Noramco LLC v. Dishman USA Inc

Court of Appeals for the Third Circuit·Decided July 16, 2024·No. 23-1396·Unpublished

Opinion

NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

No. 23-1396

NORAMCO LLC

v.

DISHMAN USA, INC.,

Appellant

On Appeal from the United States District Court for the District of Delaware (D.C. Civil No. 1-21-cv-01696)

Circuit Judge: Honorable William C. Bryson

Argued March 11, 2024

Before: BIBAS, MONTGOMERY-REEVES, and ROTH, Circuit Judges.

(Opinion filed: July 16, 2024)

Stamatios Stamoulis [ARGUED] Stamoulis & Weinblatt 800 N West Street, 3rd Floor Wilmington, DE 19801 Counsel for Appellant

Jennifer M. Mohamed [ARGUED] Andrew J. Bayne The Bayne Law Group P.O. Box 3036 Princeton, NJ 08543 Counsel for Appellee

OPINION

MONTGOMERY-REEVES, Circuit Judge.

Dishman USA, Inc. (“Dishman”) appeals the District Court’s grant of summary judgment on the breach-of-contract claim that Noramco LLC (“Noramco”) brought under Delaware law. For the reasons provided below, we will affirm in part and vacate in part the District Court’s orders granting summary judgment and remand this case for further proceedings consistent with this opinion. I. BACKGROUND A. The Failed Inspection Dishman and Noramco entered into a supply agreement (the “Supply Agreement”)

under which Dishman agreed to supply Noramco with olivetol, a raw material used to manufacture active pharmaceutical ingredients. See generally S.A. 2–23 (hereinafter, “Supply Agreement § ”).1 Dishman agreed to manufacture the olivetol at its “cGMP- compliant manufacturing facilities” in India (the “India Facility”). Id. §§ 1.7, 2.1. “cGMP” referred to “current good manufacturing practices” recognized by food and drug

 The Honorable William C. Bryson, District Judge sitting by designation pursuant to 28 U.S.C. § 291(b).  This disposition is not an opinion of the full Court and pursuant to I.O.P. 5.7 does not constitute binding precedent. 1 This volume of the appendix is part of the public record.

regulators in the United States, the European Union, Switzerland, and other jurisdictions. Id. § 1.4.

In February 2020, representatives of the European Directorate for the Quality of Medicines & HealthCare (“EQDM”) and the Swiss Agency for Therapeutic Products (“Swissmedic”) inspected the India Facility. The inspection focused on whether the India Facility complied with cGMP and should be certified as such. While awaiting the inspection’s result, Dishman manufactured several batches of olivetol for Noramco.

On March 19, EQDM informed Dishman that the India Facility was “not compliant with [cGMP]” and suspended the India Facility’s certificates of suitability for two substances, neither of which was olivetol. S.A. 136. According to EQDM, inspectors flagged “one critical and several major deficiencies to [cGMP]” that, combined, “constitute[d] a critical risk of producing products[] which could be harmful to the patient,” id., including a major violation with a reactor unit that Dishman used to make the olivetol. EQDM “reminded” Dishman that it had a “responsibility to inform all [of its] customers about this decision.” S.A. 141.

B. Rejection of Olivetol On April 16, EQDM denied Dishman’s appeal of the failed inspection. EQDM explained that Dishman “did not provide information that would justify the reconsideration of the decision” “[c]onsidering . . . that there was a serious risk for the safety of human patients or animals due to the critical and major deficiencies raised by the inspection.” S.A. 233. The next day, Dishman told Noramco that the India Facility failed a cGMP inspection. Dishman hedged, however, that the inspection purportedly

raised no concerns about olivetol because inspectors focused on other substances that Dishman manufactured at the India Facility.

On April 20, Swissmedic issued a statement of non-compliance with cGMP concluding that the India Facility “d[id] not comply with [cGMP]” and recommending that French authorities withdraw the India Facility’s cGMP certificate. S.A. 144. EQDM followed suit the next day and provided Dishman with a “consolidated list of deficiencies” noting “a number of failures to comply with the principles and guidelines of [cGMP].” S.A. 148.

About a week later, Dishman sent Noramco an internet link to the Swissmedic report. Like before, Dishman equivocated about whether the failed inspection meant that Dishman did not manufacture the olivetol consistent with cGMP.

Dishman and Noramco continued to correspond about the olivetol. Among other things, Dishman provided Noramco with a risk analysis supposedly showing that the olivetol was safe and pure. And Noramco decided to open and sample some of the drums of olivetol, potentially rendering that olivetol worthless to other buyers. Finally, on August 19, Noramco sent a letter to Dishman formally rejecting the olivetol because it

“d[id] not meet the EU GMP standards” and thus deviated from what Dishman promised to deliver under the Supply Agreement. S.A. 253.

C. Procedural History Dishman appeared to agree to refund Noramco for the olivetol.2 But that deal fell through. So Noramco sued Dishman for breaching the Supply Agreement.

During a hearing in October 2022, the District Court proposed an early “motion for Summary Judgment in the case, which would be predicated on the Swissmedic Report being dispositive” of whether Dishman breached the Supply Agreement. App. 466. The parties submitted briefs on liability. And the District Court held that there was no genuine dispute of material fact that Dishman breached the Supply Agreement. The parties then submitted briefs on damages. The District Court held that there was no genuine dispute of material fact about damages and granted Noramco summary judgment on the issues relevant to this appeal.3 Dishman appealed.

2 Noramco paid for the olivetol in June 2020.

3 In its opinion granting summary judgment on damages, the District Court held that Dishman “forfeited the right to assert as a defense that Noramco failed to timely reject the olivetol” because Dishman did not make that argument when opposing summary judgment on liability. Noramco LLC v. Dishman USA, Inc., No. 21-1696, 2023 WL 1765566, at *3 (D. Del. Feb. 3, 2023). Still, the District Court analyzed the merits of Dishman’s untimely rejection argument and explained why the Court viewed that argument as wrong.

Dishman filed a motion for relief from judgment under Federal Rule of Civil Procedure 59(e) arguing that the District Court manifestly erred by treating Dishman’s untimely rejection argument as forfeited and rejecting that argument on the merits. The District

II. DISCUSSION4 Dishman raises three issues on appeal. First, is there a genuine dispute of material fact about whether Dishman breached the Supply Agreement by shipping defective olivetol? Second, assuming that the olivetol was defective, is there a genuine dispute of material fact about whether Noramco timely rejected the olivetol? Third, is there a genuine dispute of material fact about whether Noramco failed to mitigate damages? We address each issue below.

A. Breach of Contract Section 4.1 of the Supply Agreement provides that Dishman “shall . . . manufacture[] and store[] [olivetol] in accordance with all Appliable Laws relevant to

Court denied the motion for the same core reasons that the Court provided when granting summary judgment. 4 The District Court had jurisdiction under 28 U.S.C. § 1332. We have jurisdiction under 28 U.S.C. § 1291.

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