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Document Preview Subscription, Joint Development and Operating Agreement [Amended and Restated] |
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Title: |
Subscription, Joint Development and Operating Agreement [Amended and Restated] |
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Entities: |
Elan Corp., plc; ISIS Pharmaceuticals, Inc.; Elan International Services, Ltd.; Orasense Ltd. |
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Date: |
2002 |
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Size: |
Preview shows 12KB of 86KB total |
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Price: |
$52 |
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ID: |
#282189 |
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THIS AMENDED AND RESTATED SUBSCRIPTION, JOINT DEVELOPMENT AND OPERATING AGREEMENT is made this 24th day of October 2002,
among:
(1) ELAN CORPORATION, PLC, a public limited company incorporated under the laws of Ireland, and having its registered office at Lincoln House, Lincoln Place, Dublin 2, Ireland ("Elan");
(2) ELAN INTERNATIONAL SERVICES, LTD., a private limited company incorporated under the laws of Bermuda, and having its registered office at Clarendon House, 2 Church St., Hamilton, Bermuda ("EIS");
(3) ISIS PHARMACEUTICALS, INC., a corporation incorporated under the laws of Delaware and having its principal place of business at 2292 Faraday Avenue, Carlsbad, CA 92008, United States of America ("Isis"); and
(4) ORASENSE LTD., a private limited company incorporated under the laws of Bermuda, and having its registered office at Clarendon House, 2 Church St., Hamilton, Bermuda ("Orasense").
RECITALS:
Capitalized terms shall have the meanings set forth below unless otherwise defined.
D. As of the date hereof, Elan (as defined below) has entered into the Elan License Agreement with Orasense and Isis, and Isis has entered into the Isis License Agreement with Orasense and Elan, in connection with the license to Orasense of the Elan Intellectual Property and the Isis Intellectual Property, respectively.
E. Elan and Isis have agreed to co-operate in the management of Orasense for the research, development and Commercialization of the Product based on their respective technologies.
F. Elan, EIS, Isis and Orasense are parties to that certain Subscription, Joint Development and Operating Agreement (the "Original Agreement") dated April 20, 1999 (the "Original Effective Date"). The parties have agreed to enter into this Agreement for the purpose of amending and restating the Original Agreement and recording the terms and conditions of the joint venture and of regulating their relationship with each other and certain aspects of the affairs of and their dealings with Orasense.
NOW IT IS HEREBY AGREED AS FOLLOWS:
CLAUSE 1
DEFINITIONS
1.1 In this Agreement, the following terms shall, where not inconsistent with the context, have the following meanings respectively.
"Affiliate" shall mean, with respect to Isis or Elan, any corporation or entity other than Orasense (and entities controlled by it) controlling, controlled or under the common control of Isis or Elan, as the case may be, and, with respect to Orasense, any corporation or entity under control of Orasense, but excluding, in the case of Elan, an Elan JV. A corporation or non-corporate entity shall be regarded as in control of another corporation if it owns or directly or indirectly controls at least fifty percent (50%) of the voting stock of the other corporation or (a) in the absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation or (b) in the case of a non-corporate entity, the power to direct or cause the direction of the management and policies of such corporation or non-corporate entity, as applicable.
"Agreement" shall mean this amended and restated agreement (which expression shall be deemed to include the Recitals and the Schedules hereto).
"Business" shall mean the business of Orasense as described in Clause 2 and as more particularly specified in the Research Plan and such other business as the Directors may agree from time to time in writing should be carried on by Orasense.
"Commercialization" shall mean the manufacture, promotion, distribution, marketing and sale of the Products.
"Common Stock" shall mean the common stock, par value $1.00 per share of Orasense.
"Common Stock Equivalents" shall mean any options, warrants, rights or any other securities convertible, exercisable or exchangeable, in whole or in part, for or into Common Stock.
"Control" shall mean the ability of Elan, Isis or Orasense, as the case may be, to grant a license or sublicense as contemplated herein without having to obtain the prior consent of any third party or having to amend any agreement between Elan, Isis or Orasense, as the case may be, and a third party.
"Development Candidate" shall mean, ISIS 104838, [***] TNF-a, as more specifically detailed in the License Agreements.
"Development Product" shall mean any product containing as an active ingredient the Development Candidate formulated using the Oral Platform for humans.
"Directors" shall mean, at any time, the directors of Orasense.
"EIS Director" shall have the meaning set forth in Clause 7.
"Elan Intellectual Property" shall have the meaning set forth in the Elan License Agreement.
"Elan License" shall have the meaning set forth in the Elan License Agreement.
"Elan License Agreement" shall mean the amended and restated license agreement between Elan, Orasense and Isis, of even date herewith.
"Elan Minority Interest" will be deemed to have occurred if at any time after [***], Elan's ownership interest in Orasense falls below [***]
"Encumbrance" shall mean any liens, charges, encumbrances, equities, claims, options, proxies, pledges, security interests, or other similar rights of any nature.
"Exchange Act" shall mean the Securities Exchange Act of 1934, as amended.
"Failure to Fund" shall have the meaning set forth in Section 9.5.
"Field" shall mean the research, development and Commercialization of the Oral Platform for use with Oligonucleotide Drugs.
"Financial Year" means each year commencing on January 1 (or in the case of the first Financial Year, the date hereof) and expiring on December 31 of each year.
"Fully Diluted Common Stock" shall mean all of the issued and outstanding Common Stock, assuming the conversion, exercise or exchange of all outstanding Common Stock Equivalents.
"Independent Third Party" shall mean any person other than Orasense, Isis, Elan or any of their respective Affiliates.
"Isis Blocking Invention" shall mean [***]
"Isis Delivery Technology" shall have the meaning given to such term in the Isis License Agreement.
"Isis Directors" has the meaning set forth in Clause 7.
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