inVentiv Health Clinical, LLC v. Odonate Therapeutics, Inc.

CourtSuperior Court of Delaware
DecidedJanuary 26, 2021
DocketN19C-12-033 PRW CCLD
StatusPublished

This text of inVentiv Health Clinical, LLC v. Odonate Therapeutics, Inc. (inVentiv Health Clinical, LLC v. Odonate Therapeutics, Inc.) is published on Counsel Stack Legal Research, covering Superior Court of Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
inVentiv Health Clinical, LLC v. Odonate Therapeutics, Inc., (Del. Ct. App. 2021).

Opinion

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE

inVENTIV HEALTH CLINICAL, LLC, ) ) Plaintiff / Counterclaim Defendant, ) ) v. ) C.A. No. N19C-12-033 ) PRW CCLD ODONATE THERAPEUTICS, INC., ) ) Defendant / Counterclaim Plaintiff. )

Submitted: November 20, 2020 Decided: January 26, 2021

MEMORANDUM OPINION AND ORDER

Upon Plaintiff inVentiv Health Clinical, LLC’s Motion to Dismiss GRANTED IN PART, DENIED IN PART.

Jody C. Barillare, Esquire, MORGAN, LEWIS & BOCKIUS LLP, Wilmington, Delaware; Brian W. Shaffer, Esquire, MORGAN, LEWIS & BOCKIUS LLP, Philadelphia, Pennsylvania; John A. Vassallo, III, Esquire, MORGAN, LEWIS & BOCKIUS LLP, New York, New York, Attorneys for Plaintiff/ Counterclaim Defendant inVentiv Health Clinical, LLC.

Catherine A. Gaul, Esquire, ASHBY & GEDDES, Wilmington, Delaware; Shireen Barday, Esquire, GIBSON DUNN, New York, New York; Joshua H. Lerner, Esquire, GIBSON DUNN, San Francisco, California, Attorneys for Defendant/ Counterclaim Plaintiff Odonate Therapeutics, Inc.

WALLACE, J. This case arises from a dispute between the parties to pharmaceutical drug

trial agreements. inVentiv Health Clinical, LLC (“Syneos”1), is a privately owned

global provider of biopharmaceutical services that includes Contract Research

Organization services. Odonate Therapeutics, Inc., is a biotechnology company that

focuses on development of therapeutics for cancer patients; it has primarily focused

on the development of a drug called tesetaxel, a treatment drug for patients with

breast cancer.

Each party, among other counts, alleges that the other breached the several

agreements between them. Syneos alleges that Odonate owes it nearly $12 million

in unpaid invoices.2 Odonate alleges that Syneos overbilled for more than $7

million, is not honoring $4.65 million in credits for missed milestones, and that it

fraudulently induced the contracts.3 Before the Court now is Syneos’s motion to

dismiss Odonate’s counterclaims.

Syneos’s Motion is DENIED as to Counterclaim Count I

(breach of contract) and is GRANTED as to Counterclaim Counts II and III (breach

of the implied covenant of good faith and fair dealing and fraud in the inducement).

1 In 2018, inVentiv Health rebranded as Syneos Health. In most of the parties’ briefing, inVentiv is referred to as Syneos. So the Court uses that new name herein to avoid confusion. 2 Pl.’s Compl. at ¶ 1, Dec. 12, 2019 (D.I. 1). 3 Def.’s Am. Countercl. at ¶ 1, Mar. 9, 2020 (D.I. 15).

-1- I. FACTUAL BACKGROUND

In early 2017, Odonate was looking for a contract research organization

(“CRO”) to provide Phase III clinical drug study and regulatory approval services

for its cancer drug study, CONTESSA—a multinational study of the novel

therapeutic agent, tesetaxel, for patients with breast cancer.4 Odonate began

discussions with Syneos, during which Syneos made specific representations as to

its expertise, ability to hit mutually agreed upon timelines, ability to complete

CONTESSA enrollment by February 2019 and to provide continuity of Clinical

Research Associates (“CRAs”) during the entire study.5 Based on Syneos’s

representations of its expertise and capability, the parties entered into a Start-Up

Services Agreement (“SUSA”) in February 2017 and Odonate formally awarded the

management of CONTESSA to Syneos on March 26, 2017.6 The parties entered

into a Master Services Agreement (“MSA”) in April 2017.7 And in May 2017,

Syneos announced it was merging with INC Research.8 By that time, Odonate had

already invested a half-million dollars into its deal with Syneos.9

4 Id. at ¶ 2. 5 Id. at ¶¶ 25, 116. 6 Id. at ¶ 28. 7 Id. at ¶ 29. 8 Id. at ¶ 5. 9 Id.

-2- The parties entered an Individual Project Agreement (“IPA”) in August

2017.10 The IPA specified that Odonate would pay Syneos $29.6 million in

exchange for its services to “successfully manage CONTESSA through its

completion.”11 The IPA included bonus and penalty incentives for Syneos to

complete certain work by objective milestones.12 The milestones included dates

when a number of clinical sites would become activated or when a number of

patients had been introduced to the study.13

Syneos’s merger with INC Research was completed on August 1, 2017.14

This merger, Odonate believes, severely impacted Syneos’s ability to manage

CONTESSA.15 More specifically, the merger allegedly caused Syneos to shift

corporate priorities and the allocation of necessary resources away from its duties

under the IPA.16 Due to this shift, Odonate says, Syneos failed to live up to the

10 Id. at ¶ 30. 11 Id. at ¶ 31. 12 Id. at ¶ 66. 13 Id. at ¶ 68. 14 Id. at ¶ 38. 15 Id. at ¶ 39. 16 Id. at ¶¶ 34, 36.

-3- representations of its capacity to successfully manage CONTESSA.17 Syneos’s

alleged deficiencies in its management of CONTESSA caused it to miss every single

agreed-upon milestone by an average of 101 days.18 Additionally, during this time,

CONTESSA experienced a high rate of turnover for its CRAs, despite Syneos’s

representations of its goal for CRA continuity for the lifetime of the CONTESSA

project.19

Despite these deficiencies in performance, Odonate tried to work with Syneos

to improve its performance from October 2018 to April 2019.20 When these attempts

failed, Odonate invested in the infrastructure to take over some of the management

activities of CONTESSA.21 On May 7, 2019, Odonate informed Syneos of this

change, and Syneos agreed to create a transition plan in order to minimize disruption

to the CONTESSA project.22

On May 13, 2019, Syneos suspended its services without providing any

transition plan and informed its testing sites that Odonate had taken over full

17 Id. at ¶ 39. 18 Id. at ¶¶ 67-68. 19 Id. at ¶ 40. 20 Id. at ¶ 71. 21 Id. at ¶ 72. 22 Id.

-4- responsibility for CONTESSA.23 Despite this suspension of service, Syneos

continued to send Odonate monthly invoices of $217,717.82 for six months (totaling

$1,303,306.92) after the May suspension date.24

On November 25, 2019, Odonate exercised its right of early termination under

Section 5.2(a) of the MSA.25 Upon this termination, Syneos was obligated to

account for the number of fully-completed or partially-completed units of work it

had performed pursuant to Section 5.3(c)(i) of the MSA and Section 4 of the IPA.26

Syneos never did so.27

As of the November 25 termination date, Syneos had invoiced Odonate

approximately $25.5 million.28 Odonate’s own calculation, based on the amount of

units of work recorded, suggested that Syneos had performed approximately $18.4

million of services, and thus overbilled $7.1 million.29 Further, according to

23 Id. at ¶¶ 73-74. 24 Id. at ¶ 88. 25 Id. at ¶ 59. 26 Id. 27 Id. 28 Id. at ¶ 42. 29 Id. ¶¶ 43, 46-47.

-5- Odonate, Syneos’s missed milestones resulted in payment penalties worth $4.65

million.30

II. PARTIES’ CONTENTIONS

A. SYNEOS’S COMPLAINT

In December 2019, Syneos filed its Complaint against Odonate for breach of

contract, equitable estoppel, promissory estoppel, and unjust enrichment.31 It alleges

Odonate refused payment required by a number of different contractual provisions

of the MSA and IPA, amounting to at least $12 million in compensatory and other

damages for monthly fees, milestones, compensable expenses, and late fees.32

B. ODONATE’S COUNTERCLAIMS

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inVentiv Health Clinical, LLC v. Odonate Therapeutics, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/inventiv-health-clinical-llc-v-odonate-therapeutics-inc-delsuperct-2021.