EXHIBIT D
MANUFACTURING AGREEMENT
This Manufacturing Agreement ("this Agreement") is made and entered into as
of August 19, 1997 by and between Baxter Healthcare Corporation, Inc., a
corporation organized under the laws of the State of Delaware ("Baxter") and
AccuLase, Inc., a corporation organized under the laws of the State of
California ("AccuLase").
RECITALS
A. AccuLase and Baxter have entered into that certain Master Technology
Agreement, dated as of July 28, 1997 (the "Master Technology Agreement"),
pursuant to which, among other things, AccuLase has agreed to manufacture the
Product (as defined herein).
B. AccuLase and Baxter are entering into the License Agreement, dated as
of the date hereof (the "License Agreement"), simultaneously with the execution
and delivery of this Agreement, pursuant to which, among other things, AccuLase
agrees to license certain technical know-how, patents and products related to
the Product (as hereinafter defined).
C. AccuLase and Baxter wish to describe the terms and conditions by which
AccuLase manufactures the excimer laser for Baxter, Baxter retains rights to
manufacture the laser in the event AccuLase is unwilling or unable to
manufacture lasers and Baxter pays certain royalties to AccuLase on certain
products manufactured by Baxter.
D. Baxter and AccuLase acknowledge and agree that the intended use and
future value of the Product are uncertain as a result of the recent and
continuing development of the field of transmyocardial revascularization and the
parties further acknowledge that based on the foregoing, the consideration paid
for AccuLase's performance of its obligations set forth herein is adequate,
sufficient and fair consideration.
AGREEMENT
NOW, THEREFORE, in consideration of the covenants and representations
contained herein, the above recitals and other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties agree
as follows:
1. DEFINED TERMS. For the purposes of this Agreement, the following
terms shall have the definitions ascribed to them:
"Engineering Change" shall have the definition given it in Section 4 (c).
"Product" shall mean the excimer laser system having the specifications
attached as Exhibit A, solely for use for cardiovascular and vascular disease.
"Technology" shall mean the Specifications and the other proprietary
information referred to herein.
"Specifications" shall mean the drawings, schematics and detailed
specifications set forth in the Exhibit A, solely for the use of cardiovascular
and vascular disease.
2. MANUFACTURING RIGHTS, ORDERS, PRICES AND PAYMENTS.
(a) In consideration for the payments made by Baxter pursuant to Section
2.6 of the Master Technology Agreement, AccuLase agrees to manufacture the
Product for the exclusive use of Baxter in accordance with all of the terms and
conditions set forth within this Agreement, at the following prices:
(i) $ [*] per laser for the first eight (8) lasers,
(ii) After the first eight (8) lasers have been purchased
by Baxter and subject to Section 2(a)(iii) below, the
following prices shall apply:
Price
[*] Per Unit
------- ------------
[*] $75,000
[*] $[*]
[*] $[*]
[*] $45,000
(iii) Prices for Product shall be adjusted annually after three (3)
years, based upon changes in costs of materials (but not
overhead or profit margin).
(iv) Unless otherwise specified or required by law, all prices will
be quoted and billed exclusive of federal, state or local
excise, sales or other similar taxes. Such taxes, when
applicable, will appear as additional items on invoices.
(v) AccuLase shall be ready and able to timely supply all
quantities of the Product ordered by Baxter.
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(vi) Terms of payment are net thirty (30) days from receipt of the
Product at Baxter's designated destination.
(b) Baxter agrees to purchase a minimum of eight units of the Product from
AccuLase, pursuant to the terms and conditions stated herein, within 12 months
of the date of receipt of the two units of the Product referred to in Section
2.6 (c) of the Master Technology Agreement.
(c) Baxter agrees to purchase a minimum of twenty units of the Product
from AccuLase, pursuant to the terms and conditions state herein, in the second
12 month period following the date of receipt of the two units referred to in
Section 2.6 (c) of the Master Technology Agreement.
(d) In addition to and subsequent to the purchases set forth in
subparagraphs (b) and (c) of this Section 2, Baxter agrees to purchase units of
the Product as it deems necessary for Baxter's operations from AccuLase
throughout the term of this Agreement, and AccuLase agrees to manufacture the
Product to fill such purchase orders as defined in this subparagraph (d).
(e) Baxter shall issue purchase orders for the Product not less than
ninety (90) days prior to anticipated delivery dates. Baxter agrees to use
reasonable commercial efforts to give AccuLase ninety (90) days' notice
should schedule or quantity revisions become necessary. AccuLase shall
acknowledge promptly each subsequent Baxter purchase order in writing and
confirm delivery dates to destinations specified by Baxter. All sales of
Product shall be subject to the terms and conditions of this Agreement and,
to the extent they specify quantities, destinations and delivery dates, to
Baxter's purchase orders. If there is any conflict or difference in
interpretation between any Baxter purchase order and this Agreement, the
terms and conditions of this Agreement shall supersede those of such purchase
order. AccuLase shall not be liable for failure or delay in filling Baxter
orders because of any cause beyond the control of and occurring without the
fault of AccuLase; provided, however, that AccuLase (i) shall in all
circumstances be considered to control its relationships with its suppliers
and its internal allocation of manufacturing capacity, and (ii) shall notify
Baxter promptly of anticipated delays and shall use its reasonable commercial
efforts to fill such orders as soon as possible. Without limiting its other
available remedies, Baxter may cancel any order, in whole or in part, which
is delayed more than 60 days.
(f) In the event that Baxter reasonably determines that AccuLase is
unwilling or unable to produce the Product in compliance with all the terms of
this Agreement or one or more purchase orders subsequently issued to AccuLase,
(i) Baxter may terminate AccuLase's manufacturing rights under this Agreement
without payment or penalty to AccuLase, and (ii) Baxter may either manufacture
the Product directly or have the Product manufactured for Baxter without payment
or penalty to AccuLase.
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(g) AccuLase shall ship the Product F.O.B. AccuLase's San Diego,
California, plant via mutually agreed upon carriers. Normal cost of shipping
shall be prepaid by AccuLase and added to AccuLase's invoice to Baxter.
AccuLase shall ship Product by air freight if necessary to meet confirmed
delivery dates or to replace Product recalled or otherwise found by Baxter to
not conform to the Specifications and warranties, and AccuLase shall bear the
expense of the excess cost of air freight over normal shipping charges.
3. TERM AND TERMINATION.
(a) Unless sooner terminated pursuant to Section 8.1 of the Master
Technology Agreement, this Agreement shall remain in full force and effect until
expiration of the last to expire the Licensed Patent (as defined in the License
Agreement).
4. PRODUCT CHANGES.
(a) AccuLase shall make available to Baxter all developments or
enhancements to the Product or to other products that accomplish the same or
similar functions as the Product, provided that AccuLase shall not be required
to make available any development, enhancements, or other products which use
proprietary information of third parties. If Baxter agrees in writing to accept
such development, enhancement, or other product, it shall be added as an
amendment to the Specifications in a timely manner.
(b) AccuLase shall notify Baxter in advance and in writing of any proposed
change by AccuLase in the following aspects of the Product or its components:
(i) the composition, specifications, or source of any part, material, component
or assembly; (ii) the method of manufacture, assembly, or testing; (iii) the
specific subcontractors utilized by AccuLase; (iv) site of manufacture; or (v)
labeling. AccuLase shall not depart from or make any change to the
Specifications or the Product design or performance without prior written
consent of Baxter.
(c) Should Baxter want to make any change to the mechanical or electrical
design or Specifications which would affect the schedule, performance,
reliability, availability, appearance, dimensions, or safety of the Product, or
AccuLase's costs of manufacture, testing, labeling, or packaging ("Engineering
Change"), Baxter shall give AccuLase notice of the proposed Engineering Change.
AccuLase shall respond by giving Baxter a written evaluation of the Engineering
Change stating AccuLase's price increase or decrease, if any, to implement the
Engineering Change. If the parties agree to the Engineering Change, both
parties shall execute an amendment to the Specifications and, if a price change
is applicable, an amendment to the prices stated in Section 2 of this Agreement.
If the parties do not agree to the Engineering Change, Baxter may have the
Product manufactured by an alternative manufacturer in accordance with Section 2
(f) hereof.
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(d) By execution of the License Agreement, AccuLase hereby grants to
Baxter an exclusive license to all developments, enhancements and improvements
of the Product and to all discoveries, inventions, enhancements and improvements
of any and all technical know-how and intellectual property used in the
development of the Product, pursuant to the terms of the License Agreement, and
as further defined therein.
5. TRADEMARKS, LABELING, PATENTS, AND EXCLUSIVITY.
(a) As part of the Product and included in the prices set forth in this
Agreement, AccuLase, at its expense, shall produce and provide all artwork,
labeling, product inserts, and packaging for the Product as provided in the
Specifications. All such artwork, labels, inserts, and packaging and any use of
any trademark, trade name or logo owned or used by Baxter must be approved in
advance in writing by Baxter. If a trademark, trade-name or logo owned or used
by Baxter or its parent corporation is used in connection with the Product, the
labeling shall state "Distributed by Baxter Healthcare Corporation". AccuLase
shall obtain prior written authorization from Baxter for all changes to the
artwork, labels, inserts or packaging for the Product. Each use of a trademark,
trade name or logo owned or used by Baxter on or in connection with the Product
shall inure to the benefit of Baxter and its parent company. Should any such
use vest in AccuLase any rights in a trademark, trade name or logo used by
Baxter, AccuLase shall transfer such rights to Baxter or its designee upon
request of Baxter. Except as provided in this Agreement, AccuLase shall not use
any trademark, trade name or logo used or claimed by Baxter or any confusingly
similar trademark, trade name or logo during or after the term of this
Agreement.
(b) AccuLase shall manufacture and sell the Products exclusively for and
to Baxter unless an exception is expressly authorized by Baxter in a writing
signed by Baxter. AccuLase acknowledges that the Product is protected by one or
more patents and that this Agreement does not give AccuLase any right,
permission, or license to manufacture or sell the Product or any patented
invention which is a part of the Product except as authorized by Baxter within
this Agreement. AccuLase shall not design, sell, develop, or manufacture any
other excimer laser system for cardiovascular applications other than the
Product for any entity other than Baxter at any time during the term of this
Agreement unless an exception is expressly authorized by Baxter in a writing
signed by Baxter.
6. MANUFACTURE AND QUALITY CONTROL.
(a) For each shipment of Product, AccuLase shall conform to the
requirements set forth in Baxter's Supplier Quality Standard attached hereto as
Exhibit B and any other incoming quality standards which are agreed to by the
parties.
(b) All Product shall meet the Specifications. All product shall be
manufactured in accordance with Good Manufacturing Practices for Medical Devices
established by the United States Food and Drug Administration ("FDA") as
provided in 21 U.S.C. 360j (f) and as promulgated by regulations in 21 CFR 820.
Product shall be subjected to quality control inspection by AccuLase in
accordance with Baxter's quality control standards and the
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quality control system to be developed by AccuLase prior to production of any
Product. AccuLase shall permit Baxter to review periodically AccuLase's
production and quality control procedures and records and to visit AccuLase's
facilities at reasonable times with a representative of AccuLase present in
order to assure satisfaction of the requirements of this Agreement.
(c) Baxter may inspect or audit the product for integrity and adherence to
the Specifications. If any of the Product fails to meet AccuLase's warranties
or to conform to the Specifications, Baxter may return such lot at AccuLase's
expense for repair. If any customer of Baxter rejects or returns Product to
Baxter as a result of Product performance problems covered under AccuLase's
guaranty or warranty, Baxter shall notify AccuLase in writing within 30 days.
AccuLase shall repair or replace such Product or credit Baxter for the purchase
price of such Product. If AccuLase so requests, Baxter will return any such
Product to AccuLase at AccuLase's expense.
(d) AccuLase shall manufacture Product in such a manner that in the event
of a recall, the Product can be traced by serial number to a production run.
(e) In the event that Baxter receives any serious complaint regarding the
Product (i.e., that it is likely to cause death or serious injury), Baxter shall
notify AccuLase by facsimile within two (2) business days. In the event that
Baxter receives any other complaint regarding the Product, Baxter shall notify
AccuLase by first class mail within five (5) business days. In the event that
AccuLase receives any complaint regarding the Product, but in no event later
than 48 hours after receipt, AccuLase shall notify Baxter by facsimile,
telephone, and first class mail within 48 hours after AccuLase's receipt of the
complaint, in order to permit Baxter to comply with FDA regulatory requirements.
Baxter will make an evaluation of each complaint it receives and will conduct
all follow-up and communication which it deems appropriate to comply with
regulatory requirements.
(f) In the event that AccuLase becomes aware of any quality problem that
may render the Product unsafe for human use, misbranded, or adulterated,
AccuLase shall notify Baxter immediately by facsimile, telephone, and first
class mail and shall take corrective action as directed by Baxter.
(g) AccuLase represents that it is and will remain in compliance with all
applicable federal, state, and local laws, regulations, and orders. AccuLase
shall execute, on request of Baxter, contractor certification forms certifying
compliance with certain laws, regulations, and orders.
(h) In the event of any inspection of AccuLase's facilities by a federal,
state or local regulatory agency which inspection yields information or report
which is material to the manufacture, inspection, storage, or other handling of
the Product by AccuLase, AccuLase shall immediately notify Baxter in writing and
by telephone of such information or report.
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(i) AccuLase represents that it now has FDA and ISO 9002 certifications.
AccuLase shall maintain those certifications throughout the term of this
Agreement.
(j) Within thirty (30) days after execution of this Agreement, AccuLase
shall provide Baxter with a written list of the names and addresses of all of
the direct suppliers of parts and all subcontractors whom AccuLase will be using
in the manufacture, inspection, and testing of the Product.
7. GUARANTEE, WARRANTIES, AND INDEMNIFICATIONS.
(a) The Product is hereby guaranteed by AccuLase, as of the date of
shipment or delivery, to be on such date not adulterated or misbranded within
the meaning of the United States Federal Food, Drug and Cosmetics Act (the
"Act") and any similar federal, state, or local laws or regulations, and not an
article which may not, under the provisions of the Act, be introduced into
interstate commerce.
(b) ACCULASE WARRANTS THAT IT POSSESSES GOOD AND MARKETABLE TITLE TO THE
PRODUCT SOLD TO BAXTER AND THAT THE PRODUCT IS IN COMPLIANCE WITH THE
SPECIFICATIONS AND IS MANUFACTURED IN ACCORDANCE WITH GOOD MANUFACTURING
PRACTICES. ACCULASE WARRANTS THAT NO CHANGES WILL BE MADE IN THE SPECIFICATIONS
WITHOUT BAXTER'S PRIOR WRITTEN APPROVAL. AccuLase hereby indemnifies and agrees
to defend and to hold Baxter, its successors, affiliates, assigns, customers,
and users of the Product harmless from and against all claims, liabilities,
losses and expenses arising out of or in connection with the use of any Product
or allegedly caused by any Product, to the extent resulting from AccuLase's
negligence or the Product's failure to meet the Specifications or warranties.
(c) AccuLase further warrants for a period of one (1) year from the date
of delivery to Baxter's customer or eighteen (18) months from the date of
shipment by AccuLase, whichever is less, that the product is free from defects
in workmanship, materials and handling. AccuLase shall repair or replace, at
AccuLase's option and free of charge, any Product with any defect in workmanship
or materials which is returned to AccuLase's factory packaged, insured, and
freight pre-paid within the warranty period. AccuLase shall return the Product,
repaired or replaced, to the shipper packaged, insured, and with freight
pre-paid by AccuLase at AccuLase's expense. This warranty shall not apply to:
(i) Any modification or alteration of the Product made by anyone
other than AccuLase after shipment by AccuLase;
(ii) Any defect, loss, or damage resulting from theft, loss, fire,
misuse, abuse, vandalism, negligence, acts of God, power failures or
surges, alterations, modifications, or failure to following
installation, operations, and maintenance instructions; and
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(iii) Any other equipment, supplies, software, or data used with the
Product.
(d) Baxter hereby indemnifies and agrees to defend and to hold AccuLase ,
and its successors, affiliates and assigns harmless from and against all claims,
liabilities, losses and expenses, but not consequential damages, to AccuLase
arising out of for injury to any person or damage to property or in connection
with the use of any Product or any misrepresentation by Baxter concerning any of
the characteristics, proper manner of usage or the performance of the Product,
except to the extent resulting from the Product's failure to meet the
Specifications or AccuLase's warranties. Baxter shall not be liable for
any loss incurred by AccuLase, including any consequential damages suffered by
AccuLase, whether or not such damages are foreseeable or Baxter is given notice
of them.
8. INSURANCE. AccuLase shall obtain and keep in force during the term of
this Agreement general comprehensive liability insurance covering each
occurrence of bodily injury and property damage in an amount of not less than
$3,000,000 combined single limit with special endorsements providing coverage
for:
(i) Product and Completed Operations Liability; and
(ii) Blanket Broad Form Contractual Liability.
The insurance policy shall be endorsed to provide for written notification
to Baxter by the insurer not less than 30 days prior to cancellation, expiration
or modification. A certificate of insurance evidencing compliance with this
Section 8 and referencing this Agreement shall be furnished to Baxter by
AccuLase within 60 days of this Agreement's effective date and thereafter within
60 days after each renewal or replacement of the policy or change in the
information contained on the certificate of insurance.
9. PRODUCT RECALL. In the event that Baxter or AccuLase recalls, either
during or after the expiration or other termination of this Agreement, any of
the Product sold or distributed by Baxter because the Product is believed to
violate any provision of applicable law or fails to conform to the
Specifications or AccuLase's warranty, AccuLase shall bear all costs and
expenses of such recall, including, without limitation, expenses or obligations
to third parties, the cost of notifying customers and costs associated with the
shipment of recalled Product from customers to Baxter or AccuLase. This
obligation shall survive the expiration or other termination of this Agreement.
Baxter shall maintain complete and accurate records, for such periods as may be
required by applicable law, of all the Product sold by it. The parties will
cooperate fully with each other in effecting any recall of the Product,
including communications with any purchasers or users. If Baxter or AccuLase
elects any repair or replacement of the Product as part of a recall, AccuLase
shall complete the repair or replacement of all recalled Product within 60 days
of the announcement of the recall.
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10. LICENSE AND RESTRICTED USE OF TECHNOLOGY.
(a) AccuLase acknowledges Baxter's exclusive license of the Technology for
cardiovascular and vascular applications, and agrees that AccuLase will do
nothing inconsistent with such license. Throughout the term of this Agreement,
Baxter agrees to allow AccuLase access to the Technology solely for the purpose
of manufacturing the Product. AccuLase shall not reproduce, duplicate, copy or
otherwise disclose, distribute, or disseminate the Technology in any form except
to the extent consistent with this Agreement or otherwise approved by Baxter.
(b) AccuLase shall keep confidential and shall not disclose to anyone,
other than suppliers as needed by AccuLase in the manufacture of the Product,
the Specifications, the Product quantities, forecasts, or shipping destinations
specified by Baxter, or Baxter's customer data, such as the names, addresses,
telephone numbers, or quantities of Products owned or held by Baxter's
customers.
(c) Other than concerning warranty-covered repairs or replacements as
provided by this Agreement, AccuLase shall not communicate with any user of the
Product concerning the Product, including, but not limited to, any offer of an
extended warranty, maintenance or repair services, Product enhancements, Product
use, maintenance, or repair training, or the availability of associated or
competitive products or services.
11. ACCULASE'S EMPLOYEES. Disclosure and access to the Technology shall
be restricted to those of AccuLase's employees who are required to use the
Technology in the course of their employment, for purposes consistent with this
Agreement.
12. SUBLICENSES. AccuLase shall not grant sublicenses to use the
Technology or any part thereof in any manner to any third party, without
Baxter's prior written consent.
13. RETURN OF TECHNOLOGY. Within thirty (30) days following a termination
of this Agreement, or upon notification by Baxter that Baxter is terminating
AccuLase's manufacturing rights under this Agreement, AccuLase shall at its
expense promptly cause to be delivered to Baxter all documents related to the
Technology including, without limitation, all drawings, blueprints, manuals,
design and specification documents, lists, documentation, source or object
codes, tapes, disks, or other storage media, letters, notes, notebooks, reports,
flow charts, and all other materials in its possession or under its control
related to the Technology.
14. NOTICES. All notices and other communications hereunder shall be in
writing and shall be deemed given if delivered personally or by commercial
delivery service, or mailed by registered or certified mail (return receipt
requested) or sent via facsimile (with confirmation of receipt) to the parties
at the following address (or at such other address for a party as shall be
specified by like notice):
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(a) if to Baxter, to:
Baxter Healthcare Corporation
17221 Red Hill Avenue, m/s 98
Irvine, California 92614
Attention: Vice President, Business Development
Facsimile No.: (714) 474-6445
Telephone No.: (714) 474-6424
(b) if to AccuLase, to:
6865 Flanders Drive, Suite G
San Diego, CA 92121
Attention: Mr. Raymond A. Hartman
President and Chief Executive Officer
Facsimile No.: (619) 455-0946
Telephone No.: (619) 455-7030
with a copy to:
Donald G. Davis, Esq.
833 Via Del Monte, Suite 100
Palos Verdes Estates, CA 90274
Facsimile No.: (310) 373-5410
Telephone No.: (310) 378-8968
15. INTERPRETATION. When a reference is made in this Agreement to
exhibits, such reference shall be to an exhibit to this Agreement unless
otherwise indicated. The words "include, " "includes" and "including" when used
herein shall be deemed in each case to be followed by the words, "without
limitation." The phrase "made available" in this Agreement shall mean that the
information referred to has been made available if requested by the party to
whom such information is to be made available. The phrases
"the date of this Agreement", "the date hereof", and terms of similar import,
unless the context otherwise requires, shall be deemed to refer to the date
referred to in the introductory paragraph of this Agreement. The headings
contained in this Agreement are for reference purposes only and shall not affect
in any way the meaning or interpretation of this Agreement.
16. COUNTERPARTS. This Agreement may be executed in one or more
counterparts, all of which shall be considered one and the same Agreement and
shall become effective when one or more counterparts have been signed by each of
the parties and delivered to the other parties, it being understood that all
parties need not sign the same counterpart.
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17. ENTIRE AGREEMENT; RESTRICTIONS ON ASSIGNABILITY. This Agreement and
the documents and instruments and other agreements specifically referred to
herein or delivered pursuant hereto constitute the entire Agreement among the
parties with respect to the subject matter hereof and supersede all prior
Agreements and understandings, both written and oral, among the parties with
respect to the subject matter hereof. AccuLase may not assign its rights,
duties or obligations under this Agreement without the prior written consent of
Baxter.
18. SEVERABILITY. In the event that any provision of this Agreement, or
the application thereof, becomes or is declared by a court of competent
jurisdiction to be illegal, void or unenforceable, the remainder of this
Agreement will continue in full force and effect and the application of such
provision to other persons or circumstances will be interpreted so as reasonably
to effect the intent of the parties hereto. The parties further agree to
replace such void or unenforceable provision of this Agreement with a valid and
enforceable provision that will achieve, to the extent possible, the economic,
business and other purposes of such void or unenforceable provision.
19. AMENDMENT. This Agreement may not be altered or amended except by
writing signed by the parties hereto.
20. REMEDIES CUMULATIVE. Except as otherwise provided herein, any and all
remedies herein expressly conferred upon a party will be deemed cumulative with
and not exclusive of any other remedy conferred hereby, or by law or equity upon
such party, and the exercise by a part of any one remedy will not preclude the
exercise of any other remedy.
21. GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of California (without regard to its
principles of conflicts of law).
22. RULES OF CONSTRUCTION. The parties hereto agree that they have been
represented by counsel during the negotiation, preparation and execution of this
Agreement and, therefore, waive the application of any law, regulation, holding
or rule of construction providing that ambiguities in an agreement or other
document will be construed against the party drafting such agreement or
document.
23. EXPENSES. All costs and expenses incurred in connection with this
Agreement and the transactions contemplated by this Agreement will be paid by
the party incurring such expenses.
24. ATTORNEYS' FEES. In the event of any dispute arising under the terms
of this Agreement (including the breach thereof), the prevailing party in such
action shall be entitled to its attorneys' fees and costs in addition to such
other relief as may be awarded by a court or by an arbitrator.
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25. SECURITY INTEREST. AccuLase's performance of this Agreement and the
obligations of AccuLase arising hereunder shall be secured by that certain
Security Agreement, dated as of the date hereof, as described in Section 2.5 of
the Master Technology Agreement, upon the terms and conditions contained
therein.
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IN WITNESS WHEREOF, Baxter and AccuLase have caused this Agreement to be
executed and delivered by their respective officers thereunto duly authorized
all as of the date first written above.
Baxter Healthcare Corporation,
a corporation
By: /s/ John H. Kehl, Jr.
-------------------------------------
Name: /s/ John H. Kehl, Jr.
------------------------------
Its: /s/ Vice President, Business Development
Cardiovascular Group
-------------------------------
AccuLase, Inc., a corporation
By: /s/ Raymond A. Hartman
-------------------------------------
Name: /s/ Raymond A. Hartman
------------------------------
Its: /s/ President & CEO
-------------------------------
ATTACHMENTS:
Exhibit A - Excimer Laser Product Specifications
Exhibit B - Baxter Supplier Quality Standards writing and by telepone of such
information or report as well as the results of such insepction.