exhibit a - cbs moneywatchi.bnet.com/blogs/adderall-complaint-teva.pdf · case 1:10-cv-08386-mgc...

EXHIBIT A

Case 1:10-cv-08386-MGC Document 11-1 Filed 11/18/10 of 55

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UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK

IMPAX LABORATORIES, INC.,

Plaintiff,

v. SHIRE LLC and SHIRE LABORATORIES, INC.,

Defendants.

TEVA PHARMACEUTICALS, USA, INC.,

Plaintiff-Intervenor,

v.

SHIRE LLC,

Defendant.

Civ. Action No. 10-CV-83860MGC Judge Miriam G. Cedarbaum Magistrate Judge Andrew J. Peck

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


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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, 2009. 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, 2010.

5. 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


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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 41042. 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 41042 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.


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11. 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 2001.

13. 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

2019.

14. 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


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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, 2006.

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, 2006. 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, 2009. This license ensures that, as of April 1,


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2009, 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, 2009. 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


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(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, 2009.

21. 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


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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.


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29. 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 2009.

32. 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


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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


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New York Supreme Court to this Court on November 2, 2010.

38. 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


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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


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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


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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.


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COUNT I (Declaratory Judgment – Breach of Contract – 28 U.S.C. §§ 2201 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. §§ 2201 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. § 2-716)

60. N.Y. C.L.S. § 2-716 provides that “[s]pecific performance may be decreed where

the goods are unique or in other proper circumstances.”


62. The License Agreement is a binding and valid contract, supported by adequate

consideration.

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


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used in N.Y. C.L.S. § 2-716(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.

COUNT III (Breach of Contract – Specific Performance – Common Law)


70. The License Agreement is a binding and valid contract, supported by adequate

consideration.

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


17 LIBA/2131894.3

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


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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 10018 Tel: 212.813.8800 Fax: 212.355.3333 Christopher T. Holding (pro hac vice application pending) Robert D. Carroll (RC1028) GOODWIN PROCTER LLP Exchange Place 53 State Street Boston, MA 02109 Tel: 617.570.1000 Fax: 617.523.1231


EXHIBIT A


6/23/2010Commonwealth of KentuckyTrey Grayson, Secretary of State

Trey GraysonSecretary of State

P. O. Box 1150Frankfort, KY 40602-1150

(502) 564-3490http://www.sos.ky.gov

Annual ReportOnline Filing

ARP

LARP

0575739Trey GraysonSecretary of StateReceived and Filed

6/23/2010 5:02:46 PMFee receipt: $15.00

Company: SHIRE LLCCompany ID: 0575739State of origin: KentuckyFormation date: 1/6/2004 12:00:00 AMDate filed: 6/23/2010 5:02:46 PMFee: $15.00

Principal Office

9200 BROOKFIELD CT.SUITE 108FLORENCE, KY 41042

Registered Agent Name/Address

C T CORPORATION SYSTEM306 W MAIN STSUITE 512FRANKFORT, KY 40601

Members/Managers

Manager James Harrington 725 Chesterbrook Boulevard, PA, 19087, USA

Signatures

Signature James HarringtonTitle Manager


EXHIBIT B


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� Organization Number 0575739� 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

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Principal Office 9200 BROOKFIELD CT. SUITE 108 FLORENCE, KY 41042

� Managed By Managers

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Registered Agent C T CORPORATION SYSTEM 306 W MAIN ST SUITE 512 FRANKFORT, KY 40601

� Manager James Harrington

� Organizer SHANNON M. KUHL

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EXHIBIT C


EXHIBIT D
