AXCAN DIOMED PDT LASER DEVELOPMENT AND SUPPLY AGREEMENT
TABLE OF CONTENTS
ARTICLE 1 INTERPRETATION ................................................... 1
1.1 Definitions .......................................................... 1
1.2 Entire Agreement ..................................................... 3
1.3 Governing Law ........................................................ 3
ARTICLE 2 DEVELOPMENT ...................................................... 4
2.1 Development Commitment ............................................... 4
2.2 Development of the Laser ............................................. 4
ARTICLE 3 PROMOTION OF PDT ................................................. 4
3.1 Cooperation .......................................................... 4
3.2 CME participation .................................................... 4
3.3 Joint efforts ........................................................ 4
ARTICLE 4 MARKETING AND SALES OF LASERS .................................... 4
4.1 Forecast ............................................................. 4
4.2 Reasonable Efforts to Market ......................................... 4
4.3 Commercial Obligations ............................................... 5
4.4 Allocation of Manufacturing Resources ................................ 5
4.5 Notice of Delays ..................................................... 5
4.6 Sales to AXCAN ....................................................... 5
4.7 Reductions in Manufacturing Costs .................................... 6
4.8 AXCAN's Exclusivity .................................................. 6
4.9 DIOMED's Exclusivity ................................................. 7
ARTICLE 5 LEGAL AND REGULATORY MATTERS; AUDIT .............................. 7
5.1 Regulatory Approval .................................................. 7
5.2 Compliance with Laws ................................................. 7
5.3 Audit of Facilities .................................................. 7
5.4 Adverse Reports ...................................................... 7
5.5 Government Body and Other Inquiries .................................. 8
5.6 Recalls .............................................................. 8
5.7 Recall Procedure ..................................................... 8
5.8 Costs ................................................................ 8
ARTICLE 6 INTELLECTUAL PROPERTY ............................................ 8
6.1 Title ................................................................ 8
6.2 Confidentiality ...................................................... 9
ARTICLE 7 REPRESENTATIONS, WARRANTIES AND INDEMNIFICATION .................. 9
7.1 DIOMED's Representations and Warranties .............................. 9
7.2 No Other Warranties .................................................. 9
7.3 NO CONSEQUENTIAL DAMAGES ............................................. 9
7.4 Indemnification ...................................................... 10
7.5 Insurance ............................................................ 10
ARTICLE 8 SECURITY OF SUPPLY ............................................... 10
8.1 Security of Supply ................................................... 10
8.2 Annual Financial Due Diligence ....................................... 10
8.3 Plan for Resumption on Interruption of Supply ........................ 11
8.4 Escrow of IP ......................................................... 11
ARTICLE 9 TERM ............................................................. 11
9.1 Initial Term ......................................................... 11
9.2 Renewal Terms ........................................................ 11
ARTICLE 10 TERMINATION ..................................................... 11
10.1 Events of Termination ............................................... 11
10.2 Consequences of Termination or Expiry in Any Event .................. 12
10.3 Consequences of Termination for DIOMED's Default .................... 12
10.4 Survival of Obligations ............................................. 13
ARTICLE 11 GENERAL PROVISIONS .............................................. 13
11.1 Amendment ........................................................... 13
11.2 Arbitration ......................................................... 13
11.3 Assignment .......................................................... 14
11.4 Counterparts; Facsimile ............................................. 14
11.5 Enurement ........................................................... 14
11.6 Force Majeure ....................................................... 14
11.7 Independent Contractors ............................................. 14
11.8 Media Announcements ................................................. 14
11.9 Notice .............................................................. 15
11.10 Severability ....................................................... 15
11.11 Waiver ............................................................. 15
AXCAN QLT DIOMED PDT LASER DEVELOPMENT AND SUPPLY AGREEMENT
THIS AGREEMENT is entered into effective as of the 1st day of August, 2000 (the
"Effective Date") between DIOMED INC. ("DIOMED"), a Delaware corporation having
an office at ▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇ and YELLOWGATE
LIMITED (SUCH NAME TO BE CHANGED TO ACAN PHARMA (IRELAND) LIMITED; HEREINAFTER
REFERRED TO AS"AXCAN"), a Quebec company having an office at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇,
▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇▇, ▇▇, ▇▇▇ ▇▇▇
WHEREAS
A. QLT (as defined hereafter) and Diomed entered into a PDT Laser Development
and Supply Agreement dated February 22, 2000 ("QLT AGREEMENT") for use with
Photofrin;
B. AXCAN is a leader in the field of gastroenterology and has purchased
Photofrin(R) from QLT;
C. DIOMED is a leader in the development of medical diode laser systems, and
is developing a new compact laser to be used in combination with
Photofrin(R);
D. QLT and DIOMED have, subject to the conclusion of this Agreement, agreed to
terminate the QLT Agreement;
E. AXCAN and DIOMED have agreed to work together to continue the development
of the Laser and to get the Laser approved for use with PHOTOFRIN, for the
existing approved oncology indications transferred to AXCAN by QLT;
F. QLT has licensed or sublicensed certain intellectual property related to
fiber optic technology pertaining to or used in connection with the Laser
and
G. DIOMED and AXCAN wish to cooperate in the marketing of PDT with PHOTOFRIN
and DIOMED's T2USA laser or its equivalent in the Agreed Territories;
NOW THEREFORE, in consideration of the premises and the mutual covenants and
agreements contained in this Agreement, the parties hereto agree as follows:
ARTICLE I INTERPRETATION
1.1 Definitions
The following capitalized terms shall have the following meanings in this
Agreement:
1.1.1 "$" means United States Dollars.
1.1.2 "Affiliate" means any corporation or business entity controlled by,
controlling or under common control with a party, and "control" or
"control interest" shall mean direct or indirect beneficial
ownership of 50% or more of the voting stock of, or a 50% or greater
interest in the income of, such corporation or other business
entity, or such other relationship as, in fact constitutes actual
control.
1.1.3 "Agreed Territories" means worldwide excluding Japan.
1.1.4 "AXCAN Indemnified Parties" has the meaning set out in Section 7.4.
1.1.5 "AXCAN Pharmaceutical Partners" means pharmaceutical companies
designated by AXCAN to DIOMED from time to time as such.
1.1.6 "Business Day" means a day that is not a Saturday or a Sunday or a
statutory holiday in either Massachusetts or Quebec.
1.1.7 "Clinical Trials" means any research or clinical trial, including
trials pre- and post- regulatory approval, which include Phase IV
trials, and any trial in which AXCAN and/or, AXCAN Pharmaceutical
Partners provide AXCAN's Photosensitizers at no cost to the End
User.
1.1.8 "Confidential Information" has the meaning set out in Article 6.2.
1.1.9 "End User" means any individual or institution which administers
AXCAN's Photosensitizers to patients.
1.1.10 "EPI" means Epitaxial Products International Limited, a company
registered in England located at Pascal Close, Cypress Drive, St
Mellons, Cardiff, CF3 OEG UK.
1.1.11 "FDA" means the United States Food and Drug Administration and any
successor thereto.
1.1.12 "Fully Burdened Manufacturing Cost" means direct material costs,
direct labor costs and reasonable manufacturing and administrative
(but excluding marketing and sales) overhead costs, with such
overhead costs determined in accordance with US Generally Accepted
Accounting Principles ("USGAAP")
1.1.13 "HPD" means HPD, a New Jersey corporation located at ▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇.
1.1.14 "Intellectual Property" shall mean anything that is protected by any
patents, trademarks, copyrights, trade secrets, know-how and all
other intellectual and industrial property rights whatsoever and
worldwide (whether registered or unregistered and including rights
in any application for any of the foregoing)
1.1.15 "Initial Term" has the meaning set out in Section 9.1.
1.1.16 "Key Components" means EPI'S wafer and FWD's laser diode, which are
elements of the Laser.
1.1.17 "Laser" means the DIOMED T2USA laser and its DIOMED equivalent for
sale in jurisdictions other than the United States incorporating the
HPD 630nm diode that is compatible with PHOTOFRIN.
1.1.18 "Manufacturing" means any and all activities to acquire the Key
Components and manufacture Lasers.
1.1.19 "OEM Transfer Price" means in respect of each Laser and subject to
Article 4.7, DIOMED's Fully Burdened Manufacturing Cost of such
Laser plus 100% of same.
1.1.20 "PDT" means the field of photodynamic therapy, that is, the emerging
medical field that uses light-activated drugs and light in the
diagnosis, treatment and prevention of cancer and other diseases.
1.1.21 "PHOTOFRIN" shall mean a specific PDT drug bearing that name and
owned by QLT.
1.1.22 "Photosensitizer" means any compounds whose cytotoxic mechanism
requires activation by the direct application of light, made by or
for AXCAN or a AXCAN Pharmaceutical Partner, or any licensee,
sublicensee or distributor of either of them.
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1.1.23 "PMA" means a Premarket Approval Application under 21 C.F.R. 360(e)
et seq. pursuant to the rules and policies of the FDA.
1.1.24 "QLT" means collectively QLT Inc., a British Columbia company
(formerly known as "QLT PhotoTherapeutics Inc.") having an office at
▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇ ▇▇▇
and QLT PhotoTherapeutics Inc., a Delaware Company.
1.125 "QLT Agreement" has the meaning set out in preamble A of this
Agreement.
1.1.26 "Regulatory Authorities" means the FDA and the corresponding
authorities in each applicable jurisdiction for which AXCAN informs
DIOMED from time to time that the Lasers are to be marketed and sold
in such jurisdiction, that have responsibility for any or all of the
following:
(a) the issuance of marketing authorizations for medical devices
and/or drug device combinations; and
(b) the monitoring of quality systems compliance and/or
implementation and/or the ongoing surveillance of product
safety, efficacy, or adverse events.
1.1.27 "Recall" means (i) any action by Diomed or Axcan or any of their
Affiliates to recover title to or possession of Lasers or Photofrin
products sold or shipped to third parties and (ii) also includes the
failure by Diomed or Axcan to sell or ship Lasers or Photofrin
products to third parties which would have been subject to recall if
it had been sold or shipped provided that (iii), in the case of
Photofrin, it does not include trade returns from third parties for
past due dates, mishandling in the deliveries, etc.
1.1.28 "Renewal Term" has the meaning set out in Section 9.2.
1.1.29 "Seriously Disrupted" in a territory means that AXCAN's
Pharmaceutical Partner for that territory has ceased to market
actively PHOTOFRIN in that territory.
1.1.30 "Term" means the Initial Term and any Renewal Terms as defined in
Article 9.
1.1.31 "Transfer Price" means the OEM Transfer Price plus an increase to
cover any marketing costs incurred pursuant to Article 4.2.
1.2 ENTIRE AGREEMENT
This Agreement supersedes all previous representations, warranties, dealings,
agreements, understandings and expectations of the parties regarding the subject
matter hereof, and there are no other representations, warranties,
understandings, conditions, agreements, or expectations except as set out in
herein.
1.3 GOVERNING LAW
This Agreement shall be deemed to have been entered into and shall be construed
in accordance with the laws of the State of New York, provided that each party
hereto waives, to the fullest extent permitted by applicable law, any and all
right to trial by jury in any legal proceeding arising out of or relating to
this Agreement or the transactions contemplated hereby.
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ARTICLE 2 DEVELOPMENT
2.1 DEVELOPMENT COMMITMENT
In any future agreed development programs DIOMED will use reasonable efforts to
complete the programs in accordance with the jointly developed timelines.
2.2 DEVELOPMENT OF THE LASER
AXCAN wishes DIOMED to continue and DIOMED wishes to continue the development of
and to enable 630 nm laser diodes that can be used in, among other things, the
Laser. To do so, DIOMED will use commercially reasonable efforts to undertake,
and cause EPI and HPD to undertake, the development activities contemplated by
this development.
ARTICLE 3 PROMOTION OF PDT
3.1 COOPERATION
AXCAN and DIOMED agree to use economically reasonable efforts to cooperate in
order to promote PDT.
3.2 CME PARTICIPATION
AXCAN and DIOMED agree to provide joint support for the satellite symposium on
PDT held yearly during the International Course on Therapeutic Endoscopy in
Toronto and will examine participation in other CME events.
3.3 JOINT EFFORTS
AXCAN and DIOMED further agree to use economically reasonable efforts to promote
Photofrin-Laser combination therapy for G.I. indications pursuant to a marketing
plan to be jointly developed as set out in section 4.2 below.
ARTICLE 4 MARKETING AND SALES OF LASERS
4.1 FORECAST
AXCAN shall, with respect to all Lasers, maintain and provide to DIOMED an
annual non-binding forecast to be updated quarterly and a rolling six month
forecasted demand for Lasers from AXCAN's Pharmaceutical Partners and End Users,
such forecasts to be based on reasonable expectations of actual demand. Each
six-month forecast shall be delivered to DIOMED at the beginning of a calendar
quarter for the six-month period following the quarter in which the forecast is
given. The first ninety (90) days of each rolling six-month forecast shall be
binding on AXCAN and shall be non-binding thereafter. In the event that AXCAN
does not order the number of Lasers included in the second forty-five (45) days
of a ninety (90) day binding forecast, AXCAN agrees to pay DIOMED, within thirty
(30) days of receiving an invoice therefor, DIOMED's Fully Burdened
Manufacturing Cost for the Lasers scheduled for delivery in such second
forty-five (45) day period and diomed agrees to hold shipment of the Lasers
until such time as AXCAN notifies DIOMED to do so.
4.2 REASONABLE EFFORTS TO MARKET
AXCAN and DIOMED will cooperate in developing a marketing plan which will detail
each party's obligations.
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Subject to the above DIOMED shall make commercially reasonable efforts to market
Lasers with AXCAN's support in the Agreed Territories unless either (i)
otherwise agreed in writing between DIOMED and AXCAN or (ii) the marketing of
PHOTOFRIN in an Agreed Territory is Seriously Disrupted.
4.3 COMMERCIAL OBLIGATIONS
DIOMED shall, with respect to all Lasers:
4.3.1 Use commercially reasonable efforts to meet in a timely manner the
reasonably forecasted demand and actual sales demand therefor from
AXCAN, AXCAN's Pharmaceutical Partners, DIOMED distributors and End
Users, such that DIOMED shall ship reasonably forecasted Lasers:
(a) on average on an annualized basis, within 90 days from receipt
of an order, and
(b) 95% of the time, on an annualized basis, within 120 days of
receipt of any such order;
4.3.2 accept all reasonable purchase orders for Lasers from AXCAN, AXCAN's
Pharmaceutical Partners, DIOMED distributors and End Users and fill
same within a reasonable time from the perspective of: (i) DIOMED,
and (ii) such purchasers;
4.3.3 sell Lasers to AXCAN and to AXCAN's Pharmaceutical Partners for use
in any Clinical Trials at not more than the OEM Transfer Price of
same.
4.4 ALLOCATION OF MANUFACTURING RESOURCES
Where DIOMED's inability to deliver Lasers is due to a shortage of production
capacity caused by the allocation of such capacity to DIOMED's other customers,
DIOMED shall allocate its production capacity among AXCAN, AXCAN's
Pharmaceutical Partners, DIOMED distributors and End Users for Lasers and
DIOMED's other customers on a reasonable pro rata basis based on AXCAN's and
such other customers' forecasted production requirements for the then current
six month period.
4.5 NOTICE OF DELAYS
Where possible, DIOMED shall provide to AXCAN prompt notice of any problems
which have the potential to adversely affect the Manufacturing of any Lasers
under this Agreement, or the timely delivery of same to AXCAN, AXCAN's
Pharmaceutical Partners, DIOMED distributors and End Users for Lasers. Without
limiting the generality of the foregoing, DIOMED shall provide to AXCAN at least
six months prior written notice of any scheduled shutdown at any of its
manufacturing facilities that may impact DIOMED's ability to Manufacture and
timely deliver Lasers to AXCAN, AXCAN Pharmaceutical Partners, DIOMED
distributors and End Users for Lasers under this Agreement.
4.6 SALES TO AXCAN
Excluding Lasers sold to AXCAN under Article 4.3.3, DIOMED will make commercial
sales of Lasers on the terms set out in this Agreement to AXCAN. The terms of
the sales to AXCAN shall be:
4.6.1 AXCAN shall give DIOMED ninety (90) days notice of its desire to
purchase Lasers at the Transfer Price and the jurisdictions in which
AXCAN wishes to purchase the Lasers;
4.6.2 DIOMED shall sell such Lasers to AXCAN at the Transfer Price;
4.6.3 DIOMED shall give priority to AXCAN in the supply of such lasers;
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4.6.4 Any End User supplied with such Lasers directly or indirectly by
AXCAN will be eligible for all DIOMED product guarantees and
warranties as if said End User had been supplied directly by DIOMED
on DIOMED's standard terns for same;
4.6.5 In those countries in which AXCAN is selling Lasers, at AXCAN's
request, DIOMED shall drop ship freight collect Lasers purchased by
AXCAN to the location and party specified by AXCAN, provided that
AXCAN will specify no more than one location in each country at any
time; and
4.6.6 Except as expressly set out herein, DIOMED shall not discriminate
among AXCAN, AXCAN's Pharmaceutical Partners and End Users and other
purchasers of Lasers respecting shipping times or availability of
Lasers.
4.7 REDUCTIONS IN MANUFACTURING COSTS
DIOMED will notify AXCAN of any new technologies or new manufacturing methods
that could result or have resulted in reductions in the Fully Burdened
Manufacturing Cost. Any reductions in Fully Burdened Manufacturing Cost achieved
will be shared equally by the parties, and such sharing will be reflected in a
modification to the OEM Transfer Price.
4.8 AXCAN'S EXCLUSIVITY
In recognition of DIOMED's financial commitment to the development of the Laser,
AXCAN agrees to support, endorse and procure exclusively the Laser in the Agreed
Territories to the exclusion of other diode laser systems that incorporate a
630nm laser diode in the field of PDT for oncology using PHOTOFRIN, for a period
of five years following approval of the Laser from any regulatory authority in
any jurisdiction of the Agreed Territories. The foregoing is subject to:
4.8.1 DIOMED not being in breach of this Agreement;
4.8.2 DIOMED being able to submit the documentation required by a
regulatory authority for the approval of the Laser within a
timeframe to be jointly agreed on by AXCAN and DIOMED;
4.8.3 approval of the Laser by the Regulatory Authority is not withheld in
the applicable jurisdiction of the Agreed Territories due to:
(a) any failure of DIOMED to apply for and diligently pursue such
approval within a reasonable period of time; or
(b) any failure of or deficiencies in DIOMED's quality systems;
4.8.4 approval by the applicable Regulatory Authority of the Laser occurs
within 18 months of the date of application for same;
4.8.5 approval by the applicable Regulatory Authority of the first
generation T2USA laser (or equivalent in jurisdiction of the Agreed
Territories other than the United States) (incorporating an SDL
laser diode) is not significantly delayed by deficiencies in
DIOMED's quality systems identified in the FDA audit dated March
6/10 2000; and
4.8.6 subject to Article 4.2 DIOMED can demonstrate that it is making
reasonable efforts to market the Laser.
Further, DIOMED's period of exclusivity may be extended in a given Agreed
Territory if marketing of PHOTOFRIN in that Territory is Seriously Disrupted
during the initial three year period. Such period of extension shall equal the
period of the disruption.
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If the sale of Laser is not authorized within the period set forth in
subsection 4.8.4 or such authorization is suspended in a jurisdiction of the
Agreed territories, AXCAN shall have the right to procure (and service) other
lasers in such jurisdiction until such time when the Lasers are authorized for
sale.
Notwithstanding the rest of this Article 4.8, AXCAN shall have no obligation to
oblige any commercial customer or investigator to use a Laser.
4.9 DIOMED'S EXCLUSIVITY
During the period of exclusivity set out in Article 4.8, DIOMED shall not
without AXCAN's prior approval:
4.9.1 manufacture the Laser for any parties other than as provided for
herein; or
4.9.2 sell or otherwise dispose of any Laser except in accordance with the
terms and conditions of this Agreement.
4.9.3 replace the 630 nm diode with a diode that makes use of a different
wavelength in any of the Lasers sold by DIOMED, AXCAN or AXCAN's
Partners.
4.9.4 exchange or replace the Laser with a laser equipped with a diode
that makes use of a different wavelength.
4.9.5 provided AXCAN makes an equity investment in DIOMED, manufacture or
distribute Lasers for use as part of any PDT, PMA, MAA application
for any gastrointestinal or hepatobiliary diagnostic, therapeutic or
preventive indication except to AXCAN and DIOMED's current business
partners (being Pharmacyclics, Dusa, QLT and Scotia) without the
consent of AXCAN.
ARTICLE 5 LEGAL AND REGULATORY MATTERS; AUDIT
5.1 REGULATORY APPROVALS
DIOMED confirms that it has obtained approval from the FDA. DIOMED and AXCAN
will reasonably cooperate to obtain, when required in a jurisdiction of the
Agreed Territories, the required approval from such other Regulatory Authority
for the Laser.
5.2 COMPLIANCE WITH LAWS
In carrying out its obligations under this Agreement, DIOMED shall at all times
comply with all applicable laws and obtain and maintain in effect all applicable
licenses and permits respecting such obligations, including, without
limitation, DIOMED shall produce the Laser in compliance with standards of the
FDA, Europe Union Medical Device Directive and any other applicable Regulatory
Authorities in the Agreed Territories.
5.3 AUDIT OF FACILITIES
DIOMED shall allow AXCAN to conduct QA audits of its manufacturing facility and
applicable documents whenever AXCAN believes them to be necessary and with 15
days advance written notice. Any audit under this Article shall be conducted
during regular business hours at a time and date mutually agreeable between the
parties but no later than three (3) business days following the fifteen-day (15)
period of the notice.
5.4 ADVERSE REPORTS
Each party shall promptly advise the other party and provide the other with a
notice of any reports of unexpected side effects, adverse reactions or injury
("Adverse Reports") which have been brought to such party's attention at any
place and which are alleged to have been caused by the Laser or Photofrin. Each
party shall forward serious
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Adverse Reports and unexpected Adverse Reports without delay to the other party
as soon as such reports come its attention.
5.5 GOVERNMENT BODY AND OTHER INQUIRIES
Upon being contacted by any governmental body in the Agreed Territories in
connection with the Laser, Photofrin or any other matter which might reasonably
be expected to affect the rights or obligations of the other party under this
Agreement, the party so contacted shall immediately notify the other party. Each
party, as appropriate, shall respond to all inquiries regarding the Lasers from
governmental bodies throughout the Agreed Territories and the parties shall
provide one another with reasonable assistance in this regard.
5.6 RECALLS
In the event that an event, incident or circumstance has occurred which may
result in the need for a recall or other removal of one or more Lasers or
Photofrin product from the market, the parties shall consult with each other
with respect thereto as to the appropriate measures to be taken.
5.7 RECALL PROCEDURE
Prior to commencing any recall of Lasers, the parties shall review with one
another the manner in which the recall is to be carried out and any instructions
or suggestions of the applicable regulatory authorities. Diomed shall assume
control of any recall procedure concerning the Lasers and Axcan shall reasonably
assist (at Diomed's expenses) in any action taken pursuant to such recall. Axcan
shall assume control of any recall procedure concerning Photofrin and Diomed
shall reasonably assist (at Axcan's expense) in any action taken pursuant to
such recall.
5.8 COSTS
Diomed shall pay all costs incurred in connection with any recall of Lasers
throughout the Territory unless such recall is necessary due to a breach by
Axcan of its obligations hereunder. Axcan shall pay all costs incurred in
connection with any recall of Photofrin throughout the Territory unless such
recall is due to a breach by Diomed of its obligations hereunder.
ARTICLE 6 INTELLECTUAL PROPERTY
6.1 TITLE
Subject to the terms of this Agreement:
6.1.1 Any inventions owned by DIOMED prior to the effective date of this
Agreement or licensed or sublicensed from QLT since that date, or
invented solely by DIOMED under this Agreement, and all the work
product arising from any development carried out by DIOMED shall be
solely owned by DIOMED.
6.1.2 Any inventions owned by AXCAN prior to the effective date of this
Agreement, or invented solely by AXCAN under this Agreement, and the
work product arising from any development carried out by AXCAN shall
be solely owned by AXCAN.
6.1.3 Any inventions or work product arising from any development work
made jointly by the parties hereunder shall be jointly owned by both
parties, without any duty to account to each other and, unless
agreed to otherwise by the parties in writing, each party shall be
free to make use, sell, license or otherwise grant authorizations to
this third parties concerning any such invention without the need to
receive the prior approval or authorization of the other; the
parties hereby definitively waive any right to request partition of
such invention.
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6.1.4 Each party reserves all rights in its Intellectual Property that it
does not expressly grant to the other party in this Agreement.
6.1.5 Subject to the provisions of Subsection 6.1.3 above, the parties
will mutually agree on the protection and enforcement of their
jointly owned Intellectual Property.
6.1.6 DIOMED, AXCAN shall promptly notify each other of any suspected
infringement of the other's Intellectual Property rights.
6.2 CONFIDENTIALITY
DIOMED and AXCAN agree that all information relating to the technology arising
from the Development Program and the terms of this Agreement, disclosed by
either party in accordance with this Agreement shall be maintained by the
receiving party in secrecy, and each will use all reasonable diligence to
prevent disclosure, except to necessary personnel. DIOMED's and AXCAN's
obligations under this Article 6.2 shall be limited to a period of five years
from the date of expiry or earlier termination of this Agreement. The parties
shall not have any obligation of confidentiality with respect to any information
that is:
6.2.1 in the public domain, other than by a breach of this Agreement on
the part of the receiving party;
6.2.2 rightfully received from a third party without any obligation of
confidentiality;
6.2.3 rightfully known to the receiving party without any limitations on
use or disclosure prior to its receipt from the disclosing party as
documented in written records;
6.2.4 generally made available to third parties by the disclosing party
without restriction on disclosure; or
6.2.5 independently developed by the receiving party as documented in
written records.
Any and all information received by either party from the other, upon request
shall be promptly returned, except that the receiving party may retain one copy
of such information in its confidential files, solely for record purposes.
ARTICLE 7 REPRESENTATIONS, WARRANTIES AND INDEMNIFICATION
7.1 DIOMED'S REPRESENTATIONS AND WARRANTIES
DIOMED hereby represents and warrants to AXCAN as set out in Exhibit 7.1,
DIOMED's current applicable published warranty.
7.2 NO OTHER WARRANTIES
EXCEPT AS EXPRESSLY PROVIDED HEREIN, NEITHER PARTY MAKES TO THE OTHER PARTY ANY
WARRANTY OF ANY KIND EXPRESS OR IMPLIED, WITH RESPECT TO THIS AGREEMENT AND THE
PRODUCTS AND SERVICES CONTEMPLATED BY THIS AGREEMENT, INCLUDING, BUT NOT LIMITED
TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE.
7.3 NO CONSEQUENTIAL DAMAGES
NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, NEITHER PARTY SHALL
IN ANY CIRCUMSTANCES BE LIABLE TO THE OTHER OR ANY THIRD PARTY FOR SPECIAL,
INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES OF ANY NATURE WHATSOEVER,
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INCLUDING, BUT NOT LIMITED TO, COMMERCIAL LOSS FROM ANY CAUSE, BUSINESS
INTERRUPTION OF ANY NATURE OR LOSS OF PROFITS, EVEN IF THE PARTY THAT WOULD
OTHERWISE BE LIABLE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
7.4 INDEMNIFICATION
DIOMED shall indemnify, defend and hold harmless AXCAN and its officers,
directors, employees and agents (the "AXCAN Indemnified Parties") from and
against any and all liabilities, damages, costs and expenses, including
attorney's fees, which may be imposed upon, incurred by, or served against the
AXCAN Indemnified Parties by any third party:
7.4.1 for the infringement of or by any product supplied by DIOMED against
the patent, trademark, trade name, copyright or other intellectual
property rights of such third party;
7.4.2 challenging any right of ownership; or
7.4.3 for product liability claims arising from any of the Lasers
(including, but not limited to, claims arising out of or related to
defects in material, workmanship or design or breach of warranty).
AXCAN shall notify DIOMED in writing within a reasonable time after it becomes
aware of any such allegation, claim, charge or legal proceeding and permit
DIOMED to handle defense and settlement of any such allegation, claim, charge or
legal proceeding.
7.5 INSURANCE
DIOMED shall maintain, at its own expense, adequate comprehensive general
liability insurance and adequate product liability insurance coveting the
manufacture, marketing, use and sale of the Lasers (excluding the manufacture,
marketing, use and sale of Photofrin(R)), with waivers of subrogation, covering
AXCAN, its employees and representatives and specifically naming AXCAN as
co-insured. Upon request, DIOMED shall provide a certificate covering any such
insurance to AXCAN.
AXCAN shall maintain, at its own expense, adequate comprehensive general
liability insurance and adequate product liability insurance covering the
manufacture, marketing, use and sale of Photofrin(R) (excluding the manufacture,
marketing, use and sale of the Lasers), with waivers of subrogation, covering
DIOMED, its employees and representatives and specifically naming DIOMED as
co-insured. Upon request, AXCAN shall provide a certificate covering any such
insurance to DIOMED.
ARTICLE 8 SECURITY OF SUPPLY
8.1 SECURITY OF SUPPLY
In the event that DIOMED:
8.1.1 ceases or threatens to cease to do business or exploit the work
product other than through termination under Article 9.2 or 10.1
(where the defaulting party is AXCAN), or goes bankrupt, on written
notice to DIOMED, AXCAN shall have the non-exclusive rights set out
in Articles 10.2 and 10.3.
8.2 ANNUAL FINANCIAL DUE DILIGENCE
DIOMED shall inform AXCAN of any known material change in the situation of
DIOMED, HPD or EPI that might impact the security of supply of Lasers. On an
annual basis, and at AXCAN's request, DIOMED shall provide standard financial
information required to update AXCAN's financial due diligence records on
DIOMED.
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8.3 PLAN FOR RESUMPTION ON INTERRUPTION OF SUPPLY
If for any reason, DIOMED fails to deliver Lasers for more than 30 days after
the delivery date for shipment, or if any event occurs which will interrupt the
supply of Lasers under this Agreement where such interruption will continue for
more than 30 days, DIOMED will provide a plan to AXCAN in which DIOMED details
how DIOMED will correct the interruption of supply and provide the timelines
required to achieve this. AXCAN may, at AXCAN's sole option, accept the plan,
regardless of whether or not AXCAN has exercised any other rights under this
Article or Article 10.
8.4 ESCROW OF IP
In furtherance of DIOMED's obligations under this Agreement, upon notice from
AXCAN from time to time, DIOMED shall place a copy of all of DIOMED's current
and future Intellectual Property necessary to exploit AXCAN's rights set out in
Article 10.3 in escrow. The escrow shall:
8.4.1 be with an independent third party;
8.4.2 be paid for by AXCAN;
8.4.3 be terminable on expiry or other termination, provided that such
termination did not give rise to the opportunity for AXCAN to
exercise rights pursuant to the escrow contemplated hereby,
8.4.4 provide for the release from escrow and delivery to AXCAN of such
information upon the interruption of supply of Lasers as set out in
Articles 8.1 and 10.1 of this Agreement on the terms set out herein;
and
8.4.5 be on commercially reasonable terms
If the parties cannot agree on the terms of the escrow, either party may submit
the matter to arbitration
ARTICLE 9 TERM
9.1 INITIAL TERM
This Agreement shall commence on the Effective Date and shall remain in full
force and effect for a period of five years therefrom (the "Initial TERM"),
unless extended in accordance with Article 9.2, or earlier terminated in
accordance with the terms and conditions of this Agreement.
9.2 RENEWAL TERMS
This Agreement shall automatically renew for a period of two additional years (a
"Renewal Term") commencing on the expiration of the Initial Term or the
preceding Renewal Term, as the case may be, unless either party delivers written
notice to terminate to the other party a least three months prior to the
expiration of the initial Term or Renewal Term, as applicable. The parties may
renegotiate pricing and any other material terms and conditions of this
Agreement for any Renewal Term.
ARTICLE 10 TERMINATION
10.1 EVENTS OF TERMINATION
This Agreement may be terminated for cause including but not necessarily limited
to the following circumstances:
10.1.1 by notice given by the non-defaulting party for the following and
the defaulting party not remedying such failure within thirty days
after receipt of written notice of such default:
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(a) if a party fails to perform any material term or condition of
this Agreement or any other associated agreement in writing
between the parties;
(b) if either party fails to materially perform against agreed-to
Manufacturing schedules; or
10.12 by notice of termination for the following reason given by the
non-defaulting party, which notice will be effective upon receipt,
upon the dissolution or insolvency of either party, or the
appointment of a receiver or receiver-manager of any part of the
property or business of either party, or the making of an
assignment, proposal, or arrangement by either party for the benefit
of creditors, or the filing of a petition in bankruptcy again to
either party, or the commencement of any proceedings under any
bankruptcy or insolvency laws in respect of either party, or if
either party discontinues its business.
10.2 CONSEQUENCES OF TERMINATION OR EXPIRY IN ANY EVENT
Subject to Articles 10.3 and 10.4, on any expiration or earlier termination of
this Agreement through any means and for any reason, each party shall:
10.2.1 promptly cease all use of the Confidential Information of the other
party and ensure that its employees cease all use thereof; and
10.2.2 upon written request of the other party:
(a) return to the other party all original copies of the
Confidential Information of the other party in its control or
possession, subject to the retention of one copy of materials
as necessary for compliance with the requirements of Regulatory
Authorities; and
(b) destroy any and all copies or other reproductions or extracts
of the Confidential Information of the other party and all
other documents, computer files, memoranda, notes or other
writings prepared based or such Confidential Information,
except where required by law, regulation or court order to be
maintained.
10.3 CONSEQUENCES OF TERMINATION FOR DIOMED'S DEFAULT
Solely in the event of termination due to the default of DIOMED or the
occurrence of any of the events set out in Article 8.1:
10.3.1 DIOMED shall ensure that all Confidential Information, technology,
know-how, and supplier and subcontractor lists and agreements
(including licenses such as the QLT Agreement), relating to the
Manufacturing by DIOMED, HPD or EPI of Key Components or the Laser
are provided to AXCAN or its designee, all in a form and with
content reasonably satisfactory to AXCAN as required to enable
AXCAN'S reasonably competent staff to transfer the process of
Manufacturing of Lasers (to the extent such process exists at the
time of termination) to AXCAN or a third party as soon as reasonably
possible, and AXCAN shall be granted a non-exclusive, worldwide
license with a right to grant sublicenses, at a royalty rate of ten
percent of the Fully Burdened Manufacturing Cost, to use DIOMED's
Intellectual Property solely for the purpose of Manufacturing and
selling Lasers;
10.3.2 at the option of AXCAN, exercisable by written notice delivered by
AXCAN to DIOMED, DIOMED, shall, notwithstanding such termination,
continue to Manufacture Lasers for AXCAN's needs for a period not
exceeding 24 months until AXCAN has established a replacement
contractor for the Manufacturing of Lasers and replacement Laser
inventory is available and approved for use by the applicable
Regulatory Authorities. During such
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transition period, AXCAN shall pay for the products and services of
DIOMED at a commercially reasonable rate. If the parties cannot
agree on the commercially reasonable rate, either party may submit
the matter to arbitration. AXCAN shall use its best commercial
efforts to secure a new contractor for the Manufacturing of Lasers
within a reasonable time;
10.3.3 each party will co-operate reasonably and in good faith with the
other so that the transition of the services rendered by DIOMED
under this Agreement shall be timely and efficient and implemented
in a manner so as not to unduly interfere with the orderly conduct
of AXCAN's business or to DIOMED's other operations;
10.3.4 DIOMED shall participate in technical review meetings with AXCAN to
address any issues raised by AXCAN regarding the documentation and
materials transferred hereunder and the transfer of Manufacturing or
any element thereof to a third party; and
10.3.5 DIOMED shall co-operate with AXCAN by providing to AXCAN, within 60
days of the effective date of termination or the occurrence of any
of the events set out in Article 8.1, at AXCAN's expense, copies or
drafts, to the extent they exist, of:
(a) DIOMED's documentation in support of AXCAN's filing of its
marketing applications for the Lasers;
(b) DIOMED's Device History Records for the Lasers produced by
DIOMED under this Agreement;
(c) pertinent test reports and manufacturing instructions relating
to the Laser; and
(d) all other records maintained by DIOMED relating to the
Manufacturing of Laser under this Agreement.
10.4 SURVIVAL OF OBLIGATIONS
Notwithstanding expiration or earlier termination of this Agreement, the
provisions of Article 5, Article 6, Article 7, Article 10, Article 11 shall
survive the termination, expiration or cancellation of this Agreement and shall
be without prejudice to the rights and remedies of either party with respect to
the antecedent breach of any of the provisions of this Agreement.
ARTICLE 11 GENERAL PROVISIONS
11.1 AMENDMENT
Any modification or amendment to this Agreement shall be in writing, signed by
both parties.
11.2 ARBITRATION
Except for applications for injunctions required to protect Proprietary
Information, all disputes arising out of or in connection with this Agreement or
in respect of any defined legal relationship associated therewith or derived
therefrom shall be referred to and finally resolved by arbitration under the
rules of the American Arbitration Association, and in connection therewith:
11.2.1 the appointing authority shall be the American Arbitration
Association;
11.2.2 the arbitration shall be conducted by a single arbitrator unless the
parties agree otherwise;
11.2.3 the case shall be administered by the American Arbitration
Association; and
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11.2.14 the place of arbitration shall be New York, New York.
11.3 ASSIGNMENT
Except as expressly provided in this Agreement, neither party may assign,
transfer or sublicense in whole or in part any of its rights under this
Agreement without the written consent of the other party, which consent may not
be unreasonably withheld. Either party may assign, transfer or sublicense its
rights under this Agreement in whole or in part to any affiliate of the
assigning party without the consent of the other party. Either party may assign,
transfer or sublicense its rights under this Agreement without the consent of
the other party in whole or in part to any entity to whom the assigning party
has assigned the whole or any part of the business of the assigning party
related to this Agreement with the consent of the other party which shall not be
unreasonably withheld, provided that such third party has agreed with the party
not assigning to abide by and be bound by all the terms and conditions contained
in this Agreement. In all cases where an assignment of this Agreement is made to
a third party pursuant to the provisions of this paragraph, the assigning party
shall guarantee the fulfillment and execution of all obligations of the assignee
pursuant to this Agreement.
11.4 COUNTERPARTS; FACSIMILE
This Agreement may be executed in any number of counterparts with the same
effect as if all parties had all signed the same document. All counterparts
shall be construed together and shall constitute one and the same Agreement.
This Agreement may be executed by the parties and transmitted by facsimile
transmission and if so executed and transmitted this Agreement shall be for all
purposes as effective as if the parties had delivered an executed original
Agreement.
11.5 ENUREMENT
This Agreement shall enure to the benefit of and be binding upon the parties and
their respective heirs, executors, administrators, successors and permitted
assigns.
11.6 FORCE MAJEURE
Notwithstanding any other provisions of this Agreement, neither of the parties
hereto shall be liable in damages or have the right to terminate this Agreement
for any delay or default in performing hereunder if such delay or default is
caused by conditions beyond its control including, but not limited to acts of
God, governmental restrictions, wars, or insurrections, strikes, floods, work
stoppages; provided, however, that the party suffering such delay or default
shall notify the other party in writing of the reasons for the delay or default.
If such reasons for delay or default continuously exist for six months, this
Agreement may be terminated upon notice by either party.
11.7 INDEPENDENT CONTRACTORS
Except as otherwise expressly provided in this Agreement, the parties are
independent contractors, and neither party shall act as the legal agent of the
other or otherwise cause the other to incur liability in any manner whatsoever.
11.8 MEDIA ANNOUNCEMENTS
No party shall issue any press release, publish any circular or issue or release
any other public document or make any public statement, nor disclose to any
person whatsoever (other than those employees and professional advisors with a
need to know) any information, relating to or connected with or arising out of
this Agreement or the matters contained in it, without obtaining the prior
written approval of the other party to the contents and manner of the
publication of same. Notwithstanding the foregoing, either party may make any
release respecting this Agreement or the matters contemplated hereby when
required to do so by law or regulation.
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11.9 NOTICE
Any notice or other communication required or permitted to be given to either
party hereto will be in writing and will be deemed to have been properly given
and to be effective on the date of delivery if delivered in person or by telex
or facsimile or 2 business days after mailing by expedited delivery or 5 days
after mailing by registered or certified mail, postage paid, to the other party
at address on the first page of this Agreement. Either party may change its
address or fax number for communications by a notice to the other party in
accordance with this Article is 11.9.
11.10 SEVERABILITY
If any provision of this Agreement is unenforceable for any reason whatsoever,
the unenforceability shall not affect the enforceability of the remaining
provisions of this Agreement and the unenforceable or invalid provision shall be
severable from the remainder of this Agreement.
11.11 WAIVER
A waiver of any breach of any provision of this Agreement shall not be construed
as a continuing waiver of other breaches of the same or other provisions of this
Agreement.
IN WITNESS WHEREOF the parties hereto have caused this Agreement to be executed
by their duly authorized representatives on the date(s) shown below.
DIOMED INC. YELLOWGATE LIMITED
by its authorized signatory: by its authorized signatory:
/s/ ▇▇▇▇▇ ▇▇▇▇▇ /s/ ▇.▇. ▇▇▇▇▇▇▇▇
---------------------- -----------------------
Name: ▇▇▇▇▇ ▇▇▇▇▇ Name: ▇.▇. ▇▇▇▇▇▇▇▇
Title: CEO Title: CEO
Date: August 1st, 2000 Date: August 2nd, 2000
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EXHIBIT 7.1: DIOMED'S WARRANTY
DIOMED MEDICAL LASER PRODUCTS
MANUFACTURER'S 12 MONTH GUARANTEE & EXTENDED GUARANTEE
(WORLDWIDE)
Keep this document in a safe place for future reference
UK USA
Diomed Limited Diomed Inc
Cambridge Research Park ▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Tel: ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ Tel: ▇▇▇-▇▇▇-▇▇▇▇
Fax: ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ Fax: ▇▇▇-▇▇▇-▇▇▇▇
Email: ▇▇▇▇▇▇▇@▇▇▇▇▇▇-▇▇▇▇▇▇.▇▇▇ Email: ▇▇▇▇▇▇▇▇▇@▇▇▇.▇▇▇
▇▇▇▇://▇▇▇.▇▇▇▇▇▇-▇▇▇▇▇▇.▇▇▇
January 2000
LBL/0020 -
Issue 1
DIOMED Distributor
DEFINITION OF TERMS
Diomed Diomed Limited or Diomed, Inc. as appropriate
Distributor A company that has a contractual agreement with Diomed to
distribute DIOMED Products
Product A new product manufactured by Diomed and sold by Diomed or its
Distributor which is covered by this Guarantee (see paragraph
headed Products covered).
Registered User An individual or organisation that intends to use a Product
and that has completed and returned a Guarantee Registration
form (supplied with every Product) to Diomed Limited,
Cambridge, UK
TERMS OF MANUFACTURER'S 12 MONTH GUARANTEE
This Guarantee shall apply between Diomed and the Registered User concerning
the sale and supply of the following Products:
o Products covered
The Products listed below are guaranteed by Diomed to be free defects of
materials and workmanship for a period of twelve (12) months from the date of
installation at the Registered User's premises.
o DIOMED Surgical diode lasers
o DIOMED Aesthetic diode lasers
o DIOMED Aesthetic Laser Scanning Handpieces
o DIOMED PDT (photodynamic therapy) diode lasers
The following items are excluded from this Guarantee:
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o Safety Eyewear
o All optical fibres, handpieces (except Scanning Handpieces) and accessories
o Maintenance Instruments
o Footswitch and Electric Cables
o All other accessories supplied by Diomed
A repair or replacement of a Product, or part of it, will not extend the
Guarantee period for that Product.
o Circumstances rendering Guarantee invalid
This Guarantee will become invalid in respect of any Product if:
i. The Product has been damaged in any way (other than by Diomed or its
Distributor)
ii. The Product has been installed, stored, maintained, used or
adjusted otherwise than in accordance with instructions provided by Diomed in
the Product Operator's Manual
iii. The Product has been repaired, serviced, replaced, worked on or altered by
any person not authorised by Diomed
iv. The Product has been used for a purpose which is not intended for it
o CONDITIONS OF GUARANTEE
Diomed will repair or replace a Product or part which Diomed's examination
shows to have been defective.
Diomed's decision as to whether a defect is covered by this Guarantee is final.
Diomed's obligations under this Guarantee are limited to repair or replacement
of the Product or part found to be defective and shall under no circumstances
exceed the cost of the Product or part for which the claim under this
Guarantee is made.
This Guarantee contains all the warranties which Diomed gives in respect of all
Products and all other conditions and warranties whether they are implied by
statute or otherwise are expressly excluded by Diomed including without
limitation any implied warranties of merchantability or fitness for purpose.
In no event shall Diomed be liable to a Registered User for consequential
damages, loss of profits, loss of use, or any indirect damages of any kind but
Diomed does not exclude its liability for death or personal injury caused by
its negligence.
This Guarantee shall be governed by the laws of England and Wales.
o WHAT THE GUARANTEE COVERS IN THE EVENT OF A VALID CLAIM
o All parts and labour needed to repair or replace the Product at the
premises of Diomed Limited, Cambridge, UK
o If the Product needs to be returned to Diomed, Cambridge for repair, the
Registered User pays all shipping/transport & insurance costs relating to
shipment of the Product from their premises to Diomed.
o Diomed will pay for all shipping/transport & insurance costs relating to
the return of the repaired Product to the Registered User's premises.
NOTE: Any Product returned for repair must be packaged securely and adequately
to withstand international air transport handling. Diomed will not be liable
for any damage caused during transit to Diomed as a result of poor or
inadequate packaging or otherwise.
TO REGISTER THE GUARANTEE
Both the Guarantee Certificate and Guarantee Registration Form located at the
back of the Product Operator's Manual must be fully completed by the
Registered User and be countersigned / stamped by the local DIOMED Distributor.
The Registration Form should be sent by fax or mail to Diomed Limited,
Cambridge, UK, within 28 days of the installation of the product for our
reference in the event of a Guarantee claim.
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NB: The Certificate and Registration form must clearly state the date of
installation of the relevant Product.
THE REGISTERED USER SHOULD KEEP THE GUARANTEE CERTIFICATE FOR FUTURE REFERENCE.
------------------------------------------------------------------------------
WHAT TO DO IN THE EVENT OF A GUARANTEE CLAIM
If the Product breaks down or fails during use and it is believed that this
forms the basis for a claim under this Guarantee the procedure is as follows:
EUROPE/ROW:
Registered Users should contact their local DIOMED Distributor in the first
instance, who will liase with the Diomed service department.
USA:
Registered Users should contact Diomed, Inc, Boston, MA
NO LOCAL DISTRIBUTOR:
i. In the unlikely event that there is no local Distributor, the Registered
User should contact the Diomed service department, Cambridge, UK by:
Fax: ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
Email: ▇▇▇▇▇▇▇@▇▇▇▇▇▇-▇▇▇▇▇▇.▇▇▇
ii. Once the extent of the problem has been assessed, the Diomed service
department will identify the action to be taken.
NB: Prior to returning any Product to Diomed, the Registered user should obtain
authorisation from the Diomed service department when a 'Return Authorisation
Number' will be provided.
Diomed will make every reasonable effort to return the Product in the shortest
possible time.
WHAT HAPPENS WHEN THIS GUARANTEE EXPIRES?
Diomed operates an Extended Guarantee Plan (available for a maximum of 4
further years) that the Registered User can purchase either at the time of
Product installation or alternatively before this Guarantee expires.
The Extended Guarantee Plan can be purchased from the local DIOMED Distributor
or directly from Diomed if there is no local Distributor. Diomed strongly
recommends that Registered Users take out an Extended Guarantee to retain the
same level of confidence, security and peace of mind as that offered by this
Guarantee.
Details about the Extended Guarantee Plan appear on the following pages.
THE EXTENDED GUARANTEE PLAN
The Extended Guarantee Plan covers the same Products as are covered by the
initial Guarantee and can be purchased through local DIOMED Distributors, in
the US through Diomed, Inc. or through Diomed Limited directly where there is
no local Distributor.
The Extended Guarantee will commence once the initial Guarantee of 12 months
(see previous pages) has expired, and can be purchased for periods of:
1 year
2 years
3 years
4 years
If the Extended Guarantee is taken out for a period of less than 4 years, it
maybe renewed annually to a maximum of 4 years in total.
A repair or replacement of a Product, or part, will not extend the Extended
Guarantee period for that Product.
TERMS OF THE EXTENDED GUARANTEE
The Terms of the Extended Guarantee and the cover provided are identical to
those of the initial Guarantee (see pages 3-4 of this document).
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HOW TO PURCHASE AN EXTENDED GUARANTEE?
An Extended Guarantee may be purchased either:
o At the time of purchase/installation of a Product
Diomed strongly recommends that a Registered User takes out an Extended
Guarantee at the time of purchase of a Product. This will enable the Registered
User to benefit from preferential pricing and to know that the Product will
have the security of continuing Guarantee cover after the expiration of the
initial Guarantee. To apply for an Extended Guarantee, simply complete the
Extended Guarantee form at the back of this document and forward it with the
relevant payment to the local DIOMED Distributor, Diomed, Inc., Boston MA or
Diomed Limited, Cambridge as appropriate. An Extended Guarantee certificate
will be issued by Diomed within 28 days of receipt of the form at Diomed's
Cambridge premises.
Or
o When the initial Guarantee expires
If the Registered User does not take out an Extended Guarantee when the Product
is purchased, the local DIOMED Distributor or Diomed will contact the
Registered User approximately 2 months before expiry of the initial Guarantee,
to enquire whether the Registered User wishes to participate in the Extended
Guarantee Plan.
WHAT TO DO IN THE EVENT OF AN EXTENDED GUARANTEE CLAIM?
The procedure is identical to that relating to the initial Guarantee as
detailed on page 4 of this document.
WHAT HAPPENS IF THE PRODUCT IS NOT REGISTERED IN THE EXTENDED GUARANTEE CLAIM?
If the Product is not registered under the Extended Guarantee Plan, Diomed can
still undertake repairs to the Product on the following terms:
i. The Registered User will be liable for all charges incurred (ie. parts,
labour, packing, shipping & insurance).
ii. Diomed will provide an estimate for the cost of repair and will await
written permission to proceed from the Registered User before commencing any
repair work.
EXTENDED GUARANTEE APPLICATION FORM
Date of Application:
Product Type:
Product Serial Number: Date Installed:
Extended Guarantee Term required: (Tick as applicable)
1 year 2 years 3 years 4 years
Customer Name
Institution:
Address: Street:
City: Zip/Post Code:
Country
Telephone: Fax:
Email:
DIOMED Distributor Details:
What happens now . . .
o Return the completed form with the relevant payment by post or fax to your
local DIOMED Distributor or Diomed, Inc.
o The Distributor will forward this form to Diomed Limited, Cambridge.
o You will be issued with an Extended Guarantee Certificate within 28 days of
receipt of the form at Diomed premises.
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UK
Diomed Limited, Cambridge Research Park, ▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇,
▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Tel: ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ Fax: ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ Email: ▇▇▇▇▇▇▇@▇▇▇▇▇▇-▇▇▇▇▇▇.▇▇▇
USA
Diomed, Inc., ▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Tel: ▇▇▇-▇▇▇-▇▇▇▇ Fax: ▇▇▇-▇▇▇-▇▇▇▇ Email: ▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇-▇▇▇▇▇▇.▇▇▇
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