(RC) 2 Pharma Connect, LLC v. Mission Pharmacal Company

District Court, S.D. New York·Decided September 14, 2022·No. 1:21-cv-11096·Unknown

Opinion

USDC SDNY DOCUMENT UNITED STATES DISTRICT COURT ELECTRONICALLY FILED SOUTHERN DISTRICT OF NEW YORK DOC #: Sonnac nnnnns IK DATE FILED:_09/14/2022

(RC) 2 PHARMA CONNECT, LLC, : Plaintiff, : 21-cv-11096 (LJL) -v- : OPINION AND ORDER MISSION PHARMACAL COMPANY, : Defendant. :

we KX LEWIS J. LIMAN, United States District Judge: Defendant Mission Pharmacal Company (“Defendant” or “Mission”) moves for sanctions pursuant to Federal Rule of Civil Procedure 11, 28 U.S.C. § 1927, and the Court’s inherent power against Plaintiff (RC) 2 Pharma Connect, LLC (‘“Plaintiff’ or “(RC) 2”). Dkt. No. 36. Defendant argues that sanctions are appropriate because Plaintiff filed an amended complaint based on allegations it knew to be untrue and then, after Defendant asked Plaintiff to withdraw its complaint, Plaintiff refused to do so, forcing Defendant to make its successful motion to dismiss the action. For the reasons that follow, the motion for sanctions 1s granted in part and denied in part.

' Plaintiffs request to file a sur-reply in opposition to the motion for sanctions is denied as its contents would not change the result in this case. Dkt. No. 50. That sur-reply repeats an argument “already present in Defendants’ opposition brief.” Convergen Energy LLC v. Brooks, 2020 WL 4500184, at *3 (S.D.N.Y. Aug. 5, 2020), reconsideration denied, 2020 WL 5549039 (S.D.N.Y. Sept. 16, 2020); see Kapiti v. Kelly, 2008 WL 754686, at *1 n.1 (S.D.N.Y. Mar. 12, 2008) (“Allowing parties to submit surreplies is not a regular practice that courts follow, because such a procedure has the potential for placing a court in the position of refereeing an endless volley of briefs.”).

BACKGROUND Familiarity with the Court’s prior opinion and order dismissing the amended complaint for failure to state a claim for relief is assumed. Dkt. No. 87. The Court states only those facts necessary to resolve the motion for sanctions. (RC) 2 is a pharmaceutical broker that “specializes in sourcing and developing chemicals,

pharmaceutical ingredients, and pharmaceutical products in cooperation with manufacturing partners.” Dkt. No. 8 ¶ 1. Mission is a pharmaceutical company that develops and manufactures pharmaceuticals as a contract partner for third parties. Id. ¶ 2. In January and March 2019, the parties entered into two agreements relating to the development of docosanol 10% cream, a generic version of a topical medication: a non-disclosure agreement effective January 2019 (“NDA”) and a proposal agreement dated March 13, 2019 and re-executed on May 17, 2019 (“Proposal Agreement”). Id. ¶¶ 29–32, 47–48. The NDA permitted the parties to share confidential information with each other regarding docosanol 10% cream, Dkt. No. 8-1 § 3(a), (b); the Proposal Agreement required Defendant to perform specified activities to support the development of a formulation and process for the commercial launch of docosanol 10% cream

and to assist with the submission of an Abbreviated New Drug Application (“ANDA”), id. ¶¶ 47–48; Dkt. No. 8-2. Among the activities Defendant agreed to undertake was stability testing on registration batches of the cream, which would be necessary for the ultimate preparation of the ANDA. Dkt. No. 8-2. A detailed discussion of the procedural history is necessary to understand the current motion. On December 28, 2021, Plaintiff filed a complaint initiating this action. Dkt. Nos. 1, 71. The thrust of the complaint was that Defendant had violated the NDA and had either breached or clearly and unequivocally expressed its intent to breach its obligations under the Proposal Agreement between the parties. Dkt. Nos. 1, 71. The claim that Defendant had breached the NDA was based on the allegation that a request by Defendant’s in-house counsel in the summer of 2021 that the parties enter into a Technology Transfer Agreement (“TTA”) “has caused [Defendant] to intentionally breach the NDA.” Dkt. No. 71 ¶ 78. Plaintiff inferred that because Defendant would not agree to give Plaintiff an exclusive license to Defendant’s technology

developed in connection with the project that Defendant intended to use Plaintiff’s confidential information outside of the scope of permitted uses under the NDA. Id. ¶¶ 70, 73, 115. The claim regarding the breach or anticipatory breach of the Proposal Agreement was founded on two related sets of allegations. First, Plaintiff claimed that communications from Defendant had given it reason to believe that Defendant would not fulfill its obligation to collect and perform six-month stability testing on three registration batches of Plaintiff’s docosanol 10% cream on the timetable set forth in the Proposal Agreement, which included the collection of the first batch by December 21, 2021. Id. ¶¶ 82–89, 107–113. That allegation was the centerpiece of the complaint. Plaintiff alleged that the stability testing was “agreed-to” and “time-critical,”

id. at 14, and that Defendant’s recent communications had given Plaintiff “reason to believe that [Defendant] ha[d] not done what is necessary to perform the six-month stability testing as required by the FDA,” id. ¶ 87. Plaintiff alleged that “[i]f the requisite six-month stability testing is not initiated by December 31, 2021, (RC) 2 will be irreparably harmed by, inter alia, being forced to restart the entire ANDA process including, but not limited to, identifying a suitable and trustworthy partner, developing an acceptable protocol, and restarting the required manufacture and testing processes.” Id. ¶ 88. The complaint asserted that “[u]nless Mission performs the Six-Month Stability Pull for 39X21 before December 31, 2021, (RC) 2 will be completely unable to complete the development of the docosanol 10% cream and ANDA submission pursuant to the Proposal Agreement” and that “(RC) 2 would be required to restart the entire development process, the completion of which will take approximately a year.” Id. ¶ 132. Second, Plaintiff complained that if Defendant did not collect and provide to third parties certain materials that were exclusively in its possession, including registration batches, samples of the six-month stability pulls, and placebo samples, it would not be able to arrange for certain third-party studies

Defendant was required to obtain. Id. ¶ 93. Thus, Plaintiff alleged “[i]f Mission fails to timely collect the Six-Month Stability Pulls, then the Third-Party Studies will not be timely performed and Mission’s conduct will have irreparably destroyed the entire ANDA submission process pursuant to the Proposal Agreement.” Id. ¶ 94. Plaintiff asserted two claims: (1) breach of the parties’ NDA and/or intention to breach the NDA; and (2) breach of the Proposal Agreement based on Mission’s “failure to confirm” that it had performed certain batch pulls as part of the stability testing of the Product. Plaintiff alleged that the failure of Defendant to gather the first six-month stability pull and commence the stability tests by December 31, 2021, and the failure to gather the second two six-month stability

pulls by January 31, 2022 and to initiate the six-month stability tests for them would cause it irreparable harm. Id. ¶¶ 101–103. That same day, after receiving the complaint, Mission’s counsel reached out to Plaintiff’s counsel by telephone. Dkt. No. 20-2 ¶ 3. Through counsel, Defendant confirmed that it had already collected the samples that comprised the first batch one week earlier (on December 21, 2021), that it was conducting stability testing of those samples, and that it would ensure that future samples of the first batch as well as other batches of the product would be timely collected. Id.

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