EXHIBIT 10.7
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
FOR THE INFORMATION OMITTED IN THIS DOCUMENT
PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
DEVELOPMENT AND EXCLUSIVE
DISTRIBUTION AGREEMENT
BETWEEN
DEBIOTECH SA
AND
IMED CORP.
DEVELOPMENT AND EXCLUSIVE DISTRIBUTION AGREEMENT
Between
DEBIOTECH SA, a corporation organized and existing
under the laws of Switzerland, with its principal
office at:
00 xxx xxx Xxxxxxxx, XX00
XX - 0000 XXXXXXXX 9
Switzerland
(hereinafter referred to as: "DEBIOTECH")
on the one hand,
And
IMED Corp., a corporation organized and existing under
the laws of Delaware, with its principal office at:
0000 Xxxxxxxxxxxx Xxxxxx
XXX XXXXX, XX 00000-0000
XXX
(hereinafter referred to as: "IMED")
on the other hand.
WHEREAS
DEBIOTECH is an independent and autonomous company active in the development and
industrialization of new technologies for the medical field and is the holder of
all distribution rights in a patented technology (US Patent No. 5.044.902, dated
Sept. 3rd. 1991, and extensions in various countries listed in Enclosure 1) for
the parenteral administration of Medical Fluids (as defined hereafter) by means
of a disposable peristaltic cassette with rollers, connectable to a pump.
DEBIOTECH has further developed a new miniaturized Pump (as defined hereafter)
and a corresponding Cassette (as defined hereafter), which are manufactured by
third parties for DEBIOTECH exclusively. DEBIOTECH has also filed applications
for several patents covering the Pump and the Cassette as set forth on Enclosure
2. Furthermore, DEBIOTECH has already licensed the Product (as defined
hereafter) for the Field of Application (as defined hereafter) in Europe.
IMED is an independent and autonomous company, active in the commercialization
of pumps for the medical field, which expressed an interest in acquiring the
exclusive rights to use, market, sell, lease and distribute the Product for the
parenteral administration of Medical Fluids.
DEBIOTECH and IMED have signed, on February 27th 1992, and on October 21st 1993
(as extended on February 10, 1995), Non Disclosure Agreements regarding the
Product.
The subject matter of this Agreement is the further development of the Product
for the Territory (as defined hereafter) and the granting of an exclusive
distribution right in the Territory fothe Product to IMED, subject to certain
conditions and limitations.
NOW THEREFORE IN CONSIDERATION OF THE FOREGOING AND THE COVENANTS AND
UNDERTAKINGS HEREIN, THE PARTIES HERETO AGREE AS FOLLOWS:
ARTICLE 1: DEFINITIONS
Unless otherwise indicated, references to Exhibits, Enclosures, Schedules and
the like refer to those Exhibits, Enclosures, and Schedules attached hereto and
references to Articles refer to the Articles hereof.
As used herein, the following words shall have the meanings herein specified and
defined terms in this Agreement shall include both the singular and plural forms
and the past, present and future tenses thereof.
-"Accessories": any additional or optional equipment and/or accessory
specifically developed : (i) for the Product's use; or (ii) to be used
specifically with the Product in the Field of Application (including as
examples but not limited to belt clip, pole/bed fixation module,
Cassette/Reservoir Module, Cassette/Reservoir Module Housing, single
and/or multiple charger, shoulder strap fixation module, etc...), some of
these Accessories being described in Enclosure 3 as examples.
-"Accessory Net Proceeds of Sale": the total actual invoice prices
(including royalty income, if any) of each type of Accessory (other than
any Cassette/Reservoir Module) shipped and invoiced by IMED or by any of
its Affiliates (to the extent actually collected) in any Contract Year,
less the following documented items (whether or not shown on such
invoice): (a) governmental license and governmental permit fees, sales,
excise, value added and similar taxes levied on the purchase, sale or
resale of such Accessory; (b) customary trade or quantity discounts and
rebates actually allowed; (c) returns of the same Accessory for credit or
refund; and (d) freight, transportation and related transportation
insurance and handling costs to move Accessories to IMED and, provided
such costs are paid by IMED and not reimbursed, from IMED to its
customers, provided however, Accessories given away by IMED or sold below
transfer price from DEBIOTECH to IMED for marketing or other purposes
shall be excluded from the calculation. In the event of bundled sales or
other sales where the true sales price of an Accessory is not readily
determinable, the price used shall be the price determined in accordance
with IMED's accounting policies and procedures regarding such sales,
consistently applied (examples of which are contained in Schedule 1
hereto).
-"Act": The Food, Drug and Cosmetics Act (21 U.S.C. Section 301 et seq.)
and the regulations promulgated thereunder, as the same may be amended
from time to time.
-"Affiliate": Any Person that directly, or indirectly through one or more
intermediaries, Controls, or is Controlled by, or is under common Control
with the Party specified and for so long as they are Controlling, or
Controlled by, or under common Control with the Party specified.
-"Agreement": shall mean this Development and Exclusive Distribution
Agreement between DEBIOTECH and IMED.
-"Authorized Person": any Third Person authorized to market, sell, lease
or distribute any Product or Accessory.
-"Business Day": any day which is not a Saturday, Sunday, legal holiday or
day on which banking institutions are authorized or required to remain
closed in Zurich, Lausanne or New York City.
-"Cassette": the disposable peristaltic cassette with rollers, connectable
to a Pump, which is described in Enclosure 4 and which is protected by the
Cassette Patent, together with all Improvements made thereto pursuant to
Article 5.10.
-"Cassette Net Proceeds of Sale": the total actual invoice prices
(including royalty income, if any) of the Cassettes, Cassette Sets and
Cassette/Reservoir Modules shipped and invoiced by IMED or by any of its
Affiliates (to the extent actually collected) in any Contract Year, less
the following documented items (whether or not shown on such invoice): (a)
governmental license and governmental permit fees, sales, excise, value
added and similar taxes levied on the purchase, sale or resale of such
Cassettes, Cassette Sets and Cassette/Reservoir Modules; (b) customary
trade or quantity discounts and rebates actually allowed; (c) returns of
the same for credit or refund; and (d) freight, transportation and related
transportation insurance and handling costs to move Cassettes,
Cassette/Reservoir Modules and Cassette Sets to IMED and, provided such
costs are paid by IMED and not reimbursed, from IMED to its customers,
provided however, that Cassettes, Cassette Sets and Cassette/Reservoir
Modules given away by IMED or sold below transfer price from DEBIOTECH to
IMED for marketing or other purposes shall be excluded from the
calculation. In the event of bundled sales or other sales where the true
sales price of the Cassette, Cassette Set or Cassette/Reservoir Module is
not readily determinable, the price used shall be the price determined in
accordance with IMED's accounting policies and procedures regarding such
sales, consistently applied (examples of which are contained in Schedule 1
hereto).
-"Cassette Patent": US Patent No. 5.044.902 dated Sept. 3rd 1991 and/or
its extensions, divisions, continuations, continuations-in-part,
re-examinations and reissues of the foregoing listed in Enclosure 1.
-"Cassette/Reservoir Module": the bag reservoir filled or capable of being
filled with Medical Fluid attached or to be attached to a Cassette (and
any other components, as the case may be), to be manufactured by IMED,
together with all Improvements made thereto pursuant to Article 5.10
-"Cassette/Reservoir Module Housing": the casing (an example of which is
pictured and described on Enclosure 10 hereto) which will: (i) house the
Cassette/Reservoir Module; and (ii) connect to the Pump so as to create a
single integrated unit including both the Pump and the housing for the
Cassette/Reservoir Module, to be manufactured by DEBIOTECH, together with
all Improvements made thereto pursuant to Article 5.10.
- "Cassette Set" any and all sets (such as a sterile tubing set,
pre-assembled to the Cassette), provided that they are containing a
Cassette, which are put on the market by an IMED Related Person.
-"Change": a modification, change, supplement or addition (but not
including any clarification), to or with respect to, any Specification
Document and/or Project Plan which is not contemplated in such
Specification Document and/or Project Plan: (i) as of the Effective Date
with respect to Pump v.1; and (ii) for the Pump v.2, from the date of
approval by the Development Committee of the Project Plan for Pump Version
2 and/or Specification Document 2.
-"Change of Control": shall be deemed to have occurred at such time as any
Third Person (other than Advanced Medical, Inc. ("AM"), and their
respective Affiliates), together with its Affiliates, takes Control of
IMED; provided, however, that a Change in Control shall not result from:
(i) any stock transfers within the immediate family of Xxxxxx X. Picower
or among any of IMED's Affiliates; or (ii) a public sale of stock of IMED
or AM so long as IMED is not thereafter Controlled by a Third Person.
-"Confidential Information": all secret, confidential information or
proprietary information which is disclosed by one Party during the term of
this Agreement or prior thereto including, without limitation, to the
extent secret, confidential or proprietary, manufacturing know-how,
materials, data, program software, security features and/or methods,
technical data and/or results, patents, trademarks, licenses, agreements,
development programs, marketing strategies, business plans, explanations,
financial information, specifications, manufacturing procedures,
evaluation standards, assembly and/or production information, quality
information and/or controls, stability data, medical evaluations,
submissions to official agencies and/or any other information relating
to the Product and/or Accessories, their development, improvement,
manufacturing and/or distribution thereof. Confidential Information shall
not include any information which the receiving Party can show: (a) was
generally available to the public before the date of receipt by the
receiving Party; (b) has become generally available to the public after
the date of receipt by the receiving Party without the assistance or fault
of the receiving Party; (c) the receiving Party was in possession of
before its disclosure by the disclosing Party and the Confidential
Information was not acquired directly or indirectly from the disclosing
Party; or (d) has been disclosed or made available lawfully to the
receiving Party at any time by a third party who was not itself required
to hold it in confidence. The Party wishing to take advantage of any of
the exceptions (a) to (d) hereabove shall bear the burden of proving that
the exception applies.
-"Confirmed Date": as defined in Article 10.1(b).
-"Contract Year": yearly period starting from the first January 1st after
the First Introduction Date in the first country of the Territory or any
anniversary thereof. The first Contract Year shall be the partial year
starting from the beginning of the first Quarter beginning after such
First Introduction Date.
-"Contrast Media": all substances dedicated to medical diagnostic through
imaging techniques (e.g. Omnipaque(R), Ultravist(R), etc...) or similar
substances.
-"Control": the power to, directly or indirectly, direct or cause the
direction of the management and policy of a Person, whether through
ownership of voting securities, by contract, by beneficial ownership or
otherwise.
-"Cost Price": the cost price of IMED Group for the Cassette Set and/or
the empty or prefilled Cassette/Reservoir Module determined in accordance
with IMED's accounting policies and procedures consistently applied.
-"Country Year": yearly period for a given country starting from the
beginning of the first Quarter beginning after the First Introduction Date
in said country or any anniversary thereof.
-"DEBIOTECH Group": DEBIOTECH and its Affiliates.
-"DEBIOTECH Related Person": any member of the DEBIOTECH Group and any
Authorized Person by DEBIOTECH.
-"DEBIOTECH Trademarks": (i) the trademarks listed in Enclosure 9A; and
(ii) any other trademarks now or in the future owned or licensed by
DEBIOTECH for the Product which, in either case, DEBIOTECH has elected to
use for a Product or Accessory in the Territory.
-"Development Committee": as defined in Article 5.1.
-"Development Cost": a sum equal to (i) any and all direct material and
labor costs and expenses incurred by DEBIOTECH in connection with the
development of an Improvement and its manufacturing process, including,
but not limited to, any new Manufacturing Equipment (to the extent not
excluded pursuant to Article 5.10(a)) necessary for the production of such
Improvement and any necessary components, prototypes, samples and the
like, thereof; plus (ii) [CONFIDENTIAL TREATMENT REQUESTED] of such labor
costs and expenses and [CONFIDENTIAL TREATMENT REQUESTED] of such
materials (excluding new Manufacturing Equipment) costs and expenses.
-"Distributor": a wholesaler or other Third Person who purchases for
resale or other further distribution, but shall not include any Third
Person acquiring the Product, Cassette/Reservoir Module or any other
Accessory pursuant to Article 3.3. A Distributor appointed by IMED is a
"sub-Distributor".
-"Effective Date": the latest date of signature set forth below.
-"Epidemic Failure": any material defect which occurs during the normal
expected life (e.g. the operating life or shelf life contemplated in the
Specifications Documents) of a Product or Accessory and which is not due
to normal wear and tear, misuse or incorrect handling, affecting the
safety or intended use or operation of the Product or an Accessory and
involving an entire production lot or other substantial number of any such
Product or Accessory, whether or not such Product or Accessory is subject
to recall pursuant to Article 11.3(a) or 11.3(b). A defect related to any
component which is not warranted by its manufacturer (such as the
rechargeable batteries) shall not be considered an Epidemic Failure.
-"Exclusive Distribution Right": the exclusive right to use, market, sell,
lease and distribute the Product and Accessories in the Territory, limited
to the Field of Application.
-"Failure Event": the occurrence of a Failure Event 1A or Failure Event 2,
as the case may be.
-"Failure Event 1A": means any of the following: (i) the Pumps delivered
by DEBIOTECH pursuant to section (e) of the Project Plan for Pump Version
1A do not satisfy the protocol contemplated in section (f) entitled
"Version 1A 35 Unit Delivery" and would require major work and changes to
satisfy to such section (f) (as determined by tests conducted, at IMED's
request and cost within sixty days after receiving the corresponding
samples, by an independent official technical agency agreed by both
Parties and bound vis a vis DEBIOTECH by adequate confidentiality
obligations); (ii) DEBIOTECH does not satisfy the requirements of section
(c) of Project Plan for Pump Version 1A entitled "510K Filing";
(iii) FDA 510k Market Approval for such Pump v.1A or Cassette does not
occur within [CONFIDENTIAL TREATMENT REQUESTED] after the submission of
the 510k application with respect to the products contemplated in Project
Plan For Pump Version 1A to the FDA; or (iv) Product Availability of such
Pump v.1A and Cassette in the USA does not occur within [CONFIDENTIAL
TREATMENT REQUESTED] of such FDA Market Approval. No Failure Event 1A can
occur after the date of Product Availability.
-"Failure Event 2": means any of the following: (i) DEBIOTECH does not
satisfy the "Acceptance Testing and Completion of the Version 2"
requirements established in accordance with section (j) of Project Plan
for Pump Version 1A and would require major work and changes to satisfy to
such item 5 (as determined by tests conducted, at IMED's request and cost
within sixty days after receiving the corresponding samples, by an
independent official technical agency agreed by both Parties and bound vis
a vis DEBIOTECH by adequate confidentiality obligations); (ii) DEBIOTECH
does not satisfy the "510K Filing" requirements established in accordance
with section (j) of Project Plan for Pump Version 1A; (iii) FDA 510k
Market Approval for such Product or Cassette does not occur within
[CONFIDENTIAL TREATMENT REQUESTED] after the submission of the 510k
application with respect to the products contemplated in Project Plan For
Pump Version 2 to the FDA; or (iv) Product Availability of such products
in the USA does not occur within [CONFIDENTIAL TREATMENT REQUESTED] of
such FDA Market Approval. No Failure Event 2 can occur after the date of
Product Availability.
-"FDA": United States Food and Drug Administration and any successor
thereto.
-"Field of Application": is limited to the field of parenteral
administration of Medical Fluids in the human body. In particular, the
Field of Application does not include the enteral administration of
Medical Fluids, nor hemo or peritoneal dialysis, nor plasmapheresys, nor
extracorporeal circulation nor the enteral and/or parenteral
administration of Contrast Media, nor the aerosol inhalation and/or
nebulization of Medical Fluids, nor any use in veterinary therapy and/or
any laboratory use. The Field of Application does also not include the
particular use described hereafter in Article 3.1.
-"Firm Order": as defined in Article 10.1(a).
-"First Introduction Date": for each country in the Territory, the day of
the first market introduction of the Product in said country but, in any
event, not later than the latest date between (i) [CONFIDENTIAL TREATMENT
REQUESTED] after the Market Approval in said country and (ii) the Product
Availability for said country.
-"Force Majeure": as defined in Article 19.1 hereof.
-"Good Manufacturing Practice": the applicable current good manufacturing
practice promulgated from time to time by the FDA in accordance with the
Act, including those set forth in 21 CFR Part 820.
-"Gross Margin": for any annual accounting period, the sum of Accessory
Net Proceeds of Sales, Cassette Net Proceeds of Sales and Pump Net
Proceeds of Sales, minus IMED Group's aggregate cost of such Accessories,
Cassettes and Pumps included in the calculation in the respective Net
Proceeds of Sale and sold (i.e. the transfer price from DEBIOTECH to IMED
or Cost Price, as the case may be, of such Accessories, Cassettes and
Pumps, plus up to an amount equal to [CONFIDENTIAL TREATMENT REQUESTED] of
such transfer price for Pumps and Accessories to cover material handling
and overhead costs calculated in accordance with IMED's accounting
policies and procedures consistently applied).
-"IMED Group": IMED and its Affiliates.
-"IMED Related Person": any member of the IMED Group and any Authorized
Person by IMED.
-"IMED Trademarks": (i) the trademarks listed in Enclosure 9B; and (ii)
any other trademarks now or in the future owned or licensed by IMED for
the Product which, in either case, IMED has elected to use for a Product
or Accessory in the Territory.
-"Improvement": (i) any enhancement of a Product or Accessory that permits
such Product or Accessory to perform its function in a better or more
useful way; and/or (ii) any New Accessory, but excluding any New
Development and any New Competing Product.
-"Index": the manufacturing index known as the "PSD C Indice des Produits
et Services Divers C" published on a periodic basis by the French
I.N.S.E.E. or, in the event that such Index shall cease to be published in
France (or in the event that DEBIOTECH were to transfer manufacturing to a
country other than France) such successor index or substitute index mostly
closely similar to the Index for such manufacturing in such country.
-"Intellectual Property": any intellectual property including, but not
limited to, inventions, patents, patent applications, copyrights,
copyright applications, trade secrets, know-how, formulas, compositions of
matter, software, designs and other intellectual property rights related
thereto, including any foreign counterparts to any of the above.
-"Manufacturing Information": as defined in Article 10.5(c).
-"Manufacturing Equipment": all molds, machinery and equipment owned and
used by DEBIOTECH in the manufacture of the Products and Accessories,
including, without limitation, all molds, machinery and equipment used in
the manufacture of the foregoing contained in the manufacturing facilities
of Plastic Omnium and SAGEM located at La Verpilliere, France and
Montlucon, France, respectively, or any other location, as the case may be
at the Effective Date. Any new equipment, mold or machinery after the
Effective Date shall be called a "new Manufacturing Equipment".
-"Market Approval": for a given country, the approval given or issued by
the relevant government agency in such country (e.g. FDA in the USA) which
is necessary to market and sell the Product in such country.
-"Medical Fluids": total parenteral nutrition fluids, large volume
parenteral fluids, small volume solutions, blood and blood products,
parenteral nutritional additives, premixed intravenous solutions, drug
fluids and other fluids administered for medical purposes, with the
exception of Contrast Media fluids, dialysis fluids used in connection
with dialysis equipment and washing fluids.
-"Minutes": as defined in Article 5.1.
-"New Accessories": Accessories not included in Article 8.1(d).
-"New Competing Product": any new product which includes a pump using a
disposable administration set other than any Product, Improvement or New
Development, which is not commercially available at the Effective Date,
which is not depending on the Cassette Patent and which addresses the
Field of Application .
-"New Development": any new development of the Product for the Field of
Application still depending on the Cassette Patent, which both: (i) would
include substantial material differences from the Pump and the Cassette
including without limitation, operation and market differences, and which
would include at least one new patent protection applied for by DEBIOTECH
or for which DEBIOTECH is the holder of all relevant rights in the Field
of Application; and (ii) is not intended to replace or directly compete
with the Product in the Field of Application.
-"Packaging Specifications": as defined in Article 10.3(e).
-"Party": either IMED or DEBIOTECH, as the case may be.
-"Patents": any and all patents covering the Product and/or Accessories in
any country of the Territory and for which DEBIOTECH is the holder of all
relevant rights in the Field of Application.
-"Person": any individual or entity, whether a natural person, trustee,
corporation, general partnership, limited partnership, limited liability
company or partnership, joint stock company, trust, unincorporated
organization, bank, business association, firm, joint venture,
governmental agency or otherwise.
-"Prime Rate": the current official prime rate charged to its best
customers in US$ of the Citibank in New York .
-"Product": Cassettes and/or Pumps.
-"Product Availability": with respect to any Product, that point in time
as of which both: (i) all necessary Market Approvals for such Product have
been obtained; and (ii) DEBIOTECH delivers the Initial Firm Order for such
Product in accordance with Article 10.2 (or is otherwise deemed to have
occurred as provided in Article 10.2) and at such time it then has the
capability to continue normal supply.
-"Project Plan For Pump Version 1A": the development plan for the Pump
v.1A, the related Cassette, the Cassette/Reservoir Module Housing and the
related Accessories, attached hereto as Enclosure 11.
-"Project Plan For Pump Version 2": the development plan referred to in
section (j) of the Project Plan for Pump Version 1A.
-"Project Plans": the Project Plan For Pump Version 1A and the Project
Plan For Pump Version 2.
-"Proposal Data": as defined in Article 5.10(a).
-"Pump": all of the reusable miniaturized programmable pumps which are
described in the Specification Documents and in which the Cassette is to
be inserted and used once with a single patient, together with all
Improvements thereto made by DEBIOTECH pursuant to Article 5.10.
-"Pump Net Proceeds of Sale": the total actual invoice prices (including
royalty income, if any) of each type of Pump (excluding Refurbished Pumps)
shipped and invoiced by IMED or by any of its Affiliates (to the extent
actually collected) in any Contract Year, less the following documented
items (whether or not shown on such invoice): (a) governmental license and
governmental permit fees, sales, excise, value added and similar taxes
levied on the purchase, sale or resale of such Pump; (b) customary trade
or quantity discounts and rebates actually allowed; (c) returns of the
same Pump for credit or refund; and (d) freight, transportation and
related transportation insurance and handling costs to move Pumps to IMED
and, provided such costs are paid by IMED and not reimbursed, from IMED to
its customers provided however, Pumps given away by IMED or sold below
transfer price from DEBIOTECH to IMED for marketing or other purposes
shall be excluded from the calculation. In the event of bundled sales or
other sales where the true sales price of the Pump is not readily
determinable, the price used shall be the price determined in accordance
with IMED's accounting policies and procedures regarding such sales
consistently applied (examples of which are contained in Schedule 1
hereto).
-"Pump v.1": the Pump which is described in the TUV Approval.
-"Pump v.1A": the Pump which is described in the Specification Document 1A
under the heading "Version 1A".
-"Pump v.2": the Pump which is described in the Specification Document 2
under the heading "Version 2".
-"Quality Control Procedures": shall mean all of the Quality and Validity
Testing Procedures For Pump v.1A and the Quality and Validity Testing
Procedures for Pump v.2 and any other quality control procedures developed
by the Development Committee pursuant to Article 5.
-"Quarter": each three months period of each calendar year, commencing
January 1st, April 1st, July 1st and October 1st respectively.
-"Recall Amount": an amount corresponding to [CONFIDENTIAL TREATMENT
REQUESTED] of the transfer price at which those Products, Accessories
and/or Spare Parts subject to recall as contemplated in Articles 11.3,
were sold by DEBIOTECH to IMED, reduced by any amounts previously paid by
DEBIOTECH in respect of such Products, Accessories and/or Spare Parts
pursuant to the foregoing Article.
-"Recall Insurance Policy": the insurance policy, if available, procured
by DEBIOTECH as defined in Article 20.3(c) .
-"Recall Order": as defined in Article 11.3(a) .
-"Refurbished Pumps": Pumps which are taken back by IMED from a customer,
reconditioned or modified and then sold or leased by IMED in a new
transaction (as the case may be, with Spare Parts acquired from
DEBIOTECH); provided, however, that an extension or renewal of any leased
Pump or any sale of such Pump to the lessee thereof shall not constitute a
new transaction.
-"Shipment Date": as defined in Article 10.1(b).
-"Software Changes": modifications to the user interface of a Pump through
the implementation of programming changes to the software for such Pump.
-"Spare Parts": those parts and components necessary to repair, refurbish,
recondition, maintain and service the Products and Accessories.
-"Specification Document 1A": the document setting out product
specifications relating to Pump v.1A and Cassette attached hereto as
Enclosure 5A, which may be amended from time to time pursuant to Article
5.
-"Specification Document 2": the document setting forth product
specifications relating to Pump v.2 and Cassette attached hereto as
Enclosure 5B, which may be amended from time to time pursuant to Article
5.
-"Specification Documents": Specification Document 1A and Specification
Document 2.
-"Standby Agreement": as defined in Article 10.5(a).
-"Standby License": as defined in Article 10.5(b).
-"Sustaining Engineering Activities": all day to day activities in
connection with the manufacture of a product, accessory or device and the
processes of manufacturing the same, normally engaged in by a manufacturer
of a product, accessory or device.
-"Technology": all Intellectual Property relating to any Product or
Accessory in the Field of Application in which DEBIOTECH has rights,
including, without limitation, the Patents together with all patent
applications and all divisions, continuations, continuations-in-part,
re-examinations and reissues of any of the foregoing.
-"Territory": the countries and all successor countries comprising the
geographical territory of the countries in North and Central America
listed in Enclosure 7.
-"Third Person": any Person other than IMED, DEBIOTECH and their
respective Affiliates.
-"TUV": Technische Uberwachungs Verein.
-"TUV Approval": TUV approval in Germany for the Pump v.1 (Enclosure 6) .
-"USA": the United States of America.
-"US$": US dollar.
ARTICLE 2: EXCLUSIVE DISTRIBUTION RIGHT
2.1 Grant of Distribution Right. DEBIOTECH hereby grants to IMED, which
accepts, the exclusive right to use, market, sell, lease and distribute
the Product and Accessories in the Territory, limited to the Field of
Application. This Exclusive Distribution Right may be exercised solely by
IMED directly or through its Affiliates in the USA (except as provided
below) and by IMED directly or through its Affiliates or Third Person
sub-Distributors in the other countries of the Territory, provided that
IMED has informed DEBIOTECH of each of their name(s) together with the
list of countries concerned for each of them prior to their appointment
by IMED and provided further that IMED remains primarily liable for all
such Affiliates and/or Third Person sub-Distributors with respect to all
obligations hereunder.
As an exception to the general rule for the USA, IMED may distribute
through Third Person sub-Distributors in limited cases where it is
commercially reasonable under the circumstances and in areas of the USA in
which, and with sub-Distributors through which, IMED uses sub-Distributors
for its own pumps and other products and such sub-Distributors have
general distribution activities within the medical field, provided that
IMED has informed DEBIOTECH of each of their name(s) together with the
area concerned for each of them prior to their appointment by IMED and
provided further that IMED remains primarily liable for all such Third
Person sub-Distributors with respect to all obligations hereunder.
2.2 Limitation on Manufacturing Rights. Except as expressly provided in this
Agreement: (i) DEBIOTECH does not grant hereby any right whatsoever to
IMED regarding the manufacturing of all or any part of the Product and/or
Accessories; and (ii) IMED undertakes not to manufacture, directly or
indirectly, and/or acquire from any source other than DEBIOTECH all or any
part of the Product and/or Accessories without the prior written consent
of DEBIOTECH. Maintenance and servicing of Pumps and refurbishing of Pumps
(Refurbished Pumps) for resale by IMED using Spare Parts supplied by
DEBIOTECH shall not be considered manufacturing for the purpose of this
paragraph.
2.3 Limitation of Territory and Market. IMED and its Affiliates shall not, and
IMED shall enter into agreements with its Third Person sub-Distributors
whereby such sub-Distributors shall agree (the "IMED Restriction
Provision") not to, directly or indirectly use, have used, market, lease,
sell, distribute or export the Product or Accessories (i) outside the
Territory and/or (ii) within the Territory but outside the Field of
Application. In the event that IMED becomes aware, through notice by
DEBIOTECH or otherwise, that one of its Third Person sub-Distributors is
in violation of the IMED Restriction Provision, IMED shall, at IMED's sole
cost and expense, enforce the IMED Restriction Provision or immediately
cause the termination of all Product and Accessories sales to such
breaching sub-Distributor and shall be liable for any damage caused by a
material breach thereof.
2.4 DEBIOTECH Distributor Restriction. DEBIOTECH and its Affiliates shall not,
and shall enter into agreements with all DEBIOTECH Distributors (other
than IMED) whereby such DEBIOTECH Distributors shall agree (the "DEBIOTECH
Restriction Provision") not to, directly or indirectly use, market, sell,
license, lease or distribute or make available the Product or the
Accessories for the Field of Application in the Territory. In the event
that DEBIOTECH becomes aware, through notice by IMED or otherwise, that
one of DEBIOTECH Distributors is in violation of the DEBIOTECH Restriction
Provision, DEBIOTECH shall, at DEBIOTECH's sole cost and expense, enforce
the DEBIOTECH Restriction Provision or immediately cause the termination
of all Product and Accessories sales to such breaching Distributors and
shall be liable for any damage caused by a material breach thereof.
2.5 Cassette Set Assembly. IMED is hereby authorized by DEBIOTECH to assemble
each Cassette to a tubing set for parenteral medical use including,
without limitation, as the case may be, an empty or prefilled
Cassette/Reservoir Module, provided such assembly complies with all
manufacturing and quality standards required by the FDA or under the Act
for such Cassette Set assembly (including Good Manufacturing Practice).
IMED Related Person shall not market, sell, lease or distribute Cassettes
which: (i) are not directly connected to a tubing set for parenteral
medical use; and/or (ii) include enteral sets, without the prior written
consent of DEBIOTECH.
ARTICLE 3: EXCLUSIVITY RETAINED BY DEBIOTECH
3.1 Reservation of Right: Single Use/User. Notwithstanding anything to the
contrary in this Agreement, DEBIOTECH retains all the rights, and does not
grant hereby any right whatsoever to IMED, regarding the use of the
Patents, Technology and/or Improvements for the use, marketing, sale,
leasing and/or distribution of any New Development product which is both:
(i) designed for use with a cassette and reservoir; and (ii) employs a
pump which is either (a) dedicated to one single use and not reusable
after the end of its injection program or after the emptying of its
reservoir; or (b) limited to a certain number of interchangeable cassettes
and reservoirs, for one single patient's use within one single indication
and is labeled as such. According to this Article 3.1, DEBIOTECH retains
the right to grant to any Third Person and/or pharmaceutical company the
right to use, market, sell, lease and/or distribute, in the Territory, any
New Development product as described under this Article 3.1, including all
the corresponding cassettes, reservoirs and pumps.
3.2 Reservation of Rights: Cassette/Reservoir Module and Product;
Pharmaceutical Company. In the event that DEBIOTECH desires to arrange for
the Cassette/Reservoir Module and/or Product to be provided to a
pharmaceutical company in the Territory solely to permit such
pharmaceutical company to acquire the Cassette/Reservoir Module and/or
Product to be used on a dedicated basis with a drug distributed by that
pharmaceutical company, DEBIOTECH will request in writing that IMED supply
that pharmaceutical company with the Cassette/Reservoir Module and/or
Product and IMED agrees to do so upon terms and conditions specified by
IMED. In such an event, DEBIOTECH shall provide IMED with sufficient
notice to enable IMED to incorporate into its supply forecast and orders
the quantities needed to satisfy such request under the standard ordering
procedures set forth in Article 10.1 hereof.
3.3 Reservation of Rights: Cassette/Reservoir Module Product and Accessories;
Affiliate. Notwithstanding anything to the contrary in this Agreement,
IMED hereby agrees that, at DEBIOTECH's written request, it will sell the
Cassette/Reservoir Module, Product and Accessories in the Territory for
use by any licensee of DEBIOTECH Group if such Product and/or
Cassette/Reservoir Module and/or Accessories are required by such licensee
for the use with a drug developed by DEBIOTECH Group (e.g. the anti-cancer
drug LOHP(R)). In such an event: (i) DEBIOTECH shall provide IMED with
sufficient notice to enable IMED to incorporate into its supply forecast
and orders the quantities needed to satisfy such request under the
standard ordering procedures set forth in Article 10.1 hereof; and (ii)
IMED shall supply the Product and/or Cassette/Reservoir Module and/or
Accessories to DEBIOTECH for said licensee for the use with said drug at
the best price offered to any other of IMED's clients under the most
comparable conditions.
3.4 Reservation of Rights: Contrast Media; Heparin; Saline. Notwithstanding
anything to the contrary in this Agreement, as a limited exception to the
Exclusive Distribution Right granted to IMED in this Agreement, DEBIOTECH
is entitled to grant to any Person having the right to use, market,
distribute, lease or sell the Chronorad(R) Contrast Media injection device
(or the like) and cassettes (under the Patents, Technology and/or
Improvements) for Contrast Media injection in the Territory, the right to
use, market, sell, lease and/or distribute such device and cassette for
heparin injection or saline solution flush but solely if combined with, or
alternated with, a Contrast Media injection.
3.5 Reservation of Rights: Supply to Investigators. Notwithstanding anything
to the contrary in this Agreement, DEBIOTECH shall have the right for
evaluation, Market Approval and/or development purposes only, to supply
(free of charge, to the extent permitted by law) the Product,
Cassette/Reservoir Module and/or Accessories in limited quantities and to
limited investigators in the Territory for the Field of Application
provided that the Product, Cassette/Reservoir Module and/or Accessories
shall not bear the IMED Trademarks, IMED's name or the IMED label without
IMED's prior written consent. In such an event, DEBIOTECH shall inform
IMED prior thereto and mention the name and location of such
investigators. IMED shall have the right to participate in such
investigation research. DEBIOTECH shall be solely liable for any actions
taken by anyone under this Article 3.5, and agrees to insure itself
against all liabilities resulting therefrom. IMED shall not be responsible
or held accountable (criminally or civilly), and DEBIOTECH shall indemnify
IMED, for any liability, including, without limitation, costs, penalties
and damages, resulting from actions taken under this Article 3.5.
3.6 DEBIOTECH's Obligations Regarding Similar Products. Notwithstanding
anything to the contrary in this Agreement, DEBIOTECH agrees, and shall
take appropriate measures to assure, that, with respect to the countries
for which IMED has not lost exclusivity under Article 12.2 hereof, the
Cassettes have been specifically designed to fit the Pump and that no
other cassette designed, manufactured, developed, sold, licensed or
distributed, directly or indirectly, by any member of the DEBIOTECH Group
(or any DEBIOTECH Related Person with the assistance of any member of the
DEBIOTECH Group), including, without limitation: (x) any cassette for any
product contemplated in Article 3.1 or 3.4; or (y) any cassette for use
with: (a) any pump outside of the Field of Application in the Territory;
or (b) any New Competing Product, shall fit the Pump and in furtherance
thereof shall use the special IMED code of the coding system described in
Enclosure 15. DEBIOTECH agrees, and shall take appropriate measures to
assure, that any pump designed, manufactured, developed, sold, licensed or
distributed, directly or indirectly, by any member of the DEBIOTECH Group
(or any DEBIOTECH Related Person with the assistance of any member of the
DEBIOTECH Group) shall not contain the IMED Trademarks, IMED's name, the
IMED label or the color scheme of any Product or Accessory to be supplied
to IMED under this Agreement, without the prior written consent of IMED.
ARTICLE 4: TRADEMARKS/LABELING/ADVERTISEMENT
4.1 Promotion. IMED will be solely responsible for promoting the Product and
Accessories and will alone bear any related costs of such promotion for
the Field of Application in the Territory. DEBIOTECH shall cooperate with
IMED with respect to the promotion of the Product in the Territory by: (a)
communicating to IMED any request it receives from Third Parties
concerning any Product or Accessory for the Field of Application within
the Territory; (b) furnishing IMED with samples or copies of all
promotional literature and advertisements used by DEBIOTECH or, to the
extent known by DEBIOTECH, by other DEBIOTECH Authorized Persons for wide
dissemination in connection with the Product to the extent permitted by
such DEBIOTECH Authorized Persons; (c) furnishing advice to IMED as may be
reasonably requested with respect to any promotional literature and
advertisements for the Product which IMED may desire to prepare at its own
expense; (d) allowing IMED to use or reproduce, at IMED's expense, any
promotional materials (including trade show displays) used by DEBIOTECH
subject to the consent of any Third Person whose name, trademarks or
products may be included; and (e) any such other reasonable promotional
assistance customarily provided by DEBIOTECH to its other Distributors.
DEBIOTECH shall not be liable for any advice, copy or materials it may
provide in connection with any such promotional assistance for which it is
not otherwise liable under this Agreement.
4.2 Labeling. IMED shall be responsible, subject to Article 10.3(e), for the
content and adequacy for regulatory purposes of the labeling of the
Product and Accessories and packaging thereof in final form for
distribution by IMED Related Persons. All labels shall be procured and
printed by DEBIOTECH using appropriate camera-ready mock-ups submitted by
IMED. IMED shall comply with all USA, Canada and Mexico labeling
requirements with respect to such Products and Accessories and shall be
responsible for any other labeling requirements unique to any jurisdiction
within the Territory. Each Pump and Cassette shall include a label stating
as follows: "For Parenteral Use Only".
If and to the extent mandatorily required by applicable law, each label
for a Product or Accessory shall identify, in a reasonable manner,
DEBIOTECH's manufacturer as the manufacturer and IMED or one of its
Affiliates as the Distributor.
DEBIOTECH may, upon prior written notice and at DEBIOTECH's sole cost and
expense, put in a visible size and reasonable manner: (i) its name; (ii)
its license logo as set forth on Enclosure 8; (iii) any of the DEBIOTECH
Trademarks; (iv) the sentence "Product Under License from
DEBIOTECH-Switzerland"; and (v) the word "patent(s)" or "patent(s)
pending" and the number or numbers of the patents applicable thereto and
otherwise as may be necessary to preserve the maximum rights against any
infringer of the Patents, and/or other patents and/or patent applications
for which DEBIOTECH is the holder of rights in the Field of Application,
on the Product and Accessories and on any package of the Product and
Accessories.
4.3 Use of DEBIOTECH Trademarks. DEBIOTECH hereby grants to IMED the
nontransferable (except as contemplated in Article 21.1 hereof), exclusive
(or non exclusive, as the case may be, according to Article 12.2
hereafter) license to use the DEBIOTECH Trademarks, solely in connection
with the use, marketing, sale, lease and distribution for the Field of
Application of the Product and Accessories in the Territory.
IMED shall not use DEBIOTECH Trademarks in any manner which jeopardizes
the distinctiveness, significance or validity thereof; provided, however,
that IMED may use the DEBIOTECH Trademarks in any manner consistent with
the use thereof by any DEBIOTECH Distributor. IMED acknowledges and agrees
that (a) the DEBIOTECH Trademarks are the exclusive licensed properties of
DEBIOTECH, (b) any use by IMED of the DEBIOTECH Trademarks shall not give
IMED any ownership or other rights therein, (c) all uses by IMED of the
DEBIOTECH Trademarks shall inure solely to the benefit of DEBIOTECH and
(d) IMED shall only use the DEBIOTECH Trademarks in connection with the
Product and/or the Accessories for the Field of Application in the
Territory.
4.4 Use of IMED Trademarks. DEBIOTECH shall not use the IMED Trademarks in
connection with the use, marketing, sale, lease, distribution, manufacture
or delivery of any goods except for the placement of the same on the
Product or Accessory which will be delivered to IMED and the related
packaging and or related documents.
4.5 Statement Regarding Limitation on Use. IMED hereby agrees to state clearly
in any, brochure, manual, or any advertising material describing the
Product, Accessories, and Cassette Sets, that it is strictly limited to
parenteral use, by means of the following instructions for use, in the
English language in the USA, in the English language and translated into
the French language in Canada and translated into the Spanish language in
Mexico: "For Parenteral Use Only".
On DEBIOTECH's request, IMED shall, at its sole cost and expense, put in a
visible size and reasonable manner: (i) DEBIOTECH's name; (ii) DEBIOTECH's
license logo as set forth on Enclosure 8; (iii) any of DEBIOTECH
Trademarks; (iv) the sentence "Product Under License from
DEBIOTECH-Switzerland"; and (v) the word "patent(s)" or "patent(s)
pending" and the number or numbers of the patents applicable thereto and
otherwise as may be necessary to preserve the maximum rights against any
infringer of the Patents, and/or other patents and/or patent applications
for which DEBIOTECH is the holder of rights in the Field of Application,
on any Cassette Set package and any advertising, brochure, manual and the
like describing the Product and/or Accessories.
DEBIOTECH hereby agrees to state clearly, or make sure that any Third
Person entitled to use, market, sell, distribute or lease the Product and
Accessories outside the Field of Application in the Territory (e.g. for
enteral use) shall state clearly, in any document, brochure, manual, or
any advertising material regarding any such Product or Accessory, as well
as on the Product, that it is strictly limited to non parenteral use (e.g.
by means of the following instructions for use, in the English language in
the USA, in the English language and translated into the French language
in Canada and translated into the Spanish language in Mexico: "For Enteral
Use Only").
4.6 IMED as Distributor. DEBIOTECH shall have the right to mention IMED as its
exclusive (or non exclusive, as the case may be according to Article 12.2)
Distributor of Products and Accessories for the Territory in its
advertising and/or company brochure, as well as to display IMED's Product
during public events. In connection therewith, DEBIOTECH shall supply free
of charge to IMED, at least five (5) days prior to its distribution if
practicable under the circumstances, at least one (1) sample of every such
advertising and/or company brochure.
4.7 No Reference to Other Distributors. Neither IMED, its Affiliates or
sub-Distributors shall use or allow to be used, in any printed material,
the names or trademarks of any of DEBIOTECH's Related Persons except as
permitted in Article 4.3 and 4.5 hereof.
4.8 Operating Manual. IMED shall be solely responsible for the production,
content and adequacy (assuming, for this purpose, that each of the Product
and Accessories functions as intended, conforms to its specifications and
complies with the warranty provisions contained in Article 11) of any
operating manual, instruction or brochure provided to users, customers,
clients or the general public in connection with the Product and/or
Accessories and IMED shall be solely liable for any liabilities
attributable to its negligent drafting of the foregoing to the extent such
negligence caused such liabilities. This Article 4.8 shall not limit or
otherwise alter any liability DEBIOTECH may have under Article 11 or as
otherwise provided in the Agreement.
ARTICLE 5: PRODUCT DEVELOPMENT
5.1 Development Committee/Project Leader. IMED and DEBIOTECH shall establish a
development committee to coordinate, implement and follow the development
of: (i) the Pump v.1A and Pump v.2; (ii) the Cassette for each such Pump;
(iii) the Accessories, including, without limitation, the
Cassette/Reservoir Module and the Cassette/Reservoir Module Housing for
each Pump; and (iv) Improvements (the "Development Committee"). The
Development Committee will consist of one representative from each of IMED
and DEBIOTECH. The Development Committee will communicate or meet
regularly from time to time as determined by its members. IMED or
DEBIOTECH shall be entitled, upon reasonable notice, to call a meeting of
the Development Committee. The location of the Development Committee
meetings dealing with development and quality controls shall be held at
the appropriate location for the subject matter, but in general shall be
alternately held at DEBIOTECH and IMED, with the first meeting location
being at DEBIOTECH. In order to facilitate the functions of the
Development Committee, minutes will be maintained of all Development
Committee meetings and such minutes will be circulated to all Development
Committee members as promptly as practicable prior to the next meeting of
the Development Committee and shall be approved and signed by all
Development Committee members in two original copies (after such approval,
the "Minutes") of which one shall be distributed to each Party. Such
Minutes will, among other things, set forth in reasonable detail the
development status with respect to each product covered by the Project
Plans and all actions of IMED or DEBIOTECH, as the case may be, taken in
furtherance of the Project Plans and the results thereof.
The Development Committee will be the principal means through which the
Parties will exchange development concepts, ideas for Improvements and
information concerning end-user requirements and determine and monitor
development activities and Changes. The member of the Development
Committee designated by one Party shall keep the member designated by the
other Party informed with respect to the foregoing and shall act
reasonably and in good faith to address those matters regarding product
development and quality control that are properly brought to the
Development Committee for consideration in accordance with the terms of
this Article 5 (the "Area of Authority"). Any matter approved in writing
by a member of the Development Committee designated by any Party within
the Area of Authority shall be binding upon such Party; provided that, no
member of the Development Committee shall be deemed to have the authority
to bind any Party to make or incur any payment of money or supplementary
development costs and the same shall be evidenced only by a writing signed
by a Party. Each Party shall alone bear any of its costs and expenses
(including travel, hotel, etc...) relating to the Development Committee
meetings and work.
In addition, each Party shall appoint one project leader (a "Project
Leader") who shall meet regularly with the Project Leader designated by
the other Party. Each Project Leader shall be the principal liaison for
day-to-day communication and interaction between IMED and DEBIOTECH with
respect to each Project Plan, and shall be available promptly to respond
to communications. Each of the Parties retains the right, upon notice to
the other, to change the Development Committee member or the Project
Leader designated by such Party.
5.2 Project Plan For Pump Version 1A. DEBIOTECH shall develop, manufacture and
deliver the Pump v.1A, the related Cassette, the Cassette/Reservoir Module
Housing and the related Accessories specified in the Project Plan For Pump
Version 1A, pursuant to the terms of this Agreement and in accordance with
the Project Plan For Pump Version 1A. In connection therewith, each of
IMED and DEBIOTECH will use reasonable efforts to satisfy the requirements
of, and complete those actions and tasks contemplated in the Project Plan
For Pump Version 1A, on about the dates set forth therein, or, if any of
same cannot be achieved by such date, then as promptly as practical
thereafter. The Parties acknowledge that the Project Plan For Pump Version
1A assigns specific actions and tasks to particular Parties and that each
Party is responsible to perform the actions and tasks assigned to it,
however, the Project Plan For Pump Version 1A represents a joint effort to
be conducted by the Parties and each Party shall provide reasonable
assistance, cooperation and information in order to aid the other in the
performance of its assigned duties under the Project Plan For Pump Version
1A. The Parties further acknowledge that the Project Plan For Pump Version
1A is written in a summary fashion and that, in connection with fulfilling
their assigned actions and tasks thereunder, they will also take such
actions as are reasonably necessary and appropriate in connection
therewith or are otherwise consistent with such summary description.
5.3 Specification Document 1A. The Parties acknowledge that as of the
Effective Date the Specification Document 1A is preliminary and embodies
high level specifications. It is intended that through the work of the
Development Committee the Specification Document 1A will be modified and
supplemented as reasonably necessary to implement the Project Plan For
Pump Version 1A, and to reflect Changes requested by all Committee members
in completing activities contemplated in the Project Plan For Pump Version
1A. A Change to the Specification Document, for Pump v.1A shall be
effective only if set forth in a written document signed by all members of
the Development Committee, provided, however, that (i) DEBIOTECH (and the
member of the Development Committee designated by it) shall be required to
consent to any Change requested by IMED that constitutes a Software
Change, if no serious objection can be made; and (ii) each Party (and the
member of the Development Committee designated by it) shall be required to
consent to any Change which is necessary to cause each Product to be
produced as a result of the Project Plan For Pump Version 1A to be safe
and efficacious for its intended use or conforming to any regulatory
requirement.
The Minutes noting the approval of any Change shall also include any time
schedule delays which may result from such Change. Any Change which
involves new Manufacturing Equipment and/or a modification of existing
Manufacturing Equipment and/or a modified manufacturing process shall be
treated as an Improvement (except if required under (ii) hereabove).
5.4 Quality Control for Pump v.1A. In furtherance of the Project Plan For Pump
Version 1A and the manufacturing and delivery of the products contemplated
thereby, the Development Committee shall establish quality and validity
testing for the products to be conducted by DEBIOTECH (the "Quality and
Validity Testing Procedures for Pump v.1A") according to Schedule 5.4
hereto. Any change in the Quality and Validity Testing Procedures for Pump
v.1A beyond the scope of the guidelines of Schedule 5.4 shall be at the
sole cost of IMED.
5.5 Project Plan For Pump Version 2. DEBIOTECH shall develop, manufacture and
deliver the Pump v.2, the related Cassette, the Cassette/Reservoir Module
Housing and the related Accessories specified in the Project Plan For Pump
Version 2, pursuant to the terms of this Agreement and in accordance with
the Project Plan For Pump Version 2. The Project Plan For Pump 2 shall be
agreed upon by the Development Committee promptly following completion of
Project Plan For Pump Version 1A through good faith discussions. The
Project Plan For Pump Version 2 shall follow the format and methodology
(including, without limitation, task allocation and Party responsibility
and establishment of dates) set forth in Project Plan For Pump Version 1A,
as applicable to the development of Pump v.2 and taking into consideration
the Specification Document 2. In connection with the performance of the
Project Plan For Pump Version 2, each of IMED and DEBIOTECH will use
reasonable efforts to satisfy the requirements of, and complete those
actions and tasks contemplated in, the Project Plan For Pump Version 2, on
about the dates set forth therein, or, if any of same cannot be achieved
by such date, then as promptly as practical thereafter. The Parties
acknowledge that the Project Plan For Pump Version 2 will assign specific
actions and tasks to particular Parties and that each Party is responsible
to perform the actions and tasks assigned to it, however, the Project Plan
For Pump Version 2 will represent a joint effort to be conducted by the
Parties and each Party shall provide reasonable assistance, cooperation
and information in order to aid the other in the development of the
Project Plan For Pump Version 2 and the performance of its assigned duties
under the Project Plan For Pump Version 2. The Parties further acknowledge
that the Project Plan For Pump Version 2 will be written in a summary
fashion and that, in connection with fulfilling their assigned actions and
tasks thereunder, they will also take such actions as are reasonably
necessary and appropriate in connection therewith or are otherwise
consistent with such summary description.
5.6 Specification Document 2. The Parties acknowledge that as of the Effective
Date the Specification Document 2 is preliminary and embodies only certain
broadly stated attributes that IMED and DEBIOTECH desire to incorporate
into the Pump v.2. It is intended that through the work of the Development
Committee the Specification Document 2 will be modified and supplemented
as reasonably necessary to complete formal specifications following the
format and methodology set forth in the Project Plan For Pump Version 1A
in order to implement the Project Plan For Pump Version 2, and to reflect
Changes requested by all Committee members in completing activities
contemplated in the Project Plan For Pump Version 2. A Change to the
Specification Document for Pump v.2 shall be effective only if set forth
in a written document signed by all members of the Development Committee,
provided, however, that (i) DEBIOTECH (and the member of the Development
Committee designated by it) shall be required to consent to any Change
requested by IMED that constitutes a Software Change, if no serious
objection can be made; and (ii) each Party (and the member of the
Development Committee designated by it) shall be required to consent to
any Change which is necessary to cause each Product to be produced as a
result of the Project Plan For Pump Version 2 to be safe and efficacious
for its intended use or conforming to any regulatory requirement.
The Minutes noting the approval of any Change shall also include any time
schedule delays which may result from such Change. Any Change which
involves new Manufacturing Equipment and/or a modification of existing
Manufacturing Equipment and/or a modified manufacturing process shall be
treated as an Improvement (except if required under (ii) hereabove).
5.7 Quality Control for Pump v.2. In furtherance of the Project Plan For Pump
Version 2 and the manufacturing and delivery of the products contemplated
thereby, the Development Committee shall establish quality and validity
testing for the products to be conducted by DEBIOTECH (the "Quality and
Validity Testing Procedures for Pump v.2") according to Schedule 5.4
hereto. Any change in the Quality and Validity Testing Procedures for Pump
v.2 beyond the scope of the guidelines of Schedule 5.4 shall be at the
sole cost of IMED.
5.8 Sustaining Engineering Activities - Research and Development. DEBIOTECH
shall perform or cause to be performed, at its sole cost and expense, and
with reasonable competence, all Sustaining Engineering Activities.
DEBIOTECH alone shall be entitled to undertake and shall be in charge of,
all research and development involving the Product, Accessories and
Improvements thereto, as well as New Developments, based on the
Technology. IMED may not use the Technology for research and development
or other purposes without DEBIOTECH's prior written consent; provided,
however, that IMED shall be entitled to conduct research and development
on the Cassette Sets, but not the Cassette itself.
5.9 Product Changes. DEBIOTECH shall notify the Development Committee in
writing, no later than thirty (30) days in advance, if DEBIOTECH plans to
change the design, specifications, manufacturer or method of manufacture
of any Products in a manner which will increase cost (as reasonably
determined at the time such changes become effective), change the exterior
appearance, performance or service requirements or otherwise adversely
affect the operation or use of any Product in a material respect. In
addition, DEBIOTECH shall notify the Development Committee not later than
thirty (30) days in advance for any change of the Pump motor manufacturer,
the memory component manufacturer and the microprocessor manufacturer. No
such changes shall be made without the Development Committee's prior
written consent, which consent shall not be unreasonably withheld or
delayed (failure to respond to a notice within fourteen (14) days of the
receipt of such a notice shall be deemed consent thereto); provided,
however, that no such consent shall be required for any such change which
is (i) required to satisfy any applicable law, rule or legal requirement,
or directive from a competent authority, or (ii) reasonably required to
permit DEBIOTECH to comply with the warranties set forth in Article 11.1
(a) hereof. Furthermore, DEBIOTECH shall not replace SAGEM or Plastic
Omnium with another manufacturer without the prior written consent of IMED
which cannot be unreasonably withheld or delayed. In the event that
DEBIOTECH determines that it is reasonably necessary to make any changes
contemplated above pursuant to the foregoing provision, DEBIOTECH shall
notify IMED in writing in advance of such change as promptly as
practicable.
5.10 Improvements.
(a) Proposal by DEBIOTECH or upon Request by IMED. In the event that IMED
desires to have any Improvement to any Product or Accessory supplied
hereunder it must obtain the same from DEBIOTECH. IMED shall notify
DEBIOTECH that it desires to create any Improvement, and DEBIOTECH shall
notify IMED that it desires to create or has created any Improvement and
shall offer it to IMED. Then the Development Committee shall meet promptly
in order to discuss the technical and economic implications of any such
Improvement, as well as the timetable associated with the implementation
thereof. In the event that, within sixty (60) days from such discussion,
IMED were to notify DEBIOTECH that it wishes to consider proceeding with
such Improvement, DEBIOTECH shall provide to IMED a project plan for such
Improvement, addressing, as appropriate: (i) relevant product
specifications; (ii) matters of the type set forth in the Project Plans;
(iii) the cost to IMED of having DEBIOTECH proceed with such plan and
other appropriate budget information (the information contemplated in
clauses (i) through (iii) being referred to collectively as the "Proposal
Data"); and (iv) the effect of such Improvement on costs to IMED for the
Product or Accessory subject to such Improvement, pursuant to Article 8.9
hereof, which plan, following appropriate changes as approved by the
Development Committee and ratified in writing by IMED and DEBIOTECH, shall
constitute the project plan for such Improvement. IMED failure to notify
its wish to consider proceeding with such Improvement within the 60 day
period above or failure to deliver notification to DEBIOTECH of its
approval of the project plan within sixty (60) days of its receipt, shall
be deemed a rejection of the Improvement. IMED shall be required to pay
DEBIOTECH the Development Costs of such Improvement, if proposed by IMED,
and the reasonable cost (not to be less than the Development Cost of such
Improvement) if proposed by DEBIOTECH. In the event that any Improvement
includes new Manufacturing Equipment, the cost of which would be solely
paid by IMED (and not shared by any DEBIOTECH Authorized Person pursuant
to Article 5.10(b)), DEBIOTECH shall include in the Proposal Data its
election to either: (i) include the cost of such new Manufacturing
Equipment in the Development Costs of such Improvement, in which case IMED
shall be the rightful owner and title holder thereto (but shall not be
entitled to possession thereof so long as (x) DEBIOTECH continues to
supply IMED with Products and Accessories in accordance with this
Agreement and (y) the Standby Agreements or Standby License have not been
exercised); or (ii) exclude such new Manufacturing Equipment from the
Development Costs of such Improvement and reasonably amortise the cost
thereof by reasonably increasing the transfer price of the Product or
Accessories effected thereby.
(b) Allocation of Improvement Development Costs; Confidentiality. If
several DEBIOTECH Authorized Persons are to benefit from the same
Improvement, DEBIOTECH shall allocate the Development Costs among such
DEBIOTECH Authorized Persons in an equitable manner under the particular
circumstances.
If any Improvement involves material Confidential Information of one of
the DEBIOTECH Authorized Person, if shall not be available to any other
Authorized Person without the written consent of the one whose
Confidential Information is involved.
(c) Acceptance of Improvement by IMED; Implementation by DEBIOTECH. In no
event shall IMED be required to accept or acquire any Improvement for any
country in the Territory or permit it in any country for which it retains
exclusivity. Following the approval of a project plan contemplated for any
Improvement, DEBIOTECH shall proceed, using reasonable commercial efforts,
with the implementation of such plan.
5.11 New Development. DEBIOTECH agrees that IMED shall have a right of first
refusal following the procedure of Article 5.13 on each New Development.
5.12 Restriction on Development of New Competing Products. DEBIOTECH
represents, warrants, covenants and agrees that neither it nor any member
of the DEBIOTECH Group is currently developing or will, during the period
commencing on the Effective Date and continuing until one (1) year
thereafter, directly or indirectly, develop, market, sell, license, lease
or offer to any Person, a New Competing Product or assist any Person to do
so. Furthermore, DEBIOTECH agrees that IMED shall have for a period of six
(6) years after such one year period, a right of first refusal, as and to
the extent set forth in this Article 5, to use, market, sell, lease and
distribute in the Territory any New Competing Product in the Field of
Application.
5.13 Right of First Refusal. DEBIOTECH agrees that before: (i) any member of
DEBIOTECH Group enters into discussions with any Third Person with respect
to the use, marketing, sale, lease, or distribution for the Field of
Application in any country in the Territory by such Third Person of any
New Development or New Competing Product invented, created or developed,
directly or indirectly, by or with the participation of, any member of
DEBIOTECH Group; or (ii) DEBIOTECH or any member of the DEBIOTECH Group
uses, markets, sells, leases, licenses or distributes any such New
Development or New Competing Product in any country in the Territory for
the Field of Application, DEBIOTECH will give IMED a written notice
("Offer Notice") containing a description thereof, a development plan,
financial terms and all other material business terms and conditions of
the offer ("Offer Conditions"). IMED will have thirty (30) days from
receipt of such Offer Notice (the "Offer Period") to decide whether or not
it wishes to pursue discussions regarding such New Development or New
Competing Product pursuant to this Article 5.13. During such Notice
Period, DEBIOTECH will provide IMED with such additional relevant
non-confidential information in DEBIOTECH Group's possession requested by
IMED as is reasonable under the circumstances.
If within the Offer Period, IMED notifies DEBIOTECH in writing that it
desires to propose and discuss a distribution or marketing arrangement
relating to any such New Competing Product (the "Discussion Notice"), IMED
will have an additional sixty (60) day period (the "Discussion Period")
during which DEBIOTECH shall discuss such proposal exclusively with IMED;
provided, that neither party shall be required to conclude any agreement
in respect thereto.
If IMED fails to deliver the Discussion Notice during the Offer Period or
if the Parties fail to reach a written agreement for IMED to distribute or
market the New Development or New Competing Product for any reason during
such Discussion Period, DEBIOTECH shall be free to offer the New
Development or New Competing Product to any Third Person on the Offer
Conditions, or on other conditions more favorable to DEBIOTECH, at any
time within one year after the expiration of the latest of the Offer
Period or the Discussion Period, as the case may be, after which, if no
written agreement has been signed, it must again be offered to IMED
following the procedures of Discussion and Offer Periods set forth in this
Article 5.13.
ARTICLE 6: PRODUCT APPROVAL
6.1 Market Approvals Obtained by IMED. IMED will use commercially reasonable
efforts to obtain as expeditiously as possible any and all Market
Approvals in all countries in the Territory, whenever possible in the name
of both DEBIOTECH and IMED, for the Products and Accessories.
IMED shall pay the cost and expense of such procedures as charged by any
relevant agencies, as well as all necessary expenses charged by Third
Persons in relation with such procedures (e.g.: technical testing
expenses, translation expenses, etc...).
All governmental cost reimbursement or pricing approvals in the Territory
shall be the responsibility of and at the cost of IMED.
Each of IMED and DEBIOTECH shall use commercially reasonable efforts to
keep the other Party informed of the progress in obtaining such approvals,
shall allow the other Party to (i) review any correspondence with
regulatory authorities reasonably prior to their sending to such
authorities; (ii) participate in any meetings or telephone conversations
with regulatory authorities, and (iii) shall cooperate in complying with
post-marketing legal requirements. All documents, correspondence, testing
material and other material concerning or related to the Market Approvals
in all countries of the Territory shall be made available by IMED to
DEBIOTECH as promptly as practicable when available and DEBIOTECH shall
have all rights to use them.
6.2 Market Approvals Obtained by DEBIOTECH. DEBIOTECH has the right to obtain
directly or indirectly all Market Approvals in all countries inside or
outside the Territory in its own name for the Product and Accessories with
reference to all documents, correspondence, testing material and other
material made available to it under Article 6.1 hereabove, as well as by
reference to any Market Approval obtained by IMED under Article 6.1
hereabove.
6.3 Import Licenses. With IMED's reasonable assistance in respect to the
execution of documents and other ministerial actions, DEBIOTECH shall
cooperate as reasonably necessary to enable IMED to procure and maintain
all licenses reasonably necessary to ship Products and Accessories from
the point of manufacture to IMED in accordance herewith. DEBIOTECH shall
comply with, and IMED agrees to inform DEBIOTECH of any change in, to the
extent IMED is aware or has been made aware of, all other laws,
regulations and governmental directives relating to the import of
technical data, goods and services including, without limitation, those
enforced by the United States Departments of Commerce and Defense and
shall not permit the Products and Accessories to be manufactured in a
manner or with any component, or involving any jurisdiction, so that it
may not lawfully be imported into the Territory.
6.4 Assistance by Parties. Each Party shall, without incurring any cost to any
Third Person, in both cases of Articles 6.1 and 6.2 hereabove, provide
free of charge to the other Party reasonable advice and assistance
whenever requested (local address and responsible person or correspondent
for the relevant government agency, sharing of experience in approval
procedures, assistance in translation and document preparation, etc.)
based upon such Party's experiences with the FDA and other relevant
government agencies. Each Party shall keep the other Party regularly
informed about the approval procedures contemplated in this Article 6.
6.5 Cassette Set Market Approval Obtained by IMED. Pursuant to the provisions
of Article 2.5 hereabove, IMED shall be in charge and will use
commercially reasonable efforts to obtain as expeditiously as possible any
and all Market Approvals in all countries in the Territory for each
Cassette Set assembled by or for IMED. In connection thereto, DEBIOTECH
shall, at its sole expense, provide IMED with all data, assistance and
other information reasonably necessary to obtain such Market Approval.
6.6 Clinical Trials. IMED shall, at its sole expense, conduct or arrange for
others to conduct, as the case may be, all clinical trials necessary, if
any, to obtain the Market Approvals referred to in this Article 6. IMED
shall promptly provide to DEBIOTECH copies of all reports of the results
of such clinical trials.
ARTICLE 7: FINANCIAL CONDITIONS
7.1 Payments to DEBIOTECH. For the Exclusive Distribution Right granted in
Article 2 to IMED and the development of the Product according to the
Specification Documents, IMED shall pay to DEBIOTECH, in an account
designated by DEBIOTECH, the total sum of [CONFIDENTIAL TREATMENT
REQUESTED] for the USA, and additional [CONFIDENTIAL TREATMENT REQUESTED]
each for Canada and Mexico, which amounts shall be non-refundable, except
as expressly provided in this Agreement, in separate installments as
follows:
(a) [CONFIDENTIAL TREATMENT REQUESTED] not later than ten days after the
Effective Date;
(b) [CONFIDENTIAL TREATMENT REQUESTED] not later than ten days after
obtaining the 510k Market Approval from the FDA for the Pump v.1A;
(c) [CONFIDENTIAL TREATMENT REQUESTED] not later than ten days after
Product Availability of Pump v.1A;
(d) [CONFIDENTIAL TREATMENT REQUESTED] not later than ten days after the
submission by IMED of the 510k application to the FDA for the Pump v.2 but
in the event the foregoing amount has not yet been paid, [CONFIDENTIAL
TREATMENT REQUESTED] of that amount is due on the date six (6) months
after the Product Availability of Pump v.1A;
(e) [CONFIDENTIAL TREATMENT REQUESTED] not later than ten days after
obtaining the 510k Market Approval from the FDA for the Pump v.2 but in
the event the foregoing amount has not yet been paid, [CONFIDENTIAL
TREATMENT REQUESTED] of that amount is due on the date twelve (12) months
after the Product Availability of Pump v.1A;
(f) [CONFIDENTIAL TREATMENT REQUESTED] not later than ten days after
Product Availability of Pump v.2;
(g) [CONFIDENTIAL TREATMENT REQUESTED] eighteen (18) months after the
first to occur of (i) Market Approval for Canada for Pump v.1A or (ii)
510k Market Approval by the FDA for Pump v.1A, if IMED wishes to retain
Canada in the Territory. In the event IMED does not elect to retain Canada
in the Territory by making such payment, Canada shall be forthwith
excluded from the Territory. DEBIOTECH shall thereafter be free to offer
Canada to any Third Person and IMED shall have no further rights with
respect thereto including any rights to compensation for customers or
installed Pumps in Canada. However, in such event, DEBIOTECH shall
continue to provide to IMED Cassettes, services, Spare Parts and other
materials (except Pumps) necessary to service IMED's Canadian customers
but only until either DEBIOTECH or a new Distributor for Canada selected
by DEBIOTECH is willing to provide Cassettes, Spare Parts and otherwise
service IMED's Canadian customers and assumes the obligations of IMED
under such service and supply contracts. Thereafter, IMED shall cooperate
as necessary to assure a smooth transition to DEBIOTECH or to such new
Distributor, as the case may be and shall thereafter have no rights to the
Products and Accessories regarding Canada; and
(h) [CONFIDENTIAL TREATMENT REQUESTED] eighteen (18) months after the
first to occur of (i) Market Approval for Mexico for Pump v.1A or (ii)
510k Market Approval by the FDA for Pump v.1A, if IMED wishes to retain
Mexico in the Territory. In the event IMED does not elect to retain Mexico
in the Territory by making such payment, Mexico shall be forthwith
excluded from the Territory. DEBIOTECH shall thereafter be free to offer
Mexico to any Third Person and IMED shall have no further rights with
respect thereto including any rights to compensation for customers or
installed Pumps in Mexico. However, in such event, DEBIOTECH shall
continue to provide to IMED Cassettes, services, Spare Parts and other
materials (except Pumps) necessary to service IMED's Mexican customers but
only until either DEBIOTECH or a new Distributor for Mexico selected by
DEBIOTECH is willing to provide Cassettes, Spare Parts and otherwise
service IMED's Mexican customers and assumes the obligations of IMED under
such service and supply contracts. Thereafter, IMED shall cooperate as
necessary to assure a smooth transition to DEBIOTECH or to such new
Distributor, as the case may be and shall thereafter have no rights to the
Products and Accessories regarding Mexico.
7.2 Failure Event 1A. Upon the occurrence of a Failure Event 1A, then, IMED
shall have the right, as IMED's sole remedy, to terminate this Agreement
by written notice to DEBIOTECH, and DEBIOTECH shall refund by SWIFT
transfer to IMED together with interest at the Prime Rate from the
termination date, as soon as DEBIOTECH has signed with a new Distributor
for the Territory, but in any event not later than forty five (45) days
after such termination, [CONFIDENTIAL TREATMENT REQUESTED] of any and all
sums paid to DEBIOTECH under Article 7.1 (a) to (f); provided, however,
that if at the time of the occurrence of such Failure Event 1A IMED has
only paid the initial [CONFIDENTIAL TREATMENT REQUESTED] under Article
7.1(a), there shall be no refund to IMED. IMED agrees that, except as
otherwise provided in this Agreement, the other [CONFIDENTIAL TREATMENT
REQUESTED] of the foregoing amount paid by IMED pursuant to this Agreement
is non refundable by DEBIOTECH.
7.3 Failure Event 2. Upon the occurrence of a Failure Event 2, then, as IMED's
sole remedy, DEBIOTECH shall refund by SWIFT transfer to IMED, together
with interest at the Prime Rate from the date of notification by IMED to
DEBIOTECH of such Failure Event 2, within forty five (45) days after such
Failure Event 2, [CONFIDENTIAL TREATMENT REQUESTED] of any and all sums
paid to DEBIOTECH under Article 7.1 (d) through (f), provided, however,
that if at the time of the occurrence of such Failure Event 2 IMED has
only paid [CONFIDENTIAL TREATMENT REQUESTED] under either or both of
Article 7.1 (d) and/or (e), there shall be no refund to IMED in respect of
such payment(s). IMED agrees that, except as otherwise provided in this
Agreement, the other [CONFIDENTIAL TREATMENT REQUESTED] of the foregoing
amount paid by IMED pursuant to this Agreement is non refundable by
DEBIOTECH.
7.4 Effect of Termination. As soon as DEBIOTECH has received IMED's
termination notice according to Article 7.2, this Agreement shall be
deemed terminated and DEBIOTECH shall be free to seek any Third Person
regarding the Exclusive Distribution Right of the Product in the
Territory. The refunds provided in Articles 7.2 and 7.3, are mutually
exclusive and not cumulative.
ARTICLE 8: PRODUCT PRICING
8.1 Sales Price. The selling price of the Product and Accessories by DEBIOTECH
to IMED as of the Effective Date shall be as set forth below and shall
vary according to the quantities ordered by IMED per Contract Year, in
accordance with the following scale which is to remain valid throughout
the duration of this Agreement, provided, however, that a price adjustment
is to take place every year pursuant to Article 8.3:
(a) Cassette unit prices per Contract Year.
(i) [CONFIDENTIAL TREATMENT REQUESTED] per unit for the
[CONFIDENTIAL TREATMENT REQUESTED] units ordered pursuant to
Article 10.4 hereunder; such [CONFIDENTIAL TREATMENT
REQUESTED] units not to be counted in 8.1(a)(ii) to 8.1(a)(vi)
thereafter;
(ii) [CONFIDENTIAL TREATMENT REQUESTED] per unit if less than
[CONFIDENTIAL TREATMENT REQUESTED] units have been ordered per
Contract Year;
(iii) [CONFIDENTIAL TREATMENT REQUESTED] per unit if [CONFIDENTIAL
TREATMENT REQUESTED] units or more, but less than
[CONFIDENTIAL TREATMENT REQUESTED] units, have been ordered
per Contract Year;
(iv) [CONFIDENTIAL TREATMENT REQUESTED] per unit if [CONFIDENTIAL
TREATMENT REQUESTED] units or more, but less than
[CONFIDENTIAL TREATMENT REQUESTED] units, have been ordered
per Contract Year;
(v) [CONFIDENTIAL TREATMENT REQUESTED] per unit if [CONFIDENTIAL
TREATMENT REQUESTED] units or more, but less than
[CONFIDENTIAL TREATMENT REQUESTED] units, have been ordered
per Contract Year; and
(vi) [CONFIDENTIAL TREATMENT REQUESTED] per unit if more than
[CONFIDENTIAL TREATMENT REQUESTED] units have been ordered for
delivery per Contract Year.
Orders for quantities in excess of the range contemplated in Article
10.1(a) hereof shall be deemed "ordered" for purposes of Article 8.1(a)
only if confirmed for delivery by DEBIOTECH in accordance with Article
10.1(b) hereof.
These Cassettes will be delivered pursuant to the Packaging Specifications
contemplated in Article 10.3(e), non sterilized and in bulk in multiples
of at least [CONFIDENTIAL TREATMENT REQUESTED] units during the first
Contract Year and in multiples of at least [CONFIDENTIAL TREATMENT
REQUESTED] units in the Contract Years thereafter.
(b) Pump v.1A:
(i) [CONFIDENTIAL TREATMENT REQUESTED] per unit if [CONFIDENTIAL
TREATMENT REQUESTED] units or more, but less than
[CONFIDENTIAL TREATMENT REQUESTED] units, have been ordered
per Contract Year;
(ii) [CONFIDENTIAL TREATMENT REQUESTED] per unit if [CONFIDENTIAL
TREATMENT REQUESTED] units or more, but less than
[CONFIDENTIAL TREATMENT REQUESTED] units, have been ordered
per Contract Year;
(iii) [CONFIDENTIAL TREATMENT REQUESTED] per unit if [CONFIDENTIAL
TREATMENT REQUESTED] units or more, but less than
[CONFIDENTIAL TREATMENT REQUESTED] units, have been ordered
per Contract Year; and
(iv) [CONFIDENTIAL TREATMENT REQUESTED] per unit if more than
[CONFIDENTIAL TREATMENT REQUESTED] units have been ordered per
Contract Year.
Orders for quantities in excess of the range contemplated in Article
10.1(a) hereof shall be deemed "ordered" for purposes of Article 8.1(b)
only if confirmed for delivery by DEBIOTECH in accordance with Article
10.1(b) hereof.
These Pumps are delivered pursuant to the Packaging Specifications
contemplated in Article 10.3(e), with one external power supply, one
cleaning cassette and one belt clip (or pole clip, at the election of IMED
if it agrees to pay the price differential), including one rechargeable
battery module inside the Pump, in multiples of at least [CONFIDENTIAL
TREATMENT REQUESTED] units.
(c) Pump v.2:
The price for the Pump v.2 will be defined by DEBIOTECH at the date of
Market Approval of Pump v.2 but shall in no event exceed the price for the
Pump v.1A by more than [CONFIDENTIAL TREATMENT REQUESTED].
Orders for the quantities in excess of the range contemplated in Article
10.1(a) hereof shall be deemed "ordered" for purposes of Article 8.1(c)
only if confirmed for delivery by DEBIOTECH in accordance with Article
10.1(b) hereof.
These Pumps are delivered pursuant to the Packaging Specifications
contemplated in Article 10.3(e), with one external power supply, one
cleaning cassette and one belt clip (or pole clip, at the election of IMED
if it agrees to pay the price differential), including one replaceable
rechargeable battery pack inside the Pump, in multiples of at least
[CONFIDENTIAL TREATMENT REQUESTED] units.
(d) Accessories
If ordered separately from a Pump:
(i) [CONFIDENTIAL TREATMENT REQUESTED] per unit for the pole/bed
fixation module by multiple of at least [CONFIDENTIAL
TREATMENT REQUESTED] units;
(ii) [CONFIDENTIAL TREATMENT REQUESTED] per unit for the shoulder
strap fixation module by multiple of at least [CONFIDENTIAL
TREATMENT REQUESTED] units;
(iii) [CONFIDENTIAL TREATMENT REQUESTED] per unit for the belt clip
by multiple of at least [CONFIDENTIAL TREATMENT REQUESTED]
units;
(iv) [CONFIDENTIAL TREATMENT REQUESTED] per unit for the external
power supply for the Pump v.1 and v.1A by multiple of at least
[CONFIDENTIAL TREATMENT REQUESTED] units;
(v) [CONFIDENTIAL TREATMENT REQUESTED] per unit for the Pump
storage plastic casing by multiple of at least [CONFIDENTIAL
TREATMENT REQUESTED] units; and
(vi) not more than [CONFIDENTIAL TREATMENT REQUESTED] per unit for
the Cassette/Reservoir Module Housing by multiple of at least
[CONFIDENTIAL TREATMENT REQUESTED] units.
8.2 Taxes; Currency. The prices mentioned in Article 8.1 hereabove are
exclusive of any tax and for deliveries made F.O.B. freeport in Geneva, or
other European port of embarkation mutually agreed upon, such agreement
not to be unreasonably withheld by either Party, pursuant to Incoterms ICC
1990 in accordance with Article 10.3(b). IMED shall be responsible for the
payment of all taxes and customs duties, if any, that are due to
governmental authorities in connection with the importation, sale and
distribution of the Product and/or Accessories.
Invoicing will be in US$, or in any other currency agreed to by the
Parties, applying the official exchange rate of US$ to this currency
posted by Union Bank of Switzerland in Zurich on the due date of payment.
8.3 Price Increases or Decreases.
(a) Annual Manufacturing Costs. One year after the commencing of the first
Quarter in which the Effective Date occurs, and on each one year
anniversary of such date (the "Calculation Date"), the prices will be
increased or decreased, as the case may be, in respect of the following
one year period by an amount equal to the lesser of: (i) DEBIOTECH's
actual increases or decreases in manufacturing costs from the Effective
Date to the most recent Calculation Date, as evidenced by a certificate
from DEBIOTECH's original or second source manufacturer as the case may
be; and (ii) the percentage increase or decrease in the Index from the
Effective Date to the Calculation Date; provided, however, that the price
shall never be reduced below the prices applicable as of the Effective
Date. The price of the Product and Accessories will be the price valid on
the date the Firm Order is given to DEBIOTECH. DEBIOTECH shall promptly
notify IMED in writing of any price increase or decrease, which notice
shall contain the amount of such increase or decrease and shall illustrate
the calculation method used by DEBIOTECH to determine such increase or
decrease.
Should IMED find it impossible to pass to a majority of its clients the
Product and/or Accessories price increases according to this Article 8.3
in its own prices to its customers in certain countries of the Territory,
then the Parties hereto shall negotiate in good faith in order to find, if
possible, a more limited increase for the Product and/or Accessories price
for the year and in the country(ies) concerned than the price which would
result from the application of the immediately preceding paragraph. In
such an event, the price increase shall not exceed the cumulative increase
which would have resulted applying a notional index, the increase of which
would have been at the constant rate of [CONFIDENTIAL TREATMENT REQUESTED]
per year from the Effective Date.
(b) Product Changes. In the event that Product changes described in
Article 5.9 (other than those changes contemplated in clause (i) of
Article 5.9 which are due to any applicable law, rule or legal requirement
in effect on the Effective Date and which shall be made at the sole cost
of DEBIOTECH) result in an increase of direct or indirect manufacturing
costs, the transfer price will be increased accordingly; provided,
however, that any such changes which are Improvements shall be treated
under Article 5.10.
8.4 Price Forecasts; Adjustments. In order to apply a reasonable price at the
beginning of each Contract Year, the beginning unit transfer price shall
be based on the total number of units ordered by IMED during the previous
Contract Year and its increase ratio compared to volumes for the Contract
Year before, and any final adjustment being either invoiced in the last
Quarter or adjusted on the last payments for deliveries within the said
last Quarter. The price of the Pumps delivered during the first Contract
Year shall be based on the purchases anticipated for the said Contract
Year but not below [CONFIDENTIAL TREATMENT REQUESTED], the balance being
either invoiced in the last Quarter or adjusted on the last deliveries of
the said last Quarter.
8.5 Payment Terms; Interest on Late Payments. All payments concerning
deliveries by DEBIOTECH shall be made by IMED to a bank account designated
by DEBIOTECH to IMED, by SWIFT transfer, as follows: (a) [CONFIDENTIAL
TREATMENT REQUESTED] of the sum due (i) when ordering pursuant to Article
10.1(a) or (ii) three (3) months plus the remaining number of days of the
Initial Firm Order Period after ordering pursuant to Article 10.2; and (b)
the balance within [CONFIDENTIAL TREATMENT REQUESTED] days after delivery
to the port contemplated in Article 10.3(b) hereof. Sums overdue by either
Party under this Agreement will bear interest at three (3) points above
Prime Rate or at such lower rate as shall then be the maximum rate
permitted by law, calculated for the duration of the delay, on a daily
basis, starting from the due date of payment. Each substantially complete
delivery by DEBIOTECH to IMED shall constitute a separate sale obligating
IMED to pay therefor, but IMED shall have a right to advance notice of
substantially incomplete deliveries with an election to delay delivery to
the next requested delivery date.
8.6 Liquidated Damages for Delivery Delay. In the event that DEBIOTECH fails
to deliver Products or Accessories ordered by a Firm Order (Article
10.1(a)) by the Confirmed Date (Article 10.1(b)) in quantities
substantially equal to the quantities in such Firm Order, so long as
DEBIOTECH uses commercially reasonable efforts, the sole damages available
to IMED for such delay in delivery shall be liquidated damages as provided
in this Article 8.6; provided, however, that, so long as DEBIOTECH uses
commercially reasonable efforts, if such delay is due to (i) Force
Majeure, (ii) the fault of IMED, (iii) a universal delay in the supply of
a major component (other than the Pump motor) to the Product or Accessory
which was (x) commonly available from multiple sources immediately prior
to its unavailability or (y) only available from one source which was
reliable immediately prior to the unavailability of such component or (iv)
the result of design and/or manufacturing difficulties which arise in
connection with responding to a Mandatory or Voluntary Recall or Epidemic
Failure event under Article 11.3 (so long as DEBIOTECH expends
commercially reasonable efforts to eliminate the causes thereof and again
commences and continues supply in accordance with the terms of this
Agreement within the shortest time reasonable under the circumstances
following the occurrence of Recall or Epidemic Failure event), then in
such cases no damages for such delay in delivery or consequences thereof
may be claimed by IMED.
Beginning after a grace period of thirty (30) days after such Confirmed
Date, (i) IMED shall be able to deduct from any amounts then due and owing
to DEBIOTECH or (ii) if no amounts are due under the foregoing clause (i)
DEBIOTECH shall pay to IMED by SWIFT transfer within forty-five (45) days,
or reduce the invoice amount due for delayed goods delivered prior to such
45 day period, the following amounts:
- [CONFIDENTIAL TREATMENT REQUESTED] of the transfer price of any
such delayed Firm Order for each full week of delay from the first
to fifth week after the grace period; and
- [CONFIDENTIAL TREATMENT REQUESTED] of the transfer price of any
such delayed Firm Order for each full week of delay from the sixth
to fifteenth week after the grace period.
Liquidated Damages payable under this Article 8.6 shall not exceed
[CONFIDENTIAL TREATMENT REQUESTED] of the transfer price of each delayed
Firm Order.
8.7 Special Packaging Costs. All costs for special packaging as requested by
IMED in writing pursuant to Article 10.3(e) shall be in addition to the
prices of the Product and/or Accessories, and shall be paid together with
payment for the applicable Product and/or Accessories.
8.8 Letter of Credit. In the event IMED shall fail to make any payment for any
delivery when due and such failure shall continue for more than fifteen
(15) days after written notice from DEBIOTECH of such failure, DEBIOTECH
shall have the right to accept further orders and/or send confirmed
deliveries for the Product and/or Accessories in that Contract Year only
if IMED causes its bank (reasonably acceptable to DEBIOTECH) to open in
favor of DEBIOTECH a confirmed and irrevocable letter of credit, payable
in US$ upon the delivery of the corresponding Product and/or Accessories,
such letter of credit being opened when placing the order pursuant to
Article 10.1(a) or at DEBIOTECH's requested time before delivery, in an
amount equal to the balance due in respect of such order, and shall not
expire before sixty (60) days after the confirmed date of delivery. If
DEBIOTECH has the right to require such a letter of credit more than
twice, it shall have the right to require such a letter of credit for the
duration of the Agreement.
8.9 Cost of Improvements. In the event of any Improvements of either the Pump,
the Cassette or Accessories except New Accessories, pursuant to Article
5.10 hereabove, the price for the Product or Accessory including such
Improvement will be increased by [CONFIDENTIAL TREATMENT REQUESTED] of
DEBIOTECH's increased direct manufacturing costs attributable solely to
the Improvement.
8.10 Reduction in Sales Price; Other Alternatives. Subject to Articles 8.3 and
8.9, the above Pump and Cassette prices shall remain in effect for the
duration of this Agreement provided, however, that in the event IMED can
establish at any time from and after January 1, 1997 that, on the sole
basis of objective information relating to then existing market
conditions, IMED must lower its average sales price for the Pump, Cassette
and Accessories because it has not made over a consecutive twelve (12)
month period a [CONFIDENTIAL TREATMENT REQUESTED] Gross Margin, IMED may
request no more than once per Contract Year a price reduction by written
notice to DEBIOTECH including the objective information about market
conditions showing the need to lower the sales prices to customers and the
relevant Gross Margin data (in particular selling prices and sales volumes
of Pump, Cassette and Accessories). The Parties shall meet to discuss a
solution within fifteen (15) days from receipt of such notice.
In the event that the Parties are unable to agree on price reductions of
one or more of the Pump, Cassette or Accessories that are satisfactory to
IMED, within thirty (30) days from the written notice by IMED to
DEBIOTECH, then DEBIOTECH shall have the election to choose, by sending
written notice thereof to IMED, any one of the following options:
(a) DEBIOTECH may elect to lower the price of the Pump, Cassette
and/or Accessories in such amounts and combination of amounts as
DEBIOTECH may elect in its sole discretion, to a fixed level which
would provide to IMED such [CONFIDENTIAL TREATMENT REQUESTED] Gross
Margin based on the Gross Margin calculation data provided by IMED.
In such a case, IMED must accept such reduction and continue full
performance of the Agreement. Further, IMED agrees that to the
extent it shall at any time thereafter have a Gross Margin in excess
of [CONFIDENTIAL TREATMENT REQUESTED], such excess shall be used to
restore to DEBIOTECH the difference between the reduced price
provided pursuant to this Article 8.10(a) and the price DEBIOTECH
would otherwise have received under Article 8.1 and Article 8.3 but
for such a price reduction (the "Restoration Amount"). In the event
that prices shall ever be reduced under this Article 8.10(a), the
Parties shall calculate annually the Restoration Amount for each
Contract Year. At the end of any subsequent Contract Year in which
IMED shall have a Gross Margin in excess of [CONFIDENTIAL TREATMENT
REQUESTED], it shall pay such Restoration Amount to DEBIOTECH within
thirty (30) days after the end of such Contract Year. The
Restoration Amounts shall continue to accumulate during the term of
this Agreement until paid and shall be paid each Contract Year to
the extent of accumulated, but unpaid, Restoration Amounts, but
shall not bear interest; or
(b) DEBIOTECH may elect to eliminate the minimum order requirements
in Article 12.1 hereof; or
(c) DEBIOTECH may elect to send a Termination Notice and pay to IMED
the Purchase Price pursuant to Article 17.7, provided, however, that
IMED shall have the right, exercisable within ten (10) days of its
receipt of written notice of DEBIOTECH's election of this option
(c), to avoid such termination by giving written notice to DEBIOTECH
of IMED's withdrawal of its price reduction request and continuing
this Agreement by paying the transfer prices in effect.
DEBIOTECH may elect option (a), (b) or (c) each time IMED requests such a
price reduction but once option (b) has been elected, that election cannot
be changed without the consent of IMED.
ARTICLE 9: ROYALTIES
9.1 Pump. IMED shall pay to DEBIOTECH a royalty on the Pump Net Proceeds of
Sales for each type of Pump at a rate which shall be determined as
follows:
(a) if the Pump Net Proceeds of Sales are less than twice the aggregate
price paid by IMED during that Contract Year for such Pump pursuant
to Article 8 hereabove (after taking into consideration all final
adjustments pursuant to Article 8.4), the rate shall be
[CONFIDENTIAL TREATMENT REQUESTED];
(b) if the Pump Net Proceeds of Sales are more than twice, but less than
two and one half times, the aggregate price paid by IMED during that
Contract Year for such Pump pursuant to Article 8 hereabove (after
taking into consideration all final adjustments pursuant to Article
8.4), the rate shall be [CONFIDENTIAL TREATMENT REQUESTED];
(c) if the Pump Net Proceeds of Sales are over two and one half times,
but less than three times, the aggregate price paid by IMED during
that Contract Year for such Pump pursuant to Article 8 hereabove
(after taking into consideration all final adjustments pursuant to
Article 8.4), the rate shall be [CONFIDENTIAL TREATMENT REQUESTED];
(d) if the Pump Net Proceeds of Sales are more than three times, but
less three and one half times, the aggregate price paid by IMED
during that Contract Year for such Pump pursuant to Article 8
hereabove (after taking into consideration all final adjustments
pursuant to Article 8.4), the rate shall be [CONFIDENTIAL
TREATMENT REQUESTED]; or
(e) if the Pump Net Proceeds of Sales are more than three and one half
times the aggregate price paid by IMED during that Contract Year for
such Pump pursuant to Article 8 hereabove (after taking into
consideration all final adjustments pursuant to Article 8.4), the
rate shall be [CONFIDENTIAL TREATMENT REQUESTED].
9.2 Cassette. IMED shall pay to DEBIOTECH a royalty on the Cassette Net
Proceeds of Sales for Cassette/Reservoir Modules and Cassette Sets sold in
any Contract Year in connection with an empty or prefilled
Cassette/Reservoir Module (minus the cost to IMED of the drug itself if
sold by IMED or its Affiliates pre-filled) at a rate which shall be
determined as follows:
(a) if the Cassette Net Proceeds of Sales are less than twice the Cost
Price (after taking into consideration all final adjustments
pursuant to Article 8.4), the rate shall be [CONFIDENTIAL TREATMENT
REQUESTED];
(b) if the Cassette Net Proceeds of Sales are more than twice, but less
than two and one half times, the Cost Price (after taking into
consideration all final adjustments pursuant to Article 8.4), the
rate shall be [CONFIDENTIAL TREATMENT REQUESTED];
(c) if the Cassette Net Proceeds of Sales are over two and one half
times, but less than three times, the Cost Price (after taking into
consideration all final adjustments pursuant to Article 8.4), the
rate shall be [CONFIDENTIAL TREATMENT REQUESTED];
(d) if the Cassette Net Proceeds of Sales are more than three times, but
less three and one half times, the Cost Price (after taking into
consideration all final adjustments pursuant to Article 8.4), the
rate shall be [CONFIDENTIAL TREATMENT REQUESTED]; or
(e) if the Cassette Net Proceeds of Sales are more than three and one
half times the Cost Price (after taking into consideration all final
adjustments pursuant to Article 8.4), the rate shall be
[CONFIDENTIAL TREATMENT REQUESTED].
9.3 Accessories. IMED shall pay to DEBIOTECH a royalty on the Accessory Net
Proceeds of Sales for each type of Accessory at a rate which shall be
determined as follows:
(a) if the Accessory Net Proceeds of Sales are less than twice the
aggregate price paid by IMED during that Contract Year for such
Accessory pursuant to Article 8 hereabove (after taking into
consideration all final adjustments pursuant to Article 8.4), the
rate shall be [CONFIDENTIAL TREATMENT REQUESTED];
(b) if the Accessory Net Proceeds of Sales are more than twice, but less
than two and one half times, the aggregate price paid by IMED during
that Contract Year for such Accessory pursuant to Article 8
hereabove (after taking into consideration all final adjustments
pursuant to Article 8.4), the rate shall be [CONFIDENTIAL TREATMENT
REQUESTED];
(c) if the Accessory Net Proceeds of Sales are over two and one half
times, but less than three times, the aggregate price paid by IMED
during that Contract Year for such Accessory pursuant to Article 8
hereabove (after taking into consideration all final adjustments
pursuant to Article 8.4), the rate shall be [CONFIDENTIAL TREATMENT
REQUESTED];
(d) if the Accessory Net Proceeds of Sales are more than three times,
but less three and one half times, the aggregate price paid by IMED
during that Contract Year for such Accessory pursuant to Article 8
hereabove (after taking into consideration all final adjustments
pursuant to Article 8.4), the rate shall be [CONFIDENTIAL TREATMENT
REQUESTED]; or
(e) if the Accessory Net Proceeds of Sales are more than three and one
half times the aggregate price paid by IMED during that Contract
Year for such Accessory pursuant to Article 8 hereabove (after
taking into consideration all final adjustments pursuant to Article
8.4), the rate shall be [CONFIDENTIAL TREATMENT REQUESTED].
9.4 Sales to IMED Affiliates. Notwithstanding the foregoing, any sales between
IMED and its Affiliates shall not be counted as sales to Third Persons and
therefore shall not generate any royalty payment provided however that
such Affiliates are not in fact users of such Products and/or Accessories.
9.5 Payment of Royalties.
(a) Timing. The royalties pursuant to Articles 9.1, 9.2 and 9.3 hereabove
shall be paid to DEBIOTECH within [CONFIDENTIAL TREATMENT REQUESTED] after
the end of each Contract Year with a written statement specifying the
quantities of Pumps, Cassettes (in connection with an empty or prefilled
Cassette/Reservoir Module), Cassette/Reservoir Modules and other
Accessories sold during that Contract Year and the corresponding Net
Proceeds of Sales during the said Contract Year.
(b) Method. All payments shall be made by SWIFT transfer to a bank account
to be designated to IMED by DEBIOTECH in writing, in US$, or in any other
currency agreed to by the Parties, applying the official exchange rate of
US$ to this currency posted by Union Bank of Switzerland in Zurich on the
last day of the relevant Quarter.
(c) Late Rate. Overdue royalties shall bear interest at three (3) points
above Prime Rate or at such lower rate as shall then be the maximum rate
permitted by law, calculated for the duration of the delay, on a daily
basis, starting from the due date of payment.
9.6 Accounting Records. IMED and DEBIOTECH and/or any of their Affiliates, as
the case may be, shall keep accounting records regarding the sales of the
Product, Cassette/Reservoir Modules and Accessories pursuant to this
Agreement separate from its sales of other products, in order to
facilitate audits by any accountant according to the provisions of Article
21.4.
ARTICLE 10: ORDERS & DELIVERY
10.1 Orders.
(a) Firm Orders; Forecast. IMED shall deliver to DEBIOTECH a written
notice three (3) months prior to the beginning of each Quarter specifying:
(i) a firm and irrevocable order for the Product and/or Accessories for
that Quarter (the "Firm Order") (which may be divided by IMED into monthly
purchase orders) indicating requested delivery dates; and (ii) a
non-binding forecast for Product and/or Accessories for the Quarter
thereafter, accompanied, when applicable, by the information contemplated
in Article 14.4 hereof; provided, that the forecast shall not be more than
150% of the Firm Order for the immediately preceding Quarter unless IMED
gives at least nine (9) months advance notice. The Firm Order in respect
of any Quarter shall be greater than or equal to eighty percent (80%) and
less than or equal to one hundred twenty percent (120%) of the forecast
delivered to DEBIOTECH for such Quarter pursuant to clause (ii) of the
preceding sentence, with respect to any particular Product or Accessory.
(b) Purchase Orders. Each Firm Order may specify the shipment date(s)
within the applicable Quarter (each a "Shipment Date"). DEBIOTECH shall:
(i) be obligated to supply, subject only to the provisions of Article 19,
all Products and Accessories ordered pursuant to the Firm Order; and (ii)
promptly acknowledge each purchase order in writing and confirm the
Shipment Dates for all ordered Products and Accessories (or a date as soon
as possible thereafter but in any event within thirty (30) days of the
date specified by IMED, the date so confirmed by DEBIOTECH, the "Confirmed
Date") and destinations specified by IMED in accordance with Article
10.3(d). DEBIOTECH shall not be obligated (although it shall use
commercially reasonable efforts) to supply in any Quarter any quantity of
Products or Accessories, exceeding with respect to any particular Product
or Accessory, 120% of IMED's forecast for such Quarter furnished in
accordance with Article 10.1(a)(ii) above.
10.2 Initial Orders. DEBIOTECH shall notify IMED within two (2) weeks and six
(6) months in advance of the time at which it is capable of providing IMED
with production quantities of any Product (provided that, in the event
that such Product is a Pump, DEBIOTECH must then also be capable of
providing IMED with Cassettes for such Pump). IMED shall have two (2)
weeks from the receipt of such notification (the "Initial Firm Order
Period") to deliver to DEBIOTECH a Firm Order (the "Initial Firm Order")
for such Product. In the event that IMED fails to deliver the Initial Firm
Order to DEBIOTECH within the Initial Firm Order Period without any valid
reason, Product Availability for such Product shall deem to have occurred
six (6) months following the expiration of the Initial Firm Order Period.
IMED hereby places with DEBIOTECH a firm and irrevocable order for a first
delivery of [CONFIDENTIAL TREATMENT REQUESTED] Cassettes, at a unit cost
price according to Article 8.1(a)(i) and according to the conditions
stipulated in Article 8 hereof. These Cassettes will be delivered over
[CONFIDENTIAL TREATMENT REQUESTED] running from the first day of the first
Country Year for the USA, according to individual Firm Order confirmations
for delivery according to the schedule mentioned in Article 10.1
hereabove.
10.3 Delivery.
(a) Delivery Time. DEBIOTECH shall ship Products and Accessories to IMED
on the Confirmed Shipment Date. DEBIOTECH shall notify IMED at least seven
(7) days in advance when the Product and/or Accessories are ready to be
shipped. If a delivery is delayed as a result of any action or inaction of
IMED, DEBIOTECH may invoice IMED for the Product and/or Accessories as of
the Confirmed Shipment Date and may charge IMED for warehousing and other
expenses incurred directly resulting from the delay.
(b) Delivery Terms. The Products and Accessories shall be shipped to IMED
F.O.B., freeport in Geneva or other European port of embarkation mutually
agreed upon, such agreement not to be unreasonably withheld by either
Party, pursuant to Incoterms ICC 1990. Notwithstanding the foregoing
delivery terms, upon IMED's written request DEBIOTECH shall: (i) arrange
for and procure contracts of carriage and insurance on customary terms;
and (ii) provide IMED with assistance in obtaining any documents issued or
transmitted in the country of shipment which IMED may require for the
importation or export of Products and Accessories therefrom, in each case
at IMED's risk and expense.
(c) Packing List. DEBIOTECH shall include a packaging list in each
shipment of Products and/or Accessories which shall provide the following
information: (i) IMED purchase order number; (ii) quantity; and (iii)
DEBIOTECH lot number, and which shall be accompanied by the certificate
contemplated in Article 11.2(c). DEBIOTECH shall mail a copy of each
packing list to IMED at the time of shipment.
(d) Destination. The Products, Accessories and Spare Parts will be made
ready for shipment to IMED by DEBIOTECH at one address only in each
country of the Territory. IMED may change the address of such shipments
from time to time upon written notice to DEBIOTECH.
(e) Packaging. Each Product and Accessory sold to IMED by DEBIOTECH
hereunder shall be packed using the packaging specifications for such
Product or Accessory described on Enclosure 13 hereto (the "Packaging
Specifications"). IMED will deliver sufficiently in advance all manuals,
inserts, special labeling and the like to be provided by IMED and included
in the package by DEBIOTECH's manufacturer at no supplementary cost to
IMED.
IMED shall notify DEBIOTECH in writing of any special packaging
requirements or change in the Packaging Specifications when placing firm
order pursuant to Article 10.1(a). Upon receipt of such notice, DEBIOTECH
shall take all necessary measures to comply with any such request;
provided, however, that the additional costs associated with such request,
if any, shall be paid by IMED in accordance with Article 8.7.
10.4 Supply Interruption Safeguards.
(a) Minimum Cassette Supply Reserve Requirements. DEBIOTECH shall maintain
in a secure warehouse independent from manufacturing facilities a three
(3) month supply of Cassettes (based on then current sales volumes) so
that there is always a three (3) month reserve available. In addition,
either IMED or DEBIOTECH may, at its sole discretion, elect to maintain
any additional reserve.
(b) Second Source Supplier. DEBIOTECH shall, promptly after the First
Introduction Date in the USA, take all reasonably necessary measures in
order to have a second source Cassette manufacturer (reasonably acceptable
to IMED as to reliability, quality, technical capability, financial
capability and creditworthiness) ready to begin Cassette supply within six
(6) months from any first source Supply Interruption (as hereinafter
defined), such second source manufacturer being able to fulfill all
required manufacturing standards hereunder, including those set forth in
Article 11.1(a) and 11.2 hereunder, and to supply the required orders from
IMED, according to the rolling forecasts and Firm Orders communicated to
DEBIOTECH as mentioned in Article 10.1. In addition, DEBIOTECH may at any
time have a second source Pump and/or Accessory manufacturer (reasonably
acceptable to IMED as to reliability, quality, technical capability,
financial capability and creditworthiness) ready to begin Pump and/or
Accessory supply within six (6) months from any first source Supply
Interruption, such second source manufacturer being able to fulfill all
required manufacturing standards hereunder, including those set forth in
Article 11.1(a) and 11.2 hereunder, and to supply the required orders from
IMED, according to the rolling forecasts and Firm Orders communicated to
DEBIOTECH as mentioned in Article 10.1. DEBIOTECH shall keep IMED informed
in general regarding the progress of such arrangements and shall provide
to IMED the identity of such manufacturer(s) in a written request for
IMED's reasonable consent (as to reliability, quality, technical
capability, financial capability and creditworthiness).
(c) Good Faith Efforts. Each of DEBIOTECH and IMED shall cooperate in good
faith at all times during any Supply Interruption of supply of Pumps,
Cassettes or Accessories, sharing information and suggesting alternative
solutions. It is agreed that it is the intent of the Parties to find a
solution to any Supply Interruption problem that maintains the rights and
obligations of DEBIOTECH to supply Product and Accessories and, to the
extent practicable, most rapidly re-establishes the regular primary source
manufacturers.
(d) Supply Interruption Procedures. In the event of any supply
interruption from the first source to DEBIOTECH which would or does result
in a delivery delay to DEBIOTECH of more than thirty (30) days (a "Supply
Interruption"), DEBIOTECH shall inform IMED in writing immediately (the
"Supply Interruption Notice"). As the first step in the resolution of any
such Supply Interruption, DEBIOTECH and IMED shall meet within fourteen
(14) days of such Supply Interruption Notice to determine the facts and
discuss in good faith the most reasonable alternative solutions under the
circumstances. As soon as possible and in any event not later than thirty
(30) days after such Supply Interruption Notice (the "Consultation
Period"), the Parties shall use their commercially reasonable efforts to
reach a mutual good faith determination as to the nature and probable
duration of the Supply Interruption. Given the objectives of the Parties,
in general, only if it reasonably appears that such first source
manufacturer is not capable or willing to resume regular supply in a
reasonable period of time shall a shift to a second source be necessary.
Accordingly, the Parties agree to take the following actions in the
following circumstances:
(i) Less Than Three Months. If the Parties mutually agree that
the Supply Interruption appears reasonably likely to be of less than
three months duration from the Supply Interruption Notice and the
then primary manufacturer appears reasonably likely to be capable to
produce ordered quantities again before the end of such period, then
the Parties agree to assist such primary manufacturer to restore
supply in the shortest possible period and not to activate any
available second source during such three month period, unless
during such period the Supply Interruption then appears reasonably
likely to continue beyond three months.
(ii) From Three to Six Months. If the Parties mutually agree
that the Supply Interruption reasonably appears to be of more than
three but less than six months duration from the Supply Interruption
Notice or the then primary manufacturer appears reasonably unlikely
to be capable to produce ordered quantities again before the end of
such six month period, the Parties shall discuss in good faith and
decide whether it is necessary under all of the circumstances to
activate the second source in order to assure adequate future
supply, provided however, that IMED may require in the case of a
Cassette Supply Interruption that a second source Cassette
manufacturer be immediately activated.
(iii) More Than Six Months. If the Parties mutually agree that
the Supply Interruption reasonably appears to be of more than six
months duration from the Supply Interruption Notice or the then
primary manufacturer appears reasonably unlikely to be capable to
produce ordered quantities again after such period, the Parties
agree to immediately activate the second source Cassette
manufacturer (or in the case of Pumps or Accessories any second
source manufacturer selected by DEBIOTECH which is reasonably
acceptable to IMED as to reliability, quality, technical capability,
financial capability and creditworthiness) to have it operational in
the shortest possible delay.
If despite their commercially reasonable efforts the Parties cannot agree
on an analysis of the circumstances of the Supply Interruption or on the
best course of action to take, (i) either Party may subject the question
to the accelerated arbitration proceeding described in Article 22.3(a) and
until there is a final determination, DEBIOTECH shall proceed in
accordance with its commercially reasonable judgement or (ii) if neither
Party commences such an arbitration proceeding, DEBIOTECH shall in good
faith be entitled to follow its commercial reasonable judgment in solving
the Supply Interruption, both clauses (i) and (ii) being subject to the
following provisions:
(i) IMED Right to Request Second Source Activation. If during
the consultation period IMED believes that the second source
manufacturer should be immediately activated by DEBIOTECH because in
IMED's reasonable judgment the primary source will not be capable of
resuming adequate supply within six (6) months of the Supply
Interruption Notice, it shall deliver a written request to DEBIOTECH
to activate such second source ("IMED Activation Request").
(a) Debiotech Compliance. If DEBIOTECH complies with such IMED
Activation Request, the Parties shall follow such course of action
to conclusion and DEBIOTECH shall have a period of up to six (6)
months from and after receipt of the IMED Activation Request
to have such second source producing an adequate supply. In the
event that DEBIOTECH determines to comply with IMED's request
against its better judgment, it may promptly deliver a written
notice to IMED indicating the date by which it believed in its
reasonable judgment that the primary source would have been
producing an adequate supply. In the event that such notice was
provided to IMED and the primary source was able to cure the Supply
Failure prior to the date six (6) months after the IMED Activation
Request, DEBIOTECH shall be entitled to an additional grace period
under the liquidated damage provisions of Article 8.6 hereof equal
to the number of days between (x) the date of receipt of the IMED
Activation Request and (y) the date three (3) months after the
Supply Interruption Notice.
(b) DEBIOTECH Non-Compliance. If DEBIOTECH elects using its
reasonable commercial judgment to refuse to comply with the IMED
Activation Request and to continue with the first source, it shall
be entitled to follow such course of action so long as such primary
source is again producing an adequate supply before a date three (3)
months after the Supply Interruption Notice. DEBIOTECH shall
immediately activate its second source manufacturer in the event of
a Supply Interruption that is continuing after such three (3) month
period, unless (i) the Parties are then pursuing a mutually agreed
plan to continue with the primary source and such plan is reasonably
likely to result in the restoration of adequate supply within the
estimated time frame or in any event no later than six (6) months
after such IMED Activation Request or (ii) otherwise notified by
IMED. In the event that the primary source is not producing an
adequate supply six (6) months after receipt of the IMED Activation
Request or if DEBIOTECH subsequently changes it strategy and
activates the second source, DEBIOTECH shall be liable to IMED for
damages equal to the reasonable out-of- pocket costs incurred by
IMED as a direct result of being without supply during the period
between the date six (6) months after receipt of the IMED Activation
Request and the date DEBIOTECH's primary or second source
manufacturer, as the case may be, is actively producing an adequate
supply.
(ii) IMED Right to Require Arbitration. In the event that the
restoration of adequate supply has not been achieved within six (6)
months after the Supply Interruption Notice, IMED may request an
accelerated arbitration pursuant to Article 22.3 to determine the
best course of action if it reasonably believes that the current
course of action will not result in the restoration of adequate
supply more rapidly than an alternative proposed by IMED. DEBIOTECH
shall carry the burden of proof that such current course of action
will result in a restoration of adequate supply by the time
estimated.
The time periods in this Article 10.4(d) measured from the Supply
Interruption Notice shall be extended for Cassette Supply Interruptions by
two (2) days for every three days of supply reserve of Cassettes
maintained by DEBIOTECH in excess of the three (3) month reserve provided
for in Article 10.4(a) hereof and for Pump or Accessory Supply
Interruptions by one (1) day for every day of supply reserve of Pumps or
Accessories, as the case may be, maintained by DEBIOTECH, but in no event
shall the time periods be extended by more than nine (9) months.
10.5 Standby Arrangements. The parties have entered into this Article 10.5 in
order to provide to IMED the ability to obtain and sell the Products and
Accessories in the Territory under circumstances where, notwithstanding
the sequential application of the above provisions and the efforts of the
Parties hereto to perform this Agreement in good faith so as to continue
their relationships as contemplated herein, DEBIOTECH is no longer able
to, or does not, satisfy its obligations to provide IMED with its
reasonable requirements of Products and Accessories as contemplated
herein. Accordingly, in those cases where the Parties have been unable to
resolve a Supply Interruption problem pursuant to Article 10.4 through
their mutual assistance of the first source manufacturer or the transfer
of manufacture to a second source manufacturer selected by DEBIOTECH, the
second step in the resolution process will be either for IMED to contract
directly with SAGEM, Plastic Omnium or other first source manufacturer, as
the case may be, pursuant to a Standby Agreement, or for IMED to assume
direct responsibility for such manufacture pursuant to the Standby
License, in either case, in accordance with the respective provisions
which follow.
(a) Standby Agreements. On the Effective Date, DEBIOTECH shall
provide IMED with written undertakings from: (i) Malbec SA stating
that IMED will always have the opportunity to cure any DEBIOTECH
default under the license between DEBIOTECH and MALBEC SA
contemplated in Schedule 13.2 (the "Malbec License"), so that the
technology contemplated in the Malbec License will continue to be
available to IMED on terms which are at least as favorable as those
then currently provided to DEBIOTECH; and (ii) SAGEM and Plastic
Omnium to supply IMED directly with Product and Accessories on the
same terms at which IMED receives Product and Accessories from
DEBIOTECH under this Agreement, such undertakings attached hereto as
Exhibits 10.5A, 10.5B and 10.5C, respectively (the "Standby
Agreements"). IMED shall only be entitled to enforce its rights
under the Standby Agreements if: (i) the provisions of Article 10.4
have been complied with; (ii) three months have past since the
receipt of the Supply Interruption Notice; and (iii) in the event at
least one of the following has occurred: (x) the filing of a
bankruptcy case or reorganization proceeding (i.e. a composition) by
or against DEBIOTECH which has not been dismissed within ninety (90)
days; (y) the failure of DEBIOTECH to operate its business in the
ordinary course as it relates to the manufacture and sale of any
Product or Accessories for thirty (30) consecutive Business Days (or
forty (40) cumulative Business Days within any period of ninety (90)
Business Days and such failure has a material adverse effect upon
the ability of DEBIOTECH to supply such Product or Accessories in
accordance with Article 10.1; or (z) the failure of DEBIOTECH to
achieve the timely commencement of manufacture within six (6) months
of the supply interruption to IMED for the Pump or three (3) months
of the supply interruption to IMED for the Cassette (in any such
case, a "Supply Failure"); provided, however, that:
(i) Force Majeure. If the Supply Interruption is due to a
Force Majeure event, as described in Article 19.1, DEBIOTECH
shall provide notice to IMED of the occurrence of such event
within fifteen (15) days following such occurrence and
DEBIOTECH shall, upon IMED's request, provide IMED with
reasonable assurances that DEBIOTECH will manufacture (or
cause to be manufactured) and sell such Product and
Accessories to IMED within ninety (90) days of the occurrence
of such Force Majeure event, then the same shall not be deemed
to be a Supply Failure hereunder and the time periods
contemplated in Article 10.4 shall not begin to run during the
period which is the lesser of: (a) the continuing existence of
such Force Majeure event; and (b) ninety (90) days.
(ii) Recall. If the Supply Interruption is the result of
design and/or manufacturing modifications which are necessary
to respond to a Mandatory or Voluntary Recall event under
Article 11.3 hereof, then the same shall not be deemed a
Supply Failure hereunder, so long as DEBIOTECH expends its
commercially reasonable efforts to eliminate the causes
thereof and again commences and continues supply of such
Product and Accessories in accordance with the terms of this
Agreement within the shortest time reasonable under the
circumstances following the occurrence of such recall event,
and the time periods contemplated in Article 10.4 shall not
begin to run during the period of which is the lesser of: (a)
the continuing existence of such recall event; and (b) ninety
(90) days; or
(iii) Major Component. If the Supply Interruption is the
result of the general unavailability of a major component to a
Product or Accessory (other than the Pump motor) which was
(x) commonly available from multiple sources immediately prior
to its unavailability or (y) only available from one source
which was reliable immediately prior to the unavailability of
such component, which DEBIOTECH is unable to obtain either
through its own sources or with the advice and assistance of
IMED which IMED agrees to use commercially reasonable efforts
to provide, then the same shall not be deemed a Supply Failure
hereunder so long as DEBIOTECH expends commercially reasonable
efforts to eliminate the causes thereof and again commences
and continues supply of such Product and Accessories in
accordance with the terms of this Agreement, within the
shortest time reasonable under the circumstances following the
occurrence of the general unavailability of a major component.
As soon as DEBIOTECH is again able to and does assume all of its
supply obligations under the Agreement, then IMED's rights under the
Standby Agreements shall terminate with respect to such Supply
Failure.
DEBIOTECH represents and warrants that the price for the Products
and Accessories paid by IMED to SAGEM or Plastic Omnium or other
manufacturer, as the case may be, under the Standby Agreements will
not be more than the price for Products and Accessories paid by IMED
to DEBIOTECH.
(b) Standby Licenses. DEBIOTECH hereby grants IMED under all
Technology: (i) an exclusive license (or non-exclusive license
pursuant to Article 12.2, as the case may be) to use, market, sell,
lease and distribute any of the Products or Accessories in the
Territory, limited to the Field of Application; (ii) a non-
exclusive license to have made worldwide any of the Products and
Accessories by a Third Person manufacturer(s) selected by IMED which
is reasonably acceptable to DEBIOTECH (or by IMED itself, but only
if neither IMED nor DEBIOTECH can procure a Third Person
manufacturer within a reasonable period of time), and subject to
appropriate confidentiality and exclusivity undertakings to
DEBIOTECH; and (iii) a nonexclusive right to modify, adapt and
further develop any of the Products or Accessories (collectively,
the "Standby Licenses").
IMED shall be entitled to exercise its rights under the Standby
Licenses by sending a written notice to DEBIOTECH (the "Standby
Notice") only after the provisions of Article 10.4 have been fully
complied with and in the event all of the following have occurred:
(i) a Supply Failure exists; (ii) thirty (30) days have passed after
written notice from IMED to DEBIOTECH, and to SAGEM or Plastic
Omnium, as the case may be, that either SAGEM or Plastic Omnium, as
the case may be, has failed or is unable to fulfill its obligations
under the applicable Standby Agreement and such failure has not been
cured within such thirty (30) day period; and (iii) DEBIOTECH has
not undertaken effective steps to assure that adequate supply will
be restored by a second source manufacturer in a time-frame
reasonably likely to be shorter than the time that will be required
for IMED to achieve production with its Third Person manufacturer.
The Standby Licenses arising under this Article 10.5(b) shall apply
only to those Products and Accessories the supply of which is
affected and only so long as the supply is affected. In the event
that DEBIOTECH contests the existence of the conditions entitling
IMED to exercise such Standby License rights, DEBIOTECH shall have
the right to submit that question to accelerated arbitration under
Article 22.3 hereof and IMED's ability to exercise such rights shall
be stayed until a final determination by such arbitrator.
In the event that IMED were to exercise its rights under the
Standby Licenses and directly contract with a Third Person
manufacturer to manufacture Pumps, Cassettes or Accessories (or IMED
manufactures the same itself), as the case may be, DEBIOTECH shall
be immediately thereafter relieved of all obligations under this
Agreement relating to the manufacture of any Product or Accessory
pursuant to the Standby License including, without limitation, all
supply, delivery, quality control, warranty, Recall, Epidemic
Failure, and liability of all kinds and description only with
respect to those Products and Accessories so manufactured by such
Third Person manufacturer (or IMED).
With respect to all such Pumps, Cassettes or Accessories, as
the case may be, manufactured for IMED by such Third Person
manufacturer (or by IMED itself), IMED shall pay to DEBIOTECH an
annual royalty in lieu of any royalty payable under Article 9 hereof
on such Pump Net Proceeds of Sales, Cassette Net Proceeds of Sales
or Accessory Net Proceeds of Sales, as the case may be, equal to the
sum of (i) [CONFIDENTIAL TREATMENT REQUESTED] of such Net Proceeds
of Sales plus (ii) [CONFIDENTIAL TREATMENT REQUESTED] of IMED's
Gross Margin (in this case limited to such Pump, Cassette or
Accessory and before such royalty payment is taken into
consideration) in excess of [CONFIDENTIAL TREATMENT REQUESTED] but
such royalty shall not apply to any portion of IMED's Gross Margin
beyond [CONFIDENTIAL TREATMENT REQUESTED]. Such royalty shall be
paid annually at the times and in accordance with the procedures
generally provided for royalties in Article 9.5. IMED shall be able
to take as a credit against such royalties in excess of
[CONFIDENTIAL TREATMENT REQUESTED] all of its reasonable
out-of-pocket costs of transferring manufacture to a Third Person
manufacturer or the direct cost of transferring manufacture to IMED,
as the case may be. IMED agrees that so long as any such Third
Person manufacturer is reasonably capable of manufacturing
quantities of such Product or Accessory in excess of IMED's supply
requirements, (i) DEBIOTECH shall be free to obtain supply directly
from such Third Person manufacturer and (ii) such Third Person
manufacturer may, to the extent the same do not contain any of
IMED's Patented Technology (as hereinafter defined), use the molds
and equipment used to manufacture such Product or Accessory for IMED
with no payment to IMED in respect thereof.
(c) Transfer of Know-How. Following the first commercial sale of any
Product or Accessory in the Territory and upon written notice from
IMED, DEBIOTECH shall deposit duplicates of all material
Confidential Information, and other specifications, drawings,
methods and test data which relate to the manufacture of the Product
and Accessories (including procurement of all components) (the
"Manufacturing Information") in a safe deposit box, vault or
appropriate safe locked storage in a bank or other appropriate
facility located in Switzerland (the "Vault") under the joint
supervision of DEBIOTECH's General Counsel and IMED's General
Counsel. The annual cost of the Vault shall be shared equally by the
Parties. Contemporaneously therewith, DEBIOTECH shall provide to
SAGEM and PLASTIC OMNIUM and their respective approved successor
manufacturers copies of Manufacturing Information. DEBIOTECH shall
also periodically (but not less frequently than semi-annually)
deposit in the Vault duplicates of all revisions, modifications,
updates and enhancements to such information which may be developed
or acquired by DEBIOTECH from time to time during the duration of
this Agreement. IMED shall have the right periodically (but not more
frequently than quarterly), upon ten (10) Business Days' prior
written notice to DEBIOTECH, to appoint an independent
representative reasonably acceptable to DEBIOTECH and subject to
appropriate confidentiality undertakings to DEBIOTECH, to visually
inspect but not copy, photograph, take notes on (other than to
inventory the contents thereof) or otherwise remove the
Manufacturing Information to determine if such Manufacturing
Information is complete (which inspection shall be conducted at
DEBIOTECH's option in the presence of a DEBIOTECH representative).
The Manufacturing Information shall not be used by or released to
any of IMED's other representatives until ten (10) days after the
Standby Notice has been provided to DEBIOTECH in accordance with
Article 10.5(b); provided, however, that if DEBIOTECH contests the
existence of the conditions entitling IMED to exercise the Standby
License by sending IMED a written notice of objection within five
(5) Business Days from receipt of the Standby Notice, DEBIOTECH
shall have the right to submit that question to accelerated
arbitration under Article 22.3 hereof and the Manufacturing
Information shall not be used or released to any of IMED's
representatives until a final determination by such arbitrator. All
Manufacturing Information provided under this Article 10.5(c) shall
be deemed to be Confidential Information and shall be subject to the
terms of Article 18. Such Information may be used only as
contemplated in Article 10.5(a) and 10.5(b).
(d) Use of Manufacturing Equipment. DEBIOTECH agrees that SAGEM and
Plastic Omnium (or approved successors) may use the Manufacturing
Equipment (including, without limitation, new Manufacturing
Equipment) in connection with the fulfillment of their obligations
under the Standby Agreements. In addition, DEBIOTECH shall execute
such documents and take such action, or cause the same to be
executed or taken, as the case may be, as may be reasonably
necessary to enable SAGEM and Plastic Omnium to use the
Manufacturing Equipment in connection with the foregoing. Because
DEBIOTECH has supply obligations to other distributors that require
the use of the Manufacturing Equipment, DEBIOTECH grants no rights
to IMED to use the Manufacturing Equipment in connection with the
Standby Licenses.
DEBIOTECH agrees to maintain and take all reasonably necessary
actions to ensure that the Manufacturing Equipment remains free and
clear of all liens, claims and encumbrances which would prevent IMED
from exercising and utilizing any of its rights under the Standby
Agreements.
(e) Technical Assistance. Following the exercise by IMED of its
rights under the Standby Licenses, at IMED's reasonable request and
from time to time, DEBIOTECH shall provide its technical and other
personnel to provide: (a) non-documentary and other Manufacturing
Information not previously furnished; and (b) consulting assistance
to IMED in utilizing the Manufacturing Information, dealing with
regulatory agencies and in connection with the manufacture and sale
of the Product and Accessories. In addition, DEBIOTECH shall execute
such documents and take such action as may be reasonably necessary
to transfer any registrations of the Product and Accessories into
IMED's name for the purpose of enabling IMED to utilize the Standby
Licenses.
The Standby Agreements and Standby License shall apply only with respect
to the particular Pump, Cassette or Accessory, as the case may be, that
are subject to Supply Interruption. An interruption in the supply of only
one product such as Pumps, for example, shall not cause IMED to have any
rights under the Standby Agreements or Licenses with respect to any other
product such as Cassettes or Accessories, for example.
ARTICLE 11: WARRANTIES/QUALITY CONTROL/PRODUCT CHANGES
11.1 Warranty.
(a) Quality. DEBIOTECH warrants that the Products, Accessories and Spare
Parts shall be manufactured by or for DEBIOTECH by exerting the greatest
care and in accordance with applicable laws and regulations. DEBIOTECH
warrants that the Products, Accessories and Spare Parts, as delivered to
IMED or its Affiliates shall: (i) conform to the Specification Documents;
(ii) be free from manufacturing defects; and (iii) not be "adulterated" or
"misbranded" as such terms are defined in the Act.
DEBIOTECH shall be responsible, at its sole expense, for complying with
all applicable regulatory requirements relating to the manufacture of the
Product and Accessories for sale in the Territory, including the Act, Good
Manufacturing Practices and other requirements of the FDA.
(b) Title. DEBIOTECH warrants that upon delivery to and payment by IMED,
the Products, Accessories and Spare Parts shall be free from any and all
claims, demands, encumbrances, and liens affecting title, and DEBIOTECH
will defend title thereto.
(c) Exclusions. The warranties of DEBIOTECH set forth above shall not
apply to any Product which: (a) has been tampered with or otherwise
altered by Persons other than DEBIOTECH or its Affiliates or other than
pursuant to and in accordance with DEBIOTECH's directions; or (b) has been
subjected to misuse, negligence or accident by Persons other than
DEBIOTECH or its Affiliates; or (c) is a Refurbished Pump.
(d) Remedy.
(i) Pump. As IMED's sole remedy for breach of warranty, should any
failure to conform with the warranties in Article 11.1 (a) above appear
within [CONFIDENTIAL TREATMENT REQUESTED] after a Pump is delivered by
IMED to an end user, or [CONFIDENTIAL TREATMENT REQUESTED] after a Pump is
delivered to IMED by DEBIOTECH, whichever period ends first, DEBIOTECH
shall promptly repair or replace free of charge any Pump not meeting
DEBIOTECH's above warranty during the said warranty period; provided,
however, that if replacing or repairing the defective Pump fails to remedy
the defect, IMED is entitled at its choice to rescind the sales contract
insofar as the defective Pump is concerned or to reduce the purchase price
by an appropriate amount agreed by DEBIOTECH. IMED shall pay the cost of
shipping the defective Pump to DEBIOTECH and DEBIOTECH shall pay the cost
of shipping the repaired or replacement Pump to IMED.
(ii) Cassettes, Accessories and Spare Parts. As IMED's sole remedy
for breach of warranty, should any failure to conform with the warranties
in Article 11.1 (a) above appear within [CONFIDENTIAL TREATMENT REQUESTED]
after a Cassette, Accessory and/or Spare Part is delivered to IMED by
DEBIOTECH: (a) IMED shall notify DEBIOTECH of any Cassette, Accessory
and/or Spare Part not meeting DEBIOTECH's above warranty; and (b) IMED
shall, if available from IMED's customer, ship to DEBIOTECH or destroy, at
DEBIOTECH's option and IMED's cost, the defective Cassette, Accessory
and/or Spare Part; and (c) DEBIOTECH shall promptly supply to IMED a
Cassette, Accessory and/or Spare Part replacing the defective one(s) at no
cost to IMED, except that DEBIOTECH shall replace each defective Cassette
which has been supplied by IMED to a customer in a Cassette Set with two
(2) replacement Cassettes at no cost to IMED.
Notwithstanding the foregoing clauses (i) and (ii), Third Person
liabilities shall be treated in accordance with Article 20.3.
(e) Dispute concerning Defect. In the event that the Parties do not agree
as to the existence of a defect and/or the applicability of warranty
provisions, that question shall be submitted to an independent third party
expert accepted by both Parties, bound with DEBIOTECH by adequate
confidential obligations, for a final and binding determination. The cost
of such expert and expertise procedure shall be at the full charge of the
Party which was wrong in its interpretation of the defect and/or
applicability of the warranty provisions.
11.2 Quality Control.
(a) Inspection by DEBIOTECH. Prior to shipment, the Product and
Accessories shall be subjected to a quality control inspection by
DEBIOTECH or its manufacturer in accordance with the Quality Control
Procedures. Upon reasonable prior written notice, DEBIOTECH shall permit
the IMED independent person designated below to review periodically
DEBIOTECH's production and quality control procedures and records and to
visit DEBIOTECH's manufacturer's facilities, at reasonable times with a
representative of DEBIOTECH present, in order to assure satisfaction of
the requirements of this Article 11.2(a).
(b) Inspection by IMED. Upon receipt of any Cassettes or Accessories, IMED
shall perform a visual lot inspection of Cassettes or Accessories for
conformance with the Specification Documents and for manufacturing
defects.
Any quality control conducted by IMED on the production site shall be
handled at IMED's cost, by an independent Person acceptable to both
Parties and bound vis-a-vis DEBIOTECH by an appropriate confidentiality
agreement. Such on site inspection shall be limited to once per Contract
Year, except in the event of material or recurring defects.
(c) Quality Control Certificate and Records. DEBIOTECH agrees to supply,
and to attach to each shipment of Products and Accessories a quality
control certificate indicating compliance by DEBIOTECH with the
requirements of Article 11.2(a). DEBIOTECH agrees to keep for further
reference one sample Cassette of each shipment of Cassettes and all
manufacturing documentation and records pertaining to the Product and
Accessories for the period required by applicable laws or regulation in
the country where such Products and Accessories are sold.
11.3 Product Recall.
(a) Mandatory Recall. In the event that a nonappealable administrative or
judicial order (the "Recall Order") is issued or requested by an entity or
authority having legal jurisdiction in the matter, IMED shall comply with
the Recall Order and DEBIOTECH shall cooperate as herein provided. IMED
shall be responsible for the administrative and transportation costs and
expenses of complying with such Recall Order including, the cost of
notifying customers and the costs associated with handling and any
necessary shipment of such recalled Products and Accessories. DEBIOTECH
shall be responsible for the costs of repair or replacement of such
recalled Product or Accessory, up to an amount equal to the Recall Amount.
All repair or replacement costs of the Recall Order in excess of such
amount paid by DEBIOTECH shall be paid from the proceeds of the Recall
Insurance Policy obtained by DEBIOTECH to cover such risk, the premiums
for such policy being shared equally by the Parties, or if no such Recall
Insurance Policy is then available, shall be shared equally by the
Parties. Third Person liabilities shall be treated in accordance with
Article 20.3.
(b) Voluntary Recall. In the event that DEBIOTECH or IMED reasonably
believes that any Product or Accessory violates any provision of
applicable law, rule or regulation or should be recalled due to health or
safety considerations, DEBIOTECH and IMED shall consult in good faith
concerning the necessity for implementing any action and the means of
implementing the same and shall mutually agree to take such action in
respect thereof as is necessary. In such an event, the Voluntary Recall
shall be treated in accordance with Article 11.3(a) hereabove, including,
without limitation, calculation of costs.
(c) Epidemic Failure. In the event of an Epidemic Failure of any Product
or Accessory not constituting a Mandatory or Voluntary Recall and
occurring after the expiry of the warranty period, DEBIOTECH and IMED
shall consult in good faith concerning the action to be taken regarding
such Product and/or Accessory and the means of implementing the same and
shall mutually agree to take such action in respect thereof as is
necessary including those Products and Accessories to be supplied by
DEBIOTECH to IMED in the future (the "Necessary Action"). In such an
event, the Necessary Action shall be treated in a manner consistent with
Article 11.3(a) hereabove, including, without limitation, calculation of
costs.
(d) Recall Cooperation. DEBIOTECH and IMED will keep one another fully
informed with respect to any information, inquiry or correspondence from
any government, agency or authority relating to the investigation or
review of Product and Accessories compliance with applicable legal, health
or safety requirements including prompt delivery to the other Party of all
correspondence with any such government authority or agency as well as
with any purchaser, customer or other user of such Product and
Accessories. DEBIOTECH and IMED will cooperate fully with each other in
effecting any recall or any other type of corrective action with respect
to any Product and Accessories.
(e) Exclusion. Nothing in this Article 11.3 applies to any rechargeable
battery, rechargeable battery module and/or rechargeable battery pack.
11.4 Service Obligations. In addition to the obligations under Article 11.1(d)
above, DEBIOTECH shall, at its expense, to the extent DEBIOTECH determines
to modify software in order to: (i) permit the Products to comply with
applicable regulatory requirements; or (ii) to improve product safety,
provide, when possible, software update cards or other software media to
IMED for replacement by IMED or the customer; provided, however, the cost
for new microprocessors or memory chips (such as EEPROM) provided under
the Article 11.4 shall not be at DEBIOTECH's expense.
11.5 Remedy Exclusive. With respect to the warranty obligations contained in
Article 11.1 (a) and the recall obligations contained in Article 11.3, so
long as DEBIOTECH honors such obligations, IMED shall not be entitled to
ask for any losses, costs, damages, compensation, reimbursement, or
damages on account of the loss of prospective profits on anticipated
sales, or on account of expenditures or commitments incurred in connection
with the business or goodwill of IMED, interest and/or indemnification
(except for Third Party liabilities) of any type other than the repair or
replacement of the defective Product under the warranty limitation
described in Article 11.1(a) or the recall obligations described in
Article 11.3. Third Party liabilities shall be treated in accordance with
Article 20.3.
11.6 Disclaimer. DEBIOTECH makes no warranties or guarantees, express or
implied, with respect to the Product or Accessories except and to the
extent that such warranty is set forth in this Article 11. This warranty
is extended only to IMED and to no other persons. THERE SHALL BE NO OTHER
WARRANTIES, EXPRESS OR IMPLIED, ON THE PART OF DEBIOTECH WITH RESPECT TO
ANY OF THE PRODUCT OR ACCESSORIES EXCEPT THE WARRANTIES CONTAINED HEREIN.
ARTICLE 12: Minimum Orders
--------------------------
12.1 Minimum Pump and Cassette Orders. From the First Introduction Date in each
country of the Territory, the following minimum quantities of Pumps and
Cassettes shall be applicable for each Country Year:
Pumps:
COUNTRY: 1st Ye2nd Year 3rd Year 4th Ye5th Year
USA
Canada [CONFIDENTIAL TREATMENT REQUESTED]
Mexico
Cassettes:
COUNTRY: 1st Ye2nd Year 3rd Year 4th Ye5th Year
USA
Canada [CONFIDENTIAL TREATMENT REQUESTED]
Mexico
The above minimum quantities are established for each country for each
corresponding Country Year and shall be based upon Firm Orders placed by
IMED for delivery during the applicable Country Year.
Firm Orders for delivery during the last Quarter of any Country Year may,
to the extent that they exceed the minimum quantities applicable for that
Country Year, be counted towards the minimum quantities of the following
Country Year.
At the end of each five (5) year anniversary of the First Introduction
Date, the Parties shall discuss in good faith and agree for each country
of the Territory on minimums with respect to the Pump and Cassettes for
the next five (5) year period (or the balance of the term of the Agreement
if shorter) which shall be reasonable under the circumstances (including
the possibility that such minimums would decrease), with the rebuttable
presumption that such minimums should continue at the last applicable
level.
The minimum order amounts shall be increased by [CONFIDENTIAL TREATMENT
REQUESTED] in the event of the occurrence of a Change of Control of IMED
or of a sale or transfer of all or substantially all of the assets of IMED
to a Third Person.
12.2 Right of Offset; Loss of Exclusivity. Notwithstanding anything to the
contrary in this Agreement, any shortage of minimum orders in one of the
countries mentioned in Article 12.1 hereabove in any corresponding Country
Year (year "Y") may be offset by an excess of orders and distribution in
another one of such countries (however, such offsetting is possible only
one time for each country, and the excess of one country can not be
counted more than one time for the offset of another country). Otherwise,
IMED would immediately and irrevocably lose its exclusive right regarding
the Product and Accessories for such country concerned with immediate
effect after written notice by DEBIOTECH.
In the event of such an offset, IMED would have a limited further three
(3) months period to order the shortage of Cassette and Pumps in the
concerned country together with [CONFIDENTIAL TREATMENT REQUESTED] of the
minimum Quantity of Cassette and/or Pumps for the next Country Year (Year
"Y+1") in the same country (the "Minimum Order Cure Period").
In the event that IMED fails to meet the minimum order requirements for
Pumps in any Country Year, following the expiration of the Minimum Order
Cure Period and receipt of written notice thereof from DEBIOTECH, IMED
would immediately and irrevocably lose its exclusive right under Article
12.2 regarding the Product and Accessories, and its exclusive rights under
Article 2.1 and 4.3 hereof for the applicable country.
In the event that IMED fails to meet the minimum order requirements for
Cassettes in any Country Year, following the expiration of the Minimum
Order Cure Period and receipt of written notice thereof from DEBIOTECH,
IMED shall pay to DEBIOTECH a royalty on the Cassettes Sets (excluding the
Cassette/Reservoir Module) sold in the applicable country, provided that
IMED's overall Gross Margin on Products and Accessories exceeds
[CONFIDENTIAL TREATMENT REQUESTED], in an amount equal to [CONFIDENTIAL
TREATMENT REQUESTED] of the amount, if any, by which IMED's Gross Margin
on such Cassette Sets exceeds [CONFIDENTIAL TREATMENT REQUESTED].
Notwithstanding the foregoing, if IMED's failure to meet any minimum order
requirement in any Country Year is due to the failure of DEBIOTECH to
perform its obligations under the Agreement, then IMED shall be deemed to
have satisfied such minimum order requirement for such Country Year.
Furthermore, if IMED's failure to meet such minimum orders is due to a
Supply Interruption, then the Parties shall discuss in good faith and
agree on an appropriate reduction on minimum orders for Products and
Accessories for the remainder of the five year period, which shall be
reasonable under the circumstances.
If IMED loses its exclusive right regarding the Product and Accessories in
any country according to the provisions of this Article 12.2, DEBIOTECH
would continue to supply IMED for this country on a non-exclusive basis
according to the conditions set forth in Article 8 except that the price
to IMED shall not be more than the price charged by DEBIOTECH to any other
Distributor for the same Product and
Accessories for the Field of Application in the same country of the
Territory for corresponding order volumes and quality.
ARTICLE 13: PATENT RIGHTS AND KNOW-HOW
13.1 Patents. The Cassette has been patented in the USA under Nr 5.044.902. A
patent is pending in Canada under Nr 2.011.988.8. Further patents are
pending concerning the Cassette and Pump in several countries of the
Territory, as set forth on Enclosure 2.
13.2 DEBIOTECH Representations. DEBIOTECH makes no representations with respect
to the Technology, except for the representations set forth below:
(i) DEBIOTECH is the exclusive licensee of the Cassette Patent for the
Product in the Field of Application and the Cassette Patent, to the
best of DEBIOTECH's knowledge (after reasonable investigation) up to
the Effective Date, is free from third party claim of infringement;
(ii) The Cassette Patent has been properly filed, prosecuted and issued
in the respective offices and jurisdictions, and all applicable fees
due and payable have been paid;
(iii) Except as disclosed on Schedule 13.2, neither DEBIOTECH nor any
member of the DEBIOTECH Group is the licensee or sublicensee of any
Technology regarding any Product or Accessory.
(iv) The Product and Accessories, to the best of DEBIOTECH's knowledge
(after reasonable investigation) up to the Effective Date, do not
contain any Intellectual Property that infringes the Intellectual
Property rights of any Third Person;
(v) DEBIOTECH has the sole and exclusive right to enter into this
Agreement and there are no outstanding assignments, grants,
licenses, encumbrances, obligations or agreements, whether written,
oral or implied, which are inconsistent with this Agreement; and
(vi) DEBIOTECH is the owner of the existing Manufacturing Equipment.
13.3 Limitation on DEBIOTECH Representations. Except as expressly provided in
this Agreement, nothing in this Agreement shall be construed as:
(a) A warranty or representation that anything used or sold or otherwise
disposed of under any license or grant of rights in this Agreement is or
will be free from infringement of patents of Third Persons;
(b) An obligation by DEBIOTECH to bring or prosecute actions or suits
against Third Persons for infringement of any Patent; or
(c) An obligation by DEBIOTECH to furnish any Manufacturing Information to
IMED.
13.4 Infringement. In the event that (i) the Cassette or (ii) any elements of
the Pump v.1A or Pump v.2 that were based on technology contained in Pump
v.1 or on any of DEBIOTECH's issued or pending Patents on a worldwide
basis as of the Effective Date (the "Existing Patented Technology") is
determined to infringe in any country in the Territory the Intellectual
Property of any Third Person by a final, non-appealable judgment of a
court of competent jurisdiction, then DEBIOTECH shall be obligated to pay
[CONFIDENTIAL TREATMENT REQUESTED] of all royalties, damages and any other
costs associated therewith, up to an amount equal to [CONFIDENTIAL
TREATMENT REQUESTED] of DEBIOTECH's transfer price to IMED of all Products
and Accessories included in the damage award. In the event that any new
element of Pump v.1A or Pump v.2 which was not based on technology
contained in Pump v.1 or on any Existing Patented Technology or Accessory
is determined to infringe in any country in the Territory the Intellectual
Property of any Third Person by a final, nonappealable judgment of a court
of competent jurisdiction, then DEBIOTECH shall be obligated to pay
[CONFIDENTIAL TREATMENT REQUESTED] of all royalties, damages and costs
associated therewith without limit. IMED shall be obligated to pay the
balance of such royalties, damages and costs in either such case.
13.5 Patent Prosecution. DEBIOTECH and IMED shall promptly report to each other
all information received relating to any actual or threatened infringement
of any Patent or patent application concerning the Product and/or
Accessories, in any country in the Territory and shall cooperate in
defending the Patents. If any infringement occurs in the Territory, IMED
may take an action at its own expense against any such infringer
(including, without limitation, commencement of legal action) and shall
keep DEBIOTECH regularly informed about any detail of such action.
DEBIOTECH shall be free to join IMED's action at any moment, at its own
expense.
If IMED does not make a timely effort to take such action, DEBIOTECH may,
after a written notice to IMED has been left without effect for at least
two (2) months, take an action against such infringer at its own expense
and DEBIOTECH shall keep IMED regularly informed about any detail of such
action. IMED shall be free to join DEBIOTECH's action at any moment, at
its own expense.
In the event any such action should result in any indemnification of any
type (damages, expenses, etc... ) to any Party hereto, such
indemnification shall first be applied to cover the legal and other
expenses directly incurred by the Parties hereto in connection thereto,
and the surplus shall be shared in equal proportion between DEBIOTECH and
IMED.
13.6 Patent Maintenance. DEBIOTECH undertakes and agrees to use commercially
reasonable efforts to maintain or obtain, as the case may be, reasonably
necessary and desirable patent coverage with respect to the Technology,
including, without limitation: (i) using commercially reasonable efforts
to cause the Patents to remain in full force and effect until their
respective stated expiration dates; and (ii) entering into confidential
agreements with respect to the Technology.
If at any time during the duration of this Agreement, DEBIOTECH intends to
abandon or allow to lapse any of the Patents, patent applications and/or
any rights to the Technology, DEBIOTECH shall notify IMED in writing of
such intent at least forty-five (45) days before the proposed date of
abandonment or lapse.
In such event, and if requested by IMED within fifteen (15) days following
DEBIOTECH's notice, DEBIOTECH shall take any and all appropriate measures
to maintain such Patent, patent application and/or rights to Technology at
IMED's costs. In such circumstances, IMED will be allowed to recover the
costs mentioned above by offsetting them against the purchase price of the
Cassettes delivered by DEBIOTECH for the country(ies) concerned, and
within a limit of [CONFIDENTIAL TREATMENT REQUESTED] of the Cassette
price, provided such Patent precludes the distribution or sale of the
Product by Third Persons as it is manufactured for IMED.
IMED shall be under no obligation to prosecute or maintain any patent
application or Patent under the provisions of this Article 13.6.
IMED shall not challenge, directly or indirectly, the Cassette Patent.
13.7 IMED's Technology.
(a) No Patents on Product. IMED shall have freedom to carry on its normal
research and development activities involving pumps or otherwise
(including any products relating thereto). However, IMED agrees that, in
addition to its undertakings in Article 5.8 hereof, concerning research
and development, unless the parties agree otherwise, IMED will not use
DEBIOTECH's Confidential Information or Technology in preparing any patent
applications. If notwithstanding such undertakings it is determined that a
future patent obtained by IMED was prepared using DEBIOTECH's Confidential
Information or Technology, IMED shall grant DEBIOTECH a royalty free
worldwide license for all fields to manufacture, use, market, sell, or
sublicense only the technology covered by the claims of said patent which
have been determined to be based on DEBIOTECH's Confidential Information
or Technology for so long as said patent is valid (notwithstanding
termination or expiration of this Agreement). IMED will not apply for any
patent which is derivative of DEBIOTECH's Patents (such that if such
patent was filed by DEBIOTECH it would be considered under U.S. law to be
a continuation-in-part). IMED will not file patent applications as part of
a scheme to limit the improvement of the Products.
(b) DEBIOTECH Use of IMED's Technology. Consistent with the provisions of
Article 5.10(c) IMED may refuse to permit DEBIOTECH to use any IMED
patents or patent applications ("IMED's Patented Technology") for any
purpose, including, without limitation, in any Improvement to the Product,
Accessories or New Developments for which IMED has exercised its rights or
may limit the use of IMED's Patented Technology to Products, Accessories
or such New Developments manufactured by DEBIOTECH for IMED. DEBIOTECH may
refuse to incorporate IMED's Patented Technology into such Improvement if
DEBIOTECH is able to obtain an equivalent result without such
incorporation or if DEBIOTECH can reasonably show that such incorporation
would bring no material advantage to the Product or Accessory, unless IMED
agrees to grant to DEBIOTECH a royalty free non-exclusive worldwide
license on such patents, in connection with such Products, Accessories or
New Developments, with the right for DEBIOTECH to sub-license to its
Distributors outside the Territory or Field of Application, for as long as
those patents are valid (notwithstanding termination or expiration of this
Agreement).
(c) Effect of IMED's Technology on Net Proceeds of Sales. In the event
that IMED's Patented Technology is incorporated into a Pump and IMED is
able to establish with objective evidence that such Pump has a materially
improved competitive position as a direct result thereof such that the
sales price for the Pump can be increased, the Parties agree to negotiate
in good faith an appropriate exclusion from the Pump Net Proceeds of Sales
so that IMED does not pay royalties to DEBIOTECH based on the increased
margin due solely on IMED's Patented Technology and which would result
from the sale of such improvement in another product.
ARTICLE 14: SALES PROMOTION/TRAINING AND SERVICING
14.1 Direct Sales. IMED will be solely responsible for promoting the sales of
the Product in the Field of Application in the Territory, and will alone
bear any related costs of such promotion. IMED shall also maintain at all
times throughout the duration of this Agreement an appropriate sales
force, subject to IMED's right to use sub-Distributors outside the USA
pursuant to Article 2.1 hereof, for the Product commensurate with the
sales in every country of the Territory and use commercially reasonable
efforts in connection with the sale and distribution of the Products
pursuant to this Agreement.
In respect of any Contract Year and for purposes of this Article 14.1,
IMED shall be presumed to have satisfied its obligation to use
commercially reasonable efforts if IMED has satisfied the minimum orders
contemplated in Article 12.1; provided, however, that IMED's failure to
satisfy such minimum orders in any Contract Year shall not alone
constitute conclusive evidence that IMED has failed to use commercially
reasonable efforts.
14.2 Service Assistance.
(a) Disclosure. At the request of IMED, DEBIOTECH shall supply to IMED
reasonable technical information, including service manuals, regarding
each Product's and Accessory's functioning, maintenance and use.
(b) Training Assistance by DEBIOTECH; Fees and Expenses. At the request of
IMED, DEBIOTECH shall reasonably assist in the training of the service
managers of IMED and its Affiliates to maintain and service the Products
and Accessories.
Unless the Parties otherwise agree, such training shall be conducted in
the English language at DEBIOTECH facilities. The manner and extent of
instruction, the number of trainees, and the date, location, duration and
frequency of instruction shall be reasonably agreed to by DEBIOTECH. In
addition to the foregoing, DEBIOTECH agrees to provide technical
assistance for promotional events at the launch of Products as well as for
the introduction of Products to IMED's Affiliates.
DEBIOTECH will be entitled to charge IMED a per diem lump sum (per
participating member of DEBIOTECH's personnel) of seven hundred fifty
Swiss Francs (750 Sfr.), plus all reasonable related costs and expenses,
including, without limitation, travel and hotel expenses, incurred by
DEBIOTECH in connection with this Article 14.2(b).
(c) Spare Parts. In furtherance of the foregoing, DEBIOTECH will supply to
IMED Spare Parts for all Products and Accessories solely for maintenance,
repair or refurbishment. If IMED orders Spare Parts to have Pumps repaired
or refurbished under its own responsibility, the sub-units and parts will
be invoiced by DEBIOTECH to IMED at a price not to exceed the price
invoiced to DEBIOTECH by its manufacturer increased by [CONFIDENTIAL
TREATMENT REQUESTED] for overhead (the "Parts Price").
In case of a change of the Specification Document implying the change of
Spare Parts so that new Spare Parts could not be used for old Pumps or
Accessories and old Spare Parts could not be produced later on, DEBIOTECH
shall inform IMED of the occurrence of such change and IMED shall give
notice to DEBIOTECH of the reasonable quantity of Spare Parts according to
old Specification Document which need to be stored at manufacturer's plant
for the possible repair or maintenance (but not refurbishment) of old
Pumps or Accessories. IMED and DEBIOTECH shall each bear fifty per cent
(50%) of the Parts Price for such Spare Parts and their storage, the
foregoing amount paid by IMED (i) being credited against fifty per cent
(50%) of the Spare Parts Price when Spare Parts are later ordered by IMED;
and (ii) in the event that the Agreement has terminated or expired, being
reimbursed to IMED as such Spare Parts are sold by DEBIOTECH from time to
time.
14.3 Training by IMED. IMED will take all necessary measures and full
responsibility to train, in the manner normally used by IMED for its own
similar products, its own personnel, sales and service staff, hospital
staff, and all other users, in the use of the Product in a way
commensurate with its intended use in every country of the Territory, as
well as in organizing the after-sales service and maintenance for the
Product for as long as any Product may still be in use.
14.4 Progress Reports; Marketing Meetings. IMED will keep DEBIOTECH regularly
informed on the progress of sales of the Product and Accessories, country
by country. In connection therewith, IMED shall provide to DEBIOTECH: (i)
preceding each calendar year, IMED's marketing strategy, including a
tactical marketing plan, and amendments thereto, if any, from time to time
during such calendar year; and (ii) on a half yearly basis, actual
historical sales data (or estimated data to the extent the provision of
actual data is not practicable) for each Product and Accessory by relevant
market segments and geographic areas of the Territory. This information
may be transmitted with the rolling forecast mentioned in Article 10.1
hereabove. Furthermore, IMED agrees to have marketing meetings regarding
distribution of the Product at regular intervals, not less than two (2)
times a year, with representatives of DEBIOTECH in attendance. At least
one (1) month's advance notification of such meetings shall be given to
DEBIOTECH.
14.5 Promotional Material. IMED shall supply free of charge to DEBIOTECH at
least one (1) sample of every brochure, video and advertising in any
country of the Territory relating to the Product and/or the Accessories
made for the public, end-users, hospitals, clinics, nurses, medical staff
and/or technicians. IMED also agrees to supply, at DEBIOTECH's request and
at cost price, any reasonable further quantity of such brochure, video,
advertising and/or promotional material (including a picture or photograph
of any trade show display) for public events as DEBIOTECH may request.
ARTICLE 15: NON COMPETITION
15.1 Non-Solicitation. The Parties agree that for the duration of this
Agreement and for the three (3) year period following thereafter, neither
IMED Group nor DEBIOTECH Group will directly or indirectly, on its behalf
or on behalf of any other Person, employ, endeavor to solicit or induce
any employees of the other Party to leave their employment with such other
Party in order to accept employment with another Person, including
DEBIOTECH or IMED.
15.2 Presentation to Experts. Each Party shall have the right to present the
Product and Accessories in the Territory to selected external experts
(excluding business competitors of one of the Parties as long as IMED
retains its exclusivity) for Improvement and/or New Development purposes
(e.g.: during focus group meetings, but not operating such Product for use
with any living being) provided it has informed the other Party with at
least fifteen (15) day's advance written notification of such presentation
and offered to at least one of the other Party's representative to
participate in such presentation. Any Product and/or Accessories presented
by DEBIOTECH under this Article 15.2 shall not bear the IMED Trademarks or
IMED's name without IMED's prior written consent.
ARTICLE 16: DURATION
This Agreement is entered into for a duration of fifteen (15) years from the
Effective Date. The Parties agree that no less than six (6) months prior to the
end of the foregoing term, the Parties shall negotiate in good faith the
extension of this Agreement. In the event that the Parties are unable to agree
upon such an extension this Agreement shall terminate upon the expiration of
such term. Notwithstanding expiration of this Agreement, DEBIOTECH agrees to
supply non-exclusively to IMED, and IMED agrees to continue to purchase
exclusively from DEBIOTECH, Cassettes for three (3) years after such expiration
on the supply terms of this Agreement; provided, however, that if DEBIOTECH is
unable to supply IMED with a reasonable supply of Cassettes, IMED shall be
permitted to purchase Cassettes from Third Persons, but the warranty provisions
contemplated in Article 11.1(a) hereof shall not apply to any Product once used
in connection with such Cassette.
ARTICLE 17: TERMINATION
17.1 Survival of Representations and Warranties. All representations,
warranties and indemnifications contained in Articles 11.1, 13.2 and 20,
shall not terminate, but shall survive the termination or expiration of
this Agreement, for whatever reason, and continue thereafter in full force
and effect, subject to applicable statutes of limitations.
17.2 Survival of Covenants and Agreements. All: (i) covenants and agreements
contained in Articles 4.8, 6, 11, 13.7, 14.2(c), 15.1, 17, 18, 20.3, 21.4
and 21.16 and all warranty and service obligations of DEBIOTECH with
respect to all Products, Accessories and Spare Parts delivered to IMED
pursuant to this Agreement; and (ii) liabilities or obligations with
respect to any breach of this Agreement accruing prior to the termination
or expiration of this Agreement, shall not terminate, but shall survive
the termination or expiration of this Agreement, for whatever reason, and
continue thereafter in full force and effect. The expiration or
termination of this Agreement shall be effective without prejudice to the
collection of sums and/or royalties previously due or resulting from
current Firm Orders if to the benefit of DEBIOTECH, or the refund provided
under Article 17.4 if to the benefit of IMED.
17.3 Reservation of Rights. Except as otherwise provided herein, at the
termination or expiration, for whatever reason, of this Agreement and for
a further period of five (5) years, IMED shall not manufacture, market,
distribute, lease and/or sell Cassettes (as defined in Article 1
hereabove) and/or pumps to be used with Cassettes not originating from
DEBIOTECH in any country of the world without the prior written consent of
DEBIOTECH. If all the Patents for the Cassette have expired and the entire
know-how for the Cassette is in the public domain other than by a breach
of the provisions of Article 18 hereafter by IMED, IMED shall not be bound
by the terms of this Article 17.3, except if DEBIOTECH has terminated this
Agreement pursuant to Article 17.7 or 8.10(c).
17.4 Termination by IMED for Regulatory Refusal. In addition to the other
rights of IMED hereunder to terminate this Agreement, including, without
limitation, those rights contained in Article 7.2 and 17.5, IMED may
terminate this Agreement at any time upon written notice to DEBIOTECH by
certified mail return receipt requested or by Federal Express or by
another reputable express courier service, if, through no fault of IMED or
its Affiliates and due to major governmental or regulatory action
(excluding actions which constitute a Failure Event 1A or Failure Event
2), IMED or its Affiliates are unable to market any Product in the USA
without any appeal possible. In such an event, DEBIOTECH shall refund to
IMED within [CONFIDENTIAL TREATMENT REQUESTED] from receipt of such
termination notice [CONFIDENTIAL TREATMENT REQUESTED] of any and all sums
paid to DEBIOTECH under Article 7.1 (b) to (h), less any refund and/or
compensation previously paid to IMED under Article 7 or 11.3 hereabove,
less [CONFIDENTIAL TREATMENT REQUESTED] for each half (1/2) Contract Year
elapsed. However, any refund under this Article 17.4 shall be exclusive of
any other refund or payment under any other provision of this Agreement.
17.5 Material Breach.
(a) Curable Events. In the event that either Party is in material breach
with any material provision or representation of this Agreement (such as,
as examples only, for IMED, any delay in paying any material sum or
royalty, unallowed manufacturing of any part of the Product and/or
Accessories, non compliance with the insurance policy obligation according
to Article 20.3(a) hereafter, refusing to allow an audit according to the
provisions of Article 21.4 hereafter or, for DEBIOTECH, non-compliance
with delivery obligations, failure to honor warranty or Recall
obligations, etc.) and such breach is materially adverse to the interests
of the non-breaching Party, the non-breaching Party shall have the right
to terminate this Agreement at the expiration of a one hundred twenty
(120) day [thirty (30) days in case of any delay of payment of money due]
cure period (the "Cure Period"), starting on the date of receipt of a
written notice ("Breach Notice"), sent certified mail-return receipt
requested or by Federal Express or another reputable express courier
service, stating which provision has not been complied with and requesting
that it be remedied within such Cure Period. If a material breach has not
been remedied or, with respect to defaults which by their nature are not
susceptible to immediate cure, if the breaching Party has not commenced
and is not diligently pursuing the remedy within the Cure Period the non-
breaching Party may send a written notice of termination (the "Termination
Notice"), in which event the provisions of Article 17.7 hereof shall apply
upon receipt by the breaching party of such Termination Notice.
(b) Noncurable Events. Notwithstanding the terms of Article 17.5(a), in
the event that a Party receives a Breach Notice in respect of a noncurable
event (e.g., distributing the Product outside the Field of Application or
outside the Territory), the non-breaching Party may send a Termination
Notice at the end of the Cure Period only if the breaching Party has
failed to: (i) cease the noncurable activity; (ii) take all necessary and
appropriate actions to ensure that such action will not continue; and
(iii) make reparations for any damage caused.
(c) Accelerated Arbitration to Contest Breach. In the event that the Party
receiving the Breach Notice contests in good faith the existence, or the
materiality, or the adversity of the claimed breach, such Party shall have
the right to initiate accelerated arbitration proceedings under Article
22.3 hereof within fifteen (15) days of its receipt of the Breach Notice.
The question to be determined by the arbitrator shall be limited to the
existence, materiality and adversity of the claimed breach and whether the
claimed breach has been properly cured. In the event such an accelerated
arbitration is commenced in good faith, the Cure Period of one hundred
twenty (120) days (thirty (30) days in the case of material payment
defaults) shall be extended if necessary so that the Cure Period will not
end sooner than sixty (60) days (three (3) days in the case of material
payment defaults) after the date of the final determination of the
arbitrator in this accelerated proceeding; provided, however, that if the
arbitrator expressly determines that the arbitration was not commenced in
good faith, the Cure Period shall be extended for only three (3) days in
in all cases and the Party initiating the accelerated arbitration shall be
liable for all of the costs of the arbitration and the legal expense of
the other Party incurred in such proceeding. It is the intention and
expectation of the Parties that such an accelerated arbitration will take
place as rapidly as possible and will be concluded within ninety (90) days
after it is commenced. Accordingly, the Parties agree to act in good faith
and to use their commercially reasonable efforts to assure that the
arbitration proceeds rapidly and without undue delay.
(d) Exclusive Remedy. In the event that any Party elects to send a
Termination Notice pursuant to this Article 17.5 as a result of any
material and adverse breach of this Agreement, the resulting sale of the
IMED Product Business pursuant to Article 17.7 hereof and the termination
resulting therefrom shall be the sole and exclusive remedy with respect to
such breach and the non-breaching Party shall have no right to ask for any
losses, costs, damages, compensation, reimbursement, or damages on account
of the loss of prospective profits on anticipated sales, or on account of
expenditures or commitments incurred in connection with the business or
goodwill of the non-breaching Party, interest and/or indemnification of
any type, but each Party shall have the right to full performance of all
obligations incurred up to the date of termination.
17.6 Expiration; Transfer of Market Approvals. After DEBIOTECH or a new
DEBIOTECH Distributor has assumed the rights and obligations of IMED under
Article 17.8 upon expiration or termination of this Agreement for whatever
reason, to the extent permitted by law and to the extent no longer
required by IMED in connection with its Product and Accessory business,
IMED agrees to transfer, or cause the transfer of, free of charge, all
Market Approvals and/or any other documents or authorization to market the
Product in the Territory, promptly to DEBIOTECH, or to any party which
DEBIOTECH shall nominate.
17.7 Effect of Termination. In the event that a Termination Notice is sent by
any Party pursuant to and in accordance with Article 8.10(c) or 17.5
hereof the termination shall have immediate effect, except that if the
First Introduction Date in the USA has occurred and if: (i) IMED acts in a
commercially reasonable manner so as not to jeopardize the promotion of
the Product by DEBIOTECH or by its new Distributor or by its new licensee,
and (ii) IMED reasonably assists DEBIOTECH or its new Distributor or
licensee to keep the market developed by IMED, and (iii) IMED gives
DEBIOTECH the necessary documents and information to supply IMED's former
customers, then the termination shall not be effective until the following
provisions set forth in this Article 17.7 have been complied with.
Each of DEBIOTECH and IMED shall have the right to seek potential buyers
only for the entire IMED Product Business (as defined below) either
together in a cooperative effort or separately. Once an offer for the IMED
Product Business has been accepted in accordance with the terms of this
Article 17.7 and a definitive contract has been executed in respect of
such offer (the "Definitive Contract"), then DEBIOTECH shall purchase from
IMED, the IMED Product Business for a purchase price (the "Purchase
Price") equal to the sum of (i) [CONFIDENTIAL TREATMENT REQUESTED] of the
Fair Market Value (as defined below) of the then unexpired rights of IMED
under this Agreement including, without limitation, the rights to acquire
Products and Accessories and Improvements thereon under the terms and
conditions of this Agreement (the "Future Contract Rights") and (ii)
[CONFIDENTIAL TREATMENT REQUESTED] of the Fair Market Value of the right
to supply Cassette Sets to IMED's existing customers (the "Installed
Base"). In the event that the Termination Notice was sent by DEBIOTECH,
the Purchase Price shall be reduced by the difference, if any, between the
[CONFIDENTIAL TREATMENT REQUESTED] due under Article 7.1 hereof (plus
[CONFIDENTIAL TREATMENT REQUESTED] for each of Canada and Mexico if IMED
has by then elected to distribute in Canada and/or Mexico) and the amounts
actually paid by IMED under Article 7.1 at the time of such termination.
Such Purchase Price shall be paid to IMED by SWIFT transfer on the closing
date of the Definitive Contract. Upon such payment (or the initiation of
the arbitration proceeding contemplated in the penultimate paragraph of
this Article 17.7), this Agreement shall be terminated.
For purposes of this Article 17.7, the "IMED Product Business" means the
Future Contract Rights and the Installed Base.
For the purposes of this Article 17.7, "Fair Market Value" shall mean the
price at which a willing Third Person buyer not under pressure to buy
would buy and a willing seller not under pressure to sell would sell the
IMED Product Business in an arm's length transaction under contract
conditions identical to this Agreement at the particular time of the
proposed transaction. If after a reasonable search and good faith
negotiations with a potential buyer, DEBIOTECH or IMED, as the case may
be, receives a bona fide offer for the IMED Product Business from a Third
Person offeror reasonably acceptable to DEBIOTECH (an "Offeror"), it shall
deliver written notice (an "Offer Notice") to the other Party containing
material contract terms thereof and the price offered by such Offeror
shall be deemed to be the Fair Market Value of the IMED Product Business
(and the allocation made by such Offeror between the Future Contract
Rights and the Installed Base shall be deemed to be the Fair Market Value
of each such element thereof) unless DEBIOTECH or IMED, as the case may
be, shall deliver to the other Party by the later of: (x) the date which
is [CONFIDENTIAL TREATMENT REQUESTED] after receipt of the Termination
Notice; and (y) [CONFIDENTIAL TREATMENT REQUESTED] days of its receipt of
such Offer Notice, a competing bona fide written offer for the IMED
Product Business from another Offeror with a higher offer price, in which
latter event the higher offered price shall be deemed the Fair Market
Value of the IMED Product Business. DEBIOTECH may accept or reject any new
higher offer presented by an Offeror, but the Fair Market Value of the
IMED Product Business shall be the higher of the two offers. For purposes
of this paragraph, an offer which is subsequently withdrawn or which fails
to result in a Definitive Contract despite acceptance by DEBIOTECH shall
not be deemed to constitute a bona fide offer.
In the event that either Party contests in good faith the calculation of
the Purchase Price, the allocation of the Purchase Price between Future
Contract Rights and Installed Base, or the arm's length bona fide nature
of an offer presented by the other Party, it must deliver a complete
written statement of its position, arguments and calculations in detail to
the other Party within thirty (30) days of receipt of the offer it desires
to dispute. The two Parties agree to discuss and negotiate any differences
in good faith. If after thirty (30) days of such discussions the issue is
not resolved, either Party may initiate arbitration under Article 22.3
hereof; provided, however, that the arbitration proceedings shall not stay
any proposed transaction which DEBIOTECH elects to enter into with a new
Distributor but rather shall concern only the amount and payment of the
Purchase Price. Interest shall accrue on the Purchase Price (as determined
by the arbitrators) at the Prime Rate from the closing date of the
Definitive Contract until such Purchase Price is paid to IMED.
In the event that no offer for the IMED Product Business is received by
either Party within the [CONFIDENTIAL TREATMENT REQUESTED] period
following receipt of the Termination Notice, then the Fair Market Value of
the IMED Product Business shall be determined through arbitration in
accordance with Article 22.3 hereof. Once the Fair Market Value has been
so determined by a final, nonappealable order resulting from such
arbitration, DEBIOTECH shall elect by sending written notice of its
election to IMED within fifteen (15) days to either: (i) purchase the IMED
Product Business for such Fair Market Value within forty-five (45) days;
or (ii) continue this Agreement as if such Termination Notice had never
been sent.
17.8 Continued Supply; Transfer of Contracts to New Distributor. For as long as
no new Distributor has been appointed by DEBIOTECH for the Territory
notwithstanding any expiration or termination of this Agreement, DEBIOTECH
agrees to continue to supply Cassettes, services, Spare Parts necessary to
service IMED's customers pursuant to the terms of this Agreement, and IMED
agrees to continue to purchase such Cassettes, Spare Parts and other
materials from DEBIOTECH on such terms and to supply the same to its
customers according to their needs, so as to maintain the value of the
Product Business. Upon written notification from DEBIOTECH of the identity
of a new Distributor, IMED shall immediately notify all of its former
customers of the identity of such new Distributor and will cooperate in
the transfer of all service and supply contracts relating to the Products
to such new Distributor without further compensation, provided that such
Distributor is willing to and does assume the obligations of IMED under
such service and supply contracts, and the obligations of IMED to provide
Cassettes, Spare Parts and otherwise service its customers, at which time
the rights of IMED under this Article 17.8 shall cease; provided, however,
that IMED shall be entitled to collect payments from its customers on all
Products and Accessories previously sold by IMED to such customers.
ARTICLE 18: CONFIDENTIALITY
18.1 Confidentiality Period. During the term of this Agreement, and for a
period of five (5) years thereafter, each Party will maintain in
confidence all Confidential Information disclosed by the other Party
hereto. Each Party will keep the other Party's Confidential Information in
strict confidence and shall not divulge, publish or otherwise reveal such
Confidential Information, directly or indirectly, to any other person,
firm or entity, or use or grant use of such Confidential Information
except as expressly authorized by this Agreement. Each Party will
promptly notify the other Party upon discovery of any unauthorized use or
disclosure of the Confidential Information.
18.2 Limitation on Disclosure; Safeguards. A receiving Party of a disclosing
Party's Confidential Information agrees to limit the internal
dissemination of such Confidential Information to only those directors,
officers, consultants, clinical investigators and regular employees of the
receiving Party whose access to such Confidential Information is necessary
for the full exercise by the receiving Party of the rights granted
pursuant hereto and contemplated hereby and the proper performance of the
functions of such individuals in connection therewith; and further agrees
to take, and to cause its directors, officers, consultants, clinical
investigators and regular employees who may have access to such
Confidential Information to take all appropriate safeguards so as to
protect the secret and proprietary nature of such Confidential Information
and to prevent unauthorized use, reproduction, disclosure and other
dissemination thereof. Such safeguards shall include, without limitation,
the execution and delivery to the disclosing Party by such directors,
officers, consultants, clinical investigators and employees of written
undertakings of non-disclosure and non-use.
18.3 Notation on Documents. The Parties shall endeavor to xxxx all Confidential
Information with a stamp bearing the term "Confidential". Confidential
Information not stamped with the term "Confidential" shall not terminate
the confidential and proprietary status thereof.
18.4 Disclosures Required by Law. The receiving Party may disclose Confidential
Information to governmental authorities to the extent required by law to
obtain and maintain Market Approvals. Such Party will use commercially
reasonable efforts to secure confidential treatment from governmental
authorities of disclosed Confidential Information.
18.5 No Adequate Remedy at Law. Because a disclosing Party cannot be adequately
compensated by money damages in the event of a violation of Article 15.1
or 18.1, a disclosing Party shall be entitled, in addition to any other
right or remedy available to it, to an injunction in any country at the
election of the disclosing Party, to restrain such violation or any
threatened violation and to specific performance of any provision, hereof
and, in either case, no bond or other security shall be required in
connection with such injunction.
18.6 Disclosure of Agreement. The Parties agree that the contents of this
Agreement constitute Confidential Information, and as such, will not be
disclosed by either Party without the written consent of the other, except
as otherwise provided herein, required by law or as a contractual
obligation for the fulfillment of this Agreement.
However, DEBIOTECH and IMED are entitled to disclose the fact that an
Exclusive Distribution agreement concerning the Product has been signed
between both Parties hereto, provided that a limitation to the Territory
and the Field of Application is mentioned.
ARTICLE 19: FORCE MAJEURE
19.1 Force Majeure. Neither Party shall be liable for a failure to comply with
a provision herein, if it is prevented from performing the said provision
because of force majeure ("Force Majeure"), this term being defined as
strikes or other labor trouble, war, insurrection, fire, flood, explosion,
discontinuity in the supply of power, court order or governmental
interference, acts of God and the like.
19.2 Commercially Reasonable Efforts. Despite the event of Force Majeure,
either Party hereto shall use commercially reasonable efforts to comply to
the extent possible with its obligations vis-a-vis the other Party,
pursuant to this Agreement.
19.3 Notification of Force Majeure. The Party invoking an event of Force
Majeure must notify it forthwith to the other Party, must specify which
one or ones of its obligations it is being prevented from complying with,
and the nature of the event of Force Majeure, and must give an estimate of
the period during which it is likely that it shall be prevented from
complying with the said obligation or obligations.
ARTICLE 20: REPRESENTATIONS AND WARRANTIES; RESPONSIBILITY
20.1 Representations and Warranties of DEBIOTECH. DEBIOTECH hereby represents
and warrants as follows:
(a) Corporate Power. DEBIOTECH is duly organized and validly existing
under the laws of the country of Switzerland and has full corporate power
and authority to enter into this Agreement and carry out the provisions
hereof.
(b) Due Authorization. DEBIOTECH is duly authorized to execute and deliver
this Agreement and to perform its obligations under this Agreement. The
person executing this Agreement on DEBIOTECH's behalf has been duly
authorized to do so by all requisite corporate action.
(c) Binding Agreement. This Agreement is a legal and valid obligation
binding upon DEBIOTECH, and enforceable in accordance with its terms. The
execution, delivery and performance of this Agreement by DEBIOTECH does
not conflict with any agreement, instrument or understanding, oral or
written, to which it is a party or by which it may be bound, nor violate
any law or regulation of any court, governmental body or administrative or
other agency having jurisdiction over it.
(d) No Adverse Acts. DEBIOTECH represents and warrants to IMED that it
does not know of any circumstances and has not done and, throughout the
duration of this Agreement, will not do any acts that are inconsistent
with the terms of this Agreement or which infringe any of the rights of
IMED.
20.2 Representations and Warranties of IMED. IMED hereby represents and
warrants as follows:
(a) Corporate Power. IMED is duly organized and validly existing under the
laws of the State of Delaware and has full corporate power and authority
to enter into this Agreement and carry out the provisions hereof.
(b) Due Authorization. IMED is duly authorized to execute and deliver this
Agreement and to perform its obligation under this Agreement. The person
executing this Agreement on IMED's behalf has been duly authorized to do
so by all requisite corporate action.
(c) Binding Agreement. This Agreement is a legal and valid obligation
binding upon IMED, and enforceable in accordance with its terms. The
execution delivery and performance of this Agreement by IMED does not
conflict with any agreement, instrument or understanding, oral or written,
to which it is a party or by which it may be bound, nor violate any law or
regulation of any court, governmental body or administrative or other
agency having jurisdiction over it.
(d) No Adverse Acts. IMED represents and warrants to DEBIOTECH that it
does not know of any circumstances and has not done and, throughout the
duration of this Agreement, will not do any acts that are inconsistent
with the terms of this Agreement or which infringe any of the rights of
DEBIOTECH.
20.3 Maintenance of Insurance.
(a) IMED Liability Insurance. From and after the first user trials by IMED
of the Product, IMED agrees to use commercially reasonable efforts to
maintain an insurance policy having a minimum coverage of [CONFIDENTIAL
TREATMENT REQUESTED] per occurrence and in the aggregate per policy year
covering the risks and on the terms described in the insurance policy
attached hereto as Exhibit 20.3(a) (the "Original IMED Policy") so long as
such policy is reasonably available at commercially reasonable rates (as a
minimum, the current premium rates paid by IMED as of the Effective Date
increased by the annual United States inflation rate shall for all
purposes, be deemed commercially reasonable for the duration of this
Agreement). In the event that such policy is not reasonably available at
commercially reasonable rates, IMED must notify DEBIOTECH not less than
three (3) months in advance of its intention to modify the coverage and
the Parties shall discuss alternative solutions in good faith. If after
not less than thirty (30) days of good faith discussions between the
Parties no solution is found to continue the coverage in the Original IMED
Policy or any previously accepted modified policy, IMED may maintain
modified coverage and compensate adequately DEBIOTECH for any commercially
reasonable surplus premium due by DEBIOTECH to its insurance company as a
direct consequence of such modification of IMED's coverage. In the event
IMED elects to terminate even modified insurance coverage because the
premium is no longer commercially reasonable, it may terminate such
coverage after the above notice and good faith discussion periods and
become self-insured in which event IMED shall (i) only indemnify DEBIOTECH
so as to put DEBIOTECH in the same position it would have been in had the
last insurance policy so maintained by IMED been in effect (assuming for
this purpose, that such last insurance policy had a maximum coverage of
[CONFIDENTIAL TREATMENT REQUESTED] per occurrence and in the aggregate
policy year); and (ii) not be required to pay DEBIOTECH for any surplus
premium due by DEBIOTECH to its insurance company as a direct consequence
of such self-insurance by IMED.
IMED will not insure itself without insuring DEBIOTECH. From and after the
first user trials by IMED of the Product, IMED shall cause its insurer to
name DEBIOTECH as an additional insured on such policy and to deliver to
DEBIOTECH an original copy of such policy together with a certificate of
insurance addressed to DEBIOTECH assuring that such policy cannot be
canceled or amended without at least thirty (30) days prior written notice
to DEBIOTECH.
(b) DEBIOTECH Liability Insurance. From and after the First Introduction
Date in the USA, DEBIOTECH agrees to use commercially reasonable efforts
to maintain an insurance policy having a minimum coverage of [CONFIDENTIAL
TREATMENT REQUESTED] per occurrence and in the aggregate per policy year
covering the risks and on the terms described in the insurance policy
attached hereto as Exhibit 20.3(b) (the "Original DEBIOTECH Policy").
DEBIOTECH further agrees to renew such policy at or prior to the
expiration of the term thereof. In the event that the same policy coverage
is not reasonably available in the future or is available at increased
premium rates that are no longer commercially reasonable (as a minimum,
the current premium rates paid by DEBIOTECH as of the Effective Date
increased by the annual Switzerland inflation rate shall for all purposes,
be deemed commercially reasonable for the duration of this Agreement). In
the event that such policy is not reasonably available at commercially
reasonable rates, DEBIOTECH must notify IMED not less than three (3)
months in advance of its intention to modify the coverage and the Parties
shall discuss alternative solutions in good faith. If after not less than
thirty (30) days of good faith discussions between the Parties no solution
is found to continue the coverage in the Original DEBIOTECH Policy or any
previously accepted modified policy, DEBIOTECH may maintain modified
coverage and compensate adequately IMED for any commercially reasonable
surplus premium due by IMED to its insurance company as a direct
consequence of such modification of DEBIOTECH's coverage. In the event
DEBIOTECH elects to terminate even modified insurance coverage because the
premium is no longer commercially reasonable, it may terminate such
coverage after the above notice and good faith discussion periods and
become self-insured in which event DEBIOTECH shall (i) only indemnify IMED
so as to put IMED in the same position it would have been in had the last
insurance policy so maintained by DEBIOTECH been in effect (assuming for
this purpose, that such last insurance policy had a maximum coverage of
[CONFIDENTIAL TREATMENT REQUESTED] per occurrence and in the aggregate
policy year); and (ii) not be required to pay IMED for any surplus premium
due by IMED to its insurance company as a direct consequence of such
self-insurance by DEBIOTECH.
DEBIOTECH shall before the First Introduction Date in the USA cause its
insurer to add IMED in a vendor endorsement on such policy and to deliver
to IMED an original copy of such policy together with a certificate of
insurance addressed to IMED assuring that such policy cannot be canceled
or amended without at least thirty (30) days prior written notice to IMED.
(c) Recall Insurance. DEBIOTECH undertakes and agrees to use commercially
reasonable efforts to procure an insurance policy to cover the costs of
repair or replacement in connection with a recall contemplated in Article
11.3 in excess of the Recall Amount (the "Recall Insurance Policy") at or
prior to the First Introduction Date of the Product. DEBIOTECH further
agrees to use commercially reasonable efforts to renew such policy at or
prior to the expiration of the term thereof upon such comparable terms as
are available at the time of such renewal.
(d) Proceedings. In the event of any action against any Party, IMED shall
be responsible for conducting the proceedings of such action and shall
keep DEBIOTECH regularly informed about any detail of such action.
DEBIOTECH and/or its insurer shall be free to join the action at any
moment at its own expense.
20.4 Notification by IMED. IMED shall immediately and without any delay report
to DEBIOTECH any serious adverse reaction concerning the Product and/or
Accessories, as well as any relevant information concerning the Product or
Accessories which is reasonably likely to require DEBIOTECH to apply
corrective measures.
ARTICLE 21: MISCELLANEOUS
21.1 Assignment. The rights and obligations under this Agreement shall not be
assignable by one Party to any third party in the absence of the prior
written approval of the other Party; provided, however, that no such
approval shall be required in connection with any such assignment that
involves or relates to the transfer, sale, lease or financing of all or
substantially all of the assets of one of the Parties, including, without
limitation, an assignment by IMED hereunder to its existing lender as part
of IMED's continuing obligation to provide such lender with a lien on
substantially all of IMED's assets.
21.2 Severability. If any provision hereof is, or later becomes, invalid or
unenforceable or incompatible with any applicable law, such provision
shall be ineffective without affecting the validity of the remaining
provisions. The Parties shall attempt to replace the invalid provision
with a valid provision as closely aligned with the original intent of the
Parties as possible.
21.3 Entire Agreement; Waiver. This Agreement represents the entire
understanding between the Parties and supersedes any and all previous
understandings both oral and written, with respect to the subject matter
hereof. Amendments and supplements to this Agreement shall not be
effective unless in written form and signed by both Parties. The failure
of either Party to enforce at any time any of the provisions of this
Agreement shall in no way be construed to be a waiver of any such
provision, nor in any way to affect the validity of this Agreement or any
part of it or the right of either Party after any such failure to enforce
each and every such provision. No waiver of any breach of this Agreement
shall be held to be a waiver of any other or subsequent breach.
21.4 Inspection of Books and Records. Each Party shall be entitled to have an
independent public accountant of its choice, but reasonably acceptable to
the other Party and bound by adequate confidentiality obligations, inspect
all relevant accounts and other documents in the possession of the other
Party, and its Affiliates, during normal business hours, with reasonable
notice, no more often than once per calendar year, in order to satisfy
such accountant of the valid performance of this Agreement.
In the event of any shortfall amounting to five percent (5%) or more of
amounts due to a Party, the other Party shall pay to that Party, without
any delay, all costs charged for the inspection contemplated above.
21.5 Notices. All notices or other communications to a Party required or
permitted hereunder shall be in writing and shall be delivered personally
to such Party (or, in the case of an entity, to an executive officer of
such Party) or shall be given by certified mail, postage prepaid with
return receipt requested, or by Federal Express or by another reputable
express courier service addressed as follows:
if to DEBIOTECH to:
DEBIOTECH SA
00-xxx xxx Xxxxxxxx, XX00
XX - 0000 XXXXXXXX 9
Switzerland
Attention: Xxxxxxxx Xxxxxx, C.E.O.
With a copy (which shall not constitute notice) to send
simultaneously by the same medium:
Xxxxxxxx & Xxxxx Xxxxxxx
0, Xxxxxx Xx Xxxxxxxxx
Xxxxx Xxx Xxxx-Xxxxx
XX-0000 Geneve
Switzerland
Attention: Xxxx X.X. Xxxxxxx, Xx.
if to IMED to:
IMED Corp.
0000 Xxxxxxxxxxxx Xxxxxx
XXX XXXXX, XX 00000-0000
XXX
Attention: Xxxxxx X. Xxxx, President
With a copy (which shall not constitute notice) to send
simultaneously by the same medium:
Xxxxxx Xxxxxx Butowsky Xxxxxxx Shalov & Xxxx
000 Xxxx 00xx Xxxxxx - 00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
XXX
Attention: Xxxxx X. Xxxxxx
DEBIOTECH and IMED may change their respective above specified addresses
by notice to the other Party given in the manner herein prescribed. All
notices shall be deemed given on the day when actually delivered as
provided above (if delivered personally) or on the day shown on the return
receipt or express courier invoice (if delivered by mail or express
courier service).
21.6 English Language. If this Agreement is translated into any language, the
English language version shall govern in the event of any conflict or
question of construction or interpretation.
21.7 Publicity. Except as provided in Article 18.6 or as otherwise provided
below, any public disclosure of the transactions contemplated hereby and
the terms hereof or results obtained hereunder (including but not limited
to press releases or other statements made available generally by a Party
to the public) will be reviewed and consented to by each Party prior to
such disclosure. Such consent shall not be untimely or unreasonably
withheld by any Party. Notwithstanding the foregoing, any Party may,
without the prior consent of the other Party : (a) disclose: (i) the
existence of the Agreement to the extent contemplated in Article 18.6,
(ii) the general subject matter thereof (other than material business,
technical and commercial terms thereof or related thereto), and (iii) the
identity of the Party; or (b) make public disclosure of this Agreement and
of the transactions contemplated hereby, the aggregate consideration to be
paid hereunder, the terms hereof or the results obtained hereunder to the
extent that such public disclosure is required by any law, or rule or
regulation of any governmental agency, including without limitation, the
United States Securities and Exchange Commission or any securities
exchange on which securities of the disclosing party are then listed;
provided, however, that in the case of any disclosure under clause (b)
above, the disclosing Party shall endeavor to obtain confidential
treatment of information to be disclosed to the extent requested by the
other Party. In addition, the Parties agree that DEBIOTECH and IMED will,
upon execution of this Agreement by the Parties, publicly release the
statements, respectively, set forth on Enclosure 14 hereto.
21.8 Currency. All payments due hereunder shall be made in lawful coin and
currency of the USA.
21.9 No Broker. DEBIOTECH, on the one hand, and IMED, on the other hand,
represent that it has not employed any broker, finder, investment bank or
financial adviser as to whom the other Party may have an obligation to pay
any broker's or finders fee in connection with the origin, negotiation,
execution or performance of this Agreement.
21.10 Headings. The titles and headings to Articles are inserted for the
convenience of reference only and are not intended to be a part of or to
affect the meaning or interpretation of this Agreement.
21.11 Actions by Affiliates. Each Party agrees that, to the extent this
Agreement contemplates any action to be taken by an Affiliate of such
Party, such Party, as the case may be, will take all actions necessary to
ensure that such Affiliate takes such action and the failure of such
Affiliate to take such action shall be deemed a default by such Party.
21.12 Declaration of Accountant Regarding Royalties. IMED's auditors shall
provide DEBIOTECH with a certified declaration each calendar year, stating
that IMED's accounting of royalties pursuant to Article 9 to DEBIOTECH is
correct.
21.13 Independent Contractor. No Party is the legal representative or agent of
the other Party as a result of this Agreement. Nothing herein shall be
construed as creating the relationship of joint venture or partnership. No
Party shall have the right to bind the other Party in contract or
otherwise.
21.14 Change of Conditions. In the event that, during the duration of this
Agreement, the regulations in force at the time of its execution are
drastically modified, or in the event that the data on which the Parties
relied to enter into this Agreement change in such a manner that one Party
shall suffer severe hardship from its performance of this Agreement, which
could not reasonably be foreseen as of the date on which this Agreement
was executed, the Parties shall then meet and adapt the conditions of this
Agreement to the new situation, in a manner equitable to both Parties.
21.15 Counterparts. This Agreement may be executed in one or more counterparts,
all of which shall be considered one and the same Agreement, and shall
become a binding Agreement when one or more counterparts have been signed
by each Party and delivered to the other Party.
21.16 Tax Recuperation. Each Party shall cooperate with the other Party to
recuperate withholding taxes and the like, to the extent possible by law.
ARTICLE 22: ARBITRATION AND GOVERNING LAW
22.1 Mediation. In the event the Parties are unable to resolve a dispute, the
Parties may engage a mediator acceptable to both Parties. Said mediator
will immediately meet with the President of both parties to discuss the
basis for the dispute and to attempt to resolve the dispute.
22.2 Jurisdiction. The ordinary courts of the place of residence of the
defending Party have jurisdiction to grant interim injunctions as long as
an arbitration panel is not constituted. After an arbitration panel is
convened, such courts have no jurisdiction, except to the extent necessary
to execute interim orders issued by the arbitration panel.
22.3 Arbitration. With the exception of interim injunctions subject to Article
22.2 hereabove, any controversy or claim among the parties arising out of
or relating to this Agreement shall be finally settled under the rules of
arbitration set forth in Exhibit 22.3 hereto. The arbitration panel shall
have full powers to issue interim orders.
22.4 Choice of Law. This Agreement shall be construed, governed by and
interpreted in accordance with the laws of Switzerland.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized officers.
DEBIOTECH S.A. IMED Corp.
Date:May 8, 1995 Date: May 8, 1995
In: Lausanne, Switzerland In: Lausanne, Switzerland
/s/ Xxxxxxxx Xxxxxx /s/ Xxxxxx X. Xxxx
-------------------------- ----------------------------
Name: Xxxxxxxx Xxxxxx, Name: Xxxxxx X. Xxxx
C.E.O. President
