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`21 cv. 867
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`COMPLAINT
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`Plaintiff requests a trial by jury.
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`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF NEW YORK
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`APOTHECUS PHARMACEUTICAL CORP.,
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`::
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`::
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`::
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`::
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`Plaintiff,
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`- against -
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`PHARMASOL CORPORATION,
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` :
`Defendant.
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`Plaintiff Apothecus Pharmaceutical Corp., by its attorney, Stanley K. Shapiro, Esq.,
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`complaining of defendant, alleges as follows:
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`The Parties
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`1. Plaintiff Apothecus Pharmaceutical Corp. (“Apothecus”) is a New York
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`corporation, with principal executive office at 220 Townsend Square, Oyster Bay, County
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`of Nassau, State of New York, engaged in the business of developing, manufacturing,
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`marketing and commercially distributing certain over-the-counter health care products
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`under its brand name “VCF”.
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`2. On information and belief, defendant Pharmasol Corporation (“Pharmasol”), is
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`a Delaware corporation, with principal executive office in the Commonwealth of
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`Massachusetts, at One Norfolk Avenue, South Easton, Massachusetts. On information
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`and belief, Phamasol regularly does and solicits business, and derives substantial revenue
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`from goods used or consumed in New York.
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`3. At all relevant times, defendant Pharmasol held itself out as and was a contract
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`manufacturer for pharmaceutical products subject to FDA regulation. In particular,
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`Pharmasol was engaged by plaintiff as a contract manufacturer of one of plaintiff’s
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`products, contracting to supply goods and services for Apothecus in New York.
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`Jurisdiction and Venue
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`4. Federal jurisdiction is predicated on diversity of citizenship, 28 U.S.C. § 1332.
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`This action is of a civil nature involving, exclusive of interest and costs, a sum in excess
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`of $75,000. The matter in controversy herein is wholly between citizens of different States.
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`5. Venue is appropriate in this district pursuant to 28 U.S.C. §1391(a)(2) or (3), in
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`that defendant resides out of New York, and is subject to long arm jurisdiction in New York
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`for this action pursuant to NY CPLR 302.
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`As and for a First Cause of Action
`(Breach of Contract)
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`6. For more than twenty-five years and continuously through and until November
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`2019, plaintiff held proprietary rights and trade marks to and developed, manufactured and
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`commercially distributed under its proprietary VCF brand name several vaginal
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`contraceptive health care products, sold over-the-counter in pharmacies throughout the
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`United States and Canada, including since about 1996, a VCF brand vaginal contraceptive
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`foam in an aerosol spray container (the “Product”) under plaintiff’s brand name.
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`7. Pharmasol held itself out as a contract manufacturer, qualified with expertise to
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`manufacture aerosol pharmaceutical products subject to FDA regulation. Pharmasol’s
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`website represents itself as having “significant expertise and a thorough understanding of
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`aerosols”; and proclaims that its “state of the art cGMP facilities” are “designed and
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`constructed to provide optimum efficiency, safety and regulatory compliance” for the
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`manufacture and packaging of aerosols, liquids and semi-solids.
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`2
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`8. Sometime prior to 2017, plaintiff arranged with Pharmasol to serve as a contract
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`manufacturer of Apothecus’ product vaginal contraceptive foam packaged in a 0.6 oz.
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`aerosol spray container under Plaintiff’s VCF label and trade name (the “Product”).
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`9. In January 2017, plaintiff and defendant entered a written contract , denominated
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`Quality Agreement Commercial Product (the “Quality Agreement”), for the manufacture and
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`testing of the Product, including quality inspection and quality assurance, between
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`defendant Pharmasol as “Supplier” and plaintiff Apothecus as “Client”. (A copy of the
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`Quality Agreement is annexed hereto as Exhibit 1, and incorporated herein.)
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`10. The Quality Agreement set forth quality management obligations upon
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`Phamasol, for its manufacture of the Product as contract manufacturer for Apothecus.
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`which Pharmasol breached, causing Apothecus to incur substantial damages.
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`11. Under the terms of the Quality Agreement Pharmasol was obliged to conduct
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`operations in compliance with current Good Manufacturing Practices (“cGMP”) regulations
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`and other applicable FDA regulations (Quality Agreement Section 4.1.1).
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`12. The Quality Agreement specified that “PHARMASOL will ensure that Product(s)
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`are manufactured and tested in strict compliance with current US Federal Good
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`Manufacturing Practices (GMP) (US 21 CFR parts 210 and 211 for the manufacture of
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`finished medicinal product) as applicable” (Quality Agreement Section 4.2.3).
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`13. On information and belief, the Pharmasol’s manufacturing facility (”Pharmasol
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`Plant”) where it manufactured and tested the Product under the contract with plaintiff, was
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`inspected by the FDA in July and August 2018.
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`14. Under the terms of the Quality Agreement, Pharmasol was obliged to notify
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`Apothecus within three business days of receipt of any notice of inspection by the FDA;
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`3
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`and Pharmasol was obligated to notify Apothecus within one day of any regulatory
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`authority request of product samples, batch documentation, or other information related
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`to the Product. Under the Quality Agreement, Pharmasol was obligated to notify on daily
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`basis of any regulatory findings or violations, and must obtain duplicate copies of records
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`for Apothecus.
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`15. Pharmasol failed to notify Apothecus of the July and August 2018 inspections
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`of the Pharmasol Plant, and failed to notify Apothecus of requests made by the FDA with
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`respect to the Product. Pharmasol also failed to notify Apothecus of the regulatory findings
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`issued by the FDA with respect to the inspections.
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`16. Under the Quality Agreement, Pharmasol was obliged to provide Apothecus, for
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`review and comment, a copy of any Pharmasol response to any regulatory authority
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`involving the Product, no less than five business days prior to submission of the response
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`to the regularity authority.
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`17. Pharmasol failed to provide Apothecus with copies of any of its responses to the
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`FDA.
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`18. In or about March 2019, the FDA, Division of Pharmaceutical Quality
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`Operations, issued a Warning Letter to Pharmasol finding that Pharmasol failed to comply
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`with cGMP with respect to the manufacture and testing of the Product. The Warning Letter
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`to Pharmasol in March 2019 summarized the FDA’s findings of violations.
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`19. The FDA inspection of Pharmasol uncovered significant violations by Pharmasol
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`of current Good Manufacturing Practice regulations for finished pharmaceuticals effecting
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`the Product.
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`4
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`20. The FDA reported in its Warning Letter to Pharmasol, that because Pharmasol’s
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`methods, facilities, or controls for manufacturing, processing, packing, or holding do not
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`conform to cGMP, Pharmasol’s drug products are adulterated within the meaning of
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`section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C.
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`351(a)(2)(B).
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`21. The FDA Warning Letter detailed specific violations observed by the FDA
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`investigators relating to Pharmasol performance of manufacturing and testing of the
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`Product delivered under contract for Apothecus.
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`22. The Quality Agreement required Pharmasol to notify Apothecus within one
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`business day of receipt of any warning letters from any regulatory agency that relates to
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`the Product (Section 4.2.4).
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`23. Yet, Pharmasol failed to notify Apothecus of the FDA Warning Letter after
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`Pharmasol’s receipt of that letter in March 2019.
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`24. Pharmasol concealed the FDA regulatory inspections and letters from
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`Apothecus.
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`25. The FDA found that Pharmasol violated federal regulations (21 CFR 211.192)
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`by failing to thoroughly investigate unexplained discrepancy or failure of the batch or any
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`of its components to meet specifications, in respect to two batches of the Product, Lots
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`31560 and 31561.
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`26. In July 2017, Pharmasol found that the Product, Vaginal Conception Foam 0.6
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`oz., Lots 31560 and 31561 were found Out-of-Specification (“OOS”) as samples were
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`found leaking (Lab OOS #17-042, 7/12/17). (Out-of-Specification results for elevated leak
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`rate for the two lots of the Product are documented (reference Laboratory OOS# 17-042).)
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`5
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`27. According to the FDA Warning Letter in 2019, deficiencies in Pharmasol’s
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`stability program found by the FDA in the 2018 inspection of Pharmasol were repeat
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`findings from FDA inspections in 2013, 2014 and 2015 that had resulted in Phamasol being
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`cited. (Pharmasol had concealed from plaintiff the prior 2013, 2014 and 2015 FDA
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`inspection findings.)
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`28. In July 2017, Pharmasol had represented to Apothecus that Lots 31560 and
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`31561 of the Product were on 14-day hold for initiation of weight loss testing. But
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`Phamasol wrongfully cancelled the testing without notifying Apothecus, without written
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`justification and without identifying reason for the Out-Of-Specification results, and
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`released the two Lots to Apothecus for commercial distribution.
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`29. Pharmasol concealed from Apothecus, Pharmasol’s cancelation of its Quality
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`Assurance (“QA”) and Quality Improvement (“QI”) testing, and the Product manufacturing
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`and quality control Out-Of-Specification (“OOS”) failures.
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`30. Before each lot was delivered to Apothecus for release Pharmasol was obliged
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`under the Quality Agreement to provide Apothecus with a “Certificate of Analysis,” to be
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`signed by the Pharmasol Quality Assurance, for each delivered lot of Product. The
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`required “Certificate of Analysis" meant a certificate from Pharmasol certifying that: (a) the
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`Product was manufactured, packaged, tested, labeled, stored and shipped in accordance
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`with cGMPs and the Specifications and relevant standard operating procedures of
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`Pharmasol; (b) the Product meets all in-process specifications, no Investigations remain
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`unresolved, and all reconciliations and accountability have been satisfactorily completed;
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`and c) the product identification, lot number, and final product yield. (See Quality
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`Agreement Section 4.8.3).)
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`6
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`31. The Quality Agreement also called for Pharmasol to deliver to Pharmasol a
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`Certificate of Compliance for the Product lot being released, which shall specify the
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`Product description, the Client item number, the quantity released and the Product
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`expiration date, if applicable. Pharmasol was obliged to certify to Apothecus prior to
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`delivery of a lot of the Product for commercial release that the batch has been
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`manufactured in accordance with cGMPs and the Specifications; the lot was packaged in
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`accordance with cGMPs, the Specifications, and all pertinent Pharmasol SOP's. (See
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`Quality Agreement Section 4.8.3).)
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`32. In August 2017, Pharmasol provided Apothecus with signed Certificates of
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`Compliance and signed Certificates of Analysis for Lots 31560 and 31561, respectively,
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`falsely certifying that Pharmasol had manufactured, packaged, tested, labeled, stored and
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`shipped each subject lot of Product in accordance with Federal cGMP regulations (CFR
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`Title 21, Parts 210 and 211), the contract Specifications and relevant standard operating
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`procedures of Pharmasol; and that the Product meets all in-process specifications, no
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`Investigations remain unresolved, and all reconciliations and accountability have been
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`satisfactorily completed. (Copies of the Certificates of Compliance and Certificates of
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`Analysis are attached hereto as Exhibits 2 and 3.)
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`33. These Certificates of Compliance and Certificates of Analysis for Lots 31560
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`and 31561 signed and delivered by Pharmasol in August 2017 were materially false and
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`inaccurate.
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`34. Apothecus took delivery and commercially distributed the two lots of the Product
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`in reliance upon the false and inaccurate Certificates of Compliance and Certificates of
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`Analysis for Lots 31560 and 31561.
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`7
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`35. On or about April 15, 2019, the FDA began an unannounced inspection of
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`Apothecus, triggered by the violations issued against Pharmasol, that Pharmasol was
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`concealing from Apothecus.
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`36. Only after this did Apothecus became aware that the FDA made regulatory
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`inspections of Pharmasol resulting in a Warning Letter to Pharmasol regarding the Product.
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`Thereafter, following the FDA inspection of Apothecus on April 15, 2019, Pharmasol
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`repeatedly represented to Apothecus it would review, assess and report to Apothecus,
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`representing for example that Phamasol “is working on making sense of all data and is
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`working on writing it up for [Apothecus’] review”, and that Pharmasol’s report to Apothecus
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`was forthcoming. This representation was made repeatedly through the date of the
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`Product recall in November 2019, without compliance by Pharmasol (continuing to the
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`present).
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`37. Apothecus notified Pharmasol of the urgency of the information and report,
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`including leading up to and on November 5, 2019, informing Pharmasol that it was meeting
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`with FDA to discus recall of the two Lots, and that Pharmasol was waiting in urgent need
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`of the delayed data, information and report from Pharmasol owed and promised by
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`Pharmasol. Apothecus advised that there was urgent need of a conclusion and/or
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`additional information to conclude with the FDA.
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`38. Pharmasol remained in default of supplying to Apothecus required information
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`and report.
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`39. The finished Product delivered by Pharmasol failed to meet final Product
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`Specifications as established and agreed upon between it and Apothecus. Deviations from
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`Product Specifications were wrongfully concealed by Pharmasol.
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`8
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`40. In November 2019, Apothecus was compelled to recall the two Lots of the
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`Product that were deemed by the FDA to be Out-of-Specification and deficiently
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`manufactured and tested by Pharmasol in violation of applicable cGMP.
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`41. On or about November 8, 2019, the FDA issued a Warning Letter to Apothecus.
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`The Warning Letter and the violations raised therein were proximately caused by and
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`derived from Pharmasol’s default of obligations it owed to Apothecus under the Quality
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`Agreement.
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`42. The FDA held Apothecus accountable for its contract manufacturer Pharmasol’s
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`violations of current Good Manufacturing Practice (cGMP) with respect to the Product, that
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`the FDA had found on the inspections of Pharmasol, that Phamasol had concealed from
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`Apothecus.
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`43. The FDA Warning Letter to Apothecus referred to violations attributable to
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`Pharmasol of cGMP regulations for combination products with respect to the Product.
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`44. Pharmasol breached the Quality Agreement to operate and perform the
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`manufacturing services within the specifications, failed to notify Apothecus of the FDA
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`inspections, and to give advance copies to Apothecus of Pharmasol’s responses to the
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`FDA, failed to provide Apothecus with notice and a copy of the FDA’s Warning letter to
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`Pharmasol, fraudulently concealing from Apothecus QA and QI departures and the
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`regulatory inspections.
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`45. Phamasol did not comply cGMP and regulatory requirements with respect to the
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`Product released as Lots 31560, 31561. Among other respects, Pharmasol did not comply
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`9
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`Case 1:21-cv-00867-NGG-CLP Document 1 Filed 02/17/21 Page 10 of 15 PageID #: 10
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`with cGMP regulatory requirements with regard to: quality control (CFR 211.22), deviation
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`from written procedures (CFR 211.100), testing and release for distribution (CFR 211.165),
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`and laboratory records (CFR 211.194).
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`46. Pharmasol failed to adhere to the Test Procedure for Leakage Test for the VCF
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`finished Product and stability samples.
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`47. Pharmasol concealed from Apothecus the FDA inspection and regulatory
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`communications between Pharmasol and the FDA and failed to report to Apothecus the
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`FDA’s Form 483 and associated Warning Letter with regards to Phamasol’s Quality
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`Units infractions in regard to the Product.
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`48. Necessary controls and techniques with regard to product quality were not
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`in place or followed by Pharmasol’s quality unit personnel.
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`49. Phamasol breached the Specified Test Procedures for Leakage Testing for
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`the Vaginal Contraceptive Foam Finished Product and Stability Samples, as well as
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`Investigations and release review. (STP-025 Test Procedure).
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`50. Pharmasol’s Quality Unit personnel were not adequately trained in cGMP
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`and/or company procedures.
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`51. Pharmasol’s internal company procedures with regards to Investigations,
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`Deviations were never concluded or finalized.
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`52. Pharmasol wrongfully, wilfully and fraudulently concealed its breach of the
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`Quality Agreement from Apothecus.
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`53. As soon as Apothecus first learned about Pharmasol’s breach and default
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`of the Quality Agreement, once Apothecus was contacted by the FDA beginning on
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`April 15, 2019, Apothecus notified Pharmasol. Apothecus continued to put Pharmasol
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`10
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`Case 1:21-cv-00867-NGG-CLP Document 1 Filed 02/17/21 Page 11 of 15 PageID #: 11
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`on notice of the FDA investigation and demands arising from Pharmasol’s violations
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`leading up the recall of the Product in November 2019 due to Pharmasol’s breach of
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`the Quality Agreement.
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`54. Apothecus notified Pharmasol of the decision to recall the Product in
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`November 2019, within a reasonable time after Apothecus learned that the recall was
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`necessary due to Pharmasol’s breach of the Quality Agreement, upon meeting with the
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`FDA in early November 2019.
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`55. By reason of the foregoing, defendant has materially breached its contract
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`with plaintiff, and plaintiff has been damaged thereby.
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`56. By reason of the foregoing, plaintiff has and will incur substantial extra costs
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`and expenses relating to the regulatory proceedings and the Product recall, has
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`suffered significant loss of past and future sales and revenues, and profits, incurred
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`damaged and destroyed inventory, has suffered substantial harm and damage to its
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`trade name, reputation and good will, is entitled to refund of payments made to
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`defendant, due to the Warning Letter was caused to be encumbered from obtaining
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`Certification of Pharmaceutical Product from the FDA, instrumental for achieving
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`regulatory approval in foreign countries for its products, has caused a halt to progress
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`on registrations in Hong Kong and the European Union, and has been otherwise
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`damaged.
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`57. As a result and consequence of the foregoing, the Product has lost its
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`commercial distribution sales and market positions in leading retailers such as
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`Walmart, the Product was discontinued and plaintiff has lost sales and revenue of the
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`11
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`Case 1:21-cv-00867-NGG-CLP Document 1 Filed 02/17/21 Page 12 of 15 PageID #: 12
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`Product going forward of approximately Five Hundred Thousand ($500,000) Dollars per
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`year.
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`58. By reason of defendant’s aforesaid breach of the Quality Agreement, plaintiff
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`has sustained direct, incidental and consequential damages, altogether in the sum of
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`Ten Million ($10,000,000) Dollars, plus interest.
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`As and for a Second Cause of Action
`(Fraud in the Inducement, Fraud and Deceit)
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`59. The allegations contained in paragraphs 1 through 58 are realleged as if
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`repeated in full.
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`60. On information and belief, Pharmasol wilfully, wrongfully and fraudulently
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`omitted
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`to disclose, misrepresented and concealed
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`from Apothecus FDA
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`communications and findings in regard to inspections in 2013, 2014 and 2015, and
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`deficiencies found then by the FDA in Pharmasol’s stability program.
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`61. On information and belief, Pharmasol knowingly omitted to disclose to
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`Apothecus, wrongfully and fraudulently withheld, concealed and covered-up from
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`Apothecus the prior (2013, 2014 and 2015) FDA findings and citations, to induce
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`Apothecus to enter the Quality Agreement in January 2017 and continue Phamasol as
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`a contract manufacturer in reliance on Pharmasol’s misrepresentations and omissions.
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`62. Pharmasol made material misrepresentations and omissions of material facts,
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`which it knew to be false, with the intent that plaintiff rely thereon when the Quality
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`Agreement was entered into with plaintiff in January 2017.
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`63. In August 2017, Pharmasol willfully, wrongfully and fraudulently provided to
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`Apothecus Certificates of Compliance and Certificates of Analysis for Lots 31560 and
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`12
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`31561, that Phamasol knew or should have known contained false, inaccurate and
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`misleading representations and omissions of material fact, Pharmasol did so with the
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`purpose and intent of inducing Apothecus to accept delivery and release for commercial
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`distribution the said Lots of the Product under Apothecus’ trade name, in reliance upon
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`the material misrepresentations contained in the Certificates of Compliance and
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`Certificates of Analysis certified by Pharmasol.
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`64. In and after July 2017, Pharmasol made false, inaccurate and misleading
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`representations and omissions of material fact to Apothecus that Pharmasol was
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`conducting testing to assure compliance, when Pharmasol knew or should have known
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`that it had cancelled the tests without Apothecus’ knowledge or consent.
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`65. In and after July 2017, Pharmasol represented to Apothecus that Pharmasol
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`was conducting testing to assure compliance, but secretly cancelled the tests, while
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`knowing that Apothecus was commercially distributing the Product in reliance on
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`Pharmasol’s representations. Phamasol omitted to disclose and knowingly and wilfully
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`concealed such facts from Apothecus with the knowledge and intent that Apothecus
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`accepted delivery and continue commercial distribution of the Lots of the Product in
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`reliance on Pharmasol’s representations.
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`66. Pharmasol wilfully, wrongfully and fraudulently omitted to disclose and
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`concealed
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`from Apothecus
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`the FDA
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`regulatory
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`inspections, actions and
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`communications, including the March 2019 FDA Warning Letter to Phamasol, and its
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`violations of cGMP, regulations and contract specifications, with the intent to deceive
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`and defraud Apothecus.
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`13
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`67. Pharmasol wrongfully and fraudulently concealed the FDA regulatory
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`inspections and letters; and Pharmasol’s cancellation of its QA and QI testing, and the
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`Product manufacturing and quality control OOS failures.
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`68. At all times relevant hereto, Pharmasol knew that the aforesaid
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`representations, acts and omissions were materially false, deceptive, inaccurate and/or
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`misleading, and that plaintiff would rely thereon; and Pharmasol acted with the intent to
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`deceive, defraud and conceal the true state of facts from Apothecus.
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`69. Apothecus reasonably relied to its ultimate damage and detriment on the
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`representations, acts and omissions of Pharmasol.
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`70. Further, in the circumstances alleged herein, defendant engaged in
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`egregious or fraudulent conduct evincing such wanton and/or malicious dishonesty as
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`to imply a criminal indifference to civil obligations, sufficient to warrant the imposition of
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`punitive damages under New York law. Plaintiff has been damaged and is entitled to
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`direct, incidental and consequential and punitive damages by reason of defendant’s
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`unlawful and fraudulent acts and omissions.
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`71. As a proximate result of the false, deceptive, inaccurate and/or misleading
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`and fraudulent acts, omissions, misrepresentations and conduct of Phamasol, plaintiff
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`has been caused to suffer direct, incidental and consequential damages, altogether in
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`the sum of Ten Million ($10,000,000) Dollars; and are entitled also to exemplary or
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`punitive damages in the further amount of $10,000,000.
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`WHEREFORE, plaintiff demands judgment against defendants, jointly and
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`severally, in the sum of TEN MILLION DOLLARS ($10,000,000), or such other amount
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`as the jury shall deem to be reasonable, equitable, just and proper, together with
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`Case 1:21-cv-00867-NGG-CLP Document 1 Filed 02/17/21 Page 15 of 15 PageID #: 15
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`punitive and exemplary damages on the second cause of action in the added amount
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`of TEN MILLION DOLLARS ($10,000,000), or in such added amount as the jury or trier
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`of fact shall deem to be reasonable, equitable, just and proper, and to the full extent
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`allowed by law; together with interest thereon, at the New York statutory rate, from the
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`date of January 19, 2017, and costs and disbursements, and reasonable attorneys’ fees
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`of this action to the full extent allowed by law; and grant such other relief as is just and
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`proper.
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`Plaintiff requests a trial by jury.
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`Dated:
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`New York, New York
`February 17, 2021
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`/s/ Stanley K. Shapiro
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`STANLEY K. SHAPIRO, Esq.
`Attorney for Plaintiff
`225 Broadway, Suite 1803
`New York, New York 10007
`(212) 693-1076
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`15
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