Sekisui America Corporation et al v. Hart et al, No. 1:2012cv03479 - Document 143 (S.D.N.Y. 2014)
Court Description: OPINION AND ORDER re: 88 MOTION for Attorney Fees pursuant to the Court's August 15, 2013 Order filed by Mary Louise Trudel-Hart, Richard Hart. For the foregoing reasons, Sekisuis claims and the Harts' counterclaim are dismissed wi th prejudice. Sekisui is ordered to pay $83,408.36 to Sullivan & Worcester LLP in attorneys' fees pertaining to the Harts' spoliation motion, which I granted in an opinion dated August 15, 2013. The Clerk of the Court is directed to prepare a judgment and to close this case. (Signed by Judge Shira A. Scheindlin on 2/21/2014) (lmb)
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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK -------------------------------------------------------)( USDCSDNY DOCtJME.NT BLECffiONlCALLY ~BD DOC#: ---T--""'I--- DATEffi£D: SEKISUI AMERICA CORPORATION and SEKISUI MEDICAL CO., LTD., 2lzIIr1 -7 Plaintiffs, OPINION AND ORDER - against12 Civ. 3479 (SAS) RICHARD HART and MARIE LOUISE TRUDEL-HART, Defendants. )( SHIRA A. SCHEINDLIN, U.S.D.J.: I. INTRODUCTION Sekisui America Corporation ("SAC") and Sekisui Medical Co., Ltd. ("SMD") (collectively, "Sekisui") bring this action for breach of contract against Richard Hart and Marie Louise Trudel-Hart (the "Harts,,).l Sekisui alleges that the Harts breached representations and warranties set forth in Sections 4.12, 4.14(a), 4.14(c), and 4.14(d) of the parties' Stock Purchase Agreement ("SPA"). The Harts' alleged breaches fall into two categories: (1) breaches related to the failure of America Diagnostica, Inc. ("AD I") to comply with FDA regulations, known as See Complaint ~ 1. Sekisui's fraud claim was dismissed by this Court in an October 17,2012 Opinion and Order. See Dkt. No. 28. 1 Quality System Regulations ( QSRs ); and (2) breaches related to Femtelle, ADI s breast cancer prognosis assay.2 The Harts deny that they breached any provision of the SPA and counterclaim that Sekisui breached Section 2.6(d) by failing to use commercially reasonable efforts to market Femtelle and omitting to take actions to obtain FDA approval for Femtelle, thereby preventing ADI from maximizing Femtelle revenues.3 Both parties seek damages. I held a bench trial from January 13 to January 17, 2014. The parties made post-trial submissions on January 31, 2014. Pursuant to Rule 52(a) of the Federal Rules of Civil Procedure, I make the following findings of fact and conclusions of law. In reaching these findings and conclusions, I heard the testimony, examined the documentary evidence, observed the demeanor of the witnesses, and considered the arguments and submissions of counsel. II. FINDINGS OF FACT A. Background 1. 2 The Parties See Plaintiffs Trial Memorandum of Law ( Pl. Mem. ) at 1-2. 3 See Defendants Supplemental Proposed Findings of Fact and Conclusions of Law and Annotated and Abridged Original Proposed Findings of Fact and Conclusions of Law ( Def. Facts and Concl. ) at 23-24. The Harts have abandoned their declaratory judgment counterclaim. See Trial Transcript ( Tr. ) at 867:10-23 (Jonathan Kortmansky, Counsel for the Harts). 2 In 1982, the Harts founded ADI, a Connecticut corporation engaged in the discovery, manufacture, and marketing of medical diagnostic products.4 ADI manufactured and marketed products that were designated Research Use Only and products that could be used as in vitro diagnostics ( IVD ).5 ADI was the parent company of a Canadian subsidiary, a German subsidiary, and a French subsidiary.6 ADI with its subsidiaries had a maximum of thirty-five employees.7 The Harts are citizens and residents of Connecticut.8 Until Sekisui acquired ADI, the Harts owned 95.94% of the existing and outstanding shares of common stock of ADI.9 Richard Hart served as the President and Chief Executive Officer ( CEO ) of ADI and oversaw the company s operations.10 Hart left ADI in April 2010 for medical reasons.11 4 See Joint Pretrial Order ( JPTO ) at 2. 5 See Tr. at 143:12-144:9 (Kevin Morrissey). 6 See Plaintiffs Exhibit ( Pl. Ex. ) 7 (August 2008 CrossTree Confidential Memorandum). 7 See id. 8 See JPTO at 2. 9 See id. 10 See Tr. at 73:15-74:2 (Mamoru Takemura). 11 See Pl. Ex. 14 (6/23/10 Email from Hart to Mamoru Koseki); Pl. Ex. 15 (5/27/10 Email from Richard Hart to Jeffrey Ellis). 3 SAC and SMD are wholly owned subsidiaries of Sekisui Chemical Co., Ltd.12 SAC is a corporation organized under Delaware law with its principal place of business in New Jersey.13 SMD is a Japanese corporation with its principal place of business in Tokyo.14 Sekisui engages in the research, development, manufacture, sale, import, and export of plastic medical products.15 2. FDA Regulations and Procedures Section 520(f) of the Food Drug & Cosmetic Act (the Act ) gives the FDA authority to prescribe regulations requiring that the methods, facilities, and controls used for the manufacture, packing, storage, and installation of medical devices conform to good manufacturing practices.16 In 1997, the FDA promulgated the QSRs.17 Under the QSRs, medical device manufacturers should establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of the 12 See JPTO at 2. 13 See id. 14 See id. 15 See Pl. Ex. 48 (April 2009 KPMG Valuation Study). 16 See 21 U.S.C. § 360j(f). 17 See 21 C.F.R. § 820.1. 4 QSRs.18 Failure to comply with the QSRs renders a device adulterated under the Act.19 The QSRs are flexible regulations. According to the FDA, the QSRs are an umbrella . . . that specifies general objectives rather than methods. 20 Because the QSRs must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. 21 Instead, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device . . . . 22 The FDA advises its inspectors to use good judgment in determining compliance with the [QSRs], keeping in mind that it is an umbrella . . . and all 18 21 C.F.R. § 820.5. This system is known as the Quality Management System ( QMS ). See Tr. at 602:16-19 (Carrie Kuehn). 19 21 C.F.R. § 820.1(a). 20 FDA Investigations Operations Manual ( IOM ) §5.6.2. The Court takes judicial notice of the IOM and other widely available FDA publications because the facts therein are not subject to reasonable dispute and can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned. Fed. R. Evid. 201(b)(2). 21 Defendants Exhibit ( Def. Ex. ) 8M (61 Fed. Reg. 52602). 22 IOM § 5.6.2. 5 requirements may not apply or be necessary. 23 Furthermore, inspectors should not insist that a manufacturer meet non-applicable requirements. 24 Inspectors should recognize that at small firms division of work is at a minimum, with one person often assembling and testing the finished device. 25 As such, blueprints or engineering drawings could be adequate procedures, and several requirements can be met with a single procedure. 26 To determine compliance with the QSRs, the FDA conducts an Establishment Inspection ( EI ).27 An EI is an inspection of a medical device manufacturing firm s facilities and records.28 During an EI, the inspector interviews the firm s management responsible for the QMS.29 Inspectors use a top-down approach to evaluate a firm s system for addressing quality in four main areas: Management Control, Corrective and Preventive Actions ( CAPA ), 23 Id. 24 Id. 25 Id. § 5.6.7. 26 Id. 27 See 21 U.S.C. § 374. 28 See id. 29 See FDA Guide to Inspections of Quality Systems, Quality System Inspection Technique ( QSIT ) at 14-15. The Court takes judicial notice of QSIT, an FDA publication available at its website. 6 Design Controls, and Production and Process Controls.30 Nonconformities must be addressed through the CAPA process.31 CAPAs come from a company s own monitoring process, regulatory inspections, customer audits, and internal audits.32 After the EI, the inspector may issue a Form 483, which may include inspectional observations. 33 Inspectional observations are not final [FDA] determination[s] regarding [a firm s] compliance. 34 Moreover, inspectors must not report opinions, conclusions, or conditions as violative because [t]he determination of whether any condition is violative is an agency decision made after considering all circumstances, facts and evidence, involving discussions with management . . . . 35 The inspector then discusses the Form 483 with the manufacturer s senior management.36 The firm may respond at that time or send a 30 See id. at 7-8. 31 See id. at 48. 32 See id. at 25. 33 Def. Ex. 4Q (FDA Transparency Sheet). 34 Def. Ex. D (6/23/05 FDA Form 483 issued to ADI); Def. Ex. E (6/22/11 FDA Form 483 issued to ADI). 35 IOM § 5.2.3.3. 36 See QSIT at 30. 7 corrective action plan to the FDA shortly thereafter.37 The Director of the relevant field office considers the Form 483 observations, the inspector s narrative of the inspection the Establishment Inspection Report ( EIR ) and the firm s responses to the Form 483 observations.38 The Director then classifies the inspection as no action indicated ( NAI ), voluntary action indicated ( VAI ), or official action indicated ( OAI ).39 An NAI is appropriate when no objectionable conditions were found during the inspection or the significance of the documented objectionable conditions found does not justify further action. 40 A VAI is given when objectionable conditions or practices were found that do not meet the threshold of regulatory significance. 41 An OAI occurs when significant objectionable conditions or practices were found and regulatory action is warranted to address the establishment s lack of compliance. 42 After issuing an OAI, the FDA may 37 See Tr. at 215:2-9 (Morrissey); Def. Ex. V (7/7/11 Letter from Joseph Azary, ADI s Director of Quality Assurance and Regulatory Affairs, to the FDA). 38 See Def. Ex. 4Q. 39 See id. 40 Id. 41 Id. 42 Id. 8 send a Warning Letter.43 Because a Warning Letter is informal and advisory, it communicates the agency s position on a matter, but does not commit the FDA to taking enforcement action. 44 An inspection is closed when a final decision has been made not to take [administrative] action or such action has been taken and the matter has been concluded. 45 Thus, when the FDA closes an action, it is satisfied with the results of the inspection and the firm s responses.46 B. Pre-Acquisition Events 1. 2004 and 2005 FDA Inspections Since at least 2004, ADI has manufactured and sold products regulated by the FDA and has therefore been subject to the QSRs.47 In 2004, the FDA inspected ADI s facilities.48 After the inspection, the FDA sent ADI a Warning Letter, stating that [t]he inspection revealed that [ADI s] devices are 43 See FDA Regulatory Procedures Manual § 4-1-8. 44 Id. § 4-1-1. 45 21 C.F.R. §20.64(d)(3). See also Tr. at 585:14-17 (Kuehn). 46 See Def. Ex. X (1/7/09 Morgan Lewis Preliminary Legal Due Diligence Report). 47 See Tr. at 264:25-265:2 (Hugh Fryer); id. at 485:5-12 (Bhavna Gaikwad). 48 See Pl. Ex. 197 (10/15/04 FDA Warning Letter). 9 adulterated under [the Act], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the [QSRs]. 49 The letter noted that it is not intended to be an all-inclusive list of the deficiencies at [ADI], and that it is ADI s responsibility to ensure adherence to each applicable requirement of the Act and FDA regulations. 50 In June 2005, FDA returned to ADI for a follow-up inspection.51 The FDA found that [ADI] has completed corrections on several previous observations and is in the process of completing all others. 52 Specifically, the FDA noted improvement in ADI s training program, standard operating procedures ( SOPs ), device master records ( DMRs ),53 device history files ( DHFs ),54 validation processes, and more.55 49 Id. 50 Id. 51 See Def. Ex. B (10/17/05 FDA EIR). 52 Id. 53 A DMR include[s], or refer[s] to the location of the specifications and production processes for manufacturing a device, quality assurance procedures, packaging, and labeling instructions. 21 C.F.R. § 820.181. 54 A DHF contain[s] or reference[s] the records necessary to demonstrate that the design was developed in accordance with the approved design plan[.] Id. § 820.30. 55 See Def. Ex. B. 10 Nevertheless, the FDA observed that (1) [p]rocedures to ensure that equipment is routinely checked are not established, documented, and implemented; (2) procedures that describe the review and disposition process for nonconforming products were not complete; and (3) calibration procedures do not include provisions for remedial actions. 56 However, the FDA noted that all three of these observations were being addressed by [ADI] and draft SOPs were in the process as [] observed. 57 In October 2005, the FDA released the EIR to ADI, closing the inspection.58 Thus, I find that the FDA considered ADI to be in material compliance with the QSRs at that time. 2. Intertek Audits Interek is a private inspection, product testing, and certification company that operates internationally.59 Interek audits firms for compliance with the International Organization of Standardization ( ISO ).60 Intertek auditors conduct a comprehensive review of quality management system documentation 56 Id. 57 Id. 58 See id. 59 See Intertek website (Jan. 1, 2013), http://www.intertek.com. I take judicial notice of the public information on the Intertek website and in the ISO Standards Catalogue. 60 See id. 11 and then an on-site review.61 An ISO on-site inspection is similar to an FDA inspection.62 Like an FDA inspector, the ISO auditor examines the firm s QMS, management responsibility, training, product design and development process, internal audits, CAPAs, and procedures for recalling non-conforming products.63 If the auditor finds the firm compliant with ISO standards, Intertek grants ISO certification.64 ISO 13485:2003 sets forth the international standard for medical device manufacturers quality management systems, and is similar to the QSRs.65 In fact, the FDA specifically sought to make the QSRs consistent, to the extent possible with ISO 13485:2003.66 In addition, the FDA has instituted a pilot program that acknowledges ISO certification as evidence of compliance with the QSRs.67 61 See Def. Ex. L (3/24/06 Intertek Systems Certification QMS Checklist). 62 See Def. Ex. P (4/16/09 Intertek Systems Certification Audit Report). 63 See id. 64 See Intertek website. 65 See ISO Standards Catalogue, ISO 13485:2003. 66 Def. Ex. 8M. 67 See Tr. at 592:7-25 (Kuehn). 12 Intertek audited ADI six times during the relevant period.68 The first audits took place in March and April 2006.69 On March 23 and 24, 2006, Intertek reviewed all of ADI s QMS documentation.70 After finding ADI s documents ISO compliant, Intertek returned to ADI for an on-site inspection.71 ADI was certified as ISO 13485:2003 compliant.72 Intertek noted that it had verified [the] quality of [ADI s] internal audits. 73 It found that ADI had [g]ood use of customer complaints, internal audits, [and] corrective and preventative actions [CAPAs], and [that] management review [] continually improve[d]. 74 On February 5, 2007, Intertek conducted a review of ADI documents to determine whether ADI also complied with the Canadian Medical Devices Conformity Assessment System ( CMDCAS ).75 On March 21, 2007, Intertek 68 The SPA refers to January 1, 2006 through the April 20, 2009 as the relevant period for the representations and warranties at issue. See SPA § 4.14. 69 See Def. Ex. L; Def. Ex. M (4/27/06 Intertek Systems Certification Audit Report). 70 See Def. Ex. L. 71 See Def. Ex. M. 72 See id. 73 Id. 74 Id. 75 See Def. Ex. N (3/21/07 Intertek Systems Certification Audit Report). 13 conducted an on-site surveillance audit for continued ISO 13485:2003 certification and a CMDCAS upgrade.76 ADI was re-certified and upgraded.77 On April 8 and 9, 2008, Intertek conducted a surveillance audit and extended ADI s ISO certification.78 On April 14, 15, and 16, 2009 four days before Sekisui acquired ADI Intertek audited ADI and granted ISO recertification.79 Intertek noted that (1) [t]he Management System was found to be effectively implemented in spite of the minor nonconformities cited; (2) [the QMS continues to improve; (3) six sets of batch records were audited [and] found to be complete; (4) all [manufacturing] records reviewed were found to be complete; (5) [calibration] records of eight devices were sampled and found acceptable. 80 Given the similarity between ISO 13485:2003 and the QSRs, I find the Intertek audits highly probative of whether ADI materially complied with FDA regulations during the relevant period. 3. Supplier Audits The FDA requires manufacturers to evaluate suppliers from whom 76 See id. 77 See id. 78 See Def. Ex. O (4/9/08 Intertek Systems Certification Audit Report). 79 See Def. Ex. P (4/16/09 Intertek Systems Certification Audit Report). 80 Id. 14 they purchase devices or components.81 Manufacturers may not purchase from suppliers who are not compliant with the QSRs.82 Two medical device manufacturers ADI s customers audited ADI during the relevant period. On December 10, 2007, Siemens Dade Behring ( Siemens ) found that ADI had [v]ery clear structured written procedures. 83 Siemens noted that [t]he support by the ADI staff was excellent and that [a]ll documentation required by auditors was shown. 84 On September 3, 2008, Trinity Biotech audited ADI for compliance with the QSRs and ISO 134:85:2003.85 Trinity Biotech found that ADI: (1) properly documented design inputs and outputs; (2) had an adequate design verification including design reviews, testing, and validations; (3) conducted risk analysis; (4) had an adequate document control system and properly maintained records; (5) properly handled raw materials; (6) had procedures to ensure that only acceptable materials were used to manufacture products; (7) established, documented, and maintained procedures for traceability; and (8) documented 81 See 21 C.F.R. § 820.50. 82 See id. 83 Def. Ex. T (12/10/07 Siemens Audit Report) . 84 Id. 85 See Def. Ex. S (9/3/08 Trinity Biotech Supplier Audit Report). 15 equipment and process validations.86 4. Audit by the State of Connecticut Connecticut law requires in-state medical device manufacturers to register with the Connecticut Department of Consumer Protection, Drug Control Division.87 As such, Sekisui s regulatory attorneys, Morgan, Lewis & Bockius LLP ( Morgan Lewis ), urged ADI to register.88 On April 1, 2009, Connecticut inspected ADI in connection with its application for a license, which was granted seven days later.89 5. Other Observations About ADI s Compliance Sekisui s regulatory affairs expert, Carrie Kuehn, testified that ADI was not in compliance with the QSRs during the relevant period. At the outset, I note that Kuehn has never conducted or even witnessed an FDA inspection or an ISO audit.90 Her training is limited to attending regulatory conferences and reading 86 See id. 87 See Def. Ex. X. 88 See id. 89 The State of Connecticut did not issue an inspection report. 90 See Tr. at 576:17-577:7 (Kuehn). 16 relevant guidance materials.91 Nonetheless, Kuehn repeatedly testified that ADI s documents differed from what she would expect to see in an FDA-compliant company.92 The FDA expects each company to implement a QMS tailored to its size and risk-level.93 The QSRs provide a framework for companies to develop their own internal procedures.94 While Kuehn might have implemented the QSRs differently than ADI, her opinion does not render ADI non-compliant. Moreover, Kuehn s methodology is flawed. Her conclusions are based on a review of documents, at least one of which she misread.95 The documents were provided by Sekisui s counsel at least four years after the relevant time period.96 Although she interviewed four ADI employees, she failed to speak with key 91 See id. at 593:6-18 (Kuehn). 92 See, e.g., id. at 602:15-20, 608:25-609:1-2, 620:14-25 (Kuehn). 93 See IOM § 5.6.7. 94 See Def. Ex. 8M. 95 See Tr. at 697:16-21 (Kuehn). 96 See id. at 648:2-13 (Kuehn). In addition, the documents she reviewed may not have included all relevant documents. See Sekisui v. Harts, 945 F. Supp. 2d 494, 509-10 (S.D.N.Y. 2013) (finding that Sekisui willfully destroyed the Electronically Stored Information ( ESI ) of Richard Hart, Leigh Ayres, and possibly others at ADI). 17 compliance managers, such as Leigh Ayres.97 Thus, I cannot credit Kuehn s opinions over the contemporaneous conclusions of the FDA inspectors, ISO auditors, and customer auditors that visited ADI, interviewed management, and reviewed key documentation. These teams of experienced auditors and inspectors concluded that any flaws in ADI s procedures were not sufficiently material to deny ISO certification, take FDA regulatory action, or stop purchasing ADI products. Numerous fact witnesses also testified about ADI s perceived noncompliance. Hugh Fryer, an ADI research and development scientist, testified that ADI improperly extended and/or failed to record expiration dates in a batch record for Product 822.98 He also stated that no document indicated that ADI performed validation testing before extending the dates.99 Although Fryer manufactured products, he did not testify that he was involved with the manufacture of Product 822.100 Thus, his testimony is based solely on a review of the documents in the batch record. Even if the records indicate that this particular kit failed to meet 97 See id. at 745:16-20 (Kuehn). 98 See id. at 284:1-5, 290:6-294:13 (Fryer). 99 See id. at 290:20-25 (Fryer). 100 Nor does Fryer s name appear on the batch record or any document associated with Product 822. See Pl. Ex. 210 (Product 822 Lot 72401 Batch Records); Pl. Ex. 211 (Product 822 Lot 72405 Batch Records); Pl. Ex. 215 (Product 822 SOPs). 18 specifications, I do not know whether ADI conducted further testing. Because Fryer lacked personal knowledge as to this kit, Fryer s testimony is limited to his statement that we don t know what was actually done. 101 Moreover, I excluded as hearsay Fryer s statement that the practice of improperly extending expiration dates was widespread at ADI.102 Kevin Morrissey, ADI s post-acquisition President and Chief Operating Officer ( COO ), also testified about aspects of ADI s purported noncompliance, including its inadequate facilities and environmental controls.103 For the following reasons, I do not find Morrissey a credible witness. Morrissey arrived at ADI on March 31, 2010, a year after the closing date, and assumed the position of Director of Manufacturing.104 He was promoted to President and COO in October 2010.105 In 2011, Fryer began to suspect that Morrissey was spying on his emails.106 Fryer wrote an email to himself assuming Morrissey would read it stating, You have caused us an undue amount of problems with your overblown 101 Tr. at 291:24-25 (Fryer). 102 Id. at 299:10-21 (Fryer). 103 See id. at 201:11-22 (Morrissey). 104 See id. at 141:1-13 (Morrissey). 105 See id. at 141:14-20 (Morrissey). 106 See Tr. at 361:21-25 (Fryer). 19 claims. I think FDA would not be pleased with making up expertise then blaming other problems on your lack of knowledge. 107 In another email, Fryer wrote, You really aren t fooling any of us. Joe [Azary] is sick of your strange interpretations of FDA regs. But continue on this path; you make the rest of us look like geniuses. 108 Morrissey was fired in 2012 after several ADI employees complained about his incompetence.109 Moreover, although he testified about finding expired raw materials, Morrissey could not establish that ADI had used them to manufacture any product during the relevant period.110 The record contains no evidence of any customer complaint, recall, or notification to the auditors or customers regarding the use of expired materials during the relevant period. In fact, the record shows that the manufacture and sale of products using expired materials occurred if at all after the acquisition, on Sekisui s watch.111 Finally, Bhavna Gaikwad, also a research and development scientist at 107 Def. Ex. 6A (12/25/11 Email from Fryer to Fryer). 108 Def. Ex. 6B (1/4/12 Email from Fryer to Fryer). 109 See Tr. at 366:14-21 (Fryer). 110 See id. at 158:1-159:10 (Morrissey). 111 See id. at 242:18-20 (Morrissey). Accord Def. Ex. 3Z (4/26/10 Email from Kathleen Georgelos to David Teicher, regarding use of expired biotin). 20 ADI, testified about other aspects of ADI s non-compliance, such as insufficient employee training.112 Both Gaikwad and Fryer also testified that ADI recorded the design process for each product in lab notebooks, rather than maintaining DHFs.113 However, throughout the relevant period, auditors and inspectors evaluated ADI s employee training, use of expired materials, creation of batch records, adequacy of DHFs, implementation of design control procedures, and more, and found material compliance with the QSRs and ISO. For example, in 2008, Trinity Biotech reported that raw materials at ADI are quarantined until evaluated for conformance to specifications . . . [,] labeled with status and adequately controlled . . . [, and] nonconforming material [is] segregated, identified, and reviewed for disposition[.] 114 To the extent that these witnesses disagree with the auditors conclusions, I credit the auditors. 6. 2007 Femtelle 510(k) Submission Medical device manufacturers who wish to market their products in the United States must submit a 510(k) to the FDA for pre-market approval.115 Each 112 See Tr. at 484:9-22 (Gaikwad). 113 See id. at 485:13-486:5 (Gaikwad); id. at 270:23-271:8 (Fryer). 114 Def. Ex. S. 115 See 21 C.F.R. § 807.87 21 submission goes to a primary reviewer who may ask for more information.116 The manufacturer has 30 days to respond, but the FDA can grant an extension of up to 180 days if needed.117 If the manufacturer fails to provide the information by the deadline, the FDA considers the submission withdrawn.118 If the submission is withdrawn, the manufacturer must restart the process by submitting a new 510(k).119 Femtelle is a breast cancer diagnostic assay developed in the 1990s and sold in Europe by ADI s German subsidiary.120 ADI planned to market Femtelle in the United States.121 On February 7, 2007, ADI submitted a Femtelle 510(k) to the FDA.122 On March 30, 2007, the FDA sent a letter requesting more information including the data from Femtelle s analytical studies.123 ADI requested a 180 day extension to gather the materials.124 The FDA granted the extension, but ADI was 116 See Tr. at 425:10-23, 426:4-16 (Timothy Ulatowksi). 117 See 12 C.F.R. § 807.87. See also Tr. at 436:7-13 (Ulatowski). 118 See 12 C.F.R. § 807.87. 119 See Tr. at 449:12-20 (Ulatowski). 120 See Pl. Ex. 7. See also Tr. at 783:14-16 (Guy Erb). 121 See JPTO at 3. 122 See Pl. Ex. 22 (1/31/09 Letter from Hart to Jonathan Kahan, attaching the 2007 Femtelle Application). 123 See id. 124 See id. 22 unable to collect the materials in time.125 ADI requested a second 180 day extension but continued to have difficulty producing the data.126 On May 18, 2008, the FDA deemed the submission withdrawn.127 C. The Acquisition 1. Due Diligence Period In early 2008, the Harts began seeking a buyer for ADI.128 Crosstree Capital Partner ( Crosstree ) served as ADI s financial advisor.129 In February 2008, Crosstree drafted a Confidential Memorandum ( CM ) to provide to potential buyers.130 The CM discussed Femtelle without making any financial projections.131 In August 2008, Crosstree updated the CM to include Femtelle projections.132 However, the CM clearly stated: 125 See id. 126 See id.; Pl. Ex. 36 (2/28/08 Email from Hart to Manfred Schmitt). 127 See Pl. Ex. 22. 128 See Pl. Ex. 247 (1/25/08 Email from Ellis to Hart). 129 See JPTO at 2. 130 See Pl. Ex. 240 (2/20/08 Email from Ellis to Hart, attaching the February 2008 CM). 131 See id. 132 See Pl. Ex. 7 (August 2008 CM). 23 This [CM] does not constitute an offer to sell or the solicitation of an offer to purchase [ADI] s securities, and it should not and may not be relied upon in connection therewith. Any offer of [ADI s] securities will be offered only through definitive documents prepared specifically for that purpose. [I]nterested parties must conduct their own independent, in-depth investigation and analysis of [ADI] and the information set forth in this CM and any other . . . communication . . . .133 In October 2008, Crosstree sent Sekisui a copy of the CM.134 On January 7, 2009, Sekisui s accountant, KPMG, provided a due diligence report that included ADI s financial information through October 31, 2008.135 On the same date, Morgan Lewis provided a Preliminary Legal Due Diligence Report.136 Morgan Lewis reported that ADI had no significant product quality issues, that Interek had granted certification, and that the FDA was satisfied with ADI s responses to its 2004 and 2005 observations.137 On January 31, 2009, Hart provided Hogan and Hartson LLP the Harts FDA attorneys with a copy of ADI s 2007 Femtelle submission and related documentation. After discussing the 2007 submission with Hogan and 133 Id. 134 See id. 135 See Pl. Ex. 21 (1/7/09 KMPG Due Diligence Draft). 136 See Def. Ex. X. 137 See id. 24 Hartson, Morgan Lewis requested a copy.138 I find no evidence to suggest that either Hogan and Hartson or Hart whose email was willfully destroyed by Sekisui failed to provide Morgan Lewis with the information it requested.139 On December 10, 2008, Sekisui sent ADI a Letter of Interest, stating that Sekisui, along with [its] investment banker (Savvian), outside counsel (Morgan Lewis), and accountants (KPMG), are prepared to commence this effort immediately and to dedicate significant resources to the . . . transaction . . . . 140 The parties executed the letter, stating that Sekisui would pay $25.5 million for ADI, an additional two million dollars if Femtelle received FDA clearance by June 30, 2009, and earn-out payments of up to nine million dollars if Femtelle reached certain revenue targets.141 In the letter, Sekisui proposed a due diligence period of at least seventy-five days.142 Sekisui had until the April 20, 2009 closing date 138 See Pl. Ex. 245 (2/12/09 Email exchange between Hart and Dan Crosby, an attorney at Withers Bergman). 139 Furthermore, during discovery, Sekisui produced a copy of the 2007 submission and related documentation, which had been stored in the document room at ADI. See Def. Ex. 5H. Thus, I conclude that Morgan Lewis and Sekisui received the 2007 submission and related documentation during the due diligence period. Sekisui offered no testimony that it did not receive the submission and documentation. 140 Pl. Ex. 2 (12/10/08 Sekisui Letter of Interest to ADI). 141 See id. 142 See id. 25 nearly five months after it sent the letter to complete its due diligence.143 2. Sekisui s Valuation of ADI Mamoru Takemura, Sekisui Medical s General Manager of International Marketing, testified that Sekisui was interested in acquiring ADI as a platform for selling diagnostic products in the United States and found Femtelle attractive.144 On February 6, 2009, Sekisui s financial advisor, GCA Savvian ( Savvian ) advised Sekisui not to make any up front payment for Femtelle.145 As Savvian noted, Realization of Femtelle value has a certain level of uncertainty and hence, it is possible to employ Earn Out Method payment . . . . 146 To obtain board approval, Sekisui modeled three projections for the value of ADI: (1) including highest Femtelle revenue payments from the earn-out, (2) including lowest Femtelle revenue payments from the earn-out, and (3) without Femtelle at all.147 On February 9, 2009, the board approved the acquisition.148 143 See SPA ¶ 6.14. 144 See Tr. at 50:20-51:14 (Takemura). 145 146 See Def. Ex. 2M (2/9/09 Savvian Report) (English translation). Id. at 6. 147 See Tr. at 65:20-67:1 (Takemura); Pl. Ex. 49 (3/27/09 Excel spreadsheet analyzing expansion of Sekisui s diagnostic business). 148 See Tr. at 112:3-6 (Takemura). 26 Takemura testified that the board would not have approved the acquisition without projecting Femtelle to achieve at least the lowest revenue payments.149 However, I am troubled by Takemura s insistence that Sekisui did not rely on the Savvian report.150 Sekisui s analysis computing the value of ADI first without Femtelle and then with Femtelle earn-out potential closely tracks Savvian s.151 I find that Seksui s board presentation is clearly derived from the Savvian report. Sekisui submitted other evidence in an attempt to show that the purchase price included Femtelle. First, Exhibit A of the SPA purportedly revealed that the purchase price must have included Femtelle because the Harts would receive nothing for Femtelle unless it generated millions of dollars in revenue for Sekisui.152 Further, the Harts earn-out potential was capped at a certain amount each year even if Femtelle revenues were significantly higher than expected.153 Second, Sekisui introduced a Purchase Price Allocation ( PPA ) prepared by 149 See id. at 68:9-69:1 (Takemura). 150 See id. at 126:8-13 (Takemura) (testifying that he did not look too carefully at the report and that it was not used as a basis for making our decision in the company ). 151 See Pl. Ex. 49; Def. Ex. 2M. 152 See SPA at Ex. A (Schedule of Femtelle Revenue Based Payments). 153 See id. 27 KPMG, which valued Femtelle at $7.65 million of the purchase price.154 Based on this evidence, Sekisui s damages expert, Guy Erb, opined that the purchase price included the prospective value of Femtelle.155 As an initial matter, the PPA proves nothing about Sekisui s valuation of Femtelle at the time of the acquisition. KPMG prepared the PPA six months after the closing for financial and tax reporting purposes[.] 156 The PPA presents the fair value of the Subject Assets between a hypothetical willing buyer and a hypothetical willing seller in an assumed transaction on an assumed valuation date. 157 It notes in an important disclaimer that the price at which the Subject Assets might be sold in a specific transaction between specific parties on a specific date might be significantly different from the fair value expressed in our report. 158 Moreover, the PPA relies on and incorporates the Femtelle projections in 154 See Pl. Ex. 48 (10/1/09 KPMG Valuation Study). 155 See Tr. at 837: 11-15 (Erb). 156 Pl. Ex. 48. 157 Id. 158 Id. 28 the CM.159 Both the CM and the SPA expressly disclaim these projections.160 Furthermore, what Sekisui perceived as Femtelle s value is irrelevant to what Sekisui actually paid for it. Based on Exhibit A, Sekisui certainly believed Femtelle would generate millions of dollars. But as a sophisticated investor, Sekisui sought a deal that would allow it to avoid the risk of loss. Thus, the SPA expressly allocated payments for Femtelle only if certain contingencies occurred. First, Sekisui would pay two million dollars if the FDA approved Femtelle by November 20, 2009.161 Second, Sekisui would pay an earn-out in each year from 2010 through 2013 if Femtelle reached certain revenue targets.162 Consistent with Savvian s advice, Sekisui obtained an excellent deal in which it would be handsomely rewarded if Femtelle was successful but shielded if it was a loser. In short, Sekisui has not established what portion of the purchase price if any was allocated to Femtelle. 3. 159 The SPA and the Closing See id. 160 See Pl. Ex. 7; SPA § 4.29 ( The representations and warranties set forth in this [SPA] supercede and replace all prior statements, representations, projections, forecasts, warranties, and other understandings . . . including the projections set forth in the [CM] relating to [ADI] . . . . ). 161 See SPA § 2.6. 162 See id. at Ex. A. 29 On March 5, 2009, the parties voluntarily executed the SPA, stating that Sekisui would purchase all outstanding shares of ADI for $25.5 million.163 When they signed the SPA, Sekisui and the Harts were both represented by counsel.164 The deal closed on April 20, 2009.165 In the SPA, the Harts represented and warranted, in relevant part: 4.12 The buildings, plants leasehold improvements, structures, facilities, equipment and other property and assets . . . are (a) sufficient to conduct . . . the Business166 . . . , [and] (b) conform in all material respects to all Laws167 . . . relating to their construction, use and operation . . .168 4.14 (a) [ADI] and its Subsidiaries are, and have since January 1, 2006 been, in compliance in all material respects with all applicable Laws. . . (c) [ADI] holds all Permits which are required under the applicable Laws for the Products169 currently marketed by [ADI] . . . and the 163 See id. ¶ 2.2. 164 See JPTO at 2. 165 See id. 166 The Business means the business of ADI and its subsidiaries, including the in vitro diagnostic business. SPA § 1.1. 167 As defined, Laws means FDA regulations, including the QSRs, codified at 21 C.F.R. § 820. See id. § 1.1. 168 Id. § 4.12. 169 Products is defined as any products currently or formerly manufactured, sold, distributed, provided, shipped or licensed, or any services 30 conduct of [ADI s] testing, manufacturing, marketing, sales and distribution for the Products . . . All (i) correspondence with Governmental Entities related to the Products, (ii) Product Registrations and associated records and correspondence (together with all supporting documentation), (iii) data and information relating to non-clinical and clinical testing of Products, (iv) promotional literature and advertising materials . . . relating to the Products, (v) design history files, complaints, medical device reports, medical device reports event files, correction and removal reports, and (vi) memoranda or records . . . documenting decisions not to file a 510(k) pre-market notification with respect to any of the Products have been maintained in all material respects in accordance with sound business practices and complete and correct copies . . . have been made available to [Sekisui] by [ADI]. (d) [ADI s] Products are not misbranded or adulterated within the meaning of the [Act]. . . . Since January 1, 2006, the Company has not received from the FDA (i) any notice of inspectional observation, including Form 483, or a warning letter, or (ii) any correspondence or any other communication from FDA . . . that could be reasonably expected to have a Material Adverse Effect.170 Next, Sekisui represented and warranted, in relevant part,: 2.6 (d)(i)(A) [Sekisui] shall undertake commercially reasonable efforts to market or sell, or to cause the marketing and sale of the Femtelle Product, including . . . submitting to the FDA . . . submissions and filings for uses of the Femtelle Product that are reasonably related to those provided for in the Femtelle Clearance . . . [and] (B) not willfully take any actions, or omit to take any actions, with the intent of preventing the Business from meeting the Femtelle rendered by ADI or its subsidiaries. Id. § 4.11. 170 Id. § 4.14. Material Adverse Effect means any change, event, or effect that . . . has or would reasonably be expected to have a material adverse effect (a) on the assets, liabilities, condition (financial or otherwise) or results of operations of [ADI], taken as a whole. Id. § 1.1. 31 Revenue targets . . . or that could reasonably be expected to impair the ability of [ADI] to maximize Femtelle Revenues . . . .171 The SPA also set forth certain rights of the parties, in relevant part: 6.14 [ADI] and [the Harts] shall . . . afford [Sekisui] complete access upon reasonable prior notice . . . to [ADI s] officers, employees, agents, properties, books and records . . . , and shall furnish [Sekisui] with all financial, operating and other data and information as [Sekisui] may reasonably request.172 9.1 Notwithstanding any right of any party, whether or not exercised, to investigate the affairs or the accuracy of the representations and warranties contained herein . . . , each party hereto has the right to rely fully on the representation, warranties, covenants, and agreements of each other party contained herein.173 Further, pursuant to Section 7.2(e)(vii) of the SPA, Hart executed an employment agreement with ADI that allowed him to terminate his employment . . . for any or no reason during the two year period.174 D. Post-Acquisition Events 1. Observations About ADI s Compliance Hart remained CEO of ADI until early 2010 when he left for medical 171 Id.§ 2.6(d). 172 Id.§ 6.14. 173 Id.§ 9.1. 174 Pl. Ex. 6 (Hart s Employment Agreement). 32 reasons.175 During that time, the day-to-day operations of ADI remained the same.176 Morrissey testified that shortly after the acquisition, he discovered problems with ADI s QMS, including insufficient SOPs, storage of expired raw materials, and incomplete batch records.177 Morrissey hired Jose Campo, a private auditor at Advanced Quality Solutions ( AQSOL ), who reported significant quality system deficiencies at ADI.178 In response, Sekisui devised an extensive remediation plan.179 Once again, I do not credit Morrissey s testimony that extensive remediation was required. First, Morrissey s assessment may have been influenced by his relationship with Campo. Morrissey had hired Campo as an auditor in the past, and, after Morrissey was fired from ADI, Campo hired Morrissey as an auditor at AQSOL.180 Second, a wealth of evidence suggests that Morrissey s 175 See Pl. Ex. 14; Pl. Ex. 15. 176 See Tr. at 76:8-78:3 (Takemura). ADI continued to exist as an independent entity until 2012 when it was absorbed into Sekisui Diagnostics. See id. at 44:24-45:3 (Takemura). 177 See id. at 157:20-158:4, 161:14-19, 164:25-165:17, 168:19-23 (Morrissey). 178 See id. at 173:2-19, 177:11-14 (Morrissey); Pl. Ex. 46 (May 2010 AQSOL Audit Report); Pl. Ex. 84 (June 2010 AQSOL Audit Report). 179 See Pl. Ex. 53 (June 2010 Quality System Improvement Plan). 180 See Tr. 142:10-15 (Morrissey). 33 understanding of FDA regulations was poor and that Campo s evaluation of ADI s QSM was extreme.181 In fact, based on Morrissey s own admission, ADI had DHFs when he arrived at ADI.182 Third, post-acquisition audits and inspections showed that ADI was in material compliance. On June 8, 2010, Intertek conducted a surveillance audit and re-certified ADI as ISO and CMDCAS compliant.183 On March 29, 2011, Intertek conducted another audit and renewed ADI s certification.184 On June 20-22, 2011, two years after the acquisition, the FDA inspected ADI.185 The FDA made four observations: (1) complaints were not adequately documented; (2) there was no CAPA documentation prior to July 23, 2010; (3) procedures to control environmental conditions were not adequately established; and (4) schedules for adjustment, cleaning, and other equipment 181 See Def. Ex. 6B; Def. Ex. 5Z (3/27/11 Risk Reduction Actions Chart) (stating that Jose [Campo] s extreme view of ADI s quality system is causing panic in our lawyers ); Def. Ex. 6C (6/10/12 Email from Azary to Fryer). See also Tr. at 361:7-20 (Fryer) (stating that Azary and others shared his view about Morrissey s incompetence). 182 See Tr. at 157:15 (Morrissey). 183 See Def. Ex. Q (6/8/10 Intertek Systems Certification Audit Report). 184 See Def. Ex. R (3/29/11 Intertek Systems Certification Audit Report). 185 See Def. Ex. C (8/29/11 FDA EIR). 34 maintenance were not adequately established.186 On July 7, 2011, ADI wrote a letter to the FDA attaching a plan and status with regards to each observation noted on the 483. 187 ADI noted that [t]he corrective actions will be completed within the month of July 2011. 188 ADI further explained that ADI has had a [CAPA] procedure since 2006 and that [c]orrective actions were taken but were addressed in a decentralized manner using other processes within the quality system. 189 The FDA then closed the inspection and released the EIR.190 In September 2012, two years after Sekisui began its purported remediation, Siemens found ADI noncompliant to ISO 13485 and FDA standards . . . . 191 Thus, if ADI was non-compliant in 2012, the fault likely lies with Sekisui, not ADI. 2. 2009 Femtelle 510(k) Submission On March 17, 2009, after the parties had signed the SPA but before the 186 See Def. Ex. E. 187 Def. Ex. V. 188 Id. 189 Id. 190 See Def. Ex. C. 191 Id. 35 closing, ADI submitted another Femtelle 510(k).192 On May 27, 2009, the FDA requested additional information regarding Femtelle s studies and device history.193 In the letter, the FDA requested line data of all three [Femtelle] studies in extractable format, a more detailed description of the linearity study, and data to demonstrate the minimum amount of tumor cell content required to perform an acceptable assay. 194 The FDA acknowledged that ADI had already provided the line data as an image in a PDF document. 195 In January 2010, the FDA wrote another letter requesting data to support that the test adds value over other clinical variables and line data including all clinical covariates information. 196 On March 26, 2010, ADI sent the FDA a report compiling all of the data pertaining to the [Femtelle] study in Germany.197 Robert Greenfield, an ADI employee, then tried to obtain the missing 192 See JPTO at 3. 193 See Pl. Ex. 24 (5/27/09 Letter from FDA to ADI). 194 Id. 195 Id. 196 Pl. Ex. 26 (1/15/10 Email from Reena Philip, FDA Associate Director, to David Teicher, ADI s Director of Technical Affairs). 197 Pl. Ex. 28 (3/26/10 Email from Teicher to Philip). 36 data from researchers in Germany.198 Manfred Schmitt, one of the researchers, responded, [W]e have all the original data of each of the patients . . . 199 Greenfield then asked Schmitt only for the raw numbers underlying the data set provided to the FDA.200 On May 11, 2010, the FDA requested the data to support that the test adds value over other clinical variables. 201 On May 17, 2010 Greenfield informed his colleagues that ADI had information to show that it was using the same sources for raw materials [for Femtelle] today as [it was] back to 1988 . . . . 202 On May 19, 2010, Greenfield again contacted the German researchers, explaining that if Femtelle failed in the United States, [w]e may only be able to market it as an IVD in Europe under CE marking. 203 In June 2010, ADI had to reduce the number of patients relied on in the submission.204 On June 2, 2010, Schmitt told Greenfield, 198 See Pl. Ex. 42 (5/4/10-6/10/10 Email exchange between Greenfield and Manfred Schmitt). 199 Id. 200 Id. 201 Pl. Ex. 30 (5/11/10 Email from Philip to Teicher). 202 Def. Ex. 2I (5/26/10 Email from Greenfield to Gaikwad, Teicher, Fryer, Morrissey, Koseki, and Michael Smirnov). 203 Pl. Ex. 43 (5/19/10 Email from Greenfield to Schmitt). 204 See Pl. Ex. 39 (6/2/10 Email from Schmitt to Greenfield). 37 You will get a final statement from us very soon, regarding the 153 patients in focus of the FDA. [F]or some of these patients, we do not have data . . . . 205 In addition to the missing data, ADI was concerned about missing batch records from Femtelle s DHF.206 In a June 2010 conference call, ADI asked the FDA if it could proceed with the filing without the batch records.207 The FDA responded, [e]ven if you lost the batch records due to your site change, the Principal Investigator of your clinical validation study should have the information . . . . You could collect the information from them, for your records. 208 There is no evidence that the FDA told ADI that Femtelle would not be approved without certain batch records. Nevertheless, ADI concluded that it would not be able to get missing clinical data and batch records to the FDA by the July 14, 2010 deadline.209 Fryer also voiced concern that continuing to seek 510(k) clearance would invite an FDA 205 Id. 206 See Pl. Ex. 222 (6/1/10 Email from Greenfield to Fryer, Koseki, Morrissey, and Teicher). 207 See Def. Ex. 2L (6/2/10 Email from Greenfield to Koseki, Morrissey, Teicher, Fryer, Smirnov, attaching minutes from call with FDA). 208 Pl. Ex. 29 (6/28/10 Email from Philip to Teicher). 209 See Def. Ex. 2L; Pl. Ex. 143 (Minutes for ADI s 6/25/10 Femtelle Direction Meeting). 38 audit.210 Thus, in June 2010, Sekisui decided to withdraw the submission.211 Sekisui s FDA expert, Timothy Ulatowski, testified that he agreed with the decision to withdraw the submission.212 Ulatowski opined that ADI was missing too much critical information to obtain 510(k) clearance by the deadline.213 While I find Ulatowski s testimony credible, it is not particularly relevant to Sekisui s breach claims, as discussed below. 3. Subsequent Efforts to Market Femtelle After withdrawing the 2009 Femtelle 510(k) submission, Sekisui continued its efforts to achieve 510(k) clearance.214 ADI employees tried to recreate the DHF and other data.215 In September 2011, Fryer traveled to Germany to retrieve the clinical data, but did not succeed.216 Sekisui concluded that it required 210 See Pl. Ex. 143. 211 See Tr. at 80:25-81:7 (Takemura). 212 See id. at 473:2-9 (Ulatowski). 213 Id. at 472:15-473:1 (Ulatowski: In my experience . . . reviewing hundreds of 510(k) [submissions], time was up. ). 214 See Pl. Ex. 93 (8/29/11 Femtelle Regulatory Gap Analysis). 215 See Tr. at 332:9-333:2 (Fryer); Pl. Ex. 93. 216 See id. at 410:6-411:1 (Fryer). 39 new clinical studies in the United States to compile the data.217 In 2011, while Sekisui was still attempting to obtain the clinical data and recreate DHFs, Fryer reported to KPMG that there was a seventy percent chance of obtaining sufficient data, and an eighty percent chance of success on the Femtelle project if Sekisui could do so.218 Ultimately, however, Sekisui determined that the new clinical studies would cost $3.2 million and take more than three years to complete.219 Given the cost of the studies, the uncertainty of ever receiving FDA clearance, and the increased competition in the breast cancer diagnostic market, Sekisui decided not to submit another Femtelle 510(k).220 III. APPLICABLE LAW 221 To recover for breach of contract under New York law, a plaintiff must prove by a preponderance of the evidence, (1) the existence of a contract between [the plaintiff] and th[e] defendant; (2) performance of the plaintiff s obligations 217 See id. at 334:8-11 (Fryer). 218 See Def. Ex. 2E (6/30/11 KPMG Initial Information Request). 219 See Def. Ex. 4J (11/19/12 KPMG Follow-up Information Request). 220 See id. 221 The Court has subject matter jurisdiction over this case based on diversity pursuant to 28 U.S.C. § 1332. Venue is proper under 28 U.S.C. § 1391(b). See JPTO at 2. The SPA states that New York law governs interpretation of the contract. See SPA § 10.6. 40 under the contract; (3) breach of the contract by th[e] defendant; and (4) damages to the plaintiff caused by th[e] defendant s breach. 222 To recover on their counterclaim, the Harts must prove breach by a preponderance of the evidence.223 There is no dispute that a valid contract exists, that Sekisui paid the purchase price under the SPA, and that the deal closed on April 20, 2009.224 IV. CONCLUSIONS OF LAW A. Sekisui s Claim 1. Sekisui Failed to Prove that the Harts Breached Any Provision of the SPA Related to FDA Noncompliance Sekisui alleges that the Harts breached: (1) Section 4.14(a) because ADI failed to comply with the QSRs; (2) Section 4.14(c) because ADI lacked DHFs for its products; (3) Section 4.14(d) because non-compliance with the QSRs renders products adulterated; and (4) Section 4.12 because ADI s facilities and equipment failed to comply with the QSRs.225 I conclude that Sekisui has not met its burden. 222 Diesel Props S.R.L. v. Greystone Bus. Credit II LLC, 631 F.3d 42, 52 (2d Cir. 2011). Accord Mandarin Trading Ltd. v. Wildenstein, 16 N.Y.3d 173, 182 (2011). The parties do not dispute the validity of the contract. 223 See Raymond v. Marks, 116 F.3d 466, 466 (2d Cir. 1997). 224 See JPTO at 2. 225 See Plaintiffs Combined Proposed Findings of Fact and Conclusions of Law ( Pl. Facts and Concl. ) at 51. 41 First, Sekisui failed to prove that the Harts breached Section 4.14(a) because the QSRs leave it up to the manufacturer to institute a quality control system specific to the medical device it produces to ensure that such device is safe and effective. 226 I conclude that during the relevant period, ADI s QMS was commensurate with its size and risk level. While ADI may not have been an exemplar of regulatory compliance, it met the FDA s requirements. Rather than seeking perfection, the FDA expects manufacturers to investigate and correct non-conformities through their CAPA systems.227 The evidence established that ADI had a CAPA system during the relevant period.228 Thirteen contemporaneous audits and inspections concluded that ADI responded appropriately to non-conformities. Sekisui may not hold ADI to a higher standard than the FDA requires. Similarly, Sekisui has failed to prove a breach of Section 4.14(d) because ADI was in material compliance with QSRs and, thus, no product was adulterated as of the closing date.229 Sekisui does not allege any misbranding. 226 Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 279 (E.D.N.Y. 2009). 227 See 21 C.F.R. § 820.100. 228 See Def. Ex. B, Def. Ex. M, Def. Ex. V, Def. Ex. C. 229 See 21 U.S.C. § 351(f) ( A drug or device shall be deemed to be adulterated if . . . the methods used in, or the facilities or controls used for, its 42 Next, Sekisui has failed to prove a breach of Section 4.14(c), which required the Harts to maintain required documentation, including DHFs, in accordance with sound business practices. 230 A DHF need only contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan . . . . 231 The audits and inspections reflect that ADI adequately maintained DHFs and other documentation at the time of the acquisition.232 Finally, Sekisui has failed to prove a breach of Section 4.12, warranting that ADI s facilities and equipment are sufficient to conduct business.233 In isolation, I would be troubled by the FDA s 2011 observations about ADI s inadequate equipment and environmental conditions.234 But ADI promptly responded with a detailed plan to correct the problems, and the FDA closed the manufacture, packing, storage, or installation are not in conformity with [the QSRs]. ). 230 SPA § 4.14(c). 231 21 C.F.R. § 820.30. 232 See Def. Ex. B; Def. Ex. S. 233 See SPA § 4.12. 234 See Def. Ex. C. 43 inspection.235 Thus, the FDA must have concluded that ADI met its expectations. I further conclude that no post-acquisition remediation was required. Although Morrissey urged Sekisui to spend hundreds of thousands of dollars to remediate perceived problems, multiple post-acquisition Intertek audits and an FDA inspection showed that ADI was already in compliance.236 In fact, ADI was not found non-compliant until two years after Sekisui s purported remediation had begun.237 Therefore, Sekisui is not entitled to any remediation damages. 2. Sekisui Failed to Prove that the Harts Breached Any Provision of the SPA Related to Femtelle Sekisui next argues that the Harts breached Sections 4.14(c) and (d) with respect to the Harts contractual representations regarding Femtelle. Section 4.14(c) states that [a]ll . . . data . . . relating to non-clinical and clinical testing of Products . . . [and] design history files . . . have been maintained in material respects in accordance with good business practices. 238 Sekisui s theory is that ADI failed to maintain sufficient Femtelle clinical data and DHFs to support its 510(k) 235 See id.; Def. Ex. V. 236 See Def. Ex. C; Def. Ex. Q; Def. Ex. R. 237 See Def. Ex. T. 238 SPA § 4.14(c). Sekisui asserts that Products include Femtelle because Femtelle was being manufactured and sold by ADI s German subsidiary at the time of the acquisition. See Pl. Facts and Concl. at 7, 53. 44 submission.239 Relying on Ulatowski, Sekisui argues that because of this missing information, the Femtelle 510(k) was destined to fail.240 Sekisui s theory is riddled with problems. First, the SPA does not require ADI to maintain the Femtelle data and DHFs in the United States given that Femtelle is manufactured and sold only in Europe. Sekisui has failed to show that the Femtelle data and DHFs were not maintained in Germany in accordance with good business practices a term not defined in the SPA.241 Second, Ulatowski did not opine that Femtelle was destined to fail. He testified only that ADI would not be able to submit the critical information by the FDA s deadline.242 In any event, Ulatowski s testimony says nothing about how ADI maintained the information in Germany, and is, thus, irrelevant to the breach claim. Third, even if batch records were missing, ADI had all the necessary information about Femtelle s design history available in either lab notebooks or in certificates of analysis.243 In any event, DHFs can be maintained in accordance with good business practices 239 See Pl. Facts and Concl. at 53-54. 240 See id. at 38. 241 SPA § 4.14(c). 242 See Tr. at 472:15-473:1 (Ulatowski). 243 See Def. Ex. 2I (ADI report stating that certain notebook pages and certificates can demonstrate that ADI was using the same sources for raw materials [for Femtelle in 2010] as [it was] back in 1988 ). 45 without batch records. According to the FDA, DHFs need only reference the records necessary to demonstrate the design history of a product.244 Thus, the good business practices do not necessarily require ADI to maintain batch records for Femtelle. Sekisui s theory under Section 4.14(d) fares no better. Section 4.14(d) states, [s]ince January 1, 2006, [ADI] has not received from the FDA . . . any correspondence or any other communication from FDA . . . that could be reasonably expected to have a Material Adverse Effect. 245 A Material Adverse Effect must impact the assets, liabilities, condition (financial or otherwise) or results of operations of [ADI], taken as a whole. 246 Sekisui s theory is that the Harts withheld numerous communications from the FDA about deficiencies in the 2007 Femtelle submission.247 Because these communications allegedly revealed the low likelihood that Femtelle would ever obtain FDA clearance, they could have had a material adverse effect.248 As an initial matter, I have already found that the Harts provided 244 See 21 C.F.R. § 820.30(j)(emphasis added). 245 SPA § 4.14(d). 246 Id. § 1.1. 247 See Pl. Facts and Concl. at 55. 248 See id. 46 Morgan Lewis with a copy of the 2007 Femtelle 510(k) and related documentation during due diligence. Morgan Lewis discovered that ADI submitted an unsuccessful 510(k) in 2007, discussed it with Hogan and Hartson, and advised Sekisui to proceed with the closing.249 In the SPA, ADI warranted that it would furnish Sekisui with all . . . information as [Sekisui] may reasonably request. 250 I conclude that it did so. If Sekisui was dissatisfied with the information it received, it should not have closed. Moreover, Femtelle was attractive to Sekisui because of its future potential, not its value on the closing date.251 By Sekisui s own admission, Femtelle had no contribution to [ADI s] revenue and earnings at the time of the acquisition.252 Thus, Femtelle s fate had no effect materially adverse or otherwise on ADI s existing assets, liabilities, condition or operation.253 Finally, although Femtelle may have been the driving force behind the acquisition, both Sekisui and ADI knew that Femtelle s fate was uncertain. Thus, 249 See Pl. Ex. 245, Pl. Ex. 2. 250 SPA § 6.14. 251 Tr. at 54:9 (Takemura). 252 Id. at 544:16-18 (Ellis). 253 See Recticel Foam Corp., Inc. v. Bay Indus., Inc., 128 Fed. App x 798, 800 (2d Cir. 2005) (noting that a new account of what the [target] company [i]s worth does not have a material adverse effect on an acquiring company). 47 the parties structured a deal that rewarded Sekisui with a substantial upside if Femtelle succeeded and no downside if it failed. Even if ADI had breached the SPA with regard to warranties relating to Femtelle, Femtelle s value is inherently uncertain because neither the CM nor the PPA provides a reliable basis for ascertaining its dollar value. Therefore, consistent with the law of the case,254 even if the Harts breached the SPA which Sekisui has failed to prove I could not award any portion of the purchase price as damages for ADI s failure to obtain FDA approval of Femtelle. B. The Harts Counterclaim Is Dismissed Because the Harts Failed to Prove that Sekisui Breached Section 2.6(d) of the SPA The Harts allege that Sekisui breached Section 2.6(d), which warrants that Sekisui will (1) take commercially reasonable efforts to market and sell Femtelle, and (2) not . . . omit to take any actions, with the intent of preventing [ADI] from meeting Femtelle Revenue targets . . . or that could reasonably be expected to impair [ADI s ability] to maximize Femtelle Revenues. 255 The Harts have not proven that Sekisui breached this term of the SPA. First, the Harts 254 Sekisui v. Harts, No. 12 Civ. 3479, 2012 WL 5039682, at *6 (S.D.N.Y. Oct. 17, 2012) (granting in part and denying in part the Harts motion to dismiss and finding that the SPA limits Sekisui s damages in the event that Femtelle does not obtain FDA approval because in that event Sekisui is excused from paying earn-outs). 255 SPA § 2.6(d). 48 presented no evidence establishing the objective standard for commercially reasonable efforts in the FDA-regulatory context or explained how Sekisui deviated from that standard.256 In fact, Sekisui undertook considerable efforts to bring Femtelle to market, including re-creating files and traveling to Germany to obtain data.257 Sekisui diligently strived for Femtelle clearance until 2011 when it realized that the necessary studies would be prohibitively expensive and timeconsuming.258 Even if Sekisui had paid for the studies, they would not have been completed until 2014 a year after the earn-out period had ended.259 Second, the Harts have submitted no evidence that Sekisui omitted to take any actions with the intent of preventing ADI from meeting Femtelle revenue targets. In fact, Sekisui would have made millions of dollars if Femtelle reached the targets.260 Thus, I conclude that Sekisui pursued FDA approval as long it practically could. 256 See MBIA Ins. Corp. v. Patriach Partners VIII, LLC, 950 F. Supp. 2d 568, 617 (S.D.N.Y. 2013) (requiring evidence to define the commercially reasonable standard for a particular industry); B.D.G.S., Inc. v. Balio, 8 N.Y.3d 106, 113 (2006) (relying on expert testimony regarding bank practices on check endorsement for purposes of commercial reasonableness analysis). 257 See Tr. at 332:9-333:2 (Fryer); Pl. Ex. 93. 258 See Def. Ex. 4J. 259 See Pl. Ex. 5 (Schedule for Femtelle Revenue Payments, SPA Ex. A). 260 See id. 49 C. The Harts Motion for Sanctions Under 28 U.S.C. § 1927 Is Denied The Harts request sanctions under Section 1927, alleging that Sekisui brought this case in bad faith.261 Section 1927 provides: Any attorney or other person admitted to conduct cases in any court of the United States . . . who so multiplies the proceedings in any case unreasonably and vexatiously may be required by the court to satisfy personally the excess costs, expenses, and attorneys fees reasonably incurred because of such conduct.262 To impose sanctions, a court must find that the challenged claim was (i) without a colorable basis and (ii) brought in bad faith, i.e., motivated by improper purposes such as harassment or delay. 263 Although both findings must be supported by a high degree of specificity, bad faith may be inferred only if actions are so completely without merit as to require the conclusion that they must have been undertaken for some improper purpose such as delay. 264 Under this standard, I find that sanctions are not warranted. Without a doubt, Sekisui s willful destruction of the ESI of two key ADI employees has raised 261 See Tr. at 849:22-852:12 (Franklin Velie, Counsel for the Harts). 262 28 U.S.C. § 1927. 263 Enmon v. Prospect Capital Corp., 675 F.3d 138, 143 (2d Cir. 2012) (internal quotation marks omitted). 264 Id. 50 serious concerns about credibility.265 Nevertheless, I am required to resolve all doubts in favor of Sekisui s counsel.266 Although I have rejected their arguments, Sekisui s counsel made colorable claims, and there is no proof that counsel bought this action in bad faith.267 I therefore deny the Harts motion for sanctions against Sekisui s counsel. V. CONCLUSION For the foregoing reasons, Sekisui s claims and the Harts counterclaim are dismissed with prejudice. Sekisui is ordered to pay $83,408.36 to Sullivan & Worcester LLP in attorneys fees pertaining to the Harts spoliation 265 On August 15, 2013, I ruled that Sekisui willfully destroyed the ESI of Hart and Ayres and granted the Harts motion for sanctions in the form of an adverse inference instruction. See Sekisui, 945 F. Supp. 2d at 509-10. While inferring that the missing ESI is favorable to the Harts would reinforce my conclusions, I need not do so here. Even without the missing ESI, the evidence at trial was plainly insufficient to prove by a preponderance of the credible evidence that the Harts breached the SPA. Because I decided Sekisui s claim on other grounds, the adverse inference instruction is moot. 266 See Perez v. Posse Comitatus, 373 F.3d 321, 324 (2d Cir. 2004) (finding that on a motion for sanctions, the court must resolve all doubts in favor of the [pleadings] signer ) (internal citation omitted). 267 See Salovaara v. Eckert, 222 F.3d 19, 34 (2d Cir. 2000) ( A distinction must be drawn between a position which is merely losing, and one which is both losing and sanctionable. ) (internal citation omitted). 51 motion, which I granted in an opinion dated August 15, 2013. 268 The Clerk of the Court is directed to prepare a judgment and to close this case. S~ . . ... ""'" .~ . . ShiraA:. Scheindlin U.S.D.l. Dated: New York, New York February 21,2014 The Harts requested a fee of$166,816.71. However, "[t]he district court retains discretion to determine ... what constitutes a reasonable fee. '" Millea v. Metro-North R.R. Co., 658 F.3d 154,166 (2d Or. 2011) (internal quotation marks omitted). It may sometimes be necessary "to make across-the-board percentage cuts in hours as a practical means of trimming fat from a fee application." Green v. City a/New York, 403 Fed. App'x 626, 630 (2d Cir. 2010) (internal quotation marks omitted). I find the Harts' fee request excessive because it includes the cost of general litigation preparation and other work unrelated to the missing ESI of Hart and Ayres. Thus, a reduction of fifty percent is warranted to eliminate excessive time charges. 268 52 - Appearances - For Sekisui: For the Harts: Karen L. Hagberg, Esq. Craig B. Whitney, Esq. Natalie A. Fleming Nolen, Esq. Leda A. Moloff, Esq. Morrison & Foerster LLP 1290 Avenue of the Americas New York, NY 10104 (212) 468-8000 Franklin B. Velie, Esq. Jonathan G. Kortmansky, Esq. Siobhan Briley, Esq. Sullivan & Worcester LLP 1633 Broadway, 32 nd Floor New York, NY 10019 (212) 660-3000 53
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