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Title: |
Distribution and Supply Agreement |
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Entities: |
Nabi Biopharmaceuticals; Omrix Biopharmaceuticals, Inc.; Bank of New York |
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Date: |
2006 |
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Size: |
Preview shows 13KB of 155KB total |
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Price: |
$74 |
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ID: |
#1436354 |
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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.
1
<PAGE>
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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<PAGE>
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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<PAGE>
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
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