throbber
Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 1 of 21 PageID: 1
`
`Angelo A. Stio III – #014791997
`Jason J. Moreira – #174752016
`TROUTMAN PEPPER HAMILTON SANDERS LLP
`(A Georgia Limited Liability Partnership)
`301 Carnegie Center
`Suite 400
`Princeton, NJ 08543-5276
`(609) 452-0808
`Angelo.Stio@troutman.com
`Jason.Moreira@troutman.com
`
`Andrew E. Kantra – pro hac vice application to be filed
`TROUTMAN PEPPER HAMILTON SANDERS LLP
`(A Georgia Limited Liability Partnership)
`3000 Two Logan Square
`Eighteenth and Arch Street
`Philadelphia, PA 19103-2799
`(215) 981-4000
`Andrew.Kantra@Troutman.com
`
`Attorneys for Plaintiff
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`
`EAGLE PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`v.
`
`
`
`
`
`
`
`Civil Action No. 3:21-cv-20145
`
`
`MRIGLOBAL,
`
`
`
`
`COMPLAINT AND DEMAND FOR
`JURY TRIAL
`
`DOCUMENT FILED ELECTRONICALLY
`
`
`Defendant.
`
`
`Plaintiff Eagle Pharmaceuticals, Inc. (“Eagle”), by and through its undersigned
`
`counsel, Troutman Pepper Hamilton Sanders LLP, hereby files this Complaint against defendant
`
`MRIGlobal and states as follows:
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 2 of 21 PageID: 2
`
`INTRODUCTION
`
`1.
`
`Eagle brings this action to recover amounts due and owing based on
`
`MRIGlobal’s admitted material breaches of a Master Services Agreement (“MSA”) that the
`
`parties entered into in 2017.
`
`2.
`
`The MSA applied to certain preclinical studies that MRIGlobal agreed to
`
`conduct with respect to Eagle’s efforts to obtain FDA approval of a new indication for its
`
`medication, Ryanodex, to prevent or treat the effects of exposure to chemical agents that cause
`
`neurological damage.
`
`3.
`
`MRIGlobal wrote the study protocols at issue in this case, but then failed
`
`to follow its own instructions.
`
`4.
`
`As a result, more than four years after entering into the MSA with
`
`MRIGlobal and paying more than $1.8 million, Eagle lacks critical preclinical data required by
`
`FDA to obtain approval of a new indication for Ryanodex.
`
`THE PARTIES
`
`5.
`
`Eagle is a specialty pharmaceutical company working to advance safe and
`
`efficient injectable treatments for patients across critical care and other diseases. Eagle is a
`
`Delaware corporation with its principal place of business at 50 Tice Boulevard, Suite 315,
`
`Woodcliff Lake, New Jersey 07677.
`
`6.
`
`MRIGlobal is a contract research organization with expertise in medical
`
`countermeasures designed to protect against threats to public health, including exposure to
`
`chemical agents. That expertise includes the conduct of preclinical safety and efficacy studies
`
`compliant with regulatory requirements. MRIGlobal is a Missouri nonprofit corporation with its
`
`principal place of business at 425 Dr. Martin Luther King Jr. Boulevard, Kansas City, Missouri
`
`64110.
`
`-2-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 3 of 21 PageID: 3
`
`VENUE AND JURISDICTION
`
`7.
`
`This Court has jurisdiction pursuant to 28 U.S.C. § 1332 because the
`
`parties are of diverse citizenship and the amount in controversy exceeds $75,000.00, exclusive of
`
`interest and costs.
`
`8.
`
`This Court has personal jurisdiction over the Defendant because, at all
`
`relevant times, MRIGlobal conducted regular and sustained business in New Jersey, engaged in
`
`substantial commerce and business activity in New Jersey, including in Bergen County, and the
`
`claims at issue arise from MRIGlobal’s business activities.
`
`9.
`
`Venue is proper in this District pursuant to 28 U.S.C. § 1391(a) because a
`
`substantial part of the events or omissions giving rise to the claim occurred in the State of New
`
`Jersey.
`
`FACTUAL ALLEGATIONS
`
`10.
`
`As part of its mission, Eagle develops medications that can treat or prevent
`
`serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic
`
`substances.
`
`11.
`
`Eagle is studying one of its medications, Ryanodex, to evaluate its
`
`potential for treating or preventing neurological damage in people exposed to chemical nerve
`
`agents. Ryanodex is currently approved by FDA for treatment of malignant hyperthermia in
`
`conjunction with appropriate supportive measures and prevention of malignant hyperthermia in
`
`patients at high risk.
`
`12.
`
`Because of the purpose for which Ryanodex is being studied, it would not
`
`be ethical to conduct studies in humans, and field trials after accidental or deliberate exposure are
`
`not feasible.
`
`-3-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 4 of 21 PageID: 4
`
`13.
`
`Eagle is, therefore, proceeding under FDA’s Animal Rule. See 21 C.F.R.
`
`§ 314.600-650; FDA Guidance for Industry, Product Development Under the Animal Rule
`
`(October 2015) (“FDA Animal Rule Guidance”).
`
`14.
`
`Under the Animal Rule, FDA may grant approval for use in humans
`
`“based on adequate and well-controlled animal efficacy studies when the results of those studies
`
`establish that the drug is reasonably likely to produce clinical benefit in humans.” FDA Animal
`
`Rule Guidance, at 2.
`
`15.
`
`For the preclinical studies necessary to obtain FDA approval of Ryanodex
`
`under the Animal Rule, Eagle entered into a Master Services Agreement (“MSA”) with
`
`MRIGlobal, effective March 28, 2017 (attached as Exhibit 1).
`
`16.
`
`In entering into this MSA with MRIGlobal, Eagle relied on MRIGlobal’s
`
`representations about its extensive preclinical experience testing medical countermeasures to
`
`chemical agents, in compliance with the Animal Rule.
`
`17.
`
`The MSA provides that the delivery of research services will be further
`
`described in Statements of Work (“SOWs”), prepared by MRIGlobal and submitted to Eagle for
`
`approval. MSA ¶ 1.
`
`18.
`
`Initially, the parties agreed that MRIGlobal would conduct preliminary
`
`studies of Ryanodex in a rodent model.
`
`19. MRIGlobal completed its studies of Ryanodex in the rodent model in
`
`2017.
`
`20.
`
`After other work related to Ryanodex not performed by MRIGlobal, Eagle
`
`and MRIGlobal executed Project Change Order No. 4 (attached under seal as Exhibit 2), which
`
`had an effective date of September 4, 2020. The purpose of this change order was to get Eagle’s
`
`-4-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 5 of 21 PageID: 5
`
`approval of the additional Scope of Work – i.e., the drafting of protocols in nonhuman primates
`
`(NHPs) – and related price increase.
`
`21.
`
`Soon after, Project Change Order No. 5 (attached under seal as Exhibit 3),
`
`which had an effective date of November 20, 2020, identified five NHP studies needed for
`
`Eagle’s planned Ryanodex Investigational New Drug Application submission to FDA for
`
`approval under the Animal Rule.
`
`22.
`
`Each of the five NHP studies had a different purpose, and each provided
`
`necessary information for the studies that followed it.
`
`23.
`
`These precursor studies were intended to lead to a pivotal efficacy study
`
`that would support an Investigational New Drug Application for FDA approval of Ryanodex for
`
`treatment or prevention of neurological damage in people exposed to chemical nerve agents.
`
`24. MRIGlobal was responsible for drafting the protocols for each of the five
`
`NHP studies in the SOWs.
`
`25.
`
`The protocols for the five NHP studies that MRIGlobal prepared were the
`
`executable Statement of Work. The agreed-on scope of this SOW was the conduct of the studies.
`
`26.
`
`Each study protocol and any amendments thereto had to be approved by
`
`MRIGlobal’s study director and Eagle, as the study sponsor, with the study director being the
`
`last to sign.
`
`27. MRIGlobal’s study director was required to promptly communicate to
`
`Eagle, as the study sponsor, all unplanned changes to the study, also known as protocol
`
`deviations. The study director was also required to determine the importance of any deviation
`
`and its impact on the study, including data generated, results, and conclusions.
`
`-5-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 6 of 21 PageID: 6
`
`28.
`
`NHP Study Nos. 1-3 and 5 were required to comply with MRIGlobal’s
`
`SOPs and documentation practices. NHP Study No. 4 was required to comply with Good
`
`Laboratory Practices regulations.
`
`29.
`
`Execution of the in-life phase of each of the proposed NHP studies was an
`
`MRIGlobal deliverable.
`
`30.
`
`One draft and one final report for each of the NHP studies was an
`
`MRIGlobal deliverable.
`
`31.
`
`Of the five NHP studies necessary for Eagle’s planned Ryanodex
`
`submission to FDA, MRIGlobal only completed Study No. 1 and the first phase of Study No. 2.
`
`32.
`
`The purpose of Study No. 1 was to determine and refine the appropriate
`
`dose levels of Soman in the nonhuman primate model.
`
`33.
`
`34.
`
`Soman is a chemical agent that can lead to seizure-induced brain damage.
`
`The NHP is an established animal model for evaluating therapeutic
`
`interventions following Soman exposure. The first step is to determine the dose of Soman that is
`
`lethal for half of the animals (the LD50 dose). After this dose is established, each of the
`
`remaining animals in the study is given a dose that is twice the LD50 dose. However, to be useful
`
`in evaluating a proposed therapeutic intervention, the animals need to survive exposure to Soman
`
`so the extent of seizure-induced brain damage can be assessed. This is done by administering
`
`specific rescue medications in sequence, at a specific time and dose.
`
`35. MRIGlobal initiated Study No. 1 on or about December 15, 2020, and
`
`completed the in-life phase on or before May 31, 2021.
`
`36. MRIGlobal never delivered a draft or final study report for Study No. 1.
`
`-6-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 7 of 21 PageID: 7
`
`37. MRIGlobal only completed the initial phase of Study No. 2. That phase
`
`evaluated the pharmacokinetics of Ryanodex in animals also receiving rescue medications, but
`
`not Soman.
`
`38. MRIGlobal’s protocols for Study Nos. 1 and 2 provide a detailed
`
`description of the specific time, dose, and sequence for the administration of the rescue
`
`medications.
`
`39. MRIGlobal initiated Study No. 2 on or about February 24, 2021 and
`
`completed the in-life part of Phase I of that study on or before May 31, 2021.
`
`40. MRIGlobal never completed Study No. 2 and never delivered a draft or
`
`final study report for Study No. 2.
`
`41. MRIGlobal first provided the completed study data for Study No. 1 to
`
`Eagle in early May 2021.
`
`42.
`
`Eagle was concerned by the Study No. 1 data, which contrasted with
`
`observations from previous rat studies, scientific literature, and what would be expected
`
`biologically.
`
`43.
`
`Eagle was authorized to audit MRIGlobal’s services performed under
`
`SOWs. MSA ¶¶ 1, 14.
`
`44.
`
`Eagle conducted a scheduled audit of MRIGlobal on May 19 and 20,
`
`2021, and on June 7, 2021, Eagle issued a report regarding that audit (hereinafter “Audit
`
`Report”) (attached under seal as Exhibit 4).
`
`45.
`
`The audit found that MRIGlobal did not follow the approved protocols it
`
`drafted for Study Nos. 1 and 2 – the same protocols that constituted the executable Statement of
`
`Work.
`
`-7-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 8 of 21 PageID: 8
`
`46.
`
`This failure to follow the approved protocols caused several protocol
`
`deviations, which significantly affected the outcome of the studies.
`
`47. MRIGlobal’s failure to follow approved protocols was in violation of the
`
`SOW.
`
`48. MRIGlobal’s failure to follow these protocols in violation of the SOW
`
`was also a breach of paragraph 1 of the MSA, which incorporates SOWs by reference.
`
`49.
`
`These errors were not identified by MRIGlobal’s study director during
`
`either study, in violation of MRIGlobal’s SOPs that were required to be followed under the
`
`defined SOW.
`
`50. MRIGlobal’s failure to follow these SOPs in violation of the SOW was
`
`also a breach of paragraph 1 of the MSA.
`
`51.
`
`These errors were also not identified during the study director’s review of
`
`the final data, in violation of MRIGlobal’s SOPs that the defined SOW required MRIGlobal to
`
`follow.
`
`52. MRIGlobal’s failure to follow these SOPs in violation of the SOW was
`
`also a breach of paragraph 1 of the MSA.
`
`53.
`
`The executed documentation for Study Nos. 1 and 2 was not reviewed by
`
`MRIGlobal’s study director until approximately four months after study initiation, in violation of
`
`MRIGlobal’s SOPs that the defined SOW required MRIGlobal to follow.
`
`54. MRIGlobal’s failure to follow these SOPs in violation of the SOW was
`
`also a breach of paragraph 1 of the MSA.
`
`-8-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 9 of 21 PageID: 9
`
`55.
`
`At no time before Eagle conducted its audit did MRIGlobal report any of
`
`these significant protocol deviations, in violation of MRIGlobal’s own SOPs that the SOW
`
`required it to follow in Study Nos. 1 and 2.
`
`56. MRIGlobal’s failure to follow these SOPs in violation of the SOW was
`
`also a breach of paragraph 1 of the MSA.
`
`57.
`
`By proceeding with Study 2 before identifying and informing Eagle of
`
`major protocol violations in Study 1, MRIGlobal violated the same SOPs that it was required to
`
`follow under the defined SOW.
`
`58. MRIGlobal’s failure to follow these SOPs in violation of the SOW was
`
`also a breach of paragraph 1 of the MSA.
`
`59.
`
`On June 7, 2021, Eagle provided the Audit Report to MRIGlobal and
`
`requested a comprehensive plan to address the identified protocol deviations and a detailed
`
`timeline, with realistic dates, of implementation of the proposed plan for all observations. Letter
`
`from Darren Brayton to Chris Bailey, dated June 7, 2021, at 2 (attached under seal as Exhibit 4).
`
`60. MRIGlobal has admitted to multiple errors that led to major protocol
`
`deviations. See MRIGlobal Response to Audit Observations, dated May 28, 2021 (attached
`
`under seal as Exhibit 5).
`
`61. MRIGlobal’s proposal to correct the major protocol deviations was to start
`
`all over again and re-run Study Nos. 1 and 2 with additional instructions and a new study
`
`director. See MRIGlobal July 1, 2021 Audit Response at 2 (attached under seal as Exhibit 6).
`
`62.
`
`On July 21, 2021, Eagle informed MRIGlobal that it considered the audit
`
`closed because MRIGlobal had proposed a plan that, in general, satisfactorily addressed the audit
`
`observations. Eagle Audit Close-Out Letter, at 1 (attached under seal as Exhibit 7).
`
`-9-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 10 of 21 PageID: 10
`
`63.
`
`The audit close-out letter did not excuse MRIGlobal’s admitted violations
`
`of the MSA and SOWs.
`
`64.
`
`Indeed, Eagle’s audit close-out letter clarified that MRIGlobal’s proposed
`
`plan to address the audit observations did not change the fact that Study Nos. 1 and 2 were not
`
`correctly followed or executed as written and approved in the protocols.
`
`65.
`
`Based on the audit report, MRIGlobal’s status was Conditional, indicating
`
`that the major protocol deviations identified in the audit significantly affected the outcome of the
`
`studies.
`
`66. While conducting Study Nos. 1 and 2, and before Eagle conducted its
`
`audit, MRIGlobal submitted two invoices to Eagle for its work under the MSA, related SOWs,
`
`and Project Change Orders Nos. 4 and 5. Those invoices, dated December 9, 2020 (No. 33547)
`
`and February 2, 2021 (No. 33678), totaled $1,860,049.30. See Invoice No. 33547 (attached
`
`under seal as Exhibit 8); Invoice No. 33678 (attached under seal as Exhibit 9).
`
`67.
`
`These invoices included charges and expenses that were neither
`
`reasonably incurred nor for services correctly performed by MRIGlobal. See MSA ¶ 13(c).
`
`68.
`
`These invoices did not disclose, nor did MRIGlobal otherwise itemize or
`
`inform Eagle of, these charges and expenses.
`
`69. MRIGlobal overcharged Eagle for all aspects of the studies, including for
`
`the costs of the NHPs and for analysis of data which is unusable.
`
`70.
`
`Consistent with paragraph 3 of the MSA and the relevant project change
`
`order, Eagle paid Invoice Nos. 33547 and 33678 in full on March 4, 2021 and April 8, 2021,
`
`respectively.
`
`-10-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 11 of 21 PageID: 11
`
`71.
`
`Eagle paid the Invoices long before it discovered MRIGlobal’s protocol
`
`deviations and violations of its SOPs.
`
`72.
`
`Although MRIGlobal was required by the MSA and SOWs to promptly
`
`disclose major protocol deviations and their implications for the studies, Eagle only discovered
`
`them as a result of the audit it initiated after receiving the completed data for Study No.1.
`
`73.
`
`As a result of MRIGlobal’s failure to follow the instructions in the
`
`protocols it drafted or to evaluate the impact of the significant protocol deviations, Eagle has no
`
`usable data NHPs to support its Ryanodex Investigational New Drug Application to FDA.
`
`74.
`
`The MSA governing MRIGlobal’s work for Eagle allows termination for
`
`cause if either party believes the other party has failed in any material respect to perform any
`
`obligation under the MSA. MSA ¶¶ 2(d), 13(a).
`
`75.
`
`A party terminating the MSA for cause may provide written notice to the
`
`other party describing the alleged default in reasonable detail. MSA ¶ 13(a).
`
`76.
`
`After receiving written notice of the alleged default under the MSA, the
`
`defaulting party has thirty (30) calendar days “to either (a) cure the default to the reasonable
`
`satisfaction of the non-defaulting party, or (b) if the default is not one that can reasonably be
`
`cured within thirty (30) calendar days, then the non-breaching party may at its option terminate
`
`this Agreement, in whole or in part, by providing written notice to the defaulting party of the
`
`effective termination date.” MSA ¶ 13(a).
`
`77.
`
`As described in Paragraphs 44-59 and 65, Eagle’s Audit Report, provided
`
`MRIGlobal with a reasonably detailed description of major protocol deviations that had a
`
`significant impact on the outcome of Study Nos. 1 and 2.
`
`78.
`
`The Eagle Audit Report also described other areas of concern.
`
`-11-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 12 of 21 PageID: 12
`
`79. MRIGlobal proposed a plan for addressing the deficiencies identified in
`
`the Audit Report in responses dated May 28, 2021 and July 1, 2021, but has never proposed a
`
`timeline.
`
`80. MRIGlobal cannot draft new protocols for Study Nos. 1 and 2, conduct the
`
`studies, and provide the draft and final reports for those studies within 30 days.
`
`81. MRIGlobal’s proposed corrective and preventive action plan is not a
`
`“cure” of its defaults under the MSA. See MSA ¶ 13(a).
`
`82.
`
`On June 22, 2021, Eagle demanded that MRIGlobal return all of the
`
`money paid in connection with the NHP studies, based on MRIGlobal’s “clear and egregious
`
`failures to conduct the project in accordance with requisite study protocols.” See Letter from
`
`Ryan M. Debski to MRIGlobal’s Legal Department, dated June 22, 2021.
`
`83.
`
`Eagle’s June 22, 2021 letter further noted the audit found major
`
`deviations, and that MRIGlobal admitted to such. See Letter from Ryan M. Debski to
`
`MRIGlobal’s Legal Department, dated June 22, 2021.
`
`84. MRIGlobal responded to Eagle’s June 22, 2021 letter on June 28, 2021 by
`
`again offering to re-start the project. See Letter from Reachel A. Beichley to Ryan M. Debski,
`
`dated June 28, 2021.
`
`85.
`
`On July 31, 2021, Eagle advised MRIGlobal to repurpose all remaining
`
`NHPs it had purchased for Study Nos. 1 and 2. Email from Veron Browne to Claire Croutch,
`
`dated July 31, 2021.
`
`86.
`
`On August 5, 2021, Eagle provided MRIGlobal with a notice of
`
`termination for cause regarding the MSA and all open SOWs, effective July 31, 2021. Letter
`
`from Andrew E. Kantra to Reachel A. Beichley, dated August 5, 2021.
`
`-12-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 13 of 21 PageID: 13
`
`87.
`
`In connection with the notice of termination, Eagle again demanded that
`
`MRIGlobal return all of the money paid in connection with the NHP studies by August 16.
`
`88.
`
`To date, MRIGlobal has not returned any of the money paid to it for the
`
`NHP studies.
`
`89.
`
`The MSA provides that it is made under and will be construed in
`
`accordance with the law of the State of Delaware. MSA ¶ 16(j).
`
`COUNT I
`BREACH OF CONTRACT
`
`90.
`
`Eagle incorporates by reference each and every paragraph set forth above
`
`as if fully set forth herein.
`
`91.
`
`92.
`
`Eagle and MRIGlobal entered the MSA, effective March 28, 2017.
`
`The MSA is a valid, enforceable, and binding contract, under which
`
`MRIGlobal agreed to perform services, as described in SOWs, in exchange for Eagle’s payment
`
`of expenses, advance payments, and payment for services. MSA ¶¶ 1, 3.
`
`93.
`
`Eagle has fulfilled all of its obligations under the MSA, including paying
`
`MRIGlobal’s invoice numbers 33547 and 33678.
`
`94.
`
`Despite receiving over $1.8 million in payments pursuant to invoice
`
`numbers 33547 and 33678, MRIGlobal refused and failed to satisfy its obligations under the
`
`MSA and related SOWs.
`
`95. MRIGlobal breached the MSA and related SOWs by failing to follow the
`
`study protocols it drafted for the NHP studies, including but not limited to its failure to follow
`
`the approved protocols it drafted for Study Nos. 1 and 2.
`
`96. MRIGlobal further breached the MSA and related SOWs by failing to
`
`follow its SOPs regarding protocol deviations.
`
`-13-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 14 of 21 PageID: 14
`
`97. MRIGlobal further breached the MSA and related SOWs by failing to
`
`prepare the agreed-upon draft and final study reports for each of the studies.
`
`98. MRIGlobal further breached the MSA and related SOWs by failing to
`
`properly train its staff/technicians involved in Study Nos. 1 and 2.
`
`99.
`
`As a result of MRIGlobal’s breaches of the MSA and related SOWs, Eagle
`
`has suffered and continues to suffer damages.
`
`100. As a result of MRIGlobal’s performance, Eagle has now paid for two
`
`useless studies and still has no data by which to reliably evaluate the efficacy and
`
`pharmacokinetics of Ryanodex in the Soman nonhuman primate model.
`
`101. MRIGlobal’s performance further resulted in Eagle being unable to submit
`
`an Investigational New Drug Application for Ryanodex to FDA for approval under the Animal
`
`Rule.
`
`102. Eagle’s damages include, among others, the $1,860,049.30 that Eagle paid
`
`to MRIGlobal, plus interest.
`
`WHEREFORE, Eagle respectfully requests that the Court enter judgment on
`
`Count One in its favor and against MRIGlobal, as follows:
`
`trial;
`
`a.
`
`b.
`
`c.
`
`d.
`
`Finding MRIGlobal in breach of the MSA and related SOWs;
`
`Awarding Eagle actual damages in an amount to be determined at
`
`Awarding Eagle pre-judgment and post-judgment interest;
`
`Awarding Eagle all costs, expenses, fees, and reasonable attorneys’
`
`fees, as permitted by law, associated with pursing this action; and
`
`-14-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 15 of 21 PageID: 15
`
`e.
`
`Awarding such other relief the Court deems necessary, just, and
`
`proper.
`
`COUNT II
`BREACH OF COVENANT OF GOOD FAITH AND FAIR DEALING
`
`103. Eagle incorporates by reference each and every paragraph set forth above
`
`as if fully set forth herein.
`
`104. The MSA is a valid, enforceable, and binding contract.
`
`105. To the extent the MSA and related SOWs do not explicitly require
`
`MRIGlobal to conduct the NHP studies with reasonable care and/or competence, the implied
`
`covenant of good faith and fair dealing requires MRIGlobal to conduct the NHP studies with
`
`reasonable care and/or competence.
`
`106. MRIGlobal’s failure to conduct Study Nos. 1 and 2 with reasonable care
`
`and/or competence breaches its implied covenant of good faith and fair dealing and destroys the
`
`benefit to Eagle of the parties’ bargain.
`
`107. MRIGlobal has breached, and continues to breach, the implied covenant of
`
`good faith and fair dealing in the MSA and related SOWs.
`
`108. As a result of MRIGlobal’s breach of the implied covenant of good faith
`
`and fair dealing, Eagle has suffered, and continues to suffer, damages.
`
`109. As a result of MRIGlobal’s performance, Eagle has now paid for two
`
`useless studies and still has no data by which to reliably evaluate the efficacy and
`
`pharmacokinetics of Ryanodex in the Soman nonhuman primate model.
`
`110. MRIGlobal’s performance further resulted in Eagle being unable to submit
`
`an Investigational New Drug Application for Ryanodex to FDA for approval under the Animal
`
`Rule.
`
`-15-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 16 of 21 PageID: 16
`
`111. Eagle’s damages include, among others, the $1,860,049.30 that Eagle paid
`
`to MRIGlobal, plus interest.
`
`WHEREFORE, Eagle respectfully requests that the Court enter judgment on
`
`Count Two in its favor and against MRIGlobal, as follows:
`
`a.
`
`Finding MRIGlobal in breach of the duty of good faith and fair
`
`dealing under MSA and related SOWs;
`
`b.
`
`Awarding Eagle actual damages in an amount to be determined at
`
`trial;
`
`c.
`
`d.
`
`Awarding Eagle pre-judgment and post-judgment interest;
`
`Awarding Eagle all costs, expenses, fees, and reasonable attorneys’
`
`fees, as permitted by law, associated with pursing this action; and
`
`e.
`
`Awarding such other relief the Court deems necessary, just, and
`
`proper.
`
`COUNT III
`DETRIMENTAL RELIANCE UNDER DELAWARE LAW
`
`112. Eagle incorporates by reference each and every paragraph set forth above
`
`as if fully set forth herein.
`
`113. MRIGlobal made certain representations and promises as described herein
`
`to induce Eagle to enter into the MSA and related SOWs.
`
`114.
`
`In making these representations to Eagle, MRIGlobal failed to exercise
`
`reasonable care and/or competence.
`
`115. Eagle justifiably relied on these representations in deciding to enter the
`
`MSA and related SOWs.
`
`-16-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 17 of 21 PageID: 17
`
`116.
`
`In relying on MRIGlobal’s representations and, thus, entering the MSA
`
`and related SOWs, Eagle acted to its detriment.
`
`117. Eagle has been damaged as a direct and proximate result of MRIGlobal’s
`
`conduct in an amount to be determined at trial.
`
`118. As a result of MRIGlobal’s representations that induced Eagle to enter the
`
`MSA and related SOWs, Eagle has suffered and continues to suffer damages.
`
`119. As a result of MRIGlobal’s performance, Eagle has now paid for two
`
`useless studies and still has no data by which to reliably evaluate the efficacy and
`
`pharmacokinetics of Ryanodex in the Soman nonhuman primate model.
`
`120. MRIGlobal’s performance further resulted in Eagle being unable to submit
`
`an Investigational New Drug Application for Ryanodex to FDA for approval under the Animal
`
`Rule.
`
`121. Eagle’s damages include, among others, the $1,860,049.30 that Eagle paid
`
`to MRIGlobal, plus interest.
`
`WHEREFORE, Eagle respectfully requests that the Court enter judgment on
`
`Count Three in its favor and against MRIGlobal, as follows:
`
`a.
`
`Finding in Eagle’s favor and entering judgment against MRIGlobal
`
`on the detrimental reliance claim;
`
`b.
`
`Awarding Eagle actual damages in an amount to be determined at
`
`trial;
`
`c.
`
`d.
`
`Awarding Eagle pre-judgment and post-judgment interest;
`
`Awarding Eagle all costs, expenses, fees, and reasonable attorneys’
`
`fees, as permitted by law, associated with pursing this action; and
`
`-17-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 18 of 21 PageID: 18
`
`e.
`
`Awarding such other relief the Court deems necessary, just, and
`
`proper.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Eagle requests that this Court enter judgment in its favor and
`
`against MRIGlobal, as follows:
`
`a.
`
`b.
`
`Finding MRIGlobal in breach of the MSA and related SOWs;
`
`Finding MRIGlobal in breach of the duty of good faith and fair
`
`dealing under the MSA and related SOWs;
`
`c.
`
`Finding in Eagle’s favor and entering judgment against MRIGlobal
`
`on the detrimental reliance claim;
`
`d.
`
`Awarding Eagle actual damages in an amount to be determined at
`
`trial;
`
`e.
`
`f.
`
`Awarding Eagle pre-judgment and post-judgment interest;
`
`Awarding Eagle all costs, expenses, fees, and reasonable attorneys’
`
`fees, as permitted by law, associated with pursing this action; and
`
`g.
`
`Awarding such other relief the Court deems necessary, just, and
`
`proper.
`
`JURY TRIAL DEMAND
`
`Plaintiff demands a jury trial on all issues so triable.
`
`Dated: November 22, 2021
`
`Respectfully submitted,
`
`s/ Angelo A. Stio III
`
`
`Angelo A. Stio III – #014791997
`Jason J. Moreira – #174752016
`TROUTMAN PEPPER HAMILTON
`SANDERS LLP
`(A Georgia Limited Liability Partnership)
`301 Carnegie Center
`
`
`
`-18-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 19 of 21 PageID: 19
`
`Suite 400
`Princeton, NJ 08543-5276
`(609) 452-0808
`Angelo.Stio@troutman.com
`Jason.Moreira@troutman.com
`
`Andrew E. Kantra – pro hac vice application to
`be filed
`TROUTMAN PEPPER HAMILTON
`SANDERS LLP
`(A Georgia Limited Liability Partnership)
`3000 Two Logan Square
`Eighteenth and Arch Streets
`Philadelphia, PA 19103-2799
`(215) 981-4000
`Andrew.Kantra@Troutman.com
`
`Attorneys for Plaintiff
`
`
`
`
`
`
`
`-19-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 20 of 21 PageID: 20
`
`L. CIV. R. 11.2 CERTIFICATION
`
`I certify, under penalty of perjury under the laws of the United States, that the
`
`matter in controversy in this action is not the subject of any other action pending in any court or
`
`of a pending arbitration proceeding. No other action or arbitration proceeding is presently
`
`contemplated by Plaintiff, and Plaintiff represents that it is not aware of any other parties who
`
`should be joined in this action at this time.
`
`Dated: November 22, 2021
`
`
`
`
`
`
`s/ Angelo A. Stio III
`
`
`Angelo A. Stio III – #014791997
`Jason J. Moreira – #174752016
`TROUTMAN PEPPER HAMILTON
`SANDERS LLP
`(A Georgia Limited Liability Partnership)
`301 Carnegie Center
`Suite 400
`Princeton, NJ 08543-5276
`(609) 452-0808
`
`Andrew E. Kantra – pro hac vice application to
`be filed
`TROUTMAN PEPPER HAMILTON
`SANDERS LLP
`(A Georgia Limited Liability Partnership)
`3000 Two Logan Square
`Eighteenth and Arch Streets
`Philadelphia, PA 19103-2799
`(215) 981-4000
`
`-20-
`
`

`

`Case 3:21-cv-20145 Document 1 Filed 11/22/21 Page 21 of 21 PageID: 21
`
`L. CIV. R. 201.1 CERTIFICATION OF NON-ARBITRABILITY
`
`The undersigned hereby certifies, under penalty of perjury under the laws of the
`
`United States, that the damages in this action are in excess of $150,000.00, exclusive of interest
`
`and costs, and thus not eligible for arbitration under L. Civ. R. 201.1(d)(3).
`
`Dated: November 22, 2021
`
`
`
`
`
`s/ Angelo A. Stio III
`
`
`Angelo A. Stio III – #014791997
`Jason J. Moreira – #174752016
`TROUTMAN PEPPER HAMILTON
`SANDERS LLP
`(A Georgia Limited Liability Partnership)
`301 Carnegie Center
`Suite 400
`Princeton, NJ 08543-5276
`(609) 452-0808
`Angelo.Stio@troutman.com
`Jason.Moreira@troutman.com
`
`Andrew E. Kantra – pro hac vice application to
`be filed
`TROUTMAN PEPPER HAMILTON
`SANDERS LLP
`(A Georgia Limited Liability Partnership)
`3000 Two Logan Square
`Eighteenth and Arch Streets
`Philadelphia, PA 19103-2799
`(215) 981-4000
`Andrew.Kantra@troutman.com
`
`-21-
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket