Pursuant to the Order of this Court entered on December 15, 2023 and in accordance with Federal Rules of Civil Procedure 58, JUDGMENT is hereby entered in favor of the Plaintiffs 3074 Centreville LLC, Westway Services Group LLC, Westway Workplace LLC, Westway Enterprises LLC, JBM Investments LLC, and Mark Webber and against the Defendants M.A.

Cohen & Co., Inc. and Michael Cohen.

Appearance of Counsel for ()Pltf - (Colin Harris and Charles Malaret) () Deft- (Gregory Dovel and Craig Merritt)

Motion for Summary Judgment – Dkt.42

( ) Report and Recommendation to Follow ( ) Order to Follow

LLM and ELEONORA L. ZETTELER, LLM,in their capacity as insolvencypractitioners in the insolvency of Nederlandsche Algemeene Maatschappij van Levensverzekering

This matter is before the Court on Respondents Netherlands Insurance Holdings, Inc. and NIH Capital, LLC’s (“Respondents”) Unopposed Motion for Extension of Time to Answeror Otherwise Plead in Responseto the Petition to Confirm Arbitration Award.

The Court, upon consideration of the motion, is of the opinion that it should be allowed by consent.

IT IS THEREFORE ORDERED THAT Respondents’ Unopposed Motion for Extension of Time to Answer or Otherwise Plead in Responseto the Petition to Confirm Arbitration Award [Doc. #11] is GRANTED.

2024 to answer or otherwise plead in response to the Petition to Confirm Arbitration ÿÿ ÿ ÿ

And regarding forfeiture for failure to obtain tentative approval, there is no basis for conjuring one tolling rule where none exists, invoking another tolling rule where it does not apply, or requiring FDA to apply a criminal causation standard ...

ROBERT F. KENNEDY, JR., in his official capacity as Secretary of Health and Human Services, et al., Defendants, and

Defendants’ Unopposed Joint Motion to Defer Deadlines to Answer or Otherwise Respond to Norwich’s Amended Complaint The Federal Defendants, Intervenor-Defendant Teva Pharmaceuticals USA, Inc., and Intervenor-Defendant Salix Pharmaceuticals, Inc. (collectively, Defendants), respectfully move under Federal Rule of Civil Procedure 6(b)(1) for an order deferring their deadlines to answer or otherwise respond to Norwich’s Amended Complaint, ECF No. 35, until further order of this Court.

Good cause exists to defer Defendants’ answer deadlines because doing so will avoid using party and judicial resources on pleadings that are not needed to resolve this case.

Courts in this district routinely defer or dispense with defendants’ obligation to file an answer or motion under Rule 12 under similar circumstances.

1 The Federal Defendants previously proposed, in a stipulation filed jointly with Norwich, that their answer date be deferred pending summary judgment briefing.

ROBERT F. KENNEDY, in his official capacity as Secretary of Health and Human Services, et al., Defendants, and

Federal Defendants’ Cross-Motion for Summary Judgment Pursuant to Federal Rule of Civil Procedure 56, Defendants Robert F. Kennedy, Sara Brenner, and the U.S. Food and Drug Administration respectfully move this Court for summary judgment.

The grounds for this motion are fully set forth in an accompanying memorandum.

February 28, 2025

ROBERT F. KENNEDY JR., in his official capacity as Secretary of Health and Human Services, SARA BRENNER, in her official capacity as Acting Commissioner of Food and Drugs, and, UNITED STATES FOOD AND

Pursuant to Federal Rule of Civil Procedure 56 and Local Rule 7(h)(2), Intervenor- Defendant Teva Pharmaceuticals USA, Inc., moves for an order granting summary judgment in its favor on all claims and denying Plaintiff Norwich Pharmaceuticals, Inc.’s motions for summary judgment and a preliminary injunction.

In support of this motion, Teva submits the attached memorandum of points and authorities.

A proposed order also accompanies this motion.

Teva respectfully requests oral argument on this motion.

Case 1:22-cv-00043-SPW Document 50 Filed 07/31/23 Page1of 1

Uponthe parties’ Joint Status Report and Joint Motion to Extend Stay (Doc. 49), and for good cause appearing, IT IS HEREBY ORDEREDthat the Motion is GRANTED.

This matteris STAYEDuntil the earlier of (a) the filing of a stipulation of dismissalofthis action, or (b) the submissionby the parties of a joint report advising the Court that the Proposed Decreehasnot been approvedby thedistrict court in the North Dakotacase.

In the event that the Proposed Decree is not approved bythedistrict court in the North Dakotacase, the parties shall update the Court on the status of this case.

DATEDthis _=7/“day of July, 2023.

ROBERT F. KENNEDY JR., in his official capacity as Secretary of Health and Human Services, SARA BRENNER, in her official capacity as Acting Commissioner of Food and Drugs, and, UNITED STATES FOOD AND

Pursuant to Local Civil Rule 7(n)(2), Plaintiffs have conferred with the government and intervenors, and have agreed on the contents of the Rule 7(n) administrative record appendix to be filed in this case.

The public version of the agreed appendix is attached to this notice.

None of this is disputed by FDA or Intervenors.

Assuming arguendo that forfeiture is “all-or-nothing,” Intervenors have not pointed to any textual contradiction that would follow —and none exist.

For Teva’s argument to have any basis, the statutory language would have to be re-written to focus on an “application” rather than an “applicant.” Teva offers no justification for this Court to engage in such re-writing, and none exists.

Nonetheless, if this Court determines that FDA has taken a “final agency action” with respect to the 30-month stay, then Salix seeks leave to file a cross-claim.

Failure-to-market forfeiture can be triggered in a number of ways, but only one is relevant here: A first applicant (like Actavis) that submitted its ANDA more than 30 months ago, see 21 U.S.C. § 355(j)(5)(D)(i)(I)(aa)(BB), will forfeit its eligibility for 180-day exclusivity if it does not market its drug within 75 days of “the date as of which ... at least 1 of the following [enumerated events] has occurred” as to “each of the patents” underlying the paragraph IV certifications “qualifying [it] for the 180-day exclusivity period”: (AA) In an infringement action brought against that applicant[4] with respect to the patent ... a court enters a final decision from which no appeal (other than a [certiorari] petition to the Supreme Court .

At the time Actavis submitted its ANDA, FDA had published draft guidance that, if finalized, would have recommended applicants conduct “comparative dissolution testing” designed to assess the product quality of a proposed generic rather than to demonstrate its bioequivalence to Salix’s reference drug.

Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971), but must instead uphold the agency’s action if it is “rational, based on consideration of the relevant factors and within the scope of the authority delegated to the agency by the statute,” Motor Vehicle Mfrs.

Not every “result consistent with ... [a] statute’s overarching goal must be the law,” Henson v. Santander Consumer USA Inc., 582 U.S. 79, 89 (2017), which is why the Supreme Court has repeatedly cautioned against appeal “to that last redoubt of losing causes.” Dir., Off.

In Norwich’s view (and that of the decision from the District of Massachusetts on which it relies) such a tolling rule would give first applicants a stronger “incentive to obtain speedy approval,” see id. at 35, and would better align with legislative history indicating that “faster generic market entry” was one of the goals of the MMA, see Meijer, Inc. v. Ranbaxy Inc., 2016 WL 4697331, at *21-22 (D. Mass.

None of Norwich’s attempts to explain away 18 Case 1:25-cv-00091-BAH Document 65 Filed 03/26/25 Page 26 of 33 its waiver works.

But Norwich nonetheless argues (Reply 28-29) that delay caused by the 19 Case 1:25-cv-00091-BAH Document 65 Filed 03/26/25 Page 27 of 33 new dissolution study requirement is “delay[] because of a petition,” 21 U.S.C. § ...

... But as the D.C. Circuit explained in interpreting the same “caused by” phrase, “there is no textual warrant for this claim.” Kilburn, 376 F.3d at 1128. “[T]he words ‘but for’ simply do not appear” in the statute; “only ‘caused by’ do.” Id. None ...

Norwich nonetheless contends that its “matching” argument fits the statutory scheme because “the applicability of 180-[day] exclusivity is not determined in a vacuum but relative to a subsequent application.” Supp. Br. 23.

To the extent that recognizing the limited effect of the Stipulation could be considered an alternative justification that was not provided by FDA, it is nonetheless a basis to reject Norwich’s challenge to FDA’s decision.