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

Superior Court of Delaware·Decided February 18, 2021·No. N19C-12-033 PRW CCLD·Published

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 Corrected: February 18, 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).

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.

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.

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.

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.

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 In its answer, Odonate filed counterclaims against Syneos for breach of contract, breach of implied covenant of good faith and fair dealing, and fraud in the inducement.33 In Counterclaim Count I, Odonate asserts that Syneos breached the MSA and IPA through overbillings, missed contractual milestones, continued billings after suspending services, and unreturned grant funds.34

30 Id. at ¶ 68.

31 Pl.’s Compl. at ¶¶ 63-75.

32 Id. at ¶¶ 144-45, 159.

33 Def.’s Am. Countercl. at ¶¶ 83-126.

34 Id. at ¶¶ 84, 88, 91.

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

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