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OMITTED INFORMATION IS THE SUBJECT OF A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934 AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Licen

Key Takeaway: OMITTED INFORMATION IS THE SUBJECT OF A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934 AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE License and Cooperation Agreement 60314 Frankfurt am Main 750 Lexington

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OMITTED INFORMATION IS THE SUBJECT OF A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT
OF 1934 AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
License and Cooperation Agreement
60314 Frankfurt am Main
750 Lexington Avenue, 26th Floor
New York, New York 10022
Whereas, Zentaris is the owner of certain patents and know-how relating
to a compound known as Perifosine ;
Whereas, AOI desires to obtain certain licenses from Zentaris to develop
and commercialize Perifosine under the aforesaid patents and know-how, and
Zentaris is willing to grant to AOI such licenses;
Now, Therefore, in consideration of the foregoing, the parties to this
Agreement do agree as follows:
For purposes of this Agreement, the following terms
shall have the following meanings:
1.1 Affiliate shall mean and include in
relation to each Party, any person, firm, corporation or other entity: (i) if
at least fifty percent (50%) of the voting stock or other equity interest
thereof is owned, directly or indirectly, by that Party; (ii) which owns,
directly or indirectly, at least fifty percent (50%) of the voting stock or
other equity interest of that Party; or (iii) if at least fifty percent
(50%) of the voting stock or other equity interest thereof is owned, directly
or indirectly, by a person, firm, corporation or other entity that owns,
directly or indirectly, at least fifty percent (50%) of the voting stock or
other equity interest of that Party.
1.2 Agreement shall mean this agreement and
all Exhibits attached hereto, and the terms herein , hereunder , hereto and
such similar expressions shall refer to this Agreement.
1.3 Confidential Information shall mean and
include all know-how, data and information, not in the public domain, relating
to the Contract Products or Perifosine, the Field, or the business, affairs,
research and development activities, results of clinical trials, national and
multinational regulatory proceedings and affairs, finances, plans, contractual
relationships and operations of the Parties.
1.4 Contract Products shall mean and include
all pharmaceutical products, whether as mono-preparations or
combination-preparations, with Perifosine as an active ingredient, for use in
the Field, in any form of administration whatsoever, where the development,
manufacture, use, sale, offer for sale, or importation thereof by or for AOI is
covered by a Valid Claim of Zentaris Patent Rights.
1.5 Co-ordination Committee shall mean the
committee established pursuant to Section 5 hereof.
1.6 CRADA shall mean the Cooperation
Research and Development Agreement (CACR-0774) prepared by the Technology
Development and Commercialization Branch of the National Cancer Institute
regarding the clinical development of Perifosine.
1.7 Development Data shall mean reports of
clinical studies and all other documentation containing or embodying any
pre-clinical, clinical and CMC data relating to the application for Regulatory
Approval for the Contract Products and/or Perifosine or the use of the Contract
Products and/or Perifosine in the Field, including, but not limited to,
registration dossiers.
1.8 Effective Date of this Agreement shall
mean the date on which this Agreement is executed by the duly authorized
representatives of each of the parties hereto.
1.9 Field shall mean the development and
commercialization of Perifosine and Contract Products for human therapeutic
Commercial Sale shall mean in relation to each country within the Territory,
first sale by AOI or its Affiliates, licensees, or distributors of any of the
Contract Products for use in any of the indications in the Field in that
country, after obtaining all of the applicable Regulatory Approvals.
to the Contract Products or Perifosine shall mean and include any and all
Inventions, and any and all changes, modifications and amendments to Zentaris
Know-How which: (i) improve the performance or efficacy of the Contract
Products or Perifosine; (ii) reduce any side effects, drug
interactions or other adverse effects of the
Contract Products or Perifosine; or (iii) reduce the cost and/or increase
the efficiency or productivity of the manufacturing and production processes
for the Contract Products or Perifosine.
Event shall mean any event whereby a party: (i) becomes insolvent or
bankrupt; (ii) makes an assignment for the benefit of its creditors; (iii) has
a trustee or receiver for all or a substantial part of its property appointed;
or (iv) has any case or proceeding or other action commenced or taken
against or by it in bankruptcy or otherwise seeking reorganization,
liquidation, dissolution, winding-up, arrangement, composition or readjustment
of its debts or any relief under any bankruptcy, insolvency, reorganization or
other similar act or law of any jurisdiction now or hereinafter in effect.
shall mean and include any and all inventions and discoveries which are, or may
be, patentable or otherwise protectable under the patent or other intellectual
property laws of any country, which relate to Perifosine and the Contract
Products, and which are conceived, discovered or reduced to practice during the
continuance of this Agreement.
shall mean the National Cancer Institute, Rockville, Maryland, United States of
Sales shall mean the amount invoiced by AOI, its Affiliates, its licensees,
sublicensees or distributors on account of sales of Contract Products to Third
Parties in the Territory, less the following deductions to the extent (except
in the case of (v) below) actually allowed or specifically allocated to
the Contract Products by the selling party using generally accepted accounting
excise taxes and duties paid or allowed by the selling party and any other
governmental charges imposed upon the production, importation, use or sale of
such Contract Products;
quantity and cash discounts allowed on Contract Products;
or credits to customers on account of rejection or return of Contract Products
or on account of retroactive price reductions affecting such Contract Products;
Product rebates and Contract Product charge backs including those granted to
managed-care entities;
and insurance costs, if they are included in the selling price for the Contract
Products invoiced to Third Parties, provided always that such deduction shall
not be greater than the balance between the selling price actually invoiced to
Last updated: May 7, 2010