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Manufacturing and Supply Agreement

 

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Title:

Manufacturing and Supply Agreement

Entities:

Advanced Medical Optics, Inc.; Allergan, Inc.

Date:

2002

Size:

Preview shows 5KB of 59KB total

Price:

$40

ID:

#843819

 

 

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                       MANUFACTURING AND SUPPLY AGREEMENT


THIS MANUFACTURING AND SUPPLY AGREEMENT this ("Agreement") is effective as of
June 30, 2002 the ("Effective Date") by and between Allergan, Inc., a Delaware
corporation, on behalf of itself and its Affiliates ("Allergan"), having an
address at 2525 Dupont Drive, Irvine, California 92612 and Advanced Medical
Optics, Inc., a Delaware corporation, on behalf of itself and its affiliates
("AMO").

RECITALS

A. Prior to the date hereof, AMO was a wholly owned subsidiary of Allergan.

B. Pursuant to that certain Contribution and Distribution Agreement, by and
between Allergan and AMO (the "Contribution Agreement"), Allergan by the
effective date hereof, will have spun off AMO by distributing a special dividend
to all of the Allergan stockholders consisting of all of the outstanding shares
of stock of AMO held by Allergan (the "Distribution").

C. Allergan currently manufactures and distributes various optical medical
devices and contact lens care products for AMO, each as more particularly
described in Exhibit "A" attached hereto.

D. AMO desires that Allergan continue, after the Distribution, to manufacture
and supply to AMO the Product(s) (as that term is defined herein) upon the terms
and conditions contained herein and Allergan desires to manufacture and supply
to AMO the Product(s) upon the terms and conditions contained herein.

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

A. "Affiliates" of a party shall mean any corporation or other business entity
controlling, controlled by, or under common control with such party.

B."Batch" shall mean that predetermined quantity of finished Product(s) listed
on and associated with a Product on Exhibit "A".

C. "CE Mark" shall mean the mark of conformity with one or more applicable
directives of the European Union.

D. "CFR" shall mean the United States Code of Federal Regulations.

Page 1

{PAGE}

E. "COA" has the meaning given to it in Section 2.4.

F. "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.

G. "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.

H. "Cost" shall mean Allergan's cost to manufacture including direct labor,
direct material and overhead. Allergan uses full absorption inventory costing,
which includes all direct and indirect production costs. Direct and indirect
production costs are those costs incident to and necessary for production or
manufacturing operations or processes. Cost shall be consistent with the costing
methodology used by Allergan in determining 2002 prices and will be determined
in accordance with generally accepted accounting principles ("GAAP").

I. "cGMPs" shall mean the standards established by the FDA for current Good
Manufacturing Practices, as specified in 21 CFR Section 820 Quality System
Regulations; 21CFR Section 807 Establishment Registration and Device Listing for
Manufacturers of Devices; 21 CFR Section 803 Medical Device Reporting; 21CFR
Section 801 Labeling; 21CFR Section 810 Medical Devices Recall 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").

J. "ECR" (Engineering Change Request) shall mean the master change control form
defined by the Allergan Worldwide Specifications Change Control System used to
document requested changes to Product(s) Specifications or Packaging and
Labeling Specifications.

K. "Ex works" (or "EXW") means that the seller delivers title when it places the
goods at the disposal of the buyer at the seller's premises or another named
place not cleared for export and not loaded on any collecting vehicle, as
defined in the International Chamber of Commerce Incoterms 2000.

L. "Excess Materials" shall mean Raw Materials on hand and ordered consistent
with AMO's forecast at the agreed upon lead times and for which the forecasted
use is in excess of twelve (12) months. This would be a result of cancellations,

 

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