**Exhibit 10.2**

 

***TextOmitted and Filed SeparatelyConfidential Treatment RequestedUnder 17 C.F.R. Section 200.80(b)(4)And 240.24b-2

 

**AMENDED AND RESTATED COMMERCIALSUPPLY AGREEMENT**

 

**THIS AMENDED AND RESTATED COMMERCIAL SUPPLYAGREEMENT** (the ***“Agreement”***)is entered into as of April 1, 2008 (the ***“EffectiveDate”***), by and between **AMYLIN PHARMACEUTICALS,INC.** (***“Company”***), having itsprincipal place of business located at 9360 Towne Centre Drive, San Diego, CA92121, U.S.A. and Wockhardt UK (Holdings) Ltd., formerly CPPharmaceuticals Ltd., (***“Manufacturer”***),having its registered office at Ash Road North, Wrexham Industrial Estate,Wrexham LL13 9UF, United Kingdom and as of the Effective Date hereof shallamend and replace in its entirety the Commercial Supply Agreement entered intobetween Company and Manufacturer as of October 7, 2004 (the “***Commercial Supply Agreement***”), asamended.

 

**RECITALS**

 

**WHEREAS,** Manufacturer is in thebusiness of manufacturing pharmaceutical products;

 

**WHEREAS,** Company is engaged in researchand development of, and intends to commercialize, pharmaceutical products;

 

**WHEREAS,** pursuant to theDevelopment Letter Agreement between the parties dated April 13, 2004 (the***“Letter Agreement”***), Manufacturerhas assisted Company in the development of a Manufacturing Process for theProduct (each as defined herein) and has supplied the Product to Company foruse in clinical investigations and registration batches to support regulatoryfilings; and

 

**WHEREAS,** Company wishes topurchase from Manufacturer, and Manufacturer is willing to supply to Company,the Product in commercial quantities for commercial sale on the terms andconditions set forth herein.

 

**NOW, THEREFORE,** in considerationof the foregoing and the mutual covenants and premises contained in thisAgreement, the parties hereto 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; provided, however that the CollaborationPartner shall not be an Affiliate of Amylin.

 

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**1.2****                               *“Applicable Laws***” shall mean all United States, Europeanand any other jurisdiction’s federal, state, local and other laws, statutes,rules, regulations, ordinances, (including any amendments thereto), applicableto the manufacture and shipment of Product, including, without limitation, theapplicable regulations and guidance of the FDA and all applicable EUcGMPs.  Extensions to the aforementioneddefined territories shall be the subject of side letters to this Agreementwhich may be jointly agreed in good faith from time to time between theParties.

 

**1.3****                               *“Approval Date”*** shall mean the date the FDA grants finalRegulatory Approval of a Drug Approval Application submitted by the Company forthe Product.

 

**1.4****                               *“Batch***” shall mean that quantity of units of Productproduced from a single homogeneous mix in a single cycle of manufacture.

 

**1.5****                               *“Batch Record***” shall mean Manufacturer’s documentedprocedures for compounding, filling and packaging Exenatide and/or inactiveexcipients into Product as agreed upon by the parties in writing in advance ofmanufacture of the applicable Batch.

 

**1.6****                               *“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.

 

**1.7****                               *“Certificate of Analysis”*** shall mean a signedcertificate, issued by the party providing a pharmaceutical compound orproduct, attesting to the nature and/or content, as applicable, of suchcompound or product.

 

**1.8****                               *“cGMP”*** shall mean current good manufacturing practicesas defined from time to time (a) in regulations promulgated under theFDCA; (b) the principles and guidelines specified in Chapter II ofEuropean 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.

 

**1.9****                               *“Collaboration Partner”*** shall mean Eli Lilly andCompany, with whom Company has entered into a collaboration arrangementregarding Exenatide, or its successor.

 

**1.10****                        *“Confidential Information”*** of a party shall mean alldata and information, tangible or intangible, whether in written, graphic,verbal or electronic form, disclosed by such party to the other party, itsemployees or representatives, or developed for or on behalf of such party bythe other party under this Agreement.

 

**1.11****                        *“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.

 

**1.12****                        *“Control”*** shall mean, with respect to certain rights,possessing ownership of or possessing the right to grant a license to suchrights.

 

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**1.13****                        *“Drug Approval Application”*** shall mean an applicationfor Regulatory Approval required before commercial sale or use of Product as adrug in a regulatory jurisdiction.

 

**1.14****                       **“***Exenatide or Exenatide Drug Substance***”shall mean a dry powder preparation containing Exenatide peptide as provided byCompany for further manufacture into Product by Manufacturer.

 

**1.15****                        *“Facilities”*** shall mean the manufacturing plant andoffices owned by Manufacturer and located at Ash Road North, Wrexham IndustrialEstate, Wrexham LL 13 9UF, United Kingdom and a storage and distributionfacility owned by Manufacturer and located at Unit B, Spectrum Business Park,Bridge Road South, Wrexham Industrial Estate, Wrexham LL13 9QA, United Kingdom.

 

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

 

**1.17****                        *“FDCA”*** shall mean the United States Federal Food Drugand Cosmetics Act, as amended and all regulations promulgated thereunder, orany successor laws and regulations thereto

 

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

 

**1.19****                        *“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).

 

**1.20****                        *“Manufacturing Process”*** shall mean the methods,techniques, processes and procedures developed under the Development Agreementor otherwise provided to Manufacturer by the Company or its CollaborationPartner with respect to Product.

 

**1.21****                       **“***Manufacturing Technology***” shall meanthe specific and confidential technology which has been developed byManufacturer for the siliconization of glass cartridges used in the productionof the Product as defined herein and is described further in related standardoperating procedures (“SOPs”).

 

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

 

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

 

**1.24****                        *“Product”*** shall mean the finished dosage form ofExenatide, for injection in cartridge presentation as described in Exhibit Bof this Agreement.

 

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

 

**1.26****                        *“Product Requirements”*** shall mean all of therequirements referenced in Section 8.3 of this Agreement.

 

**1.27****                        *“Quality Agreement”*** shall mean the (Technical) QualityAgreement among Amylin, Collaboration Partner and Manufacturer dated as of the October 7,2004, which is incorporated into this Agreement by reference and made a parthereof.

 

**1.28****                       **“****Recall Action****”shall have the meaning ascribed to it in ****Section 5.4**** hereof.

 

**1.29****                        *“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 Commissionor the Council of the European Union), regional, state or local regulatoryagency, department, bureau, commission, council or other governmental entity,necessary for the manufacture, distribution, use or sale of Product in aregulatory jurisdiction.

 

**1.30****                        *“Regulatory Authority”*** shall mean the FDA in the UnitedStates or the MHRA, EMEA or any other the applicable regulatory agency orentity having the responsibility, jurisdiction, and authority to approve themanufacture, use, importation, packaging, labeling, marketing, and sale ofProduct in any additional country, or any successor body to any of them.

 

**1.31****                        *“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,**as amended from time to time by written agreement of the parties pursuant to Section 4.3.

 

**1.32****                        *“Term”*** shall have the meaning provided in Section 9.1.

 

**2.****                                      Purchaseand Supply.**

 

**2.1****                               Purchaseand Supply Agreement.**  During theTerm, Company agrees to buy from Manufacturer, and Manufacturer agrees to sellto Company, such quantities of the Product as may be set forth on purchaseorders placed by Company in accordance with the provisions hereof.

 

**2.2****                               MinimumOrders.**  For the time frames setforth on the attached Exhibit C, Company agrees to purchase Product fromManufacturer in an amount equal to or greater than the minimum quantities setforth on Exhibit C.  Forclarification, purposes, cartridges purchased as process validation batches,including those for which purchase orders have been submitted prior to October 7,2004 by Company to Manufacturer, will count as part of the minimum quantityrequired in the Initial Period.  In theevent that during any Purchase Period (as defined in Exhibit C) theCompany’s actual purchases of the Product from Manufacturer are less than theminimum amount specified above for said Purchase Period, Company will pay toManufacturer

 

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the difference betweenthe amount invoiced to Company for its actual purchases during the PurchasePeriod and the amount that would have been invoiced had Company purchased theminimum amount agreed to for such Purchase Period; provided, however, (i) Companyshall not be obligated to make any such payments if the Agreement has beenterminated, (ii) the Company shall only be obligated to pay for Productsupplied to the Company pursuant to this Agreement.  In any given calendar quarter, Company shallorder [***]%, plus or minus [***]%, of the minimum quantity for the PurchasePeriod in which the calendar quarter occurs. Following the Fifth Period, Manufacturer may bid, in competition withCompany’s other manufactures of the Product, to provide a greater percentage ofCompany’s requirements of the Product. For purposes of this Section 2.2, a “purchase” shall mean thesubmission by Company of a firm purchase order.

 

 

For Product orders not timely shipped by Manufacturer,Company agrees to add the balance of the delayed Product to the next PurchasePeriod with the shipment schedule to be agreed upon by both parties in writing.

 

**2.3****                               Forecasts.**  Beginning within seven days of the ApprovalDate and at the commencement of every calendar [***] thereafter, Company shallfurnish Manufacturer with non-binding forecasts of Product requirements underthis Agreement for the ensuing [***] ([***]) calendar [***].

 

**2.4****                               PurchaseOrders.**  Company shall order theProduct by submitting written purchase orders, in Company’s standard form ineffect from time to time, to Manufacturer. Each purchase order shall specify the quantities of the Product orderedwhich shall be in batch quantities or multiples thereof, the cartridge size thereof,the desired shipment date for such Product, the pricing, and any specialshipping instructions.  Company shallsubmit each purchase order to Manufacturer at least [***] Business days inadvance of the desired shipment date specified in such purchase order.  No more than ten (10) Business daysfollowing receipt of each purchase order Manufacturer shall confirm in writingits acceptance of same and shall advise Company of its planned shipment dateand its 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.   Releasesamples representing the Manufacturing Process and meeting the requirements setforth in the Batch Record will be shipped within [***] Business Days after theactual Fill Date. No later than [***] ([***]) Business days following Company’ssubmission of a purchase order Manufacturer shall ship the Product which is thesubject of the purchase order, subject to Section 5.1, and shall supplycopies of the associated documentation as described in the Quality (Technical)Agreement, including the signed Certificate of Analysis and signed Certificateof Compliance for the Product.  Anypurchase orders for the Product submitted by Company to Manufacturer shallreference this Agreement and shall be governed exclusively by the termscontained herein except to the extent set forth in the following sentence.  The terms and conditions of this Agreementshall supersede any term or condition in any order, confirmation or otherdocument furnished by Company or Manufacturer that is inconsistent with theseterms and conditions, unless it is mutually agreed between the parties heretoin writing.  If purchase orders areissued less than

 

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[***] Business days inadvance of the desired shipment date, Manufacturer shall make commercially reasonableefforts to meet Company’s requirements, however Manufacturer’s failure to meetsuch requirements shall not be deemed to be a breach of this Agreement.  In the event a purchase order is issued lessthan [***] ([***]) Business days in advance of the desired shipment date,Manufacturer shall advise Company within ten (10) Business Days whethersuch purchase order can be fulfilled by the date requested in the purchaseorder and the parties shall agree upon a delivery date of the requestedProduct.

 

**3.****                                      Pricesand Payment.**

 

**3.1****                               Price.**  Company shall pay to Manufacturer theapplicable Product Price for all Product supplied to Company pursuant to thisAgreement. All shipment and delivery costs directly related to Product shipmentshall be invoiced directly to Company. For any additional services requested byCompany via a purchase order and provided by Manufacturer, such as testing orpackaging, Company shall pay the applicable price set forth on Exhibit Ahereto provided; however, Manufacturer shall provide Company a prior writtenestimate of the costs for such services. Company shall pay to Manufacturer the actual, out-of-pocket costs forany materials for which it has agreed herein to be responsible to pay.

 

**3.2****                               PurchasePrice Adjustment.**  Company and Manufactureragree to meet no less than twice per year (12 month period) to formally reviewcontinuous improvement activities and other improvements resulting fromexperience in operating the Manufacturing Process including potentialadjustments in Materials or Materials pricing. Company and Manufacturer shallwork together to obtain process improvements. Net savings or increases in the purchase costs of Materials obtained byManufacturer according to Section 4.1(a) shall result in reductionsor increases respectively in the Purchase Price. Net savings in labour costsresulting 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 increased labour costs or changes demandedby the Company shall result in increases in the Purchase Price. Net savings inthe product cost per unit achieved due to increases in the Target Yield ormanufacturing batch size shall result in corresponding reductions in thePurchase Price.  If the parties cannot ingood faith 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 the PurchasePrice by a percent which exceeds the lesser of (i) the percentage changein the [***] or (ii) [***] percent ([***]%) of the original PurchasePrice.  The increase or decrease will beapplicable on 1st May of every calendar year.

 

**3.3****                               Invoices.**  Upon acceptance by Manufacturer of a purchaseorder, Manufacturer shall invoice Company for [***] percent ([***]%) of theestimated aggregate Product Price for the purchase order (the “Reservation Fee”).  Upon completion of the manufacture of eachpurchase order and the submission of a Certificate of Analysis and Certificateof Compliance duly approved by Manufacturer to Company for the batches of Productmanufactured for such purchase order, Manufacturer shall invoice Company theProduct Price for the quantity of Product manufactured with a credit to Companyin the amount of the Reservation Fee.

 

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**3.4****                               Cancellation Fee.**  If,after issuing a Purchase Order to the Manufacturer for quantities which are inexcess of the minimum order quantities defined in Section 2.2 for thatPurchase Period and acceptance by the Manufacturer of such Purchase Order, butbefore Manufacturer starts work to manufacture for that Purchase Order, theCompany subsequently cancels or postpones its order, then Manufacturer shallhave the right but not the obligation to charge to Company [***] percent([***]%) of the product price (“Cancellation Fee”). If, after issuing aPurchase Order to the Manufacturer, the Company subsequently cancels orpostpones its order after the Manufacturer has started work to manufacture forthat Purchase Order, the Manufacturer shall be entitled to charge to Company[***] percent ([***]%) of the Product Price for that Purchase Order.

 

**3.5****                               Timefor payments shall be of the essence.**The Manufacturer reserves the right to charge the lesser of either [***]% or the highest percentage allowed underapplicable law, per month on any overdue amount until the date of payment infull save where part or whole payment is withheld by the Company on a specificinvoice as a result of a genuine dispute over that invoice or part thereof.

 

**3.6****                               Methodof Payment; Currency.**  All paymentsdue hereunder to Manufacturer shall be paid to Manufacturer in [***] not laterthan [***] ([***]) days following the receipt of the applicable invoice, unlesssuch shipment of Product is rejected in accordance with the provisions of Section 5.3.  Company shall make payment by telegraphictransfer to the account number [***] at HSBC, 17-19 Regent Street, Wrexham NorthWales, UK. LL11 1RY or to such other account of Manufacturer designated inwriting to Company.  All currency amountsreferenced in this Agreement are to [***].

 

**3.7****                               Effectof Certain Events.**  In the event oftermination or expiration of this Agreement, Manufacturer shall providereasonable assistance to Company to implement the transfer of manufacturingresponsibility for the Product to Company or its designee.  Such reasonable assistance shall includetransfer of the Manufacturing Process as described in Section 7.7.  In the event of termination of this Agreementby Company pursuant to Section 9.2(a) or (b) or 9.3(c), suchreasonable assistance will be provided at Manufacturer’s expense. In the eventof any other termination of this Agreement pursuant to Section 9.3(b) or****Section 9.4, within [***] days Company shall pay toManufacturer a sum of [***] ([***]) and payment of such amount shall be a fulland final settlement of all obligations of Company pursuant to thisAgreement.  In the event of any othertermination or expiration of this Agreement, Company shall pay Manufacturer’sreasonable and documented costs of providing such assistance.  In the event of termination or expiration ofthis Agreement, Manufacturer will promptly return to Company all unusedExenatide provided to Manufacturer pursuant to Section 4.1 hereof andMaterials paid for by Company as directed by and at the expense of Company.

 

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**4.****                                      Manufacturing.**

 

**4.1****                               Materials.**

 

**(a)****                                 **Exceptas stated in Section 4.1(b), Manufacturer will obtain any Materialsrequired for the manufacture of the Product, and shall use commerciallyreasonable efforts to obtain the best price for such materials, in reasonablequantities consistent with Company’s most recent forecast for the Product.Company shall pay the actual, out-of-pocket cost of the Materials plus the costof related quality control testing subject to Sections 3.3 and 3.6.  Manufacturer shall store the Materials at nocost to the Company.  All Materials obtainedby 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 components,excipients and other materials required to manufacture the Batch are releasedfor use, in accordance with Manufacturer’s Quality System and requirementsstated in the then current Quality Agreement, prior to the manufacturing of theBatch. Company shall reimburse the Manufacturer all the costs of all thecomponents in stock or on order on behalf of the Company by the Manufacturer,including QC testing costs and disposal costs, if such materials becomeredundant at any time if: (i) Company or its Collaboration Partner makes agood faith determination not to continue with the commercialization of Product,(ii) Company terminates this Agreement according to Section 9.4, (iii) suchmaterials expire due to insufficient demand for Product, or (iv) suchmaterials become obsolete due to a change of specification advised by theCompany; provided, however, Manufacturer shall usecommercially reasonable efforts to either utilize such materials in other areasof its business or to return the materials, and Company shall not reimburseManufacturer for any such utilized or returned materials.  The orders will be placed keeping in view thefuture forecasts and delivery lead times. Manufacturer will maintain a safetystock level of at least [***] ([***]) calendar [***] and ([***]) calendar[***], but no more than [***] ([***]) calendar [***] of approvedmaterials.  For clarification purposes,safety stock includes materials needed to fulfill forecasts issued by Companypursuant to Section 2.3. Manufacturer and Company will review safety stock levels on a quarterlybasis and will mutually agree to make appropriate changes.

 

**(b)****                                 **Companyshall supply to Manufacturer, free of charge, freight and duties prepaid andwith transportation insurance paid by Company, quantities of Exenatide sufficientto enable Manufacturer to manufacture the quantities of the Product ordered byCompany.  Exenatide will be sampledaccording to the Quality Agreement and held by Manufacturer under appropriatestorage conditions until such time as it is required for manufacture ofProduct.  Manufacturer and Company agreethat in the case of Product manufactured prior to satisfactory completion ofthe first [***] commercial full scale batches (including process validationbatches) of each of the presentations of Product, Manufacturer shall makecommercially reasonable efforts to maximize yields but shall not be held liablefor losses of Exenatide occurring as part of the manufacturing process unlessotherwise agreed to by the parties. Company and Manufacturer agree to meet no less than twice per year (12month period) to review losses of Exenatide occurring as part of themanufacturing process and to negotiate financial responsibility.  For clarity, “satisfactory completion” of abatch will not include a batch with aberrant results.  The Target Yield shall be defined as [***]percent ([***]%) of the Batch 

 

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Yield as set forth on Exhibit A.  All shipments of Exenatide will beaccompanied by a Certificate of Analysis indicating the peptide content of suchExenatide and such other information as Amylin may specify and is to arriveapproximately [***] days in advance of planned Product manufacture to allow fortesting.  Within [***] ([***]) businessdays of receipt of any Exenatide hereunder, Manufacturer will verify thequantity and identity of such shipment of Exenatide according to test methodsapproved and provided by Company and shall inspect the Exenatide in accordancewith Manufacturer’s incoming material inspection procedures.  If Manufacturer detects any discrepancies inthe Exenatide in quantity or in the identity based on the identity testingperformed, Manufacturer shall inform Company immediately upon, but no laterthan [***] ([***]) business days after, having detected suchdiscrepancies.  Manufacturer shall alsoinform Company of any obvious damage to the Exenatide or container receivedwithin [***] ([***]) business days of Manufacturer’s receipt thereof.  Any rejected Exenatide shall be returned atCompany’s expense and direction.  Companyshall make all final determinations if material is suitable for use in Productmanufacturing.

 

**4.2****                              **Manufactureof Product.  Manufacturer willmanufacture and store Product at the Facilities in accordance with the QualityAgreement, the Specifications, applicable Regulatory Approvals, cGMPs and otherApplicable Laws, as then in effect. Manufacturer shall not rework any Batch of the Product without Company’prior written consent, which consent shall not be unreasonably withheld.  Manufacturer shall allow an employee of eachof Company and Collaboration Partner (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 agreed in writing between the Parties prior to shipment of ExenatideInjection to the Company. The Manufacturer shall test a portion of each Batchmanufactured for the Company prior to delivering such Batch to the Company, andshall provide a certificate of analysis (i) confirming that theManufacturer followed the agreed methods for the testing of such ExenatideInjection, (ii) containing the quality control and quality assurance testresults for such Batch and (iii) confirming that such Batch has beenmanufactured in accordance with the Batch records and cGMP. The Manufacturershall notify the Company immediately of any test failures noted in themanufacture of Exenatide Injection.

 

**4.3****                              **Changein Specifications or Manufacturing Process.

 

**(a)****                                 **Each party shallnotify the other in advance of any proposed changes in Specifications, releasetesting, stability testing, packaging, materials, equipment, facilities,processes or procedures used 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.

 

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**(b)****                                 **In the event Company requests any such changes bemade, other than changes described in Section 4.3(d), Manufacturer shallaccommodate Company’s requested changes to the extent technologicallyfeasible.   If such changes wouldresult in material change in the cost of manufacture, then in that event theproduct price may be suitably modified. If such changes require the purchase of capital equipment, such costsand any related installation and qualification costs will be to the account ofthe Company and such capital equipment shall be owned by the Company.

 

**(c)****                                 **In the event Manufacturer requests any suchchanges be made, other than changes described in Section 4.3(d), and suchchanges would result in a material increase in Manufacturer’s cost ofmanufacture, all costs reasonably required in connection with such changesshall be paid as mutually agreed by the parties.

 

**(d)****                                 **In the event changes are requested by aRegulatory Authority or required to bring either of the Facilities intocompliance with Applicable Laws, or additional changes, activities, ormanufacturing is required to bring the manufacturing process into compliancewith Applicable Laws, Specifications or other Product Requirements,Manufacturer shall accommodate such changes to the extent technologicallyfeasible, and all costs reasonably required in connection with such changes,activities, or manufacturing shall be borne by the Manufacturer.   In such an event the product pricemay be suitably revised to accommodate such changes

 

**4.4****                              **RegulatoryMatters.

 

**(a)****                                 **Manufacturershall provide to Company and Collaboration Partner such documentation, data andother information relating to the Facilities,Products, or Manufacturer’s manufacturing processes and procedures for Productas Company or Collaboration Partner may request for submission to RegulatoryAuthorities.

 

**(b)****                                 **Companyand Collaboration Partner shall be responsible for all filings necessary forRegulatory Approvals.  The parties agreethat Company shall be the sole and exclusive owner of all right, title andinterest in and to all Drug Approval Applications and Regulatory Approvalsrelated to the Product in the United States and the Collaboration Partner shallbe the sole and exclusive owner of all right, title and interest in and to allDrug Approval Applications and Regulatory Approvals related to the Product inany OUS Country. Manufacturer shall assist Company and Collaboration Partner inthe preparation of all documents necessary to effectuate Company’s andCollaboration Partners 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 reasonableefforts to assist Company and Collaboration Partner in obtaining suchRegulatory Approvals.  For the avoidanceof doubt, Company and Collaboration Partner have sole responsibility for thecontent of all Drug Approval Applications.

 

**4.5****                              **Compliancewith Quality Agreement and Applicable Laws. The parties shall comply with the terms and conditions of the QualityAgreement.  Manufacturer shall complywith all Applicable 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.

 

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**4.6****                              **ManufacturerFacilities.  Manufacturer warrants andrepresents that it has, and will maintain, all licenses, permits and approvalsnecessary to fulfill its obligations under this Agreement.  Manufacturer covenants to design and operatethe facilities it uses to manufacture, package, test, or store Product tosuccessfully pass inspections conducted by regulatory authorities. Manufactureragrees to maintain appropriate securitymeasures at its facilities no less stringent than measures that are customaryin the pharmaceutical industry.

 

**4.7****                              **QAAudits. Upon written notice of no less than [***] ([***]) Business Days forroutine audits to Manufacturer, Company and Collaboration Partner shall havethe right 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 and itsCollaboration Partner access to the Facility, documentation, and personnel toaudit and for observation of the production process and quality control testingof the Exenatide Injection, disposal of waste and adherence to cGMPrequirements and this Agreement. During such inspections, employees of theCompany and its Collaboration Partner (number of persons should be restrictedto not more than [***] ([***]))shall have the right to audit any aspect of the Manufacturers manufacture ofExenatide Injection, and such audit may include, without limitation,verification of Manufacturers maintenance of drug establishment registrationswith the FDA and other applicable Regulatory Authorities, and review ofconditions and documentation of any aspect of manufacture of ExenatideInjection.

 

**4.8****                              **RegulatoryInspections. Manufacturer agrees to permit the FDA and other RegulatoryAuthorities to inspect any aspect of Manufacturer’s manufacture and testing ofthe Product including, without limitations, any pre-approval inspection (“PAI”).Manufacturer shall cooperate with Company and Collaboration Partner, and withany Regulatory Authority, as necessary to facilitate prompt approvals by suchRegulatory Authority of the Manufacturing Process or testing process for theProduct, including preparation and submission of necessary data relating to themanufacturing 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 as Manufacturer becomes aware of the inspection,but not later than two (2) Business Days from the time Manufacturerbecomes aware of the inspection.  Inconnection with any such inspection, including without limitation a PAI,Manufacturer shall allow employees or representatives of each of Company andCollaboration Partner to be present during the 

 

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inspection.  Manufacturer shall allow Company andCollaboration Partner to participate in the formulation of any response toregulatory inspections or any other issues raised by any Regulatory Authorityrelated to the Product.  Manufacturerwill also simultaneously provide Company with photocopies of any responsesprovided to any Regulatory Authority, including, without limitation, responsesto any FDA 483 or similar reports. Manufacturer shall keep Company andCollaboration Partner fully informed as to any Manufacturer communication withany Regulatory Authority related to Product.

 

**4.9****                              **Investigationof Failed Batch.  Manufacturer shallinvestigate, and cooperate fully with Company and Collaboration Partner ininvestigating any Batch that fails to meet the Product Requirements or thatincurs 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 and Collaboration Partner with a final written reportdescribing the cause of the failure or deviation and summarizing the results ofthe 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 ApplicableLaws.  The sample size shall be twice thesize necessary to 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 and, if directed by Company, to Collaboration Partner.  After such time period, Manufacturer shallnotify Company prior to destroying such records and samples and, at Company’srequest and expense, shall provide copies of such records and any remainingsamples to Company.  The Manufacturershall not be obliged to retain any samples thereafter and after due intimationto the company, the Manufacturer shall destroy the remaining samples.

 

**4.11****                       **Complaintsand Adverse Reaction.  Each party shallpromptly advise the other of any complaints, adverse reaction reports, safetyissues or toxicity issues relating to Product of which it becomes aware, whichmay be the result of, or have an effect on, the manufacturing or packagingoperations performed by Manufacturer. Company or Collaboration Partner shall be responsible for all reportingof such information to Regulatory Authorities.

 

**4.12****                       **Labeling;Trademark.  Manufacturer shall affix labelingto the Product as and if directed by Company. Nothing in this Agreement gives Manufacturer the right to use anytrademark or trade name of Company or Collaboration Partner except as specifiedin writing by Company or Collaboration Partner. 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 inwriting, all shipments shall be shipped FCA (Incoterms 2000) the Facilities by air freight to thedestination specified by 

 

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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 andship the 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 purchase orders,subject to the provisions of Section 2.3. If Company is not ready to accept shipment of Product on the dateManufacturer is prepared to ship Product, then Manufacturer shall store Productin a manner consistent with customary practices for pharmaceutical products andCompany shall pay Manufacturer a commercially reasonable storage fee.  Company and Manufacturer agree to negotiatethe amount of such storage fee in good faith.

 

**5.2****                              **Title.  Title to all Exenatide shall at all timesremain in Company.  Title to allMaterials other than Exenatide, work in progress to produce Product, and allcompleted Product (except Exenatide contained therein) shall remain withManufacturer until delivery of such Product to the carrier designated byCompany.  Notwithstanding the foregoing,and regardless of whether delivery of Product to Company has occurred under Section 5.1,Manufacturer shall bear all risk of loss with respect to, and shall insure, allProduct until transfer by Manufacturer to a carrier for shipment as directed byCompany in the applicable purchase order.

 

**5.3****                              **Acceptanceand Rejection.

 

**(a)****                                 **Concurrentwith the delivery of any Batch, Manufacturer shall provide Company with alldocumentation required to be provided to Company under the Quality Agreement,including, without limitation, a Certificate of Analysis and Certificate ofCompliance for such Batch.  Company mayreject delivery of any Batch that does not conform with the ProductRequirements.  Any such notice ofrejection shall be in writing and shall indicate the reasons for suchrejection.

 

**(b)****                                 **Inorder to reject delivery of a Batch, Company must give written notice toManufacturer of Company’ rejection of any delivery within [***] ([***]) daysafter receipt of such delivery.  If nosuch notice of rejection is received, Company shall be deemed to have acceptedsuch delivery of the Batch [***] ([***]) days after delivery of the Batch,except in the case of Hidden Defects.  IfCompany discovers in a Batch a Hidden Defect, such as a Contaminant, at anytime after acceptance of such Batch, Company shall notify Manufacturer within[***] ([***]) days of discovering such Hidden Defect and shall have the rightto reject the Batch under the procedures regarding rejection set forth in Section 5.3(c),(d) and (e), as applicable.

 

**(c)****                                 **Afternotice of rejection is given, Company shall cooperate with Manufacturer indetermining whether rejection is necessary or justified.  Manufacturer shall notify Company as promptlyas reasonably possible (and in any event within [***] ([***]) days after noticeof rejection from Company) if Manufacturer does not agree that such rejectionis 

 

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justified.  If no such notice from Manufacturer isreceived, Manufacturer shall be deemed to agree that such rejection is justified.  Should Company reject any Batch andManufacturer agree that such rejection is justified or if applicable, a thirdparty determines such rejection is justified pursuant to the provisions of Section 5.3(d),Manufacturer shall reimburse Company for Company’s cost for (i) anyExenatide used in such rejected Batch, at the rates set forth in and subject tothe maximum liability stated in Section 10.3; and (ii) amounts paidto Manufacturer by Company pursuant to Section 3.3.  Compliance with the provisions of this Section 5.3(c) andpayment of the costs in Section 5.3(d) and (e) shall beManufacturer’s sole liability to Company where Company rejects a Batch of andeither Manufacturer agrees, or a third party determines under Section 5.3(d),that such rejection is justified, subject only to Section 10.4.

 

**(d)****                                 **IfManufacturer in good faith disagrees with Company’s determination thatrejection of a Batch is justified, certain of the Product in such Batch shallbe submitted to a mutually acceptable third party laboratory or expert. Suchthird party shall determine whether such Product meets the Specifications, andthe parties agree that such third party’s determination shall be final anddeterminative. The party against whom the third party tester/expert rules shallbear all costs of the third party testing and/or determination.  Whether or not Manufacturer accepts Company’sbasis for 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 the other warranties in Section 8,Company shall purchase that Batch at the agreed-upon price, irrespective ofwhether Manufacturer has already replaced it. All replacement Product shall beinvoiced as well and Company shall pay for such Product as otherwise providedunder the terms of this Agreement.  Ifthird party tester/expert agrees that rejection was justified then Manufacturershall reimburse Company for (i) Company’s cost for any Exenatide used insuch rejected Batch, at the rates set forth in and subject to the maximumliability stated in Section 10.3 and (ii) amounts paid by Companypursuant to Section 3.3. Compliance with provisions of this Section 5.3(d) andpayment of the costs in Section 5.3(e) shall be Manufacturer’s soleonly liability to Company where Company rejects a Batch of and eitherManufacturer agrees, or a third party determines under Section 5.3(d),that such rejection 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)****                                 **Companymay not destroy any Batch until [***] ([***]) days after rejection unless,prior to that date, Company receives written notification from Manufacturerthat Manufacturer does not agree that such rejection is justified or thatManufacturer requests return of such rejected Batch.  Company shall destroy such rejected Batchpromptly at Manufacturer’s cost and provide Manufacturer with certification ofsuch destruction.  Company shall, uponreceipt of Manufacturer’s request for return, promptly return such Batch toManufacturer, 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 or its Collaboration Partner to be due in part to afailure of the Manufacturer to 

 

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comply with its warranties stated in Section 8.3of this Agreement then Company or, in the case of a Recall Action in an OUSCounty, Collaboration Partner,  willnotify Manufacturer promptly of the details regarding such Recall Action,including providing copies of all relevant documentation concerning such RecallAction. Manufacturer will assist Company and its Collaboration Partner ininvestigating any such Recall Action, if Company or its Collaboration Partnerso requests, and all regulatory contacts that are made and all activitiesconcerning such Recall Action will be initiated and coordinated by Company or,in the case of a Recall Action in an OUS Country, Collaboration Partner withManufacturer’s involvement and assistance, as reasonably requested by Companyor its Collaboration Partner.

 

(b)                                 Ifany Recall Action occurs which is considered by the Company or itsCollaboration Partner to be due in part to a failure of the Manufacturer tocomply with its warranties stated in Section 8.3 of this Agreement andManufacturer agrees with said consideration then Manufacturer shall, to theextent and only to the extent of its relative responsibility, bear the cost andexpense of any such Recall Action. Therefore, if both Manufacturer and Companycontribute to the cause of such a Recall Action, the cost and expense thereofwill be shared in proportion to each party’s contribution to the problem.

 

**(c)**                                  If any Recall Action occurs which isconsidered by the Company or its Collaboration Partner to be due in part to afailure of the Manufacturer to comply with its warranties stated in Section 8.3of this Agreement and Manufacturer disagrees with said consideration then theparties shall refer to a mutually acceptable third party expert. Such thirdparty shall determine if Manufacturer has complied with its warranties statedin Section 8.3. If such a determination is made Manufacturer shall have noliability towards the cost and expense of the Recall Action. If the third partydetermines Manufacturer has not complied with its warranties stated in Section 8.3Manufacturer shall, to the extent and only to the extent of its relativeresponsibility, bear the cost and expense of any such Recall Action.

 

**6.****                                     **Protectionof Confidential Information.

 

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

 

**(a)****                                 **Touse such Confidential Information only for the purposes set forth in thisAgreement;

 

**(b)****                                 **Toreceive, maintain and hold the Confidential Information in confidence;

 

**(c)****                                 **Notto disclose, or authorize or permit the disclosure of, any ConfidentialInformation to any third party without the prior written consent of theDisclosing Party; and

 

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**(d)****                                 **Exceptas needed to fulfill its obligations hereunder, to return any ConfidentialInformation to the Disclosing Party at the request of the Disclosing Party andto retain no copies or reproductions thereof.

 

**6.2****                              **Limitations.  The Receiving Party shall not be obligated totreat as Confidential Information information that the Receiving Party can showby competent written evidence:

 

**(a)****                                 **wasalready known to the Receiving Party without any obligations of confidentialityprior to receipt from the Disclosing Party;

 

**(b)****                                 **wasgenerally available to the public or otherwise part of the public domain at thetime of its disclosure to the Receiving Party;

 

**(c)****                                 **becamegenerally available to the public or otherwise part of the public domain afterits disclosure, other than through any act or omission of the Receiving Partyin breach of any obligation of confidentiality;

 

**(d)****                                 **wasdisclosed to the Receiving Party, other than under an obligation ofconfidentiality, by a third party who had no obligation not to disclose suchinformation to others; or

 

**(e)****                                 **wasindependently discovered or developed by the Receiving Party without the use ofthe Disclosing Party’s Confidential Information.

 

**6.3****                              **AuthorizedDisclosure.  Notwithstanding Section 6.1,the Receiving Party may disclose Confidential Information, without violatingthe obligations of this Agreement, to the extent the disclosure is required byApplicable Laws or a valid order of a court or other governmental body having jurisdiction;provided that the Receiving Party gives reasonable prior written notice to theDisclosing Party of such required disclosure and makes a reasonable effort toobtain, or to assist the Disclosing Party in obtaining, a protective orderpreventing or limiting the disclosure and/or requiring that the ConfidentialInformation so disclosed be used only for the purposes for which the law orregulation requires, or for which the order was issued.  Further, the Receiving Party may discloseConfidential Information of the Disclosing Party solely to the extent (a) suchdisclosure is reasonably necessary in advising investors and the investmentcommunity of the results of the research, development or commercializationactivities hereunder (subject to the prior written consent of the DisclosingParty, which consent will not be unreasonably withheld), or (b) suchdisclosure is made to Affiliates, employees, consultants or agents (or, withrespect to Company, to Collaboration Partner), to other third parties in connectionwith due diligence by such Third Parties, or to potential third party investorsin confidential financing documents, provided, in each case, that any suchAffiliate, employee, consultant, agent or third party is subject toconfidentiality and non-use obligations with respect to such information.

 

**6.4****                              **Useof Name/Publicity.  Neither party shalluse the other party’s name, nor shall Manufacturer use Collaboration Partner’sname, in connection with any publication or promotion without the other party’swritten consent, or, as applicable to Manufacturer, Collaboration Partner’swritten consent, except as required by federal, state or local laws, rules andregulations.  Manufacturer shall notdisclose the specific content or terms of this Agreement without the priorwritten consent of Company.

 

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**6.5****                              **CollaborationPartner.  For purposes of this Agreement,Confidential Information shall include all information confidential and/orproprietary to Collaboration Partner that is provided to Manufacturer underthis Agreement and Manufacturer agrees to comply with the confidentialityobligations under this Section 6 with respect to all of such informationof Collaboration Partner supplied hereunder.

 

**7.****                                     **IntellectualProperty Rights.

 

**7.1****                               CompanyInventions.**  All right, title andinterest in and to any intellectual property rights in Exenatide and Productshall at all times be and remain the sole and exclusive property ofCompany.  Company shall solely own, andshall alone have the right to apply for patents, patent rights and inventor’scertificates, on any invention, method, process, discovery or know-how (whetheror not patentable) which is conceived solely by Company, its consultants oragents (other than Manufacturer) in the performance of this Agreement (***“Company Inventions”***).

 

**7.2****                               ManufacturerInventions.**  Manufacturer shallsolely own, and shall alone have the right to apply for patents, patent rightsand inventor’s certificates, on any invention, method, process, discovery orknow-how (whether or not patentable) which is conceived solely by Manufacturer,its consultants or agents in the performance of this Agreement ***(“Manufacturer Inventions”***).

 

**7.3****                               JointInventions.**  Any invention, method,process, discovery or know-how (whether or not patentable) not conceived solelyby either Company and Manufacturer or their respective consultants or agentsduring the performance of this Agreement (***“Joint Inventions”***)shall be jointly owned by Company and Manufacturer.  The law of joint ownership of patents of theUnited States shall apply to joint ownership of any Joint Inventions inside andoutside of the United States.  Whereappropriate, the Parties may engage outside counsel agreeable to both Parties(the costs of which shall be borne equally by the Parties) to represent themjointly in the prosecution of patent applications and the maintenance ofpatents with respect to Joint Inventions.

 

**7.4****                               Prosecution.**  Should either party not wish to file,prosecute, maintain or issue a patent application or maintain a patent coveringsuch party’s interest in a Joint 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, fully paid-up royalty-free license under the Granting Party’sinterest in the Joint Invention, with the right to grant sublicenses, todevelop, make, have made, use, import, offer to sell, have sold and sellproducts, and (ii) any necessary authority to file, prosecute, maintainand issue such a patent application or maintain such a patent, all at theexpense of the party requesting that such filing be made or action be taken.

 

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**7.5****                               Assistance.**  Upon request, Company and Manufacturer shalleach provide the other with reasonable assistance in obtaining patents and, ifnecessary, enforcing patent rights in Manufacturer Inventions, CompanyInventions or Joint Inventions, as applicable. To that end, each party agrees to assist the other in executing,verifying and delivering such documents and performing such acts as may bereasonably requested by the other party in applying for, obtaining, perfecting,evidencing, sustaining or enforcing the other party’s rights in ManufacturerInventions, Company Inventions or Joint Inventions, as applicable.  The party requesting such assistance shallreimburse the assisting party for all reasonable out-of-pocket expensesincurred and provide reasonable compensation for time spent in providing suchassistance, except in the case of any patent covered by a Joint Invention, inwhich case no compensation shall be provided and all expenses shall be [***] bythe Parties (*i.e.*, [***]% paid by Company and[***]% paid by Manufacturer).

 

**7.6****                               Infringement.**  Each party shall promptly notify the other ofany potential alleged or threatened infringement of patents claiming anyCompany Invention, Manufacturer Invention or Joint Invention, or of anyallegation by a third party of which it becomes aware that the activity ofCompany or Manufacturer pursuant to this Agreement infringes a third party’spatent rights.

 

**7.7****                               ManufacturingProcess License.**  Manufacturer herebygrants Company a perpetual, irrevocable, exclusive, worldwide, royalty-free,fully paid-up license, with the right to sublicense, to all of Manufacturer’srights in and to the Manufacturing Process, including any ManufacturerInventions, to use, make, have made, import, offer to sell, have sold and sellProduct or any other product containing Exenatide; provided however, if Companyor any sublicensee of Company or any successor business or assignee wishesManufacturer to assist in the transfer of the Manufacturing Process to anothermanufacturer, Manufacturer shall have the right to charge a commerciallyreasonable fee based on FTE rates for providing training and other assistancerequested by such party 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 compensation to be paid to the Manufacturer.

 

**8.****                                      Representationsand Warranties.**

 

**8.1****                               NoInconsistent Obligations.**  Each partyrepresents and warrants that the terms of the Agreement are not inconsistentwith its other contractual arrangements or obligations.

 

**8.2****                               DueAuthorization.**  Each party representsand warrants that (a) it has full power and authority to enter into thisAgreement, (b) this Agreement has been duly authorized by it, and (c) thisAgreement is binding upon it.

 

**8.3****                               ProductWarranties.**  Manufacturer representsand warrants that Product delivered hereunder will:

 

**(a)****                                 **bemanufactured by Manufacturer in accordance with cGMPs and relevant RegulatoryApprovals;

 

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**(b)****                                 **conformto the Specifications at the time of delivery;

 

**(c)****                                 **notcontain any Contaminant or be adulterated within the meaning of the FDCA or anyother Applicable Law in which the definitions of adulteration are substantiallythe same as those contained in the FDCA, as such laws are constituted andeffective at the time of delivery;

 

**(d)****                                 **notbe an article which may not, under the provisions of Sections 404, 505 of512 of the FDCA, be introduced into interstate commerce; and

 

**(e)****                                 **befree 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 in Section 5.3(d) above.

 

**8.4****                              **TheCompany represents, warrants and agrees that:

 

a)                                      Themanufacture of Product as contemplated herein, will not, to the Company’sknowledge, infringe any existing patents or any other proprietary rights ofthird parties, and as of the date hereof Company has not received any notice ofany claimed infringement (including without limitation patent infringement) inconnection with the Product.

 

b)                                     TheCompany, to the Company’s knowledge, and its employees have never been debarredor convicted of a crime for which a person can be debarred, under subsection (a) or(b) of 21 U.S.C. § 335a, as amended, and Company agrees that it does notnow and does not intend in the future to use in any capacity the services ofany person debarred under subsection (a) or (b) of 21 U.S.C. §335a,as amended.  If, during the term of thisAgreement, Company or any other person performing under this Agreement becomesdebarred or disqualified, or receives notice of an action or threat of anaction with respect to debarment or disqualification, Company shall promptlynotify Manufacturer.

 

**8.5****                               NoDebarred or Disqualified Persons.** Manufacturer represents and warrants thatit 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 tosimilar investigation or disqualification pursuant to any other relevantregulatory authority.  In addition,Manufacturer represents and warrants that it has not engaged in any conduct oractivity which could lead to any of the above-mentioned disqualification ordebarment actions.  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.

 

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**8.6****                               Disclaimer.**  Except as set forth above, NEITHER PARTYMAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGMENT,MERCHANTIBILITY, AND FITNESS FOR A PARTICULAR PURPOSE.

 

**8.7****                               Limitationof Liability.**  NEITHER PARTY SHALL BEENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIALOR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTEDHEREUNDER.  This Section 8.7 shallnot be construed to limit either party’s indemnification obligations under Section 10or to limit remedies available for breach of confidentiality and non-useobligations or for infringement or misappropriation of intellectual propertyrights.

 

**9.****                                      Termand Termination.**

 

**9.1****                               Term.**  The term of this Agreement shall commence onthe October 7, 2004 and, unless terminated earlier as provided herein,shall continue until the expiration of the Fifth Period (as defined in Exhibit C),subject to renewal by mutual written agreement of the parties (the ***“Term”***).

 

**9.2****                               Terminationby Either Party.**  A party mayterminate this Agreement:

 

**(a)****                                 **formaterial breach of this Agreement by the other party upon sixty (60) days’ writtennotice specifying the nature of the breach, if such breach has not been curedwithin such sixty (60) day period; provided, this Agreement may be terminatedimmediately if the breach is incapable of remedy or has not been corrected bythe breaching party within sixty (60) days after written notice; or

 

**(b)****                                 **immediately uponwritten notice to the other party, if the other party makes a general assignment for the benefit of creditors, files aninsolvency petition in bankruptcy, petitions for or acquiesces in theappointment of any receiver, trustee or similar officer to liquidate orconserve its business or any substantial part of its assets, commences underthe laws of any jurisdiction any proceeding involving its insolvency,bankruptcy, reorganization (other than a reorganization without insolvency),dissolution, liquidation or any other similar proceeding for the release offinancially distressed debtors or becomes a party to any proceeding or actionof the type described above and such proceeding or action remains undismissedor unstayed for a period of more than sixty (60) days.

 

**9.3****                               Terminationby Company.** Company may terminate this Agreement

 

**(a)****                                 **atany time after the expiration of the Fifth Period upon one (1) year’sprior written notice to Manufacturer;

 

(b)                                 atany time prior to the Approval Date in theevent that Company makes a good faith determination that it will not continuewith the commercialization of Product, upon at least sixty (60) daysprior written notice to Manufacturer, and such termination shall be effectiveat the end of such sixty (60) day period; provided that Company shall remainobligated to pay for Product ordered under any purchase orders issued byCompany to Manufacturer prior to such effective termination date

 

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(c)                                  immediatelyupon written notice to Manufacturer if Manufacturer (i)  has itsmanufacturing authorizations for the Product suspended or withheld (ii) inthe case 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 that it hasterminated development of Exenatide following the receipt by Company of noticeof final rejection by the FDA for marketing authorization for commercial saleand distribution of Product in the United States, then this Agreement shallautomatically terminate.

 

**9.5****                               SurvivalUpon Termination.**  Expiration ortermination of this Agreement will not relieve the parties of any obligationaccruing prior to such expiration or termination.  Sections 1, 4.8, 4.9, 4.10, 4.11, 6, 7,8.3, 8.5, 8.6, 8.7, 9.5, 9.6, 10, 11 and 12 will survive termination of thisAgreement.

 

**9.6****                               Remedies.**  In the event of any breach of any provisionof this Agreement, in addition to the termination rights set forth herein, eachparty shall have all other rights and remedies at law or equity to enforce thisAgreement.

 

**10.****                               Indemnification.**

 

**10.1****                        ByCompany.**  Company agrees toindemnify, defend and hold harmless Manufacturer and its Affiliates and theirrespective officers, employees and agents (***“Manufacturer Indemnitees”***)from any loss, expense (including reasonable legal counsel fees and expenses),cost, liability or damages (***“Losses”***)incurred by any Manufacturer Indemnitee as 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 under Section 10.2or the Losses are based on the negligence or willful misconduct of anyManufacturer Indemnitee.  ManufacturerIndemnitees shall promptly and in any event within thirty (30) days notifyCompany 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 no ManufacturerIndemnitee shall be required to admit fault or responsibility in connectionwith any settlement.  ManufacturerIndemnitee shall have the right to select and to obtain representation byseparate legal counsel at its own expense.

 

**10.2****                        By Manufacturer.**  Manufacturer shall indemnify and holdharmless Company and Collaboration Partner and their respective Affiliates andtheir respective officers, employees and agents (***“CompanyIndemnitees”***) from and against any and all Losses to which 

 

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any Company Indemniteemay become subject as 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 Exenatide or Product byor on behalf of Manufacturer prior to delivery of Product by Manufacturer toCompany, except to the extent Company is obligated to indemnify Manufacturerwith respect to such Losses under Section 10.1 or the Losses are based onthe negligence or willful misconduct of any Company Indemnitee.  Company Indemnitee shall promptly and in anyevent within thirty (30) days notify Manufacturer of any known Claim which isthe subject of Losses.  CompanyIndemnitees shall fully cooperate with Manufacturer in the defense orsettlement of any claim of Losses under this Section 10.2; provided,however, that no Company Indemnitee shall be required to admit fault orresponsibility in connection with any settlement.  Company Indemnitee shall have the right toselect and to obtain representation by separate legal counsel at Company’s ownexpense.

 

**10.3****                        Loss ofExenatide.**  If any Exenatide 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 ($[***]) per gram ofExenatide limited to a maximum of [***] US dollars ($[***]) for each individualincidence of loss prior to validation of the increase in batch size (the “BatchSize Increase”) and at a rate of [***] US dollars ($[***]) per gram ofExenatide limited to a maximum of [***] US dollars ($[***]) for each individualincidence of loss after the Batch Size Increase.  For the avoidance of doubt Manufacturer shallnot be liable for loss of Exenatide if peptide content has deteriorated andManufacturer has complied fully with the storage requirements for Exenatide asspecified by Company.

 

**10.4****                        Restrictionon Limitation of Liability.**  Nothingin this Agreement shall limit a party’s liability in respect of death orpersonal injury caused by the negligence of that party or its liability inrespect of fraudulent misrepresentation.

 

**11.****                               DisputeResolution**

 

**11.1****                        DiscussionsBetween the Parties.**  If any claim,dispute, or controversy of whatever nature arising out of or relating to thisAgreement, including, without limitation, any action or claim based on tort,contract, or statute (including any claims of breach or violation of statutoryor common law protections from discrimination, harassment and hostile workingenvironment), or concerning the interpretation, effect, termination, validity,performance and/or breach of this Agreement (***“DisputedClaim”***), arises between the parties and the parties cannotresolve the dispute within thirty (30) days of a written request by eitherparty to the other party, the parties agree to hold a meeting, attended by thean executive officer or their equivalent of Company and Manufacturer, toattempt in good faith to negotiate a resolution of the dispute prior topursuing other available remedies.  If,within sixty (60) days after such written request, the parties have notsucceeded in negotiating a resolution of the dispute, such dispute shall beresolved by final and binding arbitration in accordance with Section 11.2.

 

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**11.2****                        Arbitration.**

 

**(a)****                                 **Arbitrationof Disputed Claims between the parties under this Section 11.2 shall beconducted in accordance the Rules of the International Chamber ofCommerce, Court of Arbitration, Paris (the ***“ICC”***),except to the extent the provisions of this Section 11.2 conflict withsuch Rules, in which case the provisions of this Section 11.2 shallprevail. .

 

**(b)****                                 **Thearbitration shall be conducted by three (3) arbitrators who shall beknowledgeable in the subject matter which is at issue in the dispute has nocurrent or past affiliation with either party or their respectiveAffiliates.  Each party shall select oneof the arbitrators within thirty (30) days after notice of arbitration underthis Section 11.2, and the third arbitrator, who shall act as the Chair ofthe arbitration, shall be appointed by the ICC.

 

**(c)****                                 **Thearbitrators shall determine what discovery will be permitted, consistent withthe goal of limiting the cost and time that the parties must expend fordiscovery; provided that the arbitrators shall permit such discovery as thearbitrators deem necessary to permit an equitable resolution of thedispute.  The arbitrators shall have solediscretion with regard to the admissibility of any evidence.

 

**(d)****                                 **Nolater than ninety (90) days after the arbitrators are selected (or such otherperiod of time as agreed to by the parties in writing), the arbitrators willhold the arbitration hearing to resolve each of the issues identified by theparties.  The arbitrators may conductadditional arbitration hearings if the arbitrators deem appropriate; providedthat all arbitration hearings will be completed by no later than one hundredtwenty (120) days after the arbitrators are selected (or such other period oftime as agreed to by the parties in writing). Each party will have the right to be represented by counsel at any sucharbitration hearing.  The arbitrationhearings shall be held in London, England. Collaboration Partner and its counsel shall have the right to be presentat all arbitration hearings and review all documents related to or produced aspart of the arbitration.

 

**(e)****                                 **Thearbitration will be confidential and the arbitrators will issue appropriateprotective orders to safeguard each party’s Confidential Information and, tothe extent necessary, Collaboration Partner’s Confidential Information.  Except as required by law, no party will make(or instruct the arbitrators to make) any public announcement with respect tothe proceedings or decision of the arbitrators without the prior writtenconsent of the other party.  Theexistence of any Disputed Claim, and the award of the arbitrators, will be keptin confidence by the parties and the arbitrators, except as required inconnection with the enforcement of such award or as otherwise required byapplicable law.

 

**(f)****                                   **Thearbitrators shall, within thirty (30) days after the conclusion of thearbitration hearings, issue a written award and statement of decisiondescribing the essential findings and conclusions on which the award is based,including the calculation of any damages awarded.  The arbitrators shall be authorized to awardcompensatory damages, but shall NOT be authorized to (i) awardnon-economic damages, such as for emotional distress, pain and suffering orloss of consortium, (ii) award punitive damages, or (iii) reform,modify or materially change this Agreement or any other agreements contemplatedhereunder; provided, however, that the damage limitations described insubsections (i) and (ii) of this sentence will not apply if such damagesare statutorily imposed.  The arbitratorsalso shall be authorized to grant any temporary, 

 

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preliminary or permanentequitable remedy or relief they deem just and equitable and within the scope ofthis Agreement, including, without limitation, an injunction or order forspecific performance.  The decision ofthe arbitrators shall be final and binding upon the parties.  Judgment on the award rendered by thearbitrators may be entered in any court having competent jurisdictionthereof.  Nothing herein shall limit orrestrict a party’s ability to seek injunctive or other equitable relief in theevent of a breach or anticipated breach of Section 6.

 

**(g)****                                **Eachparty has the right before or during the arbitration to seek and obtain fromthe appropriate court provisional remedies, such as attachment, preliminaryinjunction or replevin, to avoid irreparable harm, maintain the status quo, orpreserve the subject matter of the arbitration. This Section 11.2 shall not apply to any dispute, controversy orclaim that concerns (i) the validity or infringement of a patent,trademark or copyright; or (ii) any antitrust, anti-monopoly orcompetition law or regulation, whether or not statutory.

 

**11.3****                        Costs andAwards.**  Each party shall bear itsown attorneys’ fees, costs, and disbursements arising out of the arbitration,and shall pay an equal share of the fees and costs of the arbitrators;provided, however, that the arbitrators shall be authorized to determinewhether a party is the prevailing party, and if so, to award to that prevailingparty reimbursement for its reasonable 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 tocorrect or vacate the arbitration award under California Code of CivilProcedure Sections 1285 through 1288.8, each party shall fully perform andsatisfy the arbitration award within fifteen (15) days of the service of theaward.

 

**11.4****                        Waiver andAcknowledgment.**  By agreeing to thisbinding arbitration provision, the parties understand that they are waivingcertain rights and protections which may otherwise be available if a DisputedClaim between the parties were determined by litigation in court, including,without limitation, the right to seek or obtain certain types of damagesprecluded by this provision, the right to a jury trial, certain rights ofappeal, and a right to invoke formal rules of procedure and evidence.

 

**12.****                               Miscellaneous.**

 

**12.1****                        No ImpliedLicenses.**  No right or license isgranted under this Agreement by either party to the other, either expressly orby implication, except those specifically set forth herein.

 

**12.2****                        Non-Solicitation**

 

**(a)****                                 **Manufacturershall not, during the Term, employ or engage or offer to employ or engage anyperson who during the [***] ([***]) months prior to the commencement of suchemployment or engagement was employed by Company or Collaboration Partner.

 

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* Confidential TreatmentRequest(ed)

 

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**(b)****                                 **Companyshall not, during the Term, employ or engage or offer to employ or engage anyperson who during the [***] ([***]) months prior to the commencement of suchemployment or engagement was employed by Manufacturer as a [***],[***] (Grade[***] or higher) [***] or a [***]employee

 

**(c)****                                 **Notwithstandingthe foregoing, nothing in this Agreement shall prohibit (i) the generaladvertisement of employment positions by a party in any trade publication orother publication of general circulation, (ii) the employment of anycurrent employee of Company by Manufacturer if such person initiates contactwith Manufacturer without any prior solicitation by Manufacturer or onManufacturer’s behalf, other than as permitted in clause (i) hereof, or (iii) theemployment of any current employee of Manufacturer by Company if such personinitiates contact with Company without any prior solicitation by Company or onCompany’s behalf, other than as permitted in clause (i) hereof.

 

**12.3****                        IndependentContractor 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 state and federal lawsgoverning self-employed individuals, including obligations such as payment oftaxes, social security, disability and other contributions based on fees paidto 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.

 

**12.4****                        EntireAgreement; Amendment.**  ThisAgreement, together with all exhibits attached hereto and hereby incorporatedherein, constitutes the final, complete and exclusive agreement of the partieswith respect to the subject matter hereof and supersedes all priorunderstandings and agreements relating to its subject matter.  This Agreement may not be changed, modified,amended or supplemented except by a written instrument signed by both parties.

 

**12.5****                        Severability.**  If any provision of this Agreement should beheld invalid or unenforceable, the remaining provisions shall be unaffected andshall remain in full force and effect, to the extent consistent with the intentof the parties as evidenced by this Agreement as a whole.

 

**12.6****                        Assignment;Delegation.**  This Agreement shallinure to the benefit of and be binding upon the successors and assigns of theparties hereto; provided, however, that neither Company nor Manufacturer shalltransfer or assign this Agreement without the prior written consent of theother party.  However, Company may assignthis Agreement and its rights and obligations hereunder without such consent toCollaboration Partner or in connection with the transfer or sale of all orsubstantially all of its assets relating to Exenatide or in the event ofCompany’s merger or consolidation or change in control of similartransaction.  Manufacturer may notsubcontract or otherwise delegate its obligations under this Agreement withoutCompany’ prior written consent.

 

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* Confidential TreatmentRequest(ed)

 

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**12.7****                        GoverningLaw.**  This Agreement shall begoverned by the laws of the State of Delaware, excluding its conflict of lawsprinciples.

 

**12.8****                        Headings.**  Section headings are for convenience of referenceonly and shall not be considered in the interpretation of this Agreement.

 

**12.9****                        Days.**  Unless otherwise specified herein, referencesto a number of days shall reference calendar days.

 

**12.10****                 Force Majeure.**  Neither party to this Agreement shall bedeemed to be in breach of this Agreement or otherwise liable to the other partyin any manner whatsoever for any failure or delay in performing its obligationsunder this Agreement due to Force Majeure (as defined herein).  If a party’s performance of its obligationsunder this Agreement is affected by Force Majeure, then it shall give writtennotice to the other party, specifying the nature and extent of the ForceMajeure, within seven (7) days of becoming aware of the Force Majeure andwill at all times use all reasonable endeavors to mitigate the severity of theForce Majeure.  If the Force Majeure inquestion prevails for a continuous period in excess of ninety (90) days afterthe date on which the Force Majeure begins, the party not in default is thenentitled to give notice in writing to the defaulting party to terminate thisAgreement.  The notice to terminate mustspecify the termination date, which must not be less than ten (10) daysafter the date on which the notice to terminate is given.  Once a notice to terminate has been validlygiven, this Agreement will terminate on the termination date set out in thenotice and neither party shall be liable for any claims, damages or penaltiesfor such failure or delay.  For thepurposes herein, “Force Majeure” means, in relation to either party, acts ofGod, acts of war or national emergency, riots, civil commotion, terrorism,fire, explosion, public utilities failure, or flood.

 

**12.11****                 Notices.**  Any notices required or permitted hereundershall be given to the appropriate party at the address specified below or atsuch other address as the party shall specify in writing.

 
| If to Company: |   | Amylin Pharmaceuticals, Inc.                                                          |
|----------------|--------|--------------------------------------------------------------------------------------------|
|           |   | 9360 Towne Centre Drive                                                                    |
|           |   | San Diego, CA 92121                                                                        |
|           |   | Attn: Director, Supply Agreements                                                          |
|           |   | Fax: (858) 552-2212                                                                        |
|           |   |                                                                                       |
|           |   | With a copy sent to the attention of General Counsel  at the same address and fax as above |

 

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| If to Manufacturer: |   | Wockhardt UK (Holdings) Ltd.   |
|---------------------|--------|--------------------------------|
|                |   | Ash Road North                 |
|                |   | Wrexham Industrial Estate      |
|                |   | Wrexham LL13 9UF               |
|                |   | United Kingdom                 |
|                |   | Attn:  Company  Secretary |
|                |   | Fax:  0044  1978 661676   |

 

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.

 

**12.12****                 Counterparts.**  This Agreement may be executed in multiplecounterparts, each of which shall be deemed an original and all of whichtogether shall constitute one and the same instrument.

 

**12.13****                 Non-Waiver.**  No failure or delay of one of the parties toinsist upon strict performance of any of its rights or powers under thisAgreement shall operate as a waiver thereof, nor shall any other single orpartial exercise of such right or power preclude any other further exercise ofany rights or remedies provided by law.

 

**12.14****                 Export.**  Manufacturer agrees not to export, directlyor indirectly, any U.S. source technical data acquired from Company or anyproducts utilizing such data to countries outside the United States, whichexport may be in violation of the United States’ export laws or regulations.

 

**12.15****                 Product LiabilityInsurance.**Manufacturer will take out product liability insurance to theextent Company so advises in writing. Company will in turn reimburse Manufacturer for such insurance premiumswithin 30 days of the receipt of the invoice for same.  Any product liability claim beyond suchamount will be solely on account of Company.

 

**12.16****                 Cooperation withCollaboration Partner.** Manufacturer acknowledges that Amylin’sCollaboration Partner will make all sales of Product outside the U.S. and willserve as the regulatory lead in all jurisdictions outside the United States.Manufacturer agrees to cooperate with Collaboration Partner in all mattersrelating to supply for and regulatory compliance in jurisdictions outside theU.S., and to permit Collaboration Partner access to all facilities, records andinformation that Collaboration Partner may reasonably request in connectiontherewith.  Lilly shall be deemed abeneficiary of this Agreement, shall have the right to cure any breach of thisAgreement by Amylin, and with the consent of Amylin, which such consent shallnot be unreasonably withheld, may institute legal action to enforce the termsof this Agreement.

 

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**IN WITNESS WHEREOF,** the partieshereto have executed this **AMENDED AND RESTATEDCOMMERCIAL SUPPLY AGREEMENT** as of the Effective Date.

 
| **AMYLIN PHARMACEUTICALS, INC.** | **WOCKHARDT UK (HOLDINGS) LTD.**        |
|----------------------------------|-----------------------------------------|
|                             |                                    |
| By:                              |   /s/ Paul  Marshall          |   | By: |   /s/  Sirjiwan Singh |
|                             |                                    |   |   |
| Printed Name:                    |   Paul  Marshall              |   | Printed Name: |   /s/  Sirjiwan Singh |
|                             |                                    |   |   |
| Title:                           |   Vice  President, Operations |   | Title: |   Managing  Director |
|                                  |                                         |  |  |  |  |  |  |  |

 

[SIGNATURE PAGE TOAMENDED AND RESTATED SUPPLY AGREEMENT]

 

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**EXHIBIT A**

 

**Pricing**

 
| Exenatide low-dose 1.2  ml cartridge  |   | [***] per naked  cartridge bulk packed in Correx trays |
|---------------------------------------|--------|--------------------------------------------------------|
|                                  |   |                                                   |
| Exenatide (Demo) 1.2 ml  cartridge    |   | [***] per naked  cartridge bulk packed in Correx trays |
|                                  |   |                                                   |
| Exenatide high-dose 2.4  ml cartridge |   | [***] per naked  cartridge bulk packed in Correx trays |
|                                  |   |                                                   |
| Exenatide 3 ml  cartridge             |   | [***] per naked  cartridge bulk packed in Correx trays |

 
| **Cartridge Size** | ** ** | **Batch Yield** |
|-------------------------|------------|----------------------|
| 1.2mL                   |       | [***]                |
| 2.4mL                   |       | [***]                |

 

Materials, in-processanalytical and microbiological testing, finished product sterility/endotoxintesting and packaging are inclusive in the prices set forth above.

 

Any additional services,such as assistance with regulatory submissions, provision of documentationcopies, non-routine quality control testing and component approval, will becharged at a rate of [***] per man-hour. These services and document copies are in addition to those required tobe supplied by the Manufacturer under this Agreement.  All services and copies, and the charges forthem, must be agreed in advance by Amylin.

 

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* Confidential TreatmentRequest(ed)

 

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**EXHIBIT B**

 

**Title:****                 ****Specification for ExenatideInjection in Cartridges**

 

CorporateSpecification for Exenatide Injection in Cartridges (AC2993-F8)

 

Description:                               [***] mg/mL peptide, [***]% (w/v) [***], [***]% (w/v) [***] in [***] mM[***] in 1.2, 2.4, or 3.0 mL cartridges with [***] and [***].

 
| **ATTRIBUTE**                           | ** ** | **ALERT LIMIT(1)**   | ** ** | **SPECIFICATION**                                                                        | ** ** | **METHOD(2)**     |
|-----------------------------------------|------------|---------------------------|------------|------------------------------------------------------------------------------------------|------------|-------------------|
| [***]                                   |       | [***]                     |       | [***]                                                                                    |       | [***](3) or [***] |
| [***]                                   |       | [***] to [***]            |       | [***] to [***]                                                                           |       | [***]             |
| [***]                                   |       | [***]                     |       | NMT [***] counts/container  NLT [***]μmNMT [***] counts/container NLT [***] μm |       | [***]             |
| [***]                                   |       | [***]                     |       | [***] to [***]/kg                                                                        |       | [***]             |
| [***]                                   |       | [***]                     |       | [***] ± [***] Da                                                                    |       | [***]             |
| [***]                                   |       | [***]                     |       | [***]                                                                                    |       |              |
| [***]                                   |       | [***]                     |       | [***]% to [***]%                                                                         |       | [***]             |
| [***]                                   |       | [***]% to [***]%[***]     |       | [***]% to [***]% of [***]                                                                |       |              |
| [***]                                   |       | NLT [***]% [***]          |       | NLT [***]%                                                                               |       |              |
| Total [***]                             |       | NMT[***]% [***]           |       | NMT [***]%                                                                               |       | ** **        |
| Individual [***][***]AC2993 [***]AC2993 |       | [***]NMT[***]% NMT [***]% |       | NMT [***]%  NMT [***]%                                                                   |       | [***]             |
| [***]                                   |       | [***]                     |       | [***]% to [***]% [***]                                                                   |       | [***]             |
| [***]                                   |       | [***]                     |       | LT [***] EU/mL                                                                           |       | [***](3) or [***] |
| [***]                                   |       | [***]                     |       | [***]                                                                                    |       | [***](3) or [***] |
| [***]                                   |       | NMT [***]                 |       | [***]                                                                                    |       | [***](3) or [***] |
| [***]                                   |       | NMT [***]                 |       | [***]                                                                                    |       | [***](3) or [***] |
| [***]                                   |       | NLT [***]                 |       | [***]                                                                                    |       | [***] or [***]    |

 

LT = less thanNLT = not less thanNMT = not more than

 

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(1) [***] represent [***], [***] or [***].  [***] or [***].

(2) [***] are used for [***] and [***], except [***] A, B, C and D areused for [***] or [***], and may be used in [***].

(3) [***] are, for [***],[***] or [***]; for [***],[***] or [***]; for[***],[***] or [***]; and for [***], [***] or [***].

 

* Confidential Treatment Request(ed)

 

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**EXHIBIT B, CONT.**

 

**Title:****                 ****Specification for ExenatideInjection in Cartridges**

 

U.S.Regulatory Specification Exenatide Injection in Cartridges (AC2993-F8)

Description:                               [***] mg/mL peptide, [***]% (w/v) [***],[***]% (w/v) [***] in [***] mM [***] in 1.2, 2.4, or 3.0 mL cartridges with[***] and [***].

 
| **ATTRIBUTE** | ** ** | **SPECIFICATION**                                                                         | ** ** | **METHOD(1)**      |
|---------------|------------|-------------------------------------------------------------------------------------------|------------|--------------------|
| [***]         |       | [***],  [***], and [***]                                                                  |       | [***](2)  or [***] |
| [***]         |       | [***]  to [***]                                                                           |       | [***]              |
| [***]         |       | NMT  [***] counts/container NLT [***]μm  NMT [***] counts/container NLT [***]μm |       | [***]              |
| [***]         |       | [***]  to [***]                                                                           |       | [***]              |
| [***]         |       | [***]                                                                                     |       | [***]              |
| [***]         |       | [***]                                                                                     |       |               |
| [***]         |       | [***]%  to [***]%                                                                         | ** ** | [***]              |
| [***]         |       | [***]%  to [***]% of [***]                                                                | ** ** |               |
| [***]         |       | NLT  [***]%                                                                               |       |               |
| [***]         |       | NMT  [***]%                                                                               | ** ** | [***]              |
| [***]         |       |                                                                                      | ** ** |               |
| [***]         |       | NMT  [***]%                                                                               | ** ** |               |
| [***]         |       | NMT  [***]%                                                                               |       |               |
| [***]         |       | [***]%  to [***]% of [***]                                                                |       | [***]              |
| [***]         |       | [***]                                                                                     |       | [***](2)  or [***] |
| [***]         |       | [***]                                                                                     |       | [***](2)  or [***] |

 

LT=less thanNLT = not less thanNMT = not more than

 

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(1)[***] are used for [***], except [***] are used for [***], and may be used in[***].

(2)[***] are, for [***], [***] or [***]; for [***], [***] or [***]; and for [***],[***] or [***].

 

*Confidentiality treatment request(ed).

 

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**EXHIBIT B, CONT.**

 

**Title:****                 ****Specification for PlaceboExenatide Injection in Cartridges**

 

CorporateSpecification for PBO-F12

 

Description:                               [***] containing [***]% (w/v) [***], [***]% (w/v) [***] in [***] mM[***], in 1.2, 2.4, or 3.0 mL cartridges

 
| **ATTRIBUTE** | ** ** | **ALERT LIMIT** | ** ** | **SPECIFICATION**                                                        | ** ** | **METHOD**        |
|---------------|------------|----------------------|------------|--------------------------------------------------------------------------|------------|-------------------|
| [***]         |       | [***]                |       | [***]                                                                    |       | [***] or [***](a) |
| [***]         |       | [***]                |       | [***]                                                                    |       | [***] or [***](a) |
| [***]         |       | [***] to [***]       |       | [***] to [***]                                                           |       | [***](a)          |
| [***]         |       | [***]                |       | [***]% to [***]%                                                         |       | [***](a)          |
| [***]         |       | [***]                |       | [***]                                                                    |       | [***](a)          |
| [***]         |       | [***]                |       | [***] counts/container [***]μm  [***] counts/container [***]μm |       | [***](a)          |
| [***]         |       | [***]                |       | [***] to [***]                                                           |       | [***](a)          |
| [***]         |       | [***]                |       | [***]                                                                    |       | [***] or [***](a) |
| [***]         |       | [***]                |       | [***]                                                                    |       | [***] or [***](a) |
| [***]         |       | [***]                |       | [***]                                                                    |       | [***]             |
| [***]         |       | [***]                |       | [***]                                                                    |       | [***]             |
| [***]         |       | [***]                |       | [***]                                                                    |       | [***]             |

 

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(a) [***] used at [***];[***] may be used during [***].

 

* Confidential treatmentrequest(ed).

 

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**EXHIBIT B, CONT.**

 

**Title:****                 ****Specification for PlaceboExenatide Injection in Cartridges**

 

RegulatorySpecification for PBO-F12

 

Description:                               [***] containing [***]% (w/v) [***], [***]%(w/v) [***] in [***] mM [***], in 1.2, 2.4, or 3.0 mL cartridges

** **
| **ATTRIBUTE** | ** ** | **SPECIFICATION**                                                         | ** ** | **METHOD**         |
|---------------|------------|---------------------------------------------------------------------------|------------|--------------------|
| [***]         |       | [***]                                                                     |       | [***]  or [***](a) |
| [***]         |       | [***]                                                                     |       | [***]  or [***](a) |
| [***]         |       | [***]  to [***]                                                           |       | [***](a)           |
| [***]         |       | [***]%  to [***]%                                                         |       | [***](a)           |
| [***]         |       | [***]                                                                     |       | [***](a)           |
| [***]         |       | [***]  counts/container [***]μm  [***] counts/container [***]μm |       | [***](a)           |
| [***]         |       | [***]  to [***]                                                           |       | [***](a)           |
| [***]         |       | [***]                                                                     |       | [***]              |
| [***]         |       | [***]                                                                     |       | [***]              |
| [***]         |       | [***]                                                                     |       | [***]              |

 

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(a) [***] used at [***];[***] may be used during [***].

* Confidential treatmentrequest(ed).

 

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** **

**EXHIBIT C**

 

**MINIMUM ORDERS**

** **

| **Purchase  Period** | ** ** | **Date Range** | ** ** | **Minimum  Quantity** |
|----------------------|------------|---------------------|------------|-----------------------|
|                 |       |                |       |                  |
| Initial Period       |       | 4-28-05 to 4-27-06  |       | [***]                 |
|                 |       |                |       |                  |
| 2nd Period           |       | 4-28-06 to 4-27-07  |       | [***]                 |
|                 |       |                |       |                  |
| 3rd Period           |       | 4-28-07 to 4-27-08  |       | [***]                 |
|                 |       |                |       |                  |
| 4th Period           |       | 4-28-08 to 4-27-09  |       | [***]                 |
|                 |       |                |       |                  |
| 5th Period           |       | 4-28-09 to 4-27-10  |       | [***]                 |

 

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* Confidential treatmentrequest(ed).

 

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