`
`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
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`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
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`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-
`
`
`
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`
`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
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`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-
`
`
`
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`
`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-
`
`
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`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-
`
`
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`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-
`
`
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`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-
`
`
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`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-
`
`