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`
`
`UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF NORTH CAROLINA
`CHARLOTTE DIVISION
`
`RUBICON RESEARCH PRIVATE LIMITED,
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`Civil Action No. _______________
`
`Plaintiff,
`
`Document Electronically Filed
`
`v.
`
`KARTHA PHARMACEUTICALS INC., and
`MANOJ BABU MAZHUVANCHERIL,
`
`Defendants.
`
`VERIFIED COMPLAINT FOR DAMAGES, INJUNCTIVE, AND OTHER RELIEF
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`Rubicon Research Private Limited (“Rubicon”), by and through their counsel, allege for
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`their Complaint against Defendants Kartha Pharmaceuticals, Inc. (“Kartha”) and Manoj Babu
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`Mazhuvancheril (“Mazhuvancheril”) (collectively “Defendants”), as follows:
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`NATURE OF THE CASE
`
`1.
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`This is a blatant case of trade secrets theft by Defendant Kartha and its principal,
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`Defendant Manoj Babu Mazhuvancheril. In 2013, Defendants started providing agency and
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`consulting services to third-party Zakłady Farmaceutyczne Polpharma SA (“Polpharma”), which
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`manufactures pharmaceutical ingredients that it supplies to its customers, including Rubicon.
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`Defendants were Polpharma’s authorized U.S. representative with the Food and Drug
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`Administration (“FDA”), and, in this capacity, had access to extensive amounts of confidential
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`and trade secret information belonging to Rubicon.
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`2.
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`More specifically, Defendants had access to the technical specifications for the
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`active pharmaceutical ingredient (“API”) Rubicon uses to manufacture its baclofen products that
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`are unique to Rubicon and that were the result of years of Rubicon’s research and development
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`efforts, including the technical specifications for Rubicon’s 5 mg strength of baclofen.
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`3.
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`The information concerning Rubicon’s 5 mg dose is particularly valuable because
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`Rubicon was the first applicant—generic or branded—to receive FDA approval to sell baclofen in
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`a 5 mg strength. Indeed, until April 2020, Rubicon was the only company approved to sell baclofen
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`5 mg, and Rubicon has become the market leader in the sales and distribution of this product.
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`4.
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`In October 2019, Defendants through Polpharma were personally introduced to
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`Rubicon. During this introductory meeting, Polpharma, Defendants, and Rubicon discussed
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`confidential raw material supply, volume, and pricing for various products, including baclofen.
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`The parties also discussed market insights, as is common between supplier and customer, but
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`would never have been discussed if Rubicon knew Defendants could become a competitor.
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`5.
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`Defendants, not disclosing that it had planned to seek approval from the FDA to
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`sell baclofen, showed specific interest in Rubicon’s baclofen program and asked many questions
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`about it, including the genesis of Rubicon’s unique idea for introducing a 5 mg strength, the
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`regulatory pathway for this approval, and Rubicon’s expected marketing strategy and consequent
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`volume share on the 5 mg strength. As a result of this discussion and subsequent communications
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`thereafter, Defendants also had information about the projected market outlook for this product
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`long before any such data would be publicly available.
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`6.
`
`Unbeknownst to Rubicon and Polpharma, at this same time, Defendants were
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`surreptitiously preparing to seek approval from the FDA to sell baclofen in 5 mg, 10 mg, and 20
`
`mg dosages in direct competition with Rubicon. With intimate knowledge of Rubicon’s trade
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`secrets regarding the development, validation, regulatory approval, market introduction and
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`commercial potential of baclofen products, Defendants prepared and filed an application to
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`manufacture baclofen products that was quickly approved by the FDA in March 2021, despite the
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`fact that this was Defendants’ first approval from the FDA to sell any drug product.
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`7.
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`As a result of the FDA’s approval of Defendants ’ baclofen application and
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`Rubicon’s investigation, Rubicon is informed and believes that Kartha will commercialize its
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`competing baclofen drug products using Rubicon’s confidential and proprietary trade secrets,
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`actions that will irreparably harm Rubicon if not enjoined.
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`8.
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`In light of these actions, Rubicon has no choice but to bring this action to prevent
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`Kartha from unfairly competing and improperly usurping Rubicon’s significant investment in
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`baclofen products.
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`THE PARTIES
`
`9.
`
`Plaintiff Rubicon is a private limited company incorporated under the Companies
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`Act, 1956 of the Republic of India bearing Corporate Identification Number (CIN)
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`U73100MH1999PTC119744 and with its registered office at MedOne House, B75, Road No 33,
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`Wagle Estate, Thane (West), Maharashtra 400604, India.
`
`10.
`
`Third-Party Zakłady Farmaceutyczne Polpharma SA (“Polpharma”)
`
`is a
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`corporation organized under the laws of Poland with its principal place of business in Starogard
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`Gdanski, Poland.
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`11.
`
`Rubicon is informed and believes that defendant Kartha Pharmaceuticals Inc. is
`
`incorporated in North Carolina and has its principal place of business at 12208 Summer Breeze
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`Court, Charlotte, North Carolina.
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`12.
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`13.
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`Kartha Pharmaceuticals Inc. is the successor entity to Kartha Pharmaceutics, LLC.
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`Rubicon is informed and believes that defendant Manoj Babu Mazhuvancheril is a
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`resident of Charlotte, North Carolina. Mazhubancheril is Kartha’s President and Chief Executive
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`Officer of Kartha.
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`14.
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`Rubicon is informed and believes that the Defendants were the agents, servants,
`
`and employees of each other, and were acting within the course and scope of their authority as
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`such agents, servants, and employees and with the permission and consent of each of them at all
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`relevant times alleged herein. In particular, Rubicon is informed and believes that Defendant
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`Mazhuvancheril has acted and is presently acting as the agent and/or employee of Kartha and
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`working on its behalf.
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`JURISDICTION AND VENUE
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`15.
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`This action arises under the Defend Trade Secrets Act of 2016, 18 U.S.C. §§ 1836,
`
`et seq. This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1331, and has
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`supplemental jurisdiction over the state law claims alleged in this Complaint pursuant to 28 U.S.C.
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`§ 1367.
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`16.
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`This Court has personal jurisdiction over Defendants because each of them is
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`domiciled in or has its principal place of business in Charlotte, North Carolina.
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`17.
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`As is further set forth herein, a substantial part of the events or omissions giving
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`rise to the claims alleged in this Complaint occurred and have a direct effect in this District. Venue
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`therefore lies in the United States District Court for the Western District of North Carolina pursuant
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`to 28 U.S.C. § 1391(b)(2).
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`GENERAL ALLEGATIONS
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`A.
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`Rubicon Obtains ANDA Approval for Baclofen.
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`18.
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`Rubicon is a pharmaceutical company focused on developing high quality products
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`using innovative technologies for the global market, including the United States. Rubicon develops
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`and manufactures over two dozen different finished drug products. One of its most profitable and
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`important products is baclofen, which is used to treat spasticity and concomitant pain, clonus, and
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`muscular rigidity in people with multiple sclerosis or with spinal cord injuries.
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`19.
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`To market a generic version of any previously-approved drug product in the United
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`States, a generic pharmaceutical company must file an abbreviated new drug application
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`(“ANDA”) with the United States Food and Drug Administration (“FDA”) that shows the
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`product’s chemical and biological equivalence to a previously-approved drug product (known as
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`the “reference listed drug” or “RLD”). Id. (citing 21 U.S.C. § 355(j)(2)(A)). This well-established
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`regulatory pathway establishes the safety and efficacy of generic drugs.
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`20.
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`To gain approval, the FDA must be satisfied that the finished drug product
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`manufactured by the generic pharmaceutical company contains the same active ingredient,
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`employs the same route of administration (e.g., oral or injected), is in the same dosage form and
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`the same strength, and “ha[s] the same therapeutic effect” as the branded equivalent on which the
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`ANDA is based. 21 U.S.C. § 355(j)(2)(A)(i)-(iv).
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`21.
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`To make these showings, generic pharmaceutical companies must submit scores of
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`information and data about the drug and describe in detail how it will be manufactured. ANDA
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`applications typically include sections on chemistry, manufacturing and controls (“CMC”),
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`clinical/bioequivalence studies, quality aspects of the drug substance and the drug product, non-
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`clinical study reports, and references to scientific publications. The ANDA application also must
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`include the ingredients used to manufacture the drug and, specifically, very detailed information
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`about the API, such as its particle size distribution and the location from where it is sourced. The
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`ANDA application also includes information on how the drug maintains its stability (or efficacy)
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`over time when stored in certain conditions. To obtain this data, the ANDA applicant must submit
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`the results of stability testing that it conducted on the finished drug product that it has actually
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`manufactured. This requirement means that the generic pharmaceutical company must
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`manufacture batches of the finished drug product, and then conduct testing on the drug product as
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`it is stored over time.
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`22.
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`Given all the information required to submit an ANDA, they are often hundreds of
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`pages or longer and it often takes more than a year—and sometimes several years—for a generic
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`pharmaceutical company to prepare an ANDA. Then, given the extensive information that must
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`be reviewed by the FDA, it is common for an ANDA approval to take twelve months before FDA
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`approval is granted, provided the FDA does not request additional information.
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`23.
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`In March 2014, in preparing its ANDA application for baclofen, Rubicon signed a
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`Mutual Confidential Disclosure Agreement (“CDA”) with Polpharma to enable the parties to
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`evaluate potential opportunities to collaborate on baclofen. Rubicon needed a supplier for baclofen
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`API to incorporate into its ANDA application and Polpharma was the leading supplier of baclofen
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`API in the world, supplying close to 80% of all baclofen API to various generic pharmaceutical
`
`companies.
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`24.
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`The CDA provided that the parties would treat all confidential information as
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`strictly confidential; would not disclose confidential information to any third party; and would not
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`use confidential information for any purpose other than evaluating the potential opportunities for
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`Rubicon and Polpharma to collaborate on baclofen. The parties further agreed only to disclose
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`confidential information to authorized recipients who needed to know the confidential information
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`for purposes of evaluating or advising on potential opportunities to collaborate on baclofen. These
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`obligations were in force for five years.
`
`25.
`
`Rubicon and Polpharma decided to collaborate on baclofen. Polpharma agreed to
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`supply baclofen API to Rubicon and Rubicon therefore indicated on its ANDA application that
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`Polpharma would be its supplier and referenced the Drug Master File (“DMF”) that Polpharma
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`keeps on file with the FDA, which details how Polpharma manufactures the API, as required by
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`the FDA. To enable Rubicon’s use of the DMF, Popharma issued a letter of access, which was
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`known to Defendants, by virtue of their engagement as the U.S. regulatory agent for Polpharma.
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`26.
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`In May 2016, after investing substantial amounts of time and money to satisfy the
`
`FDA’s requirements, Rubicon submitted an ANDA application to manufacture and sell baclofen
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`in the 5 mg, 10 mg, and 20 mg doses.
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`27.
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`Rubicon’s application was the first to seek approval to manufacture and sell
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`baclofen in the 5 mg strength. This creative idea gave Rubicon a competitive edge but also made
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`the ANDA application more complicated, because it was seeking approval for a dosage that had
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`not been approved before.
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`28.
`
`Rubicon’s creativity and substantial investment was rewarded in November 2017,
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`when the FDA approved Rubicon’s ANDA for baclofen in the 5 mg, 10 mg, and 20 mg doses,
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`issuing ANDA No. 2019102.
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`29.
`
`Rubicon was then approved to supply baclofen to customers in the United States
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`and became the first and only manufacturer and supplier of baclofen 5 mg in the United States.
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`30.
`
`Rubicon has devoted significant time and resources researching, developing, and
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`validating its baclofen products. This process involved years of effort and collaboration across
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`different departments, including laboratory research, formulation development, and analytical
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`development.
`
`B.
`
`Rubicon’s Trade Secrets and Its Extensive Measures to Protect Them.
`
`31.
`
`Rubicon’s development of baclofen, including the work performed as part of
`
`ANDA No. 209102, as well as Rubicon’s ongoing efforts to manufacture and sell its baclofen
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`products has produced a substantial amount of highly sensitive and proprietary trade secret
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`information, the confidentiality of which is critical to the significant value that these products
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`represent to Rubicon. Included among these trade secrets is technical specifications of its baclofen
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`API, including but not limited to the particle size, bulk density, and tapped density, as well as
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`confidential information relating to the manufacture, distribution, marketing, and sale of its
`
`baclofen products, industry competitive intelligence, strategic plans, results of operations, and
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`short and long-term business strategies and initiatives (collectively, the “Trade Secrets”).
`
`32.
`
`To protect the confidentiality of the Trade Secrets, Rubicon has implemented
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`numerous security measures. For example, Rubicon’s physical facilities are enclosed by brick wall
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`fences and monitored 24 hours a day by surveillance cameras and manned patrols. Entry to and
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`exit from Rubicon facilities is controlled, and access is allowed only to authorized individuals.
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`Within Rubicon’s facilities, tangible copies of Trade Secret information are maintained in secured
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`and locked locations, access to which is limited to those with a need to know and who use the
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`Trade Secrets in the development and manufacturing process.
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`33.
`
`Rubicon maintains certain Trade Secrets in the form of electronic records that are
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`accessible via the Rubicon secure computer network. Access to that network is limited to Rubicon
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`employees, and access to electronically stored Trade Secret information on that network is
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`password protected and monitored by Rubicon security personnel. All relevant Rubicon employees
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`are required to read, acknowledge, and execute a confidentiality agreement as a condition of, and
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`in consideration for, their employment, by which they agree not to disclose any confidential or
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`proprietary information to anyone outside of the company, and not to use any of that information
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`in connection with work performed for any future employer.
`
`34.
`
`Rubicon has also implemented corporate policies and trainings to protect its Trade
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`Secrets and other confidential information, including information technology security guidelines
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`that, inter alia, strictly limit the downloading, copying, or distribution of the company’s
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`confidential information by its employees, except as specifically authorized and required for the
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`performance of the employee’s duties.
`
`35.
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`Rubicon also requires third parties, such as partners, vendors, and suppliers to sign
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`non-disclosure agreements.
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`C.
`
`Rubicon’s Relationship with Polpharma and Kartha
`
`36.
`
`After Rubicon received its ANDA for baclofen in November 2017, its relationship
`
`with Polpharma expanded, as Polpharma agreed to supply all of Rubicon’s baclofen API and
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`Rubicon continued to increase its sales of baclofen.
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`37.
`
`In August 2019, Polpharma and Rubicon executed a Supply Agreement that
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`renewed Polpharma’s agreement to supply Rubicon with all of its baclofen API. Indeed, Rubicon
`
`was required to order certain minimum quantities of baclofen API.
`
`38.
`
`Similar to the CDA the parties executed in March 2014, The Supply Agreement
`
`contained a robust confidentiality provision that stated “[n]either Party shall disclose to any third
`
`party Confidential Information, without prior consent of the disclosing Party . . . as well as each
`
`Party shall use it only for proper performance of the Agreement.” The Supply Agreement further
`
`provided that “[t]he receiving Party agrees not to disclose such Confidential Information to anyone
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`except its own directors, officers, employees, attorneys, advisors, Affiliates and subcontractors
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`(Personnel) who: (i) know such information as well as (ii) are bound by confidentiality, non-use,
`
`and nondisclosure obligations at least as restrictive as those set forth in this Agreement.” All
`
`obligations related to confidentiality, non-use and nondisclosure under the Supply Agreement
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`“shall survive for a period of five (5) years from the date of expiry or termination of the [Supply]
`
`Agreement.”
`
`39.
`
`During this time, Kartha was providing services to Polpharma. The relationship
`
`between Polpharma and Kartha dates back to September 2, 2013 when Polpharma first entered
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`into a Consulting Services Agreement with Kartha for it—through Mazhuvancheril—to provide
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`services at the request of and for the benefit of Polpharma in a professional and competent manner.
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`Kartha then became Polpharma’s U.S. authorized representative with the FDA.
`
`40.
`
`In their capacity as Polpharma’s U.S. representative providing these services to
`
`Polpharma, Defendants had access to Rubicon’s Trade Secrets.
`
`41.
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`In November 2015, Polpharma and Kartha extended their relationship by executing
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`an Amendment on Consulting Services Agreement that extended the September 2013 agreement
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`for two years and provided for automatic renewals thereafter.
`
`42.
`
`Upon information and belief, the Consulting Services Agreement and its
`
`amendments contained robust confidentiality provisions.
`
`43.
`
`Although Defendants already had access to Rubicon’s Trade Secrets, in October
`
`2019, Polpharma personally introduced Rubicon to Mazhuvancheril, and thus Kartha, at CPhI, an
`
`annual industry conference for pharmaceutical professionals and companies.
`
`44.
`
`During this introductory meeting, Polpharma, Defendants, and Rubicon discussed
`
`Rubicon’s Trade Secrets, specifically confidential raw material supply, volume, and pricing for
`
`various products, including baclofen as well as market insights.
`
`45.
`
`Defendants showed a particularly keen interest in Rubicon’s baclofen program and
`
`asked many questions about it, including the genesis of Rubicon’s unique idea for introducing a 5
`
`mg strength, the regulatory pathway for this approval, and Rubicon’s expected marketing strategy
`
`and consequent volume share on the 5 mg strength.
`
`46.
`
`Thereafter, from October 2019 onwards, Mazhuvancheril began working directly
`
`with Rubicon and obtained Rubicon’s Trade Secrets from both Polpharma and directly from
`
`Rubicon. Mazhuvancheril specifically had access to Polpharma generated certificates of analysis
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`for the baclofen API supplied to Rubicon for the 5 mg, 10 mg and 20 mg doses. These certificates
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`of analysis contain details of the particle size distribution (“PSD”) and tap density and bulk density
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`(“TD and BD”) of the product. Rubicon specifically shared detailed information about Rubicon’s
`
`formulations for 5 mg, 10 mg and 20 mg doses of baclofen as well as volume forecasts.
`
`47.
`
`During this time, Mazhuvancheril showed significant interest in the technical
`
`aspects of Rubicon’s baclofen formulations, especially PSD and TD and BD and why these were
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`selected.
`
`48.
`
`The PSD is a critically important aspect of Rubicon’s baclofen formulation because
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`physicochemical and biopharmaceutical properties of drug substances and dosage forms can be
`
`highly affected by the particle size, a critical process parameter in pharmaceutical production.
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`Indeed, the PSD of the drug substance may have significant effects on final drug product
`
`performance (e.g., dissolution, bioavailability, content uniformity, stability, etc.). PSD data is
`
`particularly useful in developing a successfully bioequivalent formulation of this product. Rubicon
`
`developed its own PSD data for baclofen, which Defendants knew as a result of their access to
`
`Rubicon’s Trade Secrets.
`
`49.
`
`The TD and BD of a pharmaceutical ingredient refers to the maximum packing
`
`density of a powder that is achieved under the influence of an externally applied force, i.e., when
`
`mechanically compressing the API into a tablet. This is an important data point in the tablet
`
`production process wherein loose powders are compacted into a durable solid form with the
`
`desired mechanical strength, porosity and dissolution characteristics – all of which are critical in
`
`pharmaceutical formulations that must conform to set performance parameters in a consistent
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`manner.
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`50.
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`At no time during his communications with Rubicon did Defendants disclose that
`
`they were preparing their own baclofen ANDA application
`
`51.
`
`Having Rubicon’s PSD and TD/BD specifications as well as Rubicon’s own
`
`forecasts for baclofen, particularly its market outlook for the 5 mg dose which was exclusively
`
`marketed by Rubicon provided a road map to Defendants to develop a competing product, which
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`Defendants misappropriated from Rubicon.
`
`D.
`
`Rubicon’s Discovery of Kartha’s Misappropriation of the Trade Secrets.
`
`52.
`
`In March 2021, Rubicon first learned that, at some point after December 2019,
`
`Kartha submitted an ANDA application (ANDA No. 214374) for baclofen 5 mg, 10 mg, and 20
`
`mg doses that was approved by the FDA on March 5, 2021.
`
`53.
`
`According to publicly available information, Kartha’s baclofen ANDA application
`
`was the first ANDA approval Kartha has ever received for any drug formulation.
`
`54.
`
`Rubicon discovered
`
`that Kartha
`
`formed an
`
`Indian subsidiary, Kartha
`
`Pharmaceuticals Private Limited (“Kartha Ltd.”), in September 2019. Kartha Ltd. is registered in
`
`Bangalore as a subsidiary of a foreign company and it is involved in the manufacture of chemical
`
`products. The directors of Kartha Ltd. are Mazhuvancheril and his wife, Karthika Manoj
`
`Mazhuvancheril.
`
`55. Mazhuvancheril, through his role at Kartha as a contractor for Polpharma, had
`
`access to Rubicon’s Trade Secrets and other confidential information. He was involved in and
`
`exposed to, for example, Rubicon’s baclofen API information, including its unique PSD, as well
`
`as confidential information relating to the highly sensitive pricing and quantities of baclofen API
`
`for the manufacture of Rubicon’s baclofen products and Rubicon’s market plan and forecast
`
`regarding demand and volume forecasts.
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`56.
`
`Upon information and belief, Kartha used Rubicon’s Trade Secrets to prepare its
`
`ANDA application for baclofen.
`
`57.
`
`Rubicon is informed and believes and on that basis alleges that given
`
`Mazhuvancheril’s—and therefore Kartha’s—exposure to voluminous Rubicon confidential and
`
`proprietary information, it would be impossible for Mazhuvancheril to have prepared an ANDA
`
`application for baclofen products that would directly compete with Rubicon baclofen products
`
`without using Rubicon’s Trade Secrets.
`
`58.
`
`Upon information and belief, these allegations demonstrating Defendants’
`
`misconduct are only the tip of the iceberg, and expedited discovery of Kartha’s, Mazhuvancheril’s
`
`and their financial backers’ internal emails, documents, electronic records, and testimony under
`
`oath of Kartha principals, along with various other forms of discovery, will uncover much more,
`
`similar evidence.
`
`59.
`
`Based on the information provided above, Rubicon is informed and believes that
`
`Kartha has used or will use Rubicon’s Trade Secrets and other confidential information to
`
`commercialize baclofen products. In fact, now that Kartha has obtained an ANDA for baclofen
`
`products, Rubicon is informed and believes that Kartha will be in the position to start contacting
`
`customers and distribution channels in the next month or two in direct competition with Rubicon’s
`
`baclofen products, having used Rubicon’s Trade Secrets to do so.
`
`60.
`
`Even more critically, Defendants have knowledge of Rubicon’s interest and efforts
`
`with respect to three additional products presently under development, and based on the forgoing
`
`conduct, Rubicon believes that this information may be at risk as well.
`
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`COUNT I
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`Violation of Federal Defend Trade Secrets Act, 18 U.S.C. § 1836 (Against All Defendants)
`
`61.
`
`Rubicon re-alleges each and every allegation set forth in Paragraphs 1 through 60,
`
`inclusive, and incorporates them herein by reference.
`
`62.
`
`Rubicon is the owner of Trade Secrets and other proprietary or confidential
`
`information relating to baclofen products. These Trade Secrets are described generally above and
`
`comprise financial, business, scientific, technical, economic, and/or engineering information that
`
`are used in or intended for use in interstate commerce and that accordingly constitute “trade
`
`secrets” under 18 U.S.C. § 1839(3).
`
`63.
`
`Rubicon has taken reasonable steps to maintain the secrecy of its Trade Secrets,
`
`including by, among other things, requiring confidentiality and/or nondisclosure agreements to be
`
`signed by those granted access to Rubicon’s Trade Secrets and by taking the other reasonable
`
`measures described above.
`
`64.
`
`These confidential and proprietary Trade Secrets derive independent economic
`
`value from not being generally known to or readily ascertainable through proper means by another
`
`person who can obtain economic value from the disclosure and use of such information, and have
`
`conferred a competitive advantage on Rubicon over others in the relevant market.
`
`65.
`
`Other than through Defendants’ improper disclosure, the Trade Secrets are not
`
`known to others and are not readily ascertainable by proper means to persons who could derive
`
`value from their disclosure or use.
`
`66.
`
`Defendants misappropriated Rubicon’s Trade Secrets by improper means and
`
`without authorization, including by disclosing and using and/or threatening to disclose and use the
`
`Trade Secrets without Rubicon’s express or implied consent in the preparation and filing of an
`
`ANDA application for baclofen 5 mg, 10 mg, and 20 mg, and by using Rubicon’s pricing, market,
`
`14
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`

`

`
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`and volume information to commercialize its baclofen product, as well as the other ways described
`
`above.
`
`67.
`
`The Defendants’ actual and threatened use and disclosure of the Trade Secrets
`
`constitutes misappropriation because, among other reasons, at the time of such use and disclosure,
`
`the Defendants knew or had reason to know that their knowledge of the Trade Secrets was derived
`
`through persons who owed a duty to Rubicon and Polpharma to maintain the secrecy of the Trade
`
`Secrets.
`
`68.
`
`Defendants’ misappropriation comprises acts, including without limitation use of
`
`Rubicon’s Trade Secrets, on or after the date of the enactment of the Defend Trade Secrets Act,
`
`May 11, 2016.
`
`69.
`
`Defendants’ current and continued misappropriation of Rubicon’s Trade Secrets is
`
`reckless and malicious. Defendants know of the confidentiality, ownership, and use restrictions on
`
`the Trade Secrets.
`
`70.
`
`By reason of the above-alleged acts and conduct of Defendants, Rubicon has been
`
`damaged, and it will continue to suffer great and irreparable harm and damage. The amount of this
`
`irreparable harm will be difficult if not impossible to ascertain, and Rubicon will be without an
`
`adequate remedy at law.
`
`71.
`
`Rubicon is also entitled to recover compensatory and exemplary damages from
`
`Defendants, including but not limited to the losses resulting from their wrongful conduct and any
`
`unjust enrichment caused by their misappropriation. The amount of such relief cannot be
`
`determined precisely at this time.
`
`COUNT II
`
`Violation of The North Carolina Trade Secrets Protection Act, N.C.G.S.A. § 66-152, et seq.
`(Against All Defendants)
`
`15
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`
`
`72.
`
`Rubicon re-alleges each and every allegation set forth in Paragraphs 1 through 71
`
`inclusive, and incorporates them herein by reference.
`
`73.
`
`Rubicon is the owner of Trade Secrets and other proprietary or confidential
`
`information relating to baclofen products. These Trade Secrets are described generally above and
`
`are comprised of business or technical information, including but not limited to a formula, pattern,
`
`program, device, compilation of information, method, technique, or process that constitute “trade
`
`secrets” under N.C.G.S.A. § 66-152
`
`74.
`
`Rubicon has taken reasonable steps to maintain the secrecy of its Trade Secrets,
`
`including by, among other things, requiring confidentiality and/or nondisclosure agreements to be
`
`signed by those granted access to Rubicon’s Trade Secrets and by taking the other reasonable
`
`measures described above.
`
`75.
`
`These confidential and proprietary Trade Secrets derive independent economic
`
`value, actual or potential, from not being generally known to, and not being readily ascertainable
`
`through proper means by, others who can obtain economic value from its disclosure or use, and
`
`have conferred a competitive advantage on Rubicon in the relevant market.
`
`76.
`
`Other than through Defendants’ improper disclosure, the Trade Secrets are not
`
`known to the public and are not readily ascertainable by proper means to persons who could derive
`
`value from their disclosure or use.
`
`77.
`
`Defendants misappropriated Rubicon’s Trade Secrets by improper means and
`
`without authorization, including by disclosing and using and/or threatening to disclose and use the
`
`Trade Secrets without Rubicon’s express or implied consent in the preparation and filing of an
`
`ANDA application for baclofen 5 mg, 10 mg, and 20 mg, and by using Rubicon’s pricing, market
`
`and volume information to commercialize its baclofen product.
`
`16
` 141054.00102/125427101v.6
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`
`

`

`
`
`78.
`
`The Defendants’ actual and threatened use and disclosure of the Trade Secrets
`
`constitutes misappropriation because at the time of such use and disclosure, the Defendants knew
`
`or had reason to know that their knowledge of the Trade Secrets was derived through persons who
`
`owed a duty to Rubicon to maintain the secrecy of the Trade Secrets.
`
`79.
`
`Defendants’ current and continued misappropriation of Rubicon’s Trade Secrets is
`
`willful and malicious. Defendants know of the confidentiality, ownership, and use restrictions on
`
`the Trade Secrets.
`
`80.
`
`By reason of the above-alleged acts and conduct of Defendants, Rubicon has been
`
`damaged, and it will continue to suffer great and irreparable harm and damage. The amount of this
`
`irreparable harm will be difficult if not impossible to ascertain, and Rubicon will be without an
`
`adequate remedy at law.
`
`81.
`
`Rubicon is also ent