Sekisui America Corp. v. Hart
Sekisui America Corp. v. Hart
Opinion of the Court
OPINION AND ORDER
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”).
I held a bench trial from January 18 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. The Parties
In 1982, the Harts founded ADI, a Connecticut corporation engaged in the discovery, manufacture, and marketing of medical diagnostic products.
The Harts are citizens and residents of Connecticut.
SAC and SMD are wholly owned subsidiaries of Sekisui Chemical Co., Ltd.
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.
The QSRs are flexible regulations. According to the FDA, the QSRs are “an umbrella ... that specifies general objectives rather than methods.”
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 requirements may not apply or be necessary.”
To determine compliance with the QSRs, the FDA conducts an Establishment Inspection (“El”).
After the El, the inspector may issue a Form 483, which may include “inspeetional observations.”
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.
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.”
An inspection is “closed” when “a final decision has been made not to take [administrative] action or such action has been
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.
In June 2005, FDA returned to ADI for a follow-up inspection.
Nevertheless, the FDA observed that (1) “[procedures 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.”
2. Intertek Audits
Intertek is a private inspection, product testing, and certification company that operates internationally.
If the auditor finds the firm compliant with ISO standards, Intertek grants ISO certification.
Intertek audited ADI six times during the relevant period.
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”).
On April 8 and 9, 2008, Intertek conducted a surveillance audit and extended ADI’s ISO certification.
3.Supplier Audits
The FDA requires manufacturers to evaluate suppliers from whom they purchase devices or components.
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.”
On September 3, 2008, Trinity Biotech audited ADI for compliance with the QSRs and ISO 134:85:2003.
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.
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 au
Nonetheless, Kuehn repeatedly testified that ADI’s documents differed from what she would expect to see in an FDA-compliant company.
Moreover, Kuehn’s methodology is flawed. Her conclusions are based on a review of documents, at least one of which she misread.
Kevin Morrissey, ADI’s post-acquisition President and Chief Operating Officer
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.
Finally, Bhavna Gaikwad, also a research and development scientist at ADI, testified about other aspects of ADI’s noncompliance, such as insufficient employee training.
6. 2007 Femtelle 510(k) Submission
Medical device manufacturers who wish to market their products in the United
Femtelle is a breast cancer diagnostic assay developed in the 1990s and sold in Europe by ADI’s German subsidiary.
C. The Acquisition
1. Due Diligence Period
In early 2008, the Harts began seeking a buyer for ADI.
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. [Interested parties must conduct their own independent, in-depth investigation and analysis of [ADI] and the information set forth in this CM and any other ...*371 communication....133
In October 2008, Crosstree sent Sekisui a copy of the CM.
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 Hartson, Morgan Lewis requested a copy.
On December 10, 2008, Sekisui sent ADI a Letter of Interest, stating that Sekisui, “along with [its] investment banker (Sawi-an), outside counsel (Morgan Lewis), and accountants (KPMG), are prepared to commence this effort immediately and to dedicate significant resources to the ... transaction....”
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.
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 Fem-telle at all.
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.
As an initial matter, the PPA proves nothing about Sekisui’s valuation of Fem-telle at the time of the acquisition. KPMG prepared the PPA six months after the closing for “financial and tax reporting purposes[.]”
3. The SPA and the Closing
On March 5, 2009, the parties voluntarily executed the SPA, stating that Sekisui would purchase all outstanding shares of ADI for $25.5 million.
When they signed the SPA, Sekisui and the Harts were both represented by counsel.
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 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*374 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 mis-branded 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 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 *382 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
D. Post-Acquisition Events
1. Observations About ADI’s Compliance
Hart remained CEO of ADI until early 2010 when he left for medical reasons.
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.
On June 20-22, 2011, two years after the acquisition, the FDA inspected ADI.
In September 2012, two years after Sek-isui began its purported remediation, Siemens found ADI “noncompliant to ISO
2. 2009 Femtelle 510(k) Submission
On March 17, 2009, after the parties had signed the SPA but before the closing, ADI submitted another Femtelle 510(k).
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.”
On May 11, 2010, the FDA requested the “data to support that the test adds value over other clinical variables.”
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.
Sekisui’s FDA expert, Timothy Ulatow-ski, testified that he agreed with the decision to -withdraw the submission.
3. Subsequent Efforts to Market Femtelle
After withdrawing the 2009 Femtelle 510(k) submission, Sekisui continued its efforts to achieve 510(k) clearance.
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.
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 plaintiffs obligations 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.”
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.
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.”
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.
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.
Finally, Sekisui has failed to prove a breach of Section 4.12, warranting that ADI’s facilities and equipment are sufficient to conduct business.
I further conclude that no post-acquisition remediation was required. Although Morrissey urged Sekisui to spend hundreds of thousands of dollars to remed-iate perceived problems, multiple post-acquisition Intertek audits and an FDA inspection showed that ADI was already in compliance.
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.”
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.
Sekisui’s theory under Section 4.14(d) fares no better. Section 4.14(d) states, “[sjince 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.”
As an initial matter, I have already found that the Harts provided 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 Hart-son, and advised Sekisui to proceed with the closing.
Moreover, Femtelle was attractive to Sekisui because of its “future potential,” not its value on the closing date.
Finally, although Femtelle may have been the driving force behind the acquisition, both Sekisui and ADI knew that
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.”
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.
Any attorney or other person admitted to conduct cases in any court of the
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 serious concerns about credibility.
V. CONCLUSION
For the foregoing reasons, Seki-sui’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 motion, which I granted in an opinion dated August 15, 2013.
SO ORDERED.
. See Complaint ¶ 1. Sekisui’s fraud claim was dismissed by this Court in an October 17, 2012 Opinion and Order. See Dkt. No. 28.
. See Plaintiffs’ Trial Memorandum of Law ("PL Mem.”) at 1-2.
. 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).
. See Joint Pretrial Order ("JPTO”) at 2.
. See Tr. at 143:12-144:9 (Kevin Morrissey).
. See Plaintiffs’ Exhibit ("PL Ex.”) 7 (August 2008 CrossTree Confidential Memorandum).
. See id.
. See JPTO at 2.
. See id.
. See Tr. at 73:15-74:2 (Mamoru Takemura).
. See PI. Ex. 14 (6/23/10 Email from Hart to Mamoru Koseki); Pi. Ex. 15 (5/27/10 Email from Richard Hart to Jeffrey Ellis).
. See JPTO at 2.
. See id.
. See id.
. See PI. Ex. 48 (April 2009 KPMG Valuation Study).
. See 21 U.S.C. § 360j(f).
. See 21 C.F.R. § 820.1.
. 21 C.F.R. § 820.5. This system is known as the Quality Management System (“QMS"). See Tr. at 602:16-19 (Carrie Kuehn).
. 21 C.F.R. § 820.1(a).
. 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).
. Defendants’ Exhibit ("Def. Ex.”) 8M (61 Fed.Reg. 52602).
. IOM § 5.6.2.
. Id.
. Id.
. Id. § 5.6.7.
. Id.
. See 21 U.S.C. § 374.
. See id.
. See FDA Guide to Inspections of Quality Systems, Quality System Inspection Tech-
. See id. at 7-8.
. See id. at 48.
. See id. at 25.
. Def. Ex. 4Q (FDA Transparency Sheet).
. Def. Ex. D (6/23/05 FDA Form 483 issued to ADI); Def. Ex. E (6/22/11 FDA Form 483 issued to ADI).
. IOM § 5.2.3.3.
. See QSIT at 30.
. 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).
. See Def. Ex. 4Q.
. See id.
. Id.
. Id.
. Id.
. See FDA Regulatory Procedures Manual § 4-1-8.
. Id. § 4-1-1.
. 21 C.F.R. § 20.64(d)(3). See also Tr. at 585:14-17 (Kuehn).
. See Def. Ex. X (1/7/09 Morgan Lewis Pre-liminaiy Legal Due Diligence Report).
. See Tr. at 264:25-265:2 (Hugh Fryer); id. at 485:5-12 (Bhavna Gaikwad).
. See PI. Ex. 197 (10/15/04 FDA Warning Letter).
. Id.
. Id.
. See Def. Ex. B (10/17/05 FDA EIR).
. Id.
. 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.
. A DHF "contain[s] or referenced the records necessary to demonstrate that the design was developed in accordance with the approved design plan[.]” Id. § 820.30.
. See Def. Ex. B.
. Id.
. Id.
. See id.
. 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.
. See id.
. See Def. Ex. L (3/24/06 Intertek Systems Certification QMS Checklist).
. See Def. Ex. P (4/16/09 Intertek Systems Certification Audit Report).
. See id.
. See Intertek website.
. See ISO Standards Catalogue, ISO 13485:2003.
. Def. Ex. 8M.
. See Tr. at 592:7-25 (Kuehn).
. 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.
. See Def. Ex. L; Def. Ex. M (4/27/06 Inter-tek Systems Certification Audit Report).
. See Def. Ex. L.
. See Def. Ex. M.
. See id.
. Id.
. Id.
. See Def. Ex. N (3/21/07 Intertek Systems Certification Audit Report).
. See id.
. See id.
. See Def. Ex. O (4/9/08 Intertek Systems Certification Audit Report).
. Id. Def. Ex. P (4/16/09 Intertek Systems Certification Audit Report).
. Id.
. See 21 C.F.R. § 820.50.
. See id.
. Def. Ex. T (12/10/07 Siemens Audit Report).
. Id.
. See Def. Ex. S (9/3/08 Trinity Biotech Supplier Audit Report).
. See id.
. See Def. Ex. X.
. See id.
. The State of Connecticut did not issue an inspection report.
. See Tr. at 576:17-577:7 (Kuehn).
. See id. at 593:6-18 (Kuehn).
. See, e.g., id. at 602:15-20, 608:25-609:1-2, 620:14-25 (Kuehn).
. See IOM § 5.6.7.
. See Def. Ex. 8M.
. See Tr. at 697:16-21 (Kuehn).
. See id. at 648:2-13 (Kuehn). In addition, the documents she reviewed may not have included all relevant documents. See Sekisui v. Hart, 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).
. See id. at 745:16-20 (Kuehn).
. See id. at 284:1-5, 290:6-294:13 (Fryer).
. See id. at 290:20-25 (Fryer).
. Nor does Fryer’s name appear on the batch record or any document associated with Product 822. See PI. Ex. 210 (Product 822 Lot 72401 Batch Records); PI. Ex. 211 (Product 822 Lot 72405 Batch Records); PI. Ex. 215 (Product 822 SOPs).
. Tr. at 291:24 — 25 (Fryer).
. Id. at 299:10-21 (Fryer).
. See id. at 201:11-22 (Morrissey).
. See id. at 141:1-13 (Morrissey).
. See id. at 141:14-20 (Morrissey).
. See Tr. at 361:21-25 (Fryer).
. Def. Ex. 6A (12/25/11 Email from Fryer to Fryer).
. Def. Ex. 6B (1/4/12 Email from Fryer to Fryer).
. See Tr. at 366:14-21 (Fryer).
. See id. at 158:1-159:10 (Morrissey).
. 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).
. See Tr. at 484:9-22 (Gaikwad).
. See id. at 485:13-486:5 (Gaikwad); id. at 270:23-271:8 (Fryer).
. Def. Ex. S.
. See 21 C.F.R. § 807.87
. See Tr. at 425:10-23, 426:4-16 (Timothy Ulatowski).
. See 21 C.F.R. § 807.87. See also Tr. at 436:7-13 (Ulatowski).
. See 21 C.F.R. § 807.87.
. See Tr. at 449:12-20 (Ulatowski).
. See PI. Ex. 7. See also Tr. at 783:14-16 (Guy Erb).
. See JPTO at 3.
. See PL Ex. 22 (1/31/09 Letter from Hart to Jonathan Kahan, attaching the 2007 Fem-telle Application).
. See id.
. See id.
. See id.
. See id.; PI. Ex. 36 (2/28/08 Email from Hart to Manfred Schmitt).
. See PL Ex. 22.
. See Pl. Ex. 247 (1/25/08 Email from Ellis to Hart).
. See JPTO at 2.
. See PL Ex. 240 (2/20/08 Email from Ellis to Hart, attaching the February 2008 CM).
. See id.
. See Pl. Ex. 7 (August 2008 CM).
. Id.
. See id.
. See PI. Ex. 21 (1/7/09 KMPG Due Diligence Draft).
. See Def. Ex. X.
. See id.
. See PI. Ex. 245 (2/12/09 Email exchange between Hart and Dan Crosby, an attorney at Withers Bergman).
. 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.
. Pi. Ex. 2 (12/10/08 Sekisui Letter of Interest to ADI).
. See id.
. See id.
. See SPA ¶ 6.14.
. See Tr. at 50:20-51:14 (Takemura).
. See Def. Ex. 2M (2/9/09 Sawian Report) (English translation).
. Id. at 6.
. See Tr. at 65:20-67:1 (Takemura); Pl. Ex. 49 (3/27/09 Excel analyzing expansion of Sek-isui’s diagnostic business).
. See Tr. at 112:3-6 (Takemura).
. See id. at 68:9-69:1 (Takemura).
. 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”).
. SeePl. Ex. 49; Def. Ex. 2M.
. See SPA at Ex. A (Schedule of Femtelle Revenue Based Payments).
. See id.
. See Pl. Ex. 48 (10/1/09 KPMG Valuation Study).
. See Tr. at 837: ll-15(Erb).
. Pl. Ex. 48.
. Id.
. Id.
. See id.
. See Pl. Ex. 7; SPA § 4.29 ("The representations and warranties set forth in this [SPA] supercede and replace all prior statements,
. See SPA § 2.6.
. See id. at Ex. A.
. See id. ¶ 2.2.
. See JPTO at 2.
. See id.
. The "Business” means "the business of ADI and its subsidiaries, including the in vitro diagnostic business.” SPA § 1.1.
. As defined, “Laws” means FDA regulations, including the QSRs, codified at 21 C.F.R. § 820. See id. § 1.1.
. Id. § 4.12.
. "Products” is defined as "any products currently or formerly manufactured, sold, distributed, provided, shipped or licensed, or any services rendered” by ADI or its subsidiaries. Id. § 4.11.
. 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.
. Id. § 2.6(d).
. Id. § 6.14.
. Id. § 9.1.
. PL Ex. 6 (Hart’s Employment Agreement).
. See PL Ex. 14; Pl. Ex. 15.
. 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 (Takemu-ra).
. See id. at 157:20-158:4, 161:14-19, 164:25-165:17, 168:19-23 (Morrissey).
. See id. at 173:2-19, 177:11-14 (Morris-sey); PI. Ex. 46 (May 2010 AQSOL Audit Report); PI. Ex. 84 (June 2010 AQSOL Audit Report).
. See PI. Ex. 53 (June 2010 Quality System Improvement Plan).
. SeeTr. 142:10-15 (Morrissey).
. 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).
. See Tr. at 157:15 (Morrissey).
. See Def. Ex. Q (6/8/10 Intertek Systems Certification Audit Report).
. See Def. Ex. R (3/29/11 Intertek Systems Certification Audit Report).
. See Def. Ex. C (8/29/11 FDA EIR).
. See Def. Ex. E.
. Def. Ex. V.
. Id.
. Id.
. See Def. Ex. C.
. Id.
. See JPTO at 3.
. See PL Ex. 24 (5/27/09 Letter from FDA to ADI).
. Id.
. Id.
. PI. Ex. 26 (1/15/10 Email from Reena Philip, FDA Associate Director, to David Teicher, ADI’s Director of Technical Affairs).
. PI. Ex. 28 (3/26/10 Email from Teicher to Philip).
. See Pi. Ex. 42 (5/4/10-6/10/10 Email exchange between Greenfield and Manfred Schmitt).
. Id.
. Id.
. PI. Ex. 30 (5/11/10 Email from Philip to Teicher).
. Def. Ex. 21 (5/26/10 Email from Greenfield to Gaikwad, Teicher, Fryer, Morrissey, Koseki, and Michael Smirnov).
. PI. Ex. 43 (5/19/10 Email from Greenfield to Schmitt).
. See PI. Ex. 39 (6/2/10 Email from Schmitt to Greenfield).
. Id.
. See PL Ex. 222 (6/1/10 Email from Greenfield to Fryer, Koseki, Morrissey, and Teicher).
. See Def. Ex. 2L (6/2/10 Email from Greenfield to Koseki, Morrissey, Teicher, Fryer, Smirnov, attaching minutes from call with FDA).
. Pl. Ex. 29 (6/28/10 Email from Philip to Teicher).
. See Def. Ex. 2L; Pl. Ex. 143 (Minutes for ADI’s 6/25/10 Femtelle Direction Meeting).
. See Pl. Ex. 143.
. See Tr. at 80:25-81:7 (Takemura).
. See id. at 473:2-9 (Ulatowski).
. Id. at 472:15-473:1 (Ulatowski: "In my experience ... reviewing hundreds of 510(k) [submissions], time was up.”).
. See Pl. Ex. 93 (8/29/11 Femtelle Regulatory Gap Analysis).
. See Tr. at 332:9-333:2 (Fryer); Pl. Ex. 93.
. See id. at 410:6-411:1 (Fryer).
. See id. at 334:8-11 (Fryer).
. See Def. Ex. 2E (6/30/11 KPMG Initial Information Request).
. See Def. Ex. 4J (11/19/12 KPMG Followup Information Request).
. See id.
. 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.
. 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, 919 N.Y.S.2d 465, 944 N.E.2d 1104 (2011). The parties do not dispute the validity of the contract.
. See Raymond v. Marks, 116 F.3d 466, 466 (2d Cir. 1997).
. See JPTO at 2.
. See Plaintiffs' Combined Proposed Findings of Fact and Conclusions of Law (“PI. Facts and ConcL”) at 51.
. Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 279 (E.D.N.Y. 2009).
. See 21 C.F.R. § 820.100.
. See Def. Ex. B, Def. Ex. M, Def. Ex. V, Def. Ex. C.
. 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 manufacture, packing, storage, or installation are not in conformity with [the QSRs].”).
. SPA § 4.14(c).
. 21 C.F.R. § 820.30.
. See Def. Ex. B; Def. Ex. S.
. See SPA §4.12.
. See Def. Ex. C.
. See id.; Def. Ex. V.
. See Def. Ex. C; Def. Ex. Q; Def. Ex. R.
. See Def. Ex. T.
. SPA § 4.14(c). Sekisui asserts that "Products” include Femtelle because Fem-telle was being manufactured and sold by ADI’s German subsidiary at the time of the acquisition. See PI. Facts and Concl. at 7, 53.
. See Pi. Facts and Concl. at 53-54.
. See id. at 38.
. SPA § 4.14(c).
. See Tr. at 472:15-473:1 (Ulatowski).
. See Def. Ex. 21 (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”).
. See 21 C.F.R. § 820.30(j) (emphasis added).
. SPA § 4.14(d).
. Id. § 1.1.
. See PI. Facts and Conch at 55.
. See id.
. See PI. Ex. 245, PI. Ex. 2.
. SPA §6.14.
. Tr. at 54:9 (Takemura).
. Id. at 544:16-18 (Ellis).
. See Recticel Foam Corp., Inc. v. Bay Indus., Inc., 128 Fed.Appx. 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).
. Sekisui v. Hart, 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).
. SPA § 2.6(d).
. See MBIA Ins. Corp. v. Patriarch 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, 829 N.Y.S.2d 449, 861 N.E.2d 813 (2006) (relying on expert testimony regarding bank practices on check endorsement for purposes of commercial reasonableness analysis).
. See Tr. at 332:9-333:2 (Fryer); PL Ex. 93.
. See Def. Ex. 4J.
. See PI. Ex. 5 (Schedule for Femtelle Revenue Payments, SPA Ex. A).
. See id.
. See Tr. at 849:22-852:12 (Franklin Velie, Counsel for the Harts).
. 28 U.S.C. § 1927.
. Enmon v. Prospect Capital Corp., 675 F.3d 138, 143 (2d Cir. 2012) (internal quotation marks omitted).
. Id.
. 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.
. 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).
. 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 sanctiona-ble.”) (internal citation omitted).
. 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 Cir. 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 of New York, 403 Fed.Appx. 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.
Reference
- Full Case Name
- SEKISUI AMERICA CORPORATION and Sekisui Medical Co., Ltd. v. Richard HART and Marie Louise Trudel-Hart
- Cited By
- 7 cases
- Status
- Published