EXCLUSIVE PURCHASE AND
DISTRIBUTION AGREEMENT
This agreement (the "Agreement") dated as of March 12, 1998 between the
Spectranetics Corporation, a Delaware corporation having a place of business at
00 Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxxx, Xxxxxxxx 00000-0000 (hereinafter referred
to as "Spectranetics"); and Orbus Medical Technologies, Inc., a Florida
corporation, having an address at 000 Xxxxx Xxxxxxxx Xxxxxxxxx, Xxxxx 00, Xxxxx,
Xxxxxxx 00000 (hereinafter referred to as "OrbusMT").
WHEREAS, Spectranetics is a distributor of medical devices and has certain
expertise in the marketing and sale of medical devices; and
WHEREAS, OrbusMT is organizing a venture to engage in the design,
development, and manufacture of certain medical devices including the "R Stent"
as defined; and
WHEREAS, OrbusMT has informed Spectranetics that a patent for the R Stent,
in the name of Dr. Xxxx Xxxxxx as author, has been applied for in the European
Community under Application * * * and that Xx. Xxxxxx has agreed to transfer to
OrbusMT any patent issued pursuant to such application; and
WHEREAS, the parties acknowledge that, as of the "Commencement Date," as
defined, the R Stent has not been registered or approved for sale in any
country; and
WHEREAS, OrbusMT desires to arrange for the distribution of the R Stent in
the "Territories," as defined, and Spectranetics desires to become the exclusive
distributor of the R Stent in such Territories; and
WHEREAS, Spectranetics represents that it has adequate facilities, skills,
personnel, and financial resources to perform its duties under this Agreement;
and
WHEREAS, as consideration for the granting of the exclusive rights to
distribute the R Stent on the terms and conditions of this Agreement,
Spectranetics has agreed to invest certain monies and resources in the
registration, approval, and subsequent sales and marketing of the R Stent in the
Territories as more fully set forth in Section 3.3 hereof; and
WHEREAS, the parties acknowledge that they each must invest significant
resources in the registration, clinical trials, and production of the R Stent if
it is to be successfully marketed
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and sold;
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants
and agreements contained herein and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties hereto
agree as follows:
ARTICLE 1
DEFINITIONS
1.1. For purposes of this Agreement, the definitions set forth below shall
be applicable:
"Affiliate" shall mean a corporation or other business entity which is,
directly or indirectly, controlled by a party hereto. For this purpose, control
of a corporation or other business entity shall mean (i) direct or indirect
beneficial ownership of fifty percent (50%) or more of the voting interest in
such corporation or other business entity, (ii) direct or indirect beneficial
ownership of fifty percent (50%) or more of the equity of such corporation or
other business entity, and (iii) the existence of any other relationship between
a corporation or other business entity and another corporation or other business
entity which results in effective management control by one or the other,
regardless of whether such control is continuously exercised. The term
"Affiliates" shall not mean any corporation or other business entity which
controls a party hereto or is under common control with a party.
"Approval" means the approval, by the appropriate governmental or
quasi-governmental authorities, of the R Stent marketing and sales in the
relevant part of the Territories.
"Approval Date"" is defined in Section 11.1.
* * *
"Commencement Date" means the date of execution of this Agreement.
"Confidential Information" is defined in Section 6.3.
"Demo Unit" means a unit of the R Stent which Spectranetics gives * * * to
a customer or potential customer.
"Disclosee" is defined in Section 6.3.
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"Discloser" is defined in Section 6.3.
"FDA" shall mean the United States Department of Health and Human Services,
Food and Drug Administration, or any successor agency.
"First Contract Year" shall mean, as to each Territory, the 365-day period
beginning on * * * in such Territory (the * * * Date," as further defined in
Section * * * and ending at midnight on the 365th day thereafter. The "Second
Contract Year," as to each such Territory, shall mean the next subsequent
365-day period, and so on.
"International Regulatory Agency" shall mean any federal, state or local
governmental authority in the Territories outside the United States which
authority performs similar functions to the FDA.
* * *
* * *
"Person" or "Persons" shall mean any individual, corporation, partnership,
association, trust or other entity or organization, including a governmental or
political sub division or any agency of instrumentality thereof.
"R Stent" shall mean the OrbusMT R Stent as defined in the European patent
application * * *, a copy of which is attached hereto as Annex "1" (the
"European Patent Application"), and any modifications and improvements thereto.
"Spectranetics Claims" is defined in Section 8.3.
* * *
"Sub-Distributor" shall mean any Person or Persons chosen by Spectranetics
and approved by OrbusMT, as set forth in Section 2.1., to distribute the R Stent
in any Territory, or portion thereof, on Spectranetics' behalf.
"Subsequent Clinical Trial" means any clinical trial required to gain
Approval in a part of the Territories for a modification, additional
configuration, or other change made to the R Stent after the R Stent has
received initial Approval in such part of the Territories.
"Subsidiary" shall mean any corporation, partnership or other entity, fifty
percent (50%) or more of the outstanding shares of any class of stock, general
partnership interest, or other
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equity of which is owned by a party; and any operating division of a party not
separately incorporated or organized as an independent business Person.
* * *
"Trademark" shall mean such trademark or trademarks as OrbusMT shall
register for the R Stent. OrbusMT shall give Spectranetics prompt notice of any
and all such trademarks.
ARTICLE 2
EXCLUSIVE DISTRIBUTORSHIP
2.1. Exclusivity. OrbusMT hereby appoints Spectranetics, for the Term of
this Agreement, and Spectranetics hereby accepts such appointment, as OrbusMT's
exclusive distributor for the sale and distribution of the R Stent in the
Territories, on the terms and conditions of this Agreement. Spectranetics
acknowledges that OrbusMT is relying on its particular skills and reputation in
the scientific community and agrees that it may not appoint any Sub-Distributor
without the prior written approval of OrbusMT, which approval OrbusMT may give
or withhold in its sole discretion, with or without reason.
2.2. Sales in the Territories. During the term of this Agreement, OrbusMT
will sell and deliver to Spectranetics, and Spectranetics will purchase from
OrbusMT, the R Stent at the prices and subject to the terms and conditions
provided in this Agreement. OrbusMT agrees not to sell the R Stent in the
Territories to Persons other than Spectranetics and to forward to Spectranetics
all inquiries and orders received by OrbusMT concerning sales of the R Stent in
the Territories. Spectranetics agrees not to sell the R Stent outside the
Territories and to forward to OrbusMT all inquiries or orders received by
Spectranetics concerning sales of the R Stent outside the Territories.
2.3. Sales Outside the Territories. OrbusMT agrees not to knowingly sell
the R Stent to Persons outside the Territories who intend to sell the R Stent in
the Territories. If Spectranetics advises OrbusMT that another customer of
OrbusMT is engaged in the distribution, sale, or resale of the R Stent in the
Territories, then OrbusMT agrees to use reasonable efforts to persuade or
prevent such customer from distributing, selling, or reselling in the
Territories (which efforts need not include litigation) and, if OrbusMT is
unsuccessful in its efforts, then OrbusMT agrees to cease sales to such customer
within sixty (60) days of the date OrbusMT first becomes aware of such
customer's unauthorized activities.
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Spectranetics agrees not to sell the R Stent outside the Territories
without specific advance written authorization from OrbusMT. Spectranetics
further agrees that, during the term of this Agreement (1) it shall not
knowingly sell the R Stent to Persons located in the Territories who intend to
distribute, sell, or resell the R Stent outside the Territories; and (2) it
shall take reasonable precautions to insure that the R Stents it purchases from
OrbusMT shall only be offered for distribution, sale, or resale within the
Territories. If Spectranetics is advised by OrbusMT that one of its customers is
engaged in the distribution, sale, or resale of the R Stent outside of the
Territories, then Spectranetics agrees to use reasonable efforts to persuade or
prevent such customer from distributing, selling, or reselling the R Stent
outside of the Territories (which efforts need not include litigation) and, if
Spectranetics is unsuccessful in its efforts, then Spectranetics agrees to cease
sales to such customer within sixty (60) days of the date Spectranetics first
becomes aware of such customer's unauthorized activities.
2.4. OrbusMT's Employees. OrbusMT agrees: (1) not to send or employ any
agents or employees or other personnel of OrbusMT into the Territories to engage
in the sales or promotion of the R Stent in the Territories and (2) not to make
any efforts to sell the R Stent in the Territories from outside the Territories;
provided, however, that nothing contained in this Section 2.4 shall prevent
OrbusMT from having any employees or agents work in the Territories, on a
part-time, full-time or permanent basis, to act as liaison between Spectranetics
and OrbusMT, and to act on OrbusMT's behalf in the Territories as long as such
activities are consistent with the "Annual Marketing Plan," as defined in
Section 3.2(a) of this Agreement.
2.5. * * * Bundling. Distribution rights shall be considered to be in
effect for any Territory from the Commencement Date until such rights are
terminated pursuant to the terms of this Agreement. * * * Spectranetics may not
sell or distribute the R Stent "bundled," as defined, with any other product or
products without the prior written approval of OrbusMT. "Bundled" means the
giving of a price to a customer for two or more products without indicating what
portion of the price is for each product included.
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2.6. Payment to OrbusMT.
(a) For each Territory, Spectranetics shall determine the suggested
hospital list prices, the sales prices directly from Spectranetics to hospitals,
and the actual sales price from Spectranetics to Sub-Distributors and customers
for the R Stent. Spectranetics will inform OrbusMT in writing of such prices as
and when they change.
(b) For each R Stent sold Spectranetics agrees to pay OrbusMT * * *
(c) Spectranetics agrees to pay OrbusMT the OrbusMT Price for each R Stent
delivered to Spectranetics within thirty (30) days after receipt of the invoice
for such R Stent. Spectranetics agrees to pay any additional amount owed to
OrbusMT pursuant to Section 2.6(b) within thirty (30) days after the end of the
calendar quarter in which Spectranetics is paid by its Sub-Distributor or
customer for such R Stent.
(d) * * * the OrbusMT Price shall be subject to adjustment at OrbusMT's
option at any time and from time to time, provided that (i) OrbusMT shall have
given Spectranetics thirty (30) days' notice of such adjustment, and (ii)
OrbusMT shall be obligated to fill all orders it receives from Spectranetics
prior to the effective date of such adjustment at the immediately preceding
price levels except as may be otherwise agreed by the parties; and (iii) the
aggregate increases in the prices of the R Stent in any Contract Year shall not
be more than * * * over the prices in effect at the beginning of such Contract
Year unless the increases shall be due to a modification in the R Stent. The
parties acknowledge that the OrbusMT Price may also be adjusted to * * * .
2.7 New Products. OrbusMT shall use commercially reasonable efforts to
discuss with Spectranetics, in an informal manner, potential new products on an
ongoing basis. * * *
All discussions between OrbusMT and Spectranetics concerning any New
Product or any potential New Product shall be subject to the provisions of this
Agreement concerning confidentiality.
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ARTICLE 3
RESPONSIBILITIES OF PARTIES
3.1. Responsibilities of OrbusMT.
(a) OrbusMT will be responsible for and in charge of (i) any further
research and development needed for the production of the R Stent; and (ii) the
manufacturing (including Territory-specific labeling and packaging) of the R
Stent. In connection with these responsibilities OrbusMT will prepare an annual
business plan (the "Annual Business Plan") describing, in detail, projected
production numbers, supply schedules, and production capacities for the R Stent
in the Territories * * *. The Annual Business Plan for 1998 is attached hereto
and made a part hereof as Annex "3."
(b) OrbusMT agrees to assist Spectranetics in sales, training and other
programs intended to enhance Spectranetics' ability to market the R Stent. In
connection therewith, OrbusMT shall provide Spectranetics, at no cost to
Spectranetics, (i) access to technical personnel during normal business hours to
answer questions or inquiries concerning the R Stent; and (ii) the assistance of
a "Marketing Management Consultant" in preparing and executing education,
training and other programs for the Spectranetics sales staff. The Marketing
Management Consultant shall be available on an as needed basis to Spectranetics
until May 30, 1999 and thereafter up to twenty five percent (25%) of the
Marketing Management Consultant's work time in each calendar year during the
Term of this Agreement. Xx. Xxxxx X. Xxxx shall be the initial Marketing
Management Consultant.
In the event that OrbusMT wishes to replace Xx. Xxxx as Marketing
Management Consultant during the period from the Commencement Date until May 30,
1999, then Spectranetics must approve Xx. Xxxx'x proposed replacement. In the
event that OrbusMT wishes to replace Xx. Xxxx as Marketing Management Consultant
after May 30, 1999, then OrbusMT agrees that: (A) it shall only consider and
hire candidates with at least ten (10) years' experience in marketing medical
devices in the areas of interventional radiology and/or interventional
cardiology, and (B) it shall include Spectranetics in the interviewing and
evaluation process, Spectranetics acknowledging that the final decision shall be
that of OrbusMT.
(c) OrbusMT will provide Demo Units to Spectranetics at a maximum cost of *
* *. Spectranetics will include in the quarterly reports provided to OrbusMT
pursuant to Section 3.2 information regarding the distribution of Demo Units to
its customers.
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(d) OrbusMT shall use its best efforts to protect the intellectual property
associated with the R Stent to the fullest extent possible, including, but not
limited to, prosecuting patents for the R Stent in the Territories in a timely
manner.
(e) OrbusMT shall provide to Spectranetics R Stent packaging materials such
that Spectranetics may review and approve the packaging design thereof. OrbusMT
shall have sole responsibility for ensuring that the required Agency and other
regulatory information is incorporated in such materials.
3.2. Responsibilities of Spectranetics.
(a) Spectranetics will execute an annual sales plan (the "Annual Sales
Plan") and an annual marketing plan (the "Annual Marketing Plan"). The Annual
Sales Plan will describe, in detail, projected sales, sale prices and sales
targets for each country in the Territories. The Annual Marketing Plan will
describe, in detail, planned clinical trials, promotional activities, materials,
and related budgets for the year in question. * * * The Annual Sales Plan for
1998 and the Annual Marketing Plan for 1998 are attached hereto and made a part
hereof as Annex "4". * * *
(b) Sales. Spectranetics shall (i) take reasonable efforts to promote and
obtain sale and distribution of, and to stimulate interest in, the R Stent
throughout the Territories; and (ii) solicit orders for and sell the R Stent for
delivery to customers throughout the Territories; and, in consideration thereof,
OrbusMT hereby agrees not to appoint another distributor of the R Stent within
the Territories during the Term of this Agreement, except as specified in
Article 9.
(c) Specific Duties. In order to carry out its responsibilities,
Spectranetics agrees to undertake the following at its expense:
(i) to treat its customers and to conduct its business with a view to
maintaining and increasing the public goodwill and reputation attached
to the R Stent;
(ii) to employ, train, and maintain an efficient staff of sales and
other personnel to carry out Spectranetics' responsibilities under
this Agreement, including, without limitation, the agreed minimum
staff set forth in Annex "2" attached hereto and made a part hereof
(the "Minimum Staff"). Minimum Staff may support other Spectranetics'
products;
(iii) to organize and participate in such joint visits of
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Spectranetics' customers as may be reasonably requested by OrbusMT;
(iv) to distribute among prospective purchasers such technical or
commercial catalogues, leaflets, and other printed documentation as it
and OrbusMT may agree to;
(vi) to prepare with OrbusMT's assistance and to distribute to
prospective buyers such other catalogues, leaflets, and printed
documentation as the parties agree desirable for the marketing of the
R Stent within the Territories;
(vii) to apply to its customers conditions of sale and warranty
strictly in accordance with all applicable laws, regulations, and FDA
or International Regulatory Agency standards in the respective
Territories; and
(viii) to inform OrbusMT immediately of laws, regulations, and FDA or
International Regulatory Agency standards applicable to the R Stent in
the Territories of which Spectranetics becomes aware.
(d) Trademarks. OrbusMT hereby authorizes Spectranetics to utilize any of
its Trademarks or trade names in connection with Spectranetics' sales of the R
Stent pursuant to this Agreement. Spectranetics agrees to evidence any such
Trademarks or trade names in any advertising or sales promotion materials and to
advise OrbusMT promptly of any infringement it discovers of any of OrbusMT's
Trademarks or trade names.
Spectranetics further agrees:
(i) to utilize the Trademark only in connection with the R Stent and
the performance of this Agreement;
(ii) to evidence the Trademark in any advertising or sales promotion
program or campaign;
(iii) to comply with OrbusMT's reasonable instructions with respect to
any use of the Trademark (color, design, and so on);
(iv) to have the Trademark appear on any packaging or wrapping
materials that Spectranetics or any of its subdistributors, dealers,
or sales representatives provides concerning the R Stent;
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(v) not to associate the Trademark in a confusing manner with any
other tradename or trademark (including those of Spectranetics),
except in accordance with OrbusMT's instructions;
(vi) not to use the Trademark for other purposes than those
specifically provided herein without the prior written approval of
OrbusMT;
(vii) not to file any registration application or to register the
Trademark or any other trademarks or tradenames associating the
Trademark or the R Stent with any other products or leading to
confusion with or imitating the R Stent or the Trademark;
(viii) except as set forth in Section 11.4, to cease and desist from
the use of the Trademark from and after such time as this Agreement
shall have been terminated for any reason whatsoever; and
(ix) to impose the restrictions imposed upon it by the terms of this
Section 3.2 upon those to whom it sells.
(e) License to OrbusMT. Subject to the terms and conditions of this
Agreement, Spectranetics hereby grants to OrbusMT a non-exclusive,
non-transferable limited license to use the Spectranetics tradename and
trademarks solely for the purpose of manufacturing and packaging R Stents for
distribution under this Agreement.
(f) Standard of Conduct. Spectranetics shall conduct its affairs in an
ethical and businesslike manner, shall pay all taxes, levies, and duties
applicable to the sale of the R Stent, shall at no times knowingly engage in any
illegal, deceptive, unfair or unethical trade practices which may adversely
affect the image and reputation of OrbusMT or the R Stent, and shall not
knowingly make false, misleading, or disparaging representations regarding
OrbusMT or the R Stent.
(g) Warranties by Spectranetics. Spectranetics shall make no warranties or
guarantees with respect to the R Stent or the use of the R Stent except as may
be authorized by OrbusMT in writing. Sales shall be made under OrbusMT's
warranty as in effect from time to time and shall be extended to purchasers at
retail. Warranty cards or similar materials provided
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by OrbusMT shall be furnished by Spectranetics to each buyer.
(h) Records. Spectranetics shall maintain accurate records and accounts of
all purchase orders, invoices, sales statistics, and advertising expenditures
relating to the R Stent and shall permit examination of such records by
OrbusMT's representatives and agents upon reasonable notice and during normal
business hours. OrbusMT shall not require Spectranetics to maintain information
other than that it maintains in the normal course of its business. Spectranetics
agrees that it will permit a reputable independent certified public accounting
firm designated by OrbusMT and approved by Spectranetics, which approval shall
not be unreasonably withheld, to have access, at a mutually-agreed-upon time
during Spectranetics' normal business hours, to Spectranetics' records and books
of account which relate solely to the R Stent for the purpose of determining
whether the appropriate fees have been paid. Such audits may not be required
more often than once every year; provided, however, that OrbusMT may audit
Spectranetics within six (6) months of any audit in which a discrepancy of five
percent (5%) or greater in favor of Spectranetics is found. If a discrepancy is
discovered, the party in whose favor the error was made will promptly pay the
amount of the error to the other. OrbusMT will pay the cost of the audit,
provided that, if a discrepancy is discovered of ten percent (10%) or greater,
then Spectranetics will pay the cost of the audit.
(i) Reports. Within thirty (30) days following the end of each calendar
quarter, Spectranetics shall furnish to OrbusMT a written "Sales and Inventory
Report" setting forth such information as OrbusMT may reasonably request, in
each case on a country-by-country basis, including:
(i) quantities on hand at the beginning of such calendar quarter;
(ii) quantities purchased from OrbusMT during such calendar quarter;
(iii) quantities sold by Spectranetics to each of its customers during
such calendar quarter, the prices at which the R Stents in question
were sold, and the terms on which such R Stents were sold;
(iv) the amounts collected by Spectranetics during such calendar
quarter on account of the R Stent from each of its customers; and
(v) quantities on hand at the end of such calendar quarter.
3.3. The Approval Process. Except as provided in this Section 3.3, all
costs of obtaining Approval for the sale and marketing of the R Stent in each
part of the Territories shall
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be borne by * * * agrees to devote the time and resources necessary to obtain
Approval in each part of the Territories on the timetable set forth in Annex "6"
attached hereto and made a part hereof.
* * *
* * *
* * * shall maintain detailed records of all clinical trials, in accordance
with the accepted standards in the profession, including records of the costs of
such clinical trials. * * * shall be entitled to copies of all such records of *
* * at any time and from time to time.
In the event of modification to the design of the R Stent, * * * shall bear
the costs of all design work in connection therewith. * * * shall bear the costs
of all Subsequent Clinical Trials and applications for Approval which may be
required in connection with any such modification * * *. OrbusMT agrees to
discuss any proposed modification to the design of the R Stent with
Spectranetics prior to implementing the same and to coordinate with
Spectranetics, where possible, the timing of the introduction of any modified
version of the R Stent.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES
4.1. Representations and Warranties of OrbusMT. OrbusMT represents and
warrants that (i) it will employ or otherwise engage and maintain adequate
manpower to fulfill its responsibilities hereunder; (ii) the R Stents will
conform to the specifications submitted for Approval in the respective parts of
the Territories and will be free of defects in materials and workmanship; (iii)
the R Stents will be manufactured in accordance with all applicable regulatory
provisions, including without limitation, applicable FDA regulations as to "Good
Manufacturing Practices" including those recited for medical devices set forth
at 21 C.F.R. ss. 820, as amended from time to time, and the "Establishment
Regulation and Device Listing for Manufacturers of Devices" set forth at 21
C.F.R. ss. 807, as amended from time to time, and ISO 9002; (iv) the R Stents
will not be adulterated or misbranded within the meaning of the United States
Food, Drug and Cosmetic Act of 1938, as amended, and the regulations promulgated
thereunder; (v) when delivered to Spectranetics, the R Stents will be free and
clear of all liens, security interest, charges and encumbrances of any kind or
amount; and (vi) neither the materials comprising the R Stents sold hereunder
nor the specifications for such R Stents will be altered without prior written
notice to Spectranetics, which notice shall be given on a timely basis prior to
the making of any such alteration.
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4.2. Corporate Existence and Power. OrbusMT is a corporation, duly
organized, validly existing and in good standing under the laws of the State of
Florida. OrbusMT has full power to carry on its business and perform its
obligations under this Agreement.
4.3. Authorization and Validity of Agreement. The execution, delivery and
performance of this Agreement by OrbusMT and the consummation by OrbusMT of the
transactions contemplated hereby have been duly authorized by all necessary
action on the part of OrbusMT. This Agreement has been duly executed and
delivered by OrbusMT and this Agreement and any agreements executed and
delivered by OrbusMT pursuant hereto constitute the valid and binding agreements
of OrbusMT and each is enforceable against it in accordance with its terms,
except as may be limited by bankruptcy, insolvency, reorganization, moratorium
or other similar laws relating to creditors' rights generally or by equitable
principles (whether considered in an action at law or in equity).
4.4. No Violation; Consents. Neither the execution and delivery of this
Agreement nor the consummation of the transactions provided for herein will
violate any material agreement to which OrbusMT is a party or by which it is
bound or any law, order or decree or any provision of the Articles of
Incorporation or By-Laws. No authorization, approval, or consent of any third
party (including, without limitation, the holder or any material debt of
OrbusMT, the lessor of any material lease, any other party to any contract or
agreement, or any governmental or regulatory authority) is required in
connection with the lawful execution, delivery and performance of this Agreement
by OrbusMT.
4.5. Title to Purchased Assets. Prior to initial Approval in any Territory,
OrbusMT shall own the entire right, title and interest in and to the Patent
Application, free and clear of all mortgages, liens, pledges, charges and
encumbrances of any kind and nature.
4.6. Intellectual Property. OrbusMT has not received any notice of any
claim of infringement or any other claim or proceeding relating to any patent,
trademark, trade name, service xxxx, copyright or trade secret relating to the R
Stent.
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4.7. Representations and Warranties of Spectranetics. Spectranetics
represents and warrants that (i) it has the ability to employ and maintain
adequate manpower and organization to fulfill its responsibilities hereunder,
including without limitation, the Minimum Staff; (ii) once delivered to
Spectranetics, the R Stent will not be adulterated or misbranded within the
meaning of the United States Food, Drug and Cosmetic Act of 1938, as amended,
and the regulations promulgated thereunder; (iii) while in the possession of
Spectranetics and at the time of delivery from Spectranetics to its customers,
the R Stents will be free and clear of all liens, security interest, charges and
encumbrances of any kind or amount and (iv) Spectranetics will assure that the R
Stents are properly stored and inventoried until such time as they are delivered
to its customers, in compliance with the guidelines of OrbusMT in effect from
time to time and in compliance with all applicable laws, regulations, and
standards in the Territories. In order to guarantee that R Stents shall not be
sold beyond their shelf life, Spectranetics represents and warrants that it
shall:
(A) use the "First In, First Out" inventory system, such that the oldest R
Stents on hand are sold first; and
(B) destroy all R Stents which are past the "last sales date" or
"expiration date" printed on the packaging of each R Stent in order to
assure that the same are not sold.
In the event that Spectranetics uses any Sub-Distributor, Spectranetics
warrants that it will assure that each such Sub-Distributor warrants to it and
to OrbusMT that such Sub-Distributor will also follow the provisions of this
Section 4.7.
4.8. Corporate Existence and Power. Spectranetics is a corporation duly
organized, validly existing and in good standing under the laws of the State of
Delaware. Spectranetics has full power to enter into this Agreement and perform
its obligations hereunder.
4.9. Authorization and Validity of Agreement. The execution, delivery and
performance of this Agreement by Spectranetics and the consummation by
Spectranetics of the transactions contemplated hereby have been duly authorized
by all necessary corporate action on the part of Spectranetics. This Agreement
has been duly executed and delivered by Spectranetics and this Agreement and any
agreements executed and delivered by Spectranetics pursuant hereto constitute
the valid and binding agreements of Spectranetics and each is enforceable
against it in accordance with its terms, except as may be limited by bankruptcy,
insolvency, reorganization, moratorium or other similar laws relating to
creditors' rights generally or by equitable principles (whether considered in an
action at law or in equity).
4.10. No Violation; Consents. Neither the execution and delivery of this
Agreement
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treatment and filed separately with the Commission.
nor the consummation of the transactions provided for herein will violate any
material agreement to which Spectranetics is a party or by which it is bound or
any law, order or decree or any provision of the Articles of Incorporation or
By-Laws. Except with respect to Silicon Valley Bank, no authorization, approval,
or consent of any thirty party (including, without limitation, the holder of any
material debt of Spectranetics, the lessor of any material lease, any other
party to any contract or agreement, or any governmental or regulatory authority)
is required in connection with the lawful execution, delivery and performance of
this Agreement by Spectranetics.
4.11. Inspections. Each of OrbusMT and Spectranetics shall permit the other
such inspections as are necessary to allow the other to verify that the
representations and warranties are true. Such inspections shall not be required
more often than once in each Contract Year; provided, however, that either party
may make follow-up inspections within two (2) months of any inspection in which
a material breach of any representation or warranty is found.
ARTICLE 5
INFORMATION
5.1. Access to Information. Each party shall provide to the other access to
all relevant governmental files and submissions to which such party has access.
Each party shall provide the other with a copy of any reported adverse
experience involving the R Stent after a party receives the report of such
occurrence whether sold by it or any Person to whom a party has granted any
distribution or sales rights. Any death, serious injury, potential for
occurrence of the same, or change in the frequency or occurrence of field
experiences with respect to an R Stent which is required to be reported by a
party to the FDA or any International Regulatory Agency shall be reported to the
other party as promptly as possible to enable the other party to comply with
applicable regulations in a timely manner.
5.2. Corrective Actions - OrbusMT. Except as provided for in Section 5.3,
OrbusMT shall institute and fund any recall, corrective action, or the like in
circumstances relating to a R Stent defect or failure which requires such action
as determined by the FDA, any International Regulatory Agency, OrbusMT, or as
otherwise may be required pursuant to applicable laws, rules or regulations.
Spectranetics shall provide OrbusMT with responsible assistance in the actual
retrieval of the R Stents sold by Spectranetics.
5.3 Corrective Actions - Spectranetics. Spectranetics shall institute and
fund any recall, corrective action, or the like in circumstances relating to an
R Stent defect or failure which requires such action as determined by the FDA,
any International Regulatory Agency, OrbusMT, Spectranetics or as otherwise may
be required pursuant to applicable laws, rules or regulations if
15
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
caused by the failure of Spectranetics to properly inventory and store the R
Stent after delivered to Spectranetics. OrbusMT shall provide Spectranetics with
responsible assistance in the actual retrieval of the R Stents sold by
Spectranetics.
In the event of any recall, each party will cooperate fully with the other
in accounting for all units and acquiring the same.
5.4. Survival. The provisions of this Article 5 shall survive termination
of this Agreement.
ARTICLE 6
CONFIDENTIAL INFORMATION
6.1. Spectranetics' Confidentiality Obligation. Spectranetics hereby
covenants that it will not, directly or indirectly, disclose either during or
subsequent to the term of this Agreement, any Confidential Information of
OrbusMT, to any other Person, except to its attorneys and accountants as
required in connection with this Agreement who have been and will be instructed
to maintain its confidentiality and to third Persons, with a demonstrated need
to know such Confidential Information, who shall execute binding written
agreements requiring such third Persons not to disclose Confidential Information
disclosed to them by Spectranetics.
6.2. OrbusMT's Confidentiality Obligation. OrbusMT hereby covenants that it
will not, directly or indirectly, disclose either during or subsequent to the
term of this Agreement, any Confidential Information proprietary to
Spectranetics, to any other Person, except to OrbusMT's attorneys and
accountants as required in connection with this Agreement who have been and will
be instructed to maintain its confidentiality and to third Persons, with a
demonstrated need to know such Confidential Information, who shall execute
binding written agreements requiring such third Persons not to disclose
Confidential Information disclosed to them by OrbusMT.
6.3. Confidential Information. For purposes of this Agreement,
"Confidential Information" shall mean verbal and written disclosures from
OrbusMT or Spectranetics (the "Discloser") to the other party (the "Disclosee"),
which concern the Discloser, including without limitation information which
concerns the Discloser's business, operations, products or research and
development efforts, or which concern the R Stents, but shall not include
information which: (a) at the time of disclosure is published or otherwise
becomes a part of the public domain through no fault of Disclosee (but only
after, and only to the extent that, it is published or otherwise becomes a part
of the public domain); (b) Disclosee can show was known to it at the time of
disclosure, free of restriction; (c) has been or hereafter is disclosed to
Disclosee without any obligation of confidentiality by a third Person who is in
lawful possession of such
16
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
information and has the right to disclose it to Disclosee; (d) has been or
hereafter is disclosed by Discloser to a third Person free of any obligations of
confidentiality; (e) is developed by Disclosee independent of the Discloser's
Confidential Information; or (f) is disclosed by Disclosee pursuant to the order
or requirement of a court, administrative agency or other governmental body,
provided that the Disclosee promptly informs the Discloser of its intent to make
such disclosure, takes all reasonable steps to limit such disclosure and does
not inhibit the Discloser in taking whatever lawful steps the Discloser
considers necessary to attempt to preserve the confidentiality of such
information. Disclosures made to Disclosee by Discloser which are specific shall
not be deemed to be within the foregoing exceptions merely because they are
embraced by general disclosures in the public domain or in the possession of
Disclosee.
6.4. Remedies. The parties agree and acknowledge that any breach of this
Article 6 by OrbusMT or Spectranetics would likely cause irreparable injury to
the other party and that such other party's remedy at law for any such breach
would be inadequate. Accordingly, the parties agree that, in addition to any
other remedies provided for herein or otherwise available at law, temporary and
permanent injunctive relief and other equitable relief may be granted in any
Action which may be brought by either party to enforce the provisions of this
Article 6 without the necessity of proof of actual damage. Each party agrees
promptly to seek temporary and permanent injunctive relief against any of its
directors, officers, employees, representatives or agents who breach the
aforesaid obligations with respect to any matter relating to this Agreement. The
provisions of Section 12.8. shall not apply to this Article 6.
6.5. Survival. The provisions of this Article 6 shall survive termination
of this Agreement.
ARTICLE 7
INVENTIONS
7.1. Inventions. Spectranetics and OrbusMT each acknowledge that the other
party has heretofore developed or acquired and will continue to develop,
acquire, market and sell products, methods, processes and apparatus relative to
their respective fields of endeavor. Notwithstanding anything in this Agreement
to the contrary, Spectranetics and OrbusMT each retain all right, title and
interest in and to such products, methods, processes and apparatus developed or
owned on their respective parts.
7.2. Patents. Spectranetics acknowledges that OrbusMT has filed the
European Patent Application, and that OrbusMT may file future patent
applications in other parts of the Territories and elsewhere for the R Stent.
Spectranetics agrees that it shall assist and cooperate in a reasonable manner
with OrbusMT in obtaining patent protection pursuant to any such
17
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
applications and to protect title in the same in the name of OrbusMT. In such
event, OrbusMT shall reimburse to Spectranetics its reasonable out-of-pocket
costs in connection with such assistance.
7.3. Joint Works. There shall be no joint works between the parties.
Spectranetics acknowledges that the R Stent, any licenses associated therewith,
and all intellectual property rights related to the R Stent and any
modifications to the design or characteristics of the same are and shall remain
the sole and exclusive property of OrbusMT.
7.4. Survival. The provisions of this Article 7 shall survive termination
of this Agreement.
ARTICLE 8
INDEMNIFICATION
8.1. * * * Indemnification of * * *.
(a) * * *.
(b) * * *.
8.2. * * * Indemnification of * * *.
(a) * * *.
(b) * * *.
(c) * * *.
8.3. Survival. The provisions of this Article 8 shall survive termination
of the Agreement.
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treatment and filed separately with the Commission.
ARTICLE 9
APPLICATION DATES * * *
9.1. Application Dates. The parties agree that they each shall prepare and
execute the materials and undertakings which each is to prepare and execute
under the provisions of Section 3.3 for the registration and application for
Approval of the R Stent in each part of the Territories such that application
for Approval can be filed no later than the date given for each in Annex "6"
attached hereto and made a part hereof (the "Application Dates"). * * *. In the
event that an application is not timely filed and neither party is in default
hereunder, then both parties will continue to use reasonable efforts to effect
the filing of such application as quickly as possible.
9.2. * * *
If, as to any part of the Territories during any Contract Year, * * *,
OrbusMT shall have the right to terminate this Agreement as to such part of the
Territories, by sending six (6) months written notice to Spectranetics (the "6
Month Notice"), without any indemnity, compensation, or damage of any nature
whatsoever to be paid by OrbusMT to Spectranetics in relation to any such
termination. Spectranetics may, prior to the expiration of the 60th day
following the date of the 6 Month Notice, * * *. Otherwise, this Agreement shall
terminate on the date specified in the 6 Month Notice (being a date at least 6
months after the date the 6 Month Notice is given) as to the part of the
Territories specified in such 6 Month Notice.
* * *, then OrbusMT shall have the right to terminate this Agreement as to
such part of the Territories, by sending six (6) months written notice to
Spectranetics (the "6 Month Notice"), without any indemnity, compensation, or
damage of any nature whatsoever to be paid by OrbusMT to Spectranetics in
relation to any such termination. Spectranetics may, prior to the expiration of
the 60 day period following the date of the 6 Month Notice, * * *. Otherwise,
this Agreement shall terminate on the date specified in the 6 Month Notice
(being a date at least 6 months after the date the 6 Month Notice is given) as
to the part of the Territories specified in such 6 Month Notice.
The provisions of this Section 9.2 shall be the sole remedy of OrbusMT in
the event * * *.
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treatment and filed separately with the Commission.
ARTICLE 10
CONDITIONS OF SALES
10.1. Orders. Spectranetics shall provide OrbusMT with a non-binding 12
month rolling forecast (a "forecast") of Spectranetics' estimated requirements
for the R Stent broken down by Territory, which forecast shall be updated: (1)
every three (3) months and (ii) within thirty (30) days of initial Approval of
the R Stent in a Territory. The first of such forecasts shall be provided within
thirty (30) days after initial Approval in any Territory.
Concurrent with submitting its non-binding forecast pursuant to this
Section 10.1, Spectranetics shall place a binding purchase order with OrbusMT
for (i) 100% of the forecasted requirement for the first three (3) month period
of such forecast (the "first quarter") and (ii) fifty percent (50%) of the
forecasted requirement for the subsequent three (3) month period of such
forecast (the "second quarter"). Estimated quantities given in each forecast for
the last six (6) month period of such forecast shall be for planning purposes
only.
OrbusMT agrees to meet Spectranetics' requirements as set forth in binding
purchase orders pursuant to this Section 10.1 and any additional quantity of up
to a twenty-five percent (25%) increase over the most recent forecasted
requirements for the first and second quarters of such forecasts.
Orders accepted by OrbusMT shall result in sales contracts to be governed
and construed in accordance with the terms of this Agreement, OrbusMT's terms
and conditions of sale in effect at the time of delivery (to the extent not
inconsistent with this Agreement), and the terms of Spectranetics order (to the
extent not inconsistent with this Agreement or OrbusMT's terms and conditions of
sale). The terms of this Agreement will control over any contrary language
contained on any purchase order, acknowledgment or invoice submitted by either
party hereto in connection with any purchase or sale covered by this Agreement
whether or not such purchase order, acknowledgment or invoice refers to this
Agreement explicitly.
10.2. Sales. All sales of the R Stents to Spectranetics shall be made
F.O.B. to the "Spectranetics Designated Warehouse," as defined. The
"Spectranetics Designated Warehouse" means a single location in each of the
Territories to which orders shall be shipped. The location of the Spectranetics
Designated Warehouse in any one Territory may not be changed more than once
yearly.
10.3. Risk of Loss. Risk of loss of all units of the R Stent sold hereunder
shall pass to Spectranetics, and OrbusMT's responsibility for loss or damage to
any R Stent shall cease, immediately upon delivery of the R Stents to the
Spectranetics Designated Warehouse.
20
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
10.4. Shipping Dates. Throughout the Term of this Agreement, OrbusMT agrees
to keep Spectranetics reasonably advised of anticipated shipping dates and of
any delays in the same.
10.5 Security Interest. OrbusMT reserves a purchase money security interest
in each R Stent until such time as it receives payment for the OrbusMT Price.
OrbusMT shall be solely responsible for perfecting its security interest.
Spectranetics agrees to execute such instruments as may be required from time to
time to perfect such interest in OrbusMT.
10.6. Warranty. OrbusMT warrants to Spectranetics that each unit delivered
hereunder will be free from defects in material and workmanship. If, within one
(1) year from the date a unit is shipped to Spectranetics, it appears that the
unit does not meet the warranty specified in this Section 10.7. and
Spectranetics makes such unit available for inspection by OrbusMT, then OrbusMT
will, at its sole option:
(a) furnish a replacement for the defective unit to Spectranetics against
return at Spectranetics' premises of the defective item; or
(b) refund to Spectranetics an amount equal to the price paid by
Spectranetics to OrbusMT for such unit, against return at Spectranetics'
premises of the defective item.
OrbusMT further warrants that each R Stent provided hereunder conforms to
the requirements of the relevant Approval. OrbusMT further warrants that the R
Stents shall be merchantable for the purpose set forth in such Approval. THE
FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, WHETHER
WRITTEN, ORAL OR IMPLIED, INCLUDING THE WARRANTY OF FITNESS FOR A SPECIFIC
PURPOSE.
The liability of OrbusMT to Spectranetics arising out of the supplying of a
R Stent or its use, whether on warranty, contract, negligence or otherwise,
shall not in any case exceed the cost of replacing such R Stent except as
specifically provided in this Agreement. The foregoing shall constitute the sole
remedy of Spectranetics and the sole liability of OrbusMT in respect of any loss
or damage arising out of or connected with any order or the performance or
breach thereof or the manufacture, sale, delivery, resale or use of any R Stent.
OrbusMT shall have no obligations as to any R Stents which are subjected to
misuse, negligence, accident, or alteration by Spectranetics or any third party.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL,
INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES,
21
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS, LOSS OF BUSINESS OR OTHER LOSS
ARISING OUT OR RESULTING FROM THIS AGREEMENT EVEN IF THE PARTY HAS BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING SHALL APPLY REGARDLESS OF THE
NEGLIGENCE OR OTHER FAULT OF THE PARTY AND REGARDLESS OF WHETHER SUCH LIABILITY
SOUNDS IN CONTRACT, NEGLIGENCE, TORT, OR ANY OTHER THEORY OF LEGAL LIABILITY.
10.8. Warranty to Customers. Spectranetics agrees and warrants that each R
Stent sold shall be accompanied by a copy of OrbusMT's standard warranty
language (the "Warranty"), a copy of which is attached hereto as Annex "5." The
parties agree that neither of them shall modify the Warranty except (a) as
required by any governmental authority or (b) as jointly agreed between them.
10.9 Manufacturing. * * *
The provisions of this Section 10.9 shall not apply if (a) Spectranetics
shall be in default under the terms of this Agreement, including, but not
limited to, a failure by Spectranetics to pay OrbusMT in a timely fashion
pursuant to the provisions of Article 2 hereof, or (b) under any circumstance
where OrbusMT's failure to deliver any R Stents to Spectranetics is the result
of any action taken by Spectranetics or any state of facts related to
Spectranetics.
ARTICLE 11
TERM AND TERMINATION OF THE AGREEMENT
11.1. Term.
(a) The term of this Agreement shall commence upon the Commencement Date
and shall continue until the exclusive distributorship granted to Spectranetics
hereunder, has been terminated in each of the Territories unless terminated
earlier pursuant to the provisions of this Agreement.
(b) The Term of the exclusive distributorship in each Territory shall be *
* * from the date that official marketing approval is granted by the FDA or the
appropriate International Regulatory Agency, as the case may be, in such
Territory (the "Approval Date"). In the case of a Territory with more than one
country, the Approval Date shall be the date when approval has been granted by
the FDA or the International Regulatory Agency, as the case may be, in at least
one-half of the countries in such Territory, including the largest country in
such Territory. The Term of this Agreement for each Territory will automatically
renew for an additional * * * of the Approval Date in such Territory unless
Spectranetics shall have given
22
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
OrbusMT six (6) months prior written notice of termination of the exclusive
distributorship in that Territory or * * * from the Approval Date. The Renewal
Amount represents the unit commitment for * * * then OrbusMT may terminate this
Agreement by giving Spectranetics six (6) months prior written notice of
termination of the exclusive distributorship in that Territory. Such
terminations are Territory specific and do not affect Spectranetics' exclusive
distributorship in any other Territory.
In the event that the Term of the Agreement shall automatically renew as to
any part of the Territories, * * *.
(c) Spectranetics has the option to terminate this Agreement within ten
(10) days of receipt of the reported conclusions and recommendations of the
feasibility study now being conducted by the Rotterdam Heart Center ("RHC")
relating to the R Stent, but in no event later than May 5, 1998 (the "RHC
Report"). If Spectranetics terminates this Agreement based on the
recommendations and conclusions of RHC, OrbusMT will reimburse Spectranetics for
the actual out-of-pocket cost of such study. Upon reimbursement to Spectranetics
by OrbusMT of such cost, Spectranetics shall sign a release in favor of OrbusMT
releasing all of the rights of Spectranetics under the present Agreement and
with regard to the R Stent, the clinical trials, and the feasibility study
conducted by RHC. If Spectranetics has not sent written notice to OrbusMT by
midnight, E.S.T., on or before May 5, 1998, that Spectranetics has elected to
terminate this Agreement under the provisions of this Section 11.1.(c), then
Spectranetics shall be deemed to have waived its right to elect to terminate
this Agreement pursuant hereto.
(d) Spectranetics has the option to terminate this Agreement if OrbusMT
fails to receive a patent export license from the United States Patent and
Trademark Office by * * *. Further, if for any other reason OrbusMT fails to
receive patent protection for the R Stent in the European Union or the United
States, or such patents becomes invalid or unenforceable in the European Union
or the Untied States, then Spectranetics shall have the option of terminating
this Agreement. The termination rights set forth in this Section 11.1. (d) shall
not mature until OrbusMT has had a full and complete opportunity to prosecute
its patent and/or to fully litigate any challenges to such patent.
(e) Spectranetics may, at its option, continue to investigate patentablity
and infringement issues regarding the R Stent and, if not satisfied with such
results, terminate this Agreement by April 30, 1998.
(f) Either party may terminate this Agreement by written notice to the
other (the "11.1(f) Termination Notice") if * * *.
11.2. Termination. Notwithstanding the provisions of Section 11.1., this
Agreement
23
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
may be terminated prior to the expiration of the initial term or the renewal
term, if any, as follows:
(a) by mutual written consent of the parties hereto; or
(b) by written notice to a party hereto, upon the filing of
a petition in bankruptcy or equivalent order or petition
under the laws of any jurisdiction by or against such party;
or upon an assignment of the assets of such party for the
benefit of creditors; or upon the commencement by or against
such party of any proceeding under an act of any legislative
body, or order of a governmental authority of for the relief
of debtors seeking the relief or readjustment of
indebtedness either though reorganization, composition,
extension or otherwise; or upon the voluntary or involuntary
dissolution of such party; or
(c) by written notice to a party hereto if such party shall
fail in any material respect to comply with the terms,
covenants and conditions of this Agreement to be complied
with by it and shall fail to remedy such failure within
sixty (60) days after receipt of written notice thereof from
the other party hereto; provided, however, that, if such
default cannot by its nature be cured within sixty (60)
days, then the defaulting party shall be given a reasonable
opportunity to cure the same; or
(d) as provided in Article 9.
11.3. Force Majeure. Neither party hereto shall be in default hereunder by
reason of its delay in the performance or failure to perform any of its
obligations hereunder for any event, circumstance, or cause beyond its control
such as, but not limited to, acts of God, strikes, lock-outs, general
governmental orders or restrictions, war, threat of war, hostilities,
revolution, riots, epidemics, fire, or flood.
The party affected by any such event shall notify the other party within a
maximum period of fifteen (15) days from its occurrence. The performance of this
Agreement shall then be suspended for as long as any such event shall prevent
the affected party from performing its obligations under this Agreement.
11.4. Sale on Termination. Within ten (10) days after the expiration or
termination of this Agreement as to each part of the Territories, irrespective
of the reason therefore, Spectranetics shall furnish to OrbusMT a written
statement of the number of units of the R Stent owned by Spectranetics but not
sold by it at the date of such termination. OrbusMT shall have
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* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
the irrevocable right and option, upon written notice to Spectranetics, within
twenty (20) days after receipt of such statement from Spectranetics, to
repurchase some or all of such unsold R Stents, which R Stents Spectranetics
hereby agrees to sell to OrbusMT upon the exercise thereof. Such repurchase, if
any, shall be made at a price for each unit equal to the purchase price for such
unit paid by Spectranetics to OrbusMT. Units repurchased by OrbusMT shall be
delivered C.O.D. to OrbusMT to any location in the Territory specified by
OrbusMT no later than thirty (30) days after receipt of OrbusMT's repurchase
order.
In the event OrbusMT does not exercise the option granted to it under this
Section 11.4. hereof within the twenty (20) day period specified therein, or if
OrbusMT exercises such option with respect to less than all units on hand at the
date of termination hereof, Spectranetics shall, after the expiration of such
twenty (20) day period, have the right to sell all R Stents which OrbusMT has
not theretofore purchased, on the terms and conditions contained in this
Agreement.
In the event that, as of the expiration or termination of this Agreement,
Spectranetics does not have on hand sufficient inventory to fill firm orders in
hand for the R Stents and Spectranetics has previously placed firm orders with
OrbusMT for such units, then OrbusMT shall use its best efforts, not to include
litigation, to fill such firm orders to the extent necessary for Spectranetics
to be able to fill Spectranetics' firm orders.
11.5. Survival. The provisions of this Article 11 shall survive termination
of the Agreement.
ARTICLE 12
MISCELLANEOUS
12.1. Notices. Written communications under this Agreement shall be
effective only if addressed to the respective designees as follows (or to such
designees as the parties hereto may from time to time designate in writing):
If to Spectranetics: The Spectranetics Corporation
00 Xxxxxxxx Xxxxx
Xxxxxxxx Xxxxxxx, Xxxxxxxx 00000-0000
Attn: Chief Executive Officer
with a copy to: Xxxxxx X. Xxxxxxxxxxx, Esq.
Xxxxxx & Xxxxxxx
00 Xxxxxx Xxxx
00
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
Xxxxx Xxxx, Xxxxxxxxxx 00000
If to OrbusMT: Orbus Medical Technologies, Inc.
000 Xxxxx Xxxxxxxx Xxxxxxxxx, Xxxxx 00
Xxxxx, Xxxxxxx 00000
Attn: Chief Executive Officer
with a copy to: Xxx Xxxxxx Cheezem
Xxxxx Xxxx LLP
000 Xxxxx Xxxxxxxx Xxxxxxxxx, 00xx Xxxxx
Xxxxx, Xxxxxxx 00000
12.2. Entire Agreement. This Agreement constitutes the entire understanding
and agreement between the parties, and supersedes all previous agreements
(whether written or oral) concerning the subject matter hereof. This Agreement
may not be amended or supplemented except by a written document executed by the
parties to this Agreement.
12.3. Assignment. This Agreement shall be binding upon and shall inure to
the benefit of the parties and their respective successors and permitted
assigns, including without limitation, successors to all or substantially all of
the assets, business or operations of the corporations or entities performing a
party's obligations under this Agreement. Neither this Agreement nor the
performance of any part hereof may be assigned or transferred by either party
hereto without the prior written consent of the other party, except that a
party's rights hereunder may be transferred (i) to an Affiliate of such party
without the prior written consent of the other party, provided such party
continues to guarantee all of the payment and performance obligations of such
party; or (ii) to a successor of all or substantially all of the business and
assets of the party.
12.4. Independent Contractors. The parties hereto are independent
contractors. Neither this Agreement nor any terms and conditions herein
contained shall be construed as creating a joint venture, agency or employment
relationship. Neither party is granted any right or authority to assume or to
create any obligation or responsibility, express or implied, on behalf of or in
the name of the other party.
12.5. No Waiver. The failure of either party to exercise any right it is
granted herein or to require the performance by the other party hereto with
respect to any provision of this Agreement, shall not prevent a subsequent
exercise or enforcement of such provision or be deemed a wavier of any
subsequent breach of the same or any other provision of this Agreement.
12.6. Jurisdiction. The internal laws of the State of Delaware, United
States of America, applicable to contracts entered into and wholly to be
performed in Delaware by
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* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
Delaware residents, without reference to any principles concerning conflicts of
law, shall govern the validity of this Agreement, the construction of its terms
and the interpretation of the rights and duties of the parties hereunder;
provided, however, that this Section and the parties' rights under this Section
shall be governed by and construed in accordance with the Federal Arbitration
Act, 9 U.S.C. ss.1, et. seq.
12.7. Arbitration. Any controversy or claim arising out of or relating to
this Agreement, or the breach thereof, other than a purported breach of Article
6, shall be settled by the following procedures: Either party may send the other
written notice identifying the matter in dispute and involving the procedures of
this Section. Within fourteen (14) days after such written notice is given, one
or more principals of each party shall meet at a mutually agreeable location in
Denver, Colorado, for the purpose of determining whether they can resolve the
dispute themselves by written agreement, and, if not, whether they can agree
upon a third-party impartial arbitrator (the "Arbitrator") to whom to submit the
matter in dispute for final and binding arbitration. If the parties fail to
resolve the dispute by written agreement or agree on the Arbitrator within such
twenty one (21) day period, either party may make written application to the
Judicial Arbitrator Group, Inc. ("JAG"), Denver, Colorado, for the appointment
of a single Arbitrator to resolve the dispute by arbitration and at the request
of JAG, the parties shall meet with JAG at its offices or confer with JAG by
telephone within ten (10) calendar days of such request to discuss the dispute
and the qualifications and experience with each party respectively believes the
Arbitrator should have; provided, however, the selection of the Arbitrator shall
be the exclusive decision of JAG and shall be made within thirty (30) days of
the written application to JAG. Within thirty (30) days of the selection of the
Arbitrator, the parties shall meet in Denver, Colorado, with such Arbitrator at
a place and time designated by the Arbitrator after consultation with the
parties and present their respective positions on the dispute. Each party shall
have no longer than one (1) day to present its position, the entire proceedings
before the Arbitrator shall be no more than three (3) consecutive days, and the
award shall be made in writing no more than thirty (30) days following the end
of the proceeding. Such award shall be a final and binding determination of the
dispute and shall be fully enforceable as an arbitration award in any court
having jurisdiction and venue over the parties. The prevailing party (as
determined by the Arbitrator) shall in addition be awarded by the Arbitrator
such party's own attorneys' fees and expenses in connection with such
proceeding. The non-prevailing party (as determined by the Arbitrator) shall pay
the Arbitrator's fees and expenses. The provisions of this Section 12.7. shall
survive termination of this Agreement.
12.8. Counterparts. This Agreement may be signed in multiple counterparts,
each one of which shall be deemed effective as if each party had signed each of
such counterparts.
(signature page follows)
27
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed as of the day and year first above written.
THE SPECTRANETICS CORPORATION
By: /s/ Xxxxxxxxx Xxx
Name: Xxxxxxxxx Xxx
Title: Vice President, Sales and Marketing
ORBUS MEDICAL TECHNOLOGIES, INC.
By: /s/ Xxxxx X. Xxxx, Xx.
Name: Xxxxx X. Xxxx, Xx.
Title: Director, Sales and Marketing
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
ANNEX LIST
Annex 1 European Patent Application
Annex 2 Minimum Staff
Annex 3 Annual Business Plan for 1998
Annex 4 Annual Sales Plan for 1998 and Annual Marketing Plan for 1998
Annex 5 Warranty
Annex 6 Timetable - Application Dates
Annex 7 * * *
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
ANNEX "1"
European Patent Application
* * *
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
ANNEX "2"
Minimum Staff
Sales and Marketing
V.P. Global Sales and Marketing
Three Sales Managers
Five Account Managers
Clinical Support and Clinical Trial Monitoring
Director Clinical Affairs
Two Clinical Managers
Eleven Clinical Advisors
Customer Service/Order Handling - Worldwide
Customer Support Manager
Two Assistants
Regulatory Affairs
V.P. RA/QA
Director Regulatory Affairs
Staff for Preparing and Filing
IDE, PMA and CE Submissions
ANNEX "3"
Annual Business Plan for 1998
* * *
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
ANNEX "4"
Annual Sales Plan for 1998 and Annual Marketing Plan for 1998
* * *
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
ANNEX "5"
Warranty
OrbusMT Medical Technologies, Inc. warrants that reasonable care has been
used in the manufacture of the device. THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF
ALL OTHER WARRANTIES, WHETHER EXPRESSED, IMPLIED, WRITTEN OR ORAL, INCLUDING,
BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. As a result of biological differences in individuals, no product is
100% effective under all circumstances. Because of this fact and since we have
no control over the conditions under which the device is used, diagnosis of the
patient, methods of administration or its handling after the device leaves our
possession, OrbusMT does not warrant either a good effect or against any ill
effect following its use. OrbusMT shall not be liable for any incidental or
consequential loss, damage, or expense arising directly or indirectly from the
use of this device. OrbusMT will replace any device that we feel was defective
at the time of shipment. No representative of OrbusMT may change any of the
foregoing or assume any additional liability or responsibility in connection
with this device.
OrbusMT Medical Technologies, Inc. warrants that each component of this
system has been manufactured, packaged, and tested with reasonable care and will
be free from defects in workmanship and material. OrbusMT will not be liable for
any incidental, special, or consequential loss, damage, or expense resulting,
directly or indirectly, from the use of its product. OrbusMT's sole obligation
shall be to repair or replace, at its option, any device that OrbusMT determines
was defective at time of shipment if notice thereof is received within one year
of shipment. Buyer assumes all liability, whether based upon warranty, contract,
negligence, or otherwise, for damages resulting from the handling, possession,
use, or misuse of the OrbusMT product. Because OrbusMT has no control over the
operation, inspection, maintenance, or use of its products after sale and has no
control over the selection of patients, THIS WARRANTY IS EXPRESSLY IN LIEU OF
ANY OTHER EXPRESS OF IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF THE SELLER. The
remedies set forth in this Warranty and Limitations shall be the exclusive
remedy available to any person. No agent, employee, or representative of OrbusMT
has any authority to change any of the foregoing or assume or bind OrbusMT to
any additional liability or responsibility in connection with this device.
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
ANNEX "6"
Timetable - Application Dates
* * *
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
ANNEX "7"
* * *
* * * This portion has been omitted pursuant to a request for confidential
treatment and filed separately with the Commission.
