Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 1 of 55 EXHIBIT A

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1 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 1 of 55 EXHIBIT A

2 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 2 of 55 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK IMPAX LABORATORIES, INC., v. Plaintiff, SHIRE LLC and SHIRE LABORATORIES, INC., Defendants. TEVA PHARMACEUTICALS, USA, INC., Civ. Action No. 10-CV-83860MGC Judge Miriam G. Cedarbaum Magistrate Judge Andrew J. Peck Plaintiff-Intervenor, v. SHIRE LLC, Defendant. COMPLAINT OF PLAINTIFF-INTERVENOR TEVA PHARMACEUTICALS, USA, INC. AGAINST SHIRE LLC INTRODUCTION 1. This is an action for declaratory judgment and specific performance. The plaintiff-intervenor, Teva, is a company that manufactures and sells pharmaceutical products, including prescription generic drugs. The defendant, Shire LLC ( Shire ), is a brand name drug company. In 2006, a Shire affiliate (Shire Laboratories, Inc. ( Shire Labs )) and a company named Barr (which is now an affiliate of Teva) settled patent litigation pending in this Court arising from Barr s efforts to sell a generic version of Shire s Adderall XR drug. Barr and Shire entered into a contract as part of the settlement that required Shire to supply Adderall XR it manufactures to Barr, which Barr (and its affiliates, such as Teva) could then sell as a generic LIBA/

3 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 3 of 55 equivalent to the drug (the License Agreement ). 2. The product that Shire supplies to Barr has been distributed by Barr s affiliate Teva in the United States since April 1, On or about October 15, 2009, Barr assigned the 2006 contract to Teva, meaning that all of Barr s rights and duties under that Agreement are now rights and duties of Teva. Barr also assigned to Teva all of its claims and/or causes of action against Shire in relation to the 2006 contract. 3. Impax Laboratories, Inc. ( Impax ) filed a suit in New York Supreme Court on November 1, 2010, alleging that Shire is also required to supply Adderall XR to Impax, and seeking an emergency order to increase Shire s supply of Adderall XR product to Impax, including, inter alia, by reducing the amount of Adderall XR that Shire supplies to Teva. 4. Shire removed Impax s complaint from New York Supreme Court to this Court on November 2, Teva is entitled to intervene in this action to protect its rights pursuant to Fed. R. Civ. P. 24(a) and (b). Teva is also entitled to declaratory judgment that its supply rights will be impaired and supply agreement with Shire breached if the relief that Impax requests in this action causes Teva to receive less product from Shire than the amounts that Shire is contractually obligated to supply to Teva, and to an order requiring specific performance of Shire s contractual duty to supply it with product. PARTIES, JURISDICTION, AND VENUE 6. Plaintiff Teva Pharmaceuticals USA, Inc. is incorporated under the laws of the State of Delaware with a principal place of business in North Wales, Pennsylvania. Teva develops, manufactures, and sells brand and generic pharmaceutical products in the United States. Among the generic pharmaceutical products that Teva distributes in the United States is the generic equivalent of Adderall XR, the pharmaceutical product that is the subject of the LIBA/

4 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 4 of 55 License Agreement in this action. As of December 22, 2008, Teva also is the indirect parent company of Barr Laboratories, Inc., the company that entered into the License Agreement with Shire. 7. Defendant Shire LLC is, on information and belief, a Kentucky limited liability company with its principal place of business located at 9200 Brookfield Court, Florence, Kentucky Both Shire s most recent Annual Report, dated June 23, 2010, and Shire s current information form available from the Kentucky Secretary of State web site, as of November 18, 2010, list 9200 Brookfield Court, Florence, Kentucky as Shire s principal office. See Ex. A (Shire LLC Annual Report, June 23, 2010) & B (Shire LLC information for, downloaded from Kentucky Secretary of State web site, Nov. 18, 2010). On information and belief, Shire develops, manufactures, and sells brand and generic pharmaceutical products in the United States. Among the brand pharmaceutical products manufactured and sold by Shire is Adderall XR, the pharmaceutical product that is the subject of the License Agreement at issue in this action. 8. On or about October 15, 2009, Barr assigned the 2006 License Agreement with Shire to Teva, as permitted by the contract. In addition, Barr assigned to Teva all claims and/or causes of action Barr had against Shire in relation to the 2006 contract. 9. Jurisdiction over all claims herein is properly founded upon 28 U.S.C. 1332(a)(1) in that Plaintiff and Defendant are citizens of different states and the matter in controversy exceeds the sum or value of $75,000.00, exclusive of interest and costs. 10. Jurisdiction over the person of Defendant Shire is based upon said Defendant s transaction of business in New York, including the execution of the License Agreement that is governed by New York law, and Defendant Shire s prior written consent as per paragraph 16.7 of the License Agreement to jurisdiction in New York and the jurisdiction of this Court. LIBA/

5 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 5 of Venue is properly laid in the Southern District of New York pursuant to 28 U.S.C. 1391(a) because, upon information and belief, a substantial part of the events or omissions giving rise to the claims herein occurred therein and because paragraph 16.7 of the parties License Agreement consents to this matter being adjudicated in New York County, New York. Venue also is appropriate because Impax filed its lawsuit against Shire in this Court, which is the lawsuit into which Teva has intervened to protect its interests. FACTUAL BACKGROUND The Shire/Barr Agreement 12. Shire is a pharmaceutical drug manufacturer that, among other things, manufactures and sells the brand-name drug Adderall XR. Shire sells Adderall XR in the United States pursuant to a New Drug Application that was approved by the U.S. Food and Drug Administration (FDA) in On information and belief, Shire affiliate Shire Labs is the owner or assignee of certain patents that, Shire claims, cover its Adderall XR product. These patents include U.S. Patent No. 6,322,819, U.S. Patent No. 6,605,300, and U.S. Patent No. 6,913,768 (collectively the Adderall XR Patents ). The latest of the stated expiration dates for the Adderall XR patents is On or about November 8, 2002, Barr filed an Abbreviated New Drug Application (the Barr ANDA ) with FDA for approval to manufacture and sell generic equivalents of Adderall XR in the United States ( Generic Equivalents ). Generic equivalents are products that contain the same active ingredients, in the same dosage form and amounts, and with the same dosing regimen, as the respective strengths of the brand drug and in most states can be dispensed by pharmacists to fill a prescription written for the corresponding strength of the brand drug. As part of the Barr ANDA, Barr asserted that the Adderall XR Patents did not block Barr from LIBA/

6 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 6 of 55 manufacturing or selling Generic Equivalents in the United States. 15. In response to the Barr ANDA, Shire Labs filed a series of lawsuits against Barr in this Court, captioned as Shire v. Barr, Case Nos. 03-CV-1219, 03-CV-6632, and 05-CV-8903 (the Barr Litigation ). In these lawsuits, Shire Labs alleged that Barr s ANDA and Barr s proposed Generic Equivalents infringed the Adderall XR Patents. 16. In August of 2006, Shire Labs and Barr reached a settlement of the Barr Litigation. The settlement is incorporated in a Settlement Agreement (between Shire Labs and Barr) and the License Agreement (between Shire and Barr), both dated as of August 14, Pursuant to the Settlement Agreement, Shire Labs and Barr submitted to the court(s) in the Barr Litigation a Judgment Regarding Validity and Enforceability, Stipulated Order of Dismissal Regarding Infringement and Order of Permanent Injunction, which were entered by the Court on August 21, In that Judgment, Barr admitted that the Adderall XR Patents are valid and enforceable, admitted infringement of certain patents, but made no admission of infringement regarding other patents and did not otherwise admit any liability. 17. Part of the agreement reached by Shire and Barr to settle the Barr Litigation was a compromise of the date that Barr would start selling Generic Equivalents in the United States. The compromise gave Shire an additional time during which Barr could not commence selling Generic Equivalents, but also permitted Barr to start selling prior to expiration of the Adderall XR Patents. Section 2.1 of the License Agreement provides, among other things, that: Shire hereby grants to Barr a license, under the [Adderall XR Patents and certain other defined intellectual property rights] and under any and all statutory and regulatory exclusivities issued by any Governmental Authority to import, Manufacture, have Manufactured and Market Barr Product in the Territory on and after the License Effective Date. The license to Barr, now assigned to Teva, became effective on April 1, This license ensures that, as of April 1, LIBA/

7 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 7 of , there would be no barrier in the form of any intellectual property right or any regulatory exclusivity that would prevent Barr/Teva from selling Generic Equivalents. The License Agreement also gives Barr the right to grant sublicenses to its Affiliates which include Teva to make such sales. 18. Another essential component of the agreement reached by Shire and Barr was a guarantee by Shire to supply Barr (and Teva, as a result of the sublicense from Barr and now assignment of the License Agreement) with finished product for Barr to resell in the United States as Generic Equivalents. In order for Barr or Teva to sell Generic Equivalents that they manufactured themselves, the companies would first need to obtain final approval from FDA for the Barr ANDA (and/or a separate ANDA which had been filed by Teva), which had not occurred as of the date the License Agreement was executed. Therefore, the License Agreement provides that, in certain circumstance, Shire will supply Barr and Teva with what the parties called AG Product that is, product manufactured by Shire under its FDA approval for Adderall XR but bottled and labeled to be sold by Barr and Teva as Generic Equivalent. In the industry, such products are often referred to as authorized generics or AG products. 19. Under Section 5.1 of the License Agreement, Barr could elect to have Shire supply Barr with AG Product if Barr believed in good faith that it would be unable to obtain final approval for the Barr ANDA by the License Effective Date i.e., April 1, In the event that Barr made that election, Section 2.2 of the License Agreement provides that Shire hereby authorizes Barr to Market such AG Product in the Territory [defined as the United States and its territories (Section 1.39)], but only from and after the License Effective Date. The License Agreement defines to Market as to distribute, promote, advertise, import, market, offer to sell and sell.... (Section 1.30). 20. A primary purpose of the License Agreement, therefore, was to guarantee Barr s LIBA/

8 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 8 of 55 (and now Teva s) ability to sell Generic Equivalent in the United States after the License Effective Date. Through the License Agreement, Shire gave intellectual property licenses and a guaranteed right of product supply to be sure that there would be no impediments to Barr s (and Teva s) ability to sell Generic Equivalent after April 1, The License Agreement also specifies the process by which Barr and now Teva would order quantities of AG Product from Shire, and the timing and manner in which Shire is obligated to deliver AG Product to Barr or Teva in response to such orders. Under the Agreement, when Barr provided notice of its intent to market the AG Product, it also was required to provide Shire with a binding purchase order for the quantities of AG Product required for the launch and first three months of sales of AG Product. (Section 5.4). Thereafter, Barr or Teva is required to deliver quarterly 12-month forecasts to Shire on a rolling basis. The quantities set forth for the first three months of these rolling forecasts constitute binding purchase orders (Section 5.5). Shire, in turn, is obligated to deliver to Barr or Teva the amount of AG Product which was ordered. In addition, Shire must make the deliveries to Barr or Teva no later than 5 days after the delivery dates specified in the order (Section 5.6). 22. The License Agreement also is notable for what is does not say. The License Agreement does not limit or qualify Shire s obligations to supply on a timely basis the full quantities of AG Product for which binding purchase orders have been properly submitted. To the contrary, Shire s duty to deliver full and timely quantities of AG Product is unequivocal and absolute. The License Agreement does contain a Force Majeure provision (Section 13), but that provision is explicitly limited to enumerated circumstances that have no bearing on the current dispute and would not excuse Shire s conduct in any event. Teva s October 2009 Lawsuit Against Shire 23. On October 19, 2009, Teva filed a complaint in this Court against Shire to enforce LIBA/

9 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 9 of 55 Shire s obligation to supply it with the quantities of AG Product it had agreed to supply to Teva under the License Agreement, and seeking specific performance of the License Agreement. See Ex. C (Complaint in Teva Pharmaceuticals USA, Inc. v. Shire LLC, 09-CV-8860-MGC). 24. Impax wrote to the Court on November 16, 2009, stating that it was preparing to intervene in that case, on the ground that an injunction requiring Shire to meet all of Teva s orders for AG Product threatens Impax s right to supply under Impax s agreement with Shire for supply of an authorized generic version of Adderall XR. See Ex. D (Ltr. From Counsel for Impax to Hon. Miriam Goldman Cedarbaum, Nov. 16, 2009). 25. Teva and Shire resolved the October 2009 suit by agreement and jointly stipulated to dismissal on November 19, 2009, and the case was dismissed before Impax filed its motion to intervene. Teva Continues to Receive Supply of AG Product from Shire in Amounts Less Than Those Required By its Binding Purchase Orders to Shire. 26. Notwithstanding the resolution of the October 2009 suit by Teva and Shire, there continue to be shortfalls in Shire s supply of AG Product to Teva. Shire Continues to Retain For Itself Very Substantial Quantities of Product That Shire Could and Should be Using to Supply Product to Teva and/or Impax. 27. On information and belief, Shire has the ability to supply the full quantities of AG Product that Teva has properly ordered pursuant to the Teva Agreement. There is no actual shortage of product available to Shire to use in supplying Teva. Instead, Shire is improperly retaining product for its own use instead of using that product to fill Teva s orders, in breach of the Teva Agreement. 28. On information and belief, Shire has the ability to supply additional AG Product to Impax while also fully supplying to Teva the quantities of AG Product that Teva has properly ordered, and/or without reducing the amount of AG Product Shire supplies to Teva. LIBA/

10 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 10 of Teva first launched sales of its Generic Equivalent (by selling AG Product) in April of 2009, approximately a year and a half ago. Typically in this industry, once a generic equivalent of a branded drug becomes available, the overwhelming majority of sales shift from the brand to its lower-priced generic equivalent within a matter of weeks. Here, however, that has not happened. Instead, on information and belief, Shire continues to retain in excess of 35% of the sales (brand and generic) of Adderall XR products in the United States. It is highly unusual for a branded product to retain that high level of sales, in comparison to its generic equivalents, so long after generic entry. 30. On information and belief, the only reason that Shire continues to retain substantial sales of Adderall XR is that Shire continues to ship less product to Teva than Teva has ordered, causing a shortfall of generic product in the marketplace and forcing consumers instead to purchase the higher-priced but identical branded product that Shire sells. There is a Good Reason Why, if True, Shire Supplies More AG Product to Teva than to Impax, and There is No Basis for Ordering that Shire Supply Equal Quantities to Those Entities. 31. When Teva launched sales of Generic Equivalent in April of 2009, Teva was the only company selling Generic Equivalent for a period of six months, until Impax started selling Generic Equivalent in November of As the first entrant into the marketplace with a generic equivalent, Teva obtained the benefit of what is known as the first mover advantage. The first generic entrant for a particular brand product obtains a significant first-mover advantage, which permits that entity, through providing the first generic product to market, to retain a larger portion of the generic market than other providers of generic equivalents even after the entry of those other providers to the market. 33. The effects of the first-mover advantage that Teva obtained by being the first LIBA/

11 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 11 of 55 entrant remain evident in the marketplace today. On information and belief, Teva retains a higher level of sales of Generic Equivalent that Impax has achieved, even though Impax has been selling Generic Equivalent for a full year at this point. This sales pattern is consistent with what one would expect to see in the marketplace as a result of Teva s first-mover advantage with respect to this product. 34. Given that Teva earned and retained a higher proportion of sales of Generic Equivalent than Impax, it is logical and proper that Shire would have been supplying more AG Product to Teva than it has supplied to Impax, assuming that Impax s allegations in this regard are correct. 35. Nothing in the Teva Agreement provides that Shire is authorized to reduce the amount of AG Product Shire supplies to Teva, or to fail to fill fully Teva s orders for AG Product, in order to make sure that any other generic companies receive equal or comparable quantities of product. Teva May Sustain Substantial and Irreparable Harm From the Order that Impax Seeks the Court to Enter in This Suit. 36. In the present suit, Impax requests that the court enter an order requiring specific performance by Shire under Shire s agreement with Impax, including, inter alia, by diverting to Impax AG Product that Shire currently supplies to Teva. The relief that Impax requests may cause immediate and irreparable harm to Teva and cause additional breaches of Shire s License Agreement with Teva. 37. Impax filed a suit in New York Supreme Court on November 1, 2010, alleging that Shire is also required to supply Adderall XR to Impax, and seeking an emergency order to increase Shire s supply of Adderall XR product to Impax, including, inter alia, by reducing the amount of Adderall XR that Shire supplies to Teva. Shire removed Impax s complaint from LIBA/

12 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 12 of 55 New York Supreme Court to this Court on November 2, In paragraph 23 of its complaint, Impax alleges that Teva is receiving supply of AG Product that Impax should be receiving instead of Teva. Impax alleges as follows: Shire continues to supply some or all of the needs of Teva Pharmaceuticals USA, Inc. ( Teva ), another seller of authorized generic Adderall XR. Impax is informed and believes that Shire is supplying Teva with a much greater amount of authorized generic Adderall XR than it is supplying to Impax. Upon information and belief, Shire could have used some or all of the Adderall XR that it is selling to Teva to supply Impax s requirements for AG Product. 39. There is no source other than Shire (including its contract manufacturer for Adderall XR and AG Product, a company called DSM Pharmaceuticals, Inc.) to which Teva or Impax can turn to obtain AG Product or Generic Equivalent for sale in the United States. At this time, neither Teva nor any manufacturer other than Shire/DSM has legal authorization to manufacture Generic Equivalent for sale in the United States. 40. Shire has been able to prevent FDA from approving alternate manufacturing sources through the filing of a Citizen Petition with the FDA concerning applications by various manufacturers of generic drugs to manufacture and sell their own generic equivalents to Adderall XR (including the Barr ANDA and a separate ANDA submitted by Teva). The pendency of Shire s Citizen Petition has delayed the approval of those applications, which in turn forecloses those companies from providing supply to Teva. 41. If Impax is granted the relief it seeks in this suit, and the Court orders Shire to deliver increased quantities of AG Product to Impax at the expense of the AG Product that Teva is entitled to receive under its License Agreement, the inability of Teva to satisfy customer demand for Generic Equivalent will permanently damage Teva s position in the marketplace for sales of Generic Equivalent products. The first generic entrant for a particular brand product obtains a significant first-mover advantage. If, however, the first mover is unable to supply its LIBA/

13 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 13 of 55 customers, those customers will quickly shift their business for that product to a different generic company. Once the first mover has lost business to competitors, the first mover is unlikely to win the business back, even if it tries to win the business back by lowering its prices. 42. Teva was the first provider to offer a Generic Equivalent to Adderall XR. Therefore, Teva has benefited from the first-mover advantage in sales of Generic Equivalent. 43. Teva has an interest relating to the property or transaction that is the subject of the action the available supply of Generic Equivalent to Adderall XR and is so situated that disposing of the action may as a practical matter impair or impede Teva's ability to protect its interest. 44. Teva s interest is not protected by any party to this litigation. Shire is presently breaching the License Agreement with Teva. Also, Shire may attempt to retain product for its own use instead of supplying that product to Teva, such further makes Shire s interests adverse to Teva s. Impax, Teva s direct competitor, would benefit financially from receiving an increased supply of Generic Equivalent from Shire at the expense of reducing the amount of Generic Equivalent Shire supplies to Teva. The Presence of a Case or Controversy Concerning Teva s Rights Under Its License Agreement with Shire. 45. A case or controversy exists between Teva, and Shire concerning supply obligations under the License Agreement as between Teva and Shire, which requires a declaration of rights by this Court. 46. The relief that Impax seeks in this suit is an order that may, either explicitly or in practical effect, require that Shire sell even less product to Teva than it already sells, so that Shire would have more product to sell to Impax. 47. Shire has stated in submissions to this Court and in hearings before this Court LIBA/

14 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 14 of 55 during the October 2009 litigation that it is not obligated to fulfill the orders for providers of Generic Equivalent pursuant is license agreements by reducing the quantity of Adderall XR that Impax reserves for itself to distributed as a branded drug. 48. Impax and Teva have a present and concrete dispute concerning whether Shire may, consistent with the License Agreement, supply any Adderall XR to itself or to Impax in any period when it fails to meet the orders for Generic Equivalent that Teva has placed pursuant to the License Agreement. 49. Teva is entitled to a declaration an action by which Shire fails to supply fully the quantities of AG Product properly ordered by Teva whether in order to supply additional product to Impax, to retain product for Shire to sell itself as branded Adderall XR, or otherwise would constitute a breach of Shire s License Agreement with Teva. Teva is Sustaining Substantial and Irreparable Harm from Shire s Failure to Comply with its Obligation to Supply AG Product 50. On information and belief, Shire has the ability to supply Teva with more AG Product than Shire has supplied. 51. Shire s failure to comply with its obligation to supply the full quantities of AG Product for which Barr has submitted binding purchase orders in the delivery times specified by the License Agreement will cause significant and irreparable injury to Teva. 52. If Shire fails to deliver the quantities set out in Teva s binding purchase orders, Teva will not have sufficient inventory to meet the demands of customers for Generic Equivalent. As a result of this inadequate inventory, Teva will lose substantial volumes of sales of Generic Equivalent. 53. Unless enjoined, Shire s conduct also will cause significant reputational harms to Teva and damage the company s goodwill. Purchasers of generic drug products such as retail LIBA/

15 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 15 of 55 pharmacies who select a particular drug company to supply them with a particular product expect that company to continue to make the product available to them and not to experience supply interruptions. If Teva is not able to supply its customers with Generic Equivalent, that failure will harm Teva s relationship with its customers. In addition, it may cause Teva to lose additional business in the future, as customers may be less willing to purchase products from Teva if they no longer believe they can rely on supply of those products. Teva s Right to Specific Performance 54. An award of money damages will not provide an adequate remedy to Teva for the injury it is suffering, and will suffer, from Shire s breach of its supply obligations. Given the complete absence of alternate supply sources, Teva could not use money damages to purchase finished product to be sold as Generic Equivalent. Given the pendency of Shire s Citizen Petition with FDA, which is preventing FDA from granting final approval to any ANDAs for this product, Teva could not legally manufacture and sell its own Generic Equivalent, even were Teva to use money damages to purchase the necessary ingredients. 55. No product other than AG Product constitutes acceptable cover. Customer demand for Generic Equivalent is limited to products which can legally be dispensed, without need for intervention by a physician, to a patient who has received a prescription for Adderall XR. Under federal and state law, only brand Adderall XR and products that are therapeutic equivalents to Adderall XR i.e., generic equivalents and AG Product satisfy that legal standard. Other ADHD drugs, including other formulations of Adderall, do not. Therefore, Teva cannot meet its customers demand for Generic Equivalent with anything other than AG Product supplied by Shire, or a generic equivalent that (due to Shire s Citizen Petition) neither it nor any other company is legally permitted to manufacture. The AG Product Shire is obligated to supply under the License Agreement is the only option. LIBA/

16 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 16 of 55 COUNT I (Declaratory Judgment Breach of Contract 28 U.S.C and 2202) 56. Teva repeats the allegations of paragraphs 1 through 55 as if set forth here in full. 57. A case or controversy exists between Teva, and Shire concerning supply obligations under the License Agreement as between Teva and Shire, which requires a declaration of rights by this Court. 58. The relief that Impax seeks in this suit is an order that may, either explicitly or in practical effect, require that Shire sell even less product to Teva than it already sells, so that Shire would have more product to sell to Impax. 59. Teva is entitled to a declaration pursuant to the Declaratory Judgment Act, 28 U.S.C and 2202, that an action by which Shire fails to supply fully the quantities of AG Product properly ordered by Teva whether in order to supply additional product to Impax, to retain product for Shire to sell itself as branded Adderall XR, or otherwise would constitute a breach of Shire s License Agreement with Teva. COUNT II (Breach of Contract Specific Performance N.Y. C.L.S ) 60. N.Y. C.L.S provides that [s]pecific performance may be decreed where the goods are unique or in other proper circumstances. consideration. 61. Teva repeats the allegations of paragraphs 1 through 59 as if set forth here in full. 62. The License Agreement is a binding and valid contract, supported by adequate 63. The provisions in the License Agreement concerning the supply of AG Product by Shire to Barr constitute a contract for the sale of goods. 64. Specific performance is warranted because AG Product is unique as the term is LIBA/

17 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 17 of 55 used in N.Y. C.L.S (1). 65. Additionally, proper circumstances for specific performance exist because there is no alternative source to which Teva can turn to obtain AG Product. 66. Barr and Teva fully performed its obligations under the License Agreement prior to the assignment to Teva by, among other things, refraining from commencing sales of Generic Equivalent until the License Effective Date, providing timely notice of Barr s election to have Shire supply Barr with AG Product pursuant to the terms of the License Agreement, and providing Shire with forecasts and binding purchase orders for AG Product within the times and manners set forth in the License Agreement. Teva has fully performed its obligations under the License Agreement following the assignment. 67. Shire breached the License Agreement by failing to supply AG Product in the quantities properly ordered by Teva pursuant to binding purchase orders and within the time limits specified by the License Agreement and the binding purchase orders. 68. Shire has the ability to supply to Teva some or all the AG Product that Teva properly ordered pursuant to the License Agreement but that Shire has refused to supply. consideration. COUNT III (Breach of Contract Specific Performance Common Law) 69. Teva repeats the allegations of paragraphs 1 through 68 as if set forth here in full. 70. The License Agreement is a binding and valid contract, supported by adequate 71. Barr and Teva fully performed its obligations under the License Agreement prior to the assignment to Teva by, among other things, refraining from commencing sales of Generic Equivalent until the License Effective Date, providing timely notice of Barr s election to have Shire supply Barr with AG Product pursuant to the terms of the License Agreement, and LIBA/

18 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 18 of 55 providing Shire with forecasts and binding purchase orders for AG Product within the times and manners set forth in the License Agreement. Teva has fully performed its obligations under the License Agreement following the assignment. 72. Shire breached the License Agreement by failing to supply AG Product in the quantities properly ordered by Barr pursuant to binding purchase orders and within the time limits specified by the License Agreement and the binding purchase orders. 73. There is no alternative source to which Teva can turn to obtain AG Product. 74. Shire has the ability to supply some or all the AG Product that Teva properly ordered pursuant to the License Agreement but that Shire has refused to supply. 75. Teva has no adequate remedy at law. JURY DEMAND Teva requests a jury trial for all issues so triable. PRAYER FOR RELIEF WHEREFORE, Plaintiff Teva Pharmaceuticals USA, Inc. asks the Court to enter judgment in its favor, and against the Defendant Shire LLC, as follows: (a) Entering an order declaring that any action by Shire diverting supply of AG Product from Teva to Impax, either directly or indirectly, or otherwise failing to supply Teva with the full quantities of product ordered by Teva on a timely basis will constitute a breach of the License Agreement between Teva and Shire; (b) Entering an order declaring that retaining supply of Adderall XR product for Shire to distribute itself while failing to supply the entire amount of AG Product properly ordered by Teva will constitute a breach of the License Agreement between Teva and Shire; (c) Entering preliminary and permanent injunctive relief requiring specific LIBA/

19 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 19 of 55 performance by Shire of its obligations to fulfill all orders for AG Product made by Teva pursuant to the License Agreement; (d) Awarding Teva attorneys fees and the costs and expenses associated with its efforts to enforce the License Agreement; and (e) Granting such other and further relief in favor of Teva as this Court deems just and proper, including nominal damages. Dated: New York, New York November, 2010 Respectfully submitted, TEVA PHARMACEUTICALS USA, INC. By its attorneys, David M. Hashmall (DH9966) GOODWIN PROCTER LLP The New York Times Building 620 Eighth Avenue New York, NY Tel: Fax: Christopher T. Holding (pro hac vice application pending) Robert D. Carroll (RC1028) GOODWIN PROCTER LLP Exchange Place 53 State Street Boston, MA Tel: Fax: LIBA/

20 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 20 of 55 EXHIBIT A

21 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 21 of 55 Commonwealth of Kentucky Trey Grayson, Secretary of State LARP Trey Grayson Secretary of State Received and Filed 6/23/2010 5:02:46 PM Fee receipt: $ /23/2010 Trey Grayson Secretary of State P. O. Box 1150 Frankfort, KY (502) Annual Report Online Filing ARP Company: SHIRE LLC Company ID: State of origin: Kentucky Formation date: 1/6/ :00:00 AM Date filed: 6/23/2010 5:02:46 PM Fee: $15.00 Principal Office 9200 BROOKFIELD CT. SUITE 108 FLORENCE, KY Registered Agent Name/Address C T CORPORATION SYSTEM 306 W MAIN ST SUITE 512 FRANKFORT, KY Members/Managers Manager James Harrington 725 Chesterbrook Boulevard, PA, 19087, USA Signatures Signature Title James Harrington Manager

22 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 22 of 55 EXHIBIT B

23 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 23 of 55 Organization Number Name SHIRE LLC Profit or Non-Profit P - Profit Company Type KLC - Kentucky Limited Liability Company Status A - Active Standing G - Good State KY File Date 1/6/2004 Organization Date 1/6/2004 Last Annual Report 6/23/2010 Principal Office 9200 BROOKFIELD CT. SUITE 108 FLORENCE, KY Managed By Managers Registered Agent C T CORPORATION SYSTEM 306 W MAIN ST SUITE 512 FRANKFORT, KY Manager James Harrington Organizer SHANNON M. KUHL Documents filed with the Office of the Secretary of State on September 15, 2004 or thereafter are available as scanned images or PDF documents. Documents filed prior to September 15, 2004 will become available as the images are created.!! " # $% && " " & " & " # & " # '"( " '"( " ## " '"( ## "

24 " " "') Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page " 24 of 55 *+,-. Filing File Date Effective Date Org. Referenced # #!!!# *.. *.. " " " 6( # &! & ## # & # # # ## &#! ## # # #!! # & & ## /$01$%.,2 # /$01*3452 # # ## ## *+,-(07,*,8,'$33( Microfilm images are not available online. They can be ordered by faxing a Request For Corporate Documents to the Corporate Records Branch at '"( ## ## " "')

25 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 25 of 55 EXHIBIT C

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52 Case 1:10-cv MGC Document 11-1 Filed 11/18/10 Page 52 of 55 EXHIBIT D

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