Confidential treatment requested.
Confidential
portions of this document have been
redacted
and have been separately filed with the
Commission.
Exhibit 10.1
DISTRIBUTION
AGREEMENT
THIS AGREEMENT is effective as of the last date
of signature set forth herein and is by and between
ANGIODYNAMICS ® , Inc., (hereinafter
‘ANGIODYNAMICS”), a Delaware corporation having a
principal place of business at 603 Queensbury Avenue, Queensbury,
New York 12804, and Medical Components Inc., (hereinafter
“MEDCOMP”), a Pennsylvania corporation, having a
principal place of business at 1499 Delp Drive, Harleysville,
Pennsylvania 19438.
IN CONSIDERATION of the mutual
promises contained herein, the parties agree as follows:
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1.1
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“Territory” as used herein shall
mean the entire world except where specifically indicated
otherwise.
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1.2
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“Products” as used herein shall mean
those products as set forth in Exhibits A, B, C, D, E
(“hereinafter Exhibits A-E”) attached hereto. Exhibits
A-E may be modified from time to time, during the effective period
of this Agreement, by the mutual written consent of the
parties.
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1.3
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“Know-how” as used herein shall
include all technology and trade secrets necessary for the
manufacture, sale, research and development, and marketing of the
Products.
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1.4
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“Patent
Rights” as used herein shall include any U.S. patent,
reissued patent or patent re-examination certificate and any
foreign counterparts which have a claim that covers the Products
which are or will be licensed and/or assigned to MEDCOMP including
pending U.S. Patent Applications, as well as any and all patent
rights which are related thereto, and any patent rights acquired in
the future by MEDCOMP for any improvements, adaptations,
modifications or derivative inventions having a claim that covers
the Products, provided that for any such rights which are licensed
to or will be licensed to MEDCOMP, MEDCOMP has been granted or will
be granted a right to sublicense under such license or a right to
assign or otherwise convey the license agreement to third
parties.
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1.5
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“Trademarks” as used herein includes
all trademark(s) and trade name(s) pertaining to the Products and
any related trade dress rights.
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1.6
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“Intellectual Property Right” as
used herein shall include any and to all rights in and to the
Products in the form of Know-how, Patent Rights, Trademarks, and
copyrights which are owned, licensed or otherwise possessed by
MEDCOMP.
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1.7
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“Specifications” shall mean the
specifications for each of the Products and attached herewith in
Exhibits A-E, as they are modified during the effective period of
this Agreement by the mutual written consent of the
parties.
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2.1
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As designated
on each of the Exhibits A, B, and E, MEDCOMP hereby grants to
ANGIODYNAMICS the sole and exclusive distributorship, together with
the right to appoint others, for the Products in Exhibits A, B, and
E throughout the Territory. MEDCOMP shall not sell, either directly
or indirectly, any of the Products in Exhibits A, B, and E to any
other person or entity.
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2.2
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As designated
on Exhibit C, MEDCOMP hereby grants to ANGIODYNAMICS the sole and
exclusive distributorship, together with the right to appoint
others, for the Products listed in Exhibit C throughout the United
States, and a non-exclusive distributorship for the Products listed
in Exhibit C, together with the right to appoint others, throughout
the Territory, except for the United States which shall remain
exclusive. In the United States, MEDCOMP shall not sell, either
directly or indirectly, any of the Products in Exhibit C to any
other person or entity.
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2.3
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As designated
on Exhibit D, MEDCOMP hereby grants to ANGIODYNAMICS a
non-exclusive distributorship for the Products listed in Exhibit D
throughout the Territory, together with the right to appoint
others.
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2.4
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For each of the
appointments in paragraphs 2.1-2.3, ANGIODYNAMICS shall inform
MEDCOMP of its selection of any appointees and MEDCOMP shall have
the right to reasonably object to any such appointment.
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3.
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PRICE,
PAYMENT, AND ORDERING
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3.1
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The price of
the Products shall be as set forth in Exhibit A-E attached hereto,
as such price is indicated next to each Product. This price
includes the cost of sterilization and packaging. Such prices shall
be firm for the initial Twelve (12) month period of this
Agreement, and thereafter, such prices may be adjusted upon Thirty
(3) days notice to ANGIODYNAMICS by no more than Two percent
(2%) per year or the U.S. consumer price index which ever is
greater. The price of the Products as set forth in Exhibit A-E does
not include any applicable sales and use taxes, which MEDCOMP has
the legal obligation to pay.
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3.2
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Orders for the
Products shall be initiated by a written purchase order sent or
faxed to MEDCOMP. To facilitate MEDCOMP’s production
schedule, ANGIODYNAMICS shall submit purchase orders to MEDCOMP at
least Forty-five (45) days prior to the requested date of
delivery.
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3.3
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ANGIODYNAMICS’ purchase orders, submitted
to MEDCOMP with respect to the Products, shall be governed by the
terms and conditions of this Agreement.
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3.4
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Full payment of
the purchase price of the Products shall be net Forty-five
(45) days and payment shall be made by check, or other
instrument agreed to by both parties. Payment by
ANGIODYNAMICS’ rights under Paragraph 6 or as acceptance of
the Products delivered.
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2
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4.1
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ANGIODYNAMICS
agrees to purchase from MEDCOMP the minimum yearly number of
Product units for each set of Products as set forth in Exhibit A-E
attached hereto. In the event that ANGIODYNAMICS fails to purchase
at least 90% of the annual minimum as set forth on each Exhibit or
the adjusted minimums if this contract is extended as set forth in
Section 4.3, MEDCOMP, at its sole discretion, may convert the
distributorship for those Products set forth as exclusive on that
Exhibit for either the Territory or that portion of the Territory
that was exclusive to a non-exclusive distributorship. Such remedy
shall be MEDCOMP’s sole and exclusive remedy in the event
that ANGIODYNAMICS fails to purchase at least 90% of minimums as
set forth above.
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4.2
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It shall not be
considered a material breach by MEDCOMP if they supply at least 90%
of the minimum requirements set forth herein.
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4.3
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If this
Agreement is extended for an additional five-year term pursuant to
Section 13.6, the minimum yearly number of Product units for
each set of the Products will be 10% higher than the previous
years’ sales of each set of the Products.
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5.
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PACKAGING
AND SHIPPING
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5.1
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All Products
shipped pursuant to this Agreement shall be packaged, labeled, and
shipped in accordance with ANGIODYNAMICS’ instructions. All
freight, insurance, and other shipping expenses, as well as
applicable taxes and duties, shall be borne by ANGIODYNAMICS. Each
shipping container must be marked to show quantity, order, number,
lot number, contents, and shipper’s name. A packing slip
showing this information shall be included with the shipment. A
Certificate of Compliance shall accompany each lot within the
shipment.
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5.2
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Title to and
risk of loss of the Products shall pass to ANGIODYNAMICS from
MEDCOMP at the point of destination, ANGIODYNAMICS’ receiving
dock.
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5.3
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MEDCOMP agrees
to ship the Products with not less than three years remaining on
its stated expiration date.
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6.1
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The Products
shall meet the Specifications attached herewith in Exhibits A-E.
ANGIODYNAMICS reserves all right to return, at MEDCOMP’s sole
expense, any Product not meeting said Specifications. ANGIODYNAMICS
must inform MEDCOMP within Forty Five (45) days of receipt of
Product if it believes that any Product fails to meet the
Specification. In the event that MEDCOMP is unable to replace such
returned Product with an acceptable Product within Forty-Five
(45) days, such failure shall be considered a material breach
of this Agreement.
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3
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7.1
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MEDCOMP shall
produce all Products in accordance with all applicable regulatory
laws, rules, and regulations. MEDCOMP will permit ANGIODYNAMICS, or
its designated representative, to perform vendor audits of
MEDCOMP’s facilities and procedures. MEDCOMP will notify
ANGIODYNAMICS of any FDA inspections, observations, and/or
483’s. Any observations/483’s shall be given to
ANGIODYNAMICS in writing within 30 days of the inspection. Further,
MEDCOMP will provide ANGIODYNAMICS with a Certificate of
Compliance, a Sterilization Certificate, and certification of
non-pyrogenicity for each batch/lot of Products shipped. MEDCOMP
will allow ANGIODYNAMICS, or its designated representative, subject
to the confidentiality provisions herein, to inspect the
Products’ Design History Files and will also allow
confidential access to all technical documentation necessary to
demonstrate compliance with the European Medical Device Directive.
Additionally, MEDCOMP will notify ANGIODYNAMICS of any proposed
changes in raw materials, components, processes, or labeling, at
least Ninety (90) days prior to such action and must obtain
ANGIODYNAMICS’ written approval for such changes, which shall
not be unreasonably withheld. MEDCOMP guarantees that no Products
sold pursuant to this Agreement are adulterated or misbranded
within the meaning of The Federal Food, Drug and Cosmetics Act
(hereinafter the “Act”), and further guarantees that no
Products sold pursuant to this Agreement are barred from
introduction into inter-state commerce under the provisions in
Sections 404, 505 or 512 of the Act.
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7.2
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All customer
complaints for the Products will be processed through
ANGIODYNAMICS’ Customer Service Department. Once a complaint
has been received, it is the responsibility of ANGIODYNAMICS to
forward a copy of the complaint within five (5) working days
to MEDCOMP. If MEDCOMP receives such a complaint, MEDCOMP will
notify ANGIODYNAMICS within five (5) working days. MEDCOMP
agrees to perform an investigation of each customer complaint and
forward complaint results in writing to ANGIODYNAMICS within a
reasonable time considering the nature of the complaint.
ANGIODYNAMICS agrees to complete the complaint file and respond to
the customer. MEDCOMP agrees to comply with all applicable
regulatory laws, rules and regulations for reporting of customer
complaints by manufacturers. ANGIODYNAMICS agrees to comply with
all applicable regulatory laws, rules and regulations for the
reporting of customer complaints by distributors.
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7.3
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Recalls. Each
party agrees to notify the other party promptly if any of the
Products are 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.
MEDCOMP shall be responsible for the costs of such recall, market
withdrawal or correction, except to the extent that such recall,
market withdrawal or correction is due to ANGIODYNAMICS’
improper storage, handling, distribution or marketing of the
Products in which case ANGIODYNAMICS shall be responsible for the
costs of such recall, market withdrawal or correction.
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8.1
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MEDCOMP shall
have the obligation to design and produce all labels, labeling, and
inserts for the Products, other than the pouch and box
labels.
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8.2
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ANGIODYNAMICS
shall have the obligation to design and produce the pouch and box
labels for the Products.
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8.3
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ANGIODYNAMICS
may waive the obligation to design and produce the pouch and box
labels for the Products, if both parties agree in writing that
MEDCOMP labels are to be used.
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8.4
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Each party
shall obtain the other party’s prior written approval for the
labels they have designed, prior to production of the
same.
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8.5
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MEDCOMP shall
have the responsibility to apply all labels, including the pouch
and box labels to the Products.
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8.6
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MEDCOMP agrees
that the labeling may include the ANGIODYNAMICS’
trademark.
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8.7
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ANGIODYNAMICS
agrees that the Products and/or their packaging shall bear, where
appropriate, MEDCOMP’s trademarks, and a statutory indication
of the patent number or the legend “U.S. patent
pending” or “U.S. pat. pending” in the U.S. and
any required foreign patent marking where foreign patent rights
exist.
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8.8
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MEDCOMP shall
allow the addition of the ANGIODYNAMICS trademark to all currently
published literature and educational materials associated with the
Products.
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9.1
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MEDCOMP
warrants that the (i) title to all Product conveyed hereunder
is good, (ii) the Products delivered hereunder are free from
any security interest or other lien or encumbrance, (iii) the
Products shall be delivered free of the rightful claim of any third
party by way of infringement of any patent or trademark, and
(iv) the Products will be manufactured in accordance with the
product specifications, (v) the Products are fit for the
purposes described in the instructions for use and shall be free
any defects that may effect the intended use, (vi) the
Products shall be manufactured, produced, and delivered to
ANGIODYNAMICS in accordance with all applicable laws, rules, and
regulations, (vii) MEDComp agrees to indemnify, defend and
hold harmless ANGIODYNAMICS, its customers, and users of the
Products from all loss, damages, cost, or expense, including
reasonable attorney’s fees, arising from the breach by
MEDCOMP of the aforementioned warranties.
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10.
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OPTION FOR
FUTURE LICENSE OR TECHNOLOGY TRANSFER
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10.1
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In the event
that MEDCOMP elects not to continue manufacturing the Products, or
in the event that this Agreement is terminated for a failure to
supply as set forth in this Agreement, or due to MEDCOMP’s
insolvency or bankruptcy, MEDCOMP agrees to negotiate in good faith
a royalty-bearing non-exclusive license or sublicense to make, use
or sell Products under the Patent Rights to ANGIODYNAMICS, provided
such ability and right to license or sublicense is available to
MEDCOMP.
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10.2
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In the event
that MEDCOMP ceases manufacturing the Products, to the extent such
cessation is within MEDCOMP’s control, MEDCOMP will provide
ANGIODYNAMICS with written notice, Six (6) months in advance
of the anticipated date of cessation of manufacture.
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10.3
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In the event a
license or sublicense is successfully negotiated in accordance with
Paragraphs 10.1, MEDCOMP agrees to cooperate with ANGIODYNAMICS and
to train ANGIODYNAMICS’ personnel on manufacture, design,
assembly, quality control and packaging of the Products for a
period of Six (6) months at no cost to ANGIODYNAMICS, and to
transfer any manufacturing Know-how.
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11.1
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ANGIODYNAMICS
shall have the right to develop design improvements for the
Products, and if developed solely by ANGIODYNAMICS any associated
Intellectual Property rights shall belong solely to ANGIODYNAMICS
and such Products shall become part of this Agreement as set forth
in paragraph 11.2.
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11.2
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In the event
that such design improvements are developed by ANGIODYNAMICS, the
parties agree to amend this Agreement to add such improvements to
the Products as set forth on Exhibit A-E.
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11.3
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ANGIODYNAMICS
and MEDCOMP shall have the right to cooperate in development of
design improvements for the Products. In the event ANGIODYNAMICS
and MEDCOMP jointly develop design improvements for the Products,
any associated Intellectual Property rights shall belong to
ANGIODYNAMICS and MEDCOMP jointly and shall become part of this
Agreement and shall be added as improvements to the Products as set
forth on Exhibit A-E.
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11.4
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MEDCOMP shall
have the right to develop design improvements for the Products and
in the event that such design improvements are developed solely by
MEDCOMP, MEDCOMP shall solely own all Intellectual Property rights
to such improvements. The parties agree to amend this Agreement to
add such improvements to the Products on Exhibit A-E.
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12.
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INTELLECTUAL
PROPERTY
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12.1
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MEDCOMP shall
retain all of its rights, title and interest in and to its patents,
copyrights, trademarks, trade names, and all other industrial and
intellectual property. Except as otherwise expressly provided in
this Agreement, ANGIODYNAMICS shall have no right, title or
interest in any industrial or intellectual property relating to the
Products, except to marketing and promotional materials and reports
and all marketing data and all intellectual property relating
thereto. Nothing herein shall be construed as a license or other
grant of rights in any of the Intellectual Property of either
party.
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12.2
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Validity and
Infringement of MEDCOMP’s Patents:
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12.2.1
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In the event
ANGIODYNAMICS or MEDCOMP become aware of any actual or threatended
infringement of any MEDCOMP patents, that party shall promptly
notify the other.
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12.2.2
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MEDCOMP shall
have the first and exclusive right, but not the obligation, to
bring and control any infringement action against any person or
entity materially infringing any MEDCOMP Patent Rights directly or
contributorily and shall have the first right, but not the
obligation, to defend any MEDCOMP Patent Rights against any
challenge to the validity and enforceability of that patent in the
Courts of the United States or in the United States Patent and
Trademark Office or in any foreign jurisdiction. At the request of
MEDCOMP, ANGIODYNAMICS agrees to cooperate with MEDCOMP, at
MEDCOMP’s sole cost, in any lawsuit on any of the Patent
Rights, including being named as a party, if necessary.
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12.2.3
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MEDCOMP shall
bear the full cost of any action brought by MEDCOMP regarding its
Patent Rights and shall be entitled to all recovery from such
lawsuit.
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13.1
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Subject to
earlier termination as provided in this Section 13, this
Agreement shall be for a term of Five (5) years.
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13.2
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Either party
shall have the right to terminate this Agreement by written notice
to the other party immediately upon the occurrence of the
following:
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13.2.1
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The bankruptcy
or insolvency of the other party, or the commencement of any
proceedings by or against the other party seeking receivership,
trusteeship, bankruptcy, reorganization, assignments for the
benefit of creditors or similar proceedings.
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13.2.2
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Failure of the
other party to cure any material breach (a failure by AngioDynamics
to purchase the minimum requirements of each Product shall not be
deemed a material breach for purposes of this Agreement) of this
Agreement within Sixty (60) days after written notice of such
breach. In the event ANGIODYNAMICS purchases Sixty percent
(60%) or less of its minimum requirement for any Product,
ANGIODYNAMICS shall lose its exclusivity rights, if any, to that
Product. Furthermore, in the event ANGIODYNAMICS purchases Forty
percent (40%) or less of its minimum requirement for any
product, MEDCOMP shall have the right, upon written notice to
ANGIODYNAMICS, to cancel this Agreement as to such Product and make
any arrangements MEDCOMP believes is appropriate, in its sole and
absolute discretion, to sell such Product through other individuals
or entities.
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13.2.3
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Upon the mutual
written consent of both parties.
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13.3
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ANGIODYNAMICS
may terminate this Agreement immediately, if MEDCOMP, for any
reason, is unable to supply Products that meet the product
Specifications to ANGIODYNAMICS for a period of Ninety
(90) days.
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13.4
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Upon
termination of this Agreement, for any reason other than
ANGIODYNAMICS’ failure to pay for the Products, MEDCOMP shall
honor ANGIODYNAMICS’ orders that were placed prior to the
effective date of termination and ANGIODYNAMICS shall pay for such
orders and make any other payments due to MEDCOMP pursuant to the
terms of this Agreement. Notwithstanding that ANGIODYNAMICS’
rights to purchase the Products for distribution and s
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