**Exhibit 10.40**

***Text Omitted and Filed Separatelywith the Securities and Exchange CommissionConfidential Treatment RequestedUnder 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2.

**C****ONFIDENTIAL**

**COMMERCIALSUPPLY AGREEMENT**

**THIS SUPPLY AGREEMENT** (the ***“Agreement”***)is entered into as of October 12, 2006 (the ***“EffectiveDate”***), by and between **AMYLINPHARMACEUTICALS, INC.** (***“Company”***),having its principal place of business located at 9360 Towne Centre Drive,Suite 110, San Diego, CA 92121, U.S.A., and Wockhardt UK (Holdings) Ltd. (***“Manufacturer”***), having itsregistered office at Ash Road North, Wrexham Industrial Estate, Wrexham LL139UF, United Kingdom.

**RECITALS**

**WHEREAS,** Manufacturer is in the business ofmanufacturing pharmaceutical products;

**WHEREAS,** Company is engaged in research,development, and commercialization of pharmaceutical products; and

**WHEREAS,** Company and Manufacturer (then CPPharmaceuticals Ltd) having previously entered into a Manufacturing Agreement,effective from 28th April 1999 and now mutually wish to supercedesuch agreement with the terms and conditions set forth herein; and

**WHEREAS,** Company wishes to purchase fromManufacturer, and Manufacturer is willing to manufacture and supply to Company,the Product (as defined below) in commercial quantities for commercial sale onthe terms and conditions set forth herein.

**NOW, THEREFORE,** in consideration of the foregoing andthe mutual covenants and premises contained in this Agreement, the partieshereto agree as follows:

**1.             Definitions.**

**1.1          *“Affiliate***” shall mean an entity that, directly orindirectly, controls, is controlled by or is under common control with a party,where “control” means the possession, direct or indirect, or the power todirect or cause the direction of the management or policies of an entity,whether by ownership of at least 50% of the common stock or voting ownershipinterest of an entity, by contract or otherwise.

  

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**1.2          *“Applicable Laws***” shall mean all United States andEuropean jurisdiction’s federal, state, local and other laws, statutes, rules,regulations, ordinances, (including any amendments thereto), applicable to themanufacture and shipment of Product, including, without limitation, theapplicable regulations and guidance of the FDA, all applicable EU cGMPs. Extensionsto the aforementioned defined territories shall be the subject of side lettersto this Agreement which may be jointly agreed in good faith from time to timebetween the parties.

**1.3          *“Batch***” shall mean that quantity of units ofProduct produced from a single homogeneous mix in a single cycle ofmanufacture.

**1.4          *“Batch Record***” shall mean Manufacturer’s documentedprocedures for compounding, filling, testing, labeling, and packagingPramlintide Acetate Drug Substance and/or inactive excipients into Product asagreed upon by the parties in writing in advance of manufacture of theapplicable Batch.

**1.5          *“Business Day”*** shall mean any Monday, Tuesday,Wednesday, Thursday or Friday which is not a bank holiday in San Diego,California or the United Kingdom.

**1.6          *“Certificate of Analysis”*** shall mean a signed certificate, issuedby the party providing a pharmaceutical compound or product, attesting to thenature and/or content, as applicable, of such compound or product.

**1.7          *“cGMP”*** shall mean current good manufacturingpractices as defined from time to time (a) in regulations promulgatedunder the FDCA; (b) the principles and guidelines specified in Chapter IIof European Commission Directive 91/356/EEC, including “the rules governingmedicinal products” in the European Union Volume 4; and (c) laws, rules,or regulations of an applicable Regulatory Authority at the time of manufactureequivalent to those in (a) and (b) above.

**1.8          *“Confidential Information”*** of a party shall mean all data andinformation, tangible or intangible, whether in written, graphic, verbal orelectronic form, disclosed by such party to the other party, its employees orrepresentatives, or developed for or on behalf of such party by the other partyunder this Agreement.

**1.9          *“Contaminant”*** means a substance contained in Productthat (i) causes Product to fail to meet any Product Requirements or (ii) causesProduct to be adulterated within the meaning of the FDCA.

**1.10        *“Control”*** shall mean, with respect to certainrights, possessing ownership of or possessing the right to grant a license tosuch rights.

**1.11        *“Drug Approval Application”*** shall mean an application and/orsupplemental application for Regulatory Approval required before commercialsale or use of Product as a drug in a regulatory jurisdiction.

**1.12       *****“Facilities”***shall mean the manufacturing plant and offices owned by Manufacturer andlocated at Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF,

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United Kingdom anda storage and distribution facility owned by Manufacturer and located at UnitB, Spectrum Business Park, Bridge Road South, Wrexham Industrial Estate,Wrexham LL13 9QA, United Kingdom.

**1.13        *“FDA”*** shall mean United States Food and DrugAdministration or any successor agency.

**1.14        *“FDCA”*** shall mean the United States FederalFood Drug and Cosmetics Act, as amended, and all regulations promulgatedthereunder, or any successor laws and regulations thereto

**1.15        *“Fill Date”***shall mean that date on which themanufacture of a Batch is actually completed, notwithstanding the date on whichthe Batch manufacture begins.

**1.16        *“Hidden Defect”*** shall mean a defect that causes Productto fail to conform to the Specifications or to the warranties provided byManufacturer hereunder, which defect is not discoverable upon reasonablephysical inspection and testing performed pursuant to Section 5.3 but isdiscovered at a later time (*e.g.*, in thecourse or as a result of long-term stability studies).

**1.17        *“Launch Date”*** shall mean the date of the firstcommercial sale of Product manufactured using Manufacturer Technology underthis Agreement, in a country after approval by appropriate regulatoryauthorities for market and sale in such country.

**1.18        *“Manufacturing Process”*** shall mean any and all specifications,compositions, identities and quantities of materials, formulas, methods,techniques, processes, procedures and quality control necessary or relevant formanufacture of Product.

**1.19       *****“Manufacturer’sTechnology”***shall mean the specific and confidential technology which has been developed byManufacturer for the siliconisation of glass cartridges used in the productionof the Product as defined herein and is described further in related standardoperating procedures (“SOPs”) .

**1.20        *“Materials”*** shall mean raw materials, components,excipients and other ingredients and packaging materials used in themanufacture and packaging of Product.

**1.21        *“OUS Country”*** shall mean any country outside of theUnited States and its territories.

**1.22       *****“PramlintideAcetate***or***Pramlintide Acetate Drug Substance”***shall mean a dry bulk powder preparation containing pramlintide acetate peptideas provided by Company for further manufacture into Product by Manufacturer.

**1.23        *“Product”*** shall mean the finished dosage form ofPramlintide Acetate, for injection in cartridge presentation as described in **Exhibit B** to this Agreement.

**1.24        *“Product Price”*** shall mean the price for Product setforth in **Exhibit A**.

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**1.25        *“Product Requirements”*** shall mean all of the requirementsreferenced in Section 8.3 of this Agreement.

**1.26        *“Quality Agreement”*** shall mean the (Technical) QualityAgreement between Company and Manufacturer dated as of October 16, 2002, orthat agreed in writing on any subsequent date between the parties, which isincorporated into this Agreement by reference and made a part hereof.

**1.27       **“****RecallAction****” shall have the meaning ascribed to itin ****Section5.4**** hereof.

**1.28        *“Regulatory Approval”*** shall mean any approvals (includingsupplements, amendments, pre-marketing and post-marketing approvals, labelingapproval, and pricing and reimbursement approvals), licenses, registrations orauthorizations of any national, supra-national (*e.g.*, the European Commission or the Council of the EuropeanUnion), regional, state or local regulatory agency, department, bureau,commission, council or other governmental entity, necessary for themanufacture, distribution, use or sale of Product in a regulatory jurisdiction.

**1.29        *“Regulatory Authority”*** shall mean the FDA in the United Statesor the MHRA, EMEA or any other applicable regulatory agency or entity havingthe responsibility, jurisdiction, and authority to approve the manufacture,use, importation, packaging, labeling, marketing, and sale of Product in anyadditional country, or any successor body to any of them.

**1.30        *“Specifications”*** shall mean the regulatory,manufacturing, quality control and quality assurance procedures, processes,practices, standards, instructions and any other attributes that the partiesagree upon, or that are otherwise required, in connection with the manufactureof Product, as set forth on **Exhibit B,** asamended from time to time by written agreement of the parties pursuant toSection 4.3.

**1.31        *“Term”*** shall have the meaning provided inSection 9.1.

**2.             Purchaseand Supply.**

**2.1          Purchase and Supply Agreement.** During the Term, Company agrees to buy from Manufacturer, andManufacturer agrees to sell to Company, such quantities of the Product as maybe set forth on purchase orders placed by Company in accordance with theprovisions hereof.

**2.2          Minimum Orders.** For the time frame beginning on the Effective Date and ending on thefirst day of the calendar month after the date of the one year anniversary ofthe date of the first Regulatory Approval of the Product (the ***“Initial Period”***), Company shallonly be obligated to purchase, and Manufacturershall only be obligated to supply, that quantity of Product ordered by Company,which is submitted to Manufacturer via purchase order and Manufacturer acceptsvia a confirmation.   For the time frame beginning on the datethe Initial Period ends and ending on the one year anniversary thereof (the ***“Second Period”***), Company agrees topurchase Product from Manufacturer in an amount equal to or greater than [***]

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cartridges. Forthe time frame beginning on the date the Second Period ends and ending on theone year anniversary thereof (the ***“Third Period”***),Company agrees to purchase Product from Manufacturer in an amount equal to orgreater than [***] cartridges. For the time frame beginning on the date theThird Period ends and ending on the one year anniversary thereof (the ***“Fourth Period”***), Company agrees topurchase Product from Manufacturer in an amount equal to or greater than [***]cartridges. For the time frame beginning on the date the Fourth Period ends andending on the one year anniversary thereof (the ***“FifthPeriod,”***and together with the Initial Period, the Second Period, the ThirdPeriod, and the Fourth Period,******the***“Purchase Periods”***), Companyagrees to purchase Product from Manufacturer in an amount equal to or greaterthan [***] cartridges.  Not withstandingthe foregoing, however, the Parties agree that upon completion of the InitialPeriod, the Parties shall meet for the purpose of reconsidering each of theforegoing quantities specified for the Third, Fourth and Fifth Periods andshall, prior to the commencement of the Third Period, adjust such quantities,if necessary, upon mutual written agreement. In the event that during any Purchase Period the Company’s actualpurchases of the Product from Manufacturer are less than the minimum amountspecified above for said Purchase Period, Company will pay to Manufacturer thedifference between the amount invoiced to Company for its actual purchasesduring the Purchase Period and the amount that would have been invoiced hadCompany purchased the minimum amount agreed to for such Purchase Period; *provided*, *however*, (i) Company shall not beobligated to make any such payments if the Agreement has been terminated, and(ii) the Company shall only be obligated to pay for Product supplied to theCompany pursuant to this Agreement.  Inany given calendar quarter, Company shall order [***]% of the minimum quantity,plus or minus [***]%, for the Purchase Period in which the calendar quarteroccurs.  Following the Fifth Period,Manufacturer may bid, in competition with Company’s other manufacturers of theProduct, to provide a greater percentage of Company’s requirements of theProduct.  For purposes of this Section2.2, a “purchase” shall mean the submission by Company of a firm purchaseorder.

**2.3          Forecasts.** Beginning within seven (7) days after the Effective Date and at thecommencement of every calendar month thereafter, Company shall furnishManufacturer with non-binding forecasts of [***] Product requirements underthis Agreement for the ensuing [***] calendar [***].

**2.4          Purchase Orders.** Company shall order the Product by submitting written purchase orders,in Company’s standard form in effect from time to time, to Manufacturer.  Each purchase order shall specify thequantities of the Product ordered which shall be in Batch quantities ormultiples thereof, the cartridge size thereof, the desired shipment date forsuch Product, the pricing, and any special shipping instructions.  Company shall submit each purchase order toManufacturer at least [***] Business Days in advance of the desired shipmentdate specified in such purchase order. No more than ten (10) Business Daysfollowing receipt of each purchase order Manufacturer shall confirm in writing itsacceptance of same and shall advise Company of its planned shipment date andits designated lot numbers for the Product. Manufacturer shall make each shipment of the Product in the quantity,cartridge size and on the shipment date specified for it on Company’s purchaseorder, via the mode(s) of transportation and to the party and destinationspecified on such purchase order. Release samples representing the Manufacturing Process and meeting therequirements set forth in the Batch Record will be shipped within [***]Business Days after the actual Fill Date.

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Manufacturer shallship the Product which is the subject of the purchase order, subject to Section5.1, and shall supply copies of the associated documentation as described inthe Quality (Technical) Agreement, including the signed Certificate of Analysisand signed certificate of compliance for the Product. Any purchase orders forthe Product submitted by Company to Manufacturer shall reference this Agreementand shall be governed exclusively by the terms contained herein except to theextent set forth in the following sentence. The terms and conditions of thisAgreement shall supersede any term or condition in any order, confirmation orother document furnished by Company or Manufacturer that is inconsistent withthese terms and conditions, except to the extent that any term, provision orcondition set forth in a purchase order expressly states that it supersedes anyterm, provision or condition of this Agreement, unless it is mutually agreed between the parties hereto.  If purchase orders are issued less than [***]Business Days in advance of the desired shipment date, Manufacturer shall makecommercially reasonable efforts to meet Company’s requirements, however Manufacturer’sfailure to meet such requirements shall not be deemed to be a breach of thisAgreement.  In the event a purchase orderis issued less than [***] Business Days in advance of the desired shipmentdate, Manufacturer shall advise Company within [***] Business Days whether suchpurchase order can be fulfilled by the date requested in the purchase order andthe parties shall agree upon a delivery date of the requested Product.

**3.             Pricesand Payment.**

**3.1          Product Price.** The Product Price shall be fixed for the Initial Period of thisAgreement as specified in **Exhibit A**.

**3.2          Purchase Price Adjustment.** Upon expiration of the Initial Period, Manufacturer may adjust thePurchase Price of Product to reflect changes in [***], subject to Section4.1(b). Any such adjustment by Manufacturer shall be notified to Company noless than [***] prior to expiration of the Initial Period.  Upon commencement of the Second PeriodCompany and Manufacturer agree to meet [***] to formally review continuousimprovement activities and other improvements resulting from experience inoperating the Manufacturing Process including [***]. Company and Manufacturershall work together to obtain process improvements.  Net savings or increases in the [***] shallresult in reductions or increases respectively in the Purchase Price. [***]resulting from Manufacturer’s efficient management of the Manufacturing Processshall not result in reductions in the Purchase Price. Net increases in the costof the Manufacturing Process due to [***] shall result in increases in thePurchase Price. Net savings in the product cost per unit achieved due toincreases in the [***] shall result in corresponding reductions in the PurchasePrice.  If the parties cannot in goodfaith agree on the proposed Purchase Price adjustment, the dispute will bediscussed between the senior management of both Company and Manufacturer.  In no event may Manufacturer increase thePurchase Price following the Initial Period by [***].  The increase will be applicable on [***] ofevery calendar year.

**3.3          Invoices.** Upon acceptance by Manufacturer of a purchase order, Manufacturer shallinvoice Company for [***]%) of the estimated aggregate Product Price for thepurchase order (the “Reservation Fee”). Not withstanding the foregoing, however, the Parties agree that prior tocompletion of the Initial Period, the Parties shall meet for the purpose ofreconsidering the percentage used to determine the Reservation Fee and shall,prior to the

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commencement ofthe Second Period, adjust such percentage, if necessary, upon mutual writtenagreement. Upon completion of the manufacture of each purchase order  and the submission of a Certificate ofAnalysis and Certificate of Compliance duly approved by Manufacturer to Companyfor the batches of Product manufactured for such purchase order Manufacturershall refund Company the Reservation Fee and invoice Company the Product Pricefor the quantity of Product manufactured.

**3.4         ****Cancellation Fee.** If, after issuing a Purchase Order tothe Manufacturer for quantities which are in excess of  the minimum order quantities defined inSection 2.2 for that Purchase Period and acceptance by the Manufacturer of suchPurchase Order, but before Manufacturer starts work to manufacture for thatPurchase Order, the Company subsequently cancels or postpones its order, thenManufacturer shall have the right but not the obligation to charge to Company[***]%) of the product price (“Cancellation Fee”). If, after issuing a PurchaseOrder to the Manufacturer, the Company subsequently cancels or postpones itsorder after the Manufacturer has started work to manufacture for that PurchaseOrder, the Manufacturer shall be entitled to charge to Company [***]%) of theProduct Price for that Purchase Order.

**3.5          Time for payments shall be of theessence.**TheManufacturer reserves the right to charge the lesser of either [***]% or thehighest percentage allowed under applicable law, per month on any overdueamount until the date of payment in full save where part or whole payment iswithheld by the Company on a specific invoice as a result of a genuine disputeover that invoice or part thereof.

**3.6          Method of Payment; Currency.** All payments due hereunder toManufacturer shall be paid to Manufacturer in [***] not later than [***] daysfollowing the receipt of the applicable invoice, unless such shipment ofProduct is rejected in accordance with the provisions of Section 5.3.  Company shall make payment by telegraphictransfer to the account number 02140934 at HSBC., 17-19 Regent Street, Wrexham,LL11 1RY, UK, Sort Code 40-47-26 or to such other account of Manufacturerdesignated in writing to Company.  Allcurrency amounts referenced in this Agreement are to [***].

**3.8          Effect of Certain Events.** In the event of termination or expiration of this Agreement,Manufacturer shall provide reasonable assistance to Company to implement thetransfer of manufacturing responsibility for the Product to Company or itsdesignee.  Such reasonable assistanceshall include transfer of the Manufacturing Process as described inSection 7.7 but always with the exception of Manufacturer Inventionssubject to Section 7.2. In the event of termination of this Agreement byCompany pursuant to Section 9.2(a) or (b) or 9.3(c), such reasonableassistance will be provided at Manufacturer’s expense. In the event of anyother termination or expiration of this Agreement, Company shall payManufacturer’s reasonable and documented costs of providing suchassistance.  In the event of terminationor expiration of this Agreement, Manufacturer will promptly return to Companyall unused Pramlintide Acetate Drug Substance provided to Manufacturer pursuantto Section 4.1 hereof and Materials paid for by Company as directed by and atthe expense of Company.

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**4.             Manufacturing.**

**4.1          Materials.**

**(a)          **Except as stated in Section 4.1(b), Manufacturer willobtain any Materials with the exception of Pramlintide Acetate Drug Substancerequired for the manufacture of the Product, in reasonable quantitiesconsistent with Company’s most recent forecast for the Product. All Materialsobtained by Manufacturer pursuant to this Section 4.1(a) shall meet thespecifications stated in the Quality Agreement and Manufacturer shall order allMaterials only from vendors approved in advance by Company.  Manufacturer shall ensure all Materialsrequired to manufacture the Batch are released for use, in accordance withManufacturer’s quality system and requirements stated in the then currentQuality Agreement, prior to the manufacturing of the Batch. Company shallreimburse the Manufacturer all the costs of all the Materials in stock or onorder on behalf of the Company by the Manufacturer, including QC testing costsand disposal costs, if such Materials become redundant at any time if: (i)Company makes a good faith determination not to continue with thecommercialization of Product, (ii) Company terminates this Agreement accordingto Section 9.3(a), (iii) such materials expire due to insufficient demand forProduct, or (iv) such materials become obsolete due to a change ofspecification advised by the Company; *provided*,*however*, Manufacturershall use commercially reasonable efforts to either utilize such materials inother areas of its business or to return the materials, and Company shall notreimburse Manufacturer for any such utilized or returned materials.  The orders of Materials will be placedkeeping in view the future forecasts and delivery lead times. Manufacturer willmaintain a safety stock level of at least [***] calendar [***], but no morethan [***] calendar [***] of approved Materials unless the minimum procurementquantity for any Material provides sufficient stocks for greater than [***]calendar [***].  For clarification purposes,safety stock includes Materials needed to fulfill forecasts issued by Companypursuant to Section 2.3.  Manufacturerand Company will review safety stock levels on a quarterly basis and willmutually agree to make appropriate changes.

**(b)          **Company shall supply to Manufacturer, free of charge,freight and duties prepaid and with transportation insurance paid by Company,quantities of Pramlintide Acetate and Pramlintide Acetate reference standardsufficient to enable Manufacturer to manufacture and perform agreed analyticaltesting of the quantities of the Product ordered by Company.  Pramlintide Acetate will be sampled accordingto the Quality Agreement and held by Manufacturer under appropriate storageconditions until such time as it is required for manufacture of Product.Manufacturer and Company agree that in the case of Product manufactured priorto satisfactory completion of the first [***] commercial full scale batches(including the process validation batches) of each of the presentations of Product,Manufacturer shall make commercially reasonable efforts to maximize yields butshall not be held liable for losses of Pramlintide Acetate occurring as part ofthe Manufacturing Process. After satisfactory completion of the first [***]commercial full scale batches of each Product the parties shall meet to agreeto a target yield for future production (Target Yield). The Target Yield shallbe defined as at least [***]%)] of the average yield of the first [***] batchesof each presentations of Product. For clarity, “*satisfactory completion*” of a Batch will not include a Batchwith aberrant results.  All shipments ofPramlintide Acetate will be accompanied by a Certificate of Analysis indicatingthe peptide content of such Pramlintide Acetate and such other information asCompany may specify and is to arrive approximately thirty (30) days in advanceof planned

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Productmanufacture to allow for testing. Within fifteen (15) business days of receiptof any Pramlintide Acetate hereunder, Manufacturer will verify the quantity andidentity of such shipment of Pramlintide Acetate according to test methodsapproved and provided by Company and shall inspect the Pramlintide Acetate inaccordance with Manufacturer’s incoming material inspection procedures.  If Manufacturer detects any discrepancies inthe Pramlintide Acetate in quantity or in the identity based on the identitytesting performed, Manufacturer shall inform Company immediately upon, but nolater than five (5) Business Days after, having detected suchdiscrepancies.  Manufacturer shall alsoinform Company of any obvious damage to the Pramlintide Acetate or containerreceived within five (5) Business Days of Manufacturer’s receipt thereof.  Any rejected Pramlintide Acetate shall bereturned at Company’s expense and direction. Company shall make all finaldeterminations if Materials are suitable for use in Product manufacturing.

**4.2         ****Manufacture of Product.** Manufacturer will manufacture and store Product at the Facilities inaccordance with the Quality Agreement, the Specifications, applicableRegulatory Approvals, cGMPs and other Applicable Laws, as then in effect.  Manufacturer shall not rework any Batch ofthe Product without Company’ prior written consent, which consent shall not beunreasonably withheld.  Manufacturershall allow an employee of Company (and, with Manufacturer’s prior consent,other persons) to be present during all manufacturing of the Product. TheManufacturer shall perform quality control and quality assurance testing toprotocols and procedures agreed in writing between the parties prior toshipment of Product to the Company. The Manufacturer shall test a portion ofeach Batch manufactured for the Company prior to delivering such Batch to theCompany, and shall provide a Certificate of Analysis (i) confirming that theManufacturer followed the agreed methods for the testing of such Product, (ii)containing the quality control and quality assurance test results for suchBatch and (iii) confirming that such Batch has been manufactured in accordancewith the Batch Records and cGMP. The Manufacturer shall notify the Companyimmediately of any test failures noted in the manufacture of Product.

**4.3          Change in Specifications orManufacturing Process.**

**(a)          **Each party shall notify the other inadvance of any proposed changes in Specifications, release testing, stabilitytesting, packaging, Materials, equipment, facilities, processes or proceduresused to manufacture Product under this Agreement.  No changes in Specifications, releasetesting, stability testing, packaging or the Materials, equipment, facilities,processes or procedures used to manufacture Product under this Agreement,except changes required by any applicable Regulatory Authority, will be madeunless the parties have agreed to such changes in writing prior to adoption ofsuch changes. Any such changes to theProduct Specifications, release testing, stability testing, packaging,Materials, equipment, facilities, processes or procedures used to manufactureProduct shall be handled in accordance withthe procedures established in the Quality Agreement, with costs paid asprovided in Section 4.3(b), (c) or (d), as applicable.

**(b)          **In the eventCompany requests any such changes be made, other than changes described inSection 4.3(d), Manufacturer shall accommodate Company’s requested changesto the extent technologically feasible.  If such changes would result in materialchange in the cost of manufacture, then in that event the Product Price may besuitably

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modified. If suchchanges require the purchase of capital equipment, such costs and any relatedinstallation and qualification costs will be to the account of the Company andsuch capital equipment shall be owned by the Company.

**(c)          **In the eventManufacturer requests any such changes be made, other than changes described inSection 4.3(d), and such changes would result in a material increase inManufacturer’s cost of manufacture, all costs reasonably required in connectionwith such changes shall be paid as mutually agreed by the parties.

**(d)          **In the eventchanges are requested by a Regulatory Authority or required to bring either ofthe Facilities into compliance with Applicable Laws, or additional changes,activities, or manufacturing is required to bring the Manufacturing Processinto compliance with Applicable Laws, Specifications or other ProductRequirements, Manufacturer shall accommodate such changes to the extenttechnologically feasible, and all costs reasonably required in connection withsuch changes, activities, or manufacturing shall be borne by theManufacturer.  In such an event the Product Price may besuitably revised to accommodate such changes.

**4.4          Regulatory Matters.**

**(a)          **Manufacturer shall provide to Company suchdocumentation, data and other information relating to the Facilities, Product, or Manufacturer’sManufacturing Processes and procedures for Product as Company may request forsubmission to Regulatory Authorities.

**(b)          **Company shall be responsible for all filings necessaryfor Regulatory Approvals.  The partiesagree that Company shall be the sole and exclusive owner of all right, titleand interest in and to all Drug Approval Applications and Regulatory Approvalsrelated to the Product in the United States and any OUS Country. Manufacturershall assist Company in the preparation of all documents necessary toeffectuate Company’s rights in all Drug Approval Applications and RegulatoryApprovals related to the Product and agrees to transfer, effect, confirm,perfect, record, preserve, protect and enforce all rights, title and intereststransferred hereunder, at the reasonable request and expense of Company.Manufacturer will use commercially reasonable efforts to assist Company inobtaining such Regulatory Approvals. For the avoidance of doubt, Company hassole responsibility for the content of all Drug Approval Applications.  This Agreement automatically terminates ifAmylin terminates development of the Product following final rejection of theProduct by the FDA.

**4.5         ****Compliance with Quality Agreement andApplicable Laws. **The parties shall comply with the termsand conditions of the Quality Agreement. Manufacturer shall comply with allApplicable Laws with respect to activities under this Agreement.   Manufacturer represents and warrants toCompany that it has and will maintain during the Term all establishmentlicenses and permits, including without limitation health, safety andenvironmental permits, necessary for the conduct of Manufacturer’s activitiesunder this Agreement.

**4.6         ****Manufacturer Facilities.** Manufacturer warrants and represents that it has, and will maintain, alllicenses, permits and approvals necessary to fulfill its obligations

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under thisAgreement.  Manufacturer covenants todesign and operate the facilities it uses to manufacture, package, test, orstore Product to successfully pass inspections conducted by regulatoryauthorities. Manufacturer agrees tomaintain appropriate security measures at its facilities no less stringent thanmeasures that are customary in the pharmaceutical industry.

**4.7         ****QA Audits.** Upon written notice of no less than[***] Business Days for routine audits to Manufacturer, Company shall have theright to have representatives visit the Facilitiesduring normal business hours to review Manufacturer’s manufacturing operations,assess its compliance with cGMPs and quality assurance standards, and discussany related issues with Manufacturer’s manufacturing and managementpersonnel.  Manufacturer shall maintainthe Facilities in accordance with cGMPs. Manufacturer’s failure to correct any cGMP deficiency regarding anyaspect of Manufacturer’s manufacture within a reasonable time period afternotice of such deficiency shall be a material breach of this Agreement. Uponreasonable notice, the Manufacturer will allow employees of the Company accessto the Facility, documentation, and personnel to audit and for observation ofthe production process and quality control testing of the Product, disposal ofwaste and adherence to cGMP requirements and this Agreement. During suchinspections, employees of the Company (number of persons should be restrictedto not more than [***]) shall have the right to audit any aspect of theManufacturers manufacture of Product, and such audit may include, withoutlimitation, verification of Manufacturers maintenance of drug establishmentregistrations with the FDA and other applicable Regulatory Authorities, andreview of conditions and documentation of any aspect of manufacture of Product.

**4.8         ****Regulatory Inspections.** Manufacturer agrees to permit the FDAand other Regulatory Authorities to inspect any aspect of Manufacturer’smanufacture and testing of the Product including, without limitations, anypre-approval inspection (“PAI”). Manufacturer shall cooperate with Company, andwith any Regulatory Authority, as necessary to facilitate prompt approvals bysuch Regulatory Authority of the Manufacturing Process or testing process forthe Product, including preparation and submission of necessary data relating tothe manufacturing or testing processes, including without limitation any PAI orsubsequent inspection. Manufacturer shall notify Company if either or both ofthe Facilities are the subject of aninspection by any Regulatory Authority or any compliance inspection relatingto, or that could reasonably be expected to, affect the manufacture or storageof the Product or its production at the Facilities.Manufacturer shall provide such notification, by telephone and fax, as soon asManufacturer becomes aware of the inspection, but not later than two (2)Business Days from the time Manufacturer becomes aware of the inspection. Inconnection with any such inspection, including without limitation a PAI,Manufacturer shall allow employees or representatives of Company to be presentduring the inspection. Manufacturer shall allow Company to participate in theformulation of any response to regulatory inspections or any other issuesraised by any Regulatory Authority related to Product. Manufacturer will alsosimultaneously provide Company with photocopies of any responses provided toany Regulatory Authority, including, without limitation, responses to any FDA483 or similar reports. Manufacturer shall keep Company fully informed as toany Manufacturer communication with any Regulatory Authority related toProduct.

**4.9         ****Investigation of Failed Batch.** Manufacturer shall investigate, and cooperate fully with Company ininvestigating any Batch that fails to meet the Product

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Requirements orthat incurs a significant deviation from expected Manufacturing Process.  Manufacturer shall keep Company informed ofthe status of any investigation and, upon completion of the investigation,shall provide Company with a final written report describing the cause of thefailure or deviation and summarizing the results of the investigation.

**4.10       ****Documentation.** Manufacturer shall keep complete,accurate and authentic accounts, notes, data and records of the work performedunder this Agreement, including, without limitation, master production andcontrol records and Product complaint files, in accordance with ApplicableLaws.  In addition, Manufacturer shallretain and store samples of each Batch only as required by Applicable Laws.  The sample size shall be twice the size necessaryto conduct quality control testing. Manufacturer shall retain such records andsamples for the periods required by Applicable Laws. Upon Company’s request,Manufacturer shall make available copies of such records and portions of thesamples to Company.  After such timeperiod, Manufacturer shall notify Company prior to destroying such records andsamples and, at Company’s request and expense, shall provide copies of suchrecords and any remaining samples to Company. The Manufacturer shall not be obliged to retain any samples thereafterand after due intimation to the Company, the Manufacturer shall destroy theremaining samples.

**4.11       ****Complaints and Adverse Reaction.** Each party shall promptly advise the other of any complaints, adversereaction reports, safety issues or toxicity issues relating to Product of whichit becomes aware, which may be the result of, or have an effect on, themanufacturing or packaging operations performed by Manufacturer. Company shallbe responsible for all reporting of such information to Regulatory Authorities.

**4.12       ****Labeling; Trademark.** Manufacturer shall affix labeling to the Product as directed byCompany.  Nothing in this Agreement givesManufacturer the right to use any trademark or trade name of Company except asspecified in writing by Company. Manufacturer shall not affix any label, stamp or other mark identifyingManufacturer as the source of the Product except as instructed in writing byCompany or as may be required by Applicable Laws.

**5.             Deliveryand Acceptance.**

**5.1         ****Delivery.** Unless otherwise agreed by the parties in writing, all shipments shallbe shipped FCA (Incoterms 2000) the Facilitiesby air freight to the destination specified by Company in the applicablepurchase order. Manufacturer shall make each shipment of the Product in thequantity, cartridge size and on the shipment date specified for it on Company’spurchase order, via the mode(s) of transportation and to the party anddestination specified on such purchase order. Manufacturer will package and shipthe Product in accordance with Manufacturer’s customary practices forpharmaceutical products, unless otherwise specified by Company.  Manufacturer shall deliver Product ordered byCompany on the scheduled delivery dates set forth in the relevant purchaseorders, subject to the provisions of Section 2.4.  If Company is not ready to accept shipment ofProduct on the date Manufacturer is prepared to ship Product, then Manufacturershall store Product in a manner consistent with customary practices for pharmaceuticalproducts and Company shall pay Manufacturer a commercially reasonable storagefee.  Company and Manufacturer agree tonegotiate the amount of such storage fee in good faith.

 

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**5.2         ****Title.** Title to all Pramlintide Acetate shall at all timesremain in Company.  Title to allMaterials other than Pramlintide Acetate, work in progress to produce Product,and all completed Product (except Pramlintide Acetate contained therein) shallremain with Manufacturer until delivery of such Product to carrier designatedby the Company.  Notwithstanding theforegoing, and regardless of whether delivery of Product to Company hasoccurred under Section 5.1, Manufacturer shall bear all risk of loss withrespect to, and shall insure, all Product until transfer by Manufacturer to acarrier for shipment as directed by Company in the applicable purchase order.

**5.3          Acceptance and Rejection.**

**(a)          **Concurrent with the delivery of any Batch, Manufacturershall provide Company with all documentation required to be provided to Companyunder the Quality Agreement, including, without limitation, a Certificate ofAnalysis and Certificate of Compliance for such Batch.  Company may reject delivery of any Batch thatdoes not conform with the Product Requirements. Any such notice of rejection shall be in writing and shall indicate thereasons for such rejection.

**(b)          **In order to reject delivery of a Batch, Company mustgive written notice to Manufacturer of Company’ rejection of any deliverywithin [***] days after receipt of such delivery.  If no such notice of rejection is received,Company shall be deemed to have accepted such delivery of the Batch [***] daysafter delivery of the Batch, except in the case of Hidden Defects.  If Company discovers in a Batch a HiddenDefect, such as a Contaminant, at any time after acceptance of such Batch,Company shall notify Manufacturer within [***] days of discovering such HiddenDefect and shall have the right to reject the Batch under the proceduresregarding rejection set forth in Section 5.3(c), (d) and (e), asapplicable.

**(c)          **After notice of rejection is given, Company shallcooperate with Manufacturer in determining whether rejection is justified.  Manufacturer shall notify Company as promptlyas reasonably possible (and in any event within [***] days after notice ofrejection from Company) if Manufacturer does not agree that such rejection isjustified.  If no such notice from Manufactureris received, Manufacturer shall be deemed to agree that such rejection isjustified. Should Company reject any Batch and Manufacturer agree that suchrejection is justified or if applicable, a third party determines suchrejection is justified pursuant to the provisions of Section 5.3(d),Manufacturer shall (i) reimburse amounts paid to Manufacturer by Companypursuant to Section 3.1. and (ii) shall manufacture and supply the next Batchof Product ordered by Company at no cost to Company.  Compliance with the provisions of this Section 5.3(c)and 5.3(d) and 5.3(e) shall be Manufacturer’s sole liability to Company whereCompany rejects a Batch of and either Manufacturer agrees, or a third partydetermines under Section 5.3(d), that such rejection is justified, subjectonly to Section 10.4.

**(d)          **If Manufacturer in good faith disagrees with Company’sdetermination that rejection of a Batch is justified, certain of the Product insuch Batch shall be submitted to a mutually acceptable third party laboratoryor expert. Such third party shall determine whether such Product meets theSpecifications, and the parties agree that such third party’s determinationshall be final and determinative. The party against whom the third partytester/expert rules shall bear all costs of the third party testing.  Whether or not Manufacturer 

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accepts Company’s basisfor rejection, promptly on receipt of a notice of rejection of a Batch,Manufacturer shall replace such rejected Batch within [***] days.  If the third party tester/expert rules thatthe Batch meets Specifications and those warranties pursuant to Sections 8.3(a), (b), (c), (d) and (e), Company shall purchase that Batch at theagreed-upon price, irrespective of whether Manufacturer has already replacedit. All replacement Product shall be invoiced as well and Company shall pay forsuch Product as otherwise provided under the terms of this Agreement. If thirdparty tester/expert agrees that rejection was justified then Manufacturer shall(i) reimburse Company amounts paid by Company pursuant to Section 3.1 and (ii)shall manufacture and supply the next Batch of Product ordered by Company at nocost to Company. Compliance with the provisions of this Section 5.3(d) andpayment of the costs in Section 5.3(e) shall be Manufacturer’s sole onlyliability to Company where Company rejects a Batch of and either Manufactureragrees, or a third party determines under Section 5.3(d), that suchrejection is justified, subject only to Section 10.4.****Manufacturer shall have no further liabilityto the Company in respect of such Batch except to what is stated herein.

**(e)          **Company may not destroy any Batch until [***] daysafter rejection unless, prior to that date, Company receives writtennotification from Manufacturer that Manufacturer does not agree that suchrejection is justified or that Manufacturer requests return of such rejectedBatch.  Company shall destroy suchrejected Batch promptly at Manufacturer’s cost and provide Manufacturer withcertification of such destruction. Company shall, upon receipt of Manufacturer’s request for return,promptly return such Batch to Manufacturer, at Manufacturer’s cost.

**5.4          Recalls and Similar Actions.**

**(a)**           Ifthere is a recall, withdrawal or field correction with respect to, or anygovernmental seizure of, Product (“Recall Action”), which Recall Action isconsidered by the Company to be due in part to a failure of the Manufacturer tocomply with its warranties stated in Section 8.3 of this Agreement then Companywill notify Manufacturer promptly of the details regarding such Recall Action,including providing copies of all relevant documentation concerning such RecallAction. Manufacturer will assist Company in investigating any such RecallAction, if Company so requests, and all regulatory contacts that are made andall activities concerning such Recall Action will be initiated and coordinatedby Company with Manufacturer’s involvement and assistance, as reasonablyrequested by Company.

**(b)**           Ifany Recall Action occurs which is considered by the Company to be due in partto a failure of the Manufacturer to comply with its warranties stated inSection 8.3 of this Agreement and Manufacturer agrees with said considerationthen Manufacturer shall, to the extent and only to the extent of its relativeresponsibility, bear the cost and expense of any such Recall Action. Therefore,if both Manufacturer and Company contribute to the cause of such a RecallAction, the cost and expense thereof will be shared in proportion to each party’scontribution to the problem.

**(c)**           Ifany Recall Action occurs which is considered by the Company to be due in partto a failure of the Manufacturer to comply with its warranties stated inSection 8.3 of this Agreement and Manufacturer disagrees with said considerationthen the parties shall refer to a mutually acceptable third party expert. Suchthird party shall determine if Manufacturer 

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has complied withits warranties stated in Section 8.3. If such a determination is madeManufacturer shall have no liability towards the cost and expense of the RecallAction. If the third party determines Manufacturer has not complied with itswarranties stated in Section 8.3 Manufacturer shall, to the extent and only tothe extent of its relative responsibility, bear the cost and expense of anysuch Recall Action.

**6.             Protectionof Confidential Information.**

**6.1         **Confidentiality. During the Term and for a period of ten (10) years thereafter, eachparty (the ***“Receiving Party”***)agrees with respect to any Confidential Information of the other party (the ***“Disclosing Party”***):

**(a)          **To use such Confidential Information only for thepurposes set forth in this Agreement;

**(b)          **To receive, maintain and hold the ConfidentialInformation in confidence;

**(c)          **Not to disclose, or authorize or permit the disclosureof, any Confidential Information to any third party without the prior writtenconsent of the Disclosing Party; and

**(d)          **Except as needed to fulfill its obligations hereunder,to return any Confidential Information to the Disclosing Party at the requestof the Disclosing Party and to retain no copies or reproductions thereof.

**6.2         ****Limitations.** The Receiving Party shall not be obligated to treat as ConfidentialInformation, information that the Receiving Party can show by competent writtenevidence:

**(a)          **was already known to the Receiving Party without anyobligations of confidentiality prior to receipt from the Disclosing Party;

**(b)          **was generally available to the public or otherwisepart of the public domain at the time of its disclosure to the Receiving Party;

**(c)          **became generally available to the public or otherwisepart of the public domain after its disclosure, other than through any act oromission of the Receiving Party in breach of any obligation of confidentiality;

**(d)          **was disclosed to the Receiving Party, other than underan obligation of confidentiality, by a third party who had no obligation not todisclose such information to others; or

**(e)          **was independently discovered or developed by theReceiving Party without the use of the Disclosing Party’s ConfidentialInformation.

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**6.3         ****Authorized Disclosure.** Notwithstanding Section 6.1, the Receiving Party may discloseConfidential Information, without violating the obligations of this Agreement,to the extent the disclosure is required by Applicable Laws or a valid order ofa court or other governmental body having jurisdiction; provided that theReceiving Party gives reasonable prior written notice to the Disclosing Partyof such required disclosure and makes a reasonable effort to obtain, or toassist the Disclosing Party in obtaining, a protective order preventing orlimiting the disclosure and/or requiring that the Confidential Information sodisclosed be used only for the purposes for which the law or regulationrequires, or for which the order was issued. Further, the Receiving Party may disclose Confidential Information ofthe Disclosing Party solely to the extent (a) such disclosure isreasonably necessary in advising investors and the investment community of theresults of the research, development or commercialization activities hereunder(subject to the prior written consent of the Disclosing Party, which consentwill not be unreasonably withheld), or (b) such disclosure is made toAffiliates, employees, consultants or agents to other third parties inconnection with due diligence by such Third Parties, or to potential thirdparty investors in confidential financing documents, provided, in each case,that any such Affiliate, employee, consultant, agent or third party is subjectto confidentiality and non-use obligations with respect to such information.

**6.4         ****Use of Name/Publicity.** Neither party shall use the other party’s name in connection with anypublication or promotion without the other party’s written consent, except asrequired by federal, state or local laws, rules and regulations.  Manufacturer shall not disclose the specificcontent or terms of this Agreement without the prior written consent of Company.

**7.             IntellectualProperty Rights.**

**7.1         **Company Inventions. All right, title and interest in and to any intellectual property rightsin Pramlintide Acetate and Product shall at all times be and remain the soleand exclusive property of Company. Company shall solely own, and shall alone have the right to apply forpatents, patent rights and inventor’s certificates, on any invention, method,process, discovery or know-how (whether or not patentable) which is conceivedsolely by Company, its consultants or agents (other than Manufacturer) in theperformance of this Agreement (***“Company Inventions”***).

**7.2          Manufacturer Inventions.** Manufacturer shall solely own, and shall alone have the right to applyfor patents, patent rights and inventor’s certificates, on any invention, method,process, discovery or know-how (whether or not patentable) which is conceivedsolely by Manufacturer, its consultants or agents in the performance of thisAgreement ***(“Manufacturer Inventions”***).

**7.3          Joint Inventions.** Any invention, method, process, discovery or know-how (whether or notpatentable) not conceived solely by either Company and Manufacturer or theirrespective consultants or agents during the performance of this Agreement (***“Joint Inventions”***) shall be jointlyowned by Company and Manufacturer.  Thelaw of joint ownership of patents of the United States shall apply to jointownership of any Joint Inventions inside and outside of the United States.Where appropriate, the parties may engage outside counsel agreeable to bothparties (the costs of which shall be borne equally by the parties) to represent

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them jointly in theprosecution of patent applications and the maintenance of patents with respectto Joint Inventions.

**7.4          Prosecution.** Should either party not wish to file, prosecute, maintain or issue apatent application or maintain a patent covering such party’s interest in aJoint Invention, then such party  (the ***“Granting Party”***) shall, at theother party’s election, grant to the other party (i) a perpetual, irrevocable,exclusive (even as to the Granting Party and its Affiliates), worldwide, fullypaid-up royalty-free license under the Granting Party’s interest in the JointInvention, with the right to grant sublicenses, to develop, make, have made,use, import, offer to sell, have sold and sell products, and (ii) any necessaryauthority to file, prosecute, maintain and issue such a patent application ormaintain such a patent, all at the expense of the party requesting that suchfiling be made or action be taken.

**7.5          Assistance.** Upon request, Company and Manufacturer shall each provide the other withreasonable assistance in obtaining patents and, if necessary, enforcing patentrights in Manufacturer Inventions, Company Inventions or Joint Inventions, asapplicable.  To that end, each partyagrees to assist the other in executing, verifying and delivering suchdocuments and performing such acts as may be reasonably requested by the otherparty in applying for, obtaining, perfecting, evidencing, sustaining orenforcing the other party’s rights in Manufacturer Inventions, CompanyInventions or Joint Inventions, as applicable. The party requesting such assistance shall reimburse the assisting partyfor all reasonable out-of-pocket expenses incurred and provide reasonablecompensation for time spent in providing such assistance, except in the case ofany patent covered by a Joint Invention, in which case no compensation shall beprovided and all expenses shall be [***] by the parties (*i.e.*,[***]% paid by Company and [***]% paid by Manufacturer).

**7.6          Infringement.** Each party shall promptly notify the other of any potential alleged orthreatened infringement of patents claiming any Company Invention, ManufacturerInvention or Joint Invention, or of any allegation by a third party of which itbecomes aware that the activity of Company or Manufacturer pursuant to thisAgreement infringes a third party’s patent rights.

**7.7          Manufacturing Process License;Technology Transfer.**  Manufacturer hereby grants Company aperpetual, irrevocable, exclusive, worldwide, royalty-free, fully paid-uplicense, with the right to sublicense, to all of Manufacturer’s rights in andto the Manufacturing Process, including any Manufacturer Inventions, touse,  import, make, have made, offer tosell, have sold and sell Product or any other product containing PramlintideAcetate; *provided*, *however*, if Company or any sublicenseeof Company or any successor business or assignee wishes Manufacturer to assistin the transfer of the Manufacturing Process to another manufacturer,Manufacturer shall have the right to charge a commercially reasonable fee basedon FTE rates for providing training and other assistance requested by suchparty in connection with such technology transfer.  Notwithstanding the foregoing, if any suchtransfer of the Manufacturing Process to a third party results in a transfer ofthe Manufacturer’s Technology, the parties agree to meet for the purpose ofdetermining the appropriate royalty amount to be paid to the Manufacturer.

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**8.             Representationsand Warranties.**

**8.1          No Inconsistent Obligations.** Each party represents and warrants that the terms of the Agreement arenot inconsistent with its other contractual arrangements or obligations.

**8.2          Due Authorization.** Each party represents and warrants that (a) it has full power andauthority to enter into this Agreement, (b) this Agreement has been dulyauthorized by it, and (c) this Agreement is binding upon it.

**8.3          Product Warranties.** Manufacturer represents and warrants that Product delivered hereunderwill:

**(a)          **be manufactured by Manufacturer in accordance withcGMPs and relevant Regulatory Approvals;

**(b)          **conform to the Specifications at the time of delivery;

**(c)          **not contain any Contaminant or be adulterated withinthe meaning of the FDCA or any other Applicable Law in which the definitions ofadulteration are substantially the same as those contained in the FDCA, as suchlaws are constituted and effective at the time of delivery;

**(d)          **not be an article which may not, under the provisionsof Sections 404, 505 of 512 of the FDCA, be introduced into interstatecommerce; and

**(e)          **be free and clear of any lien or encumbrance.

Company’s remedies and Manufacturer’s liability withrespect to the warranties set forth in this Section 8.3 are set forth inSection 5.3(d) above.

**8.4         **The Company represents, warrants and agrees that:

a)             The manufacture ofProduct as contemplated herein, will not, to the Company’s knowledge, infringeany existing patents or any other proprietary rights of third parties, and asof the date hereof Company has not received any notice of any claimedinfringement (including without limitation patent infringement) in connectionwith Pramlintide Acetate.

b)            The Company, to theCompany’s knowledge, and its employees have never been debarred or convicted ofa crime for which a person can be debarred, under subsection (a) or (b) of 21U.S.C. § 335a, as amended, and Company agrees that it does not now and does notintend in the future to use in any capacity the services of any person debarredunder subsection (a) or (b) of 21 U.S.C. §335a, as amended.  If, during the term of this Agreement,Company or any other person performing under this Agreement becomes debarred ordisqualified, or receives notice of an action or threat of an action withrespect to debarment or disqualification, Company shall promptly notifyManufacturer.

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**8.5          No Debarred or Disqualified Persons.** Manufacturer represents and warrantsthat it is not currently and it shall not employ, contract with, or retain anyperson directly or indirectly to perform any services under this Agreement ifsuch a person (a) is under investigation by the FDA for debarment or ispresently debarred by the FDA pursuant to 21 U.S.C. § 335a or its successorprovisions or any regulations promulgated thereunder, (b) has adisqualification hearing pending or has been disqualified by the FDA pursuantto 21 CFR § 312.70 or its successor provisions or (c) is subject to similarinvestigation or disqualification pursuant to any other relevant regulatoryauthority.  In addition, Manufacturerrepresents and warrants that it has not engaged in any conduct or activitywhich could lead to any of the above-mentioned disqualification or debarmentactions.  If, during the Term,Manufacturer or any person employed or retained by it to perform any servicesunder this Agreement (i) comes under investigation by the FDA for adebarment action or disqualification, (ii) is debarred or disqualified, or(iii) engages in any conduct or activity that could lead to any of theabove-mentioned disqualification or debarment actions, Manufacturer shallimmediately notify Company of same.

**8.6          Disclaimer.** Except as set forth above, NEITHER PARTY MAKES ANY REPRESENTATIONS ORWARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND EXPRESSLY DISCLAIMS ALLIMPLIED WARRANTIES OF TITLE, NON-INFRINGMENT, MERCHANTIBILITY, AND FITNESS FORA PARTICULAR PURPOSE.

**8.7          Limitation of Liability.** NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANYSPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THISAGREEMENT OR ANY LICENSE GRANTED HEREUNDER. This Section 8.7 shall not be construed to limit either party’sindemnification obligations under Section 10 or to limit remediesavailable for breach of confidentiality and non-use obligations or forinfringement or misappropriation of intellectual property rights.

**9.             Termand Termination.**

**9.1          Term.**  The term ofthis Agreement shall commence on the Effective Date and, unless terminatedearlier as provided herein, shall continue until the expiration of the FifthPeriod, subject to renewal by mutual written agreement of the parties (the ***“Term”***).

**9.2          Termination by Either Party.**  Aparty may terminate this Agreement:

**(a)          **for material breach of this Agreement by the otherparty upon sixty (60) days’ written notice specifying the nature of the breach,if such breach has not been cured within such sixty (60) day period; provided,this Agreement may be terminated immediately if the breach is incapable ofremedy or has not been corrected by the breaching party within sixty (60) daysafter written notice; or

**(b)          **immediately upon written notice to theother party, if the other party makes a generalassignment for the benefit of creditors, files an insolvency petition inbankruptcy, petitions for or acquiesces in the appointment of any receiver,trustee or similar 

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officerto liquidate or conserve its business or any substantial part of its assets,commences under the laws of any jurisdiction any proceeding involving itsinsolvency, bankruptcy, reorganization (other than a reorganization withoutinsolvency), dissolution, liquidation or any other similar proceeding for therelease of financially distressed debtors or becomes a party to any proceedingor action of the type described above and such proceeding or action remainsundismissed or unstayed for a period of more than sixty (60) days.

**9.3          Termination by Company.** Company may terminate this Agreement:

**(a)          **at any time after the expiration of the Fifth Periodupon one (1) year’s prior written notice to Manufacturer;

**(b)          **at any time prior to the Launch Date in the event that Company makes a good faithdetermination that it will not continue with the commercialization of Product,upon at least sixty (60) days prior written notice to Manufacturer, andsuch termination shall be effective at the end of such sixty (60) day period;provided that Company shall remain obligated to pay for Product ordered underany purchase orders issued by Company to Manufacturer prior to such effectivetermination date.

**(c)** immediately upon written notice toManufacturer if Manufacturer (i)  has itsmanufacturing authorizations for the Product suspended or withheld (ii) in thecase of a PAI, fails to pass an inspection by a Regulatory Authority (iii) inthe case of a regulatory inspection by a Regulatory Authority fails to pass aninspection and has not taken, within one hundred (100) Business Days, suchaction as is necessary to correct the items cited by the Regulatory Authority.

**9.4          AutomaticTermination.** In the event Company notifies Manufacturer thatit has terminated development of Pramlintide Acetate following the receipt byCompany of notice of final rejection by the FDA for marketing authorization forcommercial sale and distribution of Product in the United States, then thisAgreement shall automatically terminate.

**9.5           Survival Upon Termination.** Expiration or termination of this Agreement will notrelieve the parties of any obligation accruing prior to such expiration ortermination. Sections 1, 3.8, 4.7, 4.10, 6, 7, 8.3, 8.5, 8.7, 9.5, 9.6,10, 11 and 12 will survive termination of this Agreement.

**9.6          Remedies.**  In the eventof any breach of any provision of this Agreement, in addition to the terminationrights set forth herein, each party shall have all other rights and remedies atlaw or equity to enforce this Agreement.

**10.          Indemnification.**

**10.1        By Company.** Company agrees to indemnify, defend and hold harmless Manufacturer andits Affiliates and their respective officers, employees and agents (***“Manufacturer Indemnitees”***) from anyloss, expense (including reasonable legal counsel fees and expenses), cost,liability or damages (***“Losses”***)incurred by any Manufacturer Indemnitee as 

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a result of any claim,demand, action or other proceeding by any third party (***“Claim”***)arising out of or related to (a) Company’s breach of any representation orwarranty made by Company in this Agreement or (b) the handling,possession, storage or use of Product by or on behalf of Company followingdelivery by Manufacturer to Company, except to the extent Manufacturer isobligated to indemnify Company with respect to such Losses underSection 10.2 or the Losses are based on the negligence or willful misconductof any Manufacturer Indemnitee. Manufacturer Indemnitees shall promptly and in any event within thirty(30) days notify Company of any known Claim which is the subject of Losses.  Manufacturer Indemnitees shall fullycooperate with Company in the defense or settlement of any claim of Lossesunder this Section 10.1; *provided*,*however*, that noManufacturer Indemnitee shall be required to admit fault or responsibility inconnection with any settlement. Manufacturer Indemnitees shall have the right to select and to obtainrepresentation by separate legal counsel at its own expense.

**10.2        By Manufacturer.** Manufacturer shall indemnify, defend and hold harmless Company and itsAffiliates and their respective officers, employees and agents (***“Company Indemnitees”***) from andagainst any and all Losses to which any Company Indemnitee may become subjectas a result of any Claim arising out of or related to (a) Manufacturer’sbreach of any representation or warranty made by Manufacturer in this Agreementor (b) the handling, possession, storage or use of Pramlintide Acetate orProduct by or on behalf of Manufacturer prior to delivery of Product byManufacturer to Company, except to the extent Company is obligated to indemnifyManufacturer with respect to such Losses under Section 10.1 or the Lossesare based on the negligence or willful misconduct of any CompanyIndemnitee.  Company Indemnitee shallpromptly and in any event within thirty (30) days notify Manufacturer of anyknown Claim which is the subject of Losses. Company Indemnitees shall fully cooperate with Manufacturer in thedefense or settlement of any claim of Losses under this Section 10.2; *provided*, *however*, that no Company Indemniteeshall be required to admit fault or responsibility in connection with anysettlement.  Company Indemnitees shallhave the right to select and to obtain representation by separate legal counselat Company’s own expense.

**10.3        Loss of Pramlintide Acetate DrugSubstance.**  If any Pramlintide Acetate Drug Substance isdestroyed, damaged or lost while in Manufacturer’s custody, control or storageprior to its use in the manufacture of the Product, Manufacturer’s liabilitiesshall be determined at a rate of [***] US dollars ($[***]) per gram] ofPramlintide Acetate Drug Substance and limited to a maximum of [***] US dollars($[***]) for each individual incidence of loss. For the avoidance of doubt Manufacturer shall not be liable for loss ofPramlintide Acetate Drug Substance if peptide content has deteriorated andManufacturer has complied fully with the storage requirements for PramlintideAcetate Drug Substance as specified by Company.

**10.4        Restriction on Limitation of Liability.** Nothing in this Agreement shall limit a party’s liability in respect ofdeath or personal injury caused by the negligence of that party or itsliability in respect of fraudulent misrepresentation.

**11.          DisputeResolution**

**11.1        Discussions Between the Parties.** If any claim, dispute, or controversy of whatever nature arising out ofor relating to this Agreement, including, without limitation, any action orclaim based on tort, contract, or statute (including any claims of breach orviolation of 

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statutory or common lawprotections from discrimination, harassment and hostile working environment),or concerning the interpretation, effect, termination, validity, performanceand/or breach of this Agreement (***“Disputed Claim”***),arises between the parties and the parties cannot resolve the dispute withinthirty (30) days of a written request by either party to the other party, theparties agree to hold a meeting, attended by the an executive officer or theirequivalent of Company and Manufacturer, to attempt in good faith to negotiate aresolution of the dispute prior to pursuing other available remedies.  If, within sixty (60) days after such writtenrequest, the parties have not succeeded in negotiating a resolution of thedispute, such dispute shall be resolved by final and binding arbitration inaccordance with Section 11.2.

**11.2        Arbitration.**

**(a)          **Arbitration of Disputed Claims between the partiesunder this Section 11.2 shall be conducted in accordance the Rules of theInternational Chamber of Commerce, Court of Arbitration, Paris (the ***“ICC”***), except to the extent theprovisions of this Section 11.2 conflict with such Rules, in which case theprovisions of this Section 11.2 shall prevail.

**(b)          **The arbitration shall be conducted by three (3)arbitrators who shall be knowledgeable in the subject matter which is at issuein the dispute and have no current or past affiliation with either party ortheir respective Affiliates.  Each partyshall select one of the arbitrators within thirty (30) days after notice ofarbitration under this Section 11.2, and the third arbitrator, who shall act asthe Chair of the arbitration, shall be appointed by the ICC.

**(c)          **The arbitrators shall determine what discovery will bepermitted, consistent with the goal of limiting the cost and time that theparties must expend for discovery; provided that the arbitrators shall permitsuch discovery as the arbitrators deem necessary to permit an equitableresolution of the dispute.  Thearbitrators shall have sole discretion with regard to the admissibility of anyevidence.

**(d)          **No later than ninety (90) days after the arbitratorsare selected (or such other period of time as agreed to by the parties inwriting), the arbitrators will hold the arbitration hearing to resolve each ofthe issues identified by the parties. The arbitrators may conduct additional arbitration hearings if thearbitrators deem appropriate; provided that all arbitration hearings will becompleted by no later than one hundred twenty (120) days after the arbitratorsare selected (or such other period of time as agreed to by the parties inwriting).  Each party will have the rightto be represented by counsel at any such arbitration hearing.  The arbitration hearings shall be held inLondon, England.

**(e)          **The arbitration will be confidential and thearbitrators will issue appropriate protective orders to safeguard each party’sConfidential Information.  Except asrequired by law, no party will make (or instruct the arbitrators to make) anypublic announcement with respect to the proceedings or decision of thearbitrators without the prior written consent of the other party.  The existence of any Disputed Claim, and theaward of the arbitrators, will be kept in confidence by the parties and thearbitrators, except as required in connection with the enforcement of suchaward or as otherwise required by applicable law.

 

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**(f)           **The arbitrators shall, within thirty (30) days afterthe conclusion of the arbitration hearings, issue a written award and statementof decision describing the essential findings and conclusions on which theaward is based, including the calculation of any damages awarded.  The arbitrators shall be authorized to awardcompensatory damages, but shall NOT be authorized to (i) award non-economicdamages, such as for emotional distress, pain and suffering or loss of consortium,(ii) award punitive damages, or (iii) reform, modify or materially change thisAgreement or any other agreements contemplated hereunder; *provided*, *however*, that the damage limitationsdescribed in subsections (i) and (ii) of this sentence will not apply if suchdamages are statutorily imposed.  Thearbitrators also shall be authorized to grant any temporary, preliminary orpermanent equitable remedy or relief they deem just and equitable and withinthe scope of this Agreement, including, without limitation, an injunction ororder for specific performance. The decision of the arbitrators shall be finaland binding upon the parties.  Judgmenton the award rendered by the arbitrators may be entered in any court havingcompetent jurisdiction thereof.  Nothingherein shall limit or restrict a party’s ability to seek injunctive or otherequitable relief in the event of a breach or anticipated breach of Section 6.

**(g)          **Each party has the right before or during thearbitration to seek and obtain from the appropriate court provisional remedies,such as attachment, preliminary injunction or replevin, to avoid irreparableharm, maintain the status quo, or preserve the subject matter of thearbitration.  This Section 11.2 shall notapply to any dispute, controversy or claim that concerns (i) the validity orinfringement of a patent, trademark or copyright; or (ii) any antitrust,anti-monopoly or competition law or regulation, whether or not statutory.

**11.3        Costs and Awards.** Each party shall bear its own attorneys’ fees, costs, and disbursementsarising out of the arbitration, and shall pay an equal share of the fees andcosts of the arbitrators; *provided*,*however*, that thearbitrators shall be authorized to determine whether a party is the prevailingparty, and if so, to award to that prevailing party reimbursement for itsreasonable attorneys’ fees, costs and disbursements (including, for example,expert witness fees and expenses, photocopy charges, travel expenses, etc.),and/or the fees and costs of the arbitrator. Absent the filing of an application to correct or vacate the arbitrationaward under California Code of Civil Procedure Sections 1285 through 1288.8,each party shall fully perform and satisfy the arbitration award within fifteen(15) days of the service of the award.

**11.4        Waiver and Acknowledgment.** By agreeing to this binding arbitration provision, the partiesunderstand that they are waiving certain rights and protections which mayotherwise be available if a Disputed Claim between the parties were determinedby litigation in court, including, without limitation, the right to seek orobtain certain types of damages precluded by this provision, the right to ajury trial, certain rights of appeal, and a right to invoke formal rules ofprocedure and evidence.

**12.          Miscellaneous.**

**12.1       ****Exclusive Facility Utilization Fee.**    Company agrees to pay Manufacturer an exclusive utilization fee uponreceipt of invoice from Manufacturer  of[***] in lieu of its investments made during the construction of themanufacturing facility for the exclusive manufacture of the Product pursuant tothat certain Manufacturing Agreement dated April 28, 1999 and the CommercialSupply Agreement dated 7th October 2004 for the supply of

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ExenatideCartridges entered into between the parties. If Manufacturer uses saidmanufacturing facility for itself or for a third party, then Manufacturer willprovide a credit to Company of [***] per unit of such product. Such credit willbe applied to the first [***] units of product manufactured for theManufacturer or a third party.  Further,Manufacturer shall notify the Company prior to using said manufacturingfacility for purposes of manufacturing cartridges for transfer intoManufacturer’s inventory or for sale to a third party. On or about eachanniversary date of Manufacturer’s commencing use of the manufacturing facilityfor producing units for inventory or third party sales, Manufacturer shallprovide Company written notification of the total number of such units ofcartridges transferred into inventory or sold during the preceding year.  Company shall have the right to conduct anannual audit of all such cartridges transferred into inventory or sold to thirdparties.  Promptly following each suchaudit, Company shall invoice Manufacturer for all such cartridges transferredinto inventory or sold to a third party during the preceding year.  Payment shall be due on such invoices notlater than thirty (30) days following receipt thereof.

**12.2        No Implied Licenses.** No right or license is granted under this Agreement by either party tothe other, either expressly or by implication, except those specifically setforth herein.

**12.3        Non-Solicitation.**

**(a)          **Manufacturer shall not, during the Term, employ orengage or offer to employ or engage any person who during the [***] monthsprior to the commencement of such employment or engagement was employed byCompany.

**(b)          **Company shall not, during the Term, employ or engageor offer to employ or engage any person who during the [***] months prior tothe commencement of such employment or engagement was employed by Manufactureras a [***] (Grade [***] or higher) [***] employee or a [***] employee

**(c)          **Notwithstanding the foregoing, nothing in thisAgreement shall prohibit (i) the general advertisement of employment positionsby a party in any trade publication or other publication of generalcirculation, (ii) the employment of any current employee of Company byManufacturer if such person initiates contact with Manufacturer without anyprior solicitation by Manufacturer or on Manufacturer’s behalf, other than aspermitted in clause (i) hereof, or (iii) the employment of any current employeeof Manufacturer by Company if such person initiates contact with Companywithout any prior solicitation by Company or on Company’s behalf, other than aspermitted in clause (i) hereof.

**12.4        Independent Contractor Relationship.** Manufacturer’s relationship with Company will be that of an independentcontractor and nothing in this Agreement should be construed to create apartnership, joint venture, or employer-employee relationship.  Manufacturer is not an agent of Company andis not authorized to make any representation, contract, or commitment on behalfof the Company.  Manufacturer will besolely responsible for all tax returns and payments required to be filed withor made to any federal, state or local tax authority with respect toManufacturer’s performance of services and receipt of fees under thisAgreement.  Manufacturer agrees to acceptexclusive liability for complying with all applicable

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***CONFIDENTIALTREATMENT REQUESTED

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state and federallaws governing self-employed individuals, including obligations such as paymentof taxes, social security, disability and other contributions based on feespaid to Manufacturer, its agents or employees under this Agreement.  Manufacturer hereby agrees to indemnify anddefend Company against any and all such taxes or contributions, includingpenalties and interest.

**12.5        Entire Agreement; Amendment.** This Agreement, together with all exhibits attached hereto and herebyincorporated herein, constitutes the final, complete and exclusive agreement ofthe parties with respect to the subject matter hereof and supersedes andterminates all prior understandings and agreements relating to its subjectmatter, including, without limitation, that certain Manufacturing Agreementdated April 28, 1999 entered into between the parties.  This Agreement may not be changed, modified,amended or supplemented except by a written instrument signed by both parties.

**12.6        Severability.** If any provision of this Agreement should be held invalid orunenforceable, the remaining provisions shall be unaffected and shall remain infull force and effect, to the extent consistent with the intent of the partiesas evidenced by this Agreement as a whole.

**12.7        Assignment; Delegation.** This Agreement shall inure to the benefit of and be binding upon thesuccessors and assigns of the parties hereto; *provided*, *however*,that neither Company nor Manufacturer shall transfer or assign this Agreementwithout the prior written consent of the other party.  However, Company may assign this Agreementand its rights and obligations hereunder without such consent to aCollaboration Partner (as defined below) or in connection with the transfer orsale of all or substantially all of its assets relating to Pramlintide Acetateor in the event of Company’s merger or consolidation or change in control ofsimilar transaction.  Manufacturer maynot subcontract or otherwise delegate its obligations under this Agreementwithout Company’ prior written consent.

**12.8        Governing Law.** This Agreement shall be governed by the laws of the State of Delaware,excluding its conflict of laws principles.

**12.9        Headings.**  Sectionheadings are for convenience of reference only and shall not be considered inthe interpretation of this Agreement.

**12.10      Days.**  Unlessotherwise specified herein, references to a number of days shall referencecalendar days.

**12.11      Force Majeure.** Neither party to this Agreement shall be deemed to be in breach of thisAgreement or otherwise liable to the other party in any manner whatsoever forany failure or delay in performing its obligations under this Agreement due toForce Majeure (as defined herein).  If aparty’s performance of its obligations under this Agreement is affected byForce Majeure, then it shall give written notice to the other party, specifyingthe nature and extent of the Force Majeure, within seven (7) days of becomingaware of the Force Majeure and will at all times use all reasonable endeavorsto mitigate the severity of the Force Majeure. If the Force Majeure in question prevails for a continuous period inexcess of ninety (90) days after the date on which the Force Majeure begins,the party not in default is then entitled to give notice in

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writing to thedefaulting party to terminate this Agreement. The notice to terminate must specify the termination date, which mustnot be less than ten (10) days after the date on which the notice to terminateis given.  Once a notice to terminate hasbeen validly given, this Agreement will terminate on the termination date setout in the notice and neither party shall be liable for any claims, damages orpenalties for such failure or delay.  Forthe purposes herein, “***ForceMajeure***” means, in relation to either party, acts of God, actsof war or national emergency, riots, civil commotion, terrorism, fire,explosion, public utilities failure, or flood.

**12.12      Notices.**  Any noticesrequired or permitted hereunder shall be given to the appropriate party at theaddress specified below or at such other address as the party shall specify inwriting.

If to Company:                                                                 Amylin Pharmaceuticals, Inc.

9360 Towne Centre Drive

San Diego, CA 92121

Attn:  DirectorSupply Agreements & Purchasing

Fax:  (858) 824-7645

With a copy sentto the attention of General Counsel at the same address as above, Fax:  (858) 552-1936

If to Manufacturer:                                         Wockhardt UK (Holdings) Ltd.

Ash Road North

Wrexham Industrial Estate

Wrexham LL13 9UF

United Kingdom

Attn:  CompanySecretary

Fax:  0044 1978661676

All notices shall be deemed made upon receipt by theaddressee as evidenced by the applicable written receipt or, in the case of afacsimile, as evidenced by the confirmation of transmission, or, in the case ofan email, as evidenced by a reply email.

**12.13      Counterparts.** This Agreement may be executed in multiple counterparts, each of whichshall be deemed an original and all of which together shall constitute one andthe same instrument.

**12.14      Non-Waiver.**  No failure ordelay of one of the parties to insist upon strict performance of any of itsrights or powers under this Agreement shall operate as a waiver thereof, norshall any other single or partial exercise of such right or power preclude anyother further exercise of any rights or remedies provided by law.

**12.15      Export.**  Manufactureragrees not to export, directly or indirectly, any U.S. source technical dataacquired from Company or any products utilizing such data to countries outsidethe United States, which export may be in violation of the United States’export laws or regulations.

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**12.16      Product Liability Insurance.**Manufacturer will obtain productliability insurance to the extent Company so advises in writing.  Company will in turn reimburse Manufacturerfor such insurance premiums within thirty (30) days of the receipt of theinvoice for same.  Any product liabilityclaim beyond such amount will be solely on account of Company.

**12.17      Cooperation with Collaboration Partner.** Manufacturer acknowledges that Companymay enter into a collaborative arrangement with one or more companies (eachsuch company, a “***CollaborationPartner***”) for the sale and marketing of product(s) containingPramlintide Acetate, including Product. Manufacturer agrees to cooperate withany Collaboration Partner in all matters relating to supply for and regulatorycompliance of Product, and to permit Collaboration Partner access to allfacilities, records and information that Collaboration Partner may reasonablyrequest in connection therewith. Any such Collaboration Partner shall be deemeda beneficiary of this Agreement, shall have the right to cure any breach ofthis Agreement by Company, and with the consent of Company, which such consentshall not be unreasonably withheld, may institute legal action to enforce theterms of this Agreement.

**IN WITNESS WHEREOF,** the parties hereto have executed this Agreement on the Effective Date.
| **Amylin Pharmaceuticals, Inc.** | ** **                             | **WOCKHARDT UK  (HOLDINGS) ltd.** |
|----------------------------------|----------------------------------------|-----------------------------------|
|                             |                                   |
| By:                              | /s/ Daniel M.  Bradbury                |                              | By: | /s/ Sirjiwan Singh |   |
|                             |                                   |
| Printed Name:                    | Daniel M.  Bradbury                    |                              | Printed Name: | Sirjiwan Singh |   |
|                             |                                   |
| Title:                           | President and  Chief Operating Officer |                              | Title: | Managing Director |   |
|                                  |                                        |                                   |  |  |  |  |  |  |  |  |  |  |  |  |

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**EXHIBIT A**

**Pricing**
| Pramlintide Acetate low-dose  1.5 ml cartridge                | [***] per naked cartridge bulk packed in Correx  trays |
|---------------------------------------------------------------|--------------------------------------------------------|
|                                                          |                                                   |
| Pramlintide  Acetate demonstration (Placebo) 1.5 ml cartridge | [***] per naked cartridge bulk packed in Correx  trays |
|                                                          |                                                   |
| Pramlintide  Acetate high-dose 2.7 ml cartridge               | [***] per naked cartridge bulk packed in Correx  trays |

 

Above prices areapplicable to the following nominal batch yields which, subject to Section4.1(b) herein, shall be re-determined in accordance with an agreed TargetYield:
| Product         | Batch Quantity  (litres) | Batch Yield  (cartridges) |
|-----------------|--------------------------|---------------------------|
|            |                     |                      |
| 1.5ml cartridge | [***]                    | [***]                     |
|            |                     |                      |
| 2.7ml cartridge | [***]                    | [***]                     |

 

[***] areinclusive in the prices set forth above.

Any additionalservices, such as assistance with regulatory submissions, provision ofdocumentation copies, non-routine quality control testing and componentapproval, will be charged at a rate of [***] per man-hour.  These services and document copies are inaddition to those required to be supplied by the Manufacturer under thisAgreement.  All services and copies, andthe charges for them, must be agreed in advance by Company.

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A-1

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**EXHIBIT B**

**PurchaseSpecifications for Pramlintide Acetate Injection in Cartridges**

(See attachedspecifications for SYMLIN Injection 1.5mL and 2.7mL Cartridges and

SYMLIN Placebo inCartridges (PBO-F8))

 

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