Manufacturing And Supply Agreement, Dated 11/10/2003

EXHIBIT 10.28


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.


MANUFACTURING AND SUPPLY

AGREEMENT


[AMO LOGO APPEARS HERE]


&

Nicholas Piramal India Limited

TABLE OF CONTENTS

1. DEFINITIONS 1 2. MANUFACTURE AND SALE OF PRODUCTS 4 2.1. Manufacture of Products . 4 2.2. Manufacturing Standards. 4 2.3. AMO Engineering Change Orders 4 2.4. Supplier Engineering Change Proposals 5 2.5. Tooling and Equipment 5 2.6. Location of Supplier Facilities 6 2.7. Vendors. 6 2.8. Discontinued Material 6 2.9 Trade Mark 5 3. ORDERS, MATERIAL PROCUREMENT AND FORECASTS 6 3.1. Purchase Orders 6 3.2. Acceptance of Purchase Orders 6 3.3. Delivery Address and Shipment Date Changes 6 3.4. Order Quantity Increases/Decrease 7 3.5. Configuration Mix Changes 7 3.6. Cancellation of Purchase Orders 8 3.7. Cancellation Liability 8 3.8. Material Procurement 9 3.9. Forecasts 10 4. TESTING, RECORDS AND INSPECTION 10 4.1. Quality Control Tests 10 4.2. Root Cause Analysis 10 4.3. Records 10 4.4. Inspection of Facilities and Records 10 4.5. Right of Rejection and Revocation 11 5. SHIPMENT OF PRODUCTS 11 5.1. Shipment 11 5.2. On Time Shipment 11 5.3. Early Shipment 11 5.4. Delayed Shipment 11 6. PRICE AND TERMS OF PAYMENT 12 6.1. Price 12 6.2. Cost Reductions 12 6.3. Meeting Competition 12 6.4 Most Favored Customer 11 6.5. Invoices 13 6.6. Payment 13


i 6.7 Exchange Rate Fluctuations 11 7. WARRANTY AND TECHNICAL SUPPORT 13 7.1. Product Warranty 13 7.2. Inspection Period/Defective Product 14 7.3. Replacement of Defective Products 14 7.4 RMA Procedure 12 7.5. Root Cause Analysis 14 7.6. Technical Support 15 8. TERM AND TERMINATION 15 8.1. Term 13 8.2. Termination for Breach 15 8.3. Termination for Insolvency 15 8.4. Effect of Expiration or Termination 15 8.5. Right to Purchase 15 8.6. Duty to Manufacture 16 8.7. Return of Confidential Information 16 8.8. Survival 16 9. SUPPLIER REPRESENTATIONS AND WARRANTIES 16 9.1. General Representations 16 9.2. Quality Management System Certifications. 16 9.3. Legal and Regulatory Compliance. 16 9.4 AMO 16 10. REGULATORY 17 10.1. Government Approvals 17 10.2. Regulatory Inquires 17 10.3. Regulatory Inspections 17 10.4. Product Complaints / Reports 17 10.5. Recalls. 15 11. PROPRIETARY RIGHTS 18 11.1. AMO Technology 18 11.2. Assistance 18 11.3. Supplier Technology 18 12. CONFIDENTIALITY 19 12.1. Confidential Information. 19 12.2. Restrictions on Use and Disclosure of Confidential Information 19 12.3. Exclusions 19 13. INDEMNIFICATION 20 13.1. General Indemnity by the Supplier 20 13.2. General Indemnity by AMO 20 13.3 Inetellectual Property Indemnity by AMO 18


ii 13.4 Intellectual Property Indemnity by Supplier 18 14. GENERAL PROVISIONS 21 14.1. Integration / Modification 21 14.2. Use of Form Purchase Orders, Invoices and Other Documents 21 14.3. Relationship Between the Parties 21 14.4. Insurance 22 14.5. Non-Waiver 22 14.6. Remedies 22 14.7. Assignment 19 14.8. No Third Party Beneficiaries. 22 14.9. Severability 23 14.10. Notices 23 14.11. Force Majeure. 23 14.12. Confidential Relationship. 24 14.13. Choice of Law, Forum and Jurisdiction 24 14.14. Attorney Fees 21 14.15. Captions and Headings. 24 14.16. Days 24 14.17. Ambiguities. 24 14.18. Counterparts 25 14.19. Further Assurances 25 APPENDIX A ? Products APPENDIX B ? Technical Transfer and Validation Timelines APPENDIX C ? Product Specifications APPENDIX D ? Supplier Facilities APPENDIX E ? Form Certification of Conformance APPENDIX F ? Supplier Technology


iii

MANUFACTURING AND SUPPLY

AGREEMENT


Reference No.: 0005


This Manufacturing and Supply Agreement is effective as of the 10 th day of November 2003 (the " Effective Date"), by and between Advanced Medical Optics, Inc., having its principal place of business at 1700 E. St. Andrew Place, P.O. Box 25162, Santa Ana, California 92799-5162 U.S.A. (" AMO"), and Nicholas Piramal India Limited, a Company incorporated under the laws of India, having its principal place of business at 100, Centrepoint, Dr. B. Ambedkar Road, Parel, Mumbai 400 012 (the " Supplier"). As used herein, "AMO" means Advanced Medical Optics Inc together with its Affiliates (as defined herein) and the "Supplier" means Nicholas Piramal India Ltd. with its Affiliates.


Singly as "Party" and collectively as "Parties".


RECITALS


WHEREAS, the Supplier is engaged in the manufacture, sale and distribution of medical and pharmaceutical devices;

WHEREAS, AMO desires that the Supplier manufacture for, and supply to, AMO and its Affiliates the Products more particularly described in Appendix A attached hereto (the "Products") upon the terms and conditions contained herein;


WHEREAS, the Supplier desires to manufacture for, and supply to, AMO and its Affiliates the Products more particularly described in Appendix A attached hereto upon the terms and conditions contained herein.


WHEREAS , AMO shall source the products described in Appendix A attached hereto (the "Products") exclusively from the Supplier.


NOW, THEREFORE, in consideration of the mutual covenants contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

1. DEFINITIONS

1.1. An " Affiliate" of a person or entity means any individual, sole proprietorship, firm, partnership, corporation, trust, joint venture or other entity, whether de jure or de facto, which directly or indirectly controls, is controlled by or is under common control of such person or entity. As used in this definition, "control" means the possession, directly or indirectly, of the power to direct or cause the direction of the policies and management of a person or entity, whether by the ownership of stock, by contract or otherwise.

1.2." Agreement" means this Manufacturing and Supply Agreement.


1 1.3." AMO" has the meaning given to it in the introductory paragraph to this Agreement.

1.4." AMO Technology" means the Product Specifications and all other ideas, concepts, creations, technology, inventions, discoveries, developments, techniques, processes, know-how, drawings, designs, specifications, data, formulas and algorithms related to the Products, and all underlying intellectual property rights therein, including without limitation, all copyrights, trademarks, trade secrets, patents, industrial rights and all other intellectual property rights. The foregoing notwithstanding, "AMO Technology" shall not include Supplier Technology.

1.5." AMO Tooling and Equipment" has the meaning given it in Section 2.5.

1.6." AMO IP Indemnified Claims" has the meaning given to it in Section 13.3.

1.7." AMO General Indemnified Claims" has the meaning given to it in Section 13.2.

1.8." Cancellation Claim" has the meaning given it in Section 3.7.

1.9." Cancellation Notice" has the meaning given it in Section 3.6.

1.10." Cancellation Threshold" has the meaning given in Section 3.7.

1.11." Certificate of Conformance" means the form set forth in Appendix E, as the same may be amended from time to time by written agreement of the Parties.

1.12." CFR" means the United States Code of Federal Regulations.

1.13." cGMPs" means the most recently enacted provisions of 21 CFR 211, 21 CFR 801, 21 CFR 803, 21 CFR 806, 21 CFR 807, 21 CFR 810 and 21 CFR 820 (or their successor provisions), and all sections and subparts thereof.

1.14." Commercialization Date" has the meaning of the first delivery of the product by the Supplier and acceptance by AMO. 1.15." Confidential Information" has the meaning given to it in Section 12.1.

1.16." Configuration Mix Change" has the meaning given to it in Section 3.5.

1.17." Date of Delivery" has the meaning given to it in Section 5.1.

1.18." Defective Product" means Product that fails to conform to all warranties in this Agreement. 1.19." Device History Record" means a compilation of records in accordance with cGMPs containing the production history of finished Products. 1.20." Device Master Record" means a compilation of records in accordance with cGMPs containing the procedures and specifications for finished Products.

1.21." Discontinued Materials" has the meaning given to it in Section 2.8.


2 1.22." Effective Date" has the meaning given to it in the introductory paragraph to this Agreement. 1.23." Engineering Change" means any change to the Product Specifications of a Product.

1.24." Engineering Change Order" has the meaning given to it in Section 2.3.

1.25." Engineering Change Proposal" has the meaning given to it in Section 2.4.

1.26." FDA" means the United States Food and Drug Administration.

1.27." F.C.A." has the meaning given to it in the Incoterms, 2000.

1.28." Force Majeure Event" has the meaning given to it in Section 14.11.

1.29." General Indemnified Claims" has the meaning given to it in Section 13.1.

1.30." Inspection Period" has the meaning given to it in Section 7.2.

1.31." IP Indemnified Claims" has the meaning given to it in Section 13.2.

1.32."Lot" means Products manufactured as part of a single manufacturing run.

1.33."Order Lead Time" means the time from the acceptance of the purchase order by the Supplier in terms of this Agreement until the Shipment Date .

1.34." Product" means, the products described in Appendix A, as the same may be amended from time to time by written agreement of the Parties.

1.35." Product Family" means a set of related Product models identified in Appendix A.

1.36." Product Specifications" means a detailed description of the functional and technical specifications for each Product, including dimensions, drawings, performance characteristics and requirements, Quality Control Tests and instructions relating to the packaging, packing and labeling of each Product. The Product Specifications for each Product as set forth in Appendix C, as the same may be amended from time to time by written agreement of the Parties.

1.37." Quality Control Tests" means the quality test protocols for each Product set forth in the Product Specifications. 1.38." Quantity Increase/Decrease" has the meaning given it in Section 3.4.

1.39." Supplier IP Indemnified Claims" has the meaning given to it in Section 13.4.

1.40." Supplier General Indemnified Claims" has the meaning given to it in Section 13.1.

3 1.41." Regulatory Approvals" means any approvals, licenses, registrations or authorizations of any federal, state, local or foreign, regulatory agency, department, bureau or other government entity, necessary for the manufacture, handling, storage, testing, export, import, transport and sale of the Products.

1.42." RMA Number" has the meaning given it in Section 7.4.

1.43." Root Cause Analysis" means a process to identify the underlying source or cause of nonconforming materials, components or Products. 1.44." Shipment Date" means the date or dates specified by AMO or its Affiliates in a purchase order upon which the Products are to be shipped from the F.C.A. point to AMO and its Affiliates.

1.45." Supplier" has the meaning given to it in the introductory paragraph to this Agreement.

1.46." Supplier Technology" means the items identified in Appendix F.

1.47."Warranty Claim Dispute" has the meaning given to it in Section 7.5.

1.48." Warranty Period" has the meaning given it in Section 7.1.

2. MANUFACTURE AND SALE OF PRODUCTS

2.1. Manufacture and Sale of Products . The Supplier agrees to manufacture for, and sell and deliver to, AMO and its Affiliates such Products as AMO and its Affiliates may from time to time order pursuant to the terms and conditions of this Agreement. During the term of this Agreement, Supplier shall not manufacture the Products, or products which are substantially similar to the Products, for any third party.

2.2. Manufacturing Standards . Supplier shall manufacture, store, handle, inspect, test, package, label and ship all Products in strict conformity with (i) all applicable Product Specifications; (ii) all applicable cGMPs and all other applicable federal, state and local laws and regulations (and their foreign counterparts); and (iii) all applicable current standards (including all applicable subparts) of ISO 9001 or 9002, EN 46001 or 46002, ISO 13485 or 13488, IEC 60601, EN 60601, UL 2601, CAN/CSA- C22.2 No. 601.1 ? M90 and ANSI IPC-A-610 (or any successor provisions of any of the foregoing standards). The Supplier shall not make any change in or deviate in any way from the Product Specifications except pursuant to an approved Engineering Change Order or Engineering Change Proposal as provided in this Agreement.

2.3. AMO Engineering Change Orders . AMO may from time to time request that the Supplier incorporate an Engineering Change into a Product by delivering an Engineering Change Order to the Supplier. Each Engineering Change Order shall be in writing and shall include a description of the proposed Engineering Change and the


4 proposed effective date of such Engineering Change. Within ***** of receipt of an Engineering Change Order, the Supplier shall provide AMO with a written statement that sets forth: (i) the earliest possible implementation date for the Engineering Change; (ii) any increase or decrease in the cost of the Product subject to the Engineering Change; and (iii) any changes to the Shipment Date for such Product. If a proposed Engineering Change results in a change in the cost of, or Shipment Date for, the Product subject to the Engineering Change, an equitable adjustment shall be made to the price and/or Shipment Date for such Product. The Supplier shall not be obligated to implement an Engineering Change Order until the Parties have agreed, in a writing signed by an authorized representative of each Party, to the changes to the Product Specifications required by the Engineering Change and any changes to the price and/or Shipment Date for the Product subject to the Engineering Change.

2.4. Supplier Engineering Change Proposals . In support of Supplier's ongoing efforts to improve efficiency and reduce the costs of manufacturing the Products, the Supplier may from time to time suggest that an Engineering Change be made to a Product by delivering an Engineering Change Proposal to AMO. Each Engineering Change Proposal shall be in writing and shall include a description of the proposed Engineering Change, a description of any improvements in the Product or cost reductions that will result from the Engineering Change and the effect of the Engineering Change, if any, on the price and/or Shipment Date for the Product. Each Engineering Change Proposal shall provide detail sufficient to permit AMO to evaluate the desirability of such Engineering Change. AMO agrees to consider each Engineering Change Proposal it receives from the Supplier, but reserves the right to accept or reject each such Engineering Change Proposal in AMO's sole discretion. The Supplier shall not implement any Engineering Change Proposal that has not been accepted by AMO in writing. In the event AMO rejects an Engineering Change Proposal, the Supplier agrees to continue to manufacture and deliver the Products as originally specified.

2.5. Tooling and Equipment . The Supplier shall provide all non-Product specific tooling and equipment at its expense. AMO may purchase for, and provide to, the Supplier certain Product specific tooling and equipment necessary for the manufacture and testing of the Products (" AMO Tooling and Equipment"). All AMO Tooling and Equipment shall be and remain at all times the property of AMO, and shall be kept free of any liens or encumbrances. The Supplier shall use AMO Tooling and Equipment only for the purpose of manufacturing and testing the Products. The Supplier shall be responsible for all maintenance and use of, risk of loss of, and any damage to, all AMO Tooling and Equipment at the Supplier's sole risk and expense. While any AMO Tooling and Equipment is in the Supplier's custody or control, the Supplier shall procure and maintain insurance against loss of and damage to such AMO Tooling and Equipment in an amount no less than the then current replacement cost for such AMO Tooling and Equipment, with loss payable to AMO. In the event that any AMO Tooling and Equipment is lost or destroyed for any reason, Supplier shall promptly notify AMO and, upon demand by AMO, shall promptly reimburse AMO for AMO's cost of acquiring or replacing such AMO Tooling and Equipment. Upon demand by AMO at any time, the Supplier shall promptly return to AMO, at AMO's expense, any AMO

***** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


5 Tooling and Equipment in good working condition, ordinary wear and tear excepted. For purposes hereof, "ordinary wear and tear" shall not include any damage or deterioration that would have been prevented by good maintenance practices.

2.6. Location of Supplier Facilities . The Supplier shall manufacture, test and store all Products only in Supplier facilities located at the address or addresses specified in Appendix D hereto, as the same may be amended from time to time by written agreement of the parties.

2.7. Vendors . The Supplier shall be responsible for identifying and qualifying all vendors of materials and components necessary to manufacture the Products except for those vendors that AMO specifies in their validated formulations.

2.8. Discontinued Materials . The Supplier shall be responsible for ensuring the continuity of supply of all materials and components necessary to manufacture the Products. In the event a Vendor intends to discontinue any materials or components necessary to manufacture the Products (" Discontinued Materials"), the Supplier shall give AMO ***** prior written notice before such discontinuance. During the ***** notice period, AMO may require the Supplier to purchase the Discontinued Materials for AMO in such quantities as AMO may require in accordance with the terms of this Agreement. At the end of the ***** notice period, AMO may require placement of a final purchase order for the Discontinued Materials and may stagger the Shipment Dates for such final order over an ***** period following placement of the order. The price for Discontinued Materials shall be Supplier's cost for such Discontinued Materials immediately prior to Supplier's notice of discontinuance plus a reasonable markup, which markup shall not to exceed ***** of Supplier's cost for such Discontinued Materials. 2.9. Trade Mark. The Supplier shall have the right to affix the AMO name, AMO logo, and AMO trade mark on the Products. 3. ORDERS, MATERIAL PROCUREMENT AND FORECASTS

3.1. Purchase Orders . AMO and its Affiliates shall order Products by written purchase orders issued by an authorized employee of AMO or its Affiliates to the Supplier from time to time in accordance with this Agreement. Each purchase order shall specify (i) the Products to be delivered by the Supplier; (ii) the quantity of Products to be delivered by the Supplier; (iii) the address or addresses to which the Products are to be delivered; and (iv) the Shipment Date for the Products. The Order Lead Time for the Products shall be not less than ***** from the date of acceptance the purchase order by the Supplier. 3.2. Acceptance of Purchase Orders . The Supplier shall accept all purchase orders that comply with the terms and conditions of this Agreement. The Supplier shall have ***** from the date of receipt of each purchase order to reject the purchase order if it does not comply with the terms and conditions of this Agreement. Any rejection by the Supplier

***** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


6 must be in writing and must specifically identify the rejected term or terms and proposed changes that would be acceptable to the Supplier. If AMO (or its Affiliate issuing the purchase order) does not receive a written rejection of a purchase order within ***** of its receipt by the Supplier, the purchase order shall be deemed accepted. If the Supplier delivers a written rejection of a purchase order in accordance with this Section 3.2, AMO (or its Affiliate issuing the purchase order) shall, within ***** of its receipt of the written rejection, either confirm the purchase order with the Supplier's proposed changes or withdraw the purchase order.

3.3. Delivery Address and Shipment Date Changes . For any purchase order issued in accordance with this Agreement, AMO and its Affiliates may change the delivery address or postpone the Shipment Date for any or all Products ordered, or any quantities thereof, at any time prior to shipment of such Products at no additional charge. Each such delivery address change and Shipment Date change shall be in writing, with reference the purchase order to which it pertains, and shall be effective upon receipt by the Supplier.

3.4. Order Quantity Increase/Decrease . For any purchase order issued in accordance with this Agreement, AMO and its Affiliates may increase/decrease the quantity of any or all Products ordered (a " Quantity Increase/Decrease") as follows:


Number of days before

Shipment Date

Allowable order quantity

Increase / Decrease ***** 0 % ***** up to 50 % ***** no limit


Each Quantity Increase/Decrease shall be in writing, with reference to the purchase order to which it pertains, and shall be effective to the extent of the increase or decrease in quantity upon confirmation in writing by the Supplier. For each Quantity Increase/Decrease issued in accordance with this Section 3.4 and confirmed in writing by the Supplier, the purchase order shall be adjusted by multiplying the unit price of the Products (as set forth in the purchase order) by the increased or decreased number of units of such Products. Neither AMO nor its Affiliates shall be liable for any additional costs or charges resulting from a Quantity Increase/Decrease issued in accordance with this Section 3.4, other than as described in the preceding sentence.

3.5. Configuration Mix Changes . For any purchase order issued in accordance with this Agreement, AMO and its Affiliates may substitute any Product ordered with one or more other Products within the same Product Family of such Product ordered (a " Configuration Mix Change") as follows:


Number of days before

Shipment Date

Allowable Configuration

Mix-Change (per individual

Product ordered)

***** 0%

***** up to 50%

***** 100%

***** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


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Each Configuration Mix Change shall be in writing, with reference to the purchase order to which it pertains, and shall be effective upon receipt by the Supplier. For each Configuration Mix Change issued in accordance with this Section 3.5 the purchase order shall be adjusted to reflect the new unit price for each Product substituted in place of the originally ordered Product, if such unit price differs from the unit price of the originally ordered Product. Neither AMO nor its Affiliates shall be liable for any additional costs or charges resulting from a Configuration Mix Change issued in accordance with this Section 3.5, other than as described in the preceding sentence.

3.6. Cancellation of Purchase Orders . AMO and its Affiliates may cancel all or any portion of any purchase order at any time upon written notice to the Supplier (a " Cancellation Notice") provided that AMO shall not cancel Purchase Orders of Products which are to be shipped within ***** from the date of receipt of the Cancellation Notice by the Supplier. Upon receipt of each Cancellation Notice, unless otherwise directed by AMO or its Affiliates, the Supplier shall (i) stop all work under the cancelled purchase order, or any cancelled portion thereof, (ii) use its best efforts to cancel all orders for materials and components, and all subcontracts, to the extent they relate to the cancelled purchase order, or any cancelled portion thereof, (iii) use its best efforts to reduce any inventory of materials and components related to the cancelled purchase order, or any cancelled portion thereof, by returning such materials and components for credit or using such materials and components to fulfill any outstanding purchase orders or orders placed by other customers of Supplier, (iv) use its best efforts to sell any remaining inventory of materials and components related to the cancelled purchase order, or any cancelled portion thereof, to the extent such materials and components cannot otherwise be returned for credit or used to fulfill outstanding purchase orders or orders of other customers of Supplier, and (v) place no further orders for materials and components related to the cancelled purchase order, or any cancelled portion thereof. 3.7. Cancellation Liability . AMO and its Affiliates may cancel all or any portion of any purchase order without liability of any kind, including without limitation payment for lost profits or for reimbursement of material or labor costs or other expenses, as follows:


Number of days before

Shipment Date

Quantity of Product

(per purchase order)

that may be cancelled without liability

***** 0%

***** up to 50%

***** up to 100%

***** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


8

(all of the foregoing percentages, the " Cancellation Threshold"). For any quantity of Products cancelled in excess of the Cancellation Threshold, AMO's and its Affiliates' entire liability and the Supplier's exclusive remedy for such cancellation shall be payment by AMO or its Affiliates to Supplier of a Cancellation Claim as provided herein below. Within ***** from the date of Supplier's receipt of a Cancellation Notice, the Supplier shall submit a claim to AMO (or its Affiliate, if the Cancellation Notice was issued by such Affiliate), in accordance with generally accepted accounting principals, setting forth the price of any finished Products subject to the cancellation in excess of the Cancellation Threshold, and the following costs, if any, actually incurred by the Supplier as a result of cancellation in excess of the Cancellation Threshold: (i) the cost of work in progress (including labor performed); (ii) the cost of materials and components that could not be returned, reused or sold, (iii) the net loss on the sale of materials and components, and (iv) applicable restocking or cancellation fees charged to the Supplier by material and component vendors in an amount not to exceed ***** of the Supplier's cost for such returned materials and components (all of the foregoing, a " Cancellation Cl ...