EXHIBIT 10.18
PRIVATE LABEL
PURCHASE AGREEMENT
THIS AGREEMENT is entered into as of this 22nd day of September, 2003
by and between MedArt Corporation, having its principal place of business at
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇, ▇▇▇ ▇▇▇▇▇ Hills, ▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
("Seller"), and Vascular Solutions, Inc., having its principal place of business
at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Buyer").
1. Product Description. This Agreement governs all of the terms and
conditions concerning the sale by Seller to the Buyer of a certain
specially designed product based on Seller's MedArt 426 30 watt solid
state laser console as modified and manufactured in accordance with
Buyer's specifications set forth on Schedule 1 hereto (the
"Specifications") to be sold and marketed by Buyer without limitation
as to territory under Buyer's trademarks and trade names solely for use
in endovascular therapy of vascular conditions (the "Product").
2. Product Specifications.
(a) Original Specifications. The Product sold to Buyer hereunder
shall meet the Specifications and shall be manufactured in
accordance with all applicable Quality System Regulations
("QSR") of the U.S. Food & Drug Administration (the "FDA") for
medical devices and Seller's quality system in accordance with
EN46001 or EN13485. Seller also shall certify compliance of
the Product with all applicable UL requirements at the time of
sale of the Product to the Buyer.
(b) Changes by Seller. If at any time during the term of this
Agreement Seller finds it necessary or desirable to change the
components or manufacturing procedures of the Product or
effect any other change relating to the Product which would
result in changes in the Specifications or could reasonably
require notification or approval of the FDA or any other
regulatory agency, Seller shall not effect any such change
with respect to the Product until notifying and receiving
prior written approval from Buyer for such change, which
approval shall not be unreasonably delayed or withheld.
** The appearance of a double asterisk denotes confidential information that has
been omitted from the exhibit and filed separately, accompanied by a
confidential treatment request, with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934.
Initials:
Buyer ________
Seller _______
(c) Changes by Buyer. If at any time during the term of this
Agreement Buyer finds it necessary or desirable to change the
Specifications for the Product, Buyer shall promptly notify
Seller in writing of the nature of such changes to the
Specifications. Seller and Buyer shall promptly consult with
each other regarding such proposed changes in the
Specifications. If Seller agrees to modify the Specifications
in accordance with Buyer's request, or otherwise as mutually
agreed by Seller and Buyer, all future quantities of the
Product shall be manufactured in accordance with the revised
Specifications and in accordance with a timetable mutually
agreed upon by Buyer and Seller. Buyer shall be responsible
for all inventories of Products in Seller's possession, which
are rendered obsolete as a result of Buyer's requested changes
in the Specifications. If the change in the Specifications
results in an increase or decrease in the cost to manufacture
the Product, the price for the Product manufactured under the
revised Specifications and purchased under this Agreement
shall be increased or decreased accordingly.
3. Regulatory Submissions and Approvals. At Buyer's sole cost and expense,
Seller shall perform all additional testing, qualifications and
validations of the Product that are reasonably required for Buyer's
submission of its 510(k) clearance to the FDA. All existing testing,
qualifications and validations in Seller's possession and based on the
MedArt 426 platform will be made available at no charge to Buyer. The
written protocols and reports of such testing shall be completed by
Seller, with prior review by Buyer, and Seller and Buyer shall use
their best efforts to complete such work according to the timeline
listed on Schedule 2. Seller shall, at Seller's expense maintain the
approval to apply the CE ▇▇▇▇ to the Product. In the event that device
modifications requested by Buyer result in approval expenses, the cost
of such review and approval shall be the responsibility of the buyer.
Other than as stated in the previous sentence, Buyer shall have
responsibility for filing and obtaining all required consents,
licenses, authorizations and approvals for the use and sale of the
Product in such countries, including the United States, in which Buyer
determines to sell the Product. All such consents, licenses,
authorizations and approvals of the Product obtained by Buyer shall be
held in the name of Buyer or its designee. Subject to the terms of
Section 14 below governing confidentiality, Buyer shall have access to
all test reports, manufacturing records and other documents of Seller
that may be useful in obtaining or maintaining a registration for the
Product in the United States and outside the United States and to
facilitate the commercialization of the Product. Seller shall, at
Buyer's sole cost and expense, provide continued regulatory assistance
and support for the receipt and maintenance of the 510(k) clearance and
CE ▇▇▇▇ as reasonably requested by Buyer. Buyer shall have the right to
reference the source of its Product as supplied by Seller in its
regulatory filings, product descriptions, sales literature and other
descriptions of the Product.
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Buyer ________
Seller _______
The CE Product to be distributed by Buyer will have a top foil that is
marked with the Product name and logo and have colors decided by the
buyer. A company name will not appear on the front of the product. When
the Product is distributed in Europe, a CE label shall be attached to
the back of the Product as well as a label indicating the Product is
manufactured by Seller and distributed by Buyer. It will be the
responsibility of Buyer to attach such labels to each laser unit being
sold in Europe. Product sold in the United States by Buyer under
Buyer's 510(k) Clearance will not have a CE label. The name "ASAH
Medico A/S will not be on the type label of any unit sold outside the
CE geographic region.
When Product is distributed in Europe, a dedicated CE-version of the
user instruction manual shall be included with the product. This
version will specify Seller as Manufacturer and specify Buyer as
distributor. The Seller will provide Buyer with the CE version of the
operator's manual. The CE version will be in British English. No
corrections are permitted to the CE version without prior agreement by
Seller.
4. Purchase Terms. During the Term of this Agreement, Seller agrees to
sell and Buyer agrees to purchase, on the terms and conditions herein
stated, the Product. Buyer shall purchase and use the Product solely
for endovascular treatment of vascular conditions and shall resell the
Product only for endovascular treatment of vascular conditions. During
the Term of this Agreement, Seller and its affiliates shall sell the
Product manufactured in accordance with the Specifications exclusively
to Buyer and shall not, directly or indirectly, sell the Product to any
customer, partner, distributor or other person or entity. Conversely,
Buyer shall purchase its requirements for the Product, for the
Application, solely from the Seller and not from any other person or
entity.
5. Private Label Requirements. All Products shall bear the logos,
trademarks and trade dress of Buyer (collectively "Buyer's Marks").
Buyer shall provide Seller all specifications and materials necessary
to affix Buyer's Marks to the Products or otherwise to manufacture the
Products in accordance with Buyer's Marks.
6. Purchase Prices.
(a) Initial Prices. During the Term of this Agreement, Seller
agrees to sell the Product to the Buyer at the prices set
forth in Schedule 2. The period of time from the date of FDA
approval of Buyer's 510(k) for the Product through one year
from such date shall be referred to as the First Contract
Year. The subsequent one-year period shall be referred to as
the Second Contract Year, and the subsequent one-year period
shall be referred to as the Third Contract Year, if this
Agreement is still in effect at such times.
(b) Price Changes. The prices set forth in Schedule 2 for Products
ordered shall be increased or decreased for Product ordered in
the Second Contract Year and the Third Contract Year by the
amount that the actual costs of Seller's components for the
Product increase or decrease over Seller's
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actual costs for such components purchased in the First
Contract Year, provided that the price may not increase by
more than 20% over the Term of this Agreement, not to exceed
the year 2005. Increased prices shall apply to all Products
ordered after Seller provides Buyer with written notice of
such price increase.
(c) Invoices and Payment. Seller shall invoice Buyer on each
shipment of the Product for the Products together with prepaid
freight, insurance and other costs, and payment shall be made
in U.S. dollars in all cases net 30 days from the date of
shipment. If and for so long as any invoiced amounts are due
but not paid, they shall accrue a service charge of 1% per
month or the maximum rate allowed by law, whichever is lower,
and Seller shall have the right, in its discretion, to require
payment for additional shipments by cash in advance or by
letter of credit.
(d) Taxes. The prices set forth in Schedule 2 do not include, and
Buyer shall be responsible for and pay, all taxes, including
sales, use and value added taxes, duties, assessments and
other governmental charges, however designated, imposed by any
governmental authority (other than Seller's net income taxes)
resulting from the sale of the Product to Buyer.
7. Delivery, Shipping, Risk of Loss.
(a) Delivery. All purchases of Products by Buyer hereunder shall
be FOB the manufacturing facility in Hvidovre, Denmark of
Seller's affiliate, Asah Medico A/S. All Products will be
shipped directly to one of Buyer's facilities as specified by
Buyer. Seller will use best efforts to deliver the Product in
accordance with the delivery date specified in the accepted
purchase order. If Seller fails to deliver the Product within
30 days of the delivery date specified in the accepted
purchase order, Buyer may cancel without penalty all or any
portion of the purchase order.
(b) Shipping. All Products will be shipped by Seller freight
prepaid and Buyer will reimburse Seller for the actual costs
of such shipping. All shipments will be made through a common
carrier specified by Buyer, or, if Buyer does not specify a
carrier within fifteen (15) days before the scheduled shipment
date, by a carrier selected by Seller. At Buyer's discretion,
Seller will procure insurance on all shipments of Products
against damage to or loss of the Product. Such insurance so
provided by Seller will be billed to Buyer, and Buyer will
reimburse Seller for the actual costs of such insurance.
Unless otherwise specified by Buyer and agreed to by Seller,
packaging of shipments shall be in accordance with Seller's
customary practices. No partial shipments shall be made
without Buyer's written consent.
(c) Title and Risk of Loss. Seller shall retain title and bear the
risk of loss until such time as the Product has been delivered
to the carrier designated
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by Buyer or, if no such designation has occurred, Seller's
regular carrier at the FOB point. Seller will have no further
responsibility for the Products and all risk of damage to or
loss or delay of the Products will pass to Buyer upon the
delivery of the Products at the FOB point to the common
carrier specified by Buyer or, if none is so specified, to the
common carrier selected by Seller.
8. Ordering Procedures.
(a) Purchase Orders. Sales of the Product will be made pursuant to
purchase orders issued by Buyer to Seller specifying (i)
quantities, (ii) order value (based on Schedule 2 hereof),
(iii) requested delivery dates and (iv) shipping instructions
and shipping address. All purchase orders are subject to
standard acceptance and confirmation in writing by Seller. All
purchase orders duly submitted in accordance with the terms of
this Agreement will be accepted by Seller. No accepted
purchase order may be modified or cancelled by Buyer without
the written consent of Seller. Buyer shall be entitled to use
its standard form of purchase order; provided, however, that
such purchase order shall not impose any terms not contained
in this Agreement or alter any of the terms contained in this
Agreement. In the event of any conflict between the terms of
any purchase order and the terms of this Agreement, the terms
of this Agreement shall control. For the First Contract Year,
Buyer shall issue a purchase order upon execution of this
Agreement to purchase the following number of units of the
Product according to the following schedule:
o ** units to be delivered January 15, 2004
o ** units to be delivered February 15, 2004
o ** units to be delivered May 15, 2004
o ** units to be delivered August 15, 2004
o ** units to be delivered November 15, 2004;
provided, however, that if Buyer has not received its 510(k)
clearance for the Product by January 1, 2004, the initial
delivery of Products listed above will be delayed until
receipt by Buyer of the 510(k) clearance, with each subsequent
scheduled delivery in the First Contract Year delayed a
corresponding period of time but provided further that, in the
event Buyer has not received its 510(k) clearance by July 1,
2004, Seller shall have the option to terminate this Agreement
and Buyer shall be obligated to pay to Seller, by way of
liquidated damages and not as a penalty, $490,000.
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Seller _______
(b) Forecasts. Contemporaneously with the execution of this
Agreement, Buyer will submit to Seller a forecast of Buyer's
intended purchases of the Product during each quarter of the
First Contract Year. Buyer will provide Seller no later than
thirty (30) days prior to each succeeding quarter of each
Contract Year of this Agreement with an updated forecast of
quarterly purchases for a new twelve (12) month period. Such
rolling forecasts will be done in good faith for purposes of
facilitating Seller's manufacturing lead times, but they shall
not be considered binding purchase orders for purposes of this
Agreement.
(c) Amount and Delivery Dates. Buyer shall issue purchase orders
at times within its discretion throughout the Contract Year
(but not more frequently than twice a month) requesting
delivery no sooner than 60 days from the date of the receipt
of the purchase order by Seller. Each purchase order shall
provide for a minimum of five (5) units of the Product, but
Seller shall have no obligation hereunder to accept any
purchase order which, when taken together with all other
purchase orders for the relevant quarter, would exceed Buyer's
forecast for such quarter by more than ten (10) units of the
Product unless Seller expressly agrees to accept any such
orders.
(d) Minimum Purchases. Buyer agrees to purchase a minimum of
(i) ** units of the Product in the First Contract Year and
(ii) a minimum of ** units of the Product in each of the
Second and Third Contract Years, of which Buyer must purchase
at least ** units of the Product during each quarter of each
such Contract Year except in the quarter which corresponds
most closely to the third fiscal quarter of the calendar year
during which Buyer must purchase at least ** units of the
Product. In the event that Buyer fails to meet the minimum
purchase obligation for any Contract Year, Seller shall be
entitled to terminate this Agreement pursuant to Section 13 of
this Agreement unless Buyer cures such default prior to the
end of the relevant quarter or Contract Year by placing a firm
purchase order with Seller for the amount of the shortfall in
purchased Products.
9. Complaints and Quality Control.
(a) Complaints. The Buyer will inform the Seller of any serious
adverse events or quality complaints resulting from a
defective Product within three (3) business days of being
informed thereof and will, where appropriate, provide Seller
with returned Product for evaluation. The Seller will perform
an analysis of any quality complaint or returned Product
promptly and will provide Buyer with a written report.
Defective or broken Products will be initially returned to
Buyer for analysis. Buyer may, at its discretion, forward any
defective or broken Products to Seller for repair or analysis.
Buyer will be responsible for all MDR reports of product in
the United States; however, Seller will be responsible for all
Vigilance reports within the EU. The cost of servicing or
repair of any
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Products under warranty shall be borne by Seller in accordance
with the terms of Section 11 below. The cost of servicing or
repair of any Products that are damaged or defective for any
other reason shall be paid by Buyer to Seller at Seller's then
current standard rates for such repair service as invoiced by
Seller to Buyer.
(b) Quality Standards. Buyer shall have access for purposes of
reviewing and auditing Seller's Quality Assurance Manual and
all quality systems employed by Seller in connection with the
manufacture and packaging of the Product. In addition, Seller
shall provide the documentation necessary to allow Buyer to
reference Seller's relevant regulatory file(s) in any
submissions with the FDA and any international regulatory
filings or approvals in connection with the approval of the
Product. Seller shall cooperate with Buyer's reasonable
requests for information in all FDA regulatory filings, audits
and approvals and Seller shall cooperate with Buyer to address
any GMP deficiencies noted during any FDA audit.
10. Inspection and Acceptance. Upon receipt by Buyer of a shipment of
Products, Buyer will have ten (10) working days to inspect the Products
for conformity with the Specifications and the agreed quality control
procedures and tests listed on Schedule 1 hereto. Buyer will promptly
report to Seller any damage, discrepancy or quality control failure in
or to a shipment of Products discovered by Buyer during the above ten
(10) working day acceptance period and furnish written evidence or
other appropriate documentation to Seller. If the substantiating
evidence delivered by Buyer demonstrates that such damage,
Specification discrepancy or quality control problem existed at the
time of delivery of the Products at the FOB point, Seller will promptly
deliver additional or substitute Products to Buyer in accordance with
the terms of this Agreement. For purposes of this Agreement, Buyer
shall be deemed to have accepted all Products shipped which have not
been affirmatively rejected by Buyer within the ten (10) working day
acceptance period set forth above.
11. Warranties and Service.
(a) Warranties. Seller warrants that it has all rights to sell the
Products and that the Products, when sold to Buyer, will be
free and clear from all liens and encumbrances. Seller
warrants that the Products will meet the Specifications and
will be free from defects in material and workmanship at the
time of shipment from Seller's manufacturing facility. Such
warranty shall begin on the date of invoice of the Products by
Buyer and shall continue for one (1) year and three (3) months
thereafter. Seller further warrants that the manufacture of
the product will be in conformity with QSR's of the FDA for
medical devices and in compliance with ISO 9001 series
guidelines, and that no Product delivered under this Agreement
will be adulterated or misbranded within the meaning of the
United States Food, Drug and Cosmetic Act. No substitution of
Product may be made by Seller without the express written
consent of Buyer.
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Buyer ________
Seller _______
Seller will, in its discretion, repair or replace or issue a
full refund with respect to any Product failing to meet the
above warranties; provided, that the defective Product is
returned to Seller at Seller's expense within the warranty
period. Seller will use commercially reasonable efforts to
complete any repairs and ship the Product back to Buyer within
eight (8) working days of Seller's receipt of the Product.
Seller will have no obligation to make any repairs,
replacements or refunds with respect to Products which are
rendered defective in whole or in party by accidents, the
fault or negligence of Buyer or its customers, as the result
of excessive wear and tear, or the failure of Buyer or its
customers to maintain or use the Products in accordance with
Seller's applicable operating and/or maintenance manuals. No
Product may be returned to Seller without a return
authorization approved by Seller. All replaced Products or
parts shall become the property of Seller and shall, at
Seller's instructions, be returned to Seller at Seller's
expense or destroyed.
(b) LIMITATION OF WARRANTIES, REMEDIES AND LIABILITY. THE
WARRANTIES SET FORTH IN THIS SECTION 11 ARE INTENDED SOLELY
FOR THE BENEFIT OF BUYER. ALL CLAIMS HEREUNDER SHALL BE MADE
BY BUYER AND MAY NOT BE MADE DIRECTLY ON SELLER BY BUYER'S
CUSTOMERS. THE WARRANTIES SET FORTH ABOVE ARE IN LIEU OF ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY
DISCLAIMED AND EXCLUDED BY SELLER, INCLUDING WITHOUT
LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR USE AND ALL OBLIGATIONS OR LIABILITIES
ON THE PART OF THE SELLER FOR DAMAGES ARISING OUT OF OR IN
CONNECTION WITH THE USE, REPAIR OR PERFORMANCE OF THE
PRODUCTS. THE SOLE AND EXCLUSIVE REMEDIES FOR BREACH OF ANY
AND ALL WARRANTIES AND THE SOLE REMEDIES FOR THE SELLER'S
LIABILITY OF ANY KIND (INCLUDING LIABILITY FOR NEGLIGENCE)
WITH RESPECT TO THE PRODUCTS AND ITS PERFORMANCE UNDER THIS
AGREEMENT SHALL BE LIMITED TO THE REMEDIES PROVIDED IN SECTION
11(a) ABOVE. SELLER SHALL NOT BE RESPONSIBLE FOR ANY
INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING FROM ITS BREACH OF
SAID WARRANTY OR ITS PERFORMANCE OF THIS AGREEMENT.
(c) Service. With the delivery of the Product in the first
purchase order under this Agreement, Seller shall provide
Buyer with two (2) loaner units of the Product. Thereafter,
Seller shall provide Buyer with that number of loaner units of
the Product which at any given time during the Term of this
Agreement is equal to five percent (5%) of the number of
Products purchased, and no past due invoices by Buyer which
are still under warranty to meet the reasonable requirements
of Buyer to provide such
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units to its customers while units under warranty are repaired
or replaced as provided above. The loaner pool will be
adjusted (up or down) every six months to reflect the proper
number available to support the installed base. The loaner
pool can never exceed five percent (5%) of the delivered
units. If a situation occurs that demand a higher number, a
solution will be found between the Seller and Buyer, in order
to service the customer base as intended. Such loaner units
will at all times remain the property of Seller, and shall be
returned to Asah Medico's manufacturing facility in Hvidovre,
Denmark, freight and insurance prepaid, once each twelve (12)
months for maintenance. Seller shall continue to provide
service for a minimum of seven (7) years from the date of this
Agreement on the Products at Seller's customary rates for
service. Seller also shall provide an extended service
warranty option beyond the one (1) year warranty period at
Seller's then current service charges.
12. Indemnification.
(a) Buyer's Indemnification. Buyer will assume full responsibility
with respect to the use of the Product, and it is mutually
agreed that Seller assumes no liabilities of any kind with
respect to the use by Buyer or any third party of the Product.
Buyer agrees to indemnify and hold harmless Seller, its
successors, assigns, directors, officers, agents and
employees, from and against any and all losses, damages or
expenses, including court costs and reasonable attorneys'
fees, resulting from or arising out of (i) the special design
features of the Product requested by Buyer and incorporated in
the Specifications, (ii) the marketing, sale or use of any
Product by Buyer or its customers, (iii) any modification or
alteration of the Products by Buyer or its customers or agents
without Seller's prior consent, or (iv) any acts of negligence
or misrepresentation by Buyer or its employees or agents,
unless such loss, damage or expense is the direct result of
the Product failing to meet the Specifications set forth
herein at the time of shipment from Seller's facility.
(b) Seller's Indemnification. Seller agrees, at its own expense,
to defend, indemnify and hold harmless Buyer, its successors,
assigns, directors, officers, agents and employees, from and
against any and all losses, damages or expenses, including
court costs and reasonable attorneys' fees, resulting from or
arising out of the failure of the Product to meet the
Specifications at the time of shipment to the Buyer.
(c) Indemnification Procedures. In the event that any demand or
claim is made or suit is commenced against an indemnified
party, the indemnified party shall give prompt written notice
to the indemnifying party and the indemnifying party shall
have the right to compromise such claim to the extent of its
own interest and shall undertake the defense of any such suit.
An indemnified party may engage its own counsel, at its own
expense, to monitor the defense of any such matter.
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13. Term and Termination.
(a) Term. This Agreement shall commence on the date hereof and
shall terminate on the conclusion of the Third Contract Year
hereunder, unless sooner terminated in accordance with the
terms hereof or extended by the mutual agreement of the
parties (the "Term").
(b) Termination. Either party may terminate this Agreement
immediately and cancel any purchase orders hereunder if the
other party (i) assigns this Agreement or any of its rights
hereunder in violation of the terms of this Agreement and
without the prior written consent of the other party, (ii)
makes an assignment for the benefit of creditors, or a
receiver, trustee in bankruptcy or similar officer is
appointed to take charge of all or part of its property, (iii)
is adjudged a bankrupt, (iv) breaches any material term of
this Agreement and such breach has not been remedied within
thirty (30) days after written notice thereof has been given
to the breaching party, or (v) the other party's performance
of this Agreement has been prevented by an event of Force
Majeure for at least six (6) consecutive months pursuant to
Section 15(c) below. In addition, Seller may terminate this
Agreement immediately if the Buyer fails to purchase the
minimum quantities of Products pursuant to Section 8(d) hereof
in each relevant quarter or Contract Year unless Buyer cures
such default by issuing a firm purchase order to Seller for
the shortfall in purchased Products. Any such termination
shall not release Seller or Buyer from their obligations
arising under this Agreement prior to the effective date of
termination.
14. Confidentiality.
(a) Definition. In the course performing under this Agreement,
each party may obtain information from the other party that is
of a proprietary or confidential nature ("CONFIDENTIAL
Information"). Confidential Information may include, but is
not limited to, trade secrets, manufacturing specifications,
technical data and know-how, instructional and operating
manuals, financial information, marketing and sales data and
plans, and other information or documents. Confidential
Information must either be in writing and clearly marked as
confidential or, if disclosed orally or in intangible form,
received under circumstances which can be reasonably
understood to impose an obligation of confidentiality on the
receiving party.
(b) Disclosures of Confidential Information. Neither party shall
at any time, either during or after the Term of this
Agreement, use for its own purposes or publish, disclose, or
otherwise divulge any of the other party's Confidential
Information to any person without the prior written consent of
the other party. Each party shall protect the Confidential
Information of the other party through means at least as
stringent as those used to protect that party's own
Confidential Information. Neither party shall use the
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other party's Confidential Information except in the course of
performing its obligations under this Agreement. Upon
termination of this Agreement for any reason, each party shall
immediately return to the other party all of the other party's
Confidential Information in its possession, custody, or
control.
(c) Limitations on Scope of Confidential Information. The term
Confidential Information shall not apply or shall cease to
apply to information which (i) can be demonstrated by
reasonable documentary proof to be already known to the other
party, (ii) is or becomes publicly known through no wrongful
act of the receiving party, (iii) can be demonstrated by
reasonable documentary proof to have been independently
developed by the receiving party without benefit of the
disclosing party's Confidential Information, or (iv) is
received from a third party without similar restriction and
without breach of this Agreement.
(d) Injunctive Relief. The parties acknowledge and agree that any
breach of this Section 14 may cause irreparable harm to the
non-breaching party, and therefore such party shall be
entitled to injunctive relief in addition to all other legal
remedies.
(e) Prior Agreement. Upon execution of this Agreement, the
Confidentiality Letter Agreement executed by the parties as of
June 21, 2003 shall terminate and be superseded by the
provisions of this Section 14.
15. Force Majeure.
(a) Definition. "FORCE MAJEURE" means any event or condition, not
existing or known on the date hereof, not reasonably
foreseeable as of such date, and not reasonably within the
control of either party, that prevents in whole or in material
part the performance by one of the parties of its obligations
under this Agreement or that renders the performance of such
obligations so difficult or costly as to make such performance
commercially unreasonable.
(b) Notice. Upon giving written notice to the other party, the
party whose performance is affected by an event of Force
Majeure shall be released without any liability on its part
from the performance of its obligations under this Agreement,
EXCEPT for the obligation to pay any amounts due and owing,
but only to the extent and only for the period that such
performance is so affected by the event of Force Majeure. Such
notice shall include a description of the nature of the event
of Force Majeure and its cause of possible consequences. The
party claiming Force Majeure shall promptly notify the other
party of the termination of such event.
(c) Termination. Should the period of Force Majeure continue for
more than six (6) consecutive months, either party may
terminate this Agreement
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without liability to the other party, except for payments due,
upon giving written notice to the other party.
16. Dispute Resolution.
(a) Negotiation. The parties agree to consult and negotiate in
good faith to try to resolve any dispute, controversy or claim
that arises out of or relates to this Agreement. The parties
agree that, except as provided in Section 16(b) below, neither
party will initiate formal dispute resolution under this
Agreement unless and until such party has provided written
notice of the potential claim to the other party and the
representatives of the parties shall have attempted to achieve
an amicable resolution of the claim; provided, however, that
in no event shall a party be required to delay initiation of
formal dispute resolution hereunder for more than a period of
thirty (30) days following such notice.
(b) Reservation for Litigation. Notwithstanding Section 16(a)
above and Section 16(c) below, each party expressly reserves
the right to seek emergency injunctive relief from a court of
competent jurisdiction if in such party's discretion the
circumstances warrant such relief. In addition, nothing in
this Section 16(b) shall preclude a party from seeking such
interim relief with respect to any disputes or claims arising
under this Agreement as may be available under the arbitration
rules as provided in Section 16(c) below. However, immediately
following the issuance of such injunctive relief, each party
shall consent to the stay of any judicial proceedings pending
arbitration of all underlying claims between the parties in
accordance with this Section 16.
(c) Arbitration. Subject to the rights of the parties under
Section 16(b) above, all disputes, claims or controversies
arising out of or in connection with this Agreement shall be
finally settled in accordance with the International
Arbitration Rules (the "Rules") of the International Centre
for Dispute Resolution of the American Arbitration Association
("AAA"), as modified by Section 16(d) below. Such arbitration
shall be conducted before an arbitral tribunal consisting of
three (3) members appointed in accordance with the Rules. The
award of the tribunal shall be final and binding on the
parties, and judgment upon the award rendered by the
arbitrators may be entered in any court of competent
jurisdiction. The place of arbitration shall be New York, New
York, USA. At least one arbitrator shall have knowledge of or
experience in the medical device industry.
(d) Special Rules. Notwithstanding any provision to the contrary
in the Rules, the parties hereby stipulate that any
arbitration hereunder shall be subject to the following
special rules.
(i) Each party shall have the right to request from the
arbitrators, and the arbitrators shall order upon
good cause shown, reasonable and
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Seller _______
limited pre-hearing discovery, including (1) exchange
of witness lists, (2) depositions under oath of named
witnesses, (3) written interrogatories, and (4)
document requests;
(ii) Upon conclusion of the pre-hearing discovery, the
arbitrators shall promptly hold a hearing upon the
evidence to be presented by the parties and shall
promptly render a written opinion and award;
(iii) The arbitrators may not award or assess punitive
damages against either party; and
(iv) All reasonable attorney's fees and costs incurred by
the prevailing party in any arbitration pursuant to
this Agreement, and the cost of such arbitration,
shall be paid by the losing party to the arbitration
within five (5) days after receipt of written demand
therefore from the prevailing party following the
rendition of the written decision of the arbitral
tribunal.
(e) Survival. The duty of the parties to arbitrate any dispute,
controversy or claim under this Section 17 shall survive the
termination of this Agreements for any reason.
17. Entire Agreement; Amendment. This Agreement sets forth the entire and
only agreement between Buyer and Seller concerning the subject matter
hereof. No provision of this Agreement can be modified or amended
except by an explicit written amendment signed by both Buyer and
Seller.
18. Assignment. Neither party will have the right to assign this Agreement,
in whole or in part, to any third party without the prior written
consent of a duly authorized officer of the other party.
Notwithstanding the foregoing, either party may freely assign this
Agreement (i) to any company controlling, controlled by or under common
control with that party; provided, that such assignment shall not
relieve the assigning party of any of its obligations and liabilities
under this Agreement, or (ii) to any party succeeding to the entire
business of the party to which this Agreement relates. This Agreement
will be binding upon and inure to the benefit of the parties and their
successors and assigns to which such consent, if necessary, is given.
19. General.
(a) Waivers. No waiver of any right or remedy hereunder will be
effective unless based upon a writing signed by the party
against whom it is sought to be enforced.
(b) Notices. All notices required or permitted under this
Agreement must be made in writing and delivered in person, by
certified or registered mail, postage prepaid, or by a
recognized international courier for second day delivery,
addressed to the attention of the Chief Executive Officer of
the
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Buyer or the Chief Executive Officer of the Seller at the
respective addresses of the parties first written above, or
such other address as may be given by one party to the other
by like notice.
(c) Relationship. The parties are independent contractors and
shall not be deemed to have formed any partnership, joint
venture or other relationship. Neither party shall make, or
represent to any other person that it has the power or
authority to make, any financial or other commitment on behalf
of the other party.
(d) Severability. If any provision of this Agreement is declared
invalid or unenforceable by a court of competent jurisdiction,
such provision will be severed from this Agreement and the
remaining provisions will be unaffected thereby. The parties
will promptly meet and negotiate a substitute provision
meeting as closely as possible the intent of the invalid or
unenforceable provision and, with reasonable precision,
avoiding the defects of the original provision.
(e) Governing Law. This Agreement has been entered into under the
laws of the State of New York, USA, without regard to its
principles of conflicts of law, and will be governed by and
construed in accordance with those laws as they apply to
contracts entered into and carried out solely within the State
of New York.
(f) Cumulative Remedies. Subject to the terms of this Agreement,
all rights accorded either of the parties hereunder shall be
cumulative with all other rights so granted as well as any
rights and remedies either of them may have at law or in
equity.
(g) Headings. The Section headings in this Agreement are for
convenience only and shall not affect the construction hereof.
IN WITNESS WHEREOF, the parties hereto have caused their duly
authorized representatives to execute this Agreement the day and year first
written above.
MEDART CORPORATION VASCULAR SOLUTIONS, INC.
By: /s/ Jan Enemaerke By: /s/ ▇▇▇▇▇▇ ▇▇▇▇
----------------------------------- ------------------------------
Its: President & Chief Operating Officer Its: Chief Executive Officer
----------------------------------- ------------------------------
Initials: 14
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SCHEDULE 1 - SPECIFICATIONS AND ACCEPTANCE STANDARDS
------------------------------------------------- --------------------------------------------------------------------
Laser Wavelength 810 nm +/- 10 nm
------------------------------------------------- --------------------------------------------------------------------
Output Power 30 W max
------------------------------------------------- --------------------------------------------------------------------
Power Range 1-30 W
------------------------------------------------- --------------------------------------------------------------------
Power Increments 1W
------------------------------------------------- --------------------------------------------------------------------
Operating Modes Continuous, Pulsed
------------------------------------------------- --------------------------------------------------------------------
Pulse Duration ON/OFF: Pulse mode: 10 - 1,000 milliseconds (msec)
------------------------------------------------- --------------------------------------------------------------------
CW: No "time out" on continuous
------------------------------------------------- --------------------------------------------------------------------
Display Readout: "Real Time" read out of both Time (Seconds) and Energy (Joules) on
screen while firing the laser.
------------------------------------------------- --------------------------------------------------------------------
Aiming Beam Attenuable Red-5 mw max (at
source) 635 +/- 4nm.
Aiming beam will be on all the
time (both in Stand-By and
Ready modes).
------------------------------------------------- --------------------------------------------------------------------
Output SMA-905 Type connector,
accepts:200 micron fibers up
to 5 W400, 600, and 1000
micron fibers up to 15 W. All
fibers to be .37 NA,
silica/silica multimode.
------------------------------------------------- --------------------------------------------------------------------
Size 20" x 12" x 6" overall dimensions (51cm x 30cm x 15cm)
------------------------------------------------- --------------------------------------------------------------------
Weight 28 lbs. or 13 kilos
------------------------------------------------- --------------------------------------------------------------------
Cooling Air cooled
------------------------------------------------- --------------------------------------------------------------------
Power requirements 110/220v suitable for U.S. and international AC input, as
specified in purchase order. Power cord to be included for
country of use, as specified in purchase order
------------------------------------------------- --------------------------------------------------------------------
Laser Casing Artwork to be applied by Seller at Buyer's specifications
------------------------------------------------- --------------------------------------------------------------------
Labeling All labeling to be written under Buyer's name and artwork, to be
supplied by Buyer
------------------------------------------------- --------------------------------------------------------------------
Accessories QSC -SMA converter, Foot pedal, operating manual
------------------------------------------------- --------------------------------------------------------------------
Packaging Packaged in a shipping case including the foot pedal, power cord
and operating manual
------------------------------------------------- --------------------------------------------------------------------
Inspection and Acceptance
------------------------------------------------- --------------------------------------------------------------------
Performance Feature: Acceptance Standards:
------------------------------------------------- --------------------------------------------------------------------
Run start-up and complete calibration No failure and calibrated power transmission at +/- 20% of output
power at fiber output
------------------------------------------------- --------------------------------------------------------------------
Physical defects and damage No visible damage to the outer shell, screen or working components
------------------------------------------------- --------------------------------------------------------------------
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SCHEDULE 2 - SCHEDULE AND PRICING
Seller and Buyer shall use their best efforts to meet the following
schedule for documentation, testing, report generation and regulatory filings
and approvals for the Product:
Seller delivers to Buyer all existing documentation for the 510(k)
submission:
- 510(k) for the 426 platform by September 24, 2003
- Operating manual by September 24, 2003
- Service manual by September 24, 2003
- IEC 60601 Series testing by September 24, 2003
- Software validation protocol by September 24, 2003
- Software modifications to be incorporated by September 24,
2003
- Statement of impact on software validation by September 24,
2003
- Standards compliance statement by September 24, 2003.
Buyer provides Seller with all changes to the Specifications, labeling
and artwork by September 24, 2003
Seller completes all software validations by January 1, 2004
Seller obtains CE ▇▇▇▇ authorization for the Products by November 15,
2003
Buyer files 510(k) submission by October 1, 2003
The price for the Product during each of the three Contract Years shall
be as follows, with quantities being cumulative over the three Contract Year
period
CONSOLE
------------------------- -------------------------
QUANTITY PRICE
First ** units **
Next ** units *
Next ** units *
Next ** units *
Thereafter *
------------------------- -------------------------
* Prices for all units in excess of ** units shall not exceed the price
for the first ** units except as provided in Section 6(b) and may be reduced
based on Seller's budgetary forecast of the cost of materials and labor at the
relevant time.
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Seller _______