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Execution Copy
CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT
This Co-Development and Co-Commercialization Agreement, dated as of
December 17, 2003 (the "Effective Date"), is between XOMA (US) LLC, a Delaware
limited liability company ("XOMA"), located at 2910 Seventh Street, Berkeley, CA
94710, and ALEXION PHARMACEUTICALS, INC., a Delaware corporation ("Alexion"),
located at 352 Knotter Drive, Cheshire, CT 06410.
WITNESSETH:
WHEREAS, Alexion (together with Alexion Antibody Technologies, Inc., its
wholly-owned subsidiary) possesses scientific and technical proprietary
technology, know-how, patents and resources relating to the development,
manufacture and commercialization of antibody-based products, including Antibody
116, Alexion's novel monoclonal antibody that is currently being developed as a
potential treatment in the Field (as defined below);
WHEREAS, XOMA possesses scientific and technical resources relating to the
development, manufacture and commercialization of antibody-based products; and
WHEREAS, Alexion and XOMA wish to enter into a collaborative effort to
further Develop, Manufacture and Commercialize Product(s) (as such terms are
defined below) in the Field to be governed by this Agreement (the
"Collaboration");
NOW, THEREFORE, XOMA and Alexion hereby agree as follows:
1. DEFINITIONS
1.1 Definitions. The following capitalized terms shall have the following
meanings for purposes of this Agreement:
"Adverse Drug Reaction" means any untoward medical occurrence in a patient
or subject who is administered a Product, whether or not considered related to
the Product, including any undesirable sign (including abnormal laboratory
findings of clinical concern), symptom or disease temporally associated with the
use of such Product.
"Advertising" has the meaning set forth in Schedule B.
"Affiliate" means any corporation, association or other entity that
directly or indirectly controls, is controlled by or is under common control
with the Party in question. As used herein with respect to a corporation,
association or other entity, the term "control" means control
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with possession of the power to direct, or cause the direction of, the
management and policies of such corporation, association or other entity.
"Agreement" means this document, together with all Schedules hereto.
"Alexion Background Technology" means all Patent Rights, technology,
inventions, information, data, know-how, compounds, materials and substances
(whether or not patented or patentable) that relate to or are potentially useful
for the discovery, screening, design, synthesis, delivery, development, testing,
use, manufacture, sale, import or export of any Product in the Field that exist
as of the Effective Date and are Controlled by Alexion.
"Alexion Collaboration Technology" means all Patent Rights, technology,
inventions, information, data, know-how, compounds, materials and substances
(whether or not patented or patentable) that are Controlled by Alexion (alone or
together with XOMA) and that: (a) relate to or are potentially useful in
connection with the discovery, screening, design, synthesis, delivery,
development, testing, use, manufacture, sale, import or export of any Product in
the Field, and (b) are conceived or reduced to practice by Alexion or any Third
Party on Alexion's behalf in the course of the Collaboration.
"Alexion Development Expenses" means, as to a particular Product, the sum
of the [*] percent ([*]%) of Development Expenses incurred in conducting
First-Time Pre-Clinical Development Activities for which Alexion is responsible
pursuant to Section 3.6(a) and the seventy percent (70%) of Development Expenses
incurred in conducting activities under a Development Plan that are not
First-Time Pre-Clinical Development Activities for which Alexion is responsible
pursuant to Section 3.6(b).
"Alexion Technology" means all Alexion Background Technology and Alexion
Collaboration Technology.
"Allocable Overhead" has the meaning set forth in Schedule B.
"Allowable Expenses" has the meaning set forth in Schedule B.
"Antibody 116" means that certain antibody known as "Antibody 116," and any
derivatives thereof developed hereunder, including those resulting from changes
to the manufacturing process contemplated hereunder, and any other antibody, or
modification of any thereof, approved by the JMC as a replacement for such
antibody. The current details of Antibody 116 are set forth on Schedule A.
"Arbitrable Dispute" means (a) any dispute relating to, arising out of or
based upon matters of contractual construction and interpretation of the
provisions of this Agreement, including whether a specific standard articulated
in this Agreement has been met in a particular circumstance, (b) any Early Stage
Dispute, (c) any dispute described in the fourth sentence of Section 9.2(b), (d)
any Section 5.1 Dispute and (e) any disagreement identified as an Arbitrable
Dispute in the first sentence of Section 4.9.
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"BLA" means a Biologics License Application (as defined in the FDC Act) and
any other marketing authorization application or other license, registration or
other application seeking approval from a Regulatory Authority to market a
Product in the Field in the Territory.
"Breaching Party" has the meaning set forth in Section 13.2(b).
"Budgeted Detail Effort" means for each Party, its percentage of the
Budgeted Total Detail Effort for each year.
"Budgeted Total Detail Effort" means for each calendar year the total
number of Details for each Party as budgeted by the Development Committee.
"Claim" has the meaning set forth in Section 14.1(a).
"Collaboration" has the meaning set forth in the Recitals.
"Collaboration Technology" means individually or collectively Alexion
Collaboration Technology, XOMA Collaboration Technology and Joint Collaboration
Technology.
"Combination Product" has the meaning set forth in Schedule B.
"Commercialization" or "Commercialize" means any and all activities
associated with marketing, promoting, communicating (including medical
communications and publications), distributing, importing, exporting or selling
a Product in the Field, including the conduct of Phase III(b)/IV Studies, and
activities directed to obtaining pricing and reimbursement approvals, by a
Party, its Affiliates or licensees or sublicensees.
"Commercialization Expenses" has the meaning set forth in Schedule B.
"Commercialization Program" means the Commercialization of a Product in the
Field in accordance with this Agreement.
"Commercially Reasonable and Diligent Efforts" means those efforts
consistent with the exercise of prudent scientific and business judgment, as
applied to other pharmaceutical products of similar potential and market size by
participants in the biopharmaceutical industry having similar resources to XOMA
or Alexion, as the case may be.
"Consumer Promotion" has the meaning set forth in Schedule B.
"Confidential Information" has the meaning set forth in Section 10.1.
"Continuing Party" has the meaning set forth in Section 7.5.
"Control" or "Controlled" means with respect to any material, know-how or
other information or intellectual property right, the possession (whether by
license, other than solely by virtue of licenses granted in this Agreement, or
ownership) by a Party or its Affiliates of the ability to grant to the other
Party access or a license as provided herein without violating the terms of any
agreement or other arrangement with any Third Party.
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