Exhibit 10.1
Confidential Treatment Requested.
Confidential portions of this
document have been redacted and
have been separately filed with the
Commission.
SUPPLY AND DISTRIBUTION AGREEMENT
THIS SUPPLY AND DISTRIBUTION AGREEMENT (this "Agreement") is made as of
April 1, 2002 (the "Effective Date") by and between AngioDynamics Inc., a
Delaware corporation ("AngioDynamics") and Biolitec, Inc., a New Jersey
corporation having offices at 000 Xxxxxx Xxxx, Xxxx Xxxxxxxxxx, XX 00000
("BIOLITEC").
RECITALS
WHEREAS BIOLITEC is engaged in the development and manufacturing of the
Products;
AND WHEREAS BIOLITEC and AngioDynamics desire that BIOLITEC grant to
AngioDynamics the right to market, sell, offer for sale and distribute the
Products on the terms and conditions set forth herein;
AND WHEREAS BIOLITEC and AngioDynamics further desire to enter into such
other agreements as are contained herein;
NOW THEREFORE, in consideration of the foregoing premises and the covenants
set forth below, the parties hereby agree as follows:
1. DEFINITIONS. As used herein, the following terms shall have the following
meanings:
1.1 "Adequate Supply" shall mean the supply of Products in ordered
quantity that is delivered on a timely basis according to written
purchase orders pursuant to Section 3.2(b) and that comply with the
Manufacturing Requirements.
1.2 "Affiliate" as applied to any Person, shall mean (a) any other Person
directly or indirectly controlling, controlled by or under common
control with, that Person, (b) any other Person that owns or controls
(i) 5% or more of any class of equity securities of that Person or any
of its Affiliates or (ii) 5% or more of any class of equity securities
(including any equity securities issuable upon the exercise of any
Option or convertible security) of that Person or any of its
Affiliates, or (c) any director, partner, officer, agent, employee or
relative of such Person. For the purposes of this definition,
"control" (including with correlative meanings, the terms
"controlling", "controlled by"; and "under common control with") as
applied to any Person, means the possession, directly or indirectly,
of the power to direct or cause the direction of the management and
policies of that Person, whether through ownership of voting
securities or by contract or otherwise.
1.3 "Applicable Laws" shall mean all applicable laws, rules, regulations
and guidelines within or without the Territory that may apply to the
development, manufacturing, marketing and/or sale of the Products in
the Territory or the performance of either party's obligations under
this Agreement including laws,
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regulations and guidelines governing the import, export, development,
manufacturing, marketing, distribution and sale of the Products in the
Territory, and including all Good Manufacturing Practices or Good
Clinical Practices standards or guidelines promulgated by Competent
Authorities and including the FD&C Act and trade association
guidelines.
1.4 "Competent Authorities" shall mean the entities in the Territory
responsible for the regulation of medical devices intended for human
use, and shall include the FDA.
1.5 "Confidential Information" shall mean, subject to the exceptions set
forth in Section 6.2, any information received by one party from the
other party pursuant to this Agreement, including, without limitation,
all know-how, data, process, technique, or formula relating to the
Products and any research project, work in process, future
development, scientific, engineering, manufacturing, marketing,
business plan, financial or personnel matter relating to either party,
its present or future products, sales, suppliers, customers,
employees, investors or business, whether in oral, written, graphic or
electronic form. It includes information exchanged under the Mutual
Confidentiality Agreement, dated 15th of March, 2002.
1.6 "Contract Year" shall mean the year long period commencing on the
Effective Date and ending on the twelve month anniversary and each
subsequent twelve (12) month period thereafter.
1.7 "FDA" shall mean the United States Food and Drug Administration.
1.8 "FD&C Act" shall mean the United States Federal Food, Drug and
Cosmetic Act and applicable regulations promulgated thereunder, as
amended from time to time.
1.9 "Field" shall mean the Interventional Radiology and Vascular Surgery
marketplace.
1.10 "BIOLITEC" Technology" shall mean all know how, technology, patents,
trade secrets, processes, data, methods and any physical, chemical or
biological material or other information that BIOLITEC owns, controls
or acquires or has or acquires a license to relating to the
development, manufacturing, and use of Products.
1.11 "Improvements" shall mean any improved or modified element or feature
of BIOLITEC Technology for use in the Field made during the term of
this Agreement which is applicable to a Product.
1.12 "Licenses" shall mean the licenses granted to AngioDynamics pursuant
to Section 2.1.
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1.13 "Loss" shall mean any and all damages, fines, fees, penalties,
deficiencies, liabilities, losses and expenses, including without
limitation, interest, reasonable expenses of investigation, court
costs, reasonable fees and expenses of attorneys, accountants and
other experts or other expenses of litigation or other proceedings or
of any claim, default or assessment (such fees and expenses to include
without limitation, all fees and expenses, including, without
limitation fees and expenses of attorneys, incurred in connection with
(i) the investigation or defense of any third party claims or (ii)
successfully asserting or disputing any rights under this Agreement
against any party hereto or otherwise).
1.14 "Manufacturing Requirements" shall mean the requirements set forth in
Section 3.5(a).
1.15 "Marketing Authorization" shall mean each necessary and appropriate
approval, where applicable, to put Products on the market in a
particular jurisdiction in the Territory, including any applicable
approvals from Competent Authorities.
1.16 "Minimum Purchase Default" shall mean, as to any Product, the failure
of AngioDynamics in a Contract Year to purchase the Minimum Quantities
of such Product, provided that it shall not be a Minimum Purchase
Default if such failure to purchase is to any degree due to (a)
BIOLITEC's breach of this Agreement, (b) the failure of BIOLITEC to
timely deliver sufficient Products complying with the Manufacturing
Requirements to AngioDynamics or (c) either the infringement of the
BIOLITEC Technology by any person or entity or the infringement by the
BIOLITEC Technology of the patent rights or other proprietary rights
of any person or entity.
1.17 "Minimum Quantities" shall mean for each Product, the minimum number
of units of such Product required to be purchased in a Contract Year
by AngioDynamics, as set forth on Schedule C.
1.18 "Packaging Specifications" shall mean the bulk, non-sterile packaging
specifications for the Products as may be determined by BIOLITEC and
AngioDynamics from time to time, as such specifications may be amended
from time to time by BIOLITEC and AngioDynamics.
1.19 "Product Specifications" shall mean the specifications for the
Products that are attached hereto as Schedule B, as such
specifications may be amended from time to time by mutual agreement of
the parties, including, without limitation, such amendments as may be
necessary to obtain any Marketing Authorizations or other approvals
within the Territory.
1.20 "Products" means the diode lasers and laser fibers privately labeled
for AngioDynamics as more fully described on Schedule A hereto and
also includes Improvements.
1.21 "Rights" mean the right to market, sell and/or distribute a product.
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1.22 "United States" shall mean the United States of America and its
territories and possessions.
1.23 "Territory" shall mean the United States and Canada.
2. GRANT OF RIGHTS
2.1 Appointment.
(a) Products. Subject to Section 2.1 (f), BIOLITEC hereby appoints
AngioDynamics as its exclusive (even as to BIOLITEC) distributor to market,
sell, offer for sale and distribute the Products in the Territory for the Field.
Outside the United States AngioDynamics shall have the right to sub-license the
rights granted in this Section 2.1 to (a) one or more of its Affiliates and (b)
one or more distributors, sub-distributors or dealers, provided that
AngioDynamics shall have the right to sell Products through (a) one or more of
its Affiliates and (b) one or more distributors, subdistributors or dealers
without in any such case sub-licensing the rights granted in this Section 2.1.
(b) BIOLITEC Obligations. BIOLITEC shall not directly or indirectly,
market, promote, sell or distribute any of the Products to any third party
directly or indirectly in the Field in the Territory other than AngioDynamics.
BIOLITEC shall take all appropriate actions to prevent any distributors,
sub-distributors or dealers of the Products from marketing, selling, offering
for sale or distributing the Products in or to the Field in the Territory.
BIOLITEC shall refer all inquires from the in the Territory concerning Products
to AngioDynamics. BIOLITEC shall not discontinue the manufacturing of any
Product without the prior written consent of AngioDynamics.
(c) ANGIODYNAMICS Obligations. ANGIODYNAMICS shall actively market the sale
of the Products with a marketing plan commensurate with the Sales Forecast for
each Contract Year. ANGIODYNAMICS shall keep BIOLITEC apprised of these
marketing plans as they become actionable.
(d) Cooperation Concerning Improvements. BIOLITEC agrees to keep
AngioDynamics fully informed of Improvements that it develops as it pertains to
the Product.
(e) Right of First Refusal for Improvements. Provided the appointment as
set forth in Section 2.1 (a) remains exclusive, in the event BIOLITEC develops
any Improvements which can be used for the Products, it shall provide
AngioDynamics with written notice regarding such Improvement. If AngioDynamics
desires to market and sell such Improvements, the parties shall negotiate in
good faith the price for such Improvements. If,
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after six (6) months of negotiations, the parties are unable to reach an
agreement on the price, BIOLITEC shall be entitled to offer such Improvements to
any third party, but only on such terms and conditions as were offered to
AngioDynamics. If BIOLITEC offers better terms and conditions for such
Improvements to a third party, then AngioDynamics shall have a right of first
refusal on such better terms and conditions.
(f) Loss of Exclusivity. If there is a Minimum Purchase Default as to any
Product, the exclusive licenses in Section 2.1 (a) shall thereafter be
nonexclusive. The loss of exclusivity provided for (i)in this Section 2.1 (d)
shall be the sole and exclusive remedy for a Minimum Purchase Default.
3. MANUFACTURE AND SUPPLY OF PRODUCTS
3.1 (a) Manufacturing. BIOLITEC shall be the exclusive manufacturer of the
Products sold by AngioDynamics; provided, however, that if a problem
arises with regard to Adequate Supply, then AngioDynamics shall give
BIOLITEC written notice and thirty (30) days to cure any failure to
provide Adequate Supply. If BIOLITEC does not cure such failure within
such thirty (30) day period, AngioDynamics may, with notice to
BIOLITEC, who may join in the process, take whatever steps are
necessary, including directly contacting suppliers, to obtain the
Products and in such event BIOLITEC shall grant a license to
AngioDynamics or to a new supplier selected by AngioDynamics on market
standard terms and conditions to use the BIOLITEC Technology to
manufacture Products and shall cooperate with AngioDynamics and/or
such new supplier to transfer manufacturing of the Products. If the
parties are unable to agree on the terms and conditions of such
license, the license terms and conditions shall be determined by a
panel of arbitrators experienced in licensing matters chosen in
accordance and acting in accordance with the Commercial Arbitration
Rules (Expedited Procedures) of the American Arbitration Association,
who shall specifically take into account the fact that the license is
being granted due to BIOLITEC's inability to fulfill its obligations
under this Agreement. In no event shall BIOLITEC subcontract its
manufacturing obligations under this Agreement without the prior
written consent of AngioDynamics. BIOLITEC shall only be entitled to
two thirty (30) day cure periods pursuant to this Section 3.1 in any
twelve month period.
3.2 Supply Forecasts and Ordering Procedures.
(a) AngioDynamics shall furnish the following reports to BIOLITEC:
(i) non-binding annual sales forecast reports, by Product by
month, not later than thirty (30) days prior to the
beginning of each Contract Year, with the sales forecast
report for the Contract Years being attached hereto as
Schedule D; and
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(ii) non-binding quarterly sales forecast deviation reports on a
rolling four-quarter basis for each quarter of each Contract
Year.
(b) AngioDynamics shall submit firm orders for Products at least one
hundred eighty (180) days prior to the requested delivery date. Orders may be
submitted by fax, e-mail or US mail. BIOLITEC shall confirm each order within
ten (10) days after receipt. Confirmation shall be by mail.
3.3 Delivery. All Products shall be shipped F.O.B. (Incoterms 2000) point
of departure from BIOLITEC's facility in East Longmeadow, MA to such
locations and in such manner as directed by AngioDynamics from time to
time.
3.4 Price and Payment Terms. The price for Products shall be as set forth
on Schedule E. AngioDynamics shall have payment terms of 45 days after
Invoice Date during the first six months of this agreement and thirty
(30) days after Invoice Date thereafter. The invoice date shall in no
event be earlier than the date of shipment. All payments to BIOLITEC
shall be made by check and shall be made in U.S. Dollars. The price
for Improvements shall be negotiated by the parties in good faith.
(a) BIOLITEC intends to maintain the pricing to AngioDynamics of PRODUCTS
as given in Exhibit E, but reserves the right to increase prices in light of
extraordinary, unusual increases to its manufacturing costs: In the event of any
price change BIOLITEC agrees to notify AngioDynamics, in writing, at least sixty
(60) days prior to the effective date of the increase. BIOLITEC agrees to honor
any orders it has accepted during the sixty day notice period.
3.5 Quality Control and Assurance.
(a) BIOLITEC shall manufacture and supply the Products in an ISO certified
facility in accordance with (i) the Product Specifications, (ii) the Packaging
Specifications, (iii) current good manufacturing practices specified by any
applicable Competent Authority (collectively, "cGMPs") and (iv) all other
Applicable Laws. Furthermore, BIOLITEC warrants that all Products provided
hereunder shall be free from defect in material and workmanship at the time of
shipment to AngioDynamics.
(b) BIOLITEC shall be responsible for quality control of the Products and
shall perform such quality control and quality assurance testing as is necessary
or appropriate to ensure that the Products comply with the Manufacturing
Requirements.
(c) Each time BIOLITEC ships Products to AngioDynamics, it shall provide
AngioDynamics with a certificate of compliance that sets out the test results
for each lot of Products, and that certifies that the Products shipped to
AngioDynamics have been evaluated by BIOLITEC's Quality
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Control/Quality Assurance department and that the Products comply with the
Manufacturing Requirements.
(d) BIOLITEC shall permit AngioDynamics or its designated representative to
perform such audits and inspections as may be requested by AngioDynamics of the
facilities, procedures and records that are relevant to BIOLITEC's manufacturing
of Products, and to the extent reasonably obtainable by BIOLITEC, of facilities,
procedures and records that are relevant to such audits or inspections of
unaffiliated parties with responsibility for testing, analyzing, labeling or
packaging the Product.
(e) BIOLITEC shall notify AngioDynamics of any proposed changes in critical
materials or processes which affect the form, fit or function of Products at
least ninety (90) days prior to such actions and shall not make any such change
without the prior written consent of AngioDynamics, which consent shall not be
unreasonably withheld, conditioned or delayed.
(f) BIOLITEC shall promptly inform AngioDynamics of the results of all
visits and inspections, relating to the Product, by Competent Authorities,
including, without limitation, providing AngioDynamics with copies of all
warning letters, 483s and other correspondence with the Competent Authority.
(g) In the event of any customer complaints regarding the Product, BIOLITEC
agrees to cooperate and assist AngioDynamics in investigating such complaints
and providing an appropriate response.
3.6 Packaging and Trademarks.
(a) Packaging of the Products shall comply with the Packaging
Specifications.
(b) AngioDynamics shall be responsible for final packaging, instructions
for use and labeling of the Products.
(c) BioLitec hereby grants an exclusive, royalty free license to
AngioDynamics to use the "ELVeS" trademark connection with the promotion,
marketing, and sale of the Products. AngioDynamics may use any other trademark
or trade dress as it deems appropriate in the promotion, marketing and sale of
the Products. BIOLITEC shall the right to preview and comment on items
containing its trademarks.
4. SERVICE AND PRODUCT WARRANTY
4.1 At the request of AngioDynamics, BIOLITEC will provide repair service
on the Ceralas D lasers and xxxx AngioDynamics based on an agreed upon
hourly rate per unit plus materials. AngioDynamics will administer the
service (take service
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calls, document calls and/or contacts, sell extended factory
warranties) for the Territory.
4.2 BIOLITEC will provide a product warranty from one year from the date of
installation, except for promotional lasers, with AngioDynamics
administering the warranty cards, namely having them completed,
collected and sent to BIOLITEC, within ten (10) days of installation.
5. MARKETING AUTHORIZATIONS; OTHER REGULATORY COMPLIANCE ISSUES
5.1 Marketing Authorizations. BIOLITEC shall be responsible for applying
for such Marketing Authorizations as may be necessary to market the
Products in the Territory and in the Field. (including a 510K clearance
to market the Products in the United States); provided, however, that
AngioDynamics shall be free to apply for any such additional Marketing
Authorization as it deems necessary in its sole judgment. AngioDynamics
shall own all such additional Marketing Authorizations and agrees, for
the term of this Agreement, to grant BIOLITEC the right to sell product
under such additional Marketing Authorizations except in or to the
Field, provided, however, that in the event BIOLITEC desires to sell
product under such additional Marketing Authorizations, BIOLITEC agrees
that AngioDynamics shall be its exclusive supplier for any finished
kits containing the BIOLITEC optical fiber, provided that such kits are
transferred at a reasonable price to BIOLITEC. BIOLITEC shall provide
such assistance as may be requested by AngioDynamics in connection with
obtaining such additional Marketing Authorizations, including, without
limitation, providing (i) ordered Product for testing and (ii)
requested documents and data for submission to the Competent
Authorities. AngioDynamics shall be responsible for any sterility and
biocompatibility testing of the Products as may be necessary in order
to obtain such additional Marketing Authorizations.
5.2 Compliance. AngioDynamics and BIOLITEC shall comply with all Applicable
Laws including the provision of information by AngioDynamics and
BIOLITEC to each other necessary for BIOLITEC and AngioDynamics to
comply with Applicable Laws (including reporting requirements). Each
party shall retain all records concerning the Products as may be
required under Applicable Laws.
5.3 Adverse Reaction Reporting. Each party shall advise the other party, by
telephone or facsimile, within such time as is required to comply with
Applicable Laws, after it becomes aware of any adverse reaction
involving the Products. Such advising party shall provide the other
party with a written report delivered by confirmed facsimile of any
adverse reaction, stating the full facts known to it, including but not
limited to customer name, address, telephone number, batch, lot and
serial numbers, as required by Applicable Laws. To the extent permitted
by Applicable Laws, AngioDynamics shall have full responsibility for
monitoring such adverse reactions and making any reports to the
Competent Authorities.
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5.4 Product Recall. AngioDynamics and BIOLITEC each shall notify the other
promptly if any Product is the subject of a recall, market withdrawal
or correction, and the parties shall cooperate in the handling and
disposition of such recall, market withdrawal or correction. BIOLITEC
shall bear the cost of all recalls, market withdrawals or corrections
of the Products; provided, however, that AngioDynamics shall pay for
such recall, market withdrawal or correction if and to the extent
caused by (i) the unlawful sale, promotion or distribution of the
Products by AngioDynamics in the Territory, (ii) any unauthorized
modification or alteration made by AngioDynamics to the Products, (iii)
the improper sterilization or labeling of the Products, (iv) a breach
of any representation made or warranty given in this Agreement by
AngioDynamics, (v) mishandling of fibers during unpacking and
repackaging of bulk fibers delivered to AngioDynamics for the purpose
of putting into their kits, or (vi) the design of a product solely by
AngioDynamics. AngioDynamics shall in all events be responsible for
conducting any recalls, market withdrawals or corrections with respect
to the Products.
6. CONFIDENTIALITY
6.1 Nondisclosure Obligations. During the term of this Agreement, and for a
period of 5 years after termination hereof, each party will maintain
all Confidential Information in trust and confidence and will not
disclose any Confidential Information to any third party or use any
Confidential Information for any unauthorized purpose. Each party may
use such Confidential Information only to the extent required to
accomplish the purposes of this Agreement. Confidential Information
shall not be used for any purpose or in any manner that would
constitute a violation of Applicable Laws. Confidential Information
shall not be reproduced in any form except as required to accomplish
the intent of this Agreement. Each party will use at least the same
standard of care as it uses to protect proprietary or confidential
information of its own. Each party will promptly notify the other upon
discovery of any unauthorized use or disclosure of the Confidential
Information.
6.2 Exceptions. Confidential Information shall not include any information
that:
(a) is now, or hereafter becomes, through no act or failure to act on the
part of the receiving party, generally known or available;
(b) is known by the receiving party at the time of receiving such
information, as evidenced by its written records;
(c) is hereafter furnished to the receiving party by a third party, as a
matter of right and without restriction on disclosure;
(d) is independently developed by the receiving party without any breach of
Section 6.1; .
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(e) is the subject of a written permission to disclose provided by the
disclosing party; or
The parties agree that the material financial terms of this Agreement
will be considered Confidential Information of both parties. However,
each party shall have the right to disclose the material financial
terms of this Agreement to any potential acquirer, merger partner, or
other bona fide potential financial partner, subject to a requirement
to secure confidential treatment of such information or if it is
prudent or proper to make such disclosure to comply with Applicable
Laws or to meet Generally Accepted Accounting Principles.
6.3 Authorized Disclosure. Notwithstanding any other provision of this
Agreement, each party may disclose Confidential Information if such
disclosure:
(a) is in response to a valid order of a court or other governmental body
of any jurisdiction in the Territory or of any political subdivision thereof;
provided, however, that the responding party shall first have given notice to
the other party hereto and shall have made a reasonable effort to obtain a
protective or other appropriate form of order requiring that the Confidential
Information so disclosed be used only for the purposes for which the order was
issued;
(b) is otherwise required by Applicable Laws; or
(c) is otherwise necessary to file or prosecute patent applications,
prosecute or defend litigation or comply with Applicable Laws or otherwise
establish rights or enforce obligations under this Agreement, but only to the
extent that any such disclosure is necessary.
7. INTELLECTUAL PROPERTY
7.1 Ownership of Intellectual Property. BIOLITEC shall retain all of its
rights, title and interest in and to all BIOLITEC Technology.
7.2 Infringement of Third Party Patents and Rights. BIOLITEC represents
that to the best of BIOLITEC's knowledge, the manufacture, marketing,
sale, distribution and use of the Products does not and will not
infringe any United States or foreign patent or other proprietary
rights held by any third party. If a third party asserts that a patent
or other proprietary right owned by it is infringed by the manufacture,
marketing, sale, distribution or use of a Product, the party against
whom such a claim was asserted shall provide the other party with
notice of such claim within fifteen (15) days. BIOLITEC agrees to
undertake the sole and complete defense, at its sole cost and expense,
of any such claim -through counsel of its choice and control the
settlement of any such claim. In case of any such claims, BIOLITEC
shall promptly, at its sole discretion and own cost, either (i) procure
for AngioDynamics the right to continue distributing and using such
Product, or (ii) replace the same with a comparable non-infringing non-
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violating Product, or modify the Product so that it becomes
non-infringing and non-violating. If BIOLITEC fails to take such
action, AngioDynamics shall be entitled to do so and BIOLITEC shall
promptly reimburse AngioDynamics for pre-agreed upon expenses it
incurs, including without limitation reasonable attorneys' fees and
expenses.
8. TERM AND TERMINATION OF AGREEMENT; RENEWAL RIGHTS
8.1 Term. This Agreement shall commence on the Effective Date, and issuance
of the Initial Purchase Order, as described in Exhibit C, and terminate
on the fifth (5) anniversary thereafter, unless terminated sooner as
provided in Section 8.
8.2 Termination For Material Breach. If either party is in material breach
of any obligation hereunder, the party contending there is a breach
(the charging party) may give written notice to the accused party of
the nature of the breach and shall provide thirty (30) days after the
giving of such notice for the breach to be cured to the reasonable
satisfaction of the charging party. If such breach is not cured to the
reasonable satisfaction of the charging party, the charging party by
notice to the accused party shall have the right to immediately
terminate this Agreement.
8.3 Termination for Insolvency. If either party (1) is dissolved (other
than pursuant to a consolidation, amalgamation or merger); (2) becomes
insolvent or is unable to pay its debts or fails or admits in writing
its inability generally to pay its debts as they become due; (3) makes
a general assignment, arrangement or composition with or for the
benefit of its creditors; (4) institutes or has instituted against it a
proceeding seeking a judgment of insolvency or bankruptcy or any other
relief under any bankruptcy or insolvency law or other similar law
affecting creditors' rights, or a petition is presented for its.
winding-up or liquidation, and, in the case of any such proceeding or
petition instituted or presented against it, such proceeding or
petition (A) results in a judgment of insolvency or bankruptcy or the
entry of an order for relief or the making of an order for its
winding-up or liquidation or (B) is not dismissed, discharged, stayed
or restrained in each case within 30 days of the institution or
presentation thereof; (5) has a resolution passed for its winding-up,
official management or liquidation (other than pursuant to a
consolidation, amalgamation or merger); (6) seeks or becomes subject to
the appointment of an administrator, provisional liquidator,
conservator, receiver, trustee, custodian or other similar official for
it or for all or substantially all of its assets or has a distress,
execution, attachment, sequestration, or other legal process levied,
enforced or sued on or against all or substantially all of its assets
and such secured party maintains possession, or any such process is not
dismissed, discharged, stayed or restrained, in each case within 30
days thereafter; (8)causes or is subject to any event with respect to
it which, under the applicable laws of any jurisdiction, has an
analogous effect to any of the events specified in clauses (1) to (7)
(inclusive); or (9) takes any action in furtherance of, or indicating
its consent to, approval of, or acquiescence in, any
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of the foregoing acts, than the other party shall have the right to
immediately terminate this Agreement without giving prior notice or any
right to cure.
8.4 Accrued Rights. Termination or expiration of this Agreement shall not
affect any accrued rights of either party.
8.5 Effect Of Termination. Upon termination of this Agreement for any
reason, other than for lack of payment of ordered and received Product,
AngioDynamics shall be permitted to sell off existing inventory for one
(1) year following the termination date, provided, however that
BIOLITEC shall be given a right of first refusal to purchase the
existing inventory on the same terms and conditions as to any third
party bona fide purchaser. AngioDynamics shall in any event be entitled
to continue to provide consumables to its customers of record for the
lasers. In the event of a termination due to a material breach by
AngioDynamics, AngioDynamics agrees not to sell lasers or fibers other
than the existing inventory sell off for a period of one (1) year
following said existing inventory sell off. In no event shall this
period extend beyond two (2) years following the date of termination.
8.6 Surviving Obligations; Termination or expiration of this Agreement
shall not relieve either party of its obligations under Sections 6,7,8
and 9.
8.7 Renewal Option. This Agreement may be renewed for additional five (5)
year terms by the mutual written consent of the parties.
8.8 Remedies Not Exclusive. Except in the event of a Minimum Purchase
Default, rights and remedies set forth herein shall not be exclusive
and shall be in addition to any and all rights and remedies available
to either party upon termination of this Agreement.
9. INDEMNIFICATION AND INSURANCE
9.1 Indemnification by BIOLITEC. BIOLITEC agrees to indemnify and hold
AngioDynamics harmless from and against any and all Loss that
AngioDynamics may incur to the extent that such Loss arises out of or
results from (i) a breach of any representation or warranty or
agreement given in this Agreement by BIOLITEC, or (ii) the injury,
illness or death of any person which arises out of or relates to the
manufacture or the design of Products.
9.2 Indemnification by AngioDynamics. AngioDynamics agrees to indemnify and
hold BIOLITEC harmless from and against any and all Loss that BIOLITEC
may incur to the extent that such Loss arises out of or results from
(i) the unlawful sale, promotion and distribution of the Products by
AngioDynamics in the Territory, (ii) any unauthorized modification or
alteration made by AngioDynamics to the Products, (iii) the improper
sterilization or labeling of the Products, (iv) a breach of any
representation made or warranty given in this Agreement by
AngioDynamics, (v) mishandling of fibers during unpacking and
repackaging of bulk fibers
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delivered to AngioDynamics for the purpose of putting into their
kits, or (vi) the design of a product solely by AngioDynamics.
9.3 Indemnification Procedure. The party seeking indemnification (the
"Indemnified Party") shall (i) give the other party (the
"Indemnifying Party") notice of the relevant claim, (ii) cooperate
with the Indemnifying Party, at the Indemnifying Party's expense,
in the defense of such claim, and (iii) give the Indemnifying
Party the right to control the defense and settlement of any such
claim, provided however that the Indemnifying Party shall not
enter into any settlement that affects the Indemnified Party's
rights or interests without the Indemnified Party's prior written
approval, such approval not to be unreasonably withheld,
conditioned or delayed.
9.4 Insurance. Each party shall carry comprehensive general liability
insurance of a type as may be necessary to protect their interests
and fulfill their obligations under this Agreement in an amount of
at least three million dollars (US $3,000,000) per occurrence
during the term of this Agreement and for a period of three (3)
years after the expiration or termination of this Agreement. Upon
request, each party shall provide the other party with a
certificate of insurance evidencing the minimum coverage required
by this Section 9.4. For greater certainty, this Section 8.4 shall
not limit the liability of either party pursuant to this
Agreement.
10. REPRESENTATIONS AND WARRANTIES
10.1 Representation and Warranties of BIOLITEC. BIOLITEC hereby
represents and warrants as follows:
(a) Corporate Power. BIOLITEC is duly organized and validly existing
under the laws of the State of New Jersey and has full corporate power and
authority to enter into this Agreement and to carry out the provisions hereof.
(b) Due Authorization. BIOLITEC is duly authorized to execute and deliver
this Agreement and to perform its obligations hereunder.
(c) Binding Agreement, No Conflict. This Agreement is a legal and valid
obligation binding upon BIOLITEC and is enforceable in accordance with its
terms. The execution, delivery and performance of this Agreement by BIOLITEC
does not conflict with, violate or give any person or entity rights under, any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it or its assets may be bound or affected, nor does it violate any
Applicable Laws.
10.2 Representations and Warranties of AngioDynamics. AngioDynamics
hereby represents and warrants as follows:
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(a) Corporate Power. AngioDynamics is duly organized and validly existing
under the laws of Delaware and has full corporate power and authority under
Applicable Laws to enter into this Agreement and to carry out the provisions
hereof.
(b) Due Authorization. AngioDynamics is duly authorized to execute and
deliver this Agreement and to perform its obligations hereunder.
(c) Binding Agreement, No Conflict. This Agreement is a legal and valid
obligation binding upon AngioDynamics and is enforceable in accordance with its
terms. The execution, delivery and performance of this Agreement by
AngioDynamics does not conflict with, violate or give any person or entity
rights under, any agreement, instrument or understanding, oral or written, to
which it is a party or by which it or its assets may be bound or affected, nor
does it violate any Applicable Laws.
11. ASSIGNMENT
11.1 Non-Assignment. Except as set forth in Section 11.2, neither party
shall assign its rights or delegate its duties under this
Agreement without the prior written consent of the other party.
11.2 Exception. Notwithstanding Section 11.1, each party may assign
this Agreement to any successor by merger or sale of substantially
all of its assets.
11.3 Assignment or Delegation Null and Void. Any attempted assignment
or delegation in contravention of this Article shall be void and
of no effect.
11.4 Benefits and Binding Nature of Agreement. In the case of any
permitted assignment of this Agreement, this Agreement or the
relevant provisions shall be binding upon, and inure to the
benefit of, the successors, executors, heirs, representatives,
administrators and assigns of the parties hereto.
12. MISCELLANEOUS
12.1 Entire Agreement and Amendments. This Agreement, together with any
exhibits and schedules attached and referenced herein, embodies
the final, complete and exclusive understanding between the
parties, and replaces all previous agreements, understandings or
arrangements between the parties with respect to its subject
matter. No modification or waiver of any terms or conditions
hereof, nor any representations or warranties shall be of any
force or effect unless such modification or waiver is in writing
and signed by an authorized officer of each party hereto.
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12.2 Press Release. All press releases concerning the relationship between
AngioDynamics and BIOLITEC are subject to the approval of both parties,
not to be unreasonably withheld, provided that neither party is precluded
by this Section 12.2 from taking any action to comply with Applicable
Laws.
12.3 Notice. All notices concerning this Agreement shall be in writing and
shall be deemed to have been received (a) two (2) days after being
properly sent by commercial overnight courier, or (b) one (1) day after
being transmitted by confirmed facsimile, in each case addressed to the
address below:
If to BIOLITEC:
000 Xxxxxx Xxxx
Xxxx Xxxxxxxxxx, XX 00000
Attention: Xxxxx Xxxxx, COO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
If To AngioDynamics:
000 Xxxxxxxxxx Xxxxxx
Xxxxxxxxxx, Xxx Xxxx 00000
Attention: Xxxxxx Xxxxx, President and CEO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
12.4 Waiver. Any waiver (express or implied) by either party of any default or
breach of this Agreement shall not constitute a waiver of any other or
subsequent default or breach.
12.5 Severability. In the event that any provision of this Agreement shall be
unenforceable or invalid under any Applicable Laws or be so held by
applicable court decision, such enforceability or invalidity shall not
render this Agreement unenforceable or invalid as a whole, and, in such
event, such provision shall be changed and interpreted so as to best
accomplish the objectives of such unenforceable or invalid provision
within the limits of Applicable Laws or applicable court decisions.
12.6 Rights and Remedies Cumulative. Except as expressly provided herein, the
rights and remedies provided in this Agreement shall be cumulative and
not exclusive of any other rights and remedies provided by law or
otherwise.
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12.7 Independent Contractors. Each party shall act as an independent
contractor under the terms of this Agreement. Neither party is,
nor shall it be deemed to be, an employee, agent, co-venturer,
partner or legal representative of the other for any purpose.
Neither party shall be entitled to enter into any contracts in the
name of, or on behalf of the other, nor shall either party be
entitled to pledge the credit of the other in any way or hold
itself out as having authority to do so.
12.8 Captions and Section References. The section headings appearing in
this Agreement are inserted only as a matter of convenience and in
no way define, limit, construe or describe the scope or extent of
such section or in any way affect such section.
12.9 Counterparts. This Agreement may be executed in counterparts with
the same force and effect as if each of the signatories had
executed the same instrument.
IN WITNESS WHEREOF, the parties have each caused this Agreement to be
signed and delivered by their duly authorized representatives as of the date
first written above.
BIOLITEC, Inc.
By: /s/ [Illegible]
------------------------------
Title: COO
---------------------------
AngioDynamics Inc.
By: /s/ Xxxxxx X. Xxxxx
------------------------------
Title: President & CEO
---------------------------
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Supply and Distribution Agreement Schedules
Schedule A: Products
Schedule B: Product Specifications
Schedule C: Minimum Quantities (units)
Schedule D: Sales Forecast
Schedule E: Product Pricing
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Schedule A: Products
1. Ceralas(R) X00 000 nm laser
2. Ceralas(R) D 810 nm laser
3. 600 micron optical fiber for laser transmission
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Schedule B: Product Specifications
Product 1: Ceralas(R) X00 000 nm laser
PRODUCT DEFINITION
Laser Type Integrated GaAIAs Semiconductor laser arrays
Wavelength 980nm
Output Power 15 Xxxxx (must be minimum of 15 W)
Power Range 1-15W
Increments 1W
Operating modes Continuous, Pulsed
Pulse Duration ON/OFF 0.01 to 99.9 seconds
Aiming Beam 635nm; 4mW
Cooling Air cooled
Weight 15 lbs (9kg)
Dimensions 14" x 9" x 7"
Power Requirements 110/220v
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PRODUCT 1 DRAWING
[DRAWING]
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Product 2: Ceralas(R) D 810 nm laser
PRODUCT DEFINITION
Laser Type Integrated GaAIAs Semiconductor laser arrays
Wavelength 810nm
Output Power 15 Xxxxx (must be minimum of 15 W)
Power Range 1-15W
Increments 1W
Operating modes Continuous, Pulsed
Pulse Duration ON/OFF 0.01 to 99.9 seconds
Aiming Beam 635nm; 4mW
Cooling Air cooled
Weight 15 lbs (9kg)
Dimensions 14" x 9" x 7"
Power Requirements 110/220v
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PRODUCT 2 DRAWING
[DRAWING]
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Product 3: Optical Fiber
PRODUCT DEFINITION
Fiber Type Fused Silica Optical Fiber
Core Diameter 600um
Tip Design Bare fiber with polished open tip
Fiber Proximal Connector to laser Standard SMA connector
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PRODUCT 3 DRAWING
[DRAWING]
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Schedule C: Minimum Quantities (Units)
Contract Year minimums are as follows:
Minimums- IR and VS combined
Optical Fiber Contract Year Contract Year Contract Year Contract Year Contract Year
1 2 3 4 5
Minimums *** units *** units *** units *** units *** units
Ceralas@ Laser Contract Year Contract Year Contract Year Contract Year Contract Year
1 2 3 4 5
Minimums *** Units *** Units *** Units *** Units *** Units
Upon signing of this Agreement an Initial Purchase order shall be placed for
sixteen (16) lasers and two thousand twelve (2012) disposable fiber packages of
which ten (10) lasers are for promotional use and six (6) are against the
contract Year 1 Minimum Quantity. Of the 2012 disposable fiber packages, six
hundred (600) disposable fiber packages will be delivered within six (6) weeks,
seven hundred six (706) will be delivered on July 1, 2002, and seven hundred six
(706) will be delivered on October 1, 2002 as required to warrant private
labelled fiber packages.
________________
*** Confidential material redacted and filed separately with the Commission.
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Schedule D: Sales Forecasts
Contract Year Sales Forecasts are as follows:
Sales Forecast - IR and VS combined
Optical Fiber Contract Year Contract Year Contract Year Contract Year Contract Year
1 2 3 4 5
Forecast *** Units *** Units *** Units *** Units *** Units
Ceralas(R)Laser Contract Year Contract Year Contract Year Contract Year Contract Year
1 2 3 4 5
Forecast *** *** Units *** Units *** Units *** Units *** Units
______________
*** Confidential material redacted and filed separately with the Commission.
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Schedule E: Product Pricing
F.O.B. East Longmeadow, MA
The pricing will be as follows:
(a) Pricing for the Xxxxxxx X00 980 nm laser or Xxxxxxx X00 810 nm laser
for the initial 30 units will be $*** each. This reflects a reduction in price
to-cover the 10 promotional lasers purchased within this initial group.
(b) After the initial 30 units are purchased, pricing for the Ceralas D 980
nm laser or Ceralas D 810 nm laser will be based on quantity tiered levels for a
given order:
1 - 50 units $ ***
51 - 99 units $ ***
100 - 199 units $ ***
200 + units $ ***
(c) Pricing for the laser fibers: $*** each.
(d) Pricing for sterilized laser fibers: $*** each. This requires purchase
and delivery of the minimum *** fibers before December 30, 2002. AngioDynamics
to provide labeling for the sterilized packaging.
_______________
*** Confidential material redacted and filed separately with the Commission.
