**LICENSE AND DISTRIBUTION AGREEMENT****THIS LICENSE AND DISTRIBUTION AGREEMENT**(this “Agreement”) dated this the 19th day ofJanuary, 2006 (the “Effective Date”) is hereby entered into by and between Shire LLC, a Kentuckycompany with offices located at 9200 Brookfield Court, Florence, KY 41042 (“Shire”), and ImpaxLaboratories, Inc., a Delaware corporation with offices located at 30831 Huntwood Ave., Hayward, CA94544 (“Impax”).R E C I T A L S:**WHEREAS**, a Shire Affiliate is the owner of New Drug Application No. 21-303 (“Shire’s NDA”, asfurther defined below), which was approved by the FDA for the Manufacture and sale of Adderall XRfor the treatment of Attention Deficit Hyperactivity Disorder;**WHEREAS**, Impax submitted ANDA No. 76-852 (the “Impax ANDA”) to the FDA under § 505(j) of theAct with a paragraph IV certification seeking approval to engage in the commercial Manufacture,use, and sale of product asserted to be bioequivalent to the product sold under Shire’s NDA;**WHEREAS**, Shire and Impax are Parties to a certain Settlement Agreement of even date herewith(the “Settlement Agreement”), pursuant to which Shire and Impax are settling pending litigation;and**WHEREAS**, pursuant to the Settlement Agreement, Shire and Impax have agreed to enter into thisAgreement.**NOW THEREFORE**, in consideration of the foregoing premises, mutual covenant, the terms andconditions hereof, and for other good and valuable consideration, the receipt and sufficiency ofwhich is hereby acknowledged, the Parties hereby agree as follows:**1.****Definitions****1.1.****“Act”** shall mean the United States Federal Food, Drug and Cosmetic Act, as amended fromtime to time, and the rules, regulations and guidelines promulgated thereunder.**1.2. “Adderall XR”**shall mean the pharmaceutical product that contains the Compound as itssole active ingredient which is approved for Marketing in the Territory pursuant to Shire’s NDA andsold under the tradename Adderall XR.**1.3.****“Adderall XR Intellectual Property”** shall mean (i) U.S. Patent Nos. 6,322,819, 6,605,300,and 6,913,768 and any patent that issues as a result of a reexamination or reissue thereof; (ii)any patent that issues from, or from any continuation, continuation-in-part or divisionalapplication relating to, U.S. Patent
 
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Application Serial Nos. 09/176,542, 10/353,073, 10/758,417, 10/774,697, and 11/030,174; and(iii) any other present or future U.S. patent owned or controlled by Shire which may read upon themaking, using, selling or importing of a Generic Product.**1.4. “Adverse Drug Experience”**shall mean an adverse event associated with the use of GenericProduct in humans, whether or not considered drug related, including the following: an adverseevent occurring in the course of the use of a drug product in professional practice; an adverseevent occurring from drug overdose whether accidental or intentional; an adverse event occurringfrom drug abuse; an adverse event occurring from drug withdrawal; and any failure of expectedpharmacological action. The above definition of “Adverse Drug Experience” is defined by 21 C.F.R.§ 314.80(a), and will be deemed to be changed to reflect any changes to that section of 21 C.F.R. §314.80.**1.5. “Affiliate”**shall mean a Person that controls, is controlled by or is under commoncontrol with a Party. For the purposes of this definition, the word “control” (including, withcorrelative meaning, the terms “controlled by” or “under common control with”) means the actualpower, either directly or indirectly through one or more intermediaries, to direct the managementand policies of such Person, whether by the ownership of at least fifty percent (50%) of the votinginterest of such Person (it being understood that the direct or indirect ownership of a lesserpercentage of such interest shall not necessarily preclude the existence of control), or bycontract or otherwise.**1.6. “AG Product”**shall mean generically Labeled Adderall XR, commonly called an authorizedgeneric product, approved for sale by the FDA pursuant to a labeling supplement to Shire’s NDA.**1.7. “ANDA”**shall mean an Abbreviated New Drug Application to the FDA for approval toManufacture and/or Market a pharmaceutical product in the Territory.**1.8. “Applicable Law”**shall mean the applicable Laws, rules, regulations, guidelines andrequirements of any Governmental Authority related to the development, registration, Manufactureand Marketing of the Generic Product in the Territory or the performance of either Party’sobligations under this Agreement.**1.9. “Authorization and License”**shall have the meaning assigned to such term in Section 2.3.**1.10. “Barr Product”**shall mean the Generic Equivalent that is the subject of the ANDAsubmitted by Barr to the FDA that is the subject of present litigation between Shire and Barr.**1.11. “Business Day”**shall mean any day other than a Saturday, Sunday or a day on which banksin New York, New York are authorized or required by Law to close.
 
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**1.12. “cGMP”**shall mean all applicable standards relating to manufacturing practices for finechemicals, active pharmaceutical ingredients, intermediates, bulk products or finishedpharmaceutical products, including (i) the principles detailed in the U.S. Current GoodManufacturing Practices, 21 C.F.R. Parts 210 and 211.**1.13. “Commercially Reasonable Efforts”**shall mean efforts and diligence in accordance withthe subject Party’s reasonable and sound business, legal, medical and scientific judgment and inaccordance with the efforts and resources such Party would use in other aspects of its businessthat have similar commercial value and market potential, taking into account the competitiveness ofthe marketplace, the business life-cycle, the proprietary position of the company and theprofitability of the pertinent product.**1.14. “Compound”**shall mean mixed amphetamine salts.**1.15. “Confidential Information”**shall mean any scientific, technical, formulation, process,Manufacturing, clinical, non-clinical, regulatory, Marketing, financial or commercial informationor data relating to the business, projects, employees or products of either Party and provided byone Party to the other by written, oral, electronic or other means in connection with thisAgreement.**1.16. “Cost of Goods”**shall mean the **XXXXX**to be paid by Impax to Shire for Packaged andLabeled AG Product. With respect to Impax Product, the Cost of Goods shall equal the **XXXXX**.**1.17. “Delay Payment”**has the meaning set forth in Section 5.7.**1.18. “Exclusive”**shall mean, when used in connection with a specific grant of rights that thegranting Party (i) shall retain for itself no ability to use such granted rights and (ii) shallhave no ability to authorize its Affiliates or Third Parties (other than the grantee of suchspecific rights) to use such granted rights, in the Territory and in the granted field of use, forthe term of the grant.**1.19. “FDA”**shall mean the United States Food and Drug Administration or any successor agencythereof.**1.20. “Final Court Decision”**shall mean a decision of any federal court from which no appealhas been or can be taken (other than a petition to the United States Supreme Court for a *writ ofcertiorari*).**1.21. “Force Majeure”** shall mean any circumstances reasonably beyond a Party’s control,including, without limitation, acts of God, civil disorders or commotions, acts of aggression,fire, explosions, floods, drought, war, sabotage, embargo, unexpected safety or efficacy resultsobtained with the Generic Product, utility failures, **XXXXX**, **XXXXX**, labor disturbances, a nationalhealth emergency, or appropriations of property.
 
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**1.22. “GAAP”**shall mean generally accepted accounting principles in effect in the UnitedStates from time to time, consistently applied.**1.23. “Generic Equivalent”**shall mean a pharmaceutical product which is submitted to the FDAfor Regulatory Approval pursuant to an ANDA (or equivalent regulatory mechanism) as a TherapeuticEquivalent to Adderall XR. Generic Equivalent shall also mean the AG Product.**1.24. “Generic Product”**shall mean both AG Product and Impax Product.**1.25. “Governmental Authority**” shall mean any court, tribunal, arbitrator, agency, legislativebody, commission, official or other instrumentality of (i) any government of any country, or (ii) afederal, state, province, county, city or other political subdivision thereof.**1.26. “Impax Product”**shall mean the Generic Equivalent that is the subject of the Impax ANDA.**1.27. “Impax ANDA”** shall have the meaning assigned to such term in the recitals.**1.28. “Label”**shall mean any Package (immediate container) labeling designed for use with aproduct, including the package insert for such product that is approved by the FDA, and **“Labeled”**or **“Labeling”**shall have the correlated meaning.**1.29. “Launch”**shall mean the first commercial sale of a product to an unaffiliated ThirdParty.**1.30. “Law”**or **“Laws”**shall mean all laws, statutes, rules, codes, regulations, orders,judgments and/or ordinances of any Governmental Authority.**1.31. “License Effective Date”**shall mean, subject to the further provisions of thisAgreement, the first date to occur as determined by the following subsections (a) or (b), asapplicable:**(a)****Barr Settlement****:**If Shire reaches a settlement with Barr Laboratories, Inc.(“Barr”) that provides for the Launch of a Generic Equivalent under a license from Shire (a“Licensed Barr Launch”), then the earlier of: (i) the first day, following a Licensed BarrLaunch, that the FDA grants final marketing approval for a Generic Equivalent under an ANDAfiled by a paragraph IV certification filer other than Barr or Impax, or their respectiveAffiliates, (ii) the one-hundred and eighty-first (181st) day following aLicensed Barr Launch, or (iii) January 1, 2010; or**(b)****No Barr Settlement:** If Shire has not previously reached a settlement with Barrproviding for a Licensed Barr Launch, then the earlier of: (i) January 1, 2010 or (ii) thefirst day upon which a Generic Equivalent that is the subject of
 
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Barr’s ANDA that is the subject of present litigation with Shire is sold in the Territoryfollowing a Final Court Decision that all of the patents found in the Adderall XRIntellectual Property are invalid, unenforceable, or not infringed by the Barr Product.**1.32. “Losses”**means for purposes of Section 5.7 only, **XXXXX**. For purposes of Article 12 ofthis Agreement, “Losses” means any liabilities, damages, costs or expenses, including reasonableattorneys’ fees and expert fees, incurred by any Party that arise from any claim, lawsuit or otheraction by a Third Party.**1.33. “Manufacturing Costs”**for each dosage strength of AG Product shall mean **XXXXX**, accruedin accordance with GAAP. Manufacturing Costs for each dosage strength of Impax Product shall mean**XXXXX**, accrued in accordance with GAAP.**1.34.****“Manufacture”** shall mean all activities related to the manufacturing of a pharmaceuticalproduct, or any ingredient thereof, including but not limited to manufacturing Compound or suppliesfor development, manufacturing Impax or AG Product for commercial sale, packaging, in-process andfinished product testing, release of product or any component or ingredient thereof, qualityassurance activities related to manufacturing and release of product, ongoing stability tests andregulatory activities related to any of the foregoing, and **“Manufactured”**or **“Manufacturing”**shallhave the correlated meaning.**1.35. “Market”**shall mean to distribute, promote, advertise, import, market and sell, and**“Marketing”**or **“Marketed”**shall have the correlated meaning.**1.36. “NDA”**shall mean a New Drug Application filed with the FDA pursuant to and under 21U.S.C. § 355(b) of the Act, together with the FDA’s implementing rules and regulations.**1.37. “Net Sales”**shall mean the gross invoice price of sales of Generic Product in theTerritory by Impax and its Affiliates to unaffiliated Third Parties, less applicable (i) tradediscounts, (ii) promotional allowances, (iii) cash discounts, (iv) customer refunds and credits,(v) returns, (vi) reprocurement charges, (vii) customer and government rebates (viii) chargebacks,(ix) retroactive price or shelf stock adjustments and price equalizations; and (x) Impax’s actualfreight, storage, and incremental insurance expense incurred exclusively in connection with thestorage and distribution of the Generic Product to the extent actually invoiced to the customer.All of the foregoing shall be determined in accordance with GAAP.**1.38. “Net Profits”**shall mean the difference between Net Sales for the applicable GenericProduct and the Cost of Goods for such product.**1.39. “Party”**or **“Parties”**shall mean Shire and/or Impax, as applicable.
 
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**1.40. “Package”**shall mean all primary containers, including bottles, cartons, shipping casesor any other like matter used in packaging or accompanying a product, and **“Packaged”**or **“Packaging”**shall have the correlated meaning.**1.41. “Person”**shall mean any individual, partnership, association, corporation, limitedliability company, trust, or other legal Person or entity.**1.42. “Regulatory Approval”**shall mean final Marketing approval by the FDA for the sale andMarketing of a pharmaceutical product in the Territory.**1.43. “Reporting Period”**shall have the meaning set forth in Section 9.3.**1.44. “Shire’s NDA”**shall mean Shire’s NDA No. 21-303, and all supplements filed pursuant tothe requirements of the FDA, including all documents, data and other information concerningAdderall XR which are necessary for FDA approval to Market Adderall XR in the Territory.**1.45. “Term”**shall have the meaning assigned to such term in Section 15.1.**1.46. “Territory”**shall mean the United States of America.**1.47. “Therapeutic Equivalent”**shall have the meaning given to it by the FDA in the currentedition of the “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “OrangeBook”) as may be amended from time to time during the Term.**1.48. “Third Party”**or **“Third Parties”**shall mean any Person or entity other than a Party orits Affiliates.**1.49. “Valid Claim”**shall mean an issued and unexpired patent claim which has not been held tobe invalid or unenforceable by a court of competent jurisdiction in a final unappealable decision.**2.****Authorization and License****2.1.**Subject to the terms, conditions and limitations hereof, including the conditions setforth in Section 3, Shire hereby grants to Impax a limited license, under the Adderall XRIntellectual Property and under any and all statutory and regulatory exclusivities to Manufacture,have Manufactured and Market Impax Product in the Territory on and after the applicable LicenseEffective Date.**2.2.**Solely to the extent that Shire Manufactures and supplies AG Product to Impax pursuant toSection 4 of this Agreement, and subject to the other terms, conditions and limitations hereof,including the conditions set forth in Section 3, Shire hereby authorizes Impax to Market such AGProduct in the Territory, but only from and after the License Effective Date. In connection withand solely for purposes of such
 
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authorization, Shire hereby grants to Impax a limited license under the Adderall XRIntellectual Property and under any and all statutory and regulatory exclusivities to Market suchAG Product in the Territory from and after the applicable License Effective Date.**2.3.**The authorizations and licenses granted by this Section 2.1 and 2.2 are referred toherein as the “Authorization and License.” Except to the extent of the assignment permittedpursuant to Section 16.3, Impax shall not have the right to sublicense or assign any of its rightsunder the Authorization and License.**3.****Conditions****3.1.**Impax shall not Market any Generic Product in the Territory prior to the LicenseEffective Date.**3.2.**Impax shall not Market or authorize or knowingly facilitate the Marketing of AG Productoutside the Territory and agrees to take all appropriate and legal steps as may be required toensure that its Affiliates or customers do not sell or distribute AG Product outside the Territory,including, without limitation, by limiting or terminating supplies of AG Product to customerswhich, to Impax’s knowledge, are distributing or selling AG Product outside the Territory.**3.3.**Subject to the provisions of Sections 3.4 and 3.5 below, the Authorization and Licenseshall be on an Exclusive basis.**3.4.**Shire reserves the right to license, authorize and supply Barr at Shire’s discretion toManufacture, have Manufactured and Market a Generic Equivalent in the Territory in full andcomplete settlement of the pending litigation between Shire and Barr involving the Adderall XRIntellectual Property.**3.5.**Shire reserves the right to grant licenses under the Adderall XR Intellectual Propertyand any and all statutory and regulatory exclusivities to any Third Party to Manufacture, haveManufactured and Market a Generic Equivalent, but only under its applicable ANDA, in settlement ofany then pending or threatened litigation involving the Adderall XR Intellectual Property;provided, however, that such licenses would not become effective prior to the License EffectiveDate and shall be on terms no more favorable to such Third Party than those set forth in thisAgreement.**3.6.**Except to the extent permitted under the Authorization and License, neither Impax nor anyof its Affiliates shall under any circumstances: (a) Market any Generic Equivalent that infringesor misappropriates the Adderall XR Intellectual Property or (b) aid, abet, enable or contract withany Third Party regarding the Marketing of any Generic Equivalent that infringes or misappropriatesthe Adderall XR Intellectual Property.**3.7.**Nothing set forth herein shall be deemed to prevent or restrict Impax or its Affiliatesfrom Marketing any product which would not infringe or misappropriate the Adderall XR IntellectualProperty and nothing shall prohibit Impax
 
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from entering into any agreement with a Third Party related to any Generic Equivalent thatdoes not infringe or misappropriate the Adderall XR Intellectual Property; provided, however, thatif Impax so enters into any such agreement (except an agreement that is reasonably required forImpax to Market the Generic Product and is approved by Shire pursuant to Section 8.1), Impax shallpromptly notify Shire, and Shire shall be free to terminate the Authorization and License and anysupply obligations to Impax immediately upon notice to Impax.**3.8.**In the event that, and for so long as, Impax sells AG Product, as set forth in Section 4of this Agreement, Impax agrees and covenants not to **XXXXX**.**4.****Authorized Generic****4.1.**At any time that is prior to the issuance of any tentative or final approval for theImpax ANDA and also prior to the License Effective Date, Impax may elect by providing writtennotice to Shire to have Shire supply AG Product to Impax for sale in the Territory from and afterthe applicable License Effective Date subject to all of the terms and conditions of this Agreement,including Section 5 below. Anything in this agreement to the contrary notwithstanding, Shire haveno obligation to deliver AG Product to Impax earlier than ninety days following Shire’s receipt ofwritten notice of such election from Impax.**4.2.**If, prior to the License Effective Date, Shire determines, in its sole discretion, toLaunch an authorized generic Adderall XR product then Shire shall supply Impax with AG Product, forMarketing in the Territory. Impax shall Launch such AG Product only on or after a date chosen byShire, in its sole discretion, and such date shall be deemed a License Effective Date solely withrespect to the Authorization and License under Section 2.2.**4.3.**Certain Launches of Generic Equivalents By Third Parties.(i) If Shire has not previously reached a settlement with Barr providing for aLicensed Barr Launch and Barr commences the sale or distribution in the Territory of aGeneric Equivalent (or the Parties agree such sale or distribution is imminent) at a timethat Shire is maintaining litigation in respect thereof including, for this purpose,appealing a related decision, is preserving its rights for appeal or is otherwise preparingto institute litigation in respect of such launch or the related ANDA (an “At RiskLaunch”), Shire and Impax shall confer as to the desirability of accelerating the LicenseEffective Date to permit the sale of Generic Product.(ii) If the Parties mutually agree, in light of the pending litigation referred to inSection 4.3(i), to launch a Generic Product, the License Effective Date will be the date ofthe At Risk Launch. If the Parties mutually agree not to launch a Generic Product inresponse to the At Risk Launch, the License Effective Date will continue to be determinedin accordance with as otherwise provided in this Agreement.
 
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(iii) In the event that the License Effective Date has not been accelerated pursuantto Section 4.3(ii) because the Parties have not mutually agreed to launch a Generic Productin response to an At Risk Launch and if there is ultimately a Final Court Decision in thelitigation(s) pertinent to the At Risk Launch that Shire’s U.S. Patent Nos. 6,322,819,6,605,300, and 6,913,768 are not infringed, or are invalid or unenforceable, Shire agreesto pay Impax an amount equal to (i) US $175,000 multiplied by the number of days that Barrhas been selling its Generic Equivalent to Third Parties in the Territory while Impax isnot selling a Generic Equivalent for up to two months from and after the date of the AtRisk Launch, plus (ii) US $150,000 multiplied by the number of days that Barr has beenselling its Generic Equivalent to Third Parties in the Territory while Impax is not sellinga Generic Equivalent after the two months described in (i), such amount being a good faithand mutually agreed estimate of Impax’s losses caused by the failure to accelerate theLicense Effective Date. Notwithstanding the preceding, the total payment which Shire maybe obligated to make pursuant to this Section shall not exceed US $20,000,000. Shire shallmake any payment required by this Section within 60 days of the applicable Final CourtDecision.**5.****Supply of AG Product; Forecasts; Purchase Orders****5.1.**Subject to the terms, conditions and limitations hereof, Shire agrees to supply AGProduct to Impax for Marketing pursuant to Section 4 and in accordance with the terms of thisAgreement. In order to be in a position to timely and effectively enter the generic market, theParties shall cooperate in good faith to determine and prepare for the applicable License EffectiveDate, including communicating to one another, on an ongoing basis, developments which mayreasonably affect the License Effective Date and information necessary to Label the AG Product forsale as a generic by Impax under Shire’s NDA.**5.2.**All AG Product supplied will be released for sale under a generic Label in Packaged formwhich complies with Shire’s NDA. Subject to compliance with Shire’s NDA, Impax will provide Shirewith appropriate and customary generic Package and Label design which will be utilized by Shire inManufacturing AG Product. Any costs incurred by Shire in utilizing such Packaging or Labeling, orin performing other manufacturing specifications (such as tablet imprints) requested by Impax andto which Shire agrees (such agreement not to be unreasonably withheld, delayed or conditioned),including related capital expenditures, shall be included in Manufacturing Costs. Shire shallprovide current Manufacturing Costs, for guidance purposes only, within forty-five (45) days of theexecution of this Agreement.**5.3.**Within forty-five (45) days of the execution of this Agreement Impax will provide toShire a good faith Forecast (as defined below) of the quantities of AG Product required for theinitial Launch of AG Product (including the first three months of sales, beginning with the LicenseEffective Date) (the “Launch Quantities”). The Launch Quantities may be adjusted from time to timeby Impax, upon the consent of Shire (not to be unreasonably withheld, delayed or conditioned),based on reasonable assessments of changes in market conditions. In anticipation of the Launch ofAG
 
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Product by Impax, Shire shall use Commercially Reasonable Efforts to deliver one-half of theLaunch Quantities as soon as practicable to Impax around the License Effective Date; provided,however, that based on the cooperation and communication between the Parties, Shire shall makeCommercially Reasonable Efforts to deliver such AG Product on or before the License Effective Date,so that Impax may Launch on the License Effective Date, and Shire shall in any event deliver suchfirst half of the Launch Quantities within two (2) days following the License Effective Date.Shireshall also use Commercially Reasonable Efforts to deliver the second half of the Launch Quantitieswithin a reasonable time after the delivery of the first half of the Launch Quantities, and Shireshall in any event deliver such second half of the Launch Quantities within forty-five (45) daysfollowing the License Effective Date.**5.4.**Within thirty (30) days following the License Effective Date, and on or before thebeginning of every three (3) months period thereafter during the Term beginning with the date thatis three months after the License Effective Date Impax shall deliver a forecast (a “Forecast”) toShire of the quantities of AG Product, by SKU, which Impax reasonably anticipates it will requirefor Marketing during the twelve (12) months (“Forecast Period”) beginning three months followingthe License Effective Date in the first instance, and thereafter three months following the date ofsuch Forecast and shall include quantities required to be delivered during each month of theForecast Period. The foregoing notwithstanding, Impax shall have no obligation to provideForecasts or orders beyond the term of this Agreement, and the first such Forecast shall be for thetwelve month period beginning ninety (90) days after the License Effective Date. For each suchForecast, the first three months of the Forecast Period shall be known as the “Purchase OrderPeriod” and the amounts specified in the Forecast for the Purchase Order Period shall constitute abinding purchase order for such period. Additionally, in each subsequent Forecast, the amountordered for the Purchase Order Period shall not deviate by more than fifteen percent (15%) (as tothe entire period or any month therein) from the second three (3) months of the immediatelypreceding Forecast. Other than the specifically provided in this paragraph, the the amounts setforth in the Forecasts shall only constitute a non-binding estimate of the AG Product requirementsof Impax.**5.5.**Subject to and in accordance with the terms of Section 5.3 and 5.4, Shire shall makedeliveries of AG Product to a single delivery destination specified by Impax no more than five (5)days after Impax’s specified delivery dates. All such shipments of AG Product shall be EXW(Incoterms 2000) Shire’s manufacturing facilities to a carrier designated by Impax. In no eventshall Shire be required to make more than one (1) delivery of AG Product during any month. Theterms and conditions of this Agreement shall be controlling over any conflicting terms andconditions stated in Impax’s purchase order or Shire’s invoice or confirmation. Any other documentwhich shall conflict with or be in addition to the terms and conditions of this Agreement is herebyrejected (unless the Parties shall have mutually agreed to the contrary in writing in respect of aparticular instance).**5.6.**Shire shall promptly notify Impax in writing if at any time Shire has reason to believethat Shire will not be able to fill at least ninety-five percent (95%)
 
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of an order for an AG Product in accordance with the delivery schedule specified therein byImpax and pursuant to the terms and conditions of this Agreement.**5.7.**Other than with respect to Launch Quantities, to the extent that (i) Shire’s delivery toImpax of at least ninety percent (90%) of an AG Product ordered by Impax set forth in a Firm Orderis delayed beyond the period permissible under Section 5.5 hereof and (ii) as a result of suchdelay Impax is unable to fill a commercially reasonable order by a Third Party for such an AGProduct or a Third Party rejects or fails to accept a delivery of an order that included suchdelayed Product, then Shire shall pay to Impax an amount equal to **XXXXX**(“Delay Payment”);*provided, however,*that no such Delay Payment shall be payable if the delay is caused by (i) **XXXXX**,or (ii) a material breach by Impax of its obligations under this Agreement. Any Delay Paymentshall be paid by Shire within thirty (30) days after receipt of Impax’s invoices therefor, whichinvoices shall set forth in reasonable detail the manner in which the Delay Payments werecalculated and all supporting documentation and proof for any such calculation of the DelayPayment. If Shire disputes the amount of such invoice, it shall notify Impax within thirty (30)days of its receipt of such invoice and thereafter the Parties shall enter into good faithnegotiations in order to revise, if necessary, the amount of the Delay Payment. If the Parties areunable to agree upon revisions to the Delay Payment within twenty (20) days after the date ofShire’s notification of its dispute of Impax’s invoice, any Party shall have the right, exercisableby written notice to the other Party, to invoke the provisions set forth in Section 16.13. Duringthe time period during which the Parties are unable to agree upon the amount of the Delay Payment,Shire shall pay such invoice only to the extent it is in agreement with it. **XXXXX**.**5.8.**Shire shall invoice Impax at the time of each shipment of AG Product at the **XXXXX**forsuch shipment. Impax shall pay each such invoice within thirty (30) days of receipt.**5.9.**In addition to the foregoing, the Parties shall work together in good faith and makeCommercially Reasonable Efforts to timely satisfy any changes in the quantities and delivery datesof AG Product specified in the Forecasts due to changes in demand.**5.10.**AG Products supplied by Shire shall (i) have a shelf life of at least twenty four (24)months from the date of Manufacture and (ii) conform to Shire’s NDA. The foregoingnotwithstanding, the Launch Quanties shall instead have a shelf life of at least fifteen (15)months.**5.11.**All AG Products will be in finished dosage form, filled, packaged and labeled forcommercial sale in accordance with the terms and conditions of this Agreement, the QualityAgreement, and applicable Laws.**5.12.**During the Term, and for a period of three (3) years thereafter, Shire shall, and shallensure that its Affiliates shall, keep at either its normal place of business, or at an off-sitestorage facility, detailed, accurate and up to date:
 
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**(b)**records and books of account sufficient to confirm the calculation of the Cost ofGoods; and**(c)**information and data contained in any invoices provided to Impax in connectionwith this Agreement.**5.13.**On no less than five (5) Business Days notice from Impax, to the extent that Shiresupplies AG Product to Impax, Shire shall make all such records, books of account, information anddata concerning the Manufacturing Cost of AG Product available for inspection during normalbusiness hours by Impax or its nominee for the purpose of general review or audit; provided thatImpax may not request such inspection more than once in any calendar year. Upon reasonable beliefof discrepancy or dispute, Impax’s external auditors shall be entitled to take copies or extractsfrom such records, books of account, information and data (but only to the extent related to thecontractual obligations set out in this Agreement) during any review or audit, provided theexternal auditor signs a confidentiality agreement with Shire providing that such records, books ofaccount, information and data shall be treated as Confidential Information which may be disclosedonly to Impax.**5.14.**Impax shall be solely responsible for its costs in making any such review and audit,unless Impax identifies a discrepancy in the calculation of Cost of Goods paid by Impax to Shireunder this Agreement in any calendar year from those properly payable for that calendar year offive percent (5%) or greater, in which event Shire shall be solely responsible for the cost of suchreview and audit and refund Impax any overpayment. All information disclosed by Shire or itsAffiliates pursuant to this Section 5.14 shall be deemed Confidential Information.**6.****Quality Assurance; Acceptance****6.1.**Shire represents, covenants and warrants to Impax that:**(a)**all AG Product hereunder shall be produced in accordance with cGMP and other ApplicableLaws, rules and regulations and that none of the AG Product supplied hereunder shall beadulterated or misbranded as defined by the Act; and**(b)**all shipments of AG Product supplied hereunder shall meet the specifications andquality control standards set forth in Shire’s NDA.**(c)**Shire or a Shire Affiliate will use Commercially Reasonable Efforts to maintainthroughout the term of this Agreement all permits, licenses, registrations and other formsof governmental authorization and approval required in order for Shire to perform itsobligations hereunder in accordance with all applicable Laws.**(d)**to Shire’s knowledge upon due investigation, as of the Effective Date the Manufactureor Marketing of the AG Products in the Territory pursuant to this Agreement does notinfringe, misappropriate or otherwise conflict with any intellectual property rights of anyThird Party.
 
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**(e)**Shire or a Shire Affiliate owns and possesses all right, title and interest in theShire NDA.**(f)**Shire has the right to grant all of the rights and licenses granted herein to Impaxunder the Adderall XR Intellectual Property, and it is not under any obligation to anythird party that conflicts with the terms of this Agreement.**6.2.**Shire shall perform all quality control tests and other inspections required byapplicable cGMP standards and Shire’s NDA and shall furnish to Impax a certificate of analysistogether with each lot of AG Product shipped to Impax. Shire will also provide Impax with MaterialSafety Data Sheets (hereinafter “MSDS”) as required by Law for the AG Products, and updates of sameas necessary.**6.3.**Shire will promptly notify Impax of any request from the FDA to change AG Productspecifications or Labeling and will notify Impax of any changes in specifications. No such changewhich requires FDA approval will be implemented prior to obtaining such Impax approval.**6.4.**Impax shall conduct, at its own expense, such tests as it deems necessary to determinethe compliance of the AG Product with the requirements of Section 6.1. Impax shall notify Shirewithin thirty (30) days of its receipt of each shipment of the AG Product of any non-compliance ofthe AG Product with the requirements of Section 6.1 revealed by such testing. If no notice ofnon-compliance is delivered to Shire within such thirty (30) day period, the AG Product sodelivered shall be deemed to comply with Section 6.1.**6.5.**Subject to the provisions of Section 6.6, Shire shall replace, at its own expense,including all freight costs, any AG Product that does not meet the requirements of Section 6.1.Subject only to the indemnification obligations set forth in Section 12.1, Shire shall have noother obligations to Impax in respect of such AG Product or the representations set forth inSection 6.1.**6.6.**If, following the timely delivery of a notice by Impax pursuant to the provisions ofSection 6.4, Impax and Shire do not agree that any lot or lots of the AG Product referred to in thenotice meets the requirements of Section 6.1, that lot or those lots of the AG Product shall betested for such compliance, within thirty (30) days after notice of the defect is delivered toShire, by a disinterested Third Party expert selected by the mutual agreement of Impax and Shire.The decision of such Third Party expert with respect to the question of compliance shall be bindingupon Impax and Shire for the purposes of Section 6.1 of this Agreement only. The costs of suchtesting shall be borne by Shire if such lot or lots are found not to meet the requirements ofSection 6.1 and by Impax if those lot or lots are found to meet the requirements of Section 6.1.**6.7.**At least once per calendar year following the License Effective Date, Impax will provideShire with a certificate of a duly authorized officer with regulatory responsibilities to theeffect that Impax stores and ships AG Product in accordance with all Applicable Laws andregulations, including cGMP standards.
 
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**6.8.**Impax represents, covenants and warrants to Shire that all Generic Product Marketed byImpax will be stored, shipped and handled in accordance with cGMP and all Applicable Laws, rulesand regulations and all Impax Product Manufactured by Impax, or for Impax by a Third Party, shallbe Manufactured, shipped and handled in accordance with cGMP and all Applicable Laws, rules andregulations and the Impax ANDA.**7.****Regulatory Responsibilities; Adverse Event Reporting; Recalls****7.1.**As the holder of Shire’s NDA, Shire will have sole authority to deal with regulatorymatters relating to Shire’s NDA or AG Product. During the term hereof, Shire shall maintainShire’s NDA in accordance with all applicable requirements of the FDA and other GovernmentalAuthorities, including, without limitation, the filing of all annual and other reports or filingsrequired by the FDA.**7.2.**Impax shall submit to Shire all reports of Adverse Drug Experiences, together with allrelevant information possessed by it, in time for Shire to meet all periodic and annual safetyregulatory obligations to the FDA. Impax shall also promptly submit to Shire all AG Productinquiries or complaints for handling by Shire. Each Party shall cooperate with the other andprovide information in its possession to the extent necessary for the other Party to comply withall legal requirements relating to the Manufacture or Marketing of Generic Product and the Partieswill use diligent efforts to agree upon a customary pharmacovigilance protocol as promptly aspracticable after the date hereof to provide for the necessary exchange of adverse event andrelated information to permit Shire to comply with Applicable Laws and regulations on a timelybasis.**7.3.**Each of Shire and Impax will immediately inform the other in writing if it believes oneor more lots of any AG Product should be subject to recall from distribution, setting forth thereasons therefore with reasonable specificity. To the extent permitted by legal and public safetyrequirements, the Parties will confer before initiating any recall. If the Parties do not reachagreement on the need for a recall, either Party may initiate a recall. The Party initiating therecall shall initially bear the cost thereof and shall carry out the recall in accordance with bestindustry practices. In the event it is determined that a recall resulted from a breach by a Partyof any of its representations or warranties hereunder, such Party shall be responsible for thecosts of the recall and the cost of any unnecessary or groundless recall or other recall which isnot the result of a breach by the other Party or any of its representations and warrantieshereunder, shall be borne by the Party initiating or requesting such recall. In no event shall aParty’s liability to the other hereunder exceed the actual out-of-pocket costs incurred or the costof replacement of AG Product at a price equal to the Manufacturing Costs, as the case may be, andneither Party shall be liable for lost profits or other consequential damages.**7.4.**As the holder of the Impax ANDA, Impax will have sole authority and responsibility todeal with regulatory matters relating to the Impax ANDA or Impax Product including maintaining theImpax ANDA as applicable in accordance with all
 
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applicable requirements of the FDA, including, without limitation, the filing of all annualand other reports or filings required by the FDA.**7.5.**Shire shall keep, or cause its Affiliates to keep, as required, such samples and suchrecords (or copies thereof) in respect of the AG Products as are required by applicable Law forsuch period of time as may be required thereunder.**7.6.**Each of Shire and Impax shall promptly inform the other of any correspondence from theFDA regarding the Generic Products that would materially affect its ability to meet its obligationsunder this Agreement. Each of Shire and Impax shall notify the other promptly, but in no eventlater than ten (10) Business Days following the occurrence thereof, of any materially adverseinspections by the FDA or other regulatory authorities which pertain to the Generic Products or tothe facilities of such Party or its Affiliate where the Generic Products are being manufactured orstored.**7.7.**Within thirty (30) days following the Effective Date, Impax and Shire shall enter into aQuality Agreement in form and content reasonably acceptable to Impax and Shire (“QualityAgreement”). The Quality Agreement will include protocols and specific responsibilities forhandling AG Products quality complaints, ADE reports, and professional medical service inquiries inaccordance with Shire’s standard operating procedures and in conformity with applicable Laws.**8.****Marketing of Generic Product****8.1.**Impax shall, at its sole cost and expense, utilize all Commercially Reasonable Efforts inLaunching and Marketing the Generic Product in the Territory to maximize sales and profits ofGeneric Product. During the Term Impax shall not enter into any arrangements or agreements withany other Person to Market or promote Generic Product in the Territory without Shire’s priorwritten consent, except that Impax shall not be restricted in entering into customary agreementswith its ordinary trade customers including, without limitation, distributors and retailers.**8.2.**It is the intent of the parties that Impax will seek to sell Generic Product for its fullmarket value. Impax will have sole discretion, however, in setting the price for the sale of theGeneric Product in the Territory. Impax will also agree that if it prices Generic Product in orderto gain or maintain sales of other products, then for purposes of calculating the payments duehereunder, the Net Sales of such Generic Product shall be adjusted to reverse any discount whichwas given to a customer that was in excess of customary discounts for the Generic Product (or, inthe absence of relevant data for this Generic Product, other similar products under similar marketconditions).**9.****Shire Profit Share****9.1.**During the Term, Impax shall pay to Shire a royalty of **XXXXX**percent (**XXXXX**%) of the NetProfits of Impax Product.**9.2.**In the event Impax sells AG Product pursuant to Section 4, Impax shall pay a royalty toShire as follows:
 
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**(a) XXXXX**percent (**XXXXX**%) of the Net Profits on sales of AG Product made by Impax duringany period when the AG Product is the only Generic Equivalent being Marketed in theTerritory other than a Generic Equivalent marketed by or on behalf of Barr or any successorin interest to Barr’s ANDA that is the subject of present litigation between Shire andBarr.**(b) XXXXX**percent (**XXXXX**%) of the Net Profits on sales of AG Product made by Impax duringany time period other than as described in Section 9.2(a) above.**9.3.**Payments due under this Section 9 shall be made within thirty (30) days from the end ofeach calendar quarter in which Generic Product is sold (“Reporting Period”). All such paymentsshall include an invoice detailing the calculation of Net Sales and Net Profits, as each may beapplicable and the royalties payable hereunder.**9.4.**In the event that Net Profits is a negative amount for any Reporting Period, no paymentor refund shall be due from Impax to Shire or from Shire to Impax, in respect thereof and the NetProfits with respect to the subsequent Reporting Period, shall be reduced by such negative amountfor purposes of determining Shire’s share of the Net Profits for such subsequent Reporting Period.**9.5. Maintenance of Records.** During the Term, and for a period of three (3) years thereafter,Impax shall, and shall insure that its Affiliates shall, keep at either its normal place ofbusiness, or at an off-site storage facility, detailed, accurate and up to date:(a) records and books of account sufficient to confirm the calculation of the Net Sales andNet Profits; and(b) information and data contained in any invoices or reports accompanying any payment toShire provided to Shire in connection with this Agreement.**9.6. Inspection.** On no less than five (5) Business Days notice from Shire, Impax shall makeall such records, books of account, information and data concerning this Agreement available forinspection during normal business hours by Shire or its nominee for the purpose of general reviewor audit; provided that Shire may not request such inspection more than once in any calendar year.Upon reasonable belief of discrepancy or dispute, Shire’s external auditors shall be entitled totake copies or extracts from such records, books of account, information and data (but only to theextent related to the contractual obligations set out in this Agreement) during any review or auditprovided the external auditor signs a confidentiality agreement with Impax providing that suchrecords, books of account, information and data shall be treated as Confidential Information whichmay be disclosed to Shire.**9.7. Inspection Costs.** Shire shall be solely responsible for its costs in making any suchreview and audit, unless Shire identifies a discrepancy in the calculation of Net Sales or NetProfits paid to Shire under this Agreement in any calendar year from those properly payable forthat calendar year of five percent (5%) or greater, in which
 
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event Impax shall be solely responsible for the cost of such review and audit and refund Shireany overpayment. All information disclosed by Impax or its Affiliates pursuant to this Section 9shall be deemed Confidential Information.**10.****Confidentiality****10.1. Confidentiality Obligation**. The Parties, their Affiliates and their respectiveemployees, directors, officers, consultants and contractors shall keep and maintain as confidentialany Confidential Information supplied by the other Party during the Term. The confidentiality andnon-disclosure obligations contained in this Agreement shall not apply to the extent that suchConfidential Information is:**(a)**at the time of disclosure by one Party to the other, in the public domain or otherwisepublicly known;**(b)**after disclosure by one Party to the other becomes part of the public domain, otherthan by breach of any obligation of confidentiality;**(c)**information which the receiving Party can establish by competent evidence was alreadyin its possession at the time of receipt or was independently developed by the receivingParty; or**(d)**received from a Third Party who was lawfully entitled to disclose such information freeof an obligation of confidentiality.**10.2. Exceptions.** Notwithstanding Section 10.1, the Party receiving Confidential Informationmay disclose such Confidential Information to the extent that such disclosure has been ordered by acourt of law or directed by a Governmental Authority, provided that, the disclosure is limited tothe extent ordered or directed and wherever practicable, the Party that owns the ConfidentialInformation has been given sufficient written notice in advance to enable it to seek protection orconfidential treatment of such Confidential Information.**10.3. Expiration of Confidentiality.** The confidentiality obligation contained in this Section10 shall survive the termination or expiry of this Agreement for so long as such informationremains confidential.**10.4. Disclosure.** If a Party is subpoenaed or otherwise requested by any Person including,without limitation, any Governmental Authority to give testimony or provide information which inany way relates to this Agreement, the Generic Product or practices associated with the GenericProduct, such Party shall give the other Party prompt notice of such request, and unless otherwiserequired by Law, shall make no disclosure until such other Party has had a reasonable opportunityto contest the right of the requesting Person to such disclosure. The Parties shall provide eachother with all reasonable cooperation and generally make its employees available to give testimonyor to provide reasonable assistance in connection with any lawsuits, claims, proceedings andinvestigations relating to this Agreement, the Generic Product or practices associated with theGeneric Product.
 
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**10.5.**The Parties agree that equitable relief, including injunctive relief and specificperformance, is appropriate in enforcing the confidentiality provisions of this Agreement. In theevent of any such action to construe this provision, the prevailing Party will be entitled torecover, in addition to any charges fixed by the court, its costs and expenses of suit, includingreasonable attorney’s fees. Such remedies shall not be deemed to be the exclusive remedies for abreach of this provision, but shall be in addition to all other remedies available at law orequity.**11.****Representations and Warranties of Both Parties**With respect to Sections 11.1 and 11.2 below, each of Shire and Impax represents, warrants, andcovenants, to the other Party that:**11.1. Organization and Authority.** Such Party is a corporation duly organized, validlyexisting and in good standing under the Laws of its jurisdiction of incorporation. Such Party hasthe requisite corporate power and authority to enter into this Agreement. Such Party has therequisite corporate power and authority to execute and deliver this Agreement and to perform all ofits obligations hereunder. The execution and delivery of this Agreement and the performance bysuch Party of its obligations hereunder have been authorized by all requisite corporate action onits part. This Agreement has been validly executed and delivered by such Party, and, assuming thatsuch documents have been duly authorized, executed and delivered by the other Party, constitutes avalid and binding obligation of such Party, enforceable against such Party in accordance with itsterms.**11.2. Consents and Approvals; No Violations.****(a)**Except as otherwise set forth in this Agreement or the Settlement Agreement, nomaterial filing with, and no material permit, authorization, consent such Party of thetransactions contemplated by this Agreement, except for those filings, permits,authorizations, consents or approvals, the failure of which to be made or obtained wouldnot materially impair such Party’s ability to consummate the transactions contemplatedhereby or materially delay the consummation of the transactions contemplated hereby.**(b)**Neither the execution nor the delivery of this Agreement by such Party, nor theperformance by such Party of its obligations hereunder, will (i) violate the certificate ofincorporation, by-laws or other organizational document of such Party; (ii) conflict in anymaterial respect with or result in a material violation or breach of, or constitute amaterial default under, any material contract, agreement or instrument to which such Partyis a party; or (iii) violate or conflict in any material respect with any material Law,rule, regulation, judgment, order or decree of any court or Governmental Authorityapplicable to such Party, except in the case of clause (ii) or (iii) for violations,breaches or defaults which would not have a material adverse effect on such Party’s abilityto consummate the transactions contemplated hereby.
 
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**(c)**The Parties shall submit this Agreement together with the Settlement Agreement (as partof the Settlement Documents, as defined in the Settlement Agreement) to the Federal TradeCommission (“Commission”) Bureau of Competition (“Bureau”) and the Assistant AttorneyGeneral in charge of the Antitrust Division (the “Antitrust Division”) of the Department ofJustice (the “DOJ”) as soon as practicable following its execution and in no event laterthan ten (10) business days following its execution. Following the submission to theCommission and the DOJ, the Parties shall diligently work together in good faith toactively seek out oral comments on the Settlement Documents from the Bureau, or theAntitrust Division if appropriate, as soon as is practicable.**12.****Indemnities; Product Liability; Insurance****12.1. Indemnity by Shire.** Shire shall defend, indemnify and hold harmless each of Impax andits Affiliates and its and their directors, officers, employees and contractors (“Impax Party”)from and against any and all Losses, (“Shire Liability”) arising from or in connection with:**(a)**any Third Party claim, lawsuit, investigation, proceeding, regulatory action, or othercause of action (“Claim”) resulting from any negligent acts or acts of willful misconductof any Shire Party in connection with the performance of its obligations under thisAgreement;**(b)**Shire’s failure to Manufacture, store or release the AG Product for shipment inaccordance with Applicable Laws, regulations or Shire’s NDA;**(c)**the breach by Shire of any of its representations or warranties contained in thisAgreement; or**(d)**any misuse by a Shire Party of Impax’s company name or logo or other trademark;except, in each case, to the extent that the Shire Liability is caused by the negligence,breach of the terms of this Agreement, or willful misconduct of an Impax Party.**12.2. Indemnity by Impax.** Impax shall defend, indemnify and hold harmless each of Shire andits Affiliates and its and their directors, officers, employees and contractors (“Shire Party”)from and against any and all Losses (“Impax Liability”) arising from or in connection with:**(a)**any Claim resulting from any negligent acts or acts of willful misconduct of any ImpaxParty in connection with the performance of its obligations under this Agreement;**(b)**any Claim based on or arising out of the use, Manufacturing or Marketing of ImpaxProduct, including, without limitation, any investigation by a
 
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Governmental Authority or any claim for personal injury or property damage asserted by anyuser of Impax Product;**(c)**any Claim based on or arising out of the use or Marketing of AG Product by Impax,including, without limitation, any investigation by a Governmental Authority or any claimfor personal injury or property damage asserted by any user of AG Product in each case tothe extent that such liability is a result of the acts or failure to act of Impax or itsemployees, agents, partners, contractors or the like;**(d)**the breach by Impax of any of its representations or warranties contained in thisAgreement; or**(e)**any misuse by the Impax Parties of Shire’s company name or logo or other trademark;except, in each case, to the extent that the Impax Liability is caused by the negligence,breach of the terms of this Agreement, or willful misconduct of a Shire Party.**12.3. Control of Proceedings.** A Party seeking indemnification hereunder shall provide promptwritten notice to the other Party (and, in any event, within five (5) Business Days) of theassertion of any claim against such Party as to which indemnity is to be requested hereunder. Theindemnifying Party shall have the sole control over the defense of any Claim, provided that, theindemnifying Party shall obtain the written consent of the indemnified Party prior to settling orotherwise disposing of such Claim if as a result of the settlement or Claim disposal theindemnified Party’s interests are in any way adversely affected.**12.4. No Admissions.** The indemnified Party shall not make any payment or incur any expensesin connection with any Impax Liability or Shire Liability (as the case may be), or make anyadmissions or do anything that may compromise or prejudice the defense of any Claim without theprior written consent of the indemnifying Party.**12.5. Claim Information.** Each Party shall promptly:**(a)**inform the other by written notice of any actual or threatened Claim to which Sections12.1 or 12.2 apply;**(b)**provide to the other Party copies of all papers and official documents received inrespect of any such Claim; and**(c)**cooperate as reasonably requested by the other Party in the defense of any such Claim.**12.6. Contributory Negligence.** If any Shire Liability or Impax Liability is caused by thenegligence of both Shire and Impax, the apportionment of
 
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liability shall be shared between Shire and Impax based upon the comparative degree of eachParty’s negligence and each Party shall be responsible for its own defense and its own costsincluding, but not limited to, the cost of defense attorneys’ fees and witnesses’ fees and expensesincident thereto.**12.7. Limitation of Liability.**Except as may be included in a Claim under Section 12.1 or12.2, in no event shall either Party or their respective Affiliates be liable for special,punitive, indirect, incidental or consequential loss or damage based on contract, tort or any otherlegal theory arising out of this Agreement.**12.8. Product Liability Insurance.** Each Party shall maintain, at its own cost, generalcommercial liability insurance (including comprehensive product liability) in such amount as Shireand Impax respectively, customarily maintain with respect to its other products and which isreasonable and customary in the U.S. pharmaceutical industry for companies of comparable size andactivities but in any event not less than $**XXXXX**per occurrence and $**XXXXX**in the aggregate. Inthe event the insurance policy obtained by a Party is a “claims made” policy (as opposed to an“occurrence” policy), such Party shall obtain comparable insurance for not less than six (6) yearsfollowing the expiry or termination of this Agreement. Impax will cause Shire to be named as anadditional insured under Impax’s product liability insurance.**12.9. Irreparable Harm.** Impax acknowledges that in the event of a Launch by Impax of GenericProduct in the Territory prior to the License Effective Date, the damages to Shire and its business(including, but not limited to, lost sales of Adderall XR) would be difficult to calculate and theadequacy of monetary damages calculated at Law would be uncertain. Accordingly, Impax agrees thatin any action by Shire seeking injunctive or other equitable relief in connection with any suchLaunch prior to the License Effective Date, Impax shall not assert or plead the availability of anadequate remedy at Law as a defense to the obtaining of any such remedy. Impax hereby waives anyequitable defense to such injunction including, laches, unclean hands, acquiescence or any estoppelarguments. The foregoing shall not be in lieu of any other remedy to which Shire may be entitledhereunder in equity or at Law as a result of such a breach and the Parties agree that lost profitsresulting from lost sales by Shire of Adderall XR are a reasonably foreseeable element of damageswhich Shire would suffer and to which, notwithstanding anything to the contrary set forth herein,Shire will be entitled to recover in accordance with the Law.**12.10. Limitation on Representations, Warranties and Indemnification.****NEITHER PARTY SHALL BEDEEMED TO MAKE ANY REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, EXCEPT ASSPECIFICALLY SET FORTH HEREIN. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUTLIMITATION, WITH REGARD TO THE AG PRODUCT TO BE SUPPLIED BY SHIRE HEREUNDER, THE IMPLIED WARRANTIESOF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED BY EACH PARTY.**
 
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**13.****Force Majeure****13.1. Force Majeure.** Neither Party shall be entitled to terminate this Agreement or shall beliable to the other under this Agreement for loss or damages attributable to any Force Majeure,provided the Party affected shall give prompt notice thereof to the other Party. Subject toSection 13.2, the Party giving such notice shall be excused from such of its obligations hereunderfor so long as it continues to be affected by Force Majeure.**13.2. Continued Force Majeure.**If any Force Majeure continues unabated for a period of atleast ninety (90) days, the Parties shall meet to discuss in good faith what actions to take orwhat modifications should be made to this Agreement as a consequence of such Force Majeure in orderto alleviate its consequences on the affected Party.**14.****Trademarks and Trade Names****14.1.**Except for the identification of Shire as manufacturer of AG Product on Packaging orLabeling to the extent required by Law, Impax shall have no right to use any trademark ortradedress of Shire and shall have no rights to any other intellectual property of Shire or itsAffiliates (including patents or other intellectual property relating to the shape, consistency,formulation or manufacturing process for the AG Product) other than to the extent of theAuthorization and License.**15.****Term and Termination****15.1.**Unless sooner terminated in accordance with the terms hereof, the term of this Agreementshall extend from the date hereof until the expiration of the last Valid Claim within the AdderallXR Intellectual Property. The foregoing notwithstanding, the obligations of Shire regarding supplyof AG Product under this Agreement shall extend from the date hereof only until the fifth(5th) anniversary of the License Effective Date (the “Supply Term”). Thereafter, theSupply Term shall automatically be extended for successive twelve (12) month periods (an“Additional Term” and together with the Initial Term, the “Term”), unless either Party gives to theother Party not less than one hundred eighty (180) days written notice of termination prior to theexpiration of the Initial Term, or any Additional Term, of this Agreement.**15.2. Termination.** Either Party shall be entitled to terminate this Agreement by writtennotice to the other if:**(a)**the other Party commits a material breach of this Agreement, and fails to remedy itwithin sixty (60) days of receipt of notice from the first Party of such breach and of itsintention to exercise its rights under this Section 15.2; or**(b)**an order is made or a resolution is passed for the winding up of the other Party (otherthan voluntarily for the purposes of solvent amalgamation or reconstruction) or an order ismade for the appointment of an administrator to manage the other Party’s affairs, businessand property or if a receiver (which
 
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expression shall include an administrative receiver) is appointed over any of the otherParty’s assets or undertaking or if circumstances arise which entitle the court or acreditor to appoint a receiver or manager or which entitle the court to make a winding-uporder or if a voluntary arrangement is proposed in respect of the other Party or if theother Party takes or suffers any similar or analogous action in consequence of debt, andsuch order, appointment or similar action is not removed within ninety (90) days.**15.3. Effect of Termination.** In the event of expiry or termination of this Agreement for anyreason, Impax shall:**(a)**no longer have the right to Market product under the Authorization and License;provided that Impax may continue to Market inventory then on hand for an additional periodnot to exceed six (6) months, subject to the continued payment to Shire in accordance withSection 9; and**(b)**promptly return to Shire all Confidential Information of Shire provided to Impax andsamples of the Shire Product provided to Impax or its Affiliates during the Term.**15.4. Liability on Termination.** The termination or expiry of this Agreement shall not releaseeither of the Parties from any liability which at the time of termination or expiry has alreadyaccrued to the other Party, nor affect in any way the survival of any other right, duty orobligation of the Parties which is expressly stated elsewhere in this Agreement to survive suchtermination or expiry.**15.5. Surviving Sections.**The provisions of Sections 1, 9.4, 9.5, 9.6, 10, 12, 14, 15 and 16,and any other provisions necessary and proper to give effect to the intention of the Parties as tothe effect of the Agreement after termination, shall continue in force in accordance with theirrespective terms notwithstanding expiry or termination of this Agreement for any reason.**16.****Miscellaneous****16.1. Notice.****(a)**Any notice or other document given under this Agreement shall be in writing in theEnglish language and shall be given by hand or sent by prepaid airmail, by fax transmissionor e-mail to the address of the receiving Party as set out in Section 16.2 below unless adifferent address or fax number has been notified to the other in writing for this purpose.**(b)**Each such notice or document shall:(i) if sent by hand, be deemed to have been given when delivered at therelevant address;
 
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(ii) if sent by prepaid mail, be deemed to have been given five (5) daysafter posting; or(iii) if sent by fax or email transmission be deemed to have been givenwhen transmitted, provided that, a confirmatory copy of such fax or emailtransmission shall have been sent by prepaid mail within twenty-four (24) hours ofsuch transmission.**16.2. Address for Notice.** The address for services of notices and other documents on theParties shall be:       **To Shire** **To Impax**       **Address**: **Address**:         Shire LLC   Impax Laboratories, Inc.  9200 Brookfield Court   30831 Huntwood Avenue  Florence, KY 41042   Hayward, CA 94544  United States of America   United States of America       **Attention**: Associate General