WT Representative LLC v. Philips Holdings USA Inc.

CourtCourt of Chancery of Delaware
DecidedAugust 16, 2024
DocketC.A. No. 2024-0170-PRW
StatusPublished

This text of WT Representative LLC v. Philips Holdings USA Inc. (WT Representative LLC v. Philips Holdings USA Inc.) is published on Counsel Stack Legal Research, covering Court of Chancery of Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
WT Representative LLC v. Philips Holdings USA Inc., (Del. Ct. App. 2024).

Opinion

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE

WT REPRESENTATIVE LLC in its ) Capacity as Securityholder Representative, ) ) Plaintiff, ) ) v. ) C.A. No. 2024-0170 PRW ) PHILIPS HOLDINGS USA INC., ) ) Defendant. )

Submitted: July 23, 2024 Decided: August 16, 2024

Upon Defendant Philips Holdings USA Inc.’s Motion to Dismiss, DENIED, in part; GRANTED, in part.

MEMORANDUM OPINION AND ORDER

C. Barr Flinn, Esquire, Paul J. Loughman, Esquire, Michael A. Carbonara, Jr., Esquire, YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, Delaware, Eric Leon, Esquire (argued), LATHAM & WATKINS LLP, New York, New York, Nathan A. Sandals, Esquire, LATHAM & WATKINS LLP, Boston, Massachusetts, Attorneys for Plaintiff WT Representative LLC in its Capacity as Securityholder Representative.

Patricia L. Enerio, Esquire, Emily A. Letcher, Esquire, HEYMAN ENERIO GATTUSO & HIRZELL LLP, Wilmington, Delaware, Laurence A. Schoen, Esquire (argued), Breton Leone-Quick, Esquire, MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C., Boston, Massachusetts, Attorneys for Defendant Philips Holdings USA Inc.

WALLACE, J.1

1 Sitting by designation of the Chief Justice pursuant to In re Designation of Actions Filed Pursuant to 8 Del. C. § 111 (Del. Sept. 18, 2023) (FIRST AMENDED ORDER). I. FACTUAL AND PROCEDURAL BACKGROUND2

A. THE PARTIES

Plaintiff WT Representative LLC is based in Delaware and the designated

“Securityholder Representative” in the operative agreement.3 That agreement

involves the sale of Vesper Medical, Inc., a privately-held medical equipment

company and non-party to this action.4 Vesper created a minimally invasive stent

system known as the “DUO Venous Stent System” that allows medical professionals

to treat deep venous obstructions.5

Defendant Philips Holdings USA Inc. is a Delaware corporation and the

“Parent” under the operative agreement.6

B. THE FDA PRE-APPROVAL PROCESS

In 2016, Vesper began the FDA approval process for its DUO Venous Stent

System.7 To meet the FDA’s requirements, Vesper first needed to obtain approval of

2 This background is drawn from the pleadings, which include the Verified Complaint and the documents incorporated therein. See Allen v. Encore Energy Pr’s, L.P., 72 A.3d 93, 96 n.2 (Del. 2013) (“Generally, a judge should not consider matters outside of the pleadings when he rules on a Court of Chancery Rule 12(b)(6) motion. A judge may consider documents outside of the pleadings only when: (1) the document is integral to a plaintiff’s claim and incorporated in the complaint or (2) the document is not being relied upon to prove the truth of its contents.”) (internal citations omitted)). 3 Verified Complaint (“Compl”) ¶¶ 2, 7 (D.I. 1). 4 Id. ¶ 2. 5 Id. ¶ 1. 6 Id. ¶¶ 1, 8. 7 Id. ¶ 21.

-1- an Investigational Device Exemption (“IDE”).8 Vesper filed its initial IDE in

January 2019.9 In its initial IDE, Vesper included the entire catalog of DUO Venous

Stent System sizes, from narrowest to widest and shortest to longest.10 In turn, the

stents that were 10 millimeters in diameter—the narrowest in Vesper’s stent

catalog—were included in Vesper’s initial FDA filing.11

In 2020, Vesper amended its IDE.12 In the amended version, Vesper informed

the FDA that it would no longer utilize the 10mm stents in clinical trials.13 Vesper

removed the 10mm stents because it “had received clinician feedback indicating that

the 10mm diameter extension stents are unlikely to be utilized in iliofemoral

anatomy.”14 The FDA approved Vesper’s amended IDE later that year.15 Vesper then

began its clinical trial on the DUO Venous Stent System without the 10mm stent.16

C. THE MERGER AGREEMENT

In December 2021, Philips acquired Vesper via the “Merger Agreement.”17

8 Id. ¶¶ 20-21. 9 Id. ¶ 23. 10 Id. ¶ 24. 11 Id. 12 Id. ¶ 25. 13 Id. 14 Id. 15 Id. ¶ 26. 16 Id. ¶¶ 26-27. 17 Id. ¶¶ 2, 35; see generally id., Ex. B (“Merger Agreement”).

-2- In addition to the purchase price paid at closing, the Merger Agreement

provides for a potential “Milestone Payment” relating to the DUO Venous Stent

System.18 According to Section 2.8(a), “[WT Representative] shall be eligible to

receive a [Milestone Payment]” if “the FDA Authorization Milestone is achieved”

by specified dates.19 Section 2.8(a)(ii) further specifies the Milestone Payment

amount earned if FDA Authorization with respect to the first- or second-generation

systems is achieved on separate dates.20

FDA Authorization is defined in the Merger Agreement as “the receipt by

Parent from the FDA of an order approving a Premarket Approval application or

supplemental application . . . .”21 FDA Authorization Milestone is defined as “the

receipt by a member of the Parent Group of FDA Authorization for each of the DUO

Venous Stent First Generation System and the DUO Venous Stent Second

Generation System.”22

Both the first- and second-generation DUO Venous Stent Systems are defined

as well. The first-generation system is “comprised of the DUO-HYBRID Stent, the

18 Merger Agreement § 2.8. 19 Id. § 2.8(a)(i). 20 Id. § 2.8(a)(ii). 21 Id. § 2.8(h)(vii). “Premarket Approval” is a capitalized term in the Merger Agreement but is not defined. 22 Id. § 2.8(h)(viii). “Parent Group” means Parent and Parent’s affiliates. Id. § 2.8(h)(xiii).

-3- DUO-EXTEND Stent and a pin and pull manual delivery system[.]”23 The second-

generation system is defined as “the DUO-HYBRID Stent, the DUO-EXTEND

Stent and the DUO Triaxial/Handle Stent Delivery System.”24

The “DUO-EXTEND Stent” is defined as:

the Company’s self-expanding venous stent intended to improve luminal diameter in symptomatic venous outflow obstructions, which integrates with the DUO-HYBRID Stent to treat longer lesions in the following sizes: 10mm x 40mm, 10mm x 60mm, 10mm x 80mm, 10mm x 100mm, 10mm x 120mm, 10mm x 140mm, 12mm x 40mm, 12mm x 60mm, 12mm x 80mm, 12mm x 100mm, 12mm x 120mm, 12mm x 140mm, 14mm x 40mm, 14mm x 60mm, 14mm x 80mm, 14mm x 100mm, 14mm x 120mm, 14mm x 140mm, 16mm x 40mm, 16mm x 60mm, 16mm x 80mm, 16mm x 100mm, 16mm x 120mm, 16mm x 140mm.25

“Duo-HYBRID Stent” means:

the Company’s self-expanding venous stent intended to improve luminal diameter in symptomatic venous outflow obstructions in the following sizes: 12mm x 60mm, 12mm x 80mm, 12mm x 100mm, 12mm x 120mm, 12mm x 140mm, 12mm x 160mm, 14mm x 60mm, 14mm x 80mm, 14mm x 100mm, 14mm x 120mm, 14mm x 140mm, 14mm x 160mm, 16mm x 60mm, 16mm x 80mm, 16mm x 100mm, 16mm x 120mm, 16mm x 140mm, 16mm x 160mm, 18mm x 60mm, 18mm x 80mm, 18mm x 100mm, 18mm x 120mm, 18mm x 140mm, 18mm x 160mm.26

Merger Agreement Section 2.8(b) provides certain “FDA Authorization

23 Id. § 2.8(h)(v). 24 Id. § 2.8(h)(vi). 25 Id. § 2.8(h)(ii). 26 Id. § 2.8(h)(iii).

-4- Obligations.”27 Relevant here, it says:

From and after the Closing, until the earlier of the achievement of the FDA Authorization Milestone and December 31, 2024, Parent shall, directly or through its controlled Affiliates, use Commercially Reasonable Efforts to achieve the FDA Authorization Milestone (including with respect to achieving FDA Authorization for both the DUO Venous Stent First Generation System and the DUO Venous Stent Second Generation System) . . . .28

“Commercially Reasonable Efforts” is defined as follows:

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WT Representative LLC v. Philips Holdings USA Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/wt-representative-llc-v-philips-holdings-usa-inc-delch-2024.