Chandra V. Pharmaceutical Consultants, LLC v. Bausch Health Ireland Ltd.

CourtDistrict Court, N.D. Illinois
DecidedJuly 8, 2024
Docket1:23-cv-15958
StatusUnknown

This text of Chandra V. Pharmaceutical Consultants, LLC v. Bausch Health Ireland Ltd. (Chandra V. Pharmaceutical Consultants, LLC v. Bausch Health Ireland Ltd.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Chandra V. Pharmaceutical Consultants, LLC v. Bausch Health Ireland Ltd., (N.D. Ill. 2024).

Opinion

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

CHANDRA V. PHARMACEUTICAL ) CONSULTANTS, LLC, ) ) Plaintiff, ) ) No. 23 C 15958 v. ) ) Judge Sara L. Ellis BAUSCH HEALTH IRELAND LTD., ) BAUSCH HEALTH AMERICAS, INC., ) BAUSCH + LOMB CORPORATION, and ) BAUSCH HEALTH COMPANIES, INC., ) ) Defendants. )

OPINION AND ORDER Plaintiff Chandra V. Pharmaceutical Consultants, LLC (“Chandra V”) and Defendants Bausch Health Ireland Ltd., Bausch Health Americas, Inc., Bausch + Lomb Corporation, and Bausch Health Companies, Inc. (collectively, “Bausch”) entered into separate agreements for the development of two generic ophthalmic drugs. After Bausch allegedly failed to perform its obligations under the agreements, Chandra V filed this action for breach of contract and breach of the implied duty of good faith and fair dealing. Bausch now moves under Federal Rule of Civil Procedure 12(b)(6) for the Court to dismiss Chandra V’s complaint with prejudice. Because the Court finds that Chandra V failed to allege sufficient facts to raise a plausible claim that Bausch breached the express terms of the contracts at issue, the Court grants in part Bausch’s motion to dismiss. However, the Court finds that Chandra V sufficiently alleges that Bausch breached its implied duty of good faith and fair dealing, which itself constitutes a breach of contract. The Court gives Chandra V leave to amend the complaint if it so chooses. BACKGROUND1 Chandra V is a generic pharmaceutical treatment developer. Bausch, formerly known as Valeant, develops, manufactures, markets, imports, and sells pharmaceutical products. Chandra V engaged Bausch as its partner to develop, obtain FDA approval for, manufacture, supply, and

commercialize two generic ophthalmic drugs, Tobramycin Ophthalmic Ointment (“Tobramycin”), a generic version of the branded-product TOBREX® used to treat eye infections, and Prednisolone Acetate Ophthalmic Ointment (“Pred Acetate,” together with Tobramycin, the “Drugs”), a generic version of the branded-product PRED FORTE® used for treating eye inflammation. In April 2014, Chandra V and Bausch entered a co-development, license, and distribution agreement for Tobramycin (the “Tobramycin Agreement”), and in October 2016 entered a similar co-development, license, and distribution agreement for Pred Acetate (the “Pred Acetate Agreement,” together with the Tobramycin Agreement, the “Agreements”). The Agreements are essentially identical in form. In them, Bausch agreed to perform

certain services (“the Services”) to advance development of each of the Drugs as described within Sections 1.18 and 2.1 of each of the Agreements, as well as their respective Exhibits B. The Tobramycin Agreement requires Bausch to perform four services, while the Pred Acetate Agreement requires Bausch to perform over seventy.

1 The Court takes the facts in the background section from Chandra V’s complaint and exhibits attached thereto and presumes them to be true for the purpose of resolving the defendant’s motion to dismiss. See Phillips v. Prudential Ins. Co. of Am., 714 F.3d 1017, 1019–20 (7th Cir. 2013). Although the Court normally cannot consider extrinsic evidence without converting a motion to dismiss into one for summary judgment, Jackson v. Curry, 888 F.3d 259, 263 (7th Cir. 2018), the Court may consider “documents that are central to the complaint and are referred to in it” in ruling on a motion to dismiss, Williamson v. Curran, 714 F.3d 432, 436 (7th Cir. 2013). The Court may also consider “documents attached to a motion to dismiss . . . if they are referred to in the plaintiff's complaint and are central to [its] claim.” McCready v. eBay, Inc., 453 F.3d 882, 891 (7th Cir. 2006). In Section 3.1 of both Agreements, Bausch agreed to prepare the Abbreviated New Drug Application (“ANDA”) for both Drugs, as well as any regulatory dossiers required to obtain FDA approval for the Drugs. In Sections 4.1 and 5.1 of both Agreements, Bausch agreed to manufacture each of the Drugs and, “within 90 days after receipt of a final approval from the

FDA for the ANDA” of each of the Drugs, “use Commercially Reasonable Efforts to market and sell” the Drugs. Doc. 1-1 at 6; Doc. 1-2 at 6. In Section 5.2 of both Agreements, Bausch agreed to make certain Milestone Payments to Chandra V. Exhibit C to the Tobramycin Agreement requires Bausch to make one $100,000 payment after executing the agreement and a $500,000 payment upon receipt from the FDA of the ANDA approval letter for the drug. Exhibit C to the Pred Acetate Agreement requires Bausch to make one $100,000 payment after executing the agreement, one $1,000,000 payment after initiating the clinical trial, and one $400,000 payment after submitting the Pred Acetate ANDA. In Section 11.1 of both Agreements, Bausch agreed to engage in an informal dispute resolution procedure requiring executives from each of the parties to attempt to resolve disputes before either party could resort to legal remedies. The parties

included a New York choice of law provision in the Agreements, and the Agreements remain in full force and effect. Development of the Drugs has apparently been slow-going. Bausch filed an ANDA for Tobramycin on or around January 5, 2021, just shy of seven years after the parties signed the Tobramycin Agreement. According to Chandra V, the FDA subsequently issued a Refuse-to- Receive letter due to apparent deficiencies with the Tobramycin ANDA. To date, Bausch has not yet submitted an ANDA for Pred Acetate. Chandra V pleads two counts for breach of contract in its complaint, one for each of the Agreements. In both counts, Chandra V alleges that Bausch breached the respective Agreements in multiple respects. Chandra V alleges that Bausch breached its obligation to perform the Services as outlined in Sections 1.18 and 2.1, and Exhibit B of both Agreements. Chandra V also alleges that Bausch breached its obligation to file ANDAs and successfully secure regulatory approval for the Drugs as outlined in Section 3.1. Chandra V further claims that

Bausch breached its obligation to commercialize and manufacture the Drugs as set out in Sections 4.1 and 5.1, its obligation to make Milestone Payments under Section 5.2, and its obligation to use the dispute resolution procedures outlined under Section 11.1. Within both counts alleging breach of the Agreements, Chandra V also alleges that Bausch breached its implied duty of good faith and fair dealing. Chandra V alleges Bausch did so by failing to develop the drugs “in a timely and commercially reasonable manner,” Doc. 1 ¶¶ 93(a), 106(a), “failing to obtain FDA approval for the [Drugs] in a timely and commercially reasonable manner,” id. ¶¶ 93(b), 106(b), “failing to promptly and properly remedy the deficiencies identified by the FDA,” id. ¶¶ 93(c), 106(c), “failing to provide appropriate facilities to support development, regulatory approval, manufacturing, supplying and commercialization

of the [Drugs],” id. ¶¶ 93(d), 106(d), “failing to communicate with Chandra V and keep Chandra V apprised of all the issues relating to the development [of the Drugs],” id. ¶¶ 93(e), 106(e), “failing to advise Chandra V of the Bausch Defendants’ inability and/or refusal to [pursue development of the Drugs],” id. ¶¶ 93(f), 106(f), “failing to hire the proper consultants and professionals” to secure regulatory approval and correct any deficiencies with the Drugs, id.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Bell Atlantic Corp. v. Twombly
550 U.S. 544 (Supreme Court, 2007)
Ashcroft v. Iqbal
556 U.S. 662 (Supreme Court, 2009)
Fishoff v. Coty, Inc.
634 F.3d 647 (Second Circuit, 2011)
M/a-Com Security Corporation v. Francesco Galesi
904 F.2d 134 (Second Circuit, 1990)
Brewster McCauley v. City of Chicag
671 F.3d 611 (Seventh Circuit, 2011)
Lisa Williamson v. Mark Curran, Jr.
714 F.3d 432 (Seventh Circuit, 2013)
Zena Phillips v. The Prudential Insurance Compa
714 F.3d 1017 (Seventh Circuit, 2013)
NY Univ. v. CONT'L INS CO
662 N.E.2d 763 (New York Court of Appeals, 1995)
511 West 232nd Owners Corp. v. Jennifer Realty Co.
773 N.E.2d 496 (New York Court of Appeals, 2002)
Lomaglio Associates Inc. v. LBK Marketing Corp.
892 F. Supp. 89 (S.D. New York, 1995)
Kendale L. Adams v. City of Indianapolis
742 F.3d 720 (Seventh Circuit, 2014)
Wanda Goodpaster v. City of Indianapolis
736 F.3d 1060 (Seventh Circuit, 2013)
Laura Kubiak v. City of Chicago
810 F.3d 476 (Seventh Circuit, 2016)
Daniel Jackson v. Shawn Curry
888 F.3d 259 (Seventh Circuit, 2018)
Spinelli v. National Football League
903 F.3d 185 (Second Circuit, 2018)
Ashkenazi v. Kent South Associates, LLC
51 A.D.3d 611 (Appellate Division of the Supreme Court of New York, 2008)
Cone v. Daus
120 A.D.2d 788 (Appellate Division of the Supreme Court of New York, 1986)

Cite This Page — Counsel Stack

Bluebook (online)
Chandra V. Pharmaceutical Consultants, LLC v. Bausch Health Ireland Ltd., Counsel Stack Legal Research, https://law.counselstack.com/opinion/chandra-v-pharmaceutical-consultants-llc-v-bausch-health-ireland-ltd-ilnd-2024.