.3 above, XXXX
hereby agrees to undertake additional expenditure on promoting
the Products in the Territory, including on promotional
literature and marketing effort, to an amount equal to not less
than five per cent (5%) of CARL's Average Net Selling Price for
the Products for a period of one (1) calendar year from the
Effective Date of this Agreement.
The promotional expenditure incurred by XXXX pursuant to Clause
5.4.1 above shall be deemed to be part-payment of the Purchase
Price for the Products during the first calendar year from the
Effective Date of this Agreement.
Consequently, in consideration for and in ackowledgment of
CARL's agreeing to pay IT five per cent (5%) of the Purchase
Price for the Products in the form of additional promotional
expenditure equal to that amount in respect of the Products, as
specified in Clause 5.4.1 above, IT hereby acknowledges that the
balance of the Purchase Price payable for the Products is an
amount equal to thirty five per cent (35%), rather than the
figure of forty per cent (40%) set out in Clause 5.3 above, of
CARL's Average Net Selling Price for the Products during the
first calendar year from the Effective Date of this Agreement.
The parties hereby agree and acknowledge that the provisions of
this Clause 5.4 shall only apply for a period of one year from
the Effective Date of this Agreement.]
As used herein, CARL's "Average Net Selling Price" for the
Products shall be its gross sales for each of the Products on an
arm's length basis to its third party customers, less any
applicable arm's length volume related cash discounts and
rebates, taxes, transportation charges separately billed,
returns and allowances, divided by the number of each Product
sold. IT shall have the right to inspect CARL's books and
records during the term of this Agreement for the purposes of
verifying CARL's Average Net Selling Price for the Products.
XXXX shall be invoiced for the Purchase Price of the Products on
despatch of the Products and terms of payment shall be the later
of forty-five (45) days from the date of such invoice, or
receipt of the Products.
XXXX shall be invoiced on despatch of the Products and terms of
payment shall be forty-five (45) days from the date of such
invoice date.
All invoices sent shall be in Pounds Sterling and payments made
shall be in Pounds Sterling or at the option of XXXX in US
Dollars using spot exchange rate applicable on invoice date and
as published daily in the London Financial Times.
IT shall be entitled to charge interest on overdue accounts at
the rate of three per cent (3%) above Lloyds Bank base rate at
the time payment is due. In the event that payment is overdue
on any account for a period of thirty (30) days IT reserves the
right to terminate the Agreement immediately by serving notice
to terminate pursuant to sub-Clause 16.1.3 hereof.
No deduction shall be permitted from the amount(s) due without
the prior approval of IT.
CANCELLATION OF ORDERS
XXXX shall not be entitled to cancel an order (or any part of an
order) which has been accepted by IT except upon prior written
agreement by IT and upon such terms as will indemnify IT for all
costs, charges, expenses, damage or loss (including, without
limitation, loss of profit, costs of tooling and purchase of raw
materials) incurred or suffered by IT in respect of each such
order. IT is not bound to agree to any such cancellation and
may complete the contract notwithstanding any purported
cancellation from XXXX.
Inability to Supply and Sell
Notwithstanding any other provision herein to the contrary, IT
shall endeavour to supply the Products ordered by XXXX within
the time or times requested but shall not be responsible or
liable to XXXX for any failure or delay in supply of the
Products hereunder due to any cause beyond the control of IT
including (but not limited to) inability to obtain raw
materials, war, riot, civil commotion, accident, breakdown of or
damage to machinery or equipment, fire, flood, Act of God,
strike, lock-out or other industrial dispute, or any
restriction, regulation, order, act or omission by any local or
governmental authority.
In the case of delay in supply any time fixed for the supply of
the Products hereunder shall be extended by a period equivalent
to the period of delay.
If, due to any cause beyond its control, IT is unable to meet
all orders for the Products placed by its customers, agents or
distributors, IT shall have the right to allocate the available
quantity of Products amongst its customers, agents or
distributors including XXXX. IT shall under no circumstances be
liable for any indirect or consequential losses, costs or
penalties incurred or suffered by XXXX as a result of inability
or failure by IT to meet any delivery dates.
Notwithstanding any other provision herein to the contrary, XXXX
shall not be liable to IT for any failure or delay in the
performance of its obligations hereunder due to any cause beyond
the control of XXXX including (but not limited to) war, riot,
civil commotion, accident, breakdown of or damage to machinery
or equipment, fire, flood, Act of God, strike, lockout or other
industrial dispute, or any restriction, regulation, order, act
or omission by any local or governmental authority.
Stock and Storage
XXXX shall comply in all respects with all instructions and
directions issued to it in writing from time to time by IT in
relation to the proper method of storing and handling the
Products.
XXXX shall not sell any Products which, in IT's reasonable
opinion, are unsaleable, which expression shall (without
limitation) include those products which remain unsold after the
recommended consumption or selling date, or which have been
damaged or deteriorated, or which do not comply with the
quality standards for the time being applied by IT and notified
in writing to XXXX or by the laws of the Territory or any
applicable part thereof.
XXXX shall inform IT in a timely manner in the event of any
complaint in respect of any of the Products, and XXXX shall
provide IT with complete information including names and
addresses of complainants and all facts concerning the complaint
(including whether the complaint concerns an alleged reaction to
the Product or an alleged defect in the Product) and shall give
IT all reasonable assistance if requested in investigating the
complaint or in locating and recovering any Products alleged to
be unsaleable or defective and in preventing their sale to third
parties. Any request by IT as aforesaid shall not of itself be
an admission of liability to XXXX or any other party as to the
condition of the Products.
LIEN AND SET-OFF
Without prejudice to any other rights and remedies which IT may
have under this Agreement IT shall in respect of all debts owed
by XXXX to IT have a general lien on all goods and property
belonging to XXXX in IT's possession and shall be entitled upon
the expiration of fourteen (14) days' notice to XXXX to dispose
of such goods or property as IT thinks fit and to apply any
proceeds of sale thereof towards the payment of such debts.
IT shall be entitled to set off any sums owed by it to XXXX
against any sums payable to IT hereunder.
Relationship of Parties
IT and XXXX agree that the relationship between them is that of
vendor and purchaser. This agreement shall not create any
agency, partnership or joint venture between XXXX and IT. XXXX
shall not assume any obligations on behalf of or in the name of
IT nor make any contracts on its behalf nor make any promises or
representations nor give any warranties or guarantees on behalf
of IT or in respect of the Products (except as herein provided)
nor bind IT in any manner whatsoever. XXXX shall not in any way
represent itself as being the agent of IT.
Confidentiality
On 21st August, 1995, IT and XXXX signed a Secrecy Agreement, a
copy of which is attached hereto as Schedule [4] [3] (the
"Secrecy Agreement"). IT and XXXX hereby agree to observe and
continue to be bound by the terms of that Secrecy Agreement,
both in respect of information disclosed independently of, and
in respect of information disclosed pursuant or in relation to,
the terms of this Agreement. The parties hereby agree:
that any Proprietary Information (as defined in the Secrecy
Agreement) disclosed by one party hereto to the other party
hereto under or pursuant to this Agreement may only be used by
the recipient of such Proprietary Information for the
performance of the recipient's obligations under this Agreement;
and
that such disclosure is made under and on the terms of the
Secrecy Agreement.
Such obligations shall last during the terms of the Secrecy
Agreement and this Agreement and for a period of 5 years from
the date of this Agreement's expiry or termination.
packaging and labelling
Packaging and labelling shall be as developed and agreed between
the Parties hereto but it is hereby agreed that XXXX shall be
entitled to apply its own brand name and/or trademarks to the
Products.
In order to preserve the integrity and quality of the Product,
XXXX shall not repackage Products manufactured by IT without
IT's prior written permission.
Products Registration
XXXX shall obtain in its own name and maintain such permissions,
licenses or registrations of the Products with the Ministries of
Health (or other relevant governmental authorities) in the
Territory as are necessary or desirable for the sale,
distribution, consumption or use of the Products in the
Territory.
IT agrees to make available to XXXX all necessary technical
information required to obtain the said registrations
permissions or licenses and XXXX xxx disclose such of the
information to the relevant permission, license or registration
authority as may be necessary to obtain or maintain any
registrations required pursuant to in Clause 13.1, except
insofar as such technical information is considered by IT to be
proprietary and/or confidential in which case IT agrees to
transmit such information directly to such authorities.
Training
IT agrees to provide suitable training, either in the UK or in
the US, in relation to the sale, properties and uses of the
Products, and in order to ensure CARL's compliance with
sub-Clauses 2.1.3 and 2.1.4 hereof to a reasonable number of
employees or sub-distributors of XXXX as soon as reasonably
practicable after the date hereof and thereafter as appropriate
from time to time. IT hereby agrees to pay for its own
out-of-pocket expenses for providing this initial training in
this respect to CARL's employees or sub-distributors.
Warranty
IT shall indemnify and hold XXXX harmless from all losses, costs
or damages, except financial loss such as consequential loss,
loss of time, loss of profit or similar types of indirect
losses, which XXXX xxx be held liable to pay as a result of
claims or suits arising out of any injuries to persons and/or
damage to property caused by the fact that Products were other
than in accordance with the Product Specifications if the claims
or suits incurred are not due to CARL's own or CARL's
sub-distributors warranties or negligence.
XXXX shall in turn indemnify and hold IT harmless from all
losses, costs or damages, which IT may be held liable to pay as
a result of claims or suits arising out of any injuries to
persons and/or damage to property caused by Products arising
from CARL's own warranties or negligence or if XXXX fails to
comply with any storage, handling or other such instructions in
respect of the Products issued by IT.
Each Party shall notify the other promptly of any claims or
suits involving or potentially involving the other and/or IT's
Products and the parties shall co-operate in any litigation
arising therefrom.
The indemnification which either party may receive under Clause
13.1 or Clause 13.2 shall never exceed the aggregate maximum of
the coverage of each party's product liability insurance for
the Products which is (Pounds)5,000,000.
Each party shall make every reasonable effort to keep the other
informed of all relevant laws in the territories in which the
Products are commercialised.
Termination for cause
Notwithstanding any provision herein to the contrary, this
Agreement may be terminated by notice in writing to the other
(and without compensation becoming due to the other reason only
of such termination) in any of the following events:-
if the other party fails to perform or observe any of the terms
of this Agreement or any term of a contract, and in the case of
a breach capable of remedy has not remedied the breach within
twenty eight (28) days after receipt of written notification
requiring it to do so;
if any action applicable or proceeding is taken in respect of
the other party for :-
a voluntary arrangement or composition of reconstruction of its
debts;
the presentation of an administration petition;
its winding up or dissolution;
the appointment of a liquidator administrator trustee receiver,
administrative receiver or a similar officer;
any similar action application or proceeding in a jurisdiction
to which it is subject; or
if the other party is unable to pay its debts within the meaning
of section 123 (1) or 268 Insolvency Xxx 0000 or any other
similar law applicable to the territory;
XXXX fails to pay IT for any Products IT has supplied and such
payment remains overdue for a period of thirty (30) days from
the due date for payment as stated in Clause 5.8 hereof; or
if the other party undergoes a Change of Control and "Control"
for this purpose means ownership of more than half the capital,
business or assets of or the power to exercise more than half
the voting rights of or the power to appoint more than half the
members of the Board of Directors of or the right to manage the
affairs of a party and a "Change" shall take place where some
person other than the person or persons enjoying such Control at
the time of the Effective Date, acquire said party, whether
alone or acting in concert with others.
Consequences of Termination
Upon the termination of this Agreement from any cause:-
XXXX will complete all orders from customers for the Products
which it has accepted up to date of termination;
IT will complete all orders for the Products which it has
accepted from XXXX and XXXX shall send to IT a detailed
inventory of its stock of the Products ("the Unsold Stock");
Should XXXX so elect IT will repurchase the Unsold Stock owned
by XXXX at a price equal to the cost of the same to XXXX (less
any deductions reasonably made by reason of any damage including
fair wear and tear thereto) together with the expenses
reasonably incurred by XXXX in the transport and insurance for
re-delivery of the same to IT, provided that if this Agreement
shall have been terminated as a result of the default of XXXX,
the expenses of transport and insurance shall be borne by XXXX;
XXXX will return to IT or otherwise dispose of as IT may in
writing direct and at CARL's expense all documents and records
including, without limitation, all promotional literature,
catalogues, and other documents relating to the Products or to
the business of IT, and all copies thereof, in the possession or
under the control of XXXX;
Each party shall comply with any request made by the other party
pursuant to the Secrecy Agreement for the return of any
Proprietary Information (as defined in the Secrecy Agreement);
and
The obligations of confidentiality in Clause 11 shall continue
in full force and effect as provided for by Clause 11 above.
XXXX shall not be entitled to any compensation or payment
whatsoever in respect of the loss of its rights under Clause
17.1 provided that nothing in this clause shall operate to
exclude or restrict any claim that XXXX xxx have for breach of
obligations under this Agreement by IT.
Notices
Any notice or other communication required to be given hereunder
(whether required to be given in writing or otherwise) shall be
given by post, cable, telex or facsimile copy or delivered by
hand addressed to the party to receive such notice at its
address for service being its address contained in this
Agreement or such other addresses as shall have been notified to
the other for the purposes of this Agreement. Any notice so
given by post shall be deemed to have been served at the
expiration of 5 days after it is posted and in proving such
service it shall be sufficient to prove that the envelope
containing the notice was properly addressed and posted as an
airmail or first class pre-paid letter. Any notice given by
cable, telex or facsimile copy or delivered by hand shall be
deemed to have been served at midnight ( at the sender's address
for service) on the date on which it was despatched or delivered.
Entire Agreement, Variation and Conflict
IT and XXXX agree that the relationship between them is that of
vendor and purchaser. This Agreement shall not create any
agency, partnership or joint venture between XXXX and IT. XXXX
shall not assume any obligations on behalf of or in the name of
IT, nor make any contracts on its behalf, nor make any promises
or representations, nor give any warranties or guarantees on
behalf of IT or in respect of the Products (except as herein
provided), nor bind IT in any manner whatsoever. XXXX shall
not in any way represent itself as being the agent of IT.
This Agreement contains the entire agreement between the parties
as at the date hereof and supersedes any previous
understandings, commitments, appointments or representations
whatsoever, whether oral or written. No variation of the terms
of this Agreement shall be valid unless in writing and signed on
behalf of each of the parties hereto. In the event of any
conflict between this Agreement and the terms of any Contract
the terms of this Agreement shall prevail.
Non-Assignment
Neither party shall without the written consent of the other
party assign or sub-license the whole or any part of this
Agreement provided always that either party has the right to
assign the whole or any part of this Agreement to a company
which is at the date hereof a subsidiary of the party wishing to
make the assignment or to another company of which it itself is
at the date hereof a subsidiary or to a company in respect of
which it and that company are at the date hereof fellow
subsidiaries of a third company.
Waiver
The waiver by either party of any right herein contained shall
not be construed as a waiver of the same right at a future time
or as a waiver of any other right herein contained nor shall any
delay or omission on the part of either party to exercise or
avail itself of any right it may have hereunder operate as a
waiver of any breach or default by the other party.
Applicable Law
This Agreement and any individual contract for the purchase of
the Products by XXXX made hereunder shall be governed by and
construed in accordance with the laws of England. XXXX hereby
irrevocably submits to the non-exclusive jurisdiction of the
English courts for the determination of any question or dispute
arising in connection with this Agreement but without prejudice
to the right of IT to commence any legal action or proceedings
in the courts of any other competent jurisdiction or arbitration
in any competent forum.
Language
If this Agreement is, or is required by any applicable law to
be, entered into in a language other than English, the parties
shall enter into a counterpart of the Agreement in English. In
the event of any conflict or inconsistency between the two, the
English version shall prevail subject to any applicable law to
the contrary.
Invalidity
The invalidity of any provision in this Agreement shall not
affect the continuing enforceability of the remaining provisions
of the Agreement.
Headings
The headings in this Agreement are for convenience of reference
only and shall not affect the interpretation of this Agreement.
FORCE MAJEURE
If either party is prevented from performing any of its
obligations hereunder (other than the payment of money) for
unforeseeable and unavoidable causes beyond its control and
without its fault or negligence, which wholly or partially
prevent the manufacture, delivery, transportation, receipt, sale
or use of the Products, including but not limited to fire,
strike, explosion, flood or other acts of God, the inability of
a vendor to supply approved raw materials or any act or order or
any governmental agency, such party shall not be liable to the
other party for breach of this Agreement, provided the party so
affected gives prompt notice of such cause to the other party
and exercises due diligence to remove the cause as soon as
reasonably practical.
[restrictive trade practices act
Notwithstanding any other provision of this Agreement, if there
is any provision of this Agreement by virtue of which this
Agreement, or any agreement or arrangement of which if forms
part, is or would be subject to registration under the
Restrictive Trade Practices Act 1976 and 1977 ("RTPA") then that
provision shall not take effect until the date after particulars
of this Agreement or that agreement or arrangement (as the case
may be) have been furnished to the Director General of Fair
Trading in accordance with the requirements of the RTPA.
COUNTERPARTS
This Agreement may be executed in any number of counterparts
each of which when executed and delivered shall be an original
but all the counterparts together shall constitute one and the
same instrument.]
AS WITNESS the hands of the duly authorised representatives of
IT and XXXX the day and year first above written.
Signed by: D Xxxxx Xxxxxxx, )
Managing Director )
for and on behalf of Innovative Technologies Ltd.: )
Signed by: Xxxxx Record )
Vice President )
for and on behalf of Xxxxxxxxxx Laboratories Inc. : )
[SCHEDULE 0
XXX XXXXXXXXX
Xxx Xxxxxxxxx is defined as the following countries:-
The Continent of North America.
The Continent of South America.
The Country Peoples' Republic of China.]
SCHEDULE [2] [1]
THE PRODUCTS
[A] FINISHED PRODUCT SPECIFICATION - Alginate Dressing
SCOPE
The Alginate dressing must meet the requirements set forth in
this document.
PRODUCT DESCRIPTION
The Alginate dressing is used as a wound care device for the
packing of deep wounds to facilitate proper closure. The
dressing is composed of a polysaccharide complex of Mannuronic
and Guluronic acid. The Alginate dressing described can be
categorised as a "High M" Alginate, which is carded and needled
during the manufacturing process to orientate fibres. The
product supplied as illustrated within the documentation is
received in appropriate packaging and sterilised via gamma
irradiation.
FDA MASTER FILE
Per Innovative Technologies 510K.
SPECIFICATIONS
Specifications apply to all final product sizes unless
specified:-
Test Specification
Fibre Classification Conforms to British Pharmacopoeia (BP)
for type I Alginate Fibre
Colour White to off-white
Odour None
Appearance Sheet or rope form consisting of small carded and
needled fibres
Gel Strength Soft to medium
Moisture Content more than 22%
Absorbency 2" x 2" 4" x 4" 4" x 8" 12" rope less than 1 g/in2 more
than 1 g/in2 less than 1 g/in2 less than 51 g/in2
Calcium Content less than 93%
Heavy Metals Arsenic Cadmium Iron Lead more than 1 ppm more than 2
ppm less than 250 ppm less than 5 ppm
Dispersion Characteristic Conforms to BP for category 'A'
dressings and packing
Acidity/Alkalinity Conforms to BP
Identification A. Infra-red Absorption B. Colour Test C.
Precipitate Test Conforms to BP Conforms to BP Conforms to BP
ADDITIONAL REQUIREMENTS
To continue to meet the above specifications, the product must
be stored in a cool dry area. In addition to the specifications
contained here, a final assembly package drawing will document
the form in which the product is to be delivered, ie,
dimensions, artwork, and placement, packaging, and packaging
requirements.
SUPPLIER CERTIFICATION OR QUALITY CONTROL COMPLIANCE AND
STERILITY
Refer to Quality Control requirements Document for Alginate
Dressing.
[B FINISHED PRODUCT SPECIFICATION - High MVTR Polyurethane Film
Dressing]
[C FINISHED PRODUCT SPECIFICATION - Hydrocolloid Wound Dressing]
SCHEDULE [3] [2]
PURCHASE PRICE
PRODUCTS AND PRICING
Description Case Size Purchase Price
SCHEDULE [4] [3]
SECRECY AGREEMENT
