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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK IMP AX LABORATORIES, INC., Plaintiff, v. SHIRE LLC and SHIRE LABORATORIES, INC., : Defendants. NOTICE OF REMOVAL TO THE CLERK OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK: PLEASE TAKE NOTICE that defendant Shire LLC hereby removes to this Court the state-court action described below. On November 1,2010, plaintiffImpax Laboratories, Inc. ("Impax") commenced an action in the Supreme Court of the State of New York, County of New York, entitled lmpax Laboratories, Inc. v. Shire LLC and Shire Laboratories, Inc. On November 1,2010, counsel for defendant Shire LLC received copies of the summons and complaint in the state-court action from counsel for Impax. Shire LLC timely filed this Notice of Removal on November 2,2010. Copies of all nonconfidential process, pleadings, and orders provided to Shire LLC in the state-court action are attached as Exhibit A. ef aU 8oft§eoftti6IIH6ee33, f'leagipgs, and _ -'O'r.del=S I3roYiee€l to 8mle LbC i:B: tAo stftte eoml action enc attached as Exhibit B Me Me flied ..... %Yh q Itt I 0 I 0 - 1- 0084 JOI9.DOC Case 1:10-cv-08386-MGC Document 1 Filed 11/05/10 Page 1 of 44
Transcript
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UNITED STATES DISTRICT COURTSOUTHERN DISTRICT OF NEW YORK

IMPAX LABORATORIES, INC.,

Plaintiff,

v.

SHIRE LLC and SHIRE LABORATORIES, INC., :

Defendants.

NOTICE OF REMOVAL

TO THE CLERK OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERNDISTRICT OF NEW YORK:

PLEASE TAKE NOTICE that defendant Shire LLC hereby removes to this Court the

state-court action described below.

On November 1,2010, plaintiffImpax Laboratories, Inc. ("Impax") commenced an

action in the Supreme Court of the State ofNew York, County ofNew York, entitled lmpax

Laboratories, Inc. v. Shire LLC and Shire Laboratories, Inc.

On November 1,2010, counsel for defendant Shire LLC received copies of the summons

and complaint in the state-court action from counsel for Impax. Shire LLC timely filed this

Notice of Removal on November 2,2010.

Copies of all nonconfidential process, pleadings, and orders provided to Shire LLC in the

state-court action are attached as Exhibit A. Co~ie9 ef aU 8oft§eoftti6IIH6ee33, f'leagipgs, and _

-'O'r.del=S I3roYiee€l to 8mle LbC i:B: tAo stftte eoml action enc attached as Exhibit B Me Me flied .....

%Yh q Itt ~ I~ 0 I 0

- 1 - 0084 JOI9.DOC

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This is a civil action for which this Court has original jurisdiction under 28 U.S.C.

§ 1332, and may be removed to this Court by Shire LLC pursuant to the provisions of28 U.S.C.

§1441 (b) in that it is a civil action between citizens of different states and the matter in

controversy exceeds the sum of $75,000, exclusive of interest and costs. For instance, Impax

alleges that Shire's alleged contractual breach has resulted "in millions of dollars of financial

losses to Impax." (Ex. A CompI. , 24.)

Impax alleges that it is a corporation organized under the laws of Delaware, with its

principal place of business in Hayward, California. (Ex. A CompI. , 3.) As Impax recognizes,

Shire LLC is a Kentucky limited liability company, with its principal place of business in

Wayne, Pennsylvania. (Ex. A CompI. , 4.)

The complaint also names Shire Laboratories, Inc. ("SLI") as a defendant. SLI's

citizenship should be disregarded for purposes of determining jurisdiction under 28 U.S.c.

§ 1332 and 28 U.S.c. § 1441(b) on the ground that there is no possibility that Impax will be able

to establish liability against SLI because SLI ceased to exist years ago. On December 15,2006,

SLI merged with and into Shire LLC, and thus ceased to exist as a separate and distinct corporate

entity. (See Ex. C, Agreement and Plan of Merger dated December 15,2006 at § 1.01 (b),

stating, "At the Effective Time, the Delaware Corporation shall be merged with and into the

Kentucky LLC, whereupon the separate existence of the Delaware Corporation shall cease, and

the Kentucky LLC shall be the surviving entity of the Merger....")

WHEREFORE, Shire LLC prays that this action be removed to the United States District

Court for the Southern District ofNew York.

- 2 - 00841019 DOC

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.~177.~ Dated: New York, New York

November 2, 2010 Edgar H. Haug Steven M. Amundson Michael F. Brockmeyer FROMMER LAWRENCE & HAUG LLP

745 Fifth Avenue NewYork,NewYork 10151 Telephone: (212) 588-0800 Facsimile: (212) 588-0500 [email protected] [email protected] [email protected]

Attorneys for Shire LLC

- 3 - 00841019.00C

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CERTIFICATE OF SERVICE

I certify that on this 2nd day ofNovember 2010, I caused a copy of SHIRE LLC'S NOTICE OF REMOVAL to be served on the following counsel:

BY E-MAIL and FEDERAL EXPRESS Ansim M. Bhansali, Esq. Paula L. Blizzard, Esq. Sharif E. Jacob, Esq. Keker & Van Nest LLP 710 Sansome Street San Francisco, CA 94111-1704 Attorneys for Plaintiff Impax Laboratories, Inc.

And

Jonathan Bach, Esq. Cooley LLP 1114 Avenue of the Americas New York, NY 10036 Attorneys for Plaintiff Impax Laboratories, Inc.

DATED: November 2,2010

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Exhibit A

1. Statement in Support of Assignment to Commercial Division

2. Redacted Complaint

3. Order to Show Cause with a Temporary Restraining Order

4. Emergency Affirmation of Asim Bhansali

5. Signed Order to Show Cause

Exhibit B

1. Unredacted Summons and Complaint with Exhibits

2. Plaintiffs Memo in Support of Order to Show Cause

3. Bhansali Affirmation, Including Affidavit of Todd Engle, Affidavit of Charles Hildenbrand, and Affidavit of Asim M. Bhansali

Exhibit C

1. Articles of Merger of Shire Laboratories into Shire LLC

00841 I I7.DOC

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A

Document2

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1

Documcnt2

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SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK

------------------------------------- ­IMPAX LABORATORIES, INC.,

X

-against-

Plaintiff, Index No.

SHIRE LLC and SHIRE LABORATORIES, INC.,

Defendants.

STATEMENT IN SUPPORT OF ASSIGNMENT TO COMMERCIAL DIVISION

-------------------------------------- X

ASIM M. BHANSALI, counsel for Plaintiffhnpax Laboratories, Inc., submits this

Statement and the accompanying copy of the pleadings, pursuant to Section 202.70(d)(2) of the

Unifonn Rules for the Trial CoUTts, in support of the request of said party for the assignment of

this matter to the Commercial Division of this court.

I. As counsel for Plaintiffhnpax Laboratories, Inc., I have reviewed the standards

for assignment of cases to the Commercial Division set forth in Rule 202.70. This case meets

those standards, and I therefore request that this case be assigned to the Commercial Division.

2. The sums at issue in this case are in excess of the monetary threshold of the

Division as set out in Subdivision (a) of said Section, in that the amount of damages sought

(exclusive ofpunitive damages, interest, costs, disbursements and counsel fees claimed) exceeds

S150,000, and equitable relief is sought in that, Plaintiff seeks specifIc perfonnance pursuant to

N.Y. Uc.c. Law § 2-716, and pursuant to N.Y. C.P.L.R. 6301, Plaintiff also seeks a temporary

restraining order and a preliminary injunction.

3. This case falls squarely within the standards set out in Subdivision (b) of Section

202.70 and does not fall within the types of cases set out in Subdivision (c) that will not be heard

524483.01

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in the Divisl,o~ infuatitisab:rea~h ofcontractacti,oo and mvolvestfll.t\Sactfonsgi)'vernedbythe

Unifoffi) Comm.eteial Code. Uniform Rules for Trial Courts (22 NYCRR)§202.70(b)(l),

(b)(2).

Dated: October 30, 2010

~ ~ UO/MoL~q)· ASlm M. Bhaosall Paula L. Blizzard (ProHac Vice Application

Forthcoming) SharifE. Jacob (Pro Hac Vice Application

Forthcoming) KEKER & VAN NEST LLP 710 Sansome Street San Francisco; CA 94J 11-1704 Telephone: (415) 391-5400 Facsimile: (415) 397-7188

COOLEYLLP Jonathan: Bach 1114 Avenue of the Americas New York, NY 10036 Telephone: (212) 479-6000 Facsimile: (212) 479-6275

Attorneys for Plaintiff IMPAX LABORATORlES, INC.

2 524483.01

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IREDACTED SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK

IMPAX LABORATORIES, INC., Index No. -----"-U_f/_i_9) 12010

Plaintiff,

v.

SHIRE LLC and SHIRE LABORATORIES, INC.

Defendant.

COMPLAINT AND JURY DEMAND

INTRODUCTION

1. Impax Laboratories, Inc. ("Impax") brings this case to protect Impax's right to a

supply of authorized generic Adderall XR ("AG Product") under its Settlement Agreement with.

Defendant Shire Laboratories, Inc., and its License and Distribution Agreement ("Distribution

Agreement") with Defendant Shire LLC. The Settlement Agreement and Distribution

Agreement (collectively, "Agreements") obligate Shire LLC and Shire Laboratories, Inc.

(collectively, "Shire" or "Defendan~s") to fill without delay Irnpax's orders for Shire's product

Adderall XR, which is labeled and sold as an "authorized generic" version of Adderall XR.

Defendants willfully and intentionally breached that obligation by supplying only a small

fraction of Impax's orders, even though the Agreements require Defendants to meet Impax's

requirements, and Defendants have sufficient quantity available to meet Impax's orders.

Defendants' breach has caused Impax to suffer irreparable harm to its customer relationships and

business goodwill, and substantial financial losses.

2. Impax seeks damages, specific performance, and injunctive relief to remedy

Defendants' wrong.<iQing. Because of regulatory requirements imposed by the United States

Food and Drug Administration ("FDA"), no source for the AG Product other than Shire exists;.

Irnpax has no commercially reasonable alternative--or any alternative-to Shire. Therefore,

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both damages and specific performance are necessary for Impax to obtain an adequate remedy

for Defendants' willful failure to meet their obligations under the Agreements.

PARTIES

3. Impax isa corporation organized under the laws of Delaware, with its principal

place of business in Hayward, California. Impax develops, manufactures, and sells

pharmaceutical products.

4. Defendant Shire LLC is a Kentucky limited liability company, with its principal

place of business, on information and belief, in Wayne, Pennsylvania.

5. Defendant Shire Laboratories, Inc. ("Shire Labs") is a corporation organized .

under the laws of Delaware, with its principal place of business, on information and belief, in

Wayne, Pennsylvania.

6. Shire develops and sells pharmaceutical products. Shire also manufactures

pharmaceutical products, either directly or through a contract manufacturer.

JURISDICTION AND VENUE

7. This Court has jurisdiction over all claims in this case under the N.Y. Const. art.

VI § 7(a).

8. This Court has jurisdiction over the parties because the parties executed a forum

selection clause consenting to the personal jurisdiction of this Court and designating this Court as

the forum for resolving disputes arising out of the Distribution Agreement.

9. Venue is proper in this judicial district under N.Y. c.P.L.R. 503 because, on

information and belief, none of the parties reside in this state.

FACTUAL BACKGROUND

Adderall XR and the Shire-Impax Agreements

10. Adderall XR is a prescription drug used to treat Attention Deficit Hyperactivity

Disorder ("ADHD").

11. Shire sells, among other prescription drugs, the brand-name version of Adderall

XR. Shire Labs is the owner of New Drug Application ("NDA") No. 21-303, approved by the

FDA in 2001 for the manufacture and sale of Adderall XR.

2

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12. Impax sought to enter the market with its own generic version of Adderall XR by

fIling an Abbreviated New Drug Application ("ANDA") with the FDA. In response, Shire sued

Impax for patent infringement under the Hatch:'Waxman Act; which allows branded versions of

drugs to sue their generic counterparts under certain circumstances before the ANDA is

approved by FDA.

13. On or about January 19, 2006, Shire Labs and Impax entered into a negotiated

Settlement Agreement dismissing the patent lawsuit. The negotiated settlement included the

Distribution Agreement, which Impax and Shire executed. A copy of the Settlement Agreement,

including the Distribution Agreement, is attached hereto as Exhibit A.

14. Impax's license under the Distribution Agreement became effective, under the

Distribution Agreement's terms, on or about October 1, 2009 ("Impax License Effective Date").

15. Under the Distribution Agreement, Impax could enter the market with a generic

version of Adderall XR on or after the Irnpax License Effective Date, in one of two ways. Impax

could enter the market with a generic Adderall XR product m~de by Impax under the Impax

ANDA or, alternatively, Impax had the option to elect to have Shire supply Irnpax's

requirements for authorized generic Adderall XR.

16. The FDA has not approved Irnpax's ANDA. Impax has elected to order and sell

AG Product using the promised supply from Shire, as provided for in the Distribution

.Agreement.

17. The AG Product is manufactured by Shire and/or its contractor DSM

Pharmaceuticals, Inc. ("DSM"). It is the same product as branded Adderall XR, except for

differences in appearance, such as the printing. However, the AG Product is not sold as Adderall

XR. Rather, it is labeled as a generic product and sold by Impax under the label of Global

Pharmaceuticals, the generic division of Impax.

18. The Distribution Agreement sets forth the process for Shire to fill Impax's orders

for AG Product. For Impax's initial order, Shire was required to supply Impax the quantity of

AG Product that Impax requested in a binding forecast for its initial launch of the AG Product,

including the first three months of its sales. After that initial order, Irnpax places its orders based

3

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REDACTED on its forecasted sales pursuant to Section 5.4 of the Distribution Agreement. Under Section 5.5,

Shire has to deliver hnpax's orders within five days of the requested delivery date.

19. Paragraph 14 of the Settlement Agreement provides that any breach of the

Distribution Agreement constitutes a breach of the Settlement Agreement.

Shire's Failure to Supply AG Product to Impax While Enriching Itself

20. In advance of the Impax License Effective Date, Impax timely and appropriately

notified Shire of its contractual right to have Shire manufacture and supply AG Product under

the Distribution Agreement. Impax also timely submitted its order for an initial launch quantity

of AG Product. Following its initial order, Impax has continued to submit timely orders for AG

Product, based on its forecasts, up to the present time.

21. Shire did not timely fill all of Impax's orders specifying delivery in 2009. Shire

failed to timely fill at least"of the orders that Impax placed for AG Product specifying

delivery in 2009. Despite Shire's obligations under the Distribution Agreement, Shire's failure

to meet Impax' s orders has accelerated in 2010. Without justification, Shire has not fully

delivered_of the orders specifying delivery in 20 I0, and even when it has partially filled an

order, it has been late. Shire has failed to fill any portion of at leas~of the orders due in

2010.

22. While not meeting Impax's orders, Shire continues to supply some or all of its·

own needs for Adderall XR, and is still selling substantial volumes of the product in the market.

Upon information and belief, Shire could have used some or all of the Adderall XR that it is \

selling onits own to supply Impax's requirements for AG Product.

23. 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.

24. However, Defendants have chosen to willfully breach their obligations under the

Agreements, resulting in millions of dollars of financial losses to .Impax. Moreover, the injury to

4

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. Impax is not just financial. When hnpax does not get supply from Shire, it cannot supply its own

customers, because the AG Product is a unique good that hnpax cannot obtain elsewhere.

Impax's in'ability to supply its customers results in irreparable harm to hnpax's business

goodwill and its reputation with customers.

25. Demand for Adderall XR or its authorized generics is expected to grow in the first

quarter of 2011. Impax needs immediate relief in order to prevent Shire from using denial of

supply to Impax to capture that expected growth.

26. Furthermore, customers who cannot buy.the authorized generic from Impax will

switch some or all of their orders away from Impax. They may switch to Shire's branded

Adderall XR or Teva's authorized generic Adderall XR-the only other forms of Adderall XR

available on the market. If customers move their orders to an alternative source of Adderall XR,

. Impax will have difficulty switching back those customers, even if its supply of AG Product is

revived. Thus, hnpax is irreparably harmed by Shire's failure to deliver on Impax's orders for

AG Product.

27. Defendants profit from their willful breach of the Agreements in several ways.

First, Shire sells more AdderallXR, which increases its revenues because Shire's profit on

Adderall XR is higher than the royalty Impax pays for the AG Product. Second, Shire profits

further because Impax's inability to meet customer orders means that competition is reduced.

Thus, Defendants' breach of the Agreements hurts not only Impax, but also consumers in the

marketplace, who have to pay higher prices, because less supply of hnpax 's less expensive

authorized generic is available.

Dispute Resolution Efforts

28. . Impax has made substantial efforts to resolve this dispute prior to filing this

Complaint.

29. Impax has complied with the dispute resolution provisions in Section 16.13 of the'

Distribution Agreement before filing this Complaint.

30. Indeed, Impax has made efforts above and beyond those required under Section

16.13 to resolve this dispute.

5

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FIRST CAUSE OF ACTION

Breach of Contract - Damages - Common Law

(plaintiff Impax Against Shire Defendants)

31. hnpax realleges and incorporates by reference every one of its prior allegations.

32. The Settlement Agreement entered into between I~pax and Shire Labs on'

January 19,2006 is valid, binding, and enforceable.

33. Paragraph 14 of the Settlement Agreement provides that a breach of the

Distribution Agreement constitutes a breach of the Settlement Agreement.

34. The Distribution Agreement entered into between hnpax and Shire LLC on

Janllary 19,2006 is valid, binding, and enforceable.

35. Section 5.5 of the Distribution Agreement requires Shire to supply Impax' s orders

of AG Product within five days of the specified delivery date.

36. Impax has fully performed its obligations underthe Distribution Agreement.

Among other things, Impax timely submitted its orders for AG Product pursuant to the terms of

the Distribution Agreement.

37. All conditions required by the Distribution Agreement for Shire's performance

have occurred.

38. . Defendants breached the Agreements by taking one or more actions contrary to its

terms, including but not limited to failing to fill Iinpax's orders of AG Product and their breach is

continuing to this day.

39. Defendants acted in bad faith and with reckless disregard to Impax's rights under

the Agreements.

40. As a result of Defendants' breach, Impax has suffered damages in the form of lost

profits and other incidental and consequential damages to be proved at trial. lmpax has suffered

millions of dollars of financial losses plus irreparable harm to its business reputation and

goodWill. Impax has been unable to fill its customers' orders for AG Product, and, as a result,

these customers have abandoned Impax for other suppliers, including Shire. hnpax's lost profits

were foreseeable and within the contemplation of the parties at the time the Agreements were

6

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executed. Thus, Defendants would have foreseen that if it did not make the deliveries required

Onder the Agreements, Impax would lose profits as a result.

SECOND CAUSE OF ACTION

Breach of Contract - Damages - N.Y. U.C.C. Law §§ 2-713 & 2-715

(plaintiff Impax Against Shire Defendants)

41. Impax realleges and incorporates by reference every one of its prior allegations.

42. The Settlement Agreement entered into between Impax and Shire Labs on

January 19,2006 is valid, binding, and enforceable.

43. Paragraph 14 of the Settlement Agreement provides that a breach of the

Distribution Agreement constitutes a breach of the Settlement Agreement.

44. The Distribution Agreement entered into between Impax and Shire LLC on

January 19,2006 is valid, binding, and enforceable.

45. Section 5.5 of the Distribution Agreement requires Shire to supply Impax's orders

of AG Product within five days of the specified delivery date.

46. Impax has fully performed its obligations under the Distribution Agreement.

Among other things, Impax timely submitted its orders for AG Product pursuant to the terms of

the Distribution Agreement.

47. All conditions required by the Distribution Agreement for Shire's performance

have occurred.

48. Defendants breached the Agreements by taking one or more actions contrary to its

terms, including but not limited to failing to fill Impax's orders of AG Product and their breach is

continuing to this day.

49. Defendants acted in bad faith and with reckless disregard to Impax's rights under

the Agreements ..

50. As a result of Defendants' breach, Impax has suffered damages in the form of lost

profits and other incidental and consequential damages to be proved at trial. Impax has suffered

millions of dollars of financial losses plus irreparable hairn to its business reputation and

goodwill. Impax has been unable to fill its customers' orders for AG Product, and., as a reSUlt,

7

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these customers have abandoned Impax for other suppliers, including Shire. Impax's lost profits

were foreseeable and within the contemplation of the parties at the time the Agreements were

executed. Thus, Defendants would have foreseen that if it did not make the deliveries required

under the Agreements, Impax would lose profits as a result.

51. Pursuant to N.Y. V.e.e. Law §§ 2-713 and 2-715, Impax requests an award of all

damages, including lost profits and other consequential damages, that Impax incurred as a result

of Defendants' breach of the Agreements.

THIRD CAUSE OF ACTION

Breach of Contract - Specific Performance - Common Law

(plaintiff Impax Against Shire Defendants)

52. Impax realleges and incorporates by reference everyone of its prior allegations.

53. The Settlement Agreement entered into between Impax and Shire Labs on

January 19,2006 is valid, binding, and enforceable.

54. Paragraph 14 pf the Settlement Agreement provides that a breach of the

Distribution Agreement constitutes a breach of the Settlement Agreement.

55. The Distribution Agreement entered into between Impax and Shire LLC on

January 19, 2006 is valid, binding, and enforceable.

·56. Section 5.5 of the Distribution Agreement requires Shire to supply Impax's orders

of AG Product within five days of the specified delivery date.

57. Impax has fully performed its obligations under the Distribution Agreement.

Among other things, Impax has timely submitted its orders for AG Product pursuant to the terms

of the Distribution Agreement.

58. All conditions required by the Distribution Agreement for Shire's performance

have occurred.

59. Defendants breached the Agreements by taking one or more actions contrary to its

terms, including but not limited to failing to fill Impax' s orders of AG Product and their breach is

continuing to this day.

60. As a result of Defendants' continuing breach, Impax has suffered millions of

8

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dollars of financial losses plus irreparable harm to its business reputation and goodwill. hnpax

has been unable to fIll its customers' orders for AG Product, and, as a result, these customers

have abandoned Impax for other suppliers, including Shire.

61. Shire has the ability to fill some or all ofImpax's orders of AG Product.

62. There is no adequate remedy at law to compensate Impax for Defendants' breach

of the Distribution Agreement. No alternative source exists to which Impax can turn to obtain

AG Product. Money damages are insufficient to compensate Impax for the loss of customer

goodwill and business reputation.

FOURTH CAUSE OF ACTION

Breach of Contract - Specific Performance - N.Y. U.C.C~ Law § 2-716

(Plaintiff Impax Against Shire Defendants)

63. Impax realleges and incorporates by reference everyone of its prior allegations.

64. The Settlement Agreement entered into between Impax and Shire Labs on

January 19,2006 is valid, binding, and enforceable.

65. Paragraph 14 of the Settlement Agreement provides that a breach of the

Distribution Agreement constitutes a breach of the Settlement Agreement.

66. The Distribution Agreement entered into between Impax and Shire LLC on.

January 19, 2006 is valid, binding, and enforceable.

67. Section 5.5 of the Distribution Agreement requires Shire to supply Impax's orders

of AG Product within five days of the specified delivery date.

68. Impax has fully performed its obligations under the Distribution Agreement.

Among other things, Impax has timely submitted its orders for AG Product pursuant to the terms

of the Distribution Agreement.

69. All conditions required by the Distribution Agreement for Shire's performance

have occurred.

70. Defendants breached the Agreements in bad faith by taking one or more actions

contrary to its terms, including but not limited to failing to fill Impax's orders of AG Product and

their breach is continuing to this day.

9

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71. As a result of Defendants' continuing breach, Impax has suffered millions of

dollars of financial losses plus irreparable harm to its business reputation and goodwill. Impax

has·been unable to fill its customers' orders for AG Product, and. as a result, these customers

have abandoned Impax for other suppliers, including Shire.

72. Shire has the ability to fill some or all of Impax's orders of AG Product.

73. Specific performance is warranted because AG Product is unique as the term is

used in N.Y. u.C.C. Law § 2-716(1). No alternative source exists to which Impax can tum to

obtain AG Product.

74. There is no adequate remedy at law to compensate Impax for Defendants' breach

of the Agreements. Money damages are insufficient to compensate Impax for the loss of

customer goodwill and business reputation.

FIFTH CAUSE OF ACTION

Intentional Interference With Prospective Economic Advantage

(Plaintiff Impax Against Shire Defendants)

75. Impax realleges and incorporates by reference every one of its prior allegations.

76. Iinpax had business relationships with third parties whereby Impax would supply

these third parties with AG·Product that it obtained from Shire.

77. Defendants were aware of Impax •s relationships with these third parties.

78. Defendants intentionally interfered with Impax's relationships with its customers.

Defendants chose not to meet Impax's requirements. Defendants did so knowing that such

failure to deliver AG Product would interfere with Impax's relationships with its customers.

Upon information and belief, Defendants took this action, at least in part, in order to compel

customers to use their own products.

79. Defendants acted out of malice and with the intent of inflicting harm on Impax.

80. But for Defendants' conduct, Impax would have cOntinued its relationships with

its customers. Defendants' conduct caused Impax to suffer financial losses as well as irreparable

harm to its business reputation and customer goodwill.

10

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SIXTH CAUSKOF ACTION

" Unjust Enrichment

(Plai~tiffImpax Against Shire Defendants)

81. Impax real1eges and incorporates by reference ~very one of its prior allegations.

82. Defendants have been enriched by their improper conduct. Defendants' breach of

-the Agreements has resulted in more revenue and profit for themselves. Instead of filling

hnpax's timely orders of AG Product pursuant to the Distribution Agreement;Shire, upon

information and belief, decided to sell some or all of its available product as Adderall XR.

Defendants' actions resulted in higher profits for Shire than if it had supplied AG Product to

hnpax as the Agreements require.

83. Defendants' enrichment has been at Impax's expense.

84. It is improper and unjust for Defendants to retain the benefit of any additional

profit it gained by selling Adderall XR that could have been used to supply Impax.

SEVENTH CAUSE OF ACTION

Breach of·the Covenant of Good Faith and Fair Dealing

(Plaintiff Impax Against Shire Defendants)

85. Impax realleges and incorporates by reference everyone of its prior allegations.

86. The Settlement Agreement entered into between Impax and Shire Labs on

January 19, 2006 is valid, binding, and enforceable.

87. Paragraph 14 of the Settlement Agreement provides that a breach of the

Distribution Agreement constitutes a breach of the Settlement Agreement.

." 88. The Distribution Agreement entered into between Impax and Shire LLC on

January 19,2006 is valid,.binding, and enforceable.

89. .Section 5.5 of the Distribution Agreement requires Shire to supply Impax's orders

of AG Product within five days of the specified delivery date.

90. Impax has fully performed its obligations under the Distribution Agreement.

Among other things, Impax has timely submitted its orders for AG Product pursuantto the terms

of the Distribution Agreement.

11

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91. All conditions required by the Distribution Agreement for Shire's performance

have occurred.

92. Defendants breached the Agreements in bad faith by taking one or more actions

contrary to its terms, including but not limited to failing to fIll Impax's orders of AG Product and

their breach is continuing to this day.

93. As a result of Defendants' continuing breach, Impaxhas suffered millions of

dollars of financial losses plus irreparable harm to its business reputation and goodwill. Impax

has been unable to fill its customers' orders for AG Product, and, as a result, these customers

have abandoned Impax for other suppliers, including Shire.

94. By executing the Agreements, Defendants entered into an implied covenant of

good faith and fair dealing with Impax. That covenant required Defendants to act in good faith

and to use their best efforts to fulfill its obligations under the Agreements. Defendants have

failed to do so. Instead of filling Impax's timely orders of AG Product as required by the

_ Agreements, Defendants willfully disregarded their obligations under the Agreements by not

supplying AG Product in order to further their own profit.

JURY DEMAND

95. Impax requests a jury trial for all issues so triable.

PRAYER FOR RELIEF

WHEREFORE, Impax prays for judgment as follows:

1. Entering an order requiring specific performance by Defendants of their

obligations under the Agreements to fill Impax's purchase orders for AG Product;

2. Entering preliminary injunctive relief requiring specific performance by

Defendants of their obligations under the Agreements to fill Impax's purchase orders for AG

. Product;

3. Awarding Impax damages incurred as a result of Defendants' breach of the

Agreements and other wrongful conduct, including all lost profits, incidental and consequential

damages, as allowed by law;

4. AwardingImpax recovery for any unjust enrichment of Defendants that occurred

12

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at Impax's expense;

5. Awarding Impax attorneys' fees, costs, and expenses incurred in its efforts to

enforce the Agreements; and

13

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6. Granting Impax such· other reliefas this Court deems proper.

Respectfully submitted,

Dated: November 1,2010 COOLEY LLP

By: j~ l~c....c.----,--- ­

Jonathan Bach 1114 Avenue of the Americas New York, NY 10036 Telephone: (212) 479-6000 Facsimile: (212) 479-6275

KEKER & VAN NEST Asim M. Bhansali Paula L. Blizzard Sharif E. Jacob 710 Sansome Street San Francisco, CA 94111-1704 Telephone: (415) 391-5400 Facsimile: (415) 397-7188

Attorneys for Plaintiff IMPAX LABORATORIES, INC.

14

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3

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----

At an IAS Part -'--'Room __. of the Supreme Court of the StateofNew York held in and forthe County ofNew York, at the . Courthouse located at

-~------,.-~--'

New York, New York on the __ day of October, 20 I0

SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK

IMPAX LABORATORIES, INC., Index No. kfJ jq3 12010

Plaintiff, ORDER TO SHOW CAUSE WITH A TEMPORARY RESTRAINING ORDER

-against-

SHIRE LLC and SHIRE LABORATORIES, ORAL ARGUMENT REQUESTED INC.,

Defendants.

Upon reading and filing ofPlaintiff Impax Laboratories, Inc.'s ("Impax's")

Memorandum of Law, the Emergency Affirmation of Asim M. Bhansali dated October 30, 2010,

the Transmittal Affirmation ofAsim M. Bhansali dated October 30, 20 I0, the Affidavit ofTodd

Engle sworn to on October 29, 2010 and the exhibits thereto, the Affidavit of Charles

Hildenbrand sworn to on October 29,2010 and the exhibits thereto, and the Affidavit of Asim

M. Bhansali sworn to on October 30, 2010 and the exhibits thereto, and sufficient grounds

having been shown, let Shire LLC and Shire Laboratories, InC;. (collectively, "Shire") or their

attorneys show cause before this Court, at Part __, Room __, in the Courthouse at

__________, New York, New York on , 2010, at

a.m.lp.m. or as soon thereafter as counsel may be heard, why an order should not be

issued pursuant to N.Y. C.P.L.R. 6301 granting a preliminary injunction ordering that:

I. Shire is prohibited from filling any orders for Shire or its affiliates until it has

filled all remaining orders placed by Impax that have come due;

2. Shire must immediately, and no later than 45 calendar days after entry of this

order, fill all orders placed by Impax that have come due;

517501.01

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3. Shire must fill orders placed by Impax within 5 days of the due date, and Shire

may not fill any orders for Shire or its affiliates, if doing so would interfere ~ith filling Impax's

orders; and

4. . Shire may not seek an allocation of amphetamine purchase quota from the Drug

Enforcement Administration ("DEA") iil any way that would adversely affect Shire's ability to

fill Impax's orders.

IT IS FURTHER ORDERED, pursuant to N.Y. C.P.L.R. 6301, that, pending the hearing

of this motion:

1~ Shire must immediately, and no later than two business days after entry of this

order, deliver product to fill all orders placed by Impax specifying delivery dates in February and

March 2010; and

2. Shire is required to use any additional DEA procurement quota resulting from

DSM Pharmaceuticals, Inc.'s October request to manufacture products to filllmpax's

outstanding orders.

IT IS FURTHER ORDERED that service via e-mail and overnight mail of a copy ofthis

Order to Show Cause, together with the papers upon which it is granted, on Defendants'

Associate General Counsel, Scott Applebaum, at 725 Chesterbrook Blvd., Wayne, PA 19087­

5637, on or before the day of , 2010, shall be deemed good and

sufficient; and it is further

ORDERED that answering papers, if any, are to be served on Plaintiff s counsel, Asim

M. Bhansali, Keker & Van Nest LLP, 710 Sansome Street, San Francisco, CA 94i i i, bye-mail

and overnight mail on or before the __ day of , 2010; and it is further

ORDERED that reply papers, if any, are to be served on Mr. Applebaum bye-mail and

overnight mail on or before the __ day of ,2010; and it is further

ORDERED that oral argument shall be required on the return date of this motion; and it

is further

ORDERED that, for good cause shown, in to order to protect confidential information

including sensitive competitive information and/or trade-secret information, Plaintiff may file

2517501.01

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under seal unredacted copies of the Complaint and Jury Demand and exhibits thereto,

Emergency Affirmation of Asim M. Bhansali,datedOctober 30,2010, the Transmittal

Mfirmation ofAsim M.Bhansali dated October 30, 2010, the Affidavit of Todd Engle sworn to

on September 29, 2010 and the exhibits thereto, the Affidavit of Charles Hildenbrand sworn to

on October 29, 2010 and the exhibits thereto, and Plaintiffs Memorandum of Law dated October

30,2010, provided that Plaintiff is directed to file publicly within __ days copies of the

foregoing materials from which confidential material has been redacted.

ENTER:

Rule 130-1.1 Certification ,.-, (/)

CVQ;i¥\ lJ1i 13Jv/Ji!)1..1(1/~ / I ~ Asim M. Bhansali I 0/. Paula L. Blizzard (Pro Hac Vice Application

Forthcoming) SharifE. Jacob (Pro Hac Vice Application

Forthcoming) 710 Sansome Street San Francisco, CA 94111-1704 Telephone: (415) 391-5400 Facsimile: (415) 397-7188

Jonathan Bach Cooley LLP 1114 Avenue of the Americas New York, NY 10036 (212) 479-6000

3517501.01

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'. :,,~_ .... ~"'.:;"': ".~~'::::,-~;:- ..:_:::';j::~:-;':::-~:::':-:':': _e· i.~

: 3. Shire must fill orders placed by Impax within 5 days of the due date, and Shire

ot fill any orders for Shire or its affiliates, if doing so would interfere with filling Impax's

4. Shire may not seek an allocation of amphetamine purchase quota from the Drug

rcement Administration ("DEA") in any way that would adversely affect Shire's ability to

IT IS FURTHER ORDERED, pursuant to N.Y. c.P.L.R. 6301, that, pending the hearing

1. Shire must immediately, and no later than two business days after entry ofthis

.r, deliver product to fill all orders placed by Impax specifYing delivery dates in February and

2. Shire is required to use any additional DEA procurement quota resulting from

M Pharmaceuticals, Inc.'s October request to manufacture products to fill Impax's

.••... >r::/':.~4~standing orders.

IT IS FURTHER ORDERED that service via e-mail and overnight mail of a copy of this

;Order to Show Cause, together with the papers upon which it is granted, on Defendants'

Associate General Counsel, Scott Applebaum, at 725 Chesterbrook Blvd., Wayne, PA 19087­,

f

5637, on or before the __ day of , 2010, shall be deemed good and

J,Sufficient; and it is further.. . . .

'O~ ORDERED that answenng papers, if any, are to be served on Plamtlf:fs counsel, ASllTI

:. " \ M. Bhans~li, Kek~r & Van Nest LLP, 710 Sansome Street, San Francisco, CA 9411 ~' .bYe-mail

~ and overnIght mad on or before the __ day of ,2010; and It IS further

.' cjSu ORDERED that reply papers, if any, are to be served on Mr. Applebaum bye-mail and

_______, 2010; and it is further

ORDERED that oral argument shall be required on the return date of this motion; and it

ORDERED fumt ~~wn~:~~~~ ~~~~onnation including sensitive competitive information and/or trade-secret information, Plaintiff may file

2

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er seal unredacted copies ofthe Complaint and Jury Demand and exhibits thereto,

;¢rgency Affirmation ofAsim M. Bhansali, dated October 30,2010, the Transmittal

mnation of Asim M. Bhansali dated October 30, 2010, the Affidavit of Todd Engle sworn to

;'September 29,2010 and the exhibits thereto, the Affidavit of Charles Hildenbrand sworn to

(October 29,2010 and the exhibits thereto, and Plaintiffs Memorandum of Law dated October

, 2010, providelfhat Plaintiff is directed to file publicly within __ days copies of the

egoing mate~als from which confidential material has been redacted. f1..tz- ...(', Ie s ~a it -:be' ;'.dlfYf (is +tJ11te O~/the/p,NTER: '~5 to tl/~.fl1rar'; (ITIJ r1Net(£ 0~ veeire! () r ~f'r _

. t?SI~~<f~ ~N UJ r,hN5, Uf67f

. prf~ () f f¥- j ft Rule 130-1.1 Certification err:~~$:;~ 1\

~an~1 ~d/fJ) .. Ai

tE)lYrf r(!;;'&,rJ\d · Paula L. Bliz~ard (Pro Hac Vice Application

Forthcommg) SharifE. Jacob (pro Hac Vice Application

V Forthcoming)

710 Sansome Street San Francisco, CA 94111-1704 Telephone: (415) 391-5400 Facsimile: (415) 397-7188

Jonathan Bach CooleyLLP 1114 Avenue of the Americas New York, NY 10036 (212) 479-6000

3

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4

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Plaintiff, ORDER TO SHOW CAUSE WITH A TEMPORARY RESTRAINING ORDER

-against-FEE

ORAL ARGUMENT REQUESTED PAID NOV .. 12010

Defendants. COUNT~EClN YORI<; .

LERv,s . 1\ Of:F/Cl

Upon reading and filing ofPlaintiff Impax Laboratories, Inco's ("Impax's")

randum of Law, the Emergency Affinnation of Asim M. Bhansali dated October 30,2010,

~smittal Affinnation ofAsim M. Bhansali dated October 30, 2010, the Affidavit of Todd

Sworn to on October 29,2010 and the exhibits thereto, the Affidavit of Charles ~. .

. and sworn to on October 29, 2010 and the exhibits thereto, and the Affidavit ofAsim

,sali sworn to on October 30, 2010 and the exhibits thereto, and sufficient grounds

'en shown, let Shire LLC and Shire Laboratories, Inc. (collectively, "Shire") or their

how cause before this Court, at Part&, Room ~"1-,-in the Courthouse at

\'lft ~NewYork,NewYorkon II {Aj[O , 2010, at

¢/p.m. or as soon thereafter as counsel may be heard, why an order should not be

ant to N.Y. C.P.L.R. 6301 granting a preliminary injunction ordering that:

Shire is prohibited from filling any orders for Shire or its affiliates until it has

/'ining orders placed by Impax that have come due;

.§hire must immediately, and no later than 45 calendar days after entry of this

placed by Impax that have come due;

1

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3. Shire must fill orders placed by linpax within 5 days ofthe due date, and Shire

may not fill any orders for Shire or its affiliates, if doing so would interfere with filling Impax's

orders; and

4. Shire may not seek an allocation of amphetamine purchase quota from the Drug

Enforcement Administration ("DEA") in any way that would adversely affect Shire's ability to

fill Impax's orders.

IT IS FURTHER ORDERED, pursuant to N.Y. C.P.L.R. 6301, that, pending the hearing

of this motion:

1. Shire must immediately, and no later than tw usiness days after entry of this

specifYing delivery dates in February and

ditional DEA procurement quota resulting from

quest to manufacture products to filllinpax's

, ~ Jl l '( \V1 (}. ~ ( \ to

.ght-mail of a copy of this

Scott Applebaum, at 725 Chesterbrook Blvd., Wayne, PA 19Q5.1.,..

________' 2010, shall be deemed good and

2010; and it is further

lebaum bye-mail and

,2010; and l' nher

________~,

be served on Mr. A

2

of-------->..-----r---

o

er to Show Cause, together with the papers upon which it is granted, on DefeIldan~

ERED that oral argument shall be required on the return date of this motion; and it

D fuat:C ::~~:~~r ~~!O~~i:forrnatiOn

, .' ORDERED that answering papers, if any, are to be served on Plaintiff's coun

%:iate General Counsely

utstanding orders.

, IT IS FURTHER ORDERED that service via Ii: mail :md

2. Shire is required to use any

',SM Pharmaceuticals, Inc.'s October

order, deliver product to fill all orders placed by Imp

Case 1:10-cv-08386-MGC Document 1 Filed 11/05/10 Page 34 of 44

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'. ~TrO(LNet(~ '.', rJl~{~:t-f->

..'-JiIe f,rf''''''''''.''''''.' r ... AI

, eJ) (,L1 'r .'

'r-- I

under seal unredacted copies of the Complaint and J Demand and exhibits thereto,

Emergency Affinnation of Asim M. Bhansali, ated October 30, 2010, the Transmittal

Affinnation of Asim M. Bhansali dated tober 30, 201 0, the Affidavit of Todd Engle sworn to

on September 29,2010 and the exhi . s thereto, the Affidavit of Charles Hildenbrand sworn to

on October 29, 2010 and the exh' its thereto, and Plaintiffs Memorandum of Law dated October

30,2010, provided that Plain· is directed to file publicly within __ days copies of the

foregoing materials from .ch confidential material has been redacted.~ -PI Ie s ha' t -:be

~'eJ«f {)5 +tJ111f (J~~/~I{NTER' IRA-GAMMERMAN 1JOC~5 ~ a/~.P1ar:;· V

0 veci4()rlftu~V' ~__( __ N UJ rhN5, 1m, J lTa

!JL ,J1J!taW1 Rnl~ 13~1.l Certification

w~# a;41I9fn£f ~haus1;' ~dz/l6) fU6fJI'J\ d ' Paula 1. B1iz~ard (Pro Hac Vice Application

'Forthcommg) SharifE. Jacob (Pro Hac Vice Application

Forthcoming) 710 Sansome Street San Francisco, CA 94111-1704 Telephone: (415) 391-5400 Facsimile: (415) 397-7188

Jonathan Bach Cooley LLP 1114 Avenue of the Americas New York, NY 10036 (212) 479-6000

3

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c

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I •

0575739.06 MMc~~~ARTICLES OF MERGER Trey Grayson .OF Secretary ofState

SHIRE LABORATORIES, INC. Received' and Flied INTO 12116120062:29:08 PM

SHlRELLC Fee Recefot: $50.00

. pursuant to the provisions of Section 275.360 of the Kentucky Limited Liability ComP!illY Act, KRS §275.00l. el seq., and Section 264 of the O~meral Corporation Law of the. State of Delaware, 8 DeJ.C. §101. el seq., SHIRE LABORATORIES, INC.; a corp<>ratron existing under the laws of the State of Delaware (the "Merged Entity'~, and SHIRE LLC, a limited liability company existing under the laws of the State of KentUcky (the "Surviving Entity") (the Merged Entity and the· Surviving Entity are referred to collectively as the "Constituent Entities"). adopt the following Articles of Merger for the pmpose of merging the Merged Entity into tOe Surviving Entity: . .

1. . Entities. The Merged Entity shall .be merged with and into the Surviving Entity (the "Merger") and the Surviving Entity will continue its· existence as th~

. surviving company in its prest;nt fonn and. under the name "Shire LLC" pursuant to the.provisions ofthe Kentucky Revised Statutes.

2. Agreement and Plan of Merger. The Agreement and Plan of Merger ("Plan of Merger") is set forth in Exhibit A, 'which is attached hereto and incorporated by reference herein, as approved by the Board of Director~ of t4e Merged Entity in accordance with Section 264 of t~e General Corporation Law of the State of Delaware and by the Board of M<P1agers of the Surviving Entity .jn accordance' with Section 275.350 of the Kentucky Limited Liability Company Act.

3. Compliance With Laws. As of the time of the filing of the Artj·cies of Merger, the Constituent 'Entities have complied with the laws of the states un<kr which they . exist and the laws ofthose states permit !he above referenced Merger.

. 4. Merger Authorized, By written consent dated December l£, 2006, the Pjan of Merger was approved by the sole stockholder ofthe Merged Entity and by written consent dated December .1[., 2006. the Plan of Merger was approved by the sole m·ember of the Surviving EntitY.

5. Effective Time. The Merger shall become, effective on Decemb.er 15, 20(16 at 11 :59 p.m" Eastern Standard Time....

[The remainder ofthis page intentionally left blank.] DOCU'ii:tlT till: Ij lOW l!E(i}/(ikO {jil: ()H£itllEll 27r~1l1lij lH:W):2I1P1'I TOtl~_ FEE:): 123.00 (OI.~nv ClERl{: M~ll~1l K1iW3E CUullrV: flOOt'.i: wUlm CLEM u£vlJlv ClH.,{: ELillillfiH BI1i)!~1 ilOC« 1)014J PfIGE5 11'10 - u%

. ~N) J8$$~OIISU2~6Iky,8J1leJes,Of.nitrsw.doo 12I04i06/0;J7 AM

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· IN WITNESS WHEREOF, the Constituent Entities have executed the Articles of Merger on this .!L. day ofDecember, 2006.· .

MEROEp ENTITY: SURVIV~GENTITY:

S'

".

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AGREEMENT AND PLAN OF MERGER

AGREEMENT AND PLAN OF MERGER, dated as ofDecember ~ 2006 (this "Agreement"), between Shire Laboratories Inc., a Delaware corporation (the "DClaware Corporation"). and Shire LLC, a Kentucky limited Iiability.company (the "Kentucky LLC''). .,'

WITNESSETH: . I

WHEREAS. the Kentucky LLC desires to acquire the properties and.other assets, and to assume all ofthe liabilities and obligations, of the Delaware Corporation by means of a merger ofthe Delaware Corporation with and into the . Kentucky LLC;

WHEREAS, Section 275.345 of the Kentucky Limited Ljab~lity Company Act, KRS §275.001. et seq. (the "nLCA"), and Section 264 ofthe General Corporation Law ofthe State ofDelaware, 8 DeI.C. §lOl, etseq. (the "DGCL"), authorize the merger ofa Delaware corporation with and into a Kentucky limited Ilability company;

WHEREAS, the Delaware Corporation and the Kentucky LLC now desire to merge (the "Merger"), following which the Kentucky LLC shall be the . ,

surviving entity;

WHEREAS, the Delaware Corporation's Certificate ofIncorporation and Bylaws pennit, and resolutions adopted by the Delaware Corporation's Board of., Directors authorize, this Agreement and the consummation oftbe Merger; and

WHEREAS, the requisite nwnber'ofmembers ofthe Kentucky LLC have approved this Agreement and the consuOunation ofthe Merger.

NOW TIIEREFORE, the parties hereto hereby agree as follows:

ARTICLE 1 lHeMERGER

Section l.O1. The Merger. (a) After satisfaction or, to the extent permitted hereunder, waiver of all conditions to the Merger, as the Delaware . Corporation and the Kentucky LLC shall determine, the Kentucky LLC, which shall be the surviving entity, shall merge with the Delaware Corporation and shall file a certificate ofmerger (the "Certifj(:ate of Merger") with the Secretary of State of the State ofDelaware and articles ofmerger with the Secretary ofState of the State ofKentucky (~6 "Articles of Merger") and make all other filings or recordings required by Delaware or Kentucky law in connection with the Merger. The Merger shall become effective on December 15,2006 at 11:59 p.m., Eastern Standard Time (the "Effective Time"), which such date and time shall to the

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extent necessary or appropriate be specified in the Certificate ofMerger andlor the Articles of Merger•.

(b) At the Effective Time, the Delaware Corporation shall be merged with and into the Kentucky LLC, whereupon the separate existence ofthe Delaware Corporation shall cease, and the Kentucky LLC shall be the surviving entitY ofthe Merger (the "Surviving LLC") in accordance with Section 275.345 ottbe KLLCA and Section 264 of the DOCL.

Section 1.02. Cancellation ofStock; Conversion oflnterests. At the Effective Time: (a) Each share ofcapital stock ofthe Delaware Corporation outstanding inunediately prior to the Effective Time shall, by virtue ofthe Merger and without any action on the part of tile holder thereof, be canceled and no consideration shall be issued in respect thereof; and .

(b) Each limited liability company interest in the Kentucky LLC . outstanding immediately prior to the E:fThctive Time shall, by virtue ofthe Merger

and without any action on the part ofthe holder thereof, remain unchanged and continue to remain'outstanding as a limited liability company interest in the Surviving LLC.

ARTICLE~

THE SURVIVING LIMITED LIABILITY COMPANY

Section 2.01. Artlc/es ofOrganization and Dec/aration. The articles of organization and declaration of the Kentucky LLC in effect,at the Effective Time shall be the articles ofor~lInizationlind declaration ofthe Surviving LLC unless and until amended in accordance with their terms and applicable law. The name of the Surviving LLC shaH be "Shire LLC".

ARTICLE 3 TRANSFER AND CONVBYANCE OP AssEts AND ASSUMPTION Of LIABILITIES

Section 3.01. Transfer, Conveyance andAssumption. At the Effective Time, the Kentucky LLC shall continue in existence as the Swviving LLC, and without further transfer, succeed to and possess all of the rights, privileges and powers of the Delaware Corporation, and aJI ofthe assets and property of whatever kind and character of the Delaware Corporation shall vest in the Kentucky LLC without further act or deed; thereafter, the Kentucky LLC, as the Surviving LLC, shall be liable for all of the liabilities and obligations ofthe Delaware Corporation, and any claim or judgment against the Delaware Corporation may be enforced against the Kentucky LLC,IIS the Surviving"LLC, in accordance with Section 275.365 of the KLLCA and Section 264 oftbe DGCL.

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Section 3.02. Further Assurances. If at any time the Kentucky LLC shall consider or be advised that any further. assignment, conveyance or assurance'is necessary or advisable to vest, perfect or CQnfirm ofrecord in the Surviving LLC the title to any property or right of the Delaware Corporation, or otherwise to cany out the provisions hereof, the proper representatives of the Delaware Corporation as ofthe Effective Time shall execute and deliver lJIlY and aU proper

.. deeds, assignments and assurances and do al1 things necessary or proper to·vest, perfect or convey title to such property or right in the Surviving LLC, and otherwise to carry out the provisions hereof.

ARTICLE4 ' CONDITIONS TO THE MERGER

Section 4.01. Conditions To The Obligations OfEach Party. The obligations of1he Kentucky LLC ana the Delaware Corporation to consummato the Merger are subject to the satisfaction ofthe following conditions as of the Effective Time:

(a) no provision ofany applicable law or regulation and no judgment, injunction, order or decree shall prohibit tbe conswnmation ofthe Merger; "

(b) a1l actions by or in respect ofor filings with any governmental body, agency, official or authority required to permi~ the consununation oflhe Merger shall have been obtained; and

'1

(c) this Agreement shall have been a~opted by the requisite number of the stockholders oft'he Delaware Corporation required by and ill accordance with applicable Jaw.

ARTICLE 5 TERMINATION

Section 5.01.· Termination. This Agreement may be tenninated and the Merger may be abandoned at any time prior to the Effective Time:

, (a) by mutual written consent of1he Kentucky LLC and the Board of Directors of the Delaware Corporation; or .

(b) by either the Kentucky LLC or the Board of Directors of the Delaware Corporation, if there shall be any low or regulation that makes consummation of the Merger iJlegal or otherwise prohibited, or if any judgment, injunction, order or decree enjoining the Delaware Corporation or the Kentucky LLC from consummating the Merger is entered and such judgment, injunction, order or decree shall become final and nonappealable.

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ARTICLE 6 MISCELLANEOUS

Section 6.01. Survival ofRepresentations and Warranties. .The . representations and warranties and agreements contained in any certificate or otber writing delivered pursuant hereto shall not survive the Effective Time or the termination of this Agreement

Section 6.02. Amendments; No Waivers. (a) Any provisions oftbis Agreement may, subject to applicable law, be amended or waived prior to the Effective Time if, and only if, such amendment or Waiver is in writing and signed by the Kentucky LLC and by the Delaware CoiporaU~n.

(b) No failure or delay by any party hereto in exercising any right, . power or privilege hereunder shall operate as a waiver thereofnor shall.any single

or partial exercise thereof preclude any other or further exercise thereofor the exercise ofany othe~ right, power or privilege. The rights and remedie's herein provided shall be cUDlUlative and not exclusive ofany rights or remedies-provided by la.w. I

Section 6.03. Integration. All prior or contemporaneous agreements, contracts, promises, rep~sentations, and statements, if any, between the Delaware Corporation and the Kentucky LLC, or their representatives. are merged into this Agreement, and this Agreement shaU constitut~ the entire understanding between the Delaware Corpo.ration and the Kentucky LLC with respect to the subject matter hereof.

Section 6.04. Successors andAssigns. The provisions of this Agreement shall be binding upon and inure to tbe benefit ofthe parties: hereto and their respective successors and assigns, provided that no party may assign, delegate or otherwise transfer any of Its rights or obligations under this Agreement without fue consent ofthe other party hereto.

I

Section 6.05. Governing Law. This Agreement shall be governed by and construed' in accordance with the laws ofthe State ofDelaware, without regard to principles ofconflicts oflaws. .

Section 6.06. Counterparts; FJfectiveness. This Agreement may be signerl in any number of counterparts, each ofw1).ich shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instnunent. This Agreement shall become effective when each party hereto shall have received the counterpart hereof signed by the other party hereto.

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IN WITNESS WHEREOFt the parties hereto have caused this Agreement to be duly executed by their respective, authorized representatives as of the day and year first above written; ,

SHlRE LABORATORlES INC.

By:

, ,

( (

"

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