ZYDUS WORLDWIDE DMCC v. TEVA API INC.

CourtDistrict Court, D. New Jersey
DecidedMay 20, 2020
Docket2:19-cv-17086
StatusUnknown

This text of ZYDUS WORLDWIDE DMCC v. TEVA API INC. (ZYDUS WORLDWIDE DMCC v. TEVA API INC.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
ZYDUS WORLDWIDE DMCC v. TEVA API INC., (D.N.J. 2020).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

ZYDUS WORLDWIDE DMCC, Civ. No. 19-17086 (KM) (JBC)

Plaintiff, OPINION v.

TEVA API INC.,

Defendant.

KEVIN MCNULTY, U.S.D.J.:

Now pending before the Court is the motion (DE 17) of the defendant Teva API Inc. (“TAPI”) to dismiss the Complaint (DE 1). Plaintiff Zydus Worldwide DMCC (“Zydus”) brings suit, asserting that TAPI breached the parties’ binding Letter of Intent (“LOI”). The LOI is a contract by which TAPI undertook to supply Zydus with an active pharmaceutical ingredient, Form I rotigotine, which Zydus needed to manufacture and sell a generic form of a prescription drug called Neupro. TAPI now moves to dismiss the Complaint, asserting that the parties’ dispute is subject to a forum-selection provision in a separate agreement, an Asset Purchase Agreement (“APA”) entered into between Zydus and TAPI’s parent, Teva Pharmaceutical Industries Ltd. (“Teva”). Under the forum-selection clause in the APA, says TAPI, the parties are required to submit this dispute to a federal or state court in New York. TAPI therefore moves to dismiss the entire complaint. It also moves separately to dismiss the promissory estoppel claim in Count 3 for failure to state a claim. For the reasons explained herein, I will grant in part and deny in part the motion to dismiss. For clarity, I have explicitly denied various other formal and informal requests to dismiss, stay, or transfer this action. I. Summary1 A. Rotigotine Currently, a prescription medicine with the active ingredient rotigotine is sold in the U.S. under the brand name Neupro. (Compl. ¶ 9) Neupro is prescribed for the treatment of Parkinson’s disease and moderate-to-severe primary restless leg syndrome. (Id.) Generic forms of Neupro are also being developed. Premised on the new drug application (“NDA”) for Neupro, No. 021829, TAPI’s parent, Teva, developed a generic line of rotigotine products and filed an abbreviated new drug application (“ANDA”). (Id.) Teva’s ANDA “for the generic rotigotine pharmaceutical products . . . specified that the products would be manufactured using Form I rotigotine manufactured by TAPI.” (Id. ¶ 2) B. Background to the Zydus and TAPI transaction “On or about July 26, 2015, Teva announced that it would acquire the generic drug business of Allergan plc (‘Allergan’).” (Id. ¶ 11) However, the Federal Trade Commission (“FTC”) raised antitrust objections to the potential acquisition. (Id.) To neutralize those antitrust issues, Teva negotiated with the

1 Citations to the record will be abbreviated as follows. Citations to page numbers refer to the page numbers assigned through the Electronic Court Filing system, unless otherwise indicated: “DE” = Docket entry number in this case. “Compl.” = The Complaint filed by Zydus in this action (DE 1) “TAPI Brf.” = TAPI’s Memorandum of Law in support of this motion (DE 17) “Zydus Brf.” = Zydus’s Memorandum of Law in opposition (DE 20) “TAPI Reply Brf.” = TAPI’s Memorandum of Law in reply (DE 23) “LOI” = Letter of Intent, dated May 24, 2016, between TAPI and Zydus (Walsh Decl. Ex. 3, DE 17-3 at 232; more conveniently at DE 20-2) “APA” = Asset Purchase Agreement, dated June 16, 2016, between Teva and Zydus (Walsh Decl. Ex. 2, DE 17-3 at 115) FTC to divest itself of certain assets, including Teva’s “Rotigotine Product Assets.” (Id. ¶¶ 11–12)2 Teva found a willing purchaser for those assets in Zydus. Teva agreed to divest its rotigotine products “by selling them to Zydus, which would own the associated ANDA and take over the eventual sale, following FDA approval, of the Rotigotine Products in the United States. Teva and Zydus entered into an Asset Purchase Agreement (the “APA”), dated as of June 16, 2016, under which Teva agreed to sell and assign Teva’s Rotigotine Product Assets (including the Rotigotine ANDA) to Zydus.” (Id. ¶ 13)

2 As background, I note that Zydus has submitted a copy of an FTC Decision and Order relating to the Teva/Allergan transaction, which provides as follows: Not later than ten (10) days after the Acquisition Date, Respondents shall divest the Group E Product Assets [defined to include Rotigotine Product Assets] and grant the Divestiture Product Licenses related to the Group E Products [defined to include Rotigotine Products], absolutely and in good faith, to Zydus pursuant to, and in accordance with, the Group E Product Divestiture Agreements (which agreements shall not limit or contradict, or be construed to limit or contradict, the terms of this Order, it being understood that this Order shall not be construed to reduce any rights or benefits of Zydus or to reduce any obligations of Respondents under such agreements), and each such agreement, if it becomes a Remedial Agreement related to the Group E Product Assets is incorporated by reference into this Order and made a part hereof; provided, however, that if Respondents have divested the Group E Product Assets to Zydus prior to the Order Date, and if, at the time the Commission determines to make this Order final and effective, the Commission notifies Respondents that Zydus is not an acceptable purchaser of any of the Group E Product Assets, then Respondents shall immediately rescind the transaction with Zydus, in whole or in part, as directed by the Commission, and shall divest the relevant Group E Product Assets within one hundred eighty (180) days after the Order Date, absolutely and in good faith, at no minimum price, to an Acquirer that receives the prior approval of the Commission, and only in a manner that receives the prior approval of the Commission; provided further, however, that if Respondents have divested the Group E Product Assets to Zydus prior to the Order Date, and if, at the time the Commission determines to make this Order final and effective, the Commission notifies Respondents that the manner in which the divestiture was accomplished is not acceptable, the Commission may direct Respondents, or appoint a Divestiture Trustee, to effect such modifications to the manner of divestiture of the Group E Product Assets to Zydus (including, but not limited to, entering into additional agreements or arrangements) as the Commission may determine are necessary to satisfy the requirements of this Order. (DE 17-3 at 68–69) C. Zydus and TAPI enter into LOI for supply of Form I Rotigotine Access to sufficient quantities of Form I rotigotine was necessary for Zydus to manufacture and sell generic rotigotine products, and to obtain FDA approval to do so. (Id. ¶ 14) On May 24, 2016, Zydus and TAPI entered into a binding LOI whereby TAPI committed to provide Form I rotigotine to Zydus. (Id. ¶ 15) Zydus asserts that this guaranteed supply commitment was a precondition to its agreement to purchase all of Teva’s rotigotine related assets. (Id.) “The LOI was executed between [TAPI] and [Zydus] and pertained to “the supply of the active pharmaceutical ingredient Rotigotine (collectively, the ‘API’).” (LOI, DE 17-3 at 233) The LOI acknowledged that this supply of the API was related to a transaction memorialized in a separate “Master Purchase Agreement” between Teva and Zydus, dating from 2015. The LOI did not, however, further specify or adopt by reference the terms of that Master Purchase Agreement. (Id.) The LOI provided that it “represent[ed] a binding commitment with respect to the supply terms included herein”; however, it was subject to the negotiation of a definitive supply agreement between TAPI and Zydus. (Id.) TAPI committed under the LOI to “negotiate in good faith the terms of the Definitive Agreement, pursuant to which Teva API shall supply the API on a non-exclusive basis to Zydus for use in the production of the Products and the sale by Zydus in the Territory of the Products during the Term (as defined below in Section 3).” (Id.

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ZYDUS WORLDWIDE DMCC v. TEVA API INC., Counsel Stack Legal Research, https://law.counselstack.com/opinion/zydus-worldwide-dmcc-v-teva-api-inc-njd-2020.