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EXHIBIT 10.6
DISTRIBUTION AND SUPPLY AGREEMENT
This
Distribution and Supply Agreement (the "Agreement") is made as
of
September 22, 2003 (the "Effective Date"), by and between Omrix
Biopharmaceuticals, Inc., a corporation organized under the laws of
Delaware
(hereinafter referred to as "Omrix"), and Ethicon, Inc., a
corporation organized
under the laws of New Jersey, acting by and through its Johnson
& Johnson Wound
Management division (hereinafter referred to as "Ethicon," together
with Omrix,
the "Parties" and each individually a "Party").
RECITALS
WHEREAS,
Omrix has developed a biologic surgical adhesive in the form of
a
frozen liquid fibrin sealant, including biological reagents and a
delivery
device, known as "Quixil(TM)", and is in the process of developing
a second
generation fibrin sealant product currently known as "FS2"; and
WHEREAS,
Omrix believes that one of the components of Quixil, thrombin,
can be developed as a stand-alone product with few or no process
changes; and
WHEREAS,
pursuant to a development agreement dated the date hereof (the
"Development Agreement"), the Parties agree that Omrix will, with
certain
testing and other contributions of Ethicon, further develop and
obtain marketing
authorizations for a second generation fibrin sealant product, a
thrombin
product, a product known as the "Hemostatic Pad Product" containing
biologic
component(s) from Omrix and a substrate, and a kitted product
containing a
medical device and thrombin known as "Flowable Hemostat"; and
WHEREAS,
this Distribution and Supply Agreement is being entered into to
set out the terms and conditions under which (A) Ethicon will act
as Omrix's
exclusive distributor of Quixil and the products developed under
the Development
Agreement, in each case in specific territories for hemostasis and
sealing
indications for non-consumer applications only, (B) Omrix will
supply and
Ethicon will purchase Quixil and the products covered by the
Development
Agreement once they are developed and (C) Ethicon will provide the
medical
device necessary to produce the Flowable Hemostat and may provide
the substrate
necessary to produce the Hemostatic Pad.
NOW
THEREFORE, in consideration of the mutual covenants and
consideration
set forth herein, and contingent upon the simultaneous execution of
the
Development Agreement, the Parties hereto agree as follows:
PORTIONS
OF THIS EXHIBIT MARKED BY AN *** HAVE BEEN OMITTED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH
THE
SECURITIES AND EXCHANGE COMMISSION.
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ARTICLE 1
DEFINITIONS
As used in
this Agreement, the following defined terms shall have the
meanings set out in this Article 1. Capitalized terms used but not
otherwise
defined herein, and which are defined in the Development Agreement,
shall have
the meanings given such terms in the Development Agreement.
1.1
"ACCESSORY" shall mean any of the devices or other articles listed
on
Exhibit A, as such Exhibit may be amended from time to time by
mutual agreement
of the Parties, but in no event shall mean the basic application
device
accompanying a Product.
1.2
"AFFILIATE" shall mean, in relation to either Party hereto, (a)
any
entity in which the relevant Party directly or indirectly holds
more than 50% of
the voting stock or power, (b) any entity ("Holding Entity") which
holds
directly or indirectly more than 50% of the voting stock or power
of the
relevant Party, (c) any other entity in which more than 50% of the
voting stock
or power is directly or indirectly held by any Holding Entity of
the relevant
Party or (d) any entity in which the relevant Party directly or
indirectly holds
less than 50% of the voting stock or power but has management
control of such
entity in that it has the ability to appoint and remove the
majority of the
Board of Directors (or other governing body) of such Party.
1.3
"APPLICABLE LEGAL REQUIREMENTS" shall mean: (a) any and all
federal,
national, supranational, state and local laws, regulations,
ordinances, orders
and requirements applicable to the activities under this Agreement;
and (b) any
other specifications, guidelines, procedures and directives
mutually agreed to
by the Parties, applicable to the Products, Improved Products or
Ethicon
Components, as applicable, or activities under this Agreement. In
the case of
the United States, Applicable Legal Requirements shall include,
without
limitation, all applicable laws, regulations and guidelines of and
under the
U.S. Federal Food, Drug, and Cosmetic Act and Public Health Service
Act,
including all applicable current Good Manufacturing Practices
("cGMP", see,
e.g., 21 CFR 211); provided that, in the event of any conflict
between such
sources of authority, U.S. federal law and regulations shall be
given priority.
In the case of the European Union, Applicable Legal Requirements
shall include,
without limitation, all applicable regulations and directives of
the European
Union, the European Commission and guidelines of the CPMP and all
applicable
national legislation; provided that, in the event of any conflict
between the
foregoing sources of authority, European Union law shall be given
priority.
1.4
"AVERAGE TRANSFER PRICE" with respect to any Product during any
period
shall be determined by adding up all the Quarterly Amounts (as
defined in
Exhibit C) with respect to such Product and such time period and
dividing the
sum by the aggregate number of units of such Product sold during
such period,
provided that the Average Transfer Price shall in no event be less
than the
Minimum Transfer Price nor greater than the Maximum Transfer Price
then in
effect for such Product.
1.5
"BANKRUPTCY EVENT" shall mean (a) the person or entity in
question
becomes insolvent, or voluntary or involuntary proceedings by or
against such
person or entity are instituted in bankruptcy or under any
insolvency law, or a
receiver, trustee or custodian is appointed for such person or
entity, or
proceedings are instituted by or against such person or
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entity for corporate reorganization or the dissolution of such
person or entity;
provided that an involuntary bankruptcy, dissolution or
reorganization
proceeding shall not be deemed a Bankruptcy Event unless and until
the person or
entity consents to such proceeding or such proceeding shall is not
dismissed
within 60 days after the date of filing, or (b) such person or
entity makes an
assignment for the benefit of its creditors, or substantially all
of the assets
of such person or entity are seized or attached and not released
within 60 days
thereafter.
1.6
"BASELINE COSTS" with respect to a Product shall mean Omrix's
actual
costs for the Cost Variables for manufacturing such Product
determined based on
the cost at the end of the second twelve (12) month period after
the First
Commercial Sale of that Product.
1.7 "COST
VARIABLES" shall mean the variables listed on Exhibit K hereto.
1.8
"DEVELOPMENT PRODUCTS" shall mean FS2, Thrombin, the Flowable
Hemostat
and the Hemostatic Pad Product.
1.9
"DEVELOPED TERRITORY" shall have the meaning set forth in
Section
2.3(a) hereof.
1.10
"EFFECTIVE DATE" shall have the meaning set forth in the
introduction
hereto.
1.11
"ETHICON COMPONENTS" shall have the meaning set forth in the
Development Agreement.
1.12
"EVENT OF DEFAULT" shall have the meaning given in Section 11.3
hereof.
1.13
"FAILURE TO SUPPLY" shall have the meaning set forth in Section
3.3
hereof.
1.14 "FDA"
shall mean the United States Food and Drug Administration.
1.15
"FIBRIN SEALANT PRODUCTS" shall mean Quixil and FS2.
1.16
"FIELD" shall mean Non-Consumer Applications (as defined in the
Development Agreement) using human-plasma derived products that are
indicated
for (A) hemostasis (with or without other indications) or (B)
sealing only;
except that, notwithstanding anything to the contrary in the
foregoing, the
Field does not include dentistry applications, regardless of
whether hemostasis
and/or sealing is an indication, recombinant products or any device
which uses
the patient's own blood.
1.17
"FISCAL YEAR" shall mean Ethicon's fiscal year, which varies
annually, but which is approximately the period beginning on each
January 1 and
ending on the following December 31.
1.18
"FISCAL QUARTER" shall mean each of Ethicon's fiscal quarters,
which
vary annually, but which are the approximately three (3) month
periods beginning
on or about January 1, April 1, July 1 and October 1,
respectively.
1.19
"FIRST COMMERCIAL SALE" with respect to any Primary Product
shall
mean the date of the first sale of such Product by Ethicon or its
Affiliates (or
by Omrix pursuant to an
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order solicited by Ethicon as contemplated by Section 2.5),
specifically
excluding sales to an Affiliate of Ethicon unless such Affiliate is
the end user
of the Product.
1.20
"FORCE MAJEURE EVENT" or "FORCE MAJEURE NOTICE" shall have the
meaning ascribed in Section 11.6 hereof.
1.21 "FS2"
shall mean the FS2 set forth in the Development Agreement, as
such FS2 is defined in the first Regulatory Approval for such
Product.
1.22 "FS2
TERRITORY" shall have the meaning as set forth in Section
2.3(a)
hereof.
1.23
"HEMOSTATIC PAD PRODUCT" shall mean the Hemostatic Pad Product
set
forth in the Development Agreement, as such Hemostatic Pad Product
is defined in
the first Regulatory Approval for such Product.
1.24
"IMPROVED PRODUCT" shall have the meaning set forth in the
Development Agreement.
1.25
"FLOWABLE HEMOSTAT" shall mean the Flowable Hemostat set forth in
the
Development Agreement, as such Flowable Hemostat is defined in the
first
Regulatory Approval for such Product.
1.26 "LONG
TERM FORECAST" shall mean the ten year non-binding forecast of
Ethicon's requirements for the Products set forth on Exhibit I
hereto, as
amended and updated pursuant to Section 4.5(a).
1.27
"MAXIMUM TRANSFER PRICE" shall mean (i) in the case of Fibrin
Sealant
Products, $*** per milliliter in the United States and (Euro)***
per milliliter
in the European Union, Norway, Iceland, Liechtenstein and
Switzerland and all
other portions of the Territory other than the United States and
(ii) in the
case of Thrombin, $*** per 5000 IU vial (of five (5) milliliters
per vial) in
the United States and (Euro)*** per 5000 IU vial (of five (5)
milliliters per
vial) in the European Union, Norway, Iceland, Liechtenstein and
Switzerland and
all other portions of the Territory other than the United States;
provided,
however, that the Maximum Transfer Price shall be subject to
increase from time
to time through the adjustments set forth in Section 4.2. Maximum
Transfer
Prices for all other Products shall be agreed in writing separately
by the
Parties.
1.28
"MINIMUM TRANSFER PRICE" shall mean (i) in the case of Fibrin
Sealant
Products, $*** per milliliter in the United States and (Euro)***
per milliliter
in the European Union, Norway, Iceland, Liechtenstein and
Switzerland and all
other portions of the Territory other than the United States
(provided that the
foregoing Minimum Transfer Price for Fibrin Sealant Products shall
be reduced
by ***% after the first Fiscal Year in which *** milliliters of
Fibrin Sealant
Products are sold by Ethicon in the United States) and (ii) in the
case of
Thrombin, $*** per 5000 IU vial (of five (5) milliliters per vial)
in the
United States and (Euro)*** per 5000 IU vial (of five (5)
milliliters per vial)
in the European Union, Norway, Iceland, Liechtenstein and
Switzerland and all
other portions of the Territory other than the United States
(provided that the
Minimum Transfer Price for Thrombin shall become US$*** per 5000 IU
vial (of
five(5)
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milliliters per vial) in the United States and (Euro)*** per 5000
IU vial (of
five (5) milliliters per vial) in the European Union, Norway,
Iceland,
Liechtenstein and Switzerland and all other portions of the
Territory other
than the United States after the earlier of calendar year 2010 or
the first
calendar year in which *** vials of Thrombin are sold by Ethicon,
subject to
adjustment as contemplated in the following proviso); provided,
however, that
the Minimum Transfer Price shall be subject to proportional
increase from time
to time based on the adjustments set forth in Section 4.2. Minimum
Transfer
Prices for all other Products shall be agreed in writing separately
by the
Parties.
1.29 "NET
SALES" with respect to any Product shall mean the amounts
actually invoiced by Ethicon or its Affiliates from the sale of
such Product to
non-Affiliates, less the following amounts: (i) discounts,
including cash
discounts, or rebates actually allowed and taken, (ii) credits or
allowances
actually granted upon claims or returns regardless of the Party
requesting the
return, (iii) freight charges paid for delivery if separately
invoiced to the
buyer, and (iv) taxes or other governmental charges levied on or
measured by the
invoiced amount (but not direct taxes on income) whether absorbed
by the billing
or the billed Party; provided that, with respect to any Product
sold by Ethicon
in a transaction in which any other product(s) are also provided,
the Net Sales
for the Product or Improved Product will be calculated by
multiplying the actual
Net Sales of the combination product by the fraction (A/A+B), where
A is the
invoiced price of such Product or Improved Product as if sold
separately by
Ethicon and B is the aggregate of the invoiced prices of each of
the other
product(s) included in the combination product as if each such
product was sold
separately by Ethicon; provided further that the amount deemed to
be the invoice
price for a product shall be the average amount invoiced in good
faith by
Ethicon for such product when sold individually over the prior
twelve (12) month
period.
1.30
"OMRIX FACILITY" shall mean each of (a) Omrix's facility in
Belgium
for Products to be distributed in the European Union (as it is to
be expanded in
2004, except Portugal), Norway, Iceland, Liechtenstein and
Switzerland (b)
Omrix's facility in Israel for Products to be distributed in the
United States,
Canada and other portions of the Territory and (c) any other
facility owned or
operated by Omrix in connection with this Agreement or any of the
Products.
1.31
"PRIMARY PRODUCTS" shall mean any Products, other than
Accessories
and components of Accessories.
1.32
"PRODUCTION PLAN" shall have the meaning set forth in Section
4.6
hereof.
1.33
"PRODUCTS" shall mean Quixil, the Development Products, the
Improved
Products and Accessories.
1.34
"PURCHASE PRICE" shall have the meaning set forth in Section
4.2
hereof.
1.35
"QUALITY AGREEMENT" shall have the meaning set forth in Section
3.2(e) hereof.
1.36
"QUIXIL" shall have the meaning set forth in the Development
Agreement.
1.37
"QUIXIL QUALITY AGREEMENT" shall have the meaning set forth in
Section 3.2(e) hereof.
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1.38
"QUIXIL TERRITORY" shall have the meaning set forth in Section
2.3(a)
hereof.
1.39
"REGULATORY AGENCY" with respect to a given country shall mean
the
regulatory agency or notified body in such country that performs
the same or
equivalent function as the FDA in the United States. Any reference
to a rule or
requirement of the FDA herein shall refer, if the circumstances
make it
applicable, to the equivalent rule or requirement of any Regulatory
Agency. For
avoidance of doubt, FDA shall be considered a Regulatory Agency for
purposes of
this definition.
1.40
"REGULATORY APPROVAL" shall mean EU Marketing Clearance or U.S.
Marketing Clearance, as applicable, each as defined in the
Development
Agreement, or with respect to Products in any other country, the
filing and
receipt of all other registrations, approvals, licenses and
authorizations
required for the marketing and sale of the Product in such country,
excluding
any dossiers or applications required for pricing or
reimbursement.
1.41
"REGULATORY CHANGES" shall mean any changes in or to a Product,
its
components or its Regulatory Approval imposed by the applicable
Regulatory
Agency subsequent to Regulatory Approval, except for changes to
Quixil required
for Omrix to meet the milestone set forth in Section 4.1(b) hereof.
For the
avoidance of doubt, changes which Omrix makes for product quality,
compliance
requirements, ongoing improvement programs related to viral
inactivation
processes and productivity improvements not imposed by the
applicable Regulatory
Agency shall not be considered Regulatory Changes.
1.42
"REMEDIATION PLAN" shall have the meaning set forth in Section
3.3
hereof.
1.43
"RESTRICTED COUNTRIES" shall mean, (i) with respect to Quixil
and
FS2, the United States, Canada, Japan and any country in which
Omrix has,
pursuant to a written contract in existence as of the Agreement
Date, appointed
a distributor for Quixil and (ii) with respect to any of the
Development
Products (other than FS2), Japan; provided that, if Omrix ceases to
have a
written contract with such distributor, the country excluded as a
result of such
contract with such distributor shall cease to be a Restricted
Country. Exhibit H
lists, by Product, all countries in which Omrix has a written
contract with a
distributor with respect to such Product as of the Agreement
Date.
1.44
"SHORTFALL AMOUNT" with respect to a given Product shall mean (A)
50%
of the Average Transfer Price for such Product multiplied by (B)
the excess of
the minimum quantity of such Product required to by purchased by
Ethicon
hereunder over the quantity of such Product actually purchased by
Ethicon for
the applicable period.
1.45
"SPECIFICATIONS" shall mean the specifications for the design,
composition, product safety assurance, manufacture, packaging,
and/or quality
control of any Product, as set forth on Exhibit B attached hereto
and made a
part hereof, as the same may hereafter be modified pursuant to the
Development
Agreement or by mutual agreement in writing but prior to the first
applicable
Regulatory Approval for the applicable product.
1.46
"TERRITORY" for a Product, shall mean the territory for such
product
set forth in Section 2.3.
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1.47
"THROMBIN" shall mean the Thrombin set forth in the Development
Agreement, as such Thrombin is defined in the first Regulatory
Approval for such
Product.
1.48 "UP
FRONT DIFFERENCE" shall mean *** U.S. Dollars ($***).
ARTICLE 2
DISTRIBUTION AND SUPPLY RELATIONSHIP; ESCROW
2.1
APPOINTMENT; PAYMENT. Subject to the terms and conditions of
this
Agreement, Omrix hereby appoints Ethicon, and Ethicon hereby
accepts
appointment, as Omrix's exclusive distributor of Quixil in the
Quixil Territory,
FS2 in the FS2 Territory and the Development Products and Improved
Products in
the Developed Territory (other than Improved Products arising from
Covered
Improvements to FS2, for which Omrix appoints Ethicon solely in the
FS2
Territory); provided that, Ethicon shall have no rights to market,
sell or
distribute the Products outside the Field and may only market, sell
and
distribute Improved Products within the Field after the Parties
mutually agree
on annual minimum purchases, transfer prices and/or net sales
percentages
applicable to such Improved Products; provided that the parties
shall use good
faith efforts to reach agreement on such terms; and provided,
further, that in
no event shall Omrix agree to sell the Improved Products to a third
party on
terms that are less favorable to Omrix than those proposed by
Ethicon. Omrix
understands and agrees that Ethicon may utilize its Affiliates to
act as
distributors hereunder in certain geographic areas, provided that,
such
Affiliates are subject to the same restrictions, limitations and
requirements as
are applicable to Ethicon, and Ethicon shall at all times remain
responsible for
performance of all of its and its Affiliates' obligations under
this Agreement.
In consideration of the foregoing appointment and the execution by
Omrix of this
Agreement, Ethicon shall pay Omrix within three (3) business days
of the
Effective Date *** U.S. Dollars ($***).
2.2
SUPPLY.
(a) Supply of Products. Omrix shall supply the Products to
Ethicon
on an exclusive basis in the Field in the Territory applicable to
such Product
as set forth in Section 2.3 (the "Applicable Territory") in
accordance with and
subject to the terms and conditions of this Agreement. In addition,
Omrix shall
supply the Accessories to Ethicon on a non-exclusive basis in the
Applicable
Territory for sale or distribution in connection with Primary
Products in
accordance with and subject to the terms and conditions of this
Agreement.
Ethicon shall not solicit or accept orders for any Product from any
prospective
purchaser located outside of the Applicable Territory for said
Product or for
use outside the Field, subject to applicable law. Ethicon shall not
engage in
any advertising or promotional activities relating to the Products
directed
primarily to customers located outside the Applicable Territory for
such Product
or promoting the use of any Products outside the Field. Ethicon may
not deliver
or tender (or cause to be delivered or tendered) any Product
outside of the
Applicable Territory for such Product or outside the Field.
Notwithstanding the
preceding three sentences, if Ethicon receives an unsolicited order
for Products
from a prospective purchaser located outside the Applicable
Territory for such
Product and such purchaser is likely to resell such Products back
into the
Applicable Territory, then Ethicon may accept such order. Omrix
agrees that it
will not: (i) engage in an any advertising or promotional
activities relating to
any Product for use in the Field and directed primarily to
customers located
inside the Applicable Territory for said Product; (ii)
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solicit or accept orders for any Product from any prospective
purchaser located
in the Applicable Territory for said Product for use in the Field,
or (iii)
deliver or tender (or cause to be delivered or tendered) any
Product for use in
the Field in the Applicable Territory for said Product. Omrix will
take all
reasonable measures to ensure that all of its distributors of the
Products
comply with the exclusive rights granted by Omrix to Ethicon in the
Territory
related to each particular Product under this Agreement, subject to
applicable
law.
(b) Supply of Ethicon Components. Ethicon shall supply the
Ethicon
Components, if any, to Omrix within ninety (90) days of Omrix's
orders therefor.
Ethicon hereby agrees to supply Omrix with sufficient amounts and
quality of
Ethicon Components, if applicable, in order for Omrix to meet its
supply
obligations to Ethicon with respect to the Hemostatic Pad Product
and Flowable
Hemostat hereunder, and to do so in the time frame necessary for
Omrix to meet
its delivery obligations to Ethicon hereunder. Ethicon further
covenants that
all Ethicon Components shall be delivered to Omrix with a remaining
shelf-life
equal to or greater than two (2) years.
2.3
TERRITORY.
(a) For purposes
of this Agreement, the Territory with respect to
each Primary Product shall be as follows:
(i) Quixil: The European Union (including the countries
joining in 2004 but excluding Portugal), Norway, Iceland,
Liechtenstein and
Switzerland (collectively, the "Quixil Territory").
(ii) FS2: The European Union (including the countries joining
in 2004), Norway, Iceland, Liechtenstein and Switzerland (the "FS2
Territory").
(iii) All other Products: The European Union (including the
countries joining in 2004), Norway, Iceland, Liechtenstein,
Switzerland, the
United States of America and Canada and all their territories and
possessions
(including Puerto Rico) (the "Developed Territory").
(b)
The Territory with respect to any Accessory shall be the same
as
the Territory for any Primary Product with which such Accessory can
be used.
2.4
ADDITIONAL TERRITORIES. If Omrix desires to commercially exploit
any
Product in any country that is not within the Territory for such
Product and is
not in the Restricted Countries, it shall notify Ethicon in writing
of such
intention, and thereafter Ethicon shall have three (3) months to
request, by
written notice to Omrix, that such country be added to the
Territory for such
Product. If Ethicon desires to commercially exploit any Product in
any country
that is not within the Territory for such product and is not in the
Restricted
Countries, it shall notify Omrix in writing of such intention. Upon
either
event, the Parties shall then negotiate in good faith the minimum
number of
sales of such Product by Ethicon in such country for the first
twenty-four (24)
months following the four month anniversary of Regulatory Approval
in such
country; provided that, Ethicon shall pay the necessary costs of
Regulatory
Approval for such Product in such additional country. If Ethicon
fails to make
such election
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within the applicable time frame, if the Parties fail to reach an
agreement in
writing on the terms of adding such country to the Territory within
thirty (30)
days of Ethicon's written notice to Omrix contemplated above, if
Ethicon fails
to file for Regulatory Approval in such country within one-hundred
twenty (120)
days of reaching agreement on terms that contemplate that Ethicon
will be
responsible for filing for Regulatory Approval in such country, or
if Ethicon
fails to timely pay (or reimburse Omrix) for any necessary costs of
such
Regulatory Approval, Ethicon shall have no rights to such Product
in such
country and Omrix shall be free to sell such Product in such
country directly or
through any third party distributor.
2.5
INTERIM SALES AGENCY AGREEMENT.
(a) General. Notwithstanding anything else in this Agreement,
with
respect to each country within the Territory in which Ethicon does
not have the
regulatory and other legal authorizations, licenses, approvals and
other
clearance necessary for Ethicon to distribute or sell as
principal
("Distribution Clearance") any Product (each such country, an
"Agency Country"
with respect to such Product), Ethicon shall be Omrix's exclusive
sales
representative for such Product (an "Agency Product" with respect
to such
country) in that country and Ethicon shall not distribute or sell
as principal
any such Product prior to Distribution Clearance. Within any Agency
Country,
Omrix shall not solicit directly or indirectly from any party any
purchases of
products that are Agency Products with respect to such country.
Ethicon may
solicit and transmit orders to Omrix for Agency Products, but
Ethicon shall not
be authorized to bind Omrix to any proposals, orders or agreements
of any kind.
At such time as Ethicon shall have received Distribution Clearance
for a Product
within a country that was theretofore an Agency Country, Ethicon
shall
automatically cease to serve as Omrix's sales representative and
shall
simultaneously become the exclusive distributor of such Product
within such
country, as contemplated by the other provisions of this
Agreement.
(b) Commissions. In consideration of Ethicon's sales efforts
under
this Section 2.5, Omrix will pay Ethicon a sales commission of ***
percent
(***%) of Omrix's Net Sales of the applicable Agency Product(s) in
the Agency
Country. Commissions for a calendar quarter will be paid by Omrix
to Ethicon
within 40 days after the end of such calendar quarter.
(c) Reporting. Omrix will provide Ethicon with monthly quantity
reports ("Monthly Quantity Reports") of all Agency Products sold by
Omrix in
each Agency Country. Omrix will provide the Monthly Quantity
Reports no more
than 60 days after the end of each calendar month. The Monthly
Quantity Reports
will be provided to Ethicon in electronic format and in accordance
with Omrix's
standard accounting practices. The Monthly Quantity Reports will
contain the
following information: a) Omrix's unique customer identification
number; b) end
user customer name, address, city, state, and zip code; c) product
code and
description; d) selling unit of measure; e) quantity sold in such
month; and f)
indication of positive or negative transaction (credit or return,
etc.). Ethicon
may hire, at its own expense, a mutually-agreed-upon independent
third party to
audit the Net Sales reported by Omrix under this Section 2.5(c) no
more than
once per calendar year and, if Omrix's records are insufficient for
the
foregoing purposes or any such inspection discloses an underpayment
of five
percent (5%) or more of the amount of payments actually due for any
period,
then, in addition to any other rights and remedies available to
Ethicon under
this Agreement, Omrix will pay Ethicon's reasonable cost of
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such inspection after receipt of the bill or invoice for such
inspection. Omrix
will provide reasonable access to applicable records and reasonably
cooperate
with such third party auditor. Any adjustments to Commissions will
be made
promptly following completion of the audit.
(d) Promotional
Materials. Omrix shall provide Ethicon with such
types and quantities of Omrix's standard promotional materials for
the Agency
Products as Ethicon may reasonably request in order to promote and
solicit
orders for such Products. No such promotional materials for any
Agency Country
shall refer to Ethicon if such reference is prohibited by the
Applicable Legal
Requirements in such country.
(e) Termination of UK Employee. Ethicon may within ten (10)
business
days of the Effective Date, in its sole discretion, hire Jonathan
Gillespie on
terms and conditions similar to his current employment with Omrix.
If Ethicon
chooses to hire Mr. Gillespie, Ethicon shall be responsible for
obtaining a
waiver or for paying for costs resulting from Mr. Gillespie's
contractual notice
provisions or any statutory rights solely to the extent arising
from the
termination of Mr. Gillespie by Omrix, if any, up to a maximum of
$50,000. Omrix
shall be responsible for all other costs arising from the
termination of Mr.
Gillespie's employment. If Ethicon chooses not to hire Mr.
Gillespie within ten
(10) business days of the Effective Date, Ethicon will reimburse
Omrix solely
for the costs of terminating Mr. Gillespie, including without
limitation any
contractual or statutory rights of Mr. Gillespie relating to his
termination, up
to a maximum of $50,000. Ethicon will pay Omrix's invoice therefor
within
forty-five (45) days of receipt. Omrix agrees to indemnify Ethicon
for any
liabilities arising from Mr. Gillespie's employment and any costs
arising from
the termination of Mr. Gillespie's employment in excess of the
$50,000
reimbursed by Ethicon.
2.6
EXCLUSIVE PURCHASE OF PRODUCT. For the period of the above
distribution rights, Ethicon agrees that Omrix will be Ethicon's
and its
Affiliates' exclusive supplier of human plasma derived hemostats
and sealants
for use in the Field in the Territory; provided that, Omrix agrees
that its sole
and exclusive remedy for a breach of this provision shall be to
terminate this
Agreement and/or seek damages against Ethicon (and not any of its
Affiliates)
and Omrix shall not be entitled and hereby waives any right to seek
injunctive
relief or any damages against any of Ethicon's Affiliates. For
purposes of this
Section 2.6 only, "Territory" where used without reference to one
or more of the
Products shall mean all the Territories set forth in Section 2.3
applicable to
one or more of the Products. For the avoidance of doubt, the
foregoing
restriction restricts Ethicon and its Affiliates from internally
sourcing human
plasma derived hemostats and sealants for use in the Field in the
Territory. If
such exclusivity is not enforceable under applicable law and
Ethicon or its
Affiliates sell or distribute human plasma derived hemostats and
sealants of any
party other than Omrix in a country in the Territory, and Ethicon
fails to cure
such breach or nonperformance within sixty (60) days after
receiving written
notice from Omrix thereof, Omrix may make non-exclusive, upon
written notice to
Ethicon made within sixty (60) days of the end of such cure period,
(A) if such
country is in the European Union, all exclusivity rights of Ethicon
hereunder in
the portion of the Territory that is in the European Union, (B) if
such country
is the United States, all exclusivity rights of Ethicon hereunder
in the United
States and (C) if such country is not in the European Union and is
not the
United States, all exclusivity rights of Ethicon hereunder in such
country;
provided that such termination of exclusivity shall be Omrix's sole
and
exclusive remedy for any breach of this Section 2.6. The provisions
of this
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<PAGE>
Section 2.6 shall not be interpreted in a manner that would require
Ethicon to
violate Applicable Legal Requirements in order to maintain its
exclusivity
rights hereunder. The foregoing shall not restrict Ethicon's
ability to obtain
products to replace Products for which Ethicon or Omrix has
exercised its rights
of termination under this Agreement. The provisions of this Section
2.6 are
subject to the provisions of Section 2.8(d) in all respects.
2.7
DISTRIBUTION BY OMRIX. Nothing in this Agreement will limit the
right
of Omrix to market, sell and distribute the Products outside the
Field anywhere
in the world, under any names, trademarks, logos, and other trade
dress (other
than any names, trademarks, logos and trade dress of Ethicon or
Johnson &
Johnson or their Affiliates) as Omrix in its sole discretion may
determine;
provided however, Omrix shall not directly or indirectly (through
its
Affiliates, agents or licensees) market, sell or distribute any
product under
the Quixil name or trademark anywhere in the Territory other than
Products sold
to Ethicon or Agency Products. Omrix shall not have the right,
however, to
distribute Products which incorporate an Ethicon Component.
2.8 CARVE
OUT AND EFFECTS THEREOF.
(a) Carve Out. Notwithstanding anything to the contrary in this
Agreement, Ethicon shall have no rights in the United States,
Canada or any of
their territories or possessions (including Puerto Rico) to FS2 or
Improved
Products arising from Covered Improvements to FS2 or any
Improvements to Quixil;
provided that, Omrix agrees that it and its Affiliates will not
commercialize
FS2 in the Field in the United States and its territories and
possessions
(including Puerto Rico) or enter into any transaction for the
commercialization
(including without limitation, the supply, sale, marketing,
promotion,
licensing, or distribution) of FS2 in the Field in the United
States and its
territories and possessions (including Puerto Rico) without
including Ethicon as
its exclusive distributor in the Field under terms and conditions
that are
substantially similar to this Agreement, except as otherwise
permitted by this
Section 2.8 unless the Restriction Sunset (as defined in Section
2.8(b) below)
occurs.
(b) Expansion of the FS2 Territory. The FS2 Territory under
this
Agreement may be expanded to include the United States, Canada and
their
territories and possessions (including Puerto Rico) upon the mutual
agreement in
writing of Omrix and Ethicon on the same terms and conditions as
those set forth
herein; provided that any such agreement shall require, at the
least, that (i)
Ethicon shall pay an additional fee equal to the Up Front
Difference upon such
mutual written agreement, (ii) Section 5(c) of the Development
Agreement shall
be amended and restated in its entirety to read: "a milestone of
***
dollars ($***) shall be paid by Ethicon upon the earlier of (A)
First
Commercial Sale of FS2 in the United States or (B) forty-five (45)
days after US
Marketing Clearance of FS2, less any amounts paid under this
Section 5(c) prior
to the amendment which inserted this revised Section 5(c)", (iii)
all purchases
of FS2 shall be counted towards Ethicon's Fibrin Sealant minimum
purchase
requirements under Section 4.4 herein and (iv) references to "FS2"
shall be
deleted from the first and fourth lines of Section 1.43; provided
further that,
after the four (4) year period commencing on the Effective Date, if
no mutual
agreement has yet occurred to so expand the FS2 Territory on the
foregoing
terms, and Omrix subsequently proposes to Ethicon an agreement to
so expand the
FS2 Territory on the foregoing terms, but Ethicon has not agreed in
writing
within thirty (30) days of Omrix's proposed agreement to so expand
the FS2
Territory on such terms, then Omrix shall be free to
11
<PAGE>
grant such rights in the United States, Canada and all their
territories and
possessions (including Puerto Rico) to a third party (the
occurrence of such
thirtieth (30th) day, , the "Restriction Sunset").
(c) Improvements to Quixil and Commercialization thereof. For
the
avoidance of doubt, notwithstanding anything to the contrary herein
or in the
Development Agreement, Omrix shall be free to develop Improvements
(as defined
in the Development Agreement) to Quixil, but may not commercialize
such
Improvements in the Field (i) in the Quixil Territory, except as
provided herein
and in the Development Agreement and (ii) in the United States,
Canada and all
their territories and possessions (including Puerto Rico) without
including
Ethicon as its exclusive distributor in the Field for all products
resulting
from such Improvements, until the date of the Restriction Sunset ;
provided
that, notwithstanding anything to the contrary herein or in the
Development
Agreement, Omrix shall be free to commercialize any such
improvements which are
(A) modifications to the delivery device accompanying Quixil in the
United
States, Canada and all their territories and possessions (including
Puerto Rico)
and/or (B) any variations to Quixil required by a Regulatory Agency
in the
United States, Canada and all their territories and possessions
(including
Puerto Rico).
(d) Limited Waiver of Restriction on Ethicon. Notwithstanding
anything to the contrary herein, so long as Ethicon does not have
exclusive
distribution rights to FS2 in the United States, Canada and their
territories
and possessions (including Puerto Rico), then Ethicon and its
Affiliates shall
be permitted to source and commercialize fibrin sealant products
which compete
directly with Quixil and/or FS2 in the United States, Canada and
all their
territories and possessions (including Puerto Rico), whether or not
in the
Field; provided that Ethicon has given sixty (60) days prior notice
to Omrix of
its intent to develop such competing product and Ethicon and its
Affiliates
shall not commercialize such fibrin sealant products for six (6)
months after
providing such notice to Omrix. In the event Ethicon provides such
notice or
commences such development or commercialization without such
notice, then each
of the following shall be deemed terminated and of no further force
or effect:
(A) the proviso in clause (a) of Section 2.8, (B) clause (b) of
Section 2.8 and
(C) the restrictions on commercialization by Omrix in the United
States, Canada
and all their territories and possessions (including Puerto Rico)
set forth in
Section 2.8(c)(ii).
2.9 NO
FURTHER GRANTS OR LICENSES. Except for the rights expressly
granted
by this Agreement, no further licenses are granted to Omrix or
Ethicon in or
under this Agreement, either expressly or by implication.
ARTICLE 3
LAUNCH; PROMOTION; PRODUCTION FACILITIES
3.1 LAUNCH
AND COMMERCIAL EXPLOITATION OF THE PRODUCTS.
(a) Omrix expressly understands and acknowledges that, subject
to
Section 2.6 above, Ethicon may be currently involved in, and in the
future may
evaluate and/or become involved in, other business opportunities
and products
for the hemostasis and sealant markets,
12
<PAGE>
some of which products may compete with the Products. Subject to
Section 2.6
above, Ethicon in its sole discretion may, both now and during the
term of this
Agreement, alone or in other business or research arrangements with
third
parties, sell such competing products and otherwise participate in
these and
other markets. Omrix acknowledges that the Development Costs,
milestone
payments, purchase prices, and other consideration paid or to be
paid by Ethicon
hereunder and under the Development Agreement, together with
Ethicon's agreement
to make minimum purchases hereunder, constitute complete and
adequate
consideration for Omrix entering into this Agreement and shall
constitute
complete satisfaction of any duty, whether express or implied,
which could be
imposed upon Ethicon to commercially exploit its rights under this
Agreement and
are accepted by Omrix in lieu of any other minimum efforts
obligation on the
part of Ethicon. Omrix acknowledges, understands and agrees, that
Omrix shall
not challenge in any subsequent claim or action any decision or
action regarding
the commercial exploitation of the Products made or taken by any
director,
officer, employee or individual acting as agent of Ethicon or its
Affiliates in
what such individual subjectively believes to be the best interests
of Ethicon
(or such Affiliate), and that they are not required to take into
account the
interests of Omrix, unless such decision or action constitutes a
material breach
by Ethicon of any of its obligations under this Agreement.
(b) Ethicon shall have the right to use a contract sales force
for
the commercial exploitation of the Products.
3.2
REGULATORY & QUALITY OVERSIGHT.
(a) Regulatory Approval: Omrix will use commercially reasonable
efforts to obtain and maintain the necessary Regulatory Approval to
market and
sell each Product in the Territory in the Field subject to
Ethicon's obligations
to pay for certain costs pursuant to Section 4.1 of the Development
Agreement.
For purposes of this Agreement, Omrix shall produce the various
Products under
cGMPs and Ethicon shall produce the Ethicon Components under
cGMPs.
(b) Quality Oversight. Ethicon quality and manufacturing staff
will
have the right to inspect the Omrix Facilities during regular
business hours
and, upon reasonable written notice, may review submissions to
Regulatory
Agencies before they are submitted and any correspondence/citations
from such
Regulatory Agencies, provided that Omrix has no obligation to delay
the
submission or consider any input from Ethicon. Omrix shall give
Ethicon copies
of any such submissions in advance of filing them and shall
promptly provide
Ethicon with copies of such citations and correspondence from
Regulatory
Agencies. Omrix quality and manufacturing staff will have the right
to inspect
Ethicon's facilities in which Ethicon Components are manufactured
and in which
the Products are held and stored, during regular business
hours.
(c) Agency Relations. Omrix may request that Ethicon cooperate
with
Omrix in establishing and maintaining a positive relationship with
Regulatory
Agencies concerning the applicable Product and Ethicon will then
use
commercially reasonable efforts to do so.
(d) Changes to Specifications. Omrix shall give Ethicon
reasonable
advance written notice of any change, improvement or modification
(i) to any
specification for an
13
<PAGE>
Accessory or (ii) to the method, location or process of manufacture
or
production of any Accessory or any raw material used in its
manufacture, but in
the case of this clause (ii), only if such change, improvement or
modification
would require the submission of any amendment, filing or other
documentation
with any regulatory authority or otherwise materially adversely
affect the
Accessory, the Primary Products with which it is used, or the
marketability of
either. The Parties acknowledge that Specifications for Products
and the Ethicon
Components are addressed separately under the Development
Agreement.
(e) Quality Agreement. Attached as Exhibit D is the quality
agreement for Quixil as agreed by the Parties (the "Quixil Quality
Agreement").
The Parties may enter into a separate quality agreement on a
Product-by-Product
basis or may amend the Quixil Quality Agreement to apply to such
Product and the
regulations applicable thereto (each, a "Quality Agreement"), which
Quality
Agreement shall supercede any contradictory provisions of this
Section 3.2 with
respect to the applicable Product.
3.3
REMEDIATION PLAN. In the event that Omrix encounters production
or
other problems that are causing, or Omrix believes are
significantly likely to
cause, Omrix to fail to meet its supply obligations hereunder
("Supply
Disruptions"), Omrix will provide Ethicon with written notice of a
potential
supply disruption. Within sixty (60) days of such notice, Omrix
will develop in
good faith a remediation plan ("Remediation Plan") to redress or
avoid such
Supply Disruptions. Ethicon shall have the right to consult and
comment on the
Remediation Plan and Omrix will consider its comments in good
faith. Upon
completion of the Remediation Plan, Omrix will use its best efforts
to
successfully implement the Remediation Plan. Nothing in this
Section 3.3 shall
limit Omrix's liability for failure to supply Products in
accordance with the
terms of this Agreement. Further, in the event of a Failure to
Supply (as
defined below), Omrix will pay certain liquidated damages as set
forth in
Section 4.7 hereof. For the purposes of this Agreement, "Failure to
Supply"
shall mean, with respect to any Product, (A) the failure of Omrix
to both (1)
supply at least sixty-five percent (65%) of Ethicon's binding
orders for such
Product which conform to the Forecast for a consecutive three (3)
month period
(the "Initial Shortage Period") and (2) supply at least eighty
percent (80%) of
Ethicon's binding orders for such Product which conform to the
Forecast for the
nine (9) month period that commences with the beginning of the
Initial Shortage
Period (such nine month period, a "Shortage Period") or (B) the
failure of Omrix
to supply at least ninety percent (90%) of Ethicon's binding orders
for such
Product which conform to the Forecast during any Fiscal Year (such
a Fiscal
Year, also a "Shortage Period"). Any such shortage under clauses
(A) or (B)
below ninety percent (90%) of the quantities ordered by Ethicon
pursuant to
binding orders which conform to the Forecast during the Shortage
Period is
referred to herein as a "Failure to Supply Shortfall" for such
Product (for
instance, if the Binding Orders for the Shortage Period were for
100 units of a
Product and Omrix supplied only 65 units of that Product during
that period, the
Failure to Supply Shortfall would be 25 units of that Product).
3.4 SUPPLY
AGREEMENT. Omrix agrees to use commercially reasonable efforts
to enter into (and maintain during the term of this Agreement) a
binding supply
agreement on or prior to December 31, 2003 for the supply human
plasma with NABI
Biopharmaceuticals substantially in the form attached hereto as
Exhibit M.
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<PAGE>
ARTICLE 4
MILESTONE
PAYMENTS, MINIMUM REQUIREMENTS AND PAYMENT AND ORDER TERMS
4.1 FIBRIN
SEALANT MILESTONE PAYMENTS. Ethicon shall pay to Omrix the
following payments upon the following milestones:
(a) Upon the first anniversary of the First Commercial Sale of
Quixil by Ethicon (or by Omrix pursuant to an order solicited by
Ethicon as
contemplated by Section 2.5), Ethicon shall pay Omrix *** U.S.
Dollars (US$***);
and
(b) Within thirty (30) days following EU Marketing Clearance
(as
defined in the Development Agreement) for Quixil to be used to
support
hemostasis in general surgery as per the EU Guideline
CPMP/BPWG/153/00, Ethicon
shall pay Omrix *** U.S. Dollars (US$***).
4.2
INVOICES; PURCHASE PRICE; ADJUSTMENTS.
(a) Invoices. Within five (5) days of the end of each calendar
month, Omrix will invoice Ethicon for the Purchase Price (as
defined below) for
each Product and Accessory actually received by Ethicon in
compliance with the
terms and provisions of this Agreement in such month. Ethicon shall
pay each
such invoice in full within forty-five (45) days of receipt
thereof. Omrix may
offer, in its sole discretion to Ethicon, on an invoice-by-invoice
basis, that
invoices paid in full within ten (10) days of receipt of such
invoice shall be
discounted two percent (2%) from the amount stated on such invoice.
The purchase
price (the "Purchase Price") for each Product purchased from Omrix
during the
Initial Term shall be as set forth on Exhibit C.
(b) Cost Adjustments. Within forty-five (45) days of the end of
the
second twelve (12) month period after the First Commercial Sale of
a Product
hereunder, the Parties shall agree on the Baseline Costs for such
Product or
shall appoint an independent expert to make such determination.
(i) On the second August 15 (or the next business day if such
date is not a business day) after the end of such second twelve
(12) month
period and the August 15 (or the next business day if such date is
not a
business day) of every second calendar year thereafter, if there
has been a net
increase in the unit costs of Omrix's Cost Variables for a Product
since the
determination of the Baseline Costs or the date of the most recent
price
adjustment increase pursuant to this sentence, the Parties will use
good faith
efforts to agree to an increase in the sample prices, Maximum
Transfer Price and
Minimum Transfer Price for such Product for the subsequent full
Fiscal Years
(commencing on or around January 1, 2006) that will preserve that
portion of
Omrix's percentage gross profit margin on such Product that is
solely based on
Omrix's Cost Variables for which there has been a net increase in
unit costs,
and any independent expert determining the extent of such cost
changes shall
consider only net changes in the unit costs of the Cost Variables
(Schedule 4.2
hereto sets forth an example of such calculations).
15
<PAGE>
(ii) In addition, if Omrix effectuates a change in
manufacturing a Product as a result of Regulatory Changes at any
time, the
Parties will use good faith efforts to agree to a change in the
sample price,
Maximum Transfer Price and Minimum Transfer Price for such Product
to reflect
variable costs or savings actually incurred by Omrix as a result of
such
Regulatory Changes (e.g., if such that additional costs or savings
to Omrix of
$*** per ml would increase or decrease the sample prices, Maximum
Transfer Price
and Minimum Transfer Price by $*** per ml); provided that, any
equipment costs
required to effectuate such Regulatory Changes included in such
calculation
shall be amortized for the remaining useful life of such
equipment.
(iii) Further, if Omrix incurs an extraordinary increase in
raw materials and/or supply costs of more than *** percent (***%)
for a Product,
the Parties will use good faith efforts to agree to an increase in
the sample
price, Maximum Transfer Price and Minimum Transfer Price for such
Product to
reflect such increased costs of raw materials and to preserve that
portion of
Omrix's percentage gross profit margin on such Product that is
solely based on
an extraordinary increase in raw materials or supply costs of more
than ***
percent (***%); provided that such price change shall not be
effective until at
least six (6) months after the Effective Date or the most recent
adjustment for
extraordinary increases in raw materials costs pursuant to this
sentence. If,
subsequent to an increase in the sample price, Maximum Transfer
Price or Minimum
Transfer Price to reflect an extraordinary increase in raw
materials costs,
those additional costs are subsequently reduced, the Parties will
use good faith
efforts to agree to a reduction in the sample price, Maximum
Transfer Price and
Minimum Transfer Price for the applicable Product to reflect such
reductions in
those costs; provided that such price change shall not be effective
until at
least six (6) months after the increase in prices for such
extraordinary
increases in raw materials costs pursuant to the prior
sentence.
If the Parties cannot agree on the amount of a change in sample
price, Maximum
Transfer Price and Minimum Transfer Price for a Product
contemplated above
within six (6) weeks of such price change being proposed by a
Party, the Parties
shall mutually agree on an independent expert to be responsible for
making a
final determination of whether and to what extent the sample price,
Maximum
Transfer Price and Minimum Transfer Price will be adjusted and both
Parties
agree to abide by the determination of such independent expert. In
all cases,
the Parties shall equally share in the cost of such expert. In no
event shall
the sample prices, Maximum Transfer Prices and Minimum Transfer
Prices be
adjusted to less than the original sample prices, Maximum Transfer
Prices and
Minimum Transfer Prices set forth under this Agreement. If the
Parties cannot
agree on Baseline Costs, price changes or on an independent expert
to determine
such matters within nine (9) weeks of the end of the period from
which such
Baseline Costs would be computed or of a proposal of a price change
by a Party,
the dispute shall be handled through dispute resolution pursuant to
Article 13
hereof.
4.3
SHIPPING TERMS. All shipments of Products shall be EXW (Ex
Works)
(INCOTERMS 2000) Omrix's facility in Israel for all Products other
than those
shipped to the European Union, for which the shipping terms shall
be EXW Omrix's
facility in Belgium. Each shipment shall be accompanied by a
packing slip which
describes the Products and states the purchase order number. To the
extent there
is any conflict or inconsistency between this Agreement and any
purchase order,
purchase order release, confirmation, acceptance or any similar
document, the
terms of this Agreement shall govern.
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<PAGE>
4.4
PURCHASES AND MINIMUMS.
(a) Ethicon agrees to purchase the following quantities of
Fibrin
Sealant Products:
(i) Ethicon hereby orders from Omrix *** units (1 ml
equivalent) of Quixil, for delivery on or prior to December 31,
2003 and agrees
that this clause (i) constitutes a binding "purchase order" for
that amount of
Quixil; provided that Omrix shall reallocate units so ordered to
the extent
necessary to supply customers pursuant to Section 2.5 hereof. For
the avoidance
of doubt, sales of Quixil in Agency Countries through December 31,
2003 shall
count toward Ethicon's *** unit order for Quixil in this
clause.
(ii) A minimum quantity of *** units (1 ml equivalent) of
Fibrin Sealant Products during the period commencing on January 1,
2004 and
ending September 30, 2005. Of that *** units (1 ml equivalent)
Ethicon hereby
agrees to order *** units (1 ml equivalent) of Quixil for delivery
on or prior
to June 30, 2004, an additional *** units (1 ml equivalent) of
Quixil for
delivery on or prior to September 30, 2004 and an additional ***
units (1 ml
equivalent) of Quixil for delivery on or prior to December 31,
2004. The units
ordered pursuant to clause (i) above shall not count toward the
requirements of
this clause (ii). Sales of Fibrin Sealant Products in Agency
Countries
commencing on January 1, 2004 and ending September 30, 2005 shall
count toward
Ethicon's *** unit purchase requirement of this clause (ii) as
Fibrin Sealant
Products purchased by Ethicon. For the period from October 1, 2005
through
December 31, 2005, Ethicon will purchase a minimum quantity of
Fibrin Sealant
Products equal to ***% of the quantity of units of Fibrin Sealant
sold to
Ethicon in Fiscal Year 2004 (***% of the quantity of units of
Fibrin Sealant
purchased by Ethicon in Fiscal Year 2004 prorated by ***%),
provided that, for
the avoidance of doubt, such quantities shall include any amounts
sold pursuant
to Section 2.5 hereof.
(iii) Commencing in Fiscal Year 2006, and every subsequent
Fiscal Year during the Term, a minimum quantity of units (1 ml
equivalent) of
Fibrin Sealant Products equal to *** percent (***%) of the quantity
of units of
Fibrin Sealant Products sold by Ethicon in the previous Fiscal
Year.
(b) Ethicon agrees to purchase the following quantities of
Thrombin
as a stand alone product:
(i) A minimum quantity of *** units (each unit being a 5,000
IU vial) during the period commencing on the First Commercial Sale
of Thrombin
by Ethicon and ending twenty-four (24) months thereafter.
(ii) Commencing in the first full Fiscal Year following such
twenty-four (24) month period in clause (i), and every subsequent
Fiscal Year
during the Term, a minimum quantity of units of Thrombin equal to
*** percent
(***%) of the quantity of units of Thrombin sold by Ethicon in the
previous
Fiscal Year; provided that the minimum for the remainder of the
Fiscal Year in
which such twenty-four (24) month period expires shall be ***
percent (***%) of
the quantity of units of Thrombin sold by Ethicon in the second
twelve (12)
17
<PAGE>
months of such twenty-four (24) month period, prorated based on the
portion of
such Fiscal Year then remaining.
(c)
If for any reason Ethicon fails to purchase the applicable
minimum requirements above for a Product during the corresponding
period
described in Section 4.4 (as applicable, the "Minimum Period"),
then Ethicon
shall pay the Shortfall Amount to Omrix within forty-five (45) days
of the end
of the applicable Minimum Period and Omrix's sole and exclusive
alternative
remedy for failure to pay such amount shall be to unilaterally
terminate by
written notice to Ethicon within sixty (60) days of Ethicon's
failure to pay the
Shortfall Amount within the forty-five (45) day period set forth
above provided
that Ethicon has not cured such failure to pay the Shortfall Amount
within such
sixty (60) day period (1) this Agreement with respect to such
Product only or
(2) Ethicon's rights of exclusivity with respect to distribution of
such
Product, at Omrix's sole discretion. In the event Ethicon fails to
purchase the
minimum quantities of a Product for three consecutive Minimum
Periods, then
Omrix's sole and exclusive remedy, other than collection of the
Shortfall
Amounts as contemplated above, under this Agreement shall be the
right to
terminate this Agreement by written notice to Ethicon within sixty
(60) days of
the end of the third consecutive Minimum Period with respect to
such Product
only. In no event shall Ethicon's failure to meet any minimum
requirements of
Section 4.4 constitute a breach of this Agreement; provided that
the Parties
each acknowledge that failure to pay the resulting Shortfall Amount
shall
constitute a material breach of this Agreement. Omrix shall not be
obligated to
deliver any Products in exchange for the Shortfall Amount.
(d) In the event that Ethicon's annual unit sales volume of
Fibrin
Sealant Produc