BTG International, Inc. v. Wellstat Therapeutics Corporation

Court of Chancery of Delaware·Decided September 19, 2017·No. CA 12562-VCL·Published

Opinion

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE

BTG INTERNATIONAL, INC., )

)

Plaintiff/Counterclaim Defendant, )

)

v. ) C.A. No. 12562-VCL )

WELLSTAT THERAPEUTICS ) CORPORATION, )

)

Defendant/Counterclaim Plaintiff. )

MEMORANDUM OPINION

Date Submitted: June 26, 2017 Date Decided: September 19, 2017

Lisa Zwally Brown, MONTGOMERY, McCRACKEN, WALKER & RHOADS, LLP, Wilmington, Delaware; Richard L. Scheff, Lanthrop B. Nelson, III, MONTGOMERY, McCRACKEN, WALKER & RHOADS, LLP, Philadelphia, Pennsylvania; Attorneys for BTG International, Inc.

Kelly E. Farnan, Blake Rohrbacher, Nicole K. Pedi, RICHARDS LAYTON & FINGER, P.A., Wilmington, Delaware; Stephen D. Susman, Harry P. Susman, SUSMAN GODFREY L.L.P., Houston, Texas; Cory Buland, Mark Musico, Trinity Brown, SUSMAN GODFREY L.L.P., New York, New York; Attorneys for Wellstat Therapeutics Corporation.

LASTER, Vice Chancellor.

Pursuant to an Exclusive Distribution Agreement dated July 1, 2011 (the “Distribution Agreement”), BTG International, Inc. (“BTG”) agreed to promote, distribute, and sell Vistogard,1 a drug owned by Wellstat Therapeutics Corporation (“Wellstat”). At trial, Wellstat proved that BTG breached the Distribution Agreement, and BTG did not prove a prior breach by Wellstat that would have excused BTG’s breach. Wellstat is entitled to damages of $55.8 million, pre- and post-judgment interest at the rate specified in the Distribution Agreement, costs, and a limited award of attorneys’ fees.

I. FACTUAL BACKGROUND Trial lasted five days. The parties introduced over 1,300 exhibits and lodged twenty-

nine depositions. Nine fact witnesses and seven experts testified live. The two sides presented starkly different stories, and it was not possible to reconcile all of the witness testimony and documentary evidence. This decision has relied most heavily on the contemporaneous documents. Having weighed the evidence and evaluated the credibility of the witnesses, this decision finds that the following facts were proven by a preponderance of the evidence.

1 The parties used several different names for the drug before its commercial launch.

For simplicity, this decision consistently refers to the drug as “Vistogard.”

A. Vistogard Vistogard is an orally administered antidote for 5-fluorouracil (“5-FU”), a commonly used chemotherapy drug. 5-FU toxicity can be severe, even fatal. Vistogard was the first commercially available drug to address 5-FU toxicity.

Wellstat developed Vistogard, but Wellstat lacked a sales team. Wellstat needed a partner to launch Vistogard commercially and to market and distribute the drug.

In fall 2009, Wellstat began discussions with BTG. On paper, the fit seemed strong.

BTG’s corporate objective at the time was to “become a significant player in the field of specialty pharmaceuticals,”2 a category that includes Vistogard. BTG had a dedicated specialty pharmaceuticals business unit (the “Pharmaceuticals Division”), which already marketed antidotes. BTG’s portfolio included Voraxaze, a drug that treats toxicity from another chemotherapy agent.

BTG was eager to secure the rights to Vistogard. BTG’s CEO, Louise Makin, called Vistogard “a great opportunity” for BTG and wanted to add the drug to BTG’s portfolio.3 B. The Distribution Agreement After several years of negotiations, Wellstat and BTG entered into the Distribution Agreement.4 Wellstat granted BTG “the exclusive right and license . . . to promote,

2 JX 100 at 1.

3 JX 126.

4 JX 152.

distribute and sell” Vistogard for ten years following FDA approval.5 BTG paid Wellstat a distribution rights fee of $7.5 million and agreed to pay two milestone payments of $1 million.6 BTG also agreed to pay royalties on the sales of Vistogard at rates ranging from 20-40% of the revenue attributable to the drug.7 The Distribution Agreement divided responsibility for commercializing Vistogard between Wellstat and BTG. Wellstat was required to “use Diligent Efforts, at Wellstat’s sole cost and expense, to develop [Vistogard] in order to obtain, and subsequently maintain, FDA Approval for [Vistogard] . . . , including to conduct pre- and post-FDA Approval studies necessary to obtain and maintain FDA Approval.”8 BTG was required to “use its Diligent Efforts to and be responsible for, at BTG’s sole cost and expense, all promotion, distribution and sales activities with respect to [Vistogard] . . . .”9 The Distribution Agreement defined “Diligent Efforts” as follows:

Diligent Efforts means, with respect to a Party, the carrying out of obligations specified in this Agreement in a diligent, expeditious and sustained manner using efforts and resources, including reasonably necessary personnel and financial resources, that specialty pharmaceutical companies typically devote to their own internally discovered compounds or products of most closely comparable market potential at a most closely comparable stage in their development or product life, taking into account the following factors to the

5 Id. § 3.1(a).

6 Id. §§ 4.1, 4.2.

7 Id. § 4.3.

8 Id. § 6.3(a).

9 Id. § 8.1.

extent reasonable and relevant: issues of safety and efficacy, product profile, competitiveness of alternative products in the marketplace, the patent or other proprietary position of the Subject Product, and the potential profitability of the Subject Product. Diligent Efforts shall be determined without regard to any payments owed by a Party to the other Party (excluding the transfer price for supply of such Subject Product).10

As part of its responsibilities under the Distribution Agreement, BTG was required to “prepare in good faith the initial commercial plan and budget” for Vistogard (the “Commercial Plan”).11 The Commercial Plan had to “include minimum commitments of resources, personnel and financing for pre-launch and launch activities with respect to, and subsequent promotion and distribution of” Vistogard.12 The Commercial Plan was “subject to good faith discussions between the Parties” and was to be “mutually agreed upon by the parties . . . .”13 Once the parties reached agreement, BTG was required to “promote and distribute [Vistogard] . . . in material compliance with such Commercial Plan.”14 The Distribution Agreement further called for the establishment of a joint development and commercialization committee (the “Committee”) to “manage and oversee the development and commercialization” of Vistogard.15 The Committee consisted

10 Id. § 2.11.

11 Id. § 8.1.

12 Id.

13 Id.

14 Id.

15 Id. § 5.1(a).

of four Wellstat representatives and four BTG representatives. The Committee’s responsibilities included to

review and recommend amendments to the Commercial Plan, provided that no amendment to the Commercial Plan shall materially reduce the level of efforts required under the initial Commercial Plan agreed by the parties pursuant to Section 8.1 unless reasonably justified by changes in [Vistogard’s] product lifecycle stage or changes in the market . . . .16

C. BTG’s New Strategic Plan When BTG signed the Distribution Agreement, it had high hopes for Vistogard.

Makin touted Vistogard as “an excellent fit” with BTG’s existing business that would “enable [BTG] to leverage the sales team and back office support infrastructure which [it] already [had] in place.”17 BTG executives prepared an investor Q&A announcing that Vistogard “could generate up to $60 m[illion] peak sales per annum.”18 But after BTG executed the Distribution Agreement, Makin shifted BTG’s corporate strategy away from specialty pharmaceuticals and towards interventional medicine.19 In 2013, BTG adopted a new strategic plan called the “BTG – 2020/2021 Vision.” It called for BTG to become “a leader in interventional medicine in oncology and

16 Id.

17 JX 155.

18 JX 153.

19 “Interventional medicine is the use of minimally invasive image guided techniques to diagnose and treat diseases.” JX 295 at 12.

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BTG International, Inc. v. Wellstat Therapeutics Corporation, (Del. Ct. App. 2017).

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