SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
-------------------
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): January 27, 1999
Novoste Corporation
(Exact name of registrant as specified in charter)
Florida 0-20727 59-2787476
(State or other (Commission File Number) (IRS Employer
jurisdiction of Identification No.)
incorporation)
3890 Steve Reynolds Blvd., Norcross, GA 30093
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (770) 717-0904
4350-C International Blvd., Norcross, GA 30093
(Former name or former address, if changed since last report)
<PAGE>
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibit 10.20+- Manufacturing Supply Agreement, dated April 21,
1998, between Registrant and SeaMED Corporation
and exhibits thereto.
----------
+ Portions have been omitted and filed separately with the Securities
and Exchange Commission pursuant to a request for confidential
treatment. Omitted portions of text are denoted as "< >".
2
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the Registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
Novoste Corporation
(Registrant)
By: /s/ David N. Gill
-----------------
David N. Gill
Chief Financial Officer
Dated: January 27, 1999
3
<PAGE>
EXHIBIT INDEX
Exhibit
Number Description
- ------ -----------
10.20+ Manufacturing Supply Agreement, dated April 21, 1998, between the
Registrant and SeaMED Corporation and exhibits thereto.
- ------------
+ Portions have been omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.
Omitted portions of text are denoted as "< >".
4
<PAGE>
Exhibit 10.20+
- ----------
+ Portions have been omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.
Omitted portions of text are denoted as "< >".
Manufacturing Supply Agreement
between
SeaMED Corporation
and
Novoste Corporation
April 21, 1998
1
<PAGE>
Manufacturing Supply Agreement
LIST OF EXHIBITS
Exhibit A Products, Pricing & Lead-time
Exhibit B-1 Pre-Production Pricing Formula
Exhibit B-2 Production Pricing Formula
2
<PAGE>
SUPPLY AGREEMENT
This Basic Order Agreement and all attachments (called the "Agreement") is made
by Novoste Corporation ( "Buyer" ) its principal place of business at 4350-C
International Boulevard, Norcross, GA 30093 and SeaMED Corporation,
("Contractor") its principal place of business at 14500 N.E. 87th Street,
Redmond, Washington 98052. This Agreement sets forth the mutual understanding by
which the Buyer and the Contractor will conduct business for the life of this
Agreement.
Whereas, the Contractor has the facilities and expertise to manufacture, test,
service and distribute electronic devices.
Whereas, Buyer desires to engage the services and the facilities of Contractor
for the production and ongoing maintenance of an electronic device known as the
Alpha IV (hereinafter "Product") and other related electronic assemblies as may
be specified in the future;
In return for the exclusive authorization to build the Buyer's product both
parties agree as follows:
I. DEFINITIONS
A. "Medical Device Reporting" ("MDR") shall be defined as any event
which is required to be reported to the FDA in accordance with 21
CFR Part 803.
B. "Certificate of Compliance" shall be defined as Contractor's
notification that the Product (including subassemblies for service)
conforms to all established qualification criteria agreed to between
both the Contractor and Buyer.
C. "Buyer's Equipment" shall be defined as capital equipment such as
production molds, fixtures or testing equipment purchased for and
charged to the Buyer specifically to manufacture and test the
Product.
D. "Product Complaint" shall be defined in accordance with the relevant
sections of the CGMP / QSR and EN46001 regulations.
E. "Pre-production Product" shall be defined as the fabrication of
products in the manufacturing area under CGMP / QSR and EN46001
control using pre-production released documentation.
II. GENERAL TERMS AND CONDITIONS
A. This Agreement is a supply agreement whereby the Buyer agrees to
purchase all of its requirements for the term shown from the
contractor; it does not obligate Buyer to purchase any specific
quantity but only establishes the terms and conditions for such
purchases if they occur. All such quantities will be specified on
Buyer's Purchase Orders, issued under the provision of this
Agreement and incorporated herein by reference.
B. If any term of this Agreement conflicts with any term of an issued
Purchase Order, this Agreement shall take precedence. Any terms or
conditions in the Purchase Order not covered under this agreement
must be specified on the front of purchase orders and must be
mutually and explicitly agreed to by both the Buyer and Contractor.
3
<PAGE>
C. Buyer may add products to the list of "Products" available for
purchase hereunder by adding such products to a Purchase Order that
is accepted by Contractor. Such added products shall be deemed
"Products" as defined herein as though listed in Exhibit A,
(Products, Pricing and Lead-time), at the time of executing this
Agreement. The price for which such added products shall be
available for purchase under this Agreement shall be as stated on
such accepted Purchase Orders(s), subject to the provisions of this
Agreement. The Buyer shall amend Exhibit A to reflect the added
Products and relevant pricing.
D. Payment - Payment for any shipment of product is due thirty (30)
calendar days subsequent to the date of invoice for such shipment.
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, where applicable, will
appear as additional terms on invoices.
III. PURCHASE ORDERS
A. The term "Purchase Order" shall mean Buyer's written Purchase Order
form and any documents incorporated therein by reference.
B. Acceptance by Contractor is limited to the provisions of the
Agreement and the Purchase Order. No additional or different
provisions proposed by Buyer shall apply and are hereby rejected. In
addition, the parties agree that this Agreement and issued Purchase
Orders constitute a Contract for the Sale of Goods and satisfy all
statutory and legal formalities of a contract.
IV. PURCHASE TERM
A. The term during which Buyer may issue Purchase Orders for Product
under this Agreement ("Purchase Term") will begin on April 20, 1998
and end three (3) years after the date of the sale and shipment of
the first production unit from Contractor to Buyer. Production units
shall be defined as units which are released and manufactured to
Revision A level drawings by the Contractor. This Agreement governs
Purchase Orders issued by Buyer during the Purchase Term and any
extension so long as Buyer has requested that the Product be
delivered within two (2) months beyond the end of the Purchase Term
or any extension.
B. The Purchase Term will be extended automatically for one (1) year
increments after the initial three (3) year term. Written notice not
to extend the Agreement by either party is to be provided three (3)
months in advance of completion of current Agreement term or
extension.
V. PRODUCT PRICING
A. PREPRODUCTION PRICING will be conducted on an actual time and
material basis and will include gross margin. Refer to Exhibit B-1
for SeaMED's pricing formula. Refer to the Norse Project Plan for
pricing targets.
B. PRODUCTION PRICING
(i) Initial production pricing will be established within one (1)
month from completion of the pre-production units and
acceptance of a Final Design Review or Production Readiness
Review. Labor and Material costs determined from
pre-production and the pricing formula in Exhibit B-2 will be
utilized to establish the initial selling price An initial
review of costs and adjustments to selling price based on
changes in material and labor costs will occur after a first
review at three months and on an annual basis thereafter.
(Contractor agrees to open books to Buyer for verification of
material and labor costs.) Rates will be fixed for one (1)
year from the completion of pre-production units. Refer to the
Norse Project Plan for pricing targets.
4
<PAGE>
(ii) Prices include all charges such as packaging, packing, and all
taxes except sales, use, and other such taxes imposed upon the
sale or transfer of Product. Buyer shall have no liability for
such taxes if it has complied with statutory resale tax
certificate requirements. If Buyer is liable to pay these
taxes, they shall be specifically listed in Contractor's
invoice.
VI. DELIVERY, LEAD-TIME AND FLEXIBILITY
A. Buyer's Purchase Orders shall state Contractor's committed delivery
date for Product. TIME AND RATE OF DELIVERY ARE OF THE ESSENCE OF
ALL PURCHASES MADE UNDER THIS AGREEMENT. The minimum agreed period
between Buyer's issuance of a Purchase Order and the scheduled
delivery date ("Lead-time") shall be as stated in Exhibit A.
Contractor will use reasonable efforts to supply Product in
accordance with Buyer's required ship dates. Shipment delays
requested by Buyer or due to Buyer supplied materials, design
changes, software or other factors under the primary control of the
Buyer may result in an inventory deposit from Buyer to Contractor.
B. All shipments shall be F.O.B. Origin, with title passing to Buyer at
time of final approval at Contractor's facility. Buyer shall select
the carrier and shall pay transportation charges.
C. Buyer may require that shipments of Product under this Agreement be
shipped by Contractor to various destinations. The Purchase Order
issued by the Buyer will clearly specify the "SHIP TO" location for
each Product.
D. Buyer and Contractor recognize that each program is unique and will
require program specific ordering parameters. These parameters are
mutually agreed to after the bill of material is finalized and
production quantities are provided to the Contractor in the form of
a purchase order or delivery forecast. The following parameters
offer a typical scenario where the Buyer may, without cost or
liability, increase or decrease the order quantity by mutual
agreement. Contractor will use reasonable efforts to meet Buyer's
scheduling needs.
Order Parameters
-------------------------------------------------------------------
0 to 3 Months Firm PO's, Schedule unchangeable
-------------------------------------------------------------------
4 to 6 Months Firm PO's. May move up to 30% of scheduled
deliveries on PO's out 30 days without penalty, or
in 30 days depending on material availability.
-------------------------------------------------------------------
7 to 12 May move up to 40% of scheduled deliveries on PO's
Months out 60 days without penalty, or in 60 days
depending on material availability. Delivery
slides >60 days will require an inventory deposit.
-------------------------------------------------------------------
E. During the Pre-Production phase the Contractor will order materials
in sufficient quantities to meet the requirements of the Engineering
Project Plan and initial pre-production schedule. The Contractor
will typically order critical materials and sub-assemblies at a rate
of 110% of demand.
F. Buyer plans to purchase < > Products in calendar year 1998 as
follows:
Quantity Target Delivery
-------- ---------------
< > July
< > August
< > September
< > October
< > November
5
<PAGE>
Based on the long lead times of some components used in the manufacture of
the Product (i.e., 26 weeks for some PC Board level components), if Buyer
plans to place any additional orders beyond the initial order quantity of
< > Products, Buyer should provide Contractor with written authorization
to procure long lead components. Contractor will periodically provide
Buyer with an updated list of long lead components to assist in
determining Product lead times. Should Buyer provide a forecast for
additional Products, Contractor will request written authorization from
Buyer to procure long lead materials, determine economic order quantity
buys of components or unique parts, and lot size Printed Circuit Board
Assemblies on a quarterly basis.
G. EXCESS AND OBSOLETE MATERIALS
(i) During the performance of this supply Agreement, Contractor
will purchase materials to support the requirements of the
Buyers program. Certain materials which Contractor will
acquire will be subject to minimum-buy requirements and
quantity price breaks which may result in excess material
accumulation which will be the responsibility of the Buyer
provided that Buyer has approved such purchases. Additionally,
design changes may cause materials to become obsolete.
Obsolete materials due to a design change will be returned to
suppliers when possible. Non-returnable inventory will be
charged and delivered to the Buyer.
(ii) During the performance of this supply agreement, Contractor
will provide the Buyer with periodic updates of the status and
amount of excess or obsolete material.
(iii) Contractor will use its best effort to minimize the impact of
excess material and/or obsolete materials on Buyer's program.
Contractor will return materials to suppliers for credit, less
restocking fees, when appropriate. However, final costs
associated with the accumulation of excess and obsolete
materials are chargeable and payable by the Buyer. Any excess
or obsolete inventories will be charged to the Buyer at
Contractor's cost plus 20% material burden, but without
profit. Disposition of excess or obsolete materials will be
coordinated with the Buyer to minimize the impact of cost to
the Buyer where possible. Buyer's targeted maximum
obsolescence budget is $50,000 maximum.
VII. WARRANTY
A. LIMITED WARRANTY
(i) Contractor warrants for twelve (12) months from date of
shipment to Buyer's customer from Buyer's facility that all
Product shall be free from defects in material and
workmanship, and shall conform to applicable specifications,
drawings, samples and descriptions referred to in this
Agreement, (provided shipment to Buyer's customer from Buyer's
facility occurs within three months from date of invoice to
the Buyer and the unit has only been subject to receiving and
inspection at Buyer's facility). Contractor warrants it has
the right to convey the Product and that the Product is free
of all liens and encumbrances.
(ii) Contractor shall correct such Product at its facility. At
Buyer's option, Contractor shall complete an assessment of the
returned product, (typically within five (5) days of receipt),
and repair or replace all defective Product (typically within
fifteen (15) days of receipt) unless otherwise specified. Turn
around times will vary depending on the complexity of the
product. Inbound freight will be the responsibility of the
Buyer. Contractor agrees to pay return freight to the customer
and method of shipment will be consistent with the method of
inbound freight to the Contractor. Contractor will pay for
inbound freight for any new units delivered dead on arrival
(DOA) to Buyer or Buyer's customer. DOA is defined as any
product that does not perform substantially in compliance with
the applicable specifications upon receipt by Buyer or Buyer's
Customer.
(iii) Buyer warrants that the shipment of the Product is lawful
under the FDC Act and that the Buyer holds all necessary
marketing clearance and approvals from the FDA.
6
<PAGE>
B. NON-WARRANTY
(i) Repair services outside the scope of the warranties described
in this Section VII shall be provided by the Contractor and/or
the Buyer pursuant to a Repair and Service Agreement to be
negotiated in good faith by the parties and signed within a
reasonable time following execution of this Agreement.
C. SUPPLY OF REPLACEMENT PARTS
(i) Contractor agrees to provide Buyer, upon request, Buyer's
requirements of replacement parts or a designee of the Buyer
to: (a) provide non-warranty repair services to Buyer's
customers, should Contractor not provide such repairs, and (b)
provide warranty repair services at authorized third party
service centers world-wide selected by the Buyer with
Contractor's consent. Buyer shall pay for such replacement
parts consistent with Contractor's current spares pricing
methodology, plus freight and shipping charges actually
incurred by the Contractor. The cost of replacement parts
required pursuant to (A) above, including freight and shipping
charges, shall be at the Contractor's expense as part of its
warranty services. No third party repairs would occur without
mutual consent of Contractor and Buyer.
(ii) Contractor warrants that for a period of time beginning on the
date of delivery to the Buyer or the Buyer's designee of any
replacement parts provided pursuant to this Section A, Limited
Warranty, and continuing thereafter for ninety (90) days
following delivery of such replacement parts to the Buyer's
Customer (but in no event to exceed six (6) months from the
date of delivery of such replacement parts to the Buyer), each
such part shall be free from defects in material and
workmanship. In the event any replacement part provided
pursuant to this Section does not conform with the above, the
Buyer or, at the Buyer's option, the Buyer's designee shall
return such replacement part to the Contractor, and the
Contractor shall, within seven (7) days following the receipt
(dependent on material availability), promptly repair or
replace such replacement part without charge and refund to the
Buyer or the Buyer's designee freight paid by the Buyer or the
Buyer's designee for the original and return shipment, such
freight cost not to exceed the then current surface rate,
freight charge charged by United Postal Service ("UPS") or, if
such UPS freight charge is not readily available, the rate
charged by a shipping company similar to UPS.
VIII. CONFIDENTIAL INFORMATION AND ADVERTISING
A. Contractor and Buyer shall each maintain as confidential any
specifications, drawings, blueprints, data, business information,
trade secrets, manufacturing processes, or other confidential
information which Contractor or Buyer learns or acquires by virtue
of this Agreement, except that Contractor or Buyer may disclose
Confidential Information pursuant to the order or requirement of a
court, administrative agency or other governmental body. Buyer or
Contractor must notify the other party in writing of the need for
such disclosure and take all steps possible to assure that a
protective order exists prior to disclosure. Contractor and Buyer
further agrees to protect the "Confidential Information" against
disclosure to unauthorized persons.
B. Contractor may disclose confidential information to Contractor's
employees who have a need to know and a legal duty to protect such
confidential information. At Buyer's written request Contractor
agrees to destroy or otherwise dispose of all confidential
information, except as prohibited by regulatory or safety agencies.
C. Without Buyer's prior written consent, Contractor shall not in any
manner disclose (except as required for financing), advertise, or
publish the existence of this Agreement nor the terms of
transactions under this Agreement, which shall be considered as part
of the "Confidential Information".
7
<PAGE>
D. The term confidential information shall not include information
which is in the public domain at the time of disclosure or
afterward, except where such information becomes public due to a
breach by the disclosing party of its obligations hereunder, nor
shall the term confidential information in possession at the time of
disclosure or which may be disclosed by a third party having the
right to disclose the same.
IX. OWNERSHIP
A. Specifications - Contractor acknowledges that the specifications and
all related writings, drawing, artwork, computer assisted designs
and similar works are and shall be the exclusive property of Buyer,
and Buyer retains all right, title and interest, including
copyright, relating to such material. Upon termination of this
Agreement for any reason with the exception of breach by Buyer,
Contractor agrees to return to Buyer all copies of the
specifications and related materials within twenty (20) business
days of such termination; this material shall be complete in every
respect, as to permit an experienced manufacturer to manufacture,
assemble, maintain and service the Product described in this
Agreement. In the event of Breach by the Buyer, Contractor will
return all the documentation with 20 days of resolution of any
outstanding technical issues and payment of outstanding engineering
or production invoices. If termination occurs prior to building the
product, Contractor will provide a data package containing all
information updated as of the date of termination. The material
shall include a full drawing package in reproducible form and any
revisions or updates, including but not limited to; GSF Autocad and
ProE files, fabrication drawings, approved supplier list, test
specifications, tooling specifications and drawings, manufacturing
assembly instructions, routings, quality assurance protocols, test
equipment, specs and drawings and engineering change notice history,
device master files, and device history records. Transfer of
information will be product specific not including Contractor's
proprietary policies and procedures.
B. Buyer's Equipment - Contractor shall install, maintain and account
for Buyer's Equipment at Contractor's facility or Contractor's
subcontractor's facility. Contractor hereby acknowledges that the
Buyer's Equipment is the sole and exclusive property of Buyer. Buyer
shall provide identification and ownership tags (also called asset
tags) for the Buyer's Equipment, and Contractor shall ensure that
such tags are properly placed and maintained on all Buyer's
Equipment. Contractor hereby covenants that, during the term of this
Agreement.
(i) Contractor and any subcontractor of Contractor using Buyer's
Equipment shall utilize Buyer's Equipment solely for
manufacturing Buyer's requirements of the Product as provided
hereunder,
(ii) Contractor shall not encumber any of the Buyer's Equipment,
nor shall Contractor permit the Buyer's Equipment to become
encumbered as a result of any act or omission of Contractor or
a subcontractor of Contractor.
C. Within Twenty (20) business days following termination (with the
exception of termination due to breach by Buyer )or expiration of
this Agreement, Contractor agrees to properly pack and return to
Buyer, or cause to be properly packed and returned to Buyer, F.O.B.
point of shipment, all Buyer Equipment, the same to be shipped to
such facility as Buyer directs at Buyer's expense.
D. Improvements - Contractor hereby acknowledges that improvements
funded by the Buyer, which are unique to Buyer's program, shall be
the sole property of Buyer, and Contractor shall provide Buyer, at
Buyer's request and at a reasonable charge, reasonable assistance in
securing patents for such improvements. Contractor agrees to
promptly disclose improvements to Buyer and to execute documents
reasonably requested by Buyer to evidence Buyer's ownership of such
improvements. Manufacturing process improvements developed by the
Contractor shall be the property of the Contractor.
8
<PAGE>
X. INDEMNITY
A. Buyer agrees to indemnify and hold Contractor, its affiliated
entities, and their respective officers, directors, shareholders,
employees and agents, harmless from and against all claims, losses,
damages, liability, costs and expenses (including, without
limitation, attorney's fees and legal costs and disbursements)
incurred on account of any injury to persons or property arising out
of Buyer's negligence, reckless conduct or willful misconduct;
provided, that Buyer's liability hereunder shall be reduced
proportionately by the percentage of fault, if any, that may
ultimately be assigned or imposed on Contractor by a court or
arbitrator as a result of the Contractor's own negligence, reckless
conduct or willful misconduct. In the event any claim is asserted or
any suit is filed against Contractor for which Buyer is or may be
required to indemnify Contractor under this provision, Contractor
shall give Buyer prompt written notice of same. In the event of any
such claim or suit against the Contractor, Contractor may at its
option tender defense of the claim or suit to Buyer, in which case
the Contractor shall cooperate with Buyer, at Buyer's request and
expense, in the defense of such claim or suit, and Buyer shall have
the sole right to defend and/or settle such a claim or suit,
including selecting counsel of its choice. Regardless of whether or
not Contractor tenders defense of the claim or suit to Buyer, and
regardless of whether or not any such tender is accepted or rejected
by Buyer, the requirement of this paragraph that Buyer fully
indemnify Contractor remains in full force and effect.
B. Contractor agrees to indemnify and hold Buyer, its affiliated
entities, and their respective officers, directors, shareholders,
employees and agents (hereinafter "Indemnitees") harmless from and
against all claims, losses, damages, liability, costs and expenses
(including, without limitation, attorney's fees and legal costs and
disbursements) incurred on account of any injury to persons or
property arising out of the Contractor's manufacture of the product,
provided, that Contractor's liability hereunder shall be reduced
proportionately by the percentage of fault, if any, that may
ultimately be assigned or imposed on Buyer by a court of law or
arbitrator as a result of the Buyer's own negligence, reckless
conduct or willful misconduct. In the event any claim is asserted or
any suit is filed against Buyer for which Contractor is or may be
required to indemnify Buyer under this provision, Buyer shall give
Contractor prompt written notice of same. In the event of any such
claim or suit against the Buyer, Buyer may at its option tender
defense of the claim or suit to Contractor, in which case the Buyer
shall cooperate with Contractor, at Contractor's request and
expense, in the defense of such claim or suit, and Contractor shall
have the sole right to defend and/or settle such a claim or suit,
including selecting counsel of its choice. Regardless of whether or
not Buyer tenders defense of the claim or suit to Contractor, and
regardless of whether or not any such tender is accepted or rejected
by Buyer, the requirement of this paragraph that Contractor fully
indemnify Buyer remains in full force and effect
XI. FORCE MAJEURE
Neither party shall be considered to be in default in respect of any
obligation hereunder, if failure of performance shall be due to Force
Majeure. If either party is affected by a Force Majeure event, such party
shall, within ten (10) days of its occurrence, give notice to the other
party stating the nature of the event, its anticipated duration and any
action being taken to avoid or minimize its effect. The suspension of
performance shall be of no greater scope and no longer duration than is
required and the non-performing party shall use reasonable efforts to
remedy its inability to perform. Force Majeure shall mean, without
limitation, explosion, flood, fire, war (whether declared or otherwise),
accident, labor strike, or other labor disturbance, sabotage, acts of God,
or acts of regulatory agencies.
9
<PAGE>
XII. REGULATORY MATTERS
A. Complaints and Service Reports - Buyer shall forward to Contractor
as required copies of customer complaints, user reports, MDR's and
Service reports relating to the manufacture and operation of the
Product and Contractor will cooperate fully with the Buyer in
investigating such complaints. In the event that customer complaints
or user reports are received by the Contractor they are to be
forwarded to the Buyer. Upon the request of the Buyer, and at a
charge mutually agreed upon between the parties, Contractor will,
when appropriate, investigate any Product subject to a complaint and
will promptly provide Buyer with a written report on such
investigation.
B. Registration - Contractor hereby represents to Buyer that it shall,
at its sole cost and expense, timely register with the FDA as a
Contract Medical Device Manufacturer, or cause to be timely
registered with the FDA, in accordance with the Federal Food, Drug
and Cosmetic Act 21 CFR Part 807 as amended. Additionally, the
Contractor represents that it is and will retain its ISO9001
certification and maintain a quality system in compliance with
EN46001 for the duration this Agreement.
C. FDA Inspection Reports - Contractor shall provide the Buyer with
copies of any FDA Form 483 observations, follow-up warning letters
and/or close-out reports for those portions of FDA CGMP / QSR
compliance inspection reports relating specifically to the
manufacture of the Product(s) for any facility where the Product(s)
is manufactured.
D. Contacts - Each party shall designate an individual within their
organization to be the primary contact regarding regulatory issues.
Such individual can be changed by giving written notice thereof to
the other party.
XIII. NOTICES
A. Any notice given under this Agreement shall be written or sent by
telex or facsimile. Written notice shall be sent by registered mail
or by certified mail, postage prepaid, return receipt requested. Any
telex or facsimile notice must be followed within three (3) days by
written notice. All notices shall be effective when first received
at the following addresses:
If to Contractor: If to Buyer:
Steven F. Bahr David Gill
Contracts Manager Chief Operations Officer
SeaMED Corporation Novoste Corporation
14500 NE 87th Street 4350-C International Boulevard
Redmond, WA 98052 Norcross, GA 30093
With copies to: with copies to:
Vice President, Operations John Love
Vice President, Regulatory Joan MacDonald
Affairs and Quality Assurance
10
<PAGE>
XIV. TERMINATION
A. Upon any material breach of the terms and provisions herein, this
agreement may be terminated by either party hereto if such breach is
not corrected within sixty (60) calendar days after written notice
to the defaulting party calling for remedy of such breach. If any
provision of this agreement gives any party the right to terminate
this agreement, upon the occurrence or non-occurrence of certain
stipulated events, such termination shall be effective upon written
notice to the other party.
B. In the event that this agreement is terminated, the parties agree as
follows:
(i) Regardless of which party terminates the agreement, Buyer
shall buy from Contractor, at cost plus material handling, any
and all transferable parts which are in inventory or are on
order and non-cancelable by Contractor. Buyer shall reimburse
Contractor for all finished goods, work in process and raw
materials inventory either on hand or on order and
non-cancelable, purchased and/or manufactured as a result of
Buyer's purchase orders or approved production forecasts.
Contractor shall complete any work in process if so requested
by Buyer as if no termination notice was given.
(ii) If Buyer terminates this agreement, and if Buyer requests
Contractor's assistance in establishing an alternate source
for the production of the product, Contractor shall provide to
Buyer design details, tooling and WIP relating to the product.
Buyer shall be responsible for all costs associated with
establishing an alternate source, including but not limited to
copying records and transferring transferable parts to an
alternate source. . Buyer shall also reimburse Contractor for
all outstanding costs incurred and all non-cancelable
committed costs associated with the Limited Production Phase
of this agreement. Contractor shall provide a complete listing
of parts including traceability records.
XV. SURVIVAL
The provisions of this Agreement dealing with Delivery, Payment and
Off-Set, Warranty, Confidential Information and Advertising, Intellectual
Property Indemnity, Changes Term of Availability, U.S. Customs, Marking,
Duty Drawback Requirements, and Compliance with Laws, shall survive
termination or expiration of this Agreement for a period of 5 years.
XVI. GENERAL
A. Only the authorized representatives of the parties may amend or
waive provisions of this Agreement, which amendment shall only be
effective if in writing and signed by such representatives. If
either party fails to enforce any term of this Agreement, failure to
enforce on that occasion shall not prevent enforcement on any other
occasion.
B. As used in this Agreement, except where otherwise noted, the term
"days" shall mean business days.
C. Contractor, including its agents and employees, is an independent
contractor and not an agent or employee of Buyer. Without limiting
the generality of the foregoing, Contractor is not authorized to
represent or make any commitments on behalf of Buyer, and Buyer
expressly disclaims any liability therefore.
D. All rights and remedies conferred by this Agreement, by any other
instrument, or by law are cumulative and may be exercised singularly
or concurrently. If any provision of this Agreement is held invalid
by any law or regulation of any government or by any court, such
invalidity shall not affect the enforceability of any other
provisions hereof. This Agreement and any Purchase Orders issued
hereunder shall be governed by and interpreted in accordance with
the laws of the State of Washington.
11
<PAGE>
E. Neither party shall assign this Agreement or any of their respective
duties and obligations hereunder without the prior written consent
of the other party: provided, however, that this Agreement must be
assumed by any company that is the successor to all or substantially
all of the business and property of the Contractor or Buyer.
XVII. BUSINESS REVIEWS
A. Buyer and Contractor shall, each at their own expense, meet
periodically to review performance and business transacted, and to
identify and resolve those issues which have arisen since the last
business review meeting.
B. Buyer and Contractor shall furnish agenda items not later than one
(1) week prior to scheduled business review meetings. Minutes shall
document action items, open items, and committed dates which may be
the result from such business review meetings, and shall be sent by
the drafting party to the other party within ten (10) days after
each meeting.
XVIII. INSURANCE
A. Contractor agrees to carry at all times, and with companies
acceptable to Buyer, insurance of the kinds and in the amounts
listed below:
(i) Worker's Compensation statutory limits in each state in which
Contractor is required to provide Worker's Compensation
coverage.
(ii) Comprehensive General Liability - including Contractual
Liability, Independent Contractor's Liability, Products and/or
Completed Operations Liability, and Personal Injury / Property
Damage Coverage's in a combined single limit of not less than
$2,000,000 aggregate with $1,000,000 per occurrence. In
addition, Umbrella Liability with a combined single limit of
not less than $3,000,000.
(iii) Automobile Liability for owned, non-owned and hired vehicles
in a combined single limit of not less than $1,000,000.
(iv) Business Interruption of not less than $15,000,000.
B. Buyer agrees to carry at all times, and with companies acceptable to
Contractor, insurance of the kinds and in the amounts listed below:
(i) Comprehensive General Liability - including Contractual
Liability, Independent Contractor's Liability, Products and/or
Completed Operations Liability, and Personal Injury / Property
Damage Coverage's in a combined single limit of not less than
$2,000,000 aggregate with $1,000,000 per occurrence.
(ii) Umbrella Liability a combined single limit of not less than
$3,000,000.
12
<PAGE>
XIX. LIMITATION OF LIABILITY
Except as otherwise provided in this Agreement, neither party shall be
liable to the other for special, indirect, incidental, consequential or
punitive damages.
XX. NO IMPLIED LICENSE
The parties understand that, except as may be otherwise expressly stated
herein, neither the Terms or Conditions of this Agreement, nor the acts of
either party arising out of this Agreement or related to Buyer's purchase,
use, sale, or other distribution of Product may be considered in any way
as a grant of any license whatsoever under any of Buyer's present or
future patents, copyrights, trademarks, trade secrets, or other
proprietary rights, nor is any such license granted by implication,
estoppel, or otherwise.
XXI. APPROVALS
IN WITNESS WHEREOF, the authorized representatives of the parties have
executed this Agreement under seal as of the date(s) set forth below.
SeaMED Corporation
Contractor Buyer
By By
/s/ Don Rich /s/ David N. Gill
------------------------------------- ----------------------------------
(Signature) (Signature)
Don Rich David N. Gill
------------------------------------- ----------------------------------
(Printed Name) (Printed Name)
Senior Vice President-Operations Chief Financial Officer
------------------------------------- ----------------------------------
(Title) (Title)
4/21/98 4/22/98
------------------------------------- ----------------------------------
(Date) (Date)
13
<PAGE>
Exhibit A
Products Pricing Lead Time
-------- ------- ---------
Alpha IV TBD 12-14 wks ARO*
*This lead time is based on Contractor's assurance that it will have
sufficient capacity and resources to meet Buyer's requested schedule
needs. The 12-14 week lead time excludes material availability.
Buyer may elect to provide Contractor with a purchase order to procure
material with lead times in excess of 10 weeks. Buyer and Contractor will
review and re-evaluate material lead times 3 months into the initial
production build of < > Products.
14
<PAGE>
Exhibit B-1
Pre-Production Pricing Formula
Pre-Production unit costs are difficult to determine prior to actually
manufacturing a product. For this reason, SeaMED Corporation bases the unit
price on a formula derived from the actual material and labor costs incurred.
The following formula is used to calculate pre-production unit price:
Actual Material Cost
+
Outplant Services
(PCBA & Cable Assembly, etc.)
+
Material Support Costs
(20% of Material & Outplant Costs)
+
Actual Burdened Assembly Hours @ $58hr
+
Actual Burdened Test Hours @ $58hr
=
Total Direct Manufacturing Cost
Total Unit Price = (Total Direct Manufacturing Cost divided by < > )
The above calculation yields a Pre-Production Gross Margin of < > of Unit Price
o Material Support Costs include Receiving, Receiving Inspection, Sustaining
Engineering, Stores, Purchasing, Production Control, Facilities, QSR, and
ISO controls. Material Support Costs are affected by the complexity of the
product being manufactured, the volume of product ordered and frequency of
purchase orders, and the number of unique custom mechanical parts in the
bill of material.
o Assembly and Test Burdened Rates are adjusted annually, and include
salary, benefits, and a portion of the above
o Gross margin includes Sales, General, Administrative Costs, and profit.
15
<PAGE>
Exhibit B-2
Production Pricing Formula
Accurate production pricing can only be established after the pre-production
effort has been completed and actual labor and material information is
available. Within one month of completion of pre-production units the following
formula will be used to establish go forward pricing.
Total Material Cost
+
Out plant Services
(PCBA & Cable Assembly, etc.)
+
Material Support Costs
(20% of Material & Outplant Costs)
+
Burdened Assembly Hours @ $58hr
+
Burdened Test Hours @ $58hr
=
Total Direct Manufacturing Cost
Total Unit Price = (Total Direct Manufacturing Cost divided by < > )
The above calculation yields a Production Gross Margin of < > of Unit Price
o Material includes a material yield factor.
o Material Support Costs include Receiving, Receiving Inspection, Sustaining
Engineering, Stores, Purchasing, Production Control, Facilities, QSR, and
ISO controls. Material Support Costs are affected by the complexity of the
product being manufactured, the volume of product ordered and frequency of
purchase orders, and the number of unique custom mechanical parts in the
bill of material.
o Assembly and Test Burdened Rates are adjusted annually, and include
salary, benefits, and a portion of the above.
o Gross margin includes Sales, General, Administrative Costs, and Profit.
16
