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Title: |
Collaboration Agreement |
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Date: |
2007 |
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$36 |
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#2839165 |
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
COLLABORATION AGREEMENT
THIS AGREEMENT is made the sixth day of December, 2004
Between
atugen AG, a company incorporated under the laws of Germany, whose registered office is at Robert-Rssle-Str. 10, D13125 Berlin, Germany (hereinafter Atugen), of the first Part; and
Quark Biotech, Inc., a private limited company incorporated under the laws of California whose principal office is at 6540 Kaiser Drive, Fremont CA 94555, U.S.A. and QBI Enterprises Ltd., a private company incorporated under the laws of the State of Israel whose principal office is at Weizmann Science Park, P.O. box 4071, Nes Ziona 70400, ISRAEL, of the second Part (together hereinafter, QBI)
A. Atugen has established proprietary technology and patent rights related to the development and manufacture of siRNA molecules potentially silencing any target in any species and has filed a patent application directed to biological aspects relating to the 801 gene in the field of cancer
B. QBI owns patent rights and know-how directed to the structure and function of the 801 gene and its role in diseases;
C. Atugen and QBI wish to engage in a collaborative research program with the aim of using Atugens technology to develop products directed to the 801 gene, for the treatment of cancer and other diseases in humans;
NOW, THEREFORE, it is agreed as follows:
1. DEFINITIONS
Affiliate means any enterprise which controls, is controlled by, or is under common control with, such party as long as such control exists. For the purpose of the preceding sentence, the word control means the ownership of at least 50% of the outstanding voting stock of such enterprise or, a comparable equity interest in any other type of entity
Atugen Background Technology means any and all inventions, discoveries, methods and processes, improvements, know-how, technical information, data or other technology that is heretofore or hereafter discovered, conceived, made, developed
and/or reduced to practice by Atugen or its Affiliates, or owned in whole or in part by, or licensed (with a right to sublicense) to Atugen or its Affiliates and relates to: (i) the development and manufacture of siRNA molecules silencing gene targets in animals and humans, and (ii) the preparation of (liposome-based) formulations for the delivery of siRNA therapeutic products, as well as any and all intellectual property rights therein, including without limitation Patent Rights, copyright, trademark or trade secret rights. Atugen Background Technology related to patents and patent applications as of the date of this Agreement is identified in Schedule A1. The term Atugen Background Technology does not include the Atugen Program IP.
Atugen Existing IP means the Atugen Background Technology, and the Atugen Program IP.
Atugen Products shall mean Products and Drug Products for the treatment of cancer in humans.
Atugen Program IP means certain stabilized, chemically modified siRNA molecule(s) silencing the human 801 gene and the mouse 801 gene that have been developed by Atugen prior to the date of this Agreement and certain lipids and liposome-based formulations, as identified in Schedule A2 hereto, and any and all intellectual property rights therein, including without limitation Patent Rights, copyright, trademark or trade secret rights.
Clinical Development means the trials conducted in human subjects to determine the safety, efficacy and pharmacokinetics of a compound as required by the US FDA. Clinical Development includes Phase I, Phase II, Phase III (and IV if required), and the New Drug Application (NDA) for Regulatory Approval by the FDA .
First Commercial Sale means the first sale to a third party in an arms length transaction for use or consumption in such country after required Regulatory Approval has been granted by the relevant regulatory authority in such country, provided that in a Major Market the First Commercial Sale shall not be deemed to have commenced until the annual Net Sales in that market exceeds [ * ].
Formal Preclinical Development means the aggregate of in vitro and in vivo studies required by the US FDA to determine the potential risk a compound poses to man and the environment, necessary and sufficient for an IND approval.
Drug Product means the Product formulated (such as e.g. using liposome-based Atugen Background Technology) for administration to man.
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