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Title: |
Manufacture and Supply Agreement |
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Date: |
2002 |
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$41 |
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#843874 |
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MANUFACTURE AND SUPPLY AGREEMENT
between
ALLERGAN SALES, INC.
and
CARL ZEISS, INC.
on behalf of
HUMPHREY SYSTEMS DIVISION
Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as *. A complete version of this exhibit has been filed
separately with the Securities and Exchange Commission.
{PAGE}
MANUFACTURING AND SUPPLY AGREEMENT
THIS MANUFACTURING AND SUPPLY AGREEMENT (this "Agreement") is effective
as of May 28, 1999 by and between Allergan Sales, Inc., a California
corporation, on behalf of itself and its Affiliates ("Allergan"), having an
address at 2525 Dupont Drive, Irvine, California 92612 and Carl Zeiss, Inc., a
New York corporation, on behalf of its Humphrey Systems Division ("Humphrey"),
having an address at 5160 Hacienda Drive, Dublin, California 94568.
RECITALS
A. Allergan is engaged in the design, distribution and marketing of
certain phacoemulsification equipment, including the Products described in
Exhibit "A" attached hereto, as amended by the parties from time-to-time, for
use in cataract removal surgery.
B. Humphrey has the capability and desire to manufacture, service, and
supply the Products to Allergan and Allergan desires that Humphrey manufacture,
service and supply the Products to it upon the terms and conditions contained
herein.
C. Allergan and Humphrey desire to enter into this Agreement governing
the manufacture and supply of Products by Humphrey for Allergan's exclusive use
and purposes.
AGREEMENT
NOW THEREFORE, in consideration of the covenants contained herein, the
above recitals, and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties hereto agree as
follows:
SECTION 1. DEFINITIONS.
1.1 "Affiliates" of a party shall mean any corporation or other business
entity controlling, controlled by, or under common control with such party.
1.2 "Agreement" shall mean this Manufacturing and Supply Agreement.
1.3 "Allergan" shall mean Allergan Sales, Inc., a Delaware corporation.
1.4 "CE Mark" shall mean the mark of conformity with one or more
applicable directives of the European Union.
1.5 "CFR" shall mean the United States Code of Federal Regulations.
1.6 "cGMPs" shall mean the standards established by the FDA for current
Good Manufacturing Practices, as specified in 21 CFR Section 820 Quality System
Regulations; 21 CFR Section 807 Establishment Registration and Device Listing
for Manufacturers of Devices; 21 CFR Section 803 Medical Device Reporting; 21
CFR Section 801 Labeling; 21 CFR Section 810 Medical Devices Recall
Page 1
{PAGE}
Authority; 21 CFR Section 806 Medical Devices Reports of Corrections and
Removals; the Federal Food, Drug and Cosmetic Act, as amended; EN46000, 1 and/or
2; ISO 9001 and/or 9002; and the standards established in the European Union's
Council Directive 93/42/EEC of 6/14/93 Concerning Medical Devices (the "MDD").
1.7 "Contract Year" shall mean the twelve- (12) month period following
the Effective Date of this Agreement, and each subsequent twelve- (12) month
period during the term of this Agreement.
1.8 "Control" (including "controlling", "controlled by" and "under
common control with" of any party, corporation, or other business entity) shall
mean the direct or indirect ownership of more than fifty percent (50%) of the
voting or income interest in such party, corporation, or other business entity,
respectively.
1.9 "Device Master Record" shall mean the compilation of records
containing the procedures and specifications for a component, in accordance with
21 CFR 820.
1.10 "Effective Date" shall have the meaning given to it in the
introductory paragraph hereto.
1.11 "EPA" shall mean the United States Environmental Protection Agency.
1.12 "Facility" or "Facilities" shall mean Humphrey's manufacturing
facilities at 5160 Hacienda Drive, Dublin, CA 94568.
1.13 "FDA" shall mean the United States Food and Drug Administration.
1.14 "Humphrey" shall mean Humphrey Systems, a division of Carl Zeiss,
Inc., a New York corporation.
1.15 "Intellectual Property" shall mean (i) all patents, patent
applications, patent disclosures, records of invention and any patents, U.S. or
foreign, issuing Affiliates, related to the Products; (ii) all trade names,
trademarks, copyrights, logos, symbols, and various applications therefor and
registrations thereof related to the Products; (iii) all inventions,
discoveries, devices, methods, ideas, concepts, processes, know-how, technical
data; financial, marketing, and business data, trade secrets and any other
intellectual property (whether or not patentable, reduced to practice, or
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