COMMERCIAL SUPPLY AGREEMENT

Exhibit 10.40

***Text Omitted and Filed Separately
with the Securities and Exchange Commission
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2.

C O N F I D E N T I A L

COMMERCIAL SUPPLY AGREEMENT

THIS SUPPLY AGREEMENT (the “Agreement” ) is entered into as of October 12, 2006 (the “Effective Date” ), by and between AMYLIN PHARMACEUTICALS, INC. ( “Company” ), having its principal place of business located at 9360 Towne Centre Drive, Suite 110, San Diego, CA 92121, U.S.A., and Wockhardt UK (Holdings) Ltd. ( “Manufacturer” ), having its registered office at Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, United Kingdom.

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WHEREAS, Manufacturer is in the business of manufacturing pharmaceutical products;

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

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

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

NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and premises contained in this Agreement, the parties hereto agree as follows:

1.             Definitions.

1.1          “Affiliate ” shall mean an entity that, directly or indirectly, controls, is controlled by or is under common control with a party, where “control” means the possession, direct or indirect, or the power to direct 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 ownership interest of an entity, by contract or otherwise.

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

1.3          “Batch ” shall mean that quantity of units of Product produced from a single homogeneous mix in a single cycle of manufacture.

1.4          “Batch Record ” shall mean Manufacturer’s documented procedures for compounding, filling, testing, labeling, and packaging Pramlintide Acetate Drug Substance and/or inactive excipients into Product as agreed upon by the parties in writing in advance of manufacture of the applicable Batch.

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

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

1.7          “cGMP” shall mean current good manufacturing practices as defined from time to time (a) in regulations promulgated under the FDCA; (b) the principles and guidelines specified in Chapter II of European Commission Directive 91/356/EEC, including “the rules governing medicinal products” in the European Union Volume 4; and (c) laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture equivalent to those in (a) and (b) above.

1.8          “Confidential Information” of a party shall mean all data and information, tangible or intangible, whether in written, graphic, verbal or electronic form, disclosed by such party to the other party, its employees or representatives, or developed for or on behalf of such party by the other party under this Agreement.

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

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

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

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

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

1.13        “FDA” shall mean United States Food and Drug Administration or any successor agency.

1.14        “FDCA” shall mean the United States Federal Food Drug and Cosmetics Act, as amended, and all regulations promulgated thereunder, or any successor laws and regulations thereto

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

1.16        “Hidden Defect” shall mean a defect that causes Product to fail to conform to the Specifications or to the warranties provided by Manufacturer hereunder, which defect is not discoverable upon reasonable physical inspection and testing performed pursuant to Section 5.3 but is discovered at a later time ( e.g. , in the course or as a result of long-term stability studies).

1.17        “Launch Date” shall mean the date of the first commercial sale of Product manufactured using Manufacturer Technology under this Agreement, in a country after approval by appropriate regulatory authorities for market and sale in such country.

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

1.19        “Manufacturer’s Technology” shall mean the specific and confidential technology which has been developed by Manufacturer for the siliconisation of glass cartridges used in the production of the Product as defined herein and is described further in related standard operating procedures (“SOPs”) .

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

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

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

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

1.24        “Product Price” shall mean the price for Product set forth in Exhibit A .

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

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

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

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

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

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

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

2.             Purchase and Supply.

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

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

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cartridges. For the time frame beginning on the date the Second Period ends and ending on the one year anniversary thereof (the “Third Period” ), Company agrees to purchase Product from Manufacturer in an amount equal to or greater than [***] cartridges. For the time frame beginning on the date the Third Period ends and ending on the one year anniversary thereof (the “Fourth Period” ), Company agrees to purchase Product from Manufacturer in an amount equal to or greater than [***] cartridges. For the time frame beginning on the date the Fourth Period ends and ending on the one year anniversary thereof (the “Fifth Period,” and together with the Initial Period, the Second Period, the Third Period, and the Fourth Period, the “Purchase Periods” ), Company agrees to purchase Product from Manufacturer in an amount equal to or greater than [***] cartridges.  Not withstanding the foregoing, however, the Parties agree that upon completion of the Initial Period, the Parties shall meet for the purpose of reconsidering each of the foregoing quantities specified for the Third, Fourth and Fifth Periods and shall, prior to the commencement of the Third Period, adjust such quantities, if necessary, upon mutual written agreement.  In the event that during any Purchase Period the Company’s actual purchases of the Product from Manufacturer are less than the minimum amount specified above for said Purchase Period, Company will pay to Manufacturer the difference between the amount invoiced to Company for its actual purchases during the Purchase Period and the amount that would have been invoiced had Company purchased the minimum amount agreed to for such Purchase Period; provided , however , (i) Company shall not be obligated to make any such payments if the Agreement has been terminated, and (ii) the Company shall only be obligated to pay for Product supplied to the Company pursuant to this Agreement.  In any given calendar quarter, Company shall order [***]% of the minimum quantity, plus or minus [***]%, for the Purchase Period in which the calendar quarter occurs.  Following the Fifth Period, Manufacturer may bid, in competition with Company’s other manufacturers of the Product, to provide a greater percentage of Company’s requirements of the Product.  For purposes of this Section 2.2, a “purchase” shall mean the submission by Company of a firm purchase order.

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

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

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Manufacturer shall ship the Product which is the subject of the purchase order, subject to Section 5.1, and shall supply copies of the associated documentation as described in the Quality (Technical) Agreement, including the signed Certificate of Analysis and signed certificate of compliance for the Product. Any purchase orders for the Product submitted by Company to Manufacturer shall reference this Agreement and shall be governed exclusively by the terms contained herein except to the extent set forth in the following sentence. The terms and conditions of this Agreement shall supersede any term or condition in any order, confirmation or other document furnished by Company or Manufacturer that is inconsistent with these terms and conditions, except to the extent that any term, provision or condition set forth in a purchase order expressly states that it supersedes any term, provision or condition of this Agreement, unless it is mutually agreed between the parties hereto.  If purchase orders are issued less than [***] Business Days in advance of the desired shipment date, Manufacturer shall make commercially reasonable efforts to meet Company’s requirements, however Manufacturer’s failure to meet such requirements shall not be deemed to be a breach of this Agreement.  In the event a purchase order is issued less than [***] Business Days in advance of the desired shipment date, Manufacturer shall advise Company within [***] Business Days whether such purchase order can be fulfilled by the date requested in the purchase order and the parties shall agree upon a delivery date of the requested Product.

3.             Prices and Payment.

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

3.2          Purchase Price Adjustment.   Upon expiration of the Initial Period, Manufacturer may adjust the Purchase Price of Product to reflect changes in [***], subject to Section 4.1(b). Any such adjustment by Manufacturer shall be notified to Company no less than [***] prior to expiration of the Initial Period.  Upon commencement of the Second Period Company and Manufacturer agree to meet [***] to formally review continuous improvement activities and other improvements resulting from experience in operating the Manufacturing Process including [***]. Company and Manufacturer shall work together to obtain process improvements.  Net savings or increases in the [***] shall result in reductions or increases respectively in the Purchase Price. [***] resulting from Manufacturer’s efficient management of the Manufacturing Process shall not result in reductions in the Purchase Price. Net increases in the cost of the Manufacturing Process due to [***] shall result in increases in the Purchase Price. Net savings in the product cost per unit achieved due to increases in the [***] shall result in corresponding reductions in the Purchase Price.  If the parties cannot in good faith agree on the proposed Purchase Price adjustment, the dispute will be discussed between the senior management of both Company and Manufacturer.  In no event may Manufacturer increase the Purchase Price following the Initial Period by [***].  The increase will be applicable on [***] of every calendar year.

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

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commencement of the Second Period, adjust such percentage, if necessary, upon mutual written agreement. Upon completion of the manufacture of each purchase order  and the submission of a Certificate of Analysis and Certificate of Compliance duly approved by Manufacturer to Company for the batches of Product manufactured for such purchase order Manufacturer shall refund Company the Reservation Fee and invoice Company the Product Price for the quantity of Product manufactured.

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

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

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

3.8          Effect of Certain Events.   In the event of termination or expiration of this Agreement, Manufacturer shall provide reasonable assistance to Company to implement the transfer of manufacturing responsibility for the Product to Company or its designee.  Such reasonable assistance shall include transfer of the Manufacturing Process as described in Section 7.7 but always with the exception of Manufacturer Inventions subject to Section 7.2. In the event of termination of this Agreement by Company pursuant to Section 9.2(a) or (b) or 9.3(c), such reasonable assistance will be provided at Manufacturer’s expense. In the event of any other termination or expiration of this Agreement, Company shall pay Manufacturer’s reasonable and documented costs of providing such assistance.  In the event of termination or expiration of this Agreement, Manufacturer will promptly return to Company all unused Pramlintide Acetate Drug Substance provided to Manufacturer pursuant to Section 4.1 hereof and Materials paid for by Company as directed by and at the expense of Company.

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4.             Manufacturing.

4.1          Materials.

(a)           Except as stated in Section 4.1(b), Manufacturer will obtain any Materials with the exception of Pramlintide Acetate Drug Substance required for the manufacture of the Product, in reasonable quantities consistent with Company’s most recent forecast for the Product. All Materials obtained by Manufacturer pursuant to this Section 4.1(a) shall meet the specifications stated in the Quality Agreement and Manufacturer shall order all Materials only from vendors approved in advance by Company.  Manufacturer shall ensure all Materials required to manufacture the Batch are released for use, in accordance with Manufacturer’s quality system and requirements stated in the then current Quality Agreement, prior to the manufacturing of the Batch. Company shall reimburse the Manufacturer all the costs of all the Materials in stock or on order on behalf of the Company by the Manufacturer, including QC testing costs and disposal costs, if such Materials become redundant at any time if: (i) Company makes a good faith determination not to continue with the commercialization of Product, (ii) Company terminates this Agreement according to Section 9.3(a), (iii) such materials expire due to insufficient demand for Product, or (iv) such materials become obsolete due to a change of specification advised by the Company; provided , however , Manufacturer shall use commercially reasonable efforts to either utilize such materials in other areas of its business or to return the materials, and Company shall not reimburse Manufacturer for any such utilized or returned materials.  The orders of Materials will be placed keeping in view the future forecasts and delivery lead times. Manufacturer will maintain a safety stock level of at least [***] calendar [***], but no more than [***] calendar [***] of approved Materials unless the minimum procurement quantity for any Material provides sufficient stocks for greater than [***] calendar [***].  For clarification purposes, safety stock includes Materials needed to fulfill forecasts issued by Company pursuant to Section 2.3.  Manufacturer and Company will review safety stock levels on a quarterly basis and will mutually agree to make appropriate changes.

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

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Product manufacture to allow for testing. Within fifteen (15) business days of receipt of any Pramlintide Acetate hereunder, Manufacturer will verify the quantity and identity of such shipment of Pramlintide Acetate according to test methods approved and provided by Company and shall inspect the Pramlintide Acetate in accordance with Manufacturer’s incoming material inspection procedures.  If Manufacturer detects any discrepancies in the Pramlintide Acetate in quantity or in the identity based on the identity testing performed, Manufacturer shall inform Company immediately upon, but no later than five (5) Business Days after, having detected such discrepancies.  Manufacturer shall also inform Company of any obvious damage to the Pramlintide Acetate or container received within five (5) Business Days of Manufacturer’s receipt thereof.  Any rejected Pramlintide Acetate shall be returned at Company’s expense and direction. Company shall make all final determinations if Materials are suitable for use in Product manufacturing.

4.2          Manufacture of Product.   Manufacturer will manufacture and store Product at the Facilities in accordance with the Quality Agreement, the Specifications, applicable Regulatory Approvals, cGMPs and other Applicable 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 Company (and, with Manufacturer’s prior consent, other persons) to be present during all manufacturing of the Product. The Manufacturer shall perform quality control and quality assurance testing to protocols and procedures agreed in writing between the parties prior to shipment of Product to the Company. The Manufacturer shall test a portion of each Batch manufactured for the Company prior to delivering such Batch to the Company, and shall provide a Certificate of Analysis (i) confirming that the Manufacturer followed the agreed methods for the testing of such Product, (ii) containing the quality control and quality assurance test results for such Batch and (iii) confirming that such Batch has been manufactured in accordance with the Batch Records and cGMP. The Manufacturer shall notify the Company immediately of any test failures noted in the manufacture of Product.

4.3          Change in Specifications or Manufacturing Process.

(a)           Each party shall notify the other in advance of any proposed changes in Specifications, release testing, stability testing, packaging, Materials, equipment, facilities, processes or procedures used to manufacture Product under this Agreement.  No changes in Specifications, release testing, 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 made unless the parties have agreed to such changes in writing prior to adoption of such changes. Any such changes to the Product Specifications, release testing, stability testing, packaging, Materials, equipment, facilities, processes or procedures used to manufacture Product shall be handled in accordance with the procedures established in the Quality Agreement, with costs paid as provided in Section 4.3(b), (c) or (d), as applicable.

(b)           In the event Company requests any such changes be made, other than changes described in Section 4.3(d), Manufacturer shall accommodate Company’s requested changes to the extent technologically feasible.  If such changes would result in material change in the cost of manufacture, then in that event the Product Price may be suitably

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modified. If such changes require the purchase of capital equipment, such costs and any related installation and qualification costs will be to the account of the Company and such capital equipment shall be owned by the Company.

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

(d)           In the event changes are requested by a Regulatory Authority or required to bring either of the Facilities into compliance with Applicable Laws, or additional changes, activities, or manufacturing is required to bring the Manufacturing Process into compliance with Applicable Laws, Specifications or other Product Requirements, Manufacturer shall accommodate such changes to the extent technologically feasible, 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 Price may be suitably revised to accommodate such changes.

4.4          Regulatory Matters.

(a)           Manufacturer shall provide to Company such documentation, data and other information relating to the Facilities, Product, or Manufacturer’s Manufacturing Processes and procedures for Product as Company may request for submission to Regulatory Authorities.

(b)           Company shall be responsible for all filings necessary for Regulatory Approvals.  The parties agree that Company shall be the sole and exclusive owner of all right, title and interest in and to all Drug Approval Applications and Regulatory Approvals related to the Product in the United States and any OUS Country. Manufacturer shall assist Company in the preparation of all documents necessary to effectuate Company’s rights in all Drug Approval Applications and Regulatory Approvals related to the Product and agrees to transfer, effect, confirm, perfect, record, preserve, protect and enforce all rights, title and interests transferred hereunder, at the reasonable request and expense of Company. Manufacturer will use commercially reasonable efforts to assist Company in obtaining such Regulatory Approvals. For the avoidance of doubt, Company has sole responsibility for the content of all Drug Approval Applications.  This Agreement automatically terminates if Amylin terminates development of the Product following final rejection of the Product by the FDA.

4.5          Compliance with Quality Agreement and Applicable Laws.  The parties shall comply with the terms and conditions of the Quality Agreement. Manufacturer shall comply with all Applicable Laws with respect to activities under this Agreement.   Manufacturer represents and warrants to Company that it has and will maintain during the Term all establishment licenses and permits, including without limitation health, safety and environmental permits, necessary for the conduct of Manufacturer’s activities under this Agreement.

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

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under this Agreement.  Manufacturer covenants to design and operate the facilities it uses to manufacture, package, test, or store Product to successfully pass inspections conducted by regulatory authorities. Manufacturer agrees to maintain appropriate security measures at its facilities no less stringent than measures that are customary in the pharmaceutical industry.

4.7          QA Audits. Upon written notice of no less than [***] Business Days for routine audits to Manufacturer, Company shall have the right to have representatives visit the Facilities during normal business hours to review Manufacturer’s manufacturing operations, assess its compliance with cGMPs and quality assurance standards, and discuss any related issues with Manufacturer’s manufacturing and management personnel.  Manufacturer shall maintain the Facilities in accordance with cGMPs.  Manufacturer’s failure to correct any cGMP deficiency regarding any aspect of Manufacturer’s manufacture within a reasonable time period after notice of such deficiency shall be a material breach of this Agreement. Upon reasonable notice, the Manufacturer will allow employees of the Company access to the Facility, documentation, and personnel to audit and for observation of the production process and quality control testing of the Product, disposal of waste and adherence to cGMP requirements and this Agreement. During such inspections, employees of the Company (number of persons should be restricted to not more than [***]) shall have the right to audit any aspect of the Manufacturers manufacture of Product, and such audit may include, without limitation, verification of Manufacturers maintenance of drug establishment registrations with the FDA and other applicable Regulatory Authorities, and review of conditions and documentation of any aspect of manufacture of Product.

4.8          Regulatory Inspections. Manufacturer agrees to permit the FDA and other Regulatory Authorities to inspect any aspect of Manufacturer’s manufacture and testing of the Product including, without limitations, any pre-approval inspection (“PAI”). Manufacturer shall cooperate with Company, and with any Regulatory Authority, as necessary to facilitate prompt approvals by such Regulatory Authority of the Manufacturing Process or testing process for the Product, including preparation and submission of necessary data relating to the manufacturing or testing processes, including without limitation any PAI or subsequent inspection. Manufacturer shall notify Company if either or both of the Facilities are the subject of an inspection by any Regulatory Authority or any compliance inspection relating to, or that could reasonably be expected to, affect the manufacture or