EX-10.45 4 a05-1768_1ex10d45.htm EX-10.45

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4)

And 240.24b-2

 

Exhibit 10.45

 

COMMERCIAL SUPPLY AGREEMENT

 

This Commercial Supply Agreement (this “Agreement”) is entered into and effective this 2nd day  of March, 2005 (the “Effective Date”) by and between Baxter Pharmaceutical Solutions LLC (“BAXTER”), a Delaware limited liability company having a place of business at 927 South Curry Pike, Bloomington, Indiana 47403, and Amylin Pharmaceuticals (“AMYLIN”), a Delaware corporation having a principal place of business at 9360 Towne Centre Drive, Suite 110, San Diego, California 92121.

 

 

RECITALS

 

1.                                       AMYLIN is engaged in the development of pharmaceutical products;

2.                                       BAXTER is engaged in the filling, labeling and packaging of pharmaceutical products;

3.                                       AMYLIN and BAXTER are parties to a Drug Product Development and Supply Agreement dated November 7, 2003, related to the Product (as defined below); and

4.                                       AMYLIN and BAXTER desire to have BAXTER fill, package, inspect, label, and test Product for distribution and sale by AMYLIN.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the parties agree as follows:

 

Article 1.  DEFINITIONS

 

As used in this Agreement, the following words and phrases shall have the following meanings:

 

1.1                                 “Affiliate” of a party hereto shall mean any entity that controls or is controlled by such party, or is under common control with such party.  For purposes of this definition, an entity shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of another entity (or other comparable ownership interest for an entity other than a corporation).

 

1.2                                 “AMYLIN Trademarks” shall mean the proprietary mark(s) for Product owned by AMYLIN.

 

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1.3                                 “Annual Forecast” shall be defined in Section 4.1.

1.4           “Annual Obligation” shall be defined in Section 4.3.

1.5                                 “Batch” shall mean a specific quantity of a Product or placebo comprising a number of Units mutually agreed upon between AMYLIN and BAXTER, and that (a) is intended to have uniform character and quality within specified limits, and (b) is Produced according to a single manufacturing order during the same cycle of Production.

1.6                                 “BAXTER Approval” shall mean authorizations by the appropriate Regulatory Authority necessary for BAXTER to Produce Product for commercial sale in a jurisdiction.

1.7                                 “Components” shall mean all Components used by BAXTER in the Production of Product under this Agreement.  Components are listed in Exhibit D, such Components identified as Components supplied by AMYLIN (“AMYLIN Supplied Components”) and Components supplied by BAXTER (“BAXTER Supplied Components”).

1.8                                 “Component Specifications” shall mean the specifications and testing to be performed for the Components, as set forth in Exhibit D.

1.9                                 “Confidential Information” shall mean all information and data provided by one party to the other party except any portion of such information and data which:

(i)                                     is known to the recipient as evidenced by its written records before receipt thereof from the disclosing party;

(ii)                                  is disclosed to the recipient, as demonstrated by competent evidence, by a third person who has the right to make such disclosure;

(iii)                               is or becomes part of the public domain through no fault of the recipient; or

(iv)                              the recipient can reasonably establish is independently developed by recipient without use of the information disclosed by the disclosing party.

1.10                           “Contaminant” shall mean any substance contained in Product that (a) causes Product to fail to meet Product Requirements, (b) causes Product to be adulterated within the meaning of the FD&C Act, or (c) is present in Product at a level that exceeds the level allowed under cGMP.

1.11                           “Current Good Manufacturing Practices” or “cGMP” shall mean (a) the good manufacturing practices required by the FDA and set forth in the FD&C Act or FDA Regulations (including without limitation 21 CFR 210 and 211), the principles and

 

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guidelines specified in Chapter II of European Commission Directive 91/356/Eed, including the rules governing medicinal products (in the European Union Volume 4), policies or guidelines, in effect at any time during the term of this Agreement, for the Production and testing of pharmaceutical materials as applied solely to Products, and (b) the corresponding requirements of each applicable Regulatory Authority.

1.12                           “Delivery Date” shall mean the date that Product is delivered to a common carrier designated by AMYLIN.

1.13                           “Effective Date” shall mean the date of this Agreement as set forth above.

1.14                           “FDA” shall mean (a) the United States Food and Drug Administration or any successor entity thereto and (b) the corresponding agency of each applicable Regulatory Authority.

1.15                           “FD&C Act” shall mean the United States Federal Food, Drug and Cosmetic Act, as may be amended from time to time, or such similar statute in jurisdictions other than the United States.

1.16                           “Long Range Forecast” shall be defined in Section 4.1.

1.17                           “Master Batch Record” shall mean, with respect to each Presentation of Product to be Produced hereunder, a formal set of instructions and criteria for the Production of each Presentation of such Product.

1.18                           “NDA” shall mean the FDA-required New Drug Application, and any amendments or supplements thereto, or other applicable similar submissions to a Regulatory Authority.

1.19                           “OMJ Vials” shall mean the vials of Pramlintide Drug Substance in finished dosage form in a vial container closure system produced by OMJ Pharmaceuticals, Inc. and delivered to BAXTER for packaging.

1.20                           “Pramlintide Drug Substance” shall mean a dry powder preparation containing pramlintide peptide as provided by AMYLIN for further manufacture or Production into Product by BAXTER.

1.21                           “Presentation” shall have the meaning set forth on Exhibit A.

1.22                           “Produce” or “Production” shall mean the formulation, filling, packaging, inspecting, labeling, and testing of Product by BAXTER.

1.23                           “Product” shall mean placebo or Pramlintide Drug Substance in finished dosage form filled into a vial container closure system as specified in Exhibit A and packaged as specified in the applicable Project Plan and either Produced after the first Regulatory Approval therefore or Produced as part of the Process Validation Batches, provided regulatory approval is obtained which allow commercial sale of such

 

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Process Validation Batches.  In addition, the OMJ Vials shall be deemed Product for purposes of this Agreement, except Article 4 and Exhibit F.

1.24                           “Process Validation Batches” shall mean vials produced for the purposes of validating the processing parameters for Production of Product produced pursuant to the Drug Product Development Agreement dated November 7, 2003.  The parties agree that the Product Produced in the Process Validation Batches may be sold commercially provided regulatory approval is obtained which allows commercial sale of such Process Validation Batches and that all the terms of this Agreement, except Article 7, shall apply to the Product Produced in the Process Validation Batches.

1.25                           “Product Specifications” shall mean with respect to each Product, the analytical specifications and testing to be performed for the Pramlintide Drug Substance and the Product, in connection with release and/or stability testing that are set forth in Product-specific standard operating procedures and the Master Batch Records.  The Product Specifications include only those tests/assays that BAXTER is required to conduct or cause to be conducted as specified in Exhibit C.  The Product Specifications may be modified from time to time only by written agreement of AMYLIN and BAXTER.

1.26                           “Product Requirements” shall mean the Product Specifications, Master Batch Record, and the Project Plan.

1.27                           “Project Plan” shall mean the manual containing the parameters for the Production of each Presentation of Product.  The Project Plan will be prepared by BAXTER and agreed to in writing by AMYLIN.  In no event shall BAXTER be required to schedule or commence the Production of the applicable Product unless and until a Project Plan for such Presentation of Product has been approved in writing by both parties.

1.28                           “Purchase Order” shall mean written orders from AMYLIN to BAXTER which shall specify (a) the quantity of Product ordered, (b) shipping instructions, (c) delivery dates, and (d) delivery destinations.

1.29                           “Purchase Price” shall mean the amount to be paid by AMYLIN for Product as set forth in Exhibit B and as may be amended from time to time by the parties pursuant to Section 5.3.

1.30                           “Regulatory Approval” shall mean all authorizations by the appropriate Regulatory Authority necessary for commercial sale of Product in a jurisdiction, including without limitation, approval of manufacturing, labeling, price, reimbursement and production.

1.31                           “Regulatory Authority” shall mean the FDA in the United States, or the applicable regulatory agency or entity having the responsibility, jurisdiction, and authority to approve the manufacture, use, importation, packaging, labeling, marketing, and sale

 

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of Product in any jurisdiction other than the United States, as specified in Exhibit E, as may be amended from time to time by mutual agreement of the parties.

1.32                           “Regulatory Plan” shall mean the manual containing the regulatory services and support for the development and maintenance of regulatory submissions and/or other filings, updates, or documentation required by a Regulatory Authority to be performed by BAXTER, if requested by AMYLIN.  The Regulatory Plan will be prepared by BAXTER and agreed to in writing by AMYLIN.  BAXTER shall have no obligation to conduct regulatory services for Product until the Regulatory Plan, if requested by AMYLIN, for such Product has been approved in writing by both parties.

1.33                           “Release” shall mean the delivery of the Released Executed Batch Record to AMYLIN by BAXTER.

1.34                           “Released Executed Batch Record” shall mean the completed batch record and associated documentation as described in the Quality Agreement.

1.35                           “Rolling Forecast” shall be defined in Section 4.1.

1.36                           “Unit” shall mean an individually packaged dose of Product or placebo, as specified in Exhibit B for vials.

 

Article 2,  Reserved

Article 3, PURCHASE AND SUPPLY OF PRODUCT

3.1                                 Agreement to Purchase and Supply.  Pursuant to the terms and conditions of this Agreement, AMYLIN shall purchase from BAXTER the Product, and BAXTER shall Produce and deliver to AMYLIN the Product in accordance with Article 4 of this Agreement.

3.2                                 Reproduction, Rework or Reprocessing.  If during the Production of any Batch of Product, any reprocessing, rework, or reproduction is required in order to meet the Product Specifications, BAXTER shall conduct such reprocessing, rework, or reproduction in compliance with the terms of the Quality Agreement, cGMPs, and the NDA.  Any reprocessing, rework or reproduction, and the related costs and expenses, must be approved in writing by AMYLIN prior to implementation, such approval not to be unreasonably withheld and/or delayed.  Re-packaging and re-inspection are not considered reproduction, rework or reprocessing.  Unless such reprocessing, rework, or reproduction is required as a result of the negligence or willful misconduct of BAXTER, AMYLIN shall be responsible for, and promptly reimburse BAXTER for, all costs and expenses incurred in connection with such reprocessing, rework, or reproduction.

 

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3.3                                 Pramlintide Drug Substance and AMYLIN Supplied Components.  AMYLIN, at its expense, shall deliver or cause to be delivered, (a) a reasonably sufficient amount of Pramlintide Drug Substance and applicable certificate of analysis therefore and (b) all other AMYLIN Supplied Components, if any, all to be delivered to BAXTER at least four weeks (4) weeks in advance of the filling date set forth in Section 4.2.  Upon receipt of the AMYLIN Supplied Components, if any, and Pramlintide Drug Substance as set forth above, BAXTER’s sole obligation with respect to evaluation of the AMYLIN Supplied Components and Pramlintide Drug Substance shall be to confirm, in accordance with the terms of the Quality Agreement, that the Pramlintide Drug Substance and AMYLIN Supplied Components, if any, conform with the Product Specifications and Component Specifications, respectively. BAXTER shall have no responsibility for delays in Release or delivery of Product caused by delays in receipt of Pramlintide Drug Substance or AMYLIN Supplied Components. AMYLIN shall maintain at BAXTER the Pramlintide Drug Substance and AMYLIN Supplied Components in quantities sufficient to meet AMYLIN’s Purchase Orders for Product and Rolling Forecast submitted by AMYLIN to BAXTER pursuant to Article 4.  When AMYLIN is aware of an expected delay in delivery of Pramlintide Drug Substance or AMYLIN Supplied Components, AMYLIN shall promptly notify BAXTER of such delay.

3.4                               BAXTER Supplied Components and Component Delivery Delays:  BAXTER will purchase the BAXTER Supplied Components in quantities sufficient to meet AMYLIN’s Purchase Orders for Product and Rolling Forecasts submitted by AMYLIN to BAXTER pursuant to Article 4.  BAXTER shall control such materials and shall assist AMYLIN with evaluation and purchase of modified materials in the event that AMYLIN requests a change in Presentation.  BAXTER shall not initiate any changes to materials without written approval from AMYLIN.  When BAXTER is aware of an expected delay in meeting AMYLIN’s Purchase Order, BAXTER shall promptly notify AMYLIN of such delay.

3.5                               Material Safety Data Sheet.  AMYLIN shall provide BAXTER a Material Safety Data Sheet for Pramlintide Drug Substance and for Product.  BAXTER shall immediately notify AMYLIN of any unusual health or environmental occurrence relating to the Product, including, but not limited to any claim or complaint by any employee of BAXTER or any of its Affiliates or third party that the operations of BAXTER pursuant to this Agreement have resulted in any adverse health or safety effect on an employee or third party.  BAXTER agrees to advise AMYLIN immediately of any safety or toxicity problems of which it becomes aware regarding the Product.

 

3.6                               Importer of Record.  In the event any material or equipment to be supplied by AMYLIN, including without limitation AMYLIN Supplied Components and Pramlintide Drug Substance, is imported into the United States for delivery to BAXTER (“Imported Goods”), such Imported Goods shall be imported DDP Bloomington, IN (Incoterms 2000).  AMYLIN shall be the “Importer of Record” of such Imported Goods.  As the Importer of Record, AMYLIN shall be responsible for all aspects of the Imported Goods

 

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including, without limitation (a) customs and other regulatory clearance of Imported Goods, (b) payment of all tariffs, duties, customs, fees, expenses and charges payable in connection with the importation and delivery of the Imported Goods, and (c) keeping all records, documents, correspondence and tracking information required by applicable laws, rules and regulations arising out of or in connection with the importation or delivery of the Imported Goods.

 

3.7          Storage.

3.7.1           Product Storage.  BAXTER shall store Product free of charge for [***] ([***]) calendar days after AMYLIN’s acceptance of Product pursuant to Article 7 (the “Storage Period”).  Following the Storage Period, BAXTER may continue to store Product at BAXTER for an additional period of not more than [***] ([***]) months (the “Additional Storage Period”) or at a third party facility in accordance with the terms of Section 3.7.4.  AMYLIN shall reimburse BAXTER for all costs incurred in connection with such storage beyond the Storage Period pursuant to Exhibit B.  If AMYLIN fails to provide approval of a third party storage facility, pursuant to Section 3.7.4, within the Additional Storage Period, AMYLIN shall take possession of the Product at such time by providing BAXTER with shipping instructions.

3.7.2           Component Storage.  BAXTER shall be required to store such supply of Components necessary to fulfill [***] ([***]) months of the Rolling Forecast.

3.7.3           Pramlintide Drug Substance Storage.  BAXTER shall not be required to store quantities of Pramlintide Drug Substance in excess of the capacity of AMYLIN’s freezer(s) located at BAXTER.

3.7.4                                 Third Party Storage.  BAXTER shall be permitted to store Product and Components in third party storage facilities, which are subject to audit and prior written approval by AMYLIN pursuant to a mutually agreed upon Project Plan.  BAXTER shall have no liability for, and AMYLIN releases all claims against BAXTER arising out of any damage or loss to Product or Components arising out of, or in connection with, the storage in such third party facility, unless such claims are a result of the negligence or willful misconduct of BAXTER.  If AMYLIN does not take possession of Product prior to the expiration of the Additional Storage Period, BAXTER may store Product in a third party storage facility.  BAXTER will notify AMYLIN at least [***] ([***]) calendar days before moving Product to said third party storage facility and AMYLIN will notify BAXTER within [***] ([***]) calendar days after receipt of said notice if

* Confidential Treatment Request(ed)

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AMYLIN does not want Product to be moved to the third party storage facility and provide BAXTER alternate shipping instructions.  If BAXTER fails to hear from AMYLIN within the [***] ([***]) day notice period, BAXTER may move Product to a third party storage facility in accordance with the terms herein.

3.8                                           Purchase of Materials.  BAXTER shall purchase, at BAXTER’s expense, all packaging materials listed in the Project Plan, primary container Components and secondary packaging materials required to Produce the Product; provided, however, AMYLIN shall approve in writing and in advance all specifications for AMYLIN-specific materials (i.e. non-stock items).  BAXTER shall control packaging materials listed in the Project Plan and shall assist AMYLIN with evaluation and purchase of modified materials in the event that AMYLIN requests a change in Presentation.  BAXTER shall not initiate any changes to materials without written approval from AMYLIN.

Article 4,  FORECASTS, ORDERS, and CAPACITY

4.1                                 Forecasts and Order Limits.

4.1.1                         Commencing on the date of this Agreement, and prior to October 1 of each year thereafter, AMYLIN will provide to BAXTER in writing an annual forecast, for each calendar year during the remainder of the Term, of AMYLIN’s estimated contract requirements for Product (the “Long Range Forecast”).  The annual forecast for the first full year of the Long Range Forecast shall be the “Annual Forecast”.  Commencing on the date of this Agreement and prior to each January 1, April 1, July 1 and October 1, of each year thereafter, AMYLIN will provide BAXTER in writing an [***] rolling forecast of AMYLIN’s estimated contract requirements for Product by Presentation (the “Rolling Forecast”).  BAXTER specifically agrees that such Long Range Forecasts and Rolling Forecasts submitted by AMYLIN will be for general planning purposes only, and shall not be binding on AMYLIN or BAXTER, except as specified in Section 4.1.2.

4.1.2                         Except as set forth in Section 4.1.3, during each calendar quarter, BAXTER shall supply AMYLIN with the quantity of Product ordered by AMYLIN, unless the quantity ordered in any calendar [***] exceeds [***] percent ([***]%) of the quantity purchased in the previous calendar [***], in which event BAXTER shall use good faith efforts to supply quantities in excess of such amount.  Notwithstanding the foregoing, in any given calendar quarter in no event will BAXTER be obligated to Produce, more than [***] ([***]) units more than it Produced in the previous calendar quarter.  For each Rolling Forecast submitted by AMYLIN, in no event shall AMYLIN purchase less than (a) [***] percent ([***]%) of the quantity forecasted for the [***] of such Rolling Forecast, (b) [***] percent ([***]%) of the quantity of Product forecasted by Presentation for the [***] of such Rolling Forecast, and (c) [***] percent ([***]%) of the quantity of Product forecasted by

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Presentation for the [***] quarter of such Rolling Forecast (collectively, the “Minimum Quantity”).  In each succeeding calendar [***], in the event AMYLIN purchases in any given [***] less than the corresponding portion of the Minimum Quantity for said [***] within [***] ([***]) days after the end of such [***] AMYLIN shall pay to BAXTER the difference between the Purchase Price of Product actually purchased and the Purchase Price of the corresponding portion of the Minimum Quantity in said quarter, provided, however, AMYLIN shall not be required to make any such payments to the extent AMYLIN has submitted Purchase Orders for the  Minimum Quantity and BAXTER confirmed such Purchase Orders to be Firm Purchase Orders, but BAXTER was unable to deliver such quantities of Product due to the negligence of BAXTER.  In any given Rolling Forecast, (a) the quantity forecasted for the [***] of such Rolling Forecast shall not be less than (a) [***] percent ([***]%) of the [***] forecast in the immediately preceding Rolling Forecast and (b) [***] percent ([***]%) of the [***] forecast in the immediately preceding Rolling Forecast.

4.1.3                         Pursuant to Section 4.2, beginning on the Effective Date of this Agreement and continuing through the end of the first calendar year (the year of the Effective Date of this Agreement) BAXTER shall only be obligated to supply that quantity of Product ordered by AMYLIN, which is submitted to BAXTER via a Firm Purchase Order and BAXTER accepts via a confirmation.   For the avoidance of doubt, BAXTER’s obligations under Section 4.1.2 shall not apply during 2005.

4.2                             Purchase Orders.  AMYLIN shall submit Purchase Orders to BAXTER covering AMYLIN’s purchases of Product pursuant to this Agreement.  AMYLIN shall not, without the written consent of BAXTER, designate a delivery date in a Purchase Order earlier than [***] ([***]) calendar days from the date AMYLIN submits the Purchase Order.  Within ten (10) calendar days of BAXTER’s receipt of the Purchase Order, BAXTER shall provide a confirmation of receipt of each Purchase Order setting forth a Batch (or lot) number (if available), the delivery date that BAXTER will meet and setting forth BAXTER’s filling date for such order.  Upon AMYLIN’s receipt of such confirmation, such Purchase Order shall become a non-cancelable “Firm Purchase Order”, and AMYLIN shall be obligated to purchase from BAXTER all Product ordered in a Firm Purchase Order.  If BAXTER is unable to meet the specified delivery date BAXTER shall so notify AMYLIN and provide to AMYLIN an alternative delivery date which shall not be more than [***] ([***]) calendar days later than the initial delivery date designated by AMYLIN in its Purchase Order; provided that the alternative delivery date is no longer than [***] and [***] ([***]) calendar days from the issue of the AMYLIN Purchase Order.  To the extent of any conflict between Purchase Orders submitted by AMYLIN and this Agreement, this Agreement shall control.

4.3                               Annual Obligation.  AMYLIN shall be obligated to purchase from BAXTER a minimum number of Units of such Product in each calendar year following BAXTER

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Approval during the Term of this Agreement as specified in Exhibit F (the “Annual Obligation”), which Annual Obligation shall be pro rated for any partial calendar year.  Within [***] ([***]) days after the end of each calendar year, AMLYIN shall pay to BAXTER the difference between the Purchase Price of the Product actually purchased pursuant to Sections 4.1 and 4.2 by AMYLIN and the Purchase Price of the Annual Obligation of the Product.  AMYLIN and BAXTER agree that if AMYLIN determines to market Product in a cartridge and disposable pen system in addition to a vial container closure system, then AMYLIN and BAXTER shall negotiate in good faith to modify this Agreement to include the Production of SYMLIN in the cartridge/pen system and to amend the Annual Obligations set forth on Exhibit F and include pricing for such cartridges/pens.  These good faith negotiations shall include as their objective the reduction of the number of vial Units and the addition of a number of cartridge Units in the Annual Obligations specified on Exhibit F with no overall reduction in the collective number of Units.

4.4                               Order Increases.  In any two (2) consecutive calendar quarters after the first calendar year and during the Term of this Agreement, in no event shall BAXTER be obligated to Produce more than the lesser of (a) [***] ([***]) Units more than it Produced in the preceding two (2) consecutive calendar quarters and (b) one [***] ([***]) Units of Product; provided, however, BAXTER will use good faith efforts to meet such increased demand.

Article 5,  PRICE

5.1                                Regulatory Services Price.  The price to be paid by AMYLIN for regulatory services shall be set forth in Exhibit C.

 

5.2                                Product Purchase Price.  The Purchase Price will be fixed for the Initial Term (as hereinafter defined) of this Agreement as specified in Exhibit B.  The Purchase Price for Product for each calendar year will be the price specified in Exhibit B corresponding to the annual volume which is the greater of (a) [***] percent ([***]%) of the Annual Forecast or (b) the Annual Obligation for such calendar year. AMYLIN shall pay the Purchase Price as determined above for all Product, including Units accepted by AMYLIN pursuant to Article 7, samples consumed by BAXTER for release testing, samples shipped for AMYLIN release and stability testing, and any retention samples; except as provided for in Article 7.  In the event AMYLIN requests a change in scope for Production of Product or Regulatory Authority associated with the Production, BAXTER may adjust the Purchase Price for Product or for a particular Presentation of Product as set forth in a revision to Exhibit B as mutually agreed to by the parties.

 

5.3                                 Purchase Price Adjustment.  Upon expiration of the Initial Term or any extension thereof, BAXTER may adjust the Purchase Price of Product to reflect changes in the cost of materials provided by BAXTER, labor costs paid by BAXTER in connection with the Production of such Product, improvements in the manufacturing process, and any other improvements.  Following the first year of Regulatory Approval,

* Confidential Treatment Request(ed)

 

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AMYLIN and BAXTER agree to meet no less than [***] per calendar year to formally review continuous improvement activities and other improvements resulting from experience in operating the new process including potential adjustments in Component or packaging material pricing. AMYLIN and BAXTER shall work together to obtain process improvements and any net cost savings or increases achieved by the parties shall be [***], after taking into account any necessary [***] or [***] costs related to the process improvements and any current Component, packaging [***] and [***] cost adjustments.  [***] calendar quarters prior to expiration of the Initial Term or any extension thereof, BAXTER shall provide to AMYLIN notification of such Purchase Price adjustment.  If the parties cannot in good faith agree on the proposed Purchase Price adjustment, the dispute will be discussed between the senior management of both AMYLIN and BAXTER.  In no event may BAXTER increase the Purchase Price following the Initial Term by a percent which exceeds the lesser of (i) the percentage change in the [***] ([***]) for the previous [***] ([***]) months or (ii) [***] percent ([***]%) of the original Purchase Price.

 

5.4                                 Inventory Levels.  At the end of each calendar year, the parties will review the inventory levels of Components purchased by BAXTER pursuant to AMYLIN’s Rolling Forecast.  In the event AMYLIN fails to consume pursuant to AMYLIN’s Firm Purchase Orders [***] percent ([***]%) of the Components purchased by BAXTER, AMYLIN shall pay to BAXTER the costs of such Components purchased by BAXTER and not consumed by AMYLIN.  The amount of such payments will be deducted from the Purchase Price of Product purchased by AMYLIN after BAXTER’s receipt of such payments until such time as all such paid-up Components have been consumed.

 

5.5                               Yield Requirement.  Following the Production of (a) the [***] ([***]) process validation Batches of Product and (b) the initial [***] ([***]) post-process validation Batches of Product (the “Yield Batches”) the parties will determine the expected yield (“EY”) for Product, which  EY shall be equal to the [***] by Presentation resulting from the Yield Batches less[***].  If there is a manufacturing anomaly in one or more of the Yield Batches, the parties may agree to eliminate such Batch from the EY calculation or may require an additional Batch be included.  In the event Baxter fails to meet such EY on averagefor Batches Produced in the first quarter after which EY was determined, provided such Product was Produced in such quarter, BAXTER will deliver on average during any calendar quarter thereafter not less than such mutually agreed upon EY for Product for all Batches Released during such quarter, provided a minimum of [***] ([***]) such Batches have been Released including all Units Released by BAXTER, samples consumed by BAXTER for release testing, samples shipped for AMYLIN release and stability testing, and any retention samples.  If [***] ([***]) Batches of Product were not Released in such calendar quarter, the reconciliation process described herein will be performed when the [***] ([***]) such Batch, following the most recent reconciliation, is Released and invoiced by BAXTER.  In the event that BAXTER delivers, on average, an

 

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                                                actual yield (“AY”) for Batches Released in any calendar quarter which is lower than EY set out above, at the end of such calendar quarter, Baxter will reimburse AMYLIN according to the following formula:

[***];

                                                provided, however, such amount shall not exceed [***] percent ([***]%) of the Purchase Price of Product purchased by AMYLIN in such calendar quarter, or applicable time period.  If the actual yield is low due to additional sampling, testing, technical transfer, stability, or AMYLIN requested samples for a given Batch, such Batch will not be included in the quarterly calculation and BAXTER will not reimburse AMYLIN for such deficit.  The foregoing represents the sole liability of BAXTER and the sole and exclusive remedy of AMYLIN for yield shortfall.

 

5.6                                 Loss of Pramlintide Drug Substance.  If any lot of Pramlintide Drug Substance is destroyed, damaged or lost while in BAXTER’s custody, control or storage unless such destruction, damage or loss was outside of the reasonable control of BAXTER, BAXTER shall reimburse AMYLIN for its actual out-of-pocket costs for the Pramlintide Drug Substance, provided such reimbursement shall not exceed [***] percent ([***]%) of the Purchase Price of a Batch of Product that would have been Produced from such Batch or lot of Pramlintide Drug Substance, and AMYLIN shall not be responsible for payment of the Purchase Price to BAXTER for any Batch that would have been produced for such Pramlintide Drug Substance.  The foregoing represents the sole liability of BAXTER and the sole and exclusive remedy of AMYLIN for the loss of a Batch or Pramlintide Drug Substance except as set forth in Article 7.

 

5.7                                 Effects of Certain Events.  In addition to the costs and expenses payable in Section 8.7, in the event of termination of this Agreement, except by AMYLIN as a result of a breach by BAXTER under Section 8.2 or by AMYLIN pursuant to Sections 8.3 or 8.5, AMYLIN shall pay BAXTER as liquidated damages and not as a penalty an amount equal to [***] percent ([***]%) of the greater of the Annual Obligation or the Rolling Forecast prorated for the next [***] ([***]) months.

 

Article 6,  SHIPMENT AND INVOICING

 

6.1                                 Delivery Terms.  Product shall be delivered to AMYLIN, or to a location designated by AMYLIN in the Purchase Order, EXW (Incoterms, 2000) BAXTER’s facility in Bloomington, Indiana freight collect, by a common carrier designated by AMYLIN in the Purchase Order, at AMYLIN’s expense; provided, however, BAXTER shall be responsible for the loading of the Product on departure and shall bear all costs of such loading. AMYLIN shall procure, at its cost, insurance covering damage or loss to the Product during shipping.

 

6.2                                 Exporter of Record.  AMYLIN shall be the exporter of record for any Product shipped out of the United States, as AMYLIN remains the owner of the Product.  AMYLIN warrants that all shipments of Product exported from the United States will

 

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                                                be made in compliance with all applicable United States export laws and regulations and all applicable import laws and regulations into the country of importation.

 

                                          AMYLIN shall be responsible for obtaining and paying for any licenses or other governmental authorization(s) necessary for the exportation from the United States.  AMYLIN shall select and pay the freight forwarder who shall solely be AMYLIN’s or its agent.  AMYLIN and its freight forwarder shall be solely responsible for preparing and filing the Shipper’s Export Declaration and any other documentation required for the export.

 

6.3                                 Foreign Corrupt Practices Act.  AMYLIN acknowledges it is not the agent of BAXTER and represents and warrants that it has not, and covenants that it will not, pay anything of value to any government employee in connection with the resale of the Product.

 

6.4           Payment Terms.  The following invoicing and payment terms apply:

 

Status

 

Invoice Date

 

Payment Due

 

 

 

 

 

Commercial Production

 

BAXTER’s Release

 

Invoice Date + [***] days

 

 

of Batch Record

 

 

 

 

 

 

 

Regulatory Services

 

Monthly

 

Invoice Date + [***] days

 

 

 

 

 

Article 8

 

Upon notice

 

Invoice Date + [***] days

and Section 5.7 Payments

 

 

 

 

 

For the avoidance of doubt, the process validation Batches will be manufactured under the Drug Product Development Agreement dated November 7, 2003 and will be billed according to the terms contained therein.

 

Payments shall be made in U.S. dollars by check delivered to BAXTER by overnight delivery with a reputable overnight delivery service.  Each invoice shall be payable by AMYLIN in accordance with the terms noted above.  Any payment due under this Agreement not received within the times noted above shall bear interest at the lesser of (a) the maximum rate permitted by law, or (b) [***]% per month on the outstanding balance compounded [***].

 

6.5                                 Default in Payment Obligations.  In addition to all other remedies available to BAXTER in the event of a AMYLIN default, if AMYLIN fails to make payments as required hereunder within thirty calendar days of notice of such failure to make payments, BAXTER may refuse all further Purchase Orders or refuse to Produce any Product until AMYLIN’s account is paid in full, place the account on a letter of credit basis, require full or partial payment in advance and/or suspend deliveries of Product

 

* Confidential Treatment Request(ed)

 

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                                                until AMYLIN provides assurance of performance reasonably satisfactory to BAXTER.

 

Article 7,  ACCEPTANCE OF PRODUCT

7.1                                 Product Conformity.  Within [***] ([***]) days from the date of receipt by AMYLIN of samples of Product or [***] ([***]) calendar days from the date of receipt by AMYLIN of the Released Executed Batch Record to AMYLIN, whichever is later, AMYLIN shall determine whether such Batch conforms to the Product Requirements.

7.1.1                        If AMYLIN fails to notify BAXTER within the applicable time period as specified in Section 7.1, that any Batch does not conform to the Product Requirements, then AMYLIN shall be deemed to have accepted the Batch and waived its right to revoke acceptance.

7.1.2                        If AMYLIN believes any Batch does not conform to the Product Requirements, it shall notify BAXTER by telephone including a detailed explanation of the non-conformity and shall confirm such notice in writing via overnight delivery to BAXTER.  Upon receipt of such notice, BAXTER, in accordance with the terms of the Quality Agreement, will investigate such alleged non-conformity, and (i) if BAXTER agrees such Batch is non-conforming, deliver to AMYLIN a corrective action plan within [***] ([***]) calendar days after receipt of AMYLIN’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than AMYLIN or BAXTER, or (ii) if BAXTER disagrees with AMYLIN’s determination that the Batch is non-conforming,  BAXTER shall so notify AMYLIN by telephone within the [***] ([***]) calendar day period and confirm such notice in writing by overnight delivery.

7.1.3                        If the parties dispute whether a Batch is conforming or non-conforming, the shipment of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties.

                                                7.2           Remedies for Non Conforming Product.

7.2.1                        In the event BAXTER agrees that a Batch is non-conforming or the laboratory determines that a Batch is non-conforming, BAXTER shall provide replacement Product for such non-conforming Batch which shall be Released by BAXTER within the latter of (a) [***] ([***]) calendar days from receipt of replacement Pramlintide Drug Substance from AMYLIN or (b) [***] ([***]) calendar days from the date of determination by the third party of non-conformity or agreement by BAXTER of such non-conformity.

* Confidential Treatment Request(ed)

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7.2.2                        AMYLIN shall pay for all Product, including replacement Product and the cost of  Pramlintide Drug Substance therefore, except as specifically set forth in Section 7.2.3.

7.2.3                        In the event BAXTER agrees, or the laboratory or consultant determines, that a Batch is non-conforming, solely as a result of the negligence or willful misconduct of BAXTER, AMYLIN shall not be required to pay for such Batch, BAXTER shall provide replacement Product as specified in Section 7.2.1., shall reimburse AMYLIN for its actual cost of the Pramlintide Drug Substance for the non-conforming Batch, which cost shall not exceed [***] percent ([***]%) of the Purchase Price for Units comprising the non-conforming Batch of Product, and shall bear the costs of such laboratory or consultant and any storage fees incurred by AMYLIN for the non-conforming Batch.  The foregoing shall be AMYLIN’s sole and exclusive remedy and BAXTER’s sole liability for replacement of conforming Product.

7.3                                 Latent Defect:  If, within [***] ([***]) days after AMYLIN’s acceptance of a Batch, AMYLIN discovers a latent defect such as a Contaminant in such Batch that existed in the Batch on or before AMYLIN’s acceptance of the Batch, AMYLIN shall notify BAXTER immediately of such discovery, and AMYLIN shall have the right to reject such Batch under the procedures regarding rejection set forth in Section 7.1 and 7.2 above, provided however, if BAXTER disagrees with AMYLIN’s determination that a latent defect exists or that the latent defect existed in the Batch on or before AMYLIN’s acceptance of the Batch, then BAXTER shall so notify AMYLIN within [***] ([***]) days after receiving AMYLIN’s notification about the latent defect, and in such cases, samples of the Batch of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties.  AMYLIN shall bear the costs of such laboratory or consultant, unless the laboratory or consultant determines that the non-conformance is due to the negligence or willful misconduct of BAXTER in which event BAXTER shall bear the costs of such laboratory or consultant.

7.4                                 Non-conforming Pramlintide Drug Substance.  If Product is rejected by AMYLIN, and such Product’s failure to meet the Product Requirements is the result of non-conforming Pramlintide Drug Substance, then BAXTER shall not bear any liability under this Article 7.

 

Article 8,  TERM AND TERMINATION

8.1                                 Initial Term.  This Agreement shall be effective on the Effective Date and shall continue for sixty (60) months thereafter (the “Initial Term”), unless earlier terminated in accordance with the terms of this Agreement.  This Agreement will be renewed automatically for one (1) additional twenty-four (24) month period commencing at the expiration of the Initial Term and any extensions thereof unless

* Confidential Treatment Request(ed)

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                                                either AMYLIN or BAXTER terminates the Agreement by giving the other party written notice of intent to terminate at least twenty-four (24) months prior to the expiration of the Initial Term or any extension thereof.  The Initial Term as may be extended is referred to herein as the “Term.”  Except as specifically set forth in this Article 8, neither party shall have a right to terminate this Agreement.

8.2                                 Termination for Breach.  Either party may terminate this Agreement upon the breach of any provision of this Agreement by the other party if such breach is not cured by the breaching party within fifteen (15) calendar days for monetary defaults, and thirty (30) calendar days for non-monetary defaults (or such additional time reasonably necessary to cure such non-monetary default provided the breaching party has commenced a cure within the thirty (30) day period and is diligently pursuing completion of such cure) after receipt by the breaching party of written notice of such default.  At the option of the non-breaching party, such termination may be with respect to the entire Agreement, or only with respect to the Product which is the subject of the breach.

8.3                                 Termination for Financial Matters.  This Agreement may be terminated immediately by either party by giving the other party written notice thereof in the event such other party makes a general assignment for the benefit of its creditors, or proceedings of a case are commenced in any court of competent jurisdiction by or against such party seeking (a) such party’s reorganization, liquidation, dissolution, arrangement or winding up, or the composition or readjustment of its debts, (b) the appointment of a receiver or trustee for or over such party’s property, or (c) similar relief in respect of such party under any law relating to bankruptcy, insolvency, reorganization, winding up or composition or adjustment of debt, and such proceedings shall continue undismissed, or an order with respect to the foregoing shall be entered and continue unstated, for a period of more than sixty (60) days.

8.4                                 Termination Related to AMYLIN Regulatory Status.  AMYLIN may immediately terminate this Agreement by giving written notice to BAXTER, including a certification as to the grounds for termination signed by the chief regulatory officer of AMYLIN and/or a copy of the relevant Regulatory Authority notice(s), if any Regulatory Authority (a) denies approval of Product, (b) withdraws approval of Product, or (c) does not approve BAXTER as a manufacturer of Product within eighteen (18) months after Regulatory Approval.

8.5                                 Termination Related to Regulatory Compliance.  AMYLIN may terminate this Agreement by giving ninety (90) days written notice to BAXTER if BAXTER (i) has its manufacturing authorizations for Product suspended or withheld; (ii) in the case of a PAI for Product, fails to pass an inspection by a Regulatory Authority due to an act or omission of BAXTER; or (iii) in the case of a regulatory inspection (which directly relates to or directly impacts Product) by a Regulatory Authority fails to pass an inspection and has not completed the corrective action(s) agreed upon with the Regulatory Authority within the time period agreed upon with such Regulatory Authority, unless otherwise agreed by BAXTER and AMYLIN.  BAXTER may

 

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                                                terminate this Agreement by giving ninety (90) days written notice to AMYLIN if AMYLIN, with respect to Pramlintide Drug Substance (a) has its manufacturing authorizations suspended or withheld; (b) in the case of a PAI , fails to pass an inspection by a Regulatory Authority due to an act or omission of Amylin; or (c) in the case of a regulatory inspection (which directly relates to or directly impacts Pramlintide Drug Substance) by a Regulatory Authority fails to pass an inspection and has not completed the corrective action(s) agreed upon with the Regulatory Authority within the time period agreed upon with such Regulatory Authority, unless otherwise agreed by BAXTER and AMYLIN.