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 RIGHTS AGREEMENT

 

THIS SUPPLY AND DISTRIBUTION RIGHTS AGREEMENT is entered into the             
(17) day of October, 2005;

 

BETWEEN:

   Bioniche Pharma Group Limited, a corporation incorporated under the laws of
Ireland, with a principal place of business located at Inverin, County Galway,
Ireland      (hereinafter referred to as “Bioniche”);

AND:

   AngioDynamics, Inc., a corporation incorporated under the laws of Delaware,
with its principal place of business located at Queensbury, New York, USA     
(hereinafter referred to as “AngioDynamics”)

 

WHEREAS Bioniche, directly or through its Affiliates (as hereinafter defined),
researches, develops, manufactures and markets biological and pharmaceutical
products and devices for human use;

 

WHEREAS Bioniche or its Affiliates has developed a certain pharmaceutical
product for use in the treatment of varicose veins (the “Product”, as
hereinafter defined and as more particularly described in Schedule “A” hereto);

 

WHEREAS Bioniche owns one hundred percent (100 %) of Bioniche Pharma (USA) Inc.,
a corporation incorporated under the laws of Delaware, which holds an approved
ANDA for the Product (each, as hereinafter defined) and one hundred percent
(100%) of Bioniche Pharma (Canada) Limited, a corporation incorporated under the
laws of Canada, which holds a license from Cumberland Pharmaceuticals, Inc. for
the Trade Mark (as hereinafter defined);

 

WHEREAS AngioDynamics is a distributor of healthcare products to physicians in
the North American market and has expertise in marketing and distributing
products for use in the Field in the Territory (each, as hereinafter defined);

 

WHEREAS Bioniche wishes to grant to AngioDynamics (and AngioDynamics wishes to
accept): (i) the exclusive right to distribute, sell, and offer for sale the
Product in the Field in the Territory; (ii) the exclusive right to use the Trade
Mark (as hereinafter defined) in the Territory and in the Field; and (iii) the
co-exclusive right (together with Bioniche) to market and promote the Product in
the Field in the Territory;

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AND WHEREAS Bioniche is willing to supply AngioDynamics with the Product for
distribution in the Territory on an exclusive basis for use in the Field and
AngioDynamics wishes to receive the Product on such basis, the whole in
accordance with the terms and conditions hereinafter set forth;

 

NOW, THEREFORE, THIS AGREEMENT WITNESSETH THAT, IN CONSIDERATION OF THE MUTUAL
COVENANTS SET FORTH HEREIN, THE PARTIES HEREBY AGREE AS FOLLOWS:

 

ARTICLE I

DEFINITIONS; GENERAL PROVISIONS

 

1.1 Definitions. For the purposes of this Agreement or any notice, consent,
authorization, direction or other communication required or permitted to be
given hereunder, the singular shall include the plural and vice versa and the
following expressions shall have the following meanings, respectively, unless
the context otherwise requires:

 

  a) “Affiliate” shall mean any Person which is directly or indirectly
controlled by, or controls or is under common control with another Person,
provided that “control” shall mean ownership as to more than fifty percent
(50%) of another Person or the power to direct decisions of another Person,
including, without limitation, the power to direct management and policies of
another Person, whether by reason of ownership, by contract or otherwise, and
shall specifically include, but shall not be limited to, Bioniche Pharma (USA)
Inc., the holder of the ANDA approval for the Product (as those terms are
hereinafter defined) and Bioniche Pharma (Canada) Limited, which holds a license
from Cumberland Pharmaceuticals, Inc. for the Trade Mark (as hereinafter
defined);

 

  b) “Agreement” shall mean this Supply and Distribution Rights Agreement and
all instruments supplemental hereto or in amendment or confirmation hereof;
“herein”, “hereof”, “hereto”, “hereunder” and similar expressions mean and refer
to this Agreement and not to any particular Article, Section, Subsection or
other subdivision; and “Article”, “Section”, “Subsection” or other subdivision
of this Agreement means and refers to the specified Article, Section, Subsection
or other subdivision of this Agreement;

 

  c) “ANDA” shall mean an abbreviated new drug application filed with the FDA
with respect to the Product or, with respect to jurisdictions outside the
Territory, the equivalent Governmental Body filing with respect to the Product;

 

  d) “Business Day” shall mean any day, other than a Saturday, Sunday or other
day on which the principal commercial banks located in Toronto, Ontario, Canada
or New York, New York, USA, are not open for business during normal banking
hours;

 

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  e) “Calendar Quarter” shall mean each three-month period commencing
January 1, April 1, July 1 and October 1 of each year during the Term of this
Agreement;

 

  f) “Competent Authority” shall mean each and every Governmental Body which
regulates or from which approvals are required for the marketing, distribution
and/or sale of the Product within the Territory or in other jurisdictions, as
applicable;

 

  g) “Competing Product” shall mean any sclerosing agent approved by the FDA for
use in the treatment of varicose veins or other vascular indications in the
Territory, other than the Product;

 

  h) “Contract Year” shall mean the year long period commencing July 1 and
ending the following June 30 and each subsequent twelve (12) month period
thereafter. However, the initial Contract Year under this Agreement shall not
commence until the date of the First Commercial Sale of the Product, but in any
event shall end on June 30 following the Effective Date of this Agreement. Both
Bioniche and AngioDynamics understand and acknowledge that this Agreement shall
commence on the Effective Date;

 

  i) “Device” shall have the meaning ascribed thereto in Section 321 of the
United States Food, Drug and Cosmetic Act, 21 U.S.C. §321, including any
subsequent amendments thereto, as well as any alternative definition as set
forth by the FDA from time to time; provided that, for the purposes hereof, a
“Device” shall not include any Device that AngioDynamics combines with or
packages with a Competing Product;

 

  j) “Dollar” and the symbol “$” shall mean lawful money of the USA;

 

  k) “Effective Date” shall mean the date first mentioned above;

 

  l) “FDA” shall mean the United States Food and Drug Administration or any
successor agency thereto performing the same functions in the Territory;

 

  m) “Field” shall mean the distribution and sale of the Product to the
following Persons whose professional practice involves the treatment of vascular
disorders or conditions: (i) General Surgeons; (ii) Vascular Surgeons;
(iii) General/Vascular Surgeons; (iv) Interventional Radiologists;
(v) Cardiovascular Surgeons; (vi) Cardiothoracic Surgeons; and
(vii) Cardiologists; in each case, for use in the treatment of varicose veins or
other vascular indications, as approved from time to time by the FDA. For
greater certainty, the “Field” shall not include distribution and sale of the
Product: (a) to Group Purchasing Organizations; or (b) for use by
Dermatologists, Dermatologic Surgeons, Cosmetic Dermatologists, Cosmetic
Surgeons, Plastic Surgeons, or any other specialty not mentioned under items
(i) to (vii) above that might practice sclerotherapy and/or deal with treatment
of spider veins/reticular veins/varicose veins;

 

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  n) “First Commercial Sale” shall mean the first sale of Product by
AngioDynamics to any third Person customer in the Field in the Territory;

 

  o) “GMP” or “cGMP” shall mean current Good Manufacturing Practices as
specified by any applicable Competent Authority or as required under FDA rules
and regulations, as amended from time to time;

 

  p) “Government Approvals” shall mean the approvals required from any
Governmental Body for the marketing, distribution and/or sale of the Product in
the Field within the Territory;

 

  q) “Governmental Body” shall mean (i) any domestic or foreign national,
federal, provincial, state, municipal or other government or body, (ii) any
international or multilateral body, (iii) any subdivision, ministry, department,
secretariat, bureau, agency, commission, board, instrumentality or authority of
any of the foregoing governments or bodies, (iv) any quasi-governmental or
private body exercising any regulatory, expropriation or taxing authority under
or for the account of any of the foregoing governments or bodies, or (v) any
domestic, foreign, international, multilateral, or multinational judicial,
quasi-judicial, arbitration or administrative court, grand jury, tribunal,
commission, board or panel;

 

  r) “Improvements” shall mean any modification to the chemical composition of
the Product made by Bioniche and/or AngioDynamics or by any of their Affiliates
during the term of this Agreement;

 

  s) “Intellectual Property” shall mean, whether or not reduced to writing, all
inventions, all rights to inventions, patents, patent applications and issued
patents, designs, design applications and design registrations, trade marks,
trade mark applications, trade mark registrations, trade names, trade dress,
servicemarks, logos (whether registered or unregistered), copyright, copyright
applications and registrations, processes, licenses, Know-How, technology, data,
chemical structures, formulae, customer lists, discoveries, trade secrets,
proprietary information and all other rights and intellectual property now or
hereafter owned, held or used by Bioniche or by AngioDynamics or by any of their
respective Affiliates;

 

  t) “Know-How” shall mean all information, data, knowledge, discoveries and
trade secrets, whether or not reduced to writing, pertinent to the Product, or
to the manufacture, use or sale of the Product, now or hereafter owned by, in
the possession of, known to or controlled by Bioniche or its Affiliates,
including any Improvements to any of the foregoing;

 

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  u) “Laws” shall mean:

 

  (i) all constitutions, treaties, laws, statutes, codes, ordinances, orders,
decrees, rules, regulations, and municipal by-laws, whether domestic, foreign or
international, including any such constitutions, etc. of any Governmental Body;

 

  (ii) all judgments, orders, writs, injunctions, decisions, rulings, decrees
and awards of any Governmental Body; and

 

  (iii) all policies, practices and guidelines of any Governmental Body; in each
case binding on or affecting the Party or Person referred to in the context in
which such word is used;

 

and “Law” shall mean any one of the foregoing;

 

  v) “Marketing Plan” shall mean AngioDynamics’ marketing plan for Product in
the Territory in the Field, which AngioDynamics will share with Bioniche and
regarding which the Parties will have quarterly conference calls upon Bioniche’s
request and, if necessary, other meetings as the Parties may designate from time
to time;

 

  w) “Parties” shall mean the parties hereto collectively; and “Party” shall
mean any one of them;

 

  x) “Person” shall mean an individual, corporation, company, co-operative,
partnership, organization or any similar entity;

 

  y) “Prime Rate” shall mean the annual rate of interest published from time to
time by the Wall Street Journal as a reference rate then in effect for
determining interest rates on Dollar ($) commercial loans made by major
commercial banks in the Territory;

 

  z) “Product” shall mean the pharmaceutical product Sodium Tetradecyl Sulfate,
in concentrations of 1%, 3% and any concentration subsequently approved by the
FDA, manufactured by Bioniche and/or its Affiliates, together with packaging,
labeling and such accessories, or in such other final form for patient use as
shall have been approved by the Competent Authorities, and any Improvements
thereto (including, for greater certainty, Sodium Tetradecyl Sulfate 1%, 3% and
any concentration subsequently approved by the FDA sold by Bioniche and/or its
Affiliates under any other trade name in the Territory). The Product as of the
Effective Date is more particularly described in Schedule “A” hereto;

 

  aa) “Second Entry Product” shall mean any pharmaceutical product containing
Sodium Tetradecyl Sulfate or Polidocanol as the active ingredient, other than
the Product, which is approved by the FDA for use in the treatment of varicose
veins or other vascular indications in the Territory;

 

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  bb) “Specifications” shall mean the specifications for the Product, as more
fully described in Schedule “B” hereto, as stated in the official labeling for
the Product, as sold in the Territory for use in the Field;

 

  cc) “Term” shall mean the term of this Agreement as defined in Section 9.1;

 

  dd) “Territory” shall mean the USA (as hereinafter defined), together with any
areas added from time to time as may be agreed upon in writing by the Parties;

 

  ee) “Trade Mark” shall mean the common law and statutory rights in the trade
mark Sotradecol in the Territory, including in the application, held by Bioniche
or its Affiliates, as more fully described in Schedule “C” hereto, together with
all registrations arising from such application from time to time; and

 

  ff) “USA” shall mean the United States of America and each of its territories
and possessions, including but not limited to the Commonwealth of Puerto Rico.

 

1.2 Dispute Resolution; Arbitration.

 

a)

The Parties agree that in the event of any dispute, breach, controversy or claim
between them arising from, concerning, or in any way relating to this Agreement,
the Parties shall immediately undertake good faith efforts to amicably resolve
such dispute between them. In the event such dispute cannot be so resolved
following such prompt good faith discussions between the Parties, the dispute
shall be referred to the Chief Executive Officer of each Party for prompt
resolution. Any such dispute, claim, breach or controversy which cannot be
resolved by the Chief Executive Officers of the Parties within thirty (30) days
after it has been so referred to them hereunder can then be resolved through
binding arbitration at the request of either Party. The use of arbitration to
resolve all such unresolved disputes, claims, breaches or controversies under
this Agreement shall be binding and mandatory upon the Parties for all purposes,
except as specifically provided for below in this Section 1.2. This agreement to
arbitrate all such unresolved disputes shall survive the termination, expiration
or rescission of this Agreement. The arbitration shall be conducted in
accordance with the Commercial Arbitration Rules of the American Arbitration
Association and shall be undertaken pursuant to the U.S. Federal Arbitration
Act. The arbitration shall be held in Toronto, Canada, if initiated by
AngioDynamics and in New York, New York, USA, if initiated by Bioniche; or such
other place as the Parties may agree in writing. The language of the arbitration
shall be English. The arbitration shall be conducted before a single arbitrator
to be jointly designated by the Parties. If the Parties cannot mutually agree
upon an arbitrator within twenty (20) Business Days after either Party has
notified the other Party hereunder that it desires to arbitrate any such
unresolved dispute then, and in such event, each Party shall designate, on that
date, one arbitrator from the list of arbitrators maintained by the American
Arbitration Association and the two arbitrators so chosen shall mutually
designate a third arbitrator, or if they have been unable to do so within ten
(10) Business Days after they have been so designated, application can be made
by either said arbitrator to the American Arbitration Association for it to
designate the third

 

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arbitrator for this arbitration as soon as possible. Each Party shall pay all
costs and expenses of the arbitrator designated by that Party hereunder and
shall share 50/50 all costs and expenses of any arbitrator jointly designated by
them to include any third arbitrator so chosen by their arbitrators, or by the
American Arbitration Association. Each Party shall be entitled to be represented
by counsel of its own choosing and to be represented by that counsel in all
matters before the arbitrators with each Party being solely responsible to pay
all of the costs, fees and expenses of its said counsel. The decision of the
arbitrator (or a majority of the arbitrators if 3 have been appointed) shall be
final and binding on all Parties and shall be enforceable in a court of
competent jurisdiction; provided that the arbitrator(s) shall have no authority
to grant any license to either Party to the other Party’s Intellectual Property.
For purposes of any such arbitration proceeding hereunder, this Agreement shall
be deemed to be governed by and construed in accordance with the laws of the
State of New York (without reference to the applicable choice of law rules). The
relationship created by this Agreement could give rise to the need by one or
both of the Parties for emergency judicial relief. Either Party shall be
entitled to pursue any available remedies for emergency or preliminary
injunctive relief in any court of competent jurisdiction, but immediately
following the issuance of any such emergency or injunctive relief the Party
obtaining such relief will consent to the stay of such judicial proceedings on
the merits of both this Agreement and any related transactions pending
arbitration of all of the underlying claims between the Parties in accordance
with this Section 1.2.

 

b) Bioniche agrees and consents to the jurisdiction over it in the federal and
state courts in the State of New York in relation to any enforcement action
brought after an arbitration pursuant to Section 1.2 (a) and any action filed
for emergency or preliminary injunctive relief pursuant to Section 1.2 (a).
Bioniche further agrees to accept service of process by mail or commercial
carrier sent to its last known address.

 

1.3 Entire Agreement. This Agreement, together with the Schedules hereto,
constitutes the entire agreement between the Parties and replaces and supersedes
any prior agreement or understanding pertaining to the subject matter hereof;
provided that, for greater certainty, the Confidentiality Agreement between
AngioDynamics and Bioniche Pharma (Canada) Limited (an Affiliate of Bioniche)
dated June 22, 2005 shall continue to govern disclosures of information between
the parties thereto prior to the date hereof. No amendment of this Agreement
shall be binding unless executed in writing by both Parties. Any provisions on
AngioDynamics’ purchase orders that are inconsistent with or supplement any of
the terms or conditions of this Agreement shall be of no force or effect unless
expressly agreed to in writing by Bioniche.

 

1.4 Schedules. The following are the Schedules annexed to and incorporated in
this Agreement by reference and deemed to be a part hereof:

 

Schedule “A”

  -    Description of the Product;

Schedule “B”

  -    Specifications;

Schedule “C”

  -    Trade Mark;

Schedule “D”

  -    Minimum Purchase Requirements; and

Schedule “E”

  -    Transfer Price.

 

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ARTICLE II

EXCLUSIVE RIGHTS

 

2.1 Exclusive Distributorship Rights.

 

  a) Upon and subject to the terms and conditions hereof, Bioniche and its
Affiliates hereby appoint AngioDynamics, and AngioDynamics hereby accepts its
appointment, as the exclusive distributor of the Product in the Field in the
Territory.

 

  b) AngioDynamics will also have the right of first negotiation to become the
exclusive distributor of any additional products developed by Bioniche or its
Affiliates for use in the Territory and in the Field for which Bioniche or its
Affiliates has the right to sell, license, transfer or otherwise assign
distribution rights (the “First Negotiation Products”). Accordingly, during the
Term of this Agreement, Bioniche or its Affiliates shall not sell, license,
transfer or otherwise assign its distribution rights in the Territory in the
Field to any First Negotiation Products to any third Person, without first
offering such rights to AngioDynamics in accordance with the provisions of this
Section 2.1(b). At any time following the sending of a notice from Bioniche to
AngioDynamics under this Section 2.1(b) with respect to the potential
distribution of a First Negotiation Product in the Territory in the Field, the
Parties shall have sixty (60) days (the “Negotiating Period”, which can be
extended for one further period of thirty (30) days, as provided below) to
negotiate the substantive terms of an agreement governing the First Negotiation
Product. As long as the Parties are reasonably progressing in their negotiations
as to any First Negotiation Product hereunder, either Party may, in its sole and
absolute discretion, elect to extend the Negotiating Period for an additional
period of thirty (30) days. The Parties hereby agree to negotiate diligently and
in good faith during each Negotiating Period with regard to each First
Negotiation Product that is the subject of a notice under this Section 2.1(b).
If after the termination of the Negotiating Period, the Parties have not been
able to agree as to the terms of their arrangement regarding that First
Negotiation Product, Bioniche shall be free to sell, license, transfer or
otherwise assign its rights in that First Negotiation Product to a third Person
free of any further rights, claims or entitlements of AngioDynamics under this
Agreement, on terms and conditions that are no less favourable to Bioniche, in
the aggregate, than those offered by AngioDynamics during the Negotiating
Period.

 

2.2 Retained Rights. Nothing herein shall be deemed to restrict or otherwise
impair or impede the right and/or ability of Bioniche and/or its Affiliates to:
(i) directly or indirectly market, sell, distribute, package, label, appoint
additional Persons as distributors, subcontract any

 

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such rights to or otherwise enter into any arrangement whatsoever with any
Person with respect to the Product or any First Negotiation Product anywhere
else in the world other than the Territory, or in the Territory outside the
Field; or (ii) after the termination of an unsuccessful Negotiating Period
directly market, distribute, sell, package and label any First Negotiation
Product for use in the Field in the Territory; as the case may be.

 

2.3 Competing Products.

 

  a) During the Term, AngioDynamics and its Affiliates shall not, directly or
indirectly, jointly or in conjunction with any other Person, whether as
principal, agent, shareholder, employee, independent contractor, or in any other
manner whatsoever, distribute, market or sell in the Field in the Territory, any
product (other than the Product) that: (i) is a Competing Product; and (ii) is
used in the Field.

 

  b) Notwithstanding the provisions of Section 2.3 (a), it is expressly
understood and agreed to that AngioDynamics shall not be prohibited from:
(i) distributing a First Negotiation Product for which the Parties have
successfully negotiated distribution rights under Section 2.1 (b); or
(ii) developing, manufacturing, selling, or distributing any Device, in the
Field in the Territory, or elsewhere, whether within or without the Territory
and/or Field, for the treatment of any medical condition including, but not
limited to, the treatment of vascular conditions.

 

2.4 Sales within the Territory.

 

  a) AngioDynamics shall not knowingly, and shall cause its Affiliates not to
knowingly, directly or indirectly, without the prior written consent of
Bioniche:

 

i) supply Product: (1) outside the Territory; or (2) inside the Territory,
outside the Field; or

 

ii) supply Product to any Person within the Territory for resale or use:
(1) outside the Territory; or (2) outside the Field.

 

  b) Bioniche shall not knowingly, and shall cause its Affiliates not to
knowingly, directly or indirectly, without the prior written consent of
AngioDynamics:

 

i) supply Product inside the Territory and inside the Field to any Person other
than AngioDynamics; or

 

ii) supply Product to any Person outside the Territory for resale or use within
the Territory and within the Field by any Person other than AngioDynamics.

 

2.5 Referrals. AngioDynamics shall refer to Bioniche all orders or inquiries
received by it in connection with the sales and distribution of Product outside
the Territory, or inside the Territory but outside the Field, and Bioniche shall
refer to AngioDynamics all orders or inquiries received by it in connection with
the sale and distribution of Product inside the Territory, in the Field.

 

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2.6 Subcontracting. AngioDynamics shall not subcontract to, or otherwise make
any provision or arrangement with any Person (excluding any Affiliate; provided
that AngioDynamics shall warranty and remain responsible for the performance by
its Affiliate of its obligations hereunder) for the distribution and sale of
Product, without the prior written consent of Bioniche, which consent shall not
be unreasonably withheld, conditioned or delayed. Bioniche shall not subcontract
to, or otherwise make any provision or arrangement with any person (excluding an
Affiliate; provided that Bioniche shall warranty and remain responsible for the
performance by its Affiliate of its obligations hereunder) for the manufacture
of Product, without the prior written consent of AngioDynamics, which consent
shall not be unreasonably withheld, conditioned, or delayed.

 

2.7 Packaging. AngioDynamics shall not alter, remove or conceal Bioniche’s name,
logo or drug registration number, nor the Trade Mark or any of Bioniche’s other
trademarks, trade names, trade-dress, service marks or other Intellectual
Property, nor any notices in relation to the foregoing which appear on any of
its proprietary Products, or on its packaging with regard thereto. Product
labels shall indicate that the Product is manufactured by Bioniche or a third
Person manufacturer designated by Bioniche (as approved by AngioDynamics
pursuant to Section 2.6 hereof, as applicable), if any. AngioDynamics may amend
Product packaging and/or labels to include AngioDynamics’ name and/or logo as
Product distributor with the prior written consent of Bioniche, such consent not
to be unduly withheld, conditioned or delayed. Bioniche shall be deemed to have
consented ten (10) Business Days after receipt of the proposed amendment, unless
Bioniche shall have objected thereto within said ten (10) Business Day delay.
Notwithstanding the foregoing, Bioniche’s consent shall not be required for
AngioDynamics to make any changes to the Product packaging which is required by
FDA regulations or any other applicable Laws.

 

2.8 Training. In the First Contract Year, Bioniche agrees to provide to
AngioDynamics up to twenty four (24) hours of training for a reasonable number
of AngioDynamics’ marketing and sales representatives in three (3) training
sessions at reasonable locations of AngioDynamics’ choice in the Territory. The
dates and locations of such training sessions shall be agreed to in advance
between the Parties.

 

2.9 Additional Responsibilities. In addition to the other terms of this
Agreement, AngioDynamics shall provide order entry, Product tracking,
transportation of Product to customers, customer service support, and
billing/collection functions. AngioDynamics shall keep Bioniche advised of
general market conditions and economic developments that may affect the sale of
the Product in the Territory.

 

ARTICLE III

PRODUCT PROMOTION; INTELLECTUAL PROPERTY

 

3.1 Product Promotion. AngioDynamics and Bioniche will have the co-exclusive
right to promote the Product in the Field in the Territory and, without limiting
its obligations under

 

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Section 6.2 hereof, AngioDynamics shall use commercially reasonable efforts to
promote and market the Product in the Territory for use in the Field.
AngioDynamics and Bioniche shall each bear all of their own expenses in
connection with marketing and promotion hereunder. The Parties acknowledge and
agree that the FDA must grant its approval to all packaging and labeling of the
Product prior to the marketing thereof in the Territory.

 

3.2 Trade Mark. The Parties hereby acknowledge that no license to any
Intellectual Property of the other Party or to the Trade Mark shall be granted
or deemed to be granted hereunder. Subject to the terms and conditions hereof,
AngioDynamics shall have the right as a distributor to use the Trade Mark in the
Territory during the Term solely in connection with the distribution, sale and
offer for sale of the Product in the Field. In its promotion and sale of Product
in the Territory hereunder and in its use of the Trade Mark or other
Intellectual Property indicated by Bioniche for use on or with the Product,
AngioDynamics shall indicate at all times that it is acting in its capacity as a
distributor of Bioniche and that the Trade Mark is used by Bioniche under
license from a third Person. The Trade Mark shall be followed by the symbol “TM”
and/or by any other marking as Bioniche may from time to time advise.
AngioDynamics is, however, permitted to have the Trade Mark appear on its
invoices, shipping documents and price lists, but not as trade mark and only as
an indication of Product sold or the prices thereof.

 

3.3 Intellectual Property. Subject to Section 3.2 hereof, AngioDynamics
acknowledges and agrees that, as between the Parties, all Intellectual Property
rights in the Product are and shall remain the property of Bioniche or its
Affiliates. Without limiting the generality of the foregoing, the Parties
acknowledge and agree that the ANDA and the contents of any other regulatory
dossier prepared with respect to the Product for filing with any Competent
Authority and any Government Approval relating thereto shall be and remain the
property of Bioniche or its Affiliates. Without the express written consent of
Bioniche, AngioDynamics shall not, and it shall cause its Affiliates not to,
directly or indirectly:

 

  (i) use the Trade Mark, the Product or any related Intellectual Property for
any purpose other than marketing, selling, offering to sell, and distributing
the Product in the Territory for use in the Field under the terms of this
Agreement;

 

  (ii) attempt to obtain patent or other Intellectual Property protection in
relation to the Product; however, it is understood that, subject to Article X
hereof, AngioDynamics shall have the right to obtain patent or other
Intellectual Property protection in relation to any Device which may be used to
deliver the Product; and/or

 

  (iii) use or attempt to register, directly or indirectly, a trade mark
identical or confusingly similar to the Trade Mark or any of Bioniche’s other
trade marks used with the Product identified in writing by Bioniche to
AngioDynamics.

 

3.4 Notification of Infringement. Each Party agrees to promptly notify the other
Party of any conflicting use or any suspected act of infringement, passing-off
or unfair competition involving the Intellectual Property of the other Party
used hereunder by unauthorized Persons, or any allegations that such
Intellectual Property violates the Intellectual Property rights of any

 

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third Person, of which that Party may become aware. Each Party shall have the
right, at its sole discretion, to engage in any and all proceedings or actions
necessary to protect its Intellectual Property or to settle any disputes
involving such unauthorized acts or such allegations relating to such
Intellectual Property. Each Party agrees to fully co-operate with the other
Party, at the request of the other Party, to help terminate such activities by
unauthorized Persons as to the Intellectual Property of the other Party, but
shall not, without the express written consent of the other Party, engage in any
proceedings or actions against, enter into any settlement discussions with or in
any other way attempt to terminate said activities by unauthorized Persons as to
the Intellectual Property of the other Party.

 

3.5 Assignment. AngioDynamics hereby assigns and agrees to assign to Bioniche
its ownership rights in and to any Improvements. AngioDynamics agrees to notify
Bioniche of any such Improvements and shall, when requested to do so by
Bioniche, cooperate with Bioniche in the execution of documents or provide other
assistance to Bioniche needed to vest Bioniche’s ownership rights to
Improvements, provided that such assistance by AngioDynamics shall be at
Bioniche’s sole cost and expense.

 

ARTICLE IV

MARKETING

 

4.1 Bioniche Approval. Bioniche shall have the right to review and approve all
AngioDynamics marketing materials for the Product. Such approval shall not be
unreasonably withheld, conditioned or delayed. Bioniche shall be deemed to have
consented ten (10) Business Days after receipt of the proposed materials unless
Bioniche shall have objected thereto within the ten (10) Business Day period.

 

4.2 Coordination. AngioDynamics will coordinate marketing efforts with Bioniche
and will cooperate with Bioniche in the development of marketing strategies.
Conference calls will be held on a quarterly basis as requested by Bioniche, and
additional meetings may be held, if needed and agreed upon by the Parties.

 

ARTICLE V

STANDARDS

 

5.1 Regulatory Compliance. Bioniche will permit AngioDynamics, or its designated
representative, to perform vendor audits of Bioniche’s or its Affiliates’
facilities and procedures where Product is manufactured and/or stored, no more
than once in any Contract Year, under appropriate confidentiality, insurance and
security arrangements and subject to reasonable advance notice and Bioniche’s or
its Affiliates’ scheduling concerns. Bioniche and its Affiliates will allow
AngioDynamics, or its designated representative, as part of its vendor audit, to
inspect all technical documentation relating to the Product, which is necessary
to demonstrate compliance with FDA regulations and other Laws. Additionally,
Bioniche and its Affiliates will notify AngioDynamics of any proposed changes in
raw materials, components, processes or labeling of Product, at least ninety
(90) days prior to such action. Bioniche and its Affiliates further agree to
notify AngioDynamics of any FDA inspections, observations, and/or other

 

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actions (including Form 483’s) Bioniche or its Affiliates receives in relation
to the Product, in writing within thirty (30) days of the inspection; receipt of
observations; etc.

 

5.2 ADE Reporting.

 

  a) The Parties shall keep each other informed of all reports of adverse
drug/device events (hereinafter called “ADE”), coming to either Party’s or their
Affiliates’ knowledge with regard to Product, regardless of the origin of such
reports. The term “reports” shall include publications in journals or other
media. However, AngioDynamics shall not be required to monitor such journals or
other media. The Parties shall promptly advise each other of information on
factors adversely or positively affecting Product that come to their respective
attention.

 

  b) A copy of any ADE report concerning the Product that a Party or its
Affiliate submits to the FDA or to the Council for International Organizations
of Medical Sciences (CIOMS) shall be forwarded without delay to the other Party
as soon as such reports come to either Party’s attention. Any other ADE reports
shall be reported by each Party to the other on a quarterly basis. The informing
Party or its Affiliate may provide in writing its professional evaluation of
such reports, in particular with regard to suspected causality, either together
with such reports or as soon as possible at a later date.

 

  c) Subject to fully complying with all FDA requirements as to ADE reporting,
the Parties may mutually agree upon further details of ADE reporting at a later
date.

 

  d) The Parties shall inform each other without delay, if any measures are
necessary to remove or to minimize any risk with respect to a specific
production lot or preparation of Product.

 

The Parties shall immediately consult each other with respect to any potentially
serious or unexpected ADE reports regarding Product. Following such
consultation, Bioniche or its Affiliates shall communicate such reports to the
FDA and to any other applicable Governmental Body, as required by Law. Each
Party shall immediately notify (and shall cause its Affiliates to notify) the
other Party of the receipt of any information regarding any threatened or
pending action by any Governmental Body which may affect the safety or efficacy
claims of Product or the continued marketing of same in the Territory. Upon
receipt of any such information divulged pursuant to this Section 5.2, the
Parties shall consult with each other in an effort to arrive at a mutually
acceptable procedure for taking appropriate action; provided, however, that
nothing herein shall be construed as restricting the right of Bioniche to make a
timely report of such matter to any Competent Authority or to take any further
action that Bioniche deems appropriate or required by applicable Laws.

 

5.3 Compliance with Laws. Bioniche shall comply (and shall cause its Affiliates
to comply) with all applicable Laws within or without the Territory in relation
to the manufacture, handling and storage and sale of Product until delivery of
the Product to the Point of Entry, as hereinafter defined. Following delivery of
the Product to the Point of Entry, AngioDynamics shall comply

 

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(and shall cause its Affiliates to comply) with all applicable Laws in relation
to the handling, storage, distribution and sale of the Product in the Territory.
In addition, neither Party shall (and each Party shall cause its Affiliates not
to) do anything that would disparage or adversely affect the reputation and
goodwill of the other Party, or the other Party’s Affiliates, or disparage or
adversely affect the reputation of the Product. Nothing in this Section 5.3
shall detract from the Parties’ respective rights or obligations under Sections
9.1 to 9.4.

 

5.4 Complaints. All AngioDynamics’ customer complaints for the Product will be
processed through AngioDynamics’ complaint handling department. Once a complaint
has been received, it is the responsibility of AngioDynamics to forward a copy
of the complaint within five (5) Business Days to Bioniche. If Bioniche receives
such a complaint from an AngioDynamics customer, Bioniche will notify
AngioDynamics within five (5) Business Days and shall forward a copy of the
complaint to AngioDynamics within the five (5) Business Day period. Bioniche is
responsible for determining whether such a complaint is ADE reportable and
submitting ADE reports to the FDA. Bioniche is then responsible for conducting
the complaint investigation and forwarding its investigation results to
AngioDynamics within twenty (20) Business Days of Bioniche’s initial receipt of
the complaint. If additional information is required, Bioniche will send a
written request for the additional information to AngioDynamics. AngioDynamics
will be responsible for obtaining the additional information from the
complainant. AngioDynamics is then responsible for completing the complaint file
and ensuring that the appropriate customer follow-up has been completed.

 

5.5 Recalls. If, for any reason, it shall become necessary to trace back or
recall any particular batch of Product, or to identify the customer or customers
to whom any Product from such batch has been delivered, the Parties shall
co-operate fully with each other in doing so. In the event that either Party has
reason to believe that one or more lots of Product should be recalled or
withdrawn from sale or distribution in the Territory, such Party shall
immediately notify the other Party in writing. The decision as to whether or not
to initiate a recall of any of the Products in the Territory shall be made by
Bioniche; provided that nothing in this Section 5.5 shall be read as restricting
AngioDynamics from initiating a recall in a response to the written requirements
of a Governmental Body. If the recall is required because of a modification or
withdrawal of a Governmental Approval, or a failure of the Product to conform to
its particular specifications, Bioniche shall promptly reimburse AngioDynamics
for any actual out-of-pocket costs and expenses AngioDynamics incurs in carrying
out such recall and refund the price paid by AngioDynamics for the recalled
Product. If the recall is required because of a negligent act or omission of
AngioDynamics or its representatives in the handling, storage or distribution of
the Product (or its use with or incorporation in any other product), then such
recall shall be conducted by AngioDynamics at its sole cost and expense and
AngioDynamics shall not be entitled to any such credits, replacements or refunds
from Bioniche. If such recall is required because of a joint act or omission of
the Parties hereunder, they shall jointly conduct the recall and the Parties
shall share equally in all of the costs and expenses of such recall.

 

5.6 Insurance. During the Term, (i) AngioDynamics shall carry and keep in force
product liability insurance and all risk and general liability insurance
consistent with normal business practices from time to time to cover risks
related to marketing, sales, storage and distribution of Product in the
Territory, with minimum limits of liability of $3,000,000.00 per occurrence and

 

14

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$10,000,000.00 in the aggregate. AngioDynamics shall provide Bioniche with a
certificate of such insurance and shall have Bioniche and its Affiliates named
as an additional named insured in respect thereof, and (ii) Bioniche agrees to
maintain comprehensive “occurrence” general liability insurance, including
“occurrence” product liability, contractual liability insurance and advertising
injury coverage consistent with normal business practices from time to time to
cover risks including, but not limited to those related to researching,
developing, manufacturing, marketing, storage, supply and transportation of
Product by Bioniche or its Affiliates, with minimum limits of liability of
$3,000,000.00 per occurrence and $10,000,000.00 in the aggregate. Bioniche shall
provide AngioDynamics with a certificate of such insurance and shall have
AngioDynamics and its Affiliates named as an additional named insured in respect
thereof.

 

Neither Party shall amend or terminate such coverage or allow such coverage to
lapse during the Term without the prior written consent of the other Party. It
is understood and agreed that furnishing of such insurance coverage will not
relieve either Party of its obligations under this Agreement.

 

ARTICLE VI

PERFORMANCE

 

6.1 Marketing Responsibilities. Without prejudice to its obligations under
Section 6.2, AngioDynamics shall use reasonable efforts to promote and market
Product in the Territory in the Field. AngioDynamics shall bear all costs and
expenses incurred by it in conjunction with the discharge of its marketing and
promotion obligations hereunder. Without limiting the generality of the
foregoing, AngioDynamics shall:

 

  a) advertise and promote sales of the Product in the Field;

 

  b) make and maintain regular contact with customers and potential customers of
the Product in the Field in the Territory, including, without limitation,
relevant physician specialists and their organizations and associations; and

 

  c) maintain adequate sales and warehouse facilities for the Product being
distributed in the Territory in the Field.

 

6.2 Minimum Purchase Requirements. In partial consideration for the exclusive
rights in the Territory in the Field being granted it under this Agreement,
AngioDynamics shall use reasonable efforts to achieve the minimum purchase
requirements set forth in Schedule “D” hereto for the Product. Notwithstanding
anything to the contrary herein contained, AngioDynamics shall not be
responsible for failing to achieve the minimum purchase requirements established
for it hereunder if such failure is directly attributable to: (i) the failure by
Bioniche to deliver a sufficient quantity of the Product which satisfies the
Specifications in response to purchase orders placed in accordance with
Section 7.7 hereof; and/or (ii) an Event of Force Majeure, as defined in
Section 7.10 hereof. If AngioDynamics does not achieve the minimum purchase
requirements in any particular Contract Year (the “Deficient Contract Year”),
Bioniche’s sole remedy shall be to convert the exclusive license and distributor
status of AngioDynamics into a non-exclusive relationship following ninety
(90) days written notice to

 

15

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AngioDynamics. Notwithstanding the foregoing, AngioDynamics shall be able to
cure any noticed failure to meet the minimum purchase requirements by doing the
following within the ninety (90) day notice period: (i) purchasing an amount of
Product equal to the difference between the amount of Product actually purchased
by AngioDynamics in the Deficient Contract Year and AngioDynamics’ minimum
purchase requirements for the Deficient Contract Year; and (ii) purchasing an
amount of Product equal to fifteen percent (15%) of its annual minimum purchase
requirements for the then-current Contract Year. If AngioDynamics fully complies
with (i) and (ii) above, Bioniche shall have no right to convert the exclusive
license and distributor status of AngioDynamics into a non-exclusive
relationship. Any amount of Product purchased pursuant to (i) above shall not
apply to the minimum purchase requirements of the then-current Contract Year,
but the amount of Product purchased pursuant to (ii) above shall apply to the
minimum purchase requirements of the then-current Contract Year.

 

In the event that a Second Entry Product enters the market in the Territory and
is sold in the Field at any time during the Term, any annual minimum purchase
requirements agreed to hereunder shall be automatically reduced by fifty percent
(50%). Such decrease shall be on a going forward basis only, with a pro rata
effect being calculated for any partial Contract Year.

 

6.3 Reporting of Sales. AngioDynamics shall provide Bioniche with quarterly
electronic reports and detailed semi-annual written reports regarding marketing
and sales of the Product in the Territory in the Field, which reports shall
include information as to sales volume, average selling price, and market
shares. Twice annually, AngioDynamics will allow Bioniche, upon request, to
visually review AngioDynamics’ customer list(s) for Product. Bioniche will have
no right to copy, retain, or remove any such customer list(s).

 

6.4 Reciprocal Examination Rights. Without limiting the generality of
Section 6.3, each Party, or its designated representative, shall have the right,
no more than once in any Contract Year, under appropriate confidentiality,
insurance and security arrangements and subject to reasonable advance notice, to
examine the books and records of the other Party and its Affiliates that relate
to the Product sold hereunder (including its sales in the Territory), to confirm
compliance with the terms of the Agreement, including, but not limited to,
Sections 2.4, 6.2 and 7.4. Neither the examining Party nor its designated
representatives shall have the right to copy, retain, or remove any such books
and records during such examination.

 

ARTICLE VII

PAYMENTS; ETC.

 

7.1 Consideration. In consideration for the exclusive marketing and distribution
rights as to Product in the Territory in the Field being granted by Bioniche to
AngioDynamics hereby, and in consideration of Bioniche agreeing to fulfill its
obligations hereunder, AngioDynamics hereby agrees to:

 

  a) pay Bioniche a non-refundable (subject to Section 9.4) fee of Two Million
and Three Hundred Thousand Dollars ($2,300,000.00), as follows:

 

  (i) One Million Five Hundred Thousand Dollars ($1,500,000.00) will be payable
thirty (30) days after the Effective Date of this Agreement; and

 

16

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  (ii) Eight Hundred Thousand Dollars ($800,000.00) will be payable at the end
of AngioDynamics’ first fiscal quarter following the First Commercial Sale of
the Product and in which no recalls pursuant to Section 5.5 occur; and

 

  b) make the minimum annual purchases of Product as provided for in Section 6.2
hereof, which purchases, subject to Section 7.4 hereof, will be supplied by
Bioniche at a transfer price calculated in accordance with Schedule “E” hereto.

 

7.2 Accrual; Mode of Payment.

 

  a) The payments due to Bioniche by AngioDynamics under Subsection 7.1
(a) shall accrue immediately upon the achievement of the relevant milestone, and
shall be paid to Bioniche in Dollars at the time specified in the relevant
subsection relating to such milestone. The payment due to Bioniche by
AngioDynamics for all undisputed invoices relating to Product ordered hereunder
shall be paid to Bioniche in accordance with Section 7.5 hereof. All payments
hereunder shall be paid by wire transfer, in immediately available funds, to an
account designated by Bioniche, or by such other reasonable method as Bioniche
may request, from time to time.

 

  b) Notwithstanding Section 7.2 (a), AngioDynamics must notify Bioniche in
writing if it disputes any invoiced amount within thirty (30) days of
AngioDynamics’ receipt of any invoice or receipt of Product at the Point of
Entry (as hereinafter defined), whichever is later, otherwise AngioDynamics
waives the right to dispute such invoice.

 

7.3 Taxes. Any payments required to be paid hereunder are inclusive of any taxes
or customs or other duty in respect of such payments. The Parties shall
co-operate and shall take all reasonable and lawful steps to avoid double
taxation of payments made to Bioniche hereunder. AngioDynamics shall withhold or
deduct any applicable tax from any payment made to Bioniche hereunder as
required under USA federal, state or local laws. AngioDynamics shall, upon
request, provide documentation from time to time as to confirm the payment by
AngioDynamics of such tax to the appropriate Governmental Body. AngioDynamics
shall provide to Bioniche any and all applicable sales or use tax resale
certificates as may be required by any state of the USA.

 

7.4 Transfer Price. The price to be paid by AngioDynamics to Bioniche per unit
of Product shall be the price as calculated subject to and in accordance with
Schedule “E” hereto for such Product; provided that, in the event that there are
major market changes or cost of manufacture increases, the Parties shall
negotiate price changes in good faith to attempt to find a satisfactory solution
to both Parties. In the event of the failure of the Parties to agree on price
changes in good faith within three (3) months of commencing the review, the
price for the Product shall be that prevailing immediately preceding
commencement of the review adjusted by the percentage

 

17

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change for the previous twelve (12) month period in Bioniche’s direct costs of
manufacture (including costs of raw materials) per unit of Product (without any
consideration of any of the indirect costs of manufacture of Bioniche). Bioniche
shall also provide reimbursement in the form of Product provided by Bioniche to
AngioDynamics at no additional cost as set forth in “Schedule E” hereto.

 

Bioniche agrees and promises that Bioniche’s price for Product sold to
AngioDynamics hereunder as an exclusive distributor shall always be the lowest
price which Bioniche or its Affiliates offers, charges, or accepts in full
payment for the Product from Bioniche’s or its Affiliates’ most favored customer
in the Territory including, without limitation, another distributor, unless
otherwise prohibited by applicable Laws.

 

7.5 Payment Terms; Currency. AngioDynamics shall pay the price for all Product
acquired hereunder to Bioniche in Dollars, within thirty (30) days from the date
of receipt of the invoice or of the Product at the Point of Entry (as
hereinafter defined), whichever is later, unless AngioDynamics has notified
Bioniche in writing that it is rejecting the Product under Section 7.8, or that
it is disputing the invoice under Section 7.2. In the case of a rejection of
Product under Section 7.8 or a disputed invoice under Section 7.2, payment shall
be made immediately following determination that the Product is in compliance
(or, if not in compliance, is replaced by complying Product) or following
resolution of the dispute, as the case may be.

 

7.6 Interest. Except as otherwise specifically provided for herein, any payments
due hereunder which are not paid within thirty (30) days of the date such
payments are due shall bear interest at Prime Rate plus two percent (Prime Rate
+ 2%) per annum, calculated on the number of days such payment is delinquent
under Section 7.2 (for the milestone payments made pursuant to Section 7.1 (a))
or Section 7.5 (for payments made for purchases of Product), as the case may be.
For greater certainty, neither the additional thirty (30) day grace period for
payment provided under this Section 7.6 nor the delay in payment permitted under
Section 7.5 (where the Product is found to be compliant or AngioDynamics’
dispute of the invoice is unfounded) shall be interest free.

 

7.7 Orders.

 

  a) On the Effective Date, AngioDynamics shall provide Bioniche with a forecast
(the “Forecast”) of its Product requirements. The Forecast shall be for twelve
(12) months (beginning on the first day of the first Contract Year), with the
first three (3) months of each Forecast constituting a firm order for Product,
and the additional nine (9) months of each shall be non-binding. All
requirements provided in Forecasts shall be updated on a “rolling” basis each
quarter during the Contract Year;

 

  b) Any and all purchase orders placed by AngioDynamics hereunder shall be for
a minimum quantity of one full batch of Product (as described in Schedule “B”)
or any number of full batches of Product; and

 

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  c) Without limiting the generality of Subsection 7.7 (a), unless otherwise
agreed by Bioniche in writing, all orders must be received by Bioniche at least
sixty (60) days prior to the date for required delivery of Product to
AngioDynamics.

 

7.8 Acceptance of Product Shipments. All Product shipped hereunder shall be
accompanied by a Certificate of Analysis. AngioDynamics shall have a maximum of
fifteen (15) days from the date of its receipt of any shipment of Product to
test for quality and quantity and to accept or reject such shipment. In the
event AngioDynamics does not notify Bioniche of acceptance or rejection within
such fifteen (15) day period, all units of the Product in such shipment shall be
deemed to be accepted by AngioDynamics. If AngioDynamics believes that any
shipment of Product hereunder does not meet the Specifications or the warranties
set forth in Section 8.2 hereof, AngioDynamics shall promptly notify Bioniche in
writing indicating the particular lot, time of delivery and the claimed
defective nature of the shipment. If AngioDynamics notifies Bioniche of any
claimed defect in a shipment of Product, Bioniche shall have the right, but not
the obligation, to send one or more quality control representatives to retest
such Product in cooperation with quality control representatives of
AngioDynamics. Replacement and disposition of non-compliant Product (as
determined in accordance with this Section 7.8) shall be at Bioniche’s sole cost
and expense provided that AngioDynamics shall have duly notified Bioniche as
aforesaid. Bioniche’s responsibility shall be limited to the above-mentioned
replacement and disposition of non-compliant Product only. In the event of a
disagreement between the Parties regarding the quality of one or more shipments
of Product, the Parties shall submit samples of the shipment in question to an
independent testing laboratory to make a determination, which shall be binding
upon the Parties, as to the compliance, or lack thereof, of such shipment with
the warranties set forth herein. Such independent testing laboratory will be
chosen by the mutual consent of the Parties. The costs of such testing will be
borne by Bioniche if such shipment is found to be non-compliant, or by
AngioDynamics, if such shipment is found to be in compliance.

 

7.9 Shipping.

 

  a) All Product ordered by AngioDynamics shall be delivered CIF [Incoterms; ed.
2002] the Bioniche facility in Inverin, County Galway, Ireland to AngioDynamics’
distribution center, located at Queensbury, New York in the Territory or at any
other such location in the continental USA as AngioDynamics may designate from
time to time (the “Point of Entry”). For greater certainty, Bioniche shall be
responsible for paying customs, insurance and freight charges required to
deliver the Product to the Point of Entry and the purchase price for Product
shall be payable in accordance with the provisions of Section 7.5 hereof. Title
to and risk of loss of Product shall pass from Bioniche to AngioDynamics when
Product is received by AngioDynamics at the Point of Entry;

 

  b)

AngioDynamics shall be responsible for the transportation of the Product from
the Point of Entry to AngioDynamics’ sites in the Territory and shall be
responsible for all transportation and insurance charges associated therewith.
AngioDynamics

 

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shall ensure that any carriers comply with all Laws in the Territory and the
requirements of Competent Authorities regarding the Product;

 

  c) Bioniche will use diligent efforts to ship the Product ordered by
AngioDynamics within sixty (60) days of its receipt of each order for such
Product. Portions of orders that exceed by more than twenty percent (20%) the
related firm order portion of the Forecast may not be filled or may be delayed.
Bioniche may supply partial shipments against AngioDynamics’ orders, provided
that the first shipment against an order shall constitute at least seventy five
percent (75%) of the forecasted order;

 

  d) Bioniche shall ensure that, at the time Product is delivered to the carrier
CIF under Section 7.9(a), such Product shall be at least twelve (12) months away
from its stated expiration date;

 

  e) Bioniche shall not be responsible to AngioDynamics for any loss or damages
resulting from late delivery or failure to deliver any of the Product due to an
Event of Force Majeure as defined below; and

 

  f) Without prejudice to the minimum purchase requirements provided for in
Section 6.2 hereof, AngioDynamics shall ensure that it maintains sufficient
stocks of the Product to satisfy demand for the Product in the Territory in the
Field on a timely basis.

 

7.10 Force Majeure. For the purposes of this Agreement, an “Event of Force
Majeure” shall include the following:

 

a) acts of God;

 

b) expropriation, confiscation or requisitioning of facilities or compliance
with any Law which affects to a degree not presently existing the supply,
availability or use of materials or labor;

 

c) acts or inaction on the part of any Governmental Body or Person purporting to
act therefor;

 

d) embargoes, or acts of war or the public enemy, whether war be declared or
not;

 

e) public disorder, insurrection, rebellion, riots or violent demonstrations;
and

 

f) floods, earthquakes, lightning, hail, tornadoes, hurricanes, or other natural
calamities.

 

If any Party wishes to invoke an Event of Force Majeure, then it shall
(i) immediately following the commencement of such Event of Force Majeure notify
the other Party of the occurrence of such Event of Force Majeure, the reasonably
estimated date and time on which it commenced

 

20

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and the nature of the Event of Force Majeure, and (ii) as soon as reasonably
practicable thereafter, submit to the other Party proof of the Event of Force
Majeure.

 

If one of the Parties is unable to perform its obligations under this Agreement
because of an Event of Force Majeure, then such Party shall be excused from
performance of its obligations until the Event of Force Majeure terminates and
the obligations of such Party, which cannot be met due to the Event of Force
Majeure, shall be suspended during the pendency of the Event of Force Majeure;
provided, however, that such Party uses all reasonable efforts to attempt to
prevent, avoid or remove the Event of Force Majeure, as quickly as possible and
that no such Event of Force Majeure shall, for any reason, excuse any failure or
delay beyond a period exceeding one hundred twenty (120) days from the date such
performance would have otherwise been due hereunder but for such Event of Force
Majeure. Nevertheless, an Event of Force Majeure has no effect on the obligation
to pay any sum of money owing for the purchase of any Product hereunder.

 

If either Party is excused from performance under this Agreement because of an
Event of Force Majeure, then the Parties agree to promptly meet and to work in
good faith together in an attempt to find appropriate solutions and to shorten
the duration of the Event of Force Majeure, to the extent reasonably feasible.
It is expressly provided, however, that, subject to the foregoing, if such Event
of Force Majeure shall have a duration of more than one hundred twenty
(120) days then the Party that has been notified of the Event of Force Majeure
by the other Party shall have the right and option, in its sole and absolute
discretion, to immediately terminate this Agreement after the expiration of that
period of time. If this Agreement is terminated in that circumstance, neither
Party hereto shall have any further rights, duties or obligations hereunder one
to the other thereafter, except for those that expressly survive any termination
of this Agreement, and except that if this Agreement is terminated due to such
an Event of Force Majeure on or before June 30, 2006, AngioDynamics shall be
entitled to receive from Bioniche the immediate return of fifty percent (50%) of
the milestone amounts paid under Section 7.1 (a), as liquidated damages.

 

ARTICLE VIII

REPRESENTATIONS and WARRANTIES; INDEMNIFICATION

 

8.1 Representations and Warranties of Both Parties. Each of the Parties hereby
makes the following covenants, representations and warranties to the other Party
and does so in full understanding and acknowledgement that the other Party is
relying on its said representations and warranties in entering into this
Agreement:

 

  a) Status. Each of the Parties is a corporation organized and existing under
their respective, applicable Laws of its jurisdiction. No action has been taken
by the directors, officers or shareholders of either Party to dissolve that
Party. Each Party has the corporate power and authority to enter into the
present Agreement and to perform all its obligations hereunder;

 

  b) All Necessary Proceedings. Each Party has taken all necessary corporate
actions and proceedings to enable it to enter into this Agreement;

 

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  c) No Violation. Each Party warrants that the execution, delivery and
performance of this Agreement by it: (i) does not and will not violate or
conflict with any provision of Law or any provision of its articles of
incorporation or by-laws; and (ii) does not and will not, with or without the
passage of time or the giving of notice, result in the breach of, or constitute
a default, cause the acceleration of performance, or require any consent under,
or result in the creation of any lien, charge or encumbrance upon any of its
property or assets pursuant to any material instrument or agreement to which it
is a party or by which it or its properties may be bound or affected;

 

  d) Binding Obligation. Each Party warrants that this Agreement is a legal and
valid obligation binding upon it and is enforceable against it in accordance
with its terms. The execution, delivery and performance of this Agreement by the
Party 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;

 

  e) No Restrictions. Each Party warrants that, as of the Effective Date, it is
not subject to any warning letter, consent order, decree or other restriction
imposed by any Governmental Body (including the FDA) that would prohibit it from
fulfilling its obligations under and in accordance with, the terms of this
Agreement; and

 

  f) Compliance; etc. Each Party will comply (and shall cause their Affiliates
to comply) with all applicable Laws in relation to the handling, storage,
marketing, distribution and sale of the Product.

 

8.2 Additional Representations and Warranties of Bioniche. Bioniche further
represents and warrants to AngioDynamics (and does so in full understanding and
acknowledgement that AngioDynamics is relying on such representations and
warranties in entering into this Agreement) that:

 

  a) any Product to be manufactured by it or its Affiliates and sold to
AngioDynamics hereunder shall be manufactured and supplied in accordance with
FDA regulations and cGMP, and shall meet the Specifications, as set forth on
Schedule “B”;

 

  b) to the best of Bioniche’s (or its Affiliates’) knowledge, after due
inquiry, as of the Effective Date, there is no pending or threatened claim with
respect to the Trade Mark;

 

  c) to the best of Bioniche’s (or its Affiliates’) knowledge, after due
inquiry, as of the Effective Date, neither the sale, use, nor manufacture of the
Product as provided in this Agreement infringes on the rights of any third
Person;

 

22

--------------------------------------------------------------------------------

  d) at the time of each shipment or delivery to the Point of Entry, Product
will not be adulterated or misbranded within the meaning of the USA Federal
Food, Drug and Cosmetic Act, as said Act is constituted and effective at the
time of such shipment or delivery, nor will the Product be an article which may
not, under the provisions of Sections 405, 505 and/or 512 of said Act, be
introduced into interstate commerce; and

 

  e) Bioniche: (i) as at the Effective Date holds the exclusive license to the
Trade Mark in the Territory; (ii) has the right to offer to AngioDynamics the
right to promote, distribute, sell and offer for sale Product in the Territory;
(iii) holds all necessary approvals from the FDA and/or other applicable
Competent Authorities to manufacture and sell the Product; (iv) has the right to
give AngioDynamics the right as a distributor to use the Trade Mark in the
Territory; and (v) has not granted any rights to promote, distribute, sell or
offer for sale the Product in the Field in the Territory to any other Person.

 

THE WARRANTIES SET OUT ABOVE IN SECTIONS 8.1 AND 8.2 ARE THE ONLY WARRANTIES
GIVEN BY EITHER PARTY HEREIN AND ARE MADE IN LIEU OF ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED. THERE IS NO OTHER CONDITION OR WARRANTY THAT ANY PRODUCT
SHALL BE MERCHANTABLE, OF SATISFACTORY QUALITY, FIT FOR ANY PARTICULAR PURPOSE,
IN ACCORDANCE WITH ANY SAMPLE, AS DESCRIBED IN ANY LITERATURE, OR THAT ITS SALE
OR USE DOES NOT INFRINGE THE RIGHTS OF OTHERS; NOR THAT BIONICHE SHALL BE
SUCCESSFUL IN OBTAINING ANY ADDITIONAL GOVERNMENTAL APPROVAL FOR THE PRODUCT.

 

8.3 Statements. AngioDynamics shall not make any statements about the Product
other than those as set forth in the official labeling for the Product, as
approved by the FDA or another Competent Authority.

 

8.4 Third Party Claims.

 

  a) Subject to Subsection 8.4 (e), Bioniche shall indemnify and defend
AngioDynamics, its Affiliates, and their respective directors, officers,
employees, or agents and hold it or them harmless from and against any and all
damages, actions, losses, liabilities, costs or expenses, including, but not
limited to, reasonable attorneys’ and consultants’ fees, arising from: (i) any
breach by Bioniche or its Affiliates of any representations or warranties or
obligations to AngioDynamics hereunder; (ii) the injury, illness, or death of
any third Person which arises out of or relates to the composition or the
manufacture of Product; or (iii) any negligent or willful action or omission of
Bioniche or its Affiliates or any of its or their agents, employees,
representatives, successors or assigns in connection with the manufacture,
development, marketing, sale or distribution of the Product; except, in each
case, to the extent such claims result from the fault or negligence of
AngioDynamics or its Affiliates, or their respective directors, officers,
employees, or agents, or its or their failure to comply with the terms of this
Agreement.

 

23

--------------------------------------------------------------------------------

  b) Bioniche shall not be liable under Subsection 8.4 (a) in the event that
AngioDynamics settles any such claim without the prior written consent of
Bioniche, which consent shall not be unreasonably withheld, conditioned, delayed
or denied.

 

  c) Subject to Subsection 8.4 (e), AngioDynamics shall indemnify and defend
Bioniche and its Affiliates, and their respective directors, officers,
employees, or agents and hold it or them harmless from and against any and all
damages, actions, losses, liabilities, costs or expenses, including, but not
limited to, reasonable attorneys’ and consultants’ fees, arising from: (i) any
and all third Person claims against Bioniche, based on or attributable to:
(1) any unauthorized modification or alteration made by AngioDynamics to the
Product and/or the packaging; or (2) combination by AngioDynamics of the Product
with any Device; (ii) a breach by AngioDynamics of its representations and
warranties or obligations to Bioniche hereunder; or (iii) any negligent or
willful misconduct or omission of AngioDynamics or its Affiliates or any of its
or their agents, employees, representatives, successors or permitted assigns in
connection with the marketing, sale or distribution of the Product; except, in
each case, to the extent such claims result from the fault or negligence of
Bioniche or its Affiliates, or their respective directors, officers, employees,
or agents, or its or their failure to comply with the terms of this Agreement.

 

  d) AngioDynamics shall not be liable under Subsection 8.4 (c) in the event
that Bioniche settles any such claim without the prior written consent of
AngioDynamics, which consent shall not be unreasonably withheld, conditioned,
delayed or denied.

 

  e)

A Party seeking indemnification (the “Indemnified Party”) shall notify, in
writing, the other Party (the “Indemnifying Party”) as soon as reasonably
practicable upon the assertion of any claim or discovery of any fact upon which
the Indemnified Party intends to base a claim for indemnification. An
Indemnified Party’s failure to so notify the Indemnifying Party shall not,
however, relieve such Indemnifying Party from any liability under this Agreement
to the Indemnified Party with respect to such claim except to the extent that
such Indemnifying Party is actually denied, during the period of delay in
notice, the opportunity to remedy or otherwise mitigate the event or
activity(ies) giving rise to the claim for indemnification and thereby suffers
or otherwise incurs additional liquidated or other readily quantifiable damages
as a result of such failure. The Indemnifying Party, while reserving the right
to contest its obligations to indemnify hereunder, shall be responsible for the
defense of any claim, demand, lawsuit or other proceeding in connection with
which the Indemnified Party claims indemnification hereunder. The Indemnified
Party shall have the right, at its expense (which expense shall not be
recoverable from the Indemnifying Party), to

 

24

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participate jointly with the Indemnifying Party in the defense of any such
claim, demand, lawsuit or other proceeding, but with respect to any issue
involved in such claim, demand, lawsuit or other proceeding with respect to
which the Indemnifying Party has acknowledged its obligation hereunder, the
Indemnifying Party shall have the right to select counsel, settle, try or
otherwise dispose of or handle such claim, demand, lawsuit or other proceeding
on such terms as the Indemnifying Party shall deem appropriate, subject to any
reasonable written objection of the Indemnified Party thereto.

 

8.5 No Consequential Damages. Except as otherwise specifically provided for in
Section 9.4, neither of the Parties shall be liable for any special,
consequential or punitive damages (including, without limitation, lost sales
revenues or lost profits, whether based on strict liability or any other
standard) to the non-defaulting Party, or to its Affiliates, or their respective
directors, officers, employees or agents, by reason of any default or breach of
this Agreement; provided that, if AngioDynamics has Product that is rendered
unsaleable by reason of any default or breach of the Agreement by Bioniche,
AngioDynamics shall be entitled to a refund from Bioniche for the total price
paid for said Product, as direct damages.

 

ARTICLE IX

TERM; TERMINATION

 

9.1 Term. This Agreement shall come into effect as of the Effective Date and
shall continue in force until the end of the seventh (7th) Contract Year; unless
sooner terminated by either Party in accordance with Section 9.2, below (the
initial term, together with any renewal term hereunder, referred to herein as
the “Term”). Thereafter, this Agreement will automatically renew for additional
consecutive three (3) year periods, unless expressly terminated by either Party
on written notice to the other Party at least one hundred and twenty
(120) calendar days prior to the end of the then current Term or otherwise
terminated under Section 9.2 or 9.3.

 

9.2 Termination by Either Party. Either Party may terminate this Agreement by
giving notice to the other Party:

 

  a) if the other Party becomes bankrupt, is placed into the hands of a trustee,
receiver, or manager on behalf of creditors as to the whole or a substantial
part of its business, makes an assignment for the benefit of creditors, or
ceases to carry on business; or

 

  b) if the other Party commits any material breach hereof and remains in breach
thirty (30) days after written notice thereof; except for breaches by
AngioDynamics in respect of non-payment of any monies owing hereunder, which
shall be governed by Section 9.3 hereof. AngioDynamics’ failure to meet the
minimum purchase requirements set forth on Schedule “D” shall not constitute a
material breach and remedies for such failure will be governed by Section 6.2.

 

9.3 Bioniche Termination Rights. Without limiting the generality of Section 9.2,
if: (i) AngioDynamics fails to make any payments required to be made by it
hereunder and such failure

 

25

--------------------------------------------------------------------------------

shall continue for twenty one (21) Business Days following receipt of notice to
that effect from Bioniche, then Bioniche shall have the right to terminate this
Agreement, by simple notice to that effect; provided that, such payments are not
the subject of a dispute hereunder, which is continuing and being pursued in
good faith by AngioDynamics; or (ii) AngioDynamics receives from Bioniche two
(2) notices of two (2) separate instances of overdue payments by AngioDynamics
within any single Contract Year, upon any subsequent (i.e. third) failure of
AngioDynamics to make timely payments when due hereunder within the same
Contract Year, Bioniche may terminate this Agreement.

 

9.4 Remedies Upon Default. Without prejudice to its rights under Section 9.2 or
Section 9.3 to terminate this Agreement upon the default or breach of the other
Party, the non-defaulting Party may also pursue all other remedies available to
it at Law by reason of any such default or breach, subject always to the
limitation on damages under Section 8.5. In addition, should AngioDynamics
terminate this Agreement under Section 9.2 (b) on or before June 30, 2006
following a material breach by Bioniche, the Parties specifically agree that
AngioDynamics, upon making proof of such material breach, shall be entitled to
receive from Bioniche an immediate return of the milestone amounts paid under
Section 7.1, as liquidated damages. If AngioDynamics’ Gross Margin (as defined
hereinafter in Schedule E) between the date of the First Commercial Sale and
termination of the Agreement is more than $5,000,000.00, however, AngioDynamics
shall not be entitled to a refund of the milestone amounts paid under
Section 7.1.

 

9.5 Post Termination. During a twelve (12) month period following the expiry or
termination of this Agreement, AngioDynamics may sell out its stock on hand of
Product and; provided AngioDynamics has not failed to comply with its
obligations under this Agreement (including the obligation to pay to Bioniche
any undisputed amounts owing to Bioniche hereunder), Bioniche will continue to
supply AngioDynamics with a sufficient quantity of Product to fill all orders
accepted by AngioDynamics for Products in the Field in the Territory prior to
the expiry of the Term. Promptly thereafter, or in the event that this Agreement
is otherwise terminated, each Party shall deliver to the other Party, at the
expense of the delivering Party, all documents containing any Confidential
Information, as defined below, of the other Party. All applicable provisions of
this Agreement shall survive termination for such purposes. Each Party
acknowledges and agrees that all of the Intellectual Property pertaining to the
Product shall remain exclusively with Bioniche following termination of this
Agreement.

 

9.6 Accrued and Surviving Obligations. Termination of this Agreement or expiry
of the Term shall not affect the rights of either Party to receive payment or
performance of obligations accruing prior to such termination or expiry. Without
limiting the generality of the foregoing, the provisions of Sections 1.2, 3.3,
and 7.6; and of Articles VIII, IX and X hereof shall survive termination or
expiration of this Agreement for any reason.

 

ARTICLE X

CONFIDENTIALITY

 

10.1 Confidential Information. For the purposes hereof, “Confidential
Information” means all verbal, written, electronically transmitted and/or
machine reproduced information, chemical

 

26

--------------------------------------------------------------------------------

structures, data, documents, methods and Intellectual Property of or relating to
the business of either Party or its Affiliates, already provided or disclosed by
it or its Affiliates to the other Party, or which will be provided to the other
Party, or its Affiliates, under this Agreement, and all internal materials,
data, results, reports and other documents generated by or on behalf of the
other Party, or its Affiliates, containing or regarding such information, data,
documents, methods and Intellectual Property.

 

10.2 Obligations. During the Term, each Party shall supply to the other Party
with such Confidential Information as is considered useful solely for the
purpose of enabling the other Party to perform its obligations hereunder. The
other Party shall not use or allow the use of the Confidential Information for
any other purpose.

 

Neither Party shall have any obligation of non-disclosure hereunder with respect
to any Confidential Information which:

 

  a) at the time of disclosure to the other Party is already available or known
to the public;

 

  b) after disclosure to the other Party becomes available or known to the
public through no breach of this Distribution Agreement;

 

  c) is already lawfully in the possession of the other Party at the time
disclosure hereunder was made and such possession is documented by written
evidence; or

 

  d) is received from a third Person having the right to disclose same and who
is not bound by a similar confidentiality agreement.

 

10.3 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 Law; or

 

  c) is otherwise necessary to prosecute or defend litigation or comply with
applicable Laws (other than intellectual property Laws) or otherwise establish
rights or enforce obligations under this Agreement, but only to the extent that
any such disclosure is necessary.

 

10.4 Unauthorized Use. In case either Party becomes aware or has knowledge of
any unauthorized use or disclosure of Confidential Information, it shall
promptly notify the other

 

27

--------------------------------------------------------------------------------

Party of such unauthorized use or disclosure and, thereafter, shall take all
reasonable steps to assist the other Party in attempting to minimize any
potential or actual damages or losses resulting from such unauthorized use or
disclosure.

 

10.5 Return of Documents. Each Party, upon receipt of a written request from the
other Party (or upon termination of this Agreement), shall promptly return to
the other Party all Confidential Information of such other Party, including all
reproductions and copies thereof together with all internal material and
documents generated by it containing Confidential Information or references
thereto, from which references the substance of the Confidential Information can
be implied or understood and shall delete all references thereto stored
electronically.

 

10.6 Term. The provisions of this Article X shall survive the expiry or
termination of the Agreement until all of the Confidential Information has
fallen within one of the exceptions set forth in Subsection 10.2, above.

 

ARTICLE XI

GENERAL

 

11.1 Notices. Any notice, consent, authorization, direction or other
communication required or permitted to be given hereunder by one Party to the
other shall be in writing and shall be deemed duly given when delivered to the
other Party personally or sent by facsimile transmission or by a nationally
recognized overnight courier, costs prepaid, to the addresses set forth below or
at such other addresses (or to such other Person) as any Party may designate, at
any time and from time to time, by notice to the other Party hereunder:

 

  a) in the case of AngioDynamics, to its address first stated above:

 

Attention:

   Eamonn Hobbs      603 Queensbury Avenue      Queensbury, New York 12804

Telecopier:

   518-798-3625

With a copy to:

   Gregory Champion, Esq.      Bond, Schoeneck & King, PLLC      111 Washington
Avenue      Albany, New York 12210

Telecopier:

   518-533-3299

 

28

--------------------------------------------------------------------------------

  b) in the case of Bioniche, to its address first stated above:

 

Attention:

   Damien Kelly, CFO & Secretary      Inverin, County Galway      Republic of
Ireland

Telecopier:

   00 353 91 593 228

With a copy to:

   Albert Beraldo, President & CEO      275 Labrosse Ave.      Pointe Claire,
Quebec      Canada

Telecopier:

   514-697-7966; and      J. David Butts, Esq.      Hayhurst Robinson Law
Offices      16 Sveta Nedelya; Fl. 3      Sofia 1000, Bulgaria

Telecopier:

   00 3592 981 7975

 

Any notice, consent, authorization, direction or other communication as
aforesaid shall be deemed to have been effectively delivered and received, if
sent by telex, facsimile transmission or similar telecommunications device on
the Business Day next following receipt of such transmission (confirmation of
receipt by confirmed facsimile transmission being deemed receipt of
communication sent by telex, facsimile transmission or other telecommunications
device) or, if sent by reliable overnight courier service, one (1) Business Day
after the date of deposit with such nationally recognized overnight courier, or,
if personally delivered, to have been delivered and received on the date of such
personal delivery provided, however, that if such date is not a Business Day,
then it shall be deemed to have been delivered and received on the Business Day
next following such delivery. Any Party may change its address for service by
written notice given as aforesaid.

 

11.2 Assignment.

 

  a) The rights granted to AngioDynamics hereunder are personal and neither this
Agreement nor any of the rights or obligations of AngioDynamics hereunder may be
assigned without the prior written consent of Bioniche, except that
AngioDynamics may assign, in its sole discretion, its rights and obligations
under this Agreement to any successor individual or entity of AngioDynamics
following a “Change of Control. “For purposes of this Agreement, a “Change of
Control” shall include the merger, consolidation, reorganization or sale of
substantially all of the assets or capital stock of AngioDynamics, measured by
vote or value. Notwithstanding the foregoing, AngioDynamics may not assign its
rights and obligations under this Agreement after a Change of Control to any
successor individual or entity engaged in the manufacturing for sale or sale of
sterile injectible drugs within the Territory without the prior written consent
of Bioniche. This Section 11.2 (a) shall inure to the benefit of and be binding
upon any successor individual or entity of AngioDynamics following a “Change of
Control.”

 

29

--------------------------------------------------------------------------------

  b) Bioniche may assign this Agreement or its rights and obligations hereunder
without the prior written consent of AngioDynamics. Notwithstanding the
foregoing, Bioniche shall not assign its obligations under Section 1.2 with
respect to dispute resolution, Section 8.4 with respect to third party claims,
and its obligations under Sections 9.4 and 7.10 with respect to the return of
the milestone payments unless Bioniche provides a written guaranty, acceptable
in form and substance to AngioDynamics, which consent will not be unreasonably
withheld, to guarantee the performance by the assignee of the aforementioned
obligations. Notwithstanding the foregoing, Bioniche may assign, in its sole
discretion, its rights and obligations under this Agreement to any successor
individual or entity of Bioniche following a “Change of Control. “For purposes
of this Agreement, a “Change of Control” shall include the merger,
consolidation, reorganization or sale of substantially all of the assets or
capital stock of Bioniche, measured by vote or value. This Section 11.2
(b) shall inure to the benefit of and be binding upon any successor individual
or entity of Bioniche following a “Change of Control.”

 

11.3 Successors and Assigns. This Agreement and the provisions hereof shall
inure to the benefit of and be binding upon each Party and its respective
successors and permitted assigns.

 

11.4 Limitation. The Parties acknowledge and agree that the International Sale
of Goods Act and the United Nations Convention on Contracts for the
International Sale of Goods have no application to this Agreement.

 

11.5 Waiver. A waiver of any breach of any provision of this Agreement by a
Party shall not be construed as a continuing waiver of other breaches of the
same or other provisions of this Agreement.

 

11.6 Severability. If any provision of this Agreement is illegal or
unenforceable, such provision shall be inoperative and the remainder of the
enforceable provisions of this Agreement shall remain valid, binding and
effective upon the Parties.

 

11.7 Relationship of the Parties. The relationship between the Parties is that
of independent contractors and each Party agrees to conduct its affairs
accordingly. Neither Party shall, by reason of this Agreement, be deemed to be a
member of a partnership or joint venture with the other Party. Each of the
Parties agrees that it is not and shall not represent itself to be an agent of
the other Party or of any of the Affiliates of the other Party or of any
supplying company for any purpose and shall not incur any obligations nor make
any promise or representation on behalf of any of the foregoing, and
AngioDynamics further agrees to use reasonable commercial efforts to ensure that
its sales force does not incur any such obligations or make any such promises or
representations with regard to any Product it is selling or distributing
pursuant to this Agreement.

 

30

--------------------------------------------------------------------------------

11.8 Headings. The section headings contained in this Agreement are included for
convenience only, form no part of the agreement between the Parties, and shall
not be utilized in interpreting the meaning of any section of this Agreement.

 

11.9 Publicity. Without limiting the generality of Article X, neither Party
shall issue any public announcement relating to the existence or terms of this
Agreement without the prior written consent of the other Party (which consent
shall not be unreasonably withheld or delayed), except where, upon advice of
counsel, such announcements are required by Law. Any Party shall be entitled to
make any such legally required announcement, without obtaining the consent of
the other Party thereto. The Parties shall cooperate in issuing (an) initial
public release(s) with respect to the signing of this Agreement, either
separately or as a joint release.

 

11.10 Counterparts. This Agreement may be executed in any number of counterparts
and any Party hereto may execute any such counterpart, each of which when
executed and delivered shall be deemed to be an original and all of which
counterparts taken together shall constitute but one and the same instrument.
This Agreement shall become binding when one or more counterparts taken together
shall have been executed and delivered by the Parties. It shall not be necessary
in making proof of this Agreement or any counterpart hereof to produce or
account for any of the other counterparts. Delivery of an executed signature
page to this Agreement by facsimile transmission shall be as effective as
delivery of a manually signed counterpart.

 

11.11 Governing Law. This Agreement shall be construed and interpreted in
accordance with and governed and enforced in all respects by the laws of the
State of New York; and, except as otherwise provided in Section 1.2, each of the
Parties hereby consents and submits to the jurisdiction and venue of the federal
and state courts in the State of New York. Bioniche further agrees to accept
service of process by mail or commercial carrier sent to its last known address.

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first above mentioned.

 

ANGIODYNAMICS, INC.       BIONICHE PHARMA GROUP LIMITED

By:

  /s/    ROBERT M. ROSSELL               By:   /s/    DAMIEN KELLEY        

Name:

  Robert M. Rossell      

Name:

  Damien Kelly

Title:

  Vice President, Marketing      

Title:

  Chief Financial Officer & Secretary

Date: 17-10-05

     

Date: 17/10/05

 

31

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SCHEDULE “A”

to the

Supply and Distribution Rights Agreement

dated October 17, 2005

by and between

AngioDynamics, Inc. (“AngioDynamics”) and Bioniche Pharma Group Limited
(“Bioniche”)

 

DESCRIPTION OF THE PRODUCT

 

Sodium Tetradecyl Sulfate branded as Sotradecol, in two concentrations: 1%, 3%
and any other concentration subsequently approved by the FDA for use in
Territory and in the Field. Product will be distributed under two different
product codes according to concentrations. Product will be packaged by
concentration, where each box will contain 5 X 2mL vials of Sotradecol, each
vial contains the relevant concentration.

 

32

--------------------------------------------------------------------------------

SCHEDULE “B”

to the

Supply and Distribution Rights Agreement

dated October 17, 2005

by and between

AngioDynamics, Inc. (“AngioDynamics”) and Bioniche Pharma Group Limited
(“Bioniche”)

 

SPECIFICATIONS

 

At the Effective Date, Product is manufactured in the following minimum batch
sizes:

 

1%        Fourteen Thousand (14,000) units/batch; and

3%        Fourteen Thousand (14,000) units/batch.

 

Copies of the package inserts, the packaging cartons, and the packaging labels
for the 1% and 3% concentrations of the Product, as designed by and provided by
Bioniche, are attached as a part of this Schedule “B.”

 

33

--------------------------------------------------------------------------------

SOTRADEACOL® (Sodium Tetradecyl Sulfate Injection)

 

FOR INTRAVENOUS USE ONLY

 

Rx Only

 

DESCRIPTION

 

Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy
solid. The structural formula is as follows:

 

LOGO [g69111img0_1.jpg]

 

Sotradecol® (sodium tetradecyl sulfate injection) is a sterile nonpyrogenic
solution for intravenous use as a sclerosing agent.

 

1% (10 mg/mL): Each mL contains sodium tetradecyl sulfate 10 mg, benzyl alcohol
0.02 mL and dibasic sodium phosphate, anhydrous 4.0 mg in Water for injection.
pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for
pH adjustment.

 

3% (30 mg/mL): Each mL contains sodium tetradecyl sulfate 30 mg, benzyl alcohol
0.02 mL and dibasic sodium phosphate, anhydrous 9.0 mg in Water for injection.
pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for
pH adjustment.

 

CLINICAL PHARMACOLOGY

 

Sotradecol® (sodium tetradecyl sulfate injection) is a sclerosing agent.
Intravenous injection causes intima inflammation and thrombus formation. This
usually occludes the injected vein. Subsequent formation of fibrous tissue
results in partial or complete vein obliteration that may or may not be
permanent.

 

INDICATIONS AND USAGE

 

Sotradecol® (sodium tetradecyl sulfate injection) is indicated in the treatment
of small uncomplicated varicose veins of the lower extremities that show simple
dilation with competent valves. The benefit-to-risk ratio should be considered
in selected patients who are great surgical risks.

 

CONTRAINDICATIONS

 

Sotradecol® (sodium tetradecyl sulfate injection) is contraindicated in previous
hypersensitivity reactions to the drug; in acute superficial thrombophlebitis;
valvular or deep vein incompetence; huge superficial veins with wide open
communications to deeper veins; phlebitis migrans; acute cellulitis; allergic
conditions; acute infections; varicosities caused by abdominal and pelvic tumors
unless the tumor has been removed; bedridden patients; such uncontrolled
systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma,
neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.

 

WARNINGS

 

Sotradecol® (sodium tetradecyl sulfate injection) should only be administered by
a physician familiar with venous anatomy and the diagnosis and treatment of
conditions affecting the venous system and familiar with proper injection
technique. Severe adverse local effects, including tissue necrosis, may occur
following extravasation; therefore, extreme care in intravenous needle placement
and using the minimal effective volume at each injection site are important.

 

Emergency resuscitation equipment should be immediately available. Allergic
reactions, Including fatal anaphylaxis, have been reported. As a precaution
against anaphylactic shock, It is recommended that 0.5 mL of Sotradecol® be
injected into a varicosity, followed by observation of the patient for several
hours before administration of a second or larger dose. The possibility of an
anaphylactic reaction should be kept in mind, and the physician should be
prepared to treat it appropriately.

 

Because of the danger of thrombosis extension into the deep venous system,
thorough preinjection evaluation for valvular competency should be carried out
and slow injections with a small amount (not over 2 mL) of the preparation
should be injected into the varicosity. Deep venous patency must be determined
by angiography or noninvasive testing such as duplex ultrasound. Venous
sclerotherapy should not be undertaken if tests such as Trendelenberg and
Perthes, and angiography show significant valvular or deep venous incompetence.

 

The development of deep vein thrombosis and pulmonary embolism have been
reported following sclerotherapy treatment of superficial varicosities. Patients
should have post-treatment follow-up of sufficient duration to assess for the
development of deep vein thrombosis. Embolism may occur as long as four weeks
after injection of sodium tetradecyl sulfate. Adequate post-treatment
compression may decrease the incidence of deep vein thrombosis.

 

PRECAUTIONS

 

GENERAL

 

Extreme caution must be exercised in the presence of underlying arterial disease
such as marked peripheral arteriosclerosis or thromboangiitis obliterans
(Buerger’s Disease).

 

DRUG INTERACTIONS

 

No well-controlled studies have been performed on patients taking antiovulatory
agents. The physician must use judgment and evaluate any patient taking
antiovulatory drugs prior to initiating treatment with Sotradecol®. (See ADVERSE
REACTIONS section).

 

Heparin should not be included in the same syringe as Sotradecol®, since the two
are incompatible.

--------------------------------------------------------------------------------

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

 

When tested in the L5178YTK +/- mouse lymphoma assay, sodium tetradecyl sulfate
did not induce a dose-related increase in the frequency of thymidine
kinase-deficient mutants and, therefore, was judged to be nonmutagenic in this
system. However, no long-term animal carcinogenicity studies with sodium
tetradecyl sulfate have been performed.

 

PREGNANCY

 

Teratogenic Effects – Pregnancy Category C. Animal reproduction studies have not
been conducted with Sotradecol®. It is also not known whether Sotradecol® can
cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Sotradecol® should be given to a pregnant woman only if
clearly needed and the benefits outweigh the risks.

 

NURSING MOTHERS

 

It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when Sotradecol® is
administered to a nursing woman.

 

PEDIATRIC USE

 

Safety and effectiveness in pediatric patients have not been established.

 

ADVERSE REACTIONS

 

Local reactions consisting of pain, urticaria or ulceration may occur at the
site of injection. A permanent discoloration may remain along the path of the
sclerosed vein segment. Sloughing and necrosis of tissue may occur following
extravasation of the drug. (See WARNINGS section).

 

Allergic reactions such as hives, asthma, hayfever and anaphylactic shock have
been reported. Mild systemic reactions that have been reported include headache,
nausea and vomiting. (See WARNINGS section).

 

At least six deaths have been reported with the use of Sotradecol®. Four cases
of anaphylactic shock leading to death have been reported in patients who
received Sotradecol®. One of these four patients reported a history of asthma, a
contraindication to the administration of Sotradecol®. (See WARNINGS section).

 

One death has been reported in a patient who received Sotradecol® and who had
been receiving an antiovulatory agent. Another death (fatal pulmonary embolism)
has been reported in a 36-year-old female treated with sodium tetradecyl acetate
and who was not taking oral contraceptives.

 

DOSAGE AND ADMINISTRATION

 

Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration. Do not use if precipitated or discolored.

 

Sotradecol® (sodium tetradecyl sulfate injection) is for intravenous use only.
The strength of solution required depends on the size and degree of varicosity.
In general, the 1% solution will be found most useful with the 3% solution
preferred for larger varicosities. The dosage should be kept small, using 0.5 to
2 mL (preferably 1 mL maximum) for each injection, and the maximum single
treatment should not exceed 10 mL.

 

HOW SUPPLIED

 

Sotradecol® (sodium tetradecyl sulfate injection)

 

1% (10 mg/mL) - 2 mL vials; in packages of 5 (NDC 67457-162-02)

3% (30 mg/mL) - 2 mL vials; in packages of 5 (NDC 67457-163-02)

 

STORAGE

 

Store at 20°C to 25°C (68°F to 77°F)(See USP Controlled Room Temperature).

 

ANIMAL TOXICOLOGY

 

The intravenous LD® of sodium tetradecyl sulfate in mice was reported to be 90 ±
5 mg/kg.

 

In the rat, the acute intravenous LD® of sodium tetradecyl sulfate was estimated
to be between 72 mg/kg and 108 mg/kg.

 

Purified sodium tetradecyl sulfate was found to have an LD® of 2 g/kg when
administered orally by stomach tube as a 25% aqueous solution to rats. In rats
given 0.15 g/kg in drinking water for 30 days, no appreciable toxicity was seen,
although some growth inhibition was discernible.

 

Manufactured for:

Bioniche Pharma U.S.A. Inc.

Bogart, GA 30622

 

Manufactured by

Bioniche Teo

Inverin, Co. Galway, Ireland

 

Issued: October 2004

   0521L100

 

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SCHEDULE “C”

to the

Supply and Distribution Rights Agreement

dated October 17, 2005

by and between

AngioDynamics, Inc. (“AngioDynamics”) and Bioniche Pharma Group Limited

(“Bioniche”)

 

TRADE MARK

 

Mark

--------------------------------------------------------------------------------

  

Goods and Services

--------------------------------------------------------------------------------

  

US Trademark Serial Number

--------------------------------------------------------------------------------

Sotradecol

   Pharmaceutical preparations, namely composition for treatment of varicose
veins    76385054

 

Attached as a part of this Schedule “C” is the applicable Statement of Use,
filed by Cumberland Pharmaceuticals, Inc., on October 4, 2005.

 

The Registration Statement is to be provided by Bioniche when available, and
will be attached to this Schedule “C.”

 

34

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PTO Form 1553 (Rev 4/2000)

OMB Control #0651-0009 (Exp. 06/30/2005)

 

Trademark/Service Mark Statement of Use

 

The table below presents the data as entered.

 

SERIAL NUMBER    76385054 LAW OFFICE ASSIGNED    LAW OFFICE 115 NOTICE OF
ALLOWANCE    YES EXTENSION OF USE    NO REQUEST TO DIVIDE    NO MARK SECTION   
  STANDARD CHARACTERS    NO LITERAL ELEMENT    SOTRADECOL OWNER SECTION
(current)      NAME    Cumberland Pharmaceuticals Inc. STREET    209 Tenth
Avenue South, Suite 332 CITY    Nashville STATE    Tennessee ZIP/POSTAL CODE   
37203 COUNTRY    United States OWNER SECTION (proposed)      NAME    Cumberland
Pharmaceuticals Inc. INTERNAL ADDRESS    Suite 950 STREET    2525 West End
Avenue CITY    Nashville STATE    Tennessee ZIP/POSTAL CODE    37203 COUNTRY   
United States PHONE    615-259-1030 FAX    615-259-1470 EMAIL   
amy.weaver@arlaw.com ATTORNEY SECTION (current)     

--------------------------------------------------------------------------------

NAME    Reber M. Boult ATTORNEY SECTION (proposed)      NAME    Reber M. Boult
DOCKET NUMBER    604816-000007 GOODS AND/OR SERVICES SECTION      INTERNATIONAL
GLASS    005 GOODS AND/OR SERVICES    KEEP ALL LISTED FIRST USE ANYWHERE DATE   
07/25/2005 FIRST USE IN COMMERCE DATE    07/25/2005 SPECIMEN FILE NAME(S)   
\\TICRS\EXPORT8\IMAGEOUT8\763\850\76385054\xmll\SO U0002.JPG SPECIMEN
DESCRIPTION    Photograph of label/packaging PAYMENT SECTION      NUMBER OF
CLASSES    1 SUBTOTAL AMOUNT    100 TOTAL AMOUNT    100 SIGNATURE SECTION     
SIGNATURE    /reber m. boult/ SIGNATORY NAME    Reber M. Boult SIGNATORY DATE   
10/04/2005 SIGNATORY POSITION    Attorney FILING INFORMATION      SUBMIT DATE   
Tue Oct 04 16:20:14 EDT 2005 TEAS STAMP   

USPTO/SOU-209.149.60.98-2

0051004162014572219-76385

054-250a168c3f03474c4dc8a

d72a2c7a87d0a3-DA-288-200

51004161601906958

 

PTO Form 1553 (Rev 4/2000)

OMB Control #0651-0009 (Exp. 06/30/2005)

 

Trademark/Service Mark Statement of Use

(15 U.S.C. Section 1051(d))

 

To the Commissioner for Trademarks:

 

MARK: SOTRADECOL

SERIAL NUMBER: 76385054

--------------------------------------------------------------------------------

This Allegation of Use is being filed after a Notice of Allowance has issued.

 

The applicant, Cumberland Pharmaceuticals Inc., residing at Suite 950,2525 West
End Avenue, Nashville, Tennessee (TN) United States (USX) 37203, is using or is
using through a related company or licensee the mark in commerce on or in
connection with the goods and/or services as follows:

 

For International Class: 005, the applicant, or the applicant’s related company
or licensee, is using the mark in commerce on or in connection with all goods
and/or services listed in the application or Notice of Allowance.

 

The mark was first used by the applicant, or the applicant’s related company,
licensee, or predecessor in interest at least as early as 07/25/2005, and first
used in commerce at least as early as 07/25/2005, and is now in use in such
commerce. The applicant is submitting one specimen for the class showing the
mark as used in commerce on or in connection with any item in the class,
consisting of a(n) Photograph of label/packaging. Specimen-1

 

The applicant hereby appoints Reber M. Boult to submit this Trademark/Service
Mark Statement of Use on behalf of the applicant. The attorney docket/reference
number is 604816-000007.

 

A fee payment in the amount of $100 will be submitted with the form,
representing payment for 1 class.

 

Declaration

 

Applicant requests registration of the above-identified trademark/service mark
in the United States Patent and Trademark Office on the Principal Register
established by the Act of July 5, 1946 (15 U.S.C. Section 1051 et seq., as
amended). Applicant is the owner of the mark sought to be registered, and is
using the mark in commerce on or in connection with the goods/services
identified above, as evidenced by the attached specimen(s) showing the mark as
used in commerce.

 

The undersigned being hereby warned that willful false statements and the like
are punishable by fine or imprisonment, or both, under 18 U.S.C. Section 1001,
and that such willful false statements and the like may jeopardize the validity
of this document, declares that he/she is properly authorized to execute this
document on behalf of the Owner; and all statements made of his/her own
knowledge are true and that all statements made on information and belief are
believed to be true.

 

Signature:

  /s/    REBER M. BOULT        

Signatory’s Name:

  Reber M. Boult

Signatory’s Position:

  Attorney Date: 10/04/2005

 

RAM Sale Number: 288

RAM Accounting Date: 10/05/2005

 

Serial Number: 76385054

Internet Transmission Date: Tue Oct 04 16:20:14 EDT 2005

TEAS Stamp: USPTO/SOU-209.149.60.98-2005100416201457

2219-76385054-250a168c3f03474c4dc8ad72a2

c7a87d0a3-DA-288-20051004161601906958

Go Back

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FEE RECORD SHEET    Serial Number:         76385054      LOGO [g69111img0_9.jpg]
RAM Sale Number: 288    Total Fees:         $100

RAM Accounting Date: 20051005

         

 

Transaction

--------------------------------------------------------------------------------

   Fee
Code

--------------------------------------------------------------------------------

   Transaction
Date

--------------------------------------------------------------------------------

   Fee per
Class

--------------------------------------------------------------------------------

   Number
of Classes

--------------------------------------------------------------------------------

   Total
Fee

--------------------------------------------------------------------------------

Statement of Use (SOU)

   7003    20051004    $ 100    1    $ 100

 

Transaction Date: 20051004    

 

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SCHEDULE “D”

to the

Supply and Distribution Rights Agreement

dated October 17, 2005

by and between

AngioDynamics, Inc. (“AngioDynamics”) and Bioniche Pharma Group Limited

(“Bioniche”)

 

MINIMUM PURCHASE REQUIREMENTS

 

AngioDynamics will use reasonable efforts to achieve the following minimum
purchase requirements of total vials/units in the first five (5) Contract Years
of the Term of the Agreement:1

 

•      First year:

   *** units/*** Product boxes

•      Second year:

  

*** units/*** Product boxes

•      Third year:

  

*** units/*** Product boxes

•      Fourth year:

  

*** units/*** Product boxes

•      Fifth year:

  

*** units/*** Product boxes

 

At least twelve (12) months prior to the end of the fifth Contract Year, the
Parties shall enter discussions in good faith with respect to establishing
minimum purchase requirements for the sixth and seventh Contract Years of the
Term. In the unlikely event that the Parties are unable to agree on minimum
purchase requirements for the sixth and seventh Contract Years of the Term on or
before the end of the first Calendar Quarter in the fifth Contract Year, the
minimum purchase requirements for the sixth and seventh Contract Years shall be
equal to the minimum purchase requirements for the fifth Contract Year. The
Parties shall negotiate in good faith with respect to establishing minimum
purchase requirements for the Contract Years extending beyond the seventh
Contract Year. If the Parties are unable to agree upon the minimum purchase
requirements for any Contract Year beyond the seventh Contract Year within the
first Calendar Quarter of the preceding Contract Year, the minimum purchase
requirements for the succeeding Contract Year shall be equal to the minimum
purchase requirements for the preceding Contract Year.

 

Note: Total units are irrespective of concentration. (1 vial = 1 unit) (1 box =5
units).

--------------------------------------------------------------------------------

1 The Parties agree, however, that if the first Contract Year does not actually
contain a full 365 days, the minimum purchase requirement for the first Contract
Year will be computed according to the following formula:

 

*** boxes

  X       the actual number of days in the first Contract Year   = minimum
purchase requirement (in boxes)                 365    

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*** Confidential material redacted and filed separately with the Commission.

 

35

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SCHEDULE “E”

to the

Supply and Distribution Rights Agreement

dated October 17, 2005

by and between

AngioDynamics, Inc. (“AngioDynamics”) and Bioniche Pharma Group Limited

(“Bioniche”)

 

TRANSFER PRICE

 

All pricing for 1% and 3% vials shall be per box of Product. Each box of Product
shall contain five (5) vials, each vial containing two (2) milliliters of
Sotradecol.

 

The Transfer Price for each box of Product shall be calculated using the
following formula:

 

Bioniche’s Published List Price X ***% = Transfer Price

 

For purposes of this Agreement, Bioniche’s Published List Price shall mean the
price for each concentration of Product as set forth in Bioniche’s standard
product catalog or the equivalent thereof for the applicable Contract Year,
which is attached to this Schedule E as a part thereof, and as may be amended on
a yearly basis by Bioniche.

 

At the end of each Calendar Quarter, Bioniche will provide AngioDynamics with a
reimbursement to increase AngioDynamics’ Gross Margin percentage by up to ***
percent (***%) for each concentration of Product sold by AngioDynamics in that
preceding Calendar Quarter to the extent that AngioDynamics achieves less than a
***% Gross Margin percentage for any such concentration of Product.

 

The reimbursement shall be in the form of the relevant concentration of Product
provided to AngioDynamics by Bioniche at no cost to AngioDynamics. For the
purposes of this calculation, the value of no cost Product provided to
AngioDynamics shall be based on AngioDynamics’ Actual Selling Price for the
relevant concentration of Product in the preceding Calendar Quarter.

 

Following the end of each Calendar Quarter, AngioDynamics will provide to
Bioniche a schedule showing AngioDynamics’ Actual Selling Price and Gross Margin
separately stated for each concentration of Product for that preceding Calendar
Quarter.

 

For the purposes of this Agreement, AngioDynamics’ Actual Selling Price shall
mean AngioDynamics’ actual revenues from the sale of each concentration of
Product in any particular Calendar Quarter exclusive of trade discounts (in the
nature of discounts for prompt payment).

 

For the purposes of this Agreement, Gross Margin shall mean AngioDynamics’
Actual Selling Price for each concentration of Product less the Transfer Price
for that concentration of Product in any particular Calendar Quarter.

 

36

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The following example of the reimbursement methodology discussed above is
provided for illustration:

 

Assume Transfer Price for 1% solution = $***

Assume AngioDynamics’ Actual Selling Price= $***

Assume Total sales = *** units or $*** ($*** X ***)

Gross Margin percentage = ***% (($*** —$***)/$***)

No cost goods reimbursement = ***% (***%—***%)

AngioDynamics’ Actual Selling Price would need to be $*** to achieve a ***%
Gross Margin ($*** /***%)

$*** - $*** = $***

$*** X *** units sold = $***

*** units ($*** /$***) provided by Bioniche to AngioDynamics at no cost

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*** Confidential material redacted and filed separately with the Commission.

 

37

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1% - Box of 5 vials    $*** 3% - Box of 5 vials    $***

 

For information Contact: BIONICHE Customer Service:

888-258-4199

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*** Confidential material redacted and filed separately with the Commission.