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Title: |
Development Agreement |
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Date: |
2006 |
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$50 |
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ID: |
#1436352 |
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CONFIDENTIAL
DEVELOPMENT AGREEMENT
THIS DEVELOPMENT AGREEMENT (the "Agreement") is made as of September 22,
2003 (the "Agreement 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 fibrin sealant, Quixil(TM), including the
medical device applicator and other related devices;
WHEREAS, Omrix is in the process of developing further, biological fibrin
sealant products and devices and intellectual property related thereto, such as
thrombin and a second generation fibrin sealant;
WHEREAS, Ethicon desires to provide medical devices, and components of
such devices, for use in connection with certain of Omrix's biological fibrin
sealants in specific products;
WHEREAS, Ethicon and Omrix desire to further develop specific fibrin
sealant products and thrombin products, and medical devices for use in
connection with such products;
WHEREAS, Ethicon and Omrix desire to provide a mechanism for development
of certain improvements which may arise in the course of developing the
aforementioned products; and
WHEREAS, Ethicon and Omrix are simultaneously entering to a Distribution
and Supply Agreement (the "Supply Agreement") for Ethicon to purchase and resell
Quixil(TM) and the products developed hereunder in specified territories;
NOW, THEREFORE, in consideration of the premises and of the mutual
promises and covenants herein contained, effective upon the Effective Date, the
Parties hereto agree as follows:
1. Definitions. The following terms, when used with initial capital
letters, shall have the meanings set forth below.
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.
<PAGE>
1.1 "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.
1.2 "BAC" shall mean the substance that is a component of Quixil
that is manufactured from cryoprecipitate extracted from "Human Plasma for
Fractionation" the production processes for which include various combinations
of both tranexamic acid and arginine and/or their derivatives and meets the
specifications for BAC set forth on Exhibit B hereto.
1.3 "BAC2" shall mean a different version of BAC identified by Omrix
in its sole discretion that contains different combinations of the same
components of BAC, but that is essentially free of plasminogen activity and
tranexamic acid.
1.4 "Covered Improvement" shall mean an Improvement to a Development
Product, made or proposed to be made during the Term of this Agreement, for
which both (i) the primary indication for use is in the Field and (ii) the
Improvement includes, or results in an improved version of a Development Product
that includes, (A) in the case of an Improvement to FS2, an improved version of
BAC2 and/or an improved version of Thrombin delivered together through a device
functionally equivalent to the device first approved for use with FS2, (B) in
the case of Thrombin, an improved sterile solution or lyophilized version of
Thrombin and (C) in the case of the Hemostatic Pad Product, an improved version
of the substrate, BAC2 and/or Thrombin used in the Hemostatic Pad Product or the
process of incorporation of BAC2 and/or Thrombin with a substrate.
1.5 "Development Costs" shall mean all reasonable costs and expenses
incurred by Omrix in connection with the Project (including, without limitation,
all costs and expenses relating to clinical studies and regulatory filing fees
and costs of subcontractors and consultants, provided that such subcontractors
or consultants do not replace full-time, permanent Omrix personnel positions) in
a manner consistent with parameters set forth in a budget approved by the DAB,
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