Sahel Oncology, LLC v. STA Pharmaceutical Hong King Limited

CourtDistrict Court, S.D. California
DecidedJune 18, 2024
Docket3:23-cv-01458
StatusUnknown

This text of Sahel Oncology, LLC v. STA Pharmaceutical Hong King Limited (Sahel Oncology, LLC v. STA Pharmaceutical Hong King Limited) is published on Counsel Stack Legal Research, covering District Court, S.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sahel Oncology, LLC v. STA Pharmaceutical Hong King Limited, (S.D. Cal. 2024).

Opinion

1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 SAHEL ONCOLOGY, LLC Case No. 23-cv-1458-BAS-DDL

12 Plaintiff, ORDER 13 v. 1. GRANTING DEFENDANT’S REQUEST 14 STA PHARMACEUTICAL HONG FOR JUDICIAL NOTICE KONG LIMITED, 15 (ECF NO. 28-2), and Defendant. 2. GRANTING IN PART AND 16 DENYING IN PART 17 DEFENDANT’S MOTION TO DISMISS THE FIRST 18 AMENDED COMPLAINT 19 (ECF No. 28-1)

22 Presently before the Court is Defendant STA Pharmaceutical Hong King Limited’s 23 (“STA” or “Defendant”) Motion to Dismiss the First Amended Complaint of Plaintiff 24 Sahel Oncology (“Sahel” or “Plaintiff”). (ECF No. 28-1 (“MTD”).) Defendant moves to 25 dismiss on the grounds that Plaintiff fails to plead a claim upon which relief may be 26 granted. (Id.) Sahel opposes. (ECF No. 29 (“Resp.”).) Defendant replies. (ECF No. 30 27 (“Reply”).) Defendant additionally requests judicial notice of eleven exhibits attached to 28 its motion to dismiss. (ECF No. 28-2.) Plaintiff does not oppose. 1 The Court finds the motions suitable for determination on the papers submitted and 2 without oral argument. Fed. R. Civ. P. 78(b); Civ. L.R. 7.1(d)(1). For the reasons set forth 3 below, the Court GRANTS Defendant’s Request for Judicial Notice (ECF No. 28-2), and 4 GRANTS IN PART and DENIES IN PART Defendant’s motion to dismiss the First 5 Amended Complaint (“FAC”) (ECF No. 28-1). 6 I. BACKGROUND 7 This case concerns a written contract between two companies to develop and 8 manufacture a new cancer drug. Sahel brings claims under multiple theories of liability: 9 alleging the contract as written is invalid, or one of its provisions is invalid, or the contract 10 is valid but STA breached it. For these claims, Sahel seeks damages. Sahel also seeks 11 reformation of the contract via declaratory relief on the grounds of equitable estoppel or 12 unconscionability. 13 Plaintiff Sahel Oncology (“Sahel” or “Plaintiff”) develops drugs for cancer patients 14 and has its principal place of business in California. (ECF No. 27 (“FAC”) ¶¶ 1, 5.) It has 15 over eight years of experience in “experimental therapeutics” in this field, which includes 16 the design of “several clinical trials, including trials to treat patients with brain cancer.” 17 (Id. ¶ 6.) STA is a pharmaceutical contract development and manufacturing company with 18 its principal place of business in China. (Id. ¶¶ 2, 7.) 19 Contract negotiations. The parties entered into the relevant written contract on or 20 around June 6, 2023. (FAC ¶ 9.) In the contract, STA agreed to manufacture and produce 21 a cancer-fighting compound developed by Sahel. (Id.) 22 Sahel entered into this contract because it was attempting to manufacture its drug for 23 a terminally ill cancer patient who “urgently needed” it. (Id. ¶ 11.) STA was aware of this 24 during contract negotiations. (Id.) Ultimately, after the parties entered into the written 25 contract, STA did not deliver the drug according to the approximate timetable in the 26 contract and, to this Court’s knowledge, still has not delivered it. (Id. ¶ 28.) 27 The parties dispute STA’s representations and their meanings during the contract 28 negotiation period. Sahel alleges two main misrepresentations by STA. First, Sahel alleges 1 that “STA represented to Sahel it would source the required API (Active Pharmaceutical 2 Ingredient) for the manufacture of the new drug in 8 weeks or less.” (Id. ¶ 12.) Second, 3 Sahel alleges STA represented that it would produce enough of the drug and of a sufficient 4 quality that it could be used on the cancer patient within a two- to three-month period after 5 the parties signed the contract. (Id. ¶¶ 11, 13–14.) The contract contradicts this, though, 6 and Sahel admits that the contract itself states that the first batch would be produced under 7 GLP1 conditions, which are not suitable for use on humans. (Id. ¶ 15.) 8 Although the contract’s language contradicts Sahel’s allegations regarding STA’s 9 second misrepresentation, Sahel alleges that language does not reflect the understanding of 10 the parties when they agreed to the contract. When Sahel attempted to change the 11 contractual language to require the first phase of drug manufacturing to be of a sufficient 12 quality for emergency compassionate use, STA told it that the agreement “was its standard 13 form contract, that Sahel could not change it, and Sahel needed to sign it in the form 14 presented (i.e. with the first batch[] produced under GLP conditions).” (Id. ¶ 19.) While 15 Sahel tried to change the language away from manufacturing the first batch of the drug 16 under GLP conditions, Sahel also argues that STA misled Sahel to believe that the GLP 17 conditions would suffice for Sahel’s planned emergency compassionate use. (Id. ¶¶ 16– 18 18.) Sahel further alleges that, were it not for these misrepresentations, Sahel would not 19 have entered into the contract in the first place. (Id. ¶ 10.) It only entered into the contract 20 in reliance on STA’s promises and misrepresentations. (Id.) According to the FAC, STA 21 used Sahel’s urgency in procuring the drug to “lure[] Sahel into signing a contract which 22 contained form, boiler-plate terms that differed from what STA had promised.” (Id. ¶ 21.) 23 Contract terms. As already noted, the FAC alleges the terms as written in the 24 contract do not reflect the agreement reached by the parties. The twenty-one-page contract 25 is filled with timelines, assumptions, and industry terms. 26 27

28 1 First, according to the contract, STA was responsible for “sourc[ing] and 2 purchas[ing] the required quantity” of the active pharmaceutical ingredient with the 3 necessary safety and quality certifications. (ECF No. 28-4 at 7.) In the contract, the parties 4 estimated sourcing the active pharmaceutical ingredient would take two months, and Sahel 5 agreed to pay for the substance at “actual cost.” (Id. at 4.) The contract makes clear, 6 however, that if a material like the active pharmaceutical ingredient “is not commercially 7 available,” then Sahel could either supply the material at its expense or amend the 8 agreement “to permit the use of a commercially available substitute.” (Id. at 15.) 9 Second, STA agreed to manufacture Sahel’s drug in two phases. Initially, STA was 10 to produce a toxicology and engineering batch of the drug, which would be “non-GMP”2 11 and used for “microbiological test methods verification and defective rate information.” 12 (Id. at 5.) There was no suggestion in the contract that this first batch would be used in 13 humans. STA further agreed to later produce a “GMP”3 drug batch after using a “Class C 14 clean room for solution preparation” and taking other precautions. (Id. at 6, 10.) In contrast 15 to the first batch, this second batch was to be used for “clinical supplies.” (Id. at 6.) 16 Third, the contract required STA to provide periodic progress updates to Sahel via 17 team meetings. (Id. at 7.) The frequency of the updates was to be determined at the project 18 kickoff meeting, and STA was to provide a written update to Sahel prior to each project 19 update meeting. (Id. at 14.) 20 The contract includes a confidentiality clause that states the parties will “maintain 21 the Confidential Information in confidence.” (Id. at 18.) This section of the contract has 22 23 2 “Non-GMP” production here means GLP production. (FAC ¶ 16.) 24 3 The Court briefly touches upon the contract’s use of “GMP” and “GLP” when describing the 25 manufacturing services. The contract incorporates the Food, Drug, and Cosmetic Act’s good manufacturing practices (“GMP”) for producing drugs. (See ECF No. 28-4 at 7 (defining GMP to include 26 “current good manufacturing practices and regulations . . .

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Sahel Oncology, LLC v. STA Pharmaceutical Hong King Limited, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sahel-oncology-llc-v-sta-pharmaceutical-hong-king-limited-casd-2024.