throbber
Case: 1:22-cv-04620 Document #: 1 Filed: 08/30/22 Page 1 of 67 PageID #:1
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`
`AltaThera Pharmaceuticals LLC,
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`
`
`
`
`Plaintiff,
`
`Civil Action No.
`
`vs.
`
`
`
`Hyloris Pharmaceuticals SA, Academic
`Pharmaceuticals Inc., John C. Somberg, M.D.,
`
`DEMAND FOR JURY TRIAL
`
`Defendants.
`
`COMPLAINT
`
`Plaintiff AltaThera Pharmaceuticals LLC (“AltaThera”) brings this action for
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`compensatory and punitive damages and permanent injunctive relief against Defendants Hyloris
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`Pharmaceuticals SA (“Hyloris”), Academic Pharmaceuticals Inc. (“API”), and John C. Somberg,
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`M.D. (“Dr. Somberg”) (collectively, the “Defendants”), for their misappropriation of
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`AltaThera’s highly valuable trade secrets and confidential information, breaches of contract, and
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`other tortious misconduct, in violation of both federal law under the Defend Trade Secrets Act
`
`and state law.
`
`AltaThera also seeks a declaration that it is the owner of U.S. Patent Application No.
`
`16/449,796 (“the ’796 application”), and any patents that issue from that application (including
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`U.S. Patent No. 11,364,213, or “the ’213 patent”), as well as any patents and patent applications
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`that claim priority to that application (including U.S. Patent Application No. 17/380,413 (“the
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`’413 application”)). AltaThera also brings this action pursuant to 35 U.S.C. § 256 to correct the
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`inventorship of the ’213 patent, to add Brandon Kashfian as a co-inventor of the subject matter
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`claimed in that patent. AltaThera alleges as follows:
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`1
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`

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`NATURE OF THE ACTION
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`1.
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`AltaThera is a hospital-focused pharmaceutical company dedicated to addressing
`
`unmet medical needs, including by developing innovative ways to repurpose existing drugs and
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`administer treatments that are efficient, safe, and effective and provide excellent outcomes for
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`patients.
`
`2.
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`AltaThera is the exclusive distributor in the United States of the drug product
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`sotalol hydrochloride injection for intravenous use (“Sotalol IV”) (NDA 022306) approved by
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`the Food and Drug Administration (“FDA”) in 2009. Sotalol IV is an antiarrhythmic agent
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`indicated for “the maintenance of normal sinus rhythm” in certain circumstances.1
`
`Antiarrhythmic agents such as Sotalol IV are medications that are used to treat and prevent heart
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`rhythms that are too fast and/or irregular, i.e., arrhythmias. Sotalol IV was originally approved as
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`a substitute for oral sotalol for patients unable to take sotalol orally.
`
`3.
`
`Consistent with AltaThera’s strategic focus, the company developed an innovative
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`method for administering Sotalol IV in a way that would allow patients who would otherwise
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`need to spend three days in the hospital to spend only one day there. Using the method, sotalol is
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`administered via IV for approximately one hour. After that, the patient may be switched to oral
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`sotalol, and may be safely discharged from the hospital within one day.
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`4.
`
`AltaThera’s work in developing and obtaining FDA approval for its new one-day
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`dosing method for Sotalol IV required the investment of millions of dollars over several years
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`and the development of significant, highly valuable trade secrets and confidential information
`
`
`
`1 Sotalol IV is a Vaughan Williams class III antiarrhythmic agent. According to its label, Sotalol
`IV “has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action
`potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties.”
`2
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`

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`Case: 1:22-cv-04620 Document #: 1 Filed: 08/30/22 Page 3 of 67 PageID #:3
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`across a range of areas, including technological innovations, business growth strategies,
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`physician relationship building efforts, market research, commercialization planning, and
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`regulatory strategies.
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`5.
`
`Like many pharmaceutical companies, AltaThera’s ability to invest the resources
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`necessary to develop, launch, and market its innovative therapy depended on appropriate
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`protections for the company’s intellectual property, so that others could not launch and market a
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`competing antiarrhythmic agent built on AltaThera’s investments in a way that would deprive
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`the company of an appropriate return on those investments.
`
`6.
`
`AltaThera accordingly maintained its innovative one-day dosing method for
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`Sotalol IV and related business and commercial strategies as confidential while it worked to
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`prepare confidential patent applications to protect its technological innovation, materials to be
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`confidentially submitted to the FDA in order to obtain FDA approval for this new method of use,
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`research on the market potential for this new method, and a plan for selling Sotalol IV for use
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`with this new method to the doctors and hospitals who could provide the drug to patients.
`
`7.
`
`AltaThera shared its confidential information and trade secrets with Dr.
`
`Somberg—a longtime consultant purportedly acting in AltaThera’s interests through Dr.
`
`Somberg’s consulting company, API—and Hyloris—a publicly-traded Belgian company from
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`which AltaThera had licensed Sotalol IV.
`
`8.
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`Dr. Somberg, API
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` entered into contracts agreeing that they
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`would not disclose AltaThera’s confidential information or use it for their own business
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`purposes. Pursuant to these contractual guarantees, AltaThera routinely provided its highly
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`confidential and valuable information to
`
` in the normal course of the parties’ business
`
`relationships.
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`3
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`

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`9.
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`Unbeknownst to AltaThera,
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` Dr. Somberg, API, and
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`Hyloris were secretly working together to take AltaThera’s novel ideas, confidential drafts and
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`materials, market research, and know-how, and using them to bring a competing antiarrhythmic
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`drug to market: “intravenous dofetilide” or “Dofetilide IV.”
`
`10.
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`By the time AltaThera learned that Defendants were using its confidential
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`information and intellectual property to pursue a competing product, Defendants were already
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`two years into their efforts to obtain patent protection and FDA approval for a Dofetilide IV one-
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`day dosing method. They expect to bring the product to market in 2023.
`
`11.
`
`On information and belief, Dr. Somberg, API, and Hyloris never would have
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`pursued Dofetilide IV at all—or, in the alternative, would not have been in a position to pursue
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`Dofetilide IV at the times and in the ways they have—if not for their improper use of
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`AltaThera’s confidential and proprietary ideas, information, know-how, and other materials.
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`Through AltaThera’s confidential information and intellectual property, Defendants learned
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`about the scientific and commercial potential of an antiarrhythmic drug which can be
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`administered intravenously during a short hospital stay, resulting in savings of time and money
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`for hospitals and patients.
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`12.
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`For example, Defendants learned about AltaThera’s processes which make it
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`possible to administer antiarrhythmic drugs intravenously safely over a short time period during
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`a one-day hospital stay.
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`13.
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`Defendants also learned how this shorter hospital stay makes an antiarrhythmic
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`drug a more attractive option for hospitals and patients, and the resulting market potential.
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`Hyloris has admitted as much, publicly stating that, “based on [a] survey performed by …
`
`4
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`

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`AltaThera … a significant portion of the existing dofetilide use in hospitals for loading of
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`patients could be converted to IV.” (emphasis added).
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`14.
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`Further, following a confidential meeting AltaThera had with the FDA
`
`
`
`, Defendants learned about a cheaper, faster pathway to FDA approval and AltaThera’s
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`confidential roadmap for quickly obtaining approval using that pathway for a new method of
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`administering an antiarrhythmic drug. Defendants also learned that the FDA would be receptive
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`to the use of this new regulatory pathway for the approval of new formulations, methods of use,
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`or indications for an IV antiarrhythmic agent.
`
`15. With the benefit of AltaThera’s intellectual property and confidential information,
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`Defendants secretly began to develop Dofetilide IV. For example, Dr. Somberg copied verbatim
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`significant portions of a highly confidential patent application he helped prepare for AltaThera
`
`into a patent application for Dofetilide IV in his own name, and in doing so failed to identify the
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`inventive contributions of AltaThera’s founder, Brandon Kashfian. On information and belief,
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`Dr. Somberg similarly copied portions of AltaThera’s confidential regulatory materials prepared
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`in connection with AltaThera’s efforts to secure FDA approval of the one-day method for
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`administering Sotalol IV. As for Hyloris, Hyloris has publicly admitted that “[b]ased on the
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`similarities between sotalol and dofetilide, Hyloris has adopted a very similar development
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`strategy [to AltaThera’s strategy for Sotalol IV] for Dofetilide IV”—a development strategy
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`Hyloris was able to learn only through access to AltaThera’s confidential information and trade
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`secrets—and “will therefore develop Dofetilide IV and propose a new loading dose strategy
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`based on the same scientific rationale [as that of the Sotalol IV one-day method] … reducing
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`hospitalization duration.”
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`5
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`

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`16.
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`AltaThera brings this action to obtain relief—including damages and injunctive
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`relief—from Defendants’ breaches of contract and tortious misconduct, and to protect
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`AltaThera’s intellectual property.
`
`PARTIES
`
`17.
`
`Plaintiff AltaThera is a limited liability company organized under the laws of the
`
`State of Delaware. Its principal place of business is 311 South Wacker Drive, Suite 6030,
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`Chicago, Illinois, 60606.
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`18.
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`Defendant Hyloris is a public limited liability company organized under the laws
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`of Belgium. Its principal place of business is Boulevard Gustave Kleyer 17, 4000 Liège,
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`Belgium.
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`19.
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`Defendant API is a corporation organized under the laws of the State of New
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`York. Its principal place of business is 21 N. Skokie Highway, Suite G3, Lake Bluff, Illinois,
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`60045.
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`20.
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`Defendant Dr. Somberg is an individual who resides in Lake Forest, Illinois
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`60045. He is the President, Chief Executive Officer, and sole owner of API.
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`JURISDICTION AND VENUE
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`21.
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`This action arises in part under the Defend Trade Secrets Act, 18 U.S.C.
`
`§ 1836(b) (“DTSA”). The Court therefore has jurisdiction over Plaintiff’s claims for violation of
`
`the DTSA under 28 U.S.C. § 1331; 18 U.S.C. § 1836(c). The action also arises in part under the
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`Patent Act, and in particular under 35 U.S.C. § 256(b), which empowers federal courts to order
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`the correction of the inventorship on a patent. The court therefore has jurisdiction over Plaintiff’s
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`claims for correction of inventorship under 28 U.S.C. §§ 1331.
`
`6
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`

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`22.
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`The Court has supplemental jurisdiction over AltaThera’s state-law claims
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`pursuant to 28 U.S.C. § 1367. Those claims form part of the same case or controversy under
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`Article III of the United States Constitution. AltaThera’s state-law claims share common
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`operative facts with its federal-law claims, and the parties are identical. Resolving AltaThera’s
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`federal and state-law claims in a single action serves the interests of judicial economy,
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`convenience, consistency, and fairness to the parties.
`
`23.
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`Hyloris is subject to personal jurisdiction in this Court. Hyloris has purposefully
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`availed itself of the laws of the United States by entering an agreement with Chicago-based
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`AltaThera for the distribution of its Sotalol IV product, supplying AltaThera with Sotalol IV, and
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`coordinating with AltaThera regarding AltaThera’s efforts to obtain FDA approval for new
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`indications and methods of use for Sotalol IV. Hyloris has continuous and systematic contacts
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`with this State and acts it committed within Illinois and this District give rise to this action.
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`24.
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`Hyloris has also expressly consented to personal jurisdiction in this Court. This
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`complaint alleges a breach of
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` between
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`. In that
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`
`
`
`
`
`
`2
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`25.
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`In the alternative, this Court has personal jurisdiction over Hyloris because the
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`requirements of Federal Rule of Civil Procedure 4(k)(2) are met. First, AltaThera brings claims
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`under federal law. Second, Hyloris, a Belgian company, is not subject to general personal
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`jurisdiction in the courts of any U.S. state. And finally, Hyloris has sufficient minimum contacts
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`with the United States as a whole to satisfy Due Process. Indeed, Hyloris’s business model is
`
`2
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`
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`7
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`

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`built around the U.S. FDA’s process for approval. Hyloris describes its “development strategy”
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`on its website as “reformulating and repurposing approved pharmaceuticals primarily utili[zing]
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`the 505(b)(2) regulatory pathway in the U.S. and similar pathways in other countries.”3 And
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`Hyloris is working to commercialize its products “with [its] own small, specialist sales force in
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`the U.S. targeting hospital-based cardiologists.”4
`
`26.
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`API is subject to personal jurisdiction in this Court because API is headquartered
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`in this District, has continuous and systematic contacts with this State, and has committed acts
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`within Illinois and this District that give rise to this action.
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`27.
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`Dr. Somberg is subject to personal jurisdiction in this Court because he is natural
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`person who resides in this District, has continuous and systematic contacts with this State, and
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`has committed acts within Illinois and this District that give rise to this action.
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`28.
`
`Venue is proper in this District against all of the Defendants pursuant to 28 U.S.C.
`
`§ 1391(b)(1), because all Defendants reside in this District for venue purposes. Dr. Somberg is a
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`natural person domiciled in this District, 35 U.S.C. § 1391(c)(1), and Hyloris and API are each
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`subject to personal jurisdiction in this District with respect to this action, 35 U.S.C. § 1391(c)(2).
`
`29.
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`Venue is also proper in this District against all of the Defendants pursuant to 28
`
`U.S.C. § 1391(b)(2), because a substantial part of the events or omissions giving rise to this
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`action occurred in this District, including specific actions by each of Hyloris, API, and Dr.
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`Somberg. Among other things, Dr. Somberg and API entered into relevant contracts in this
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`District with AltaThera, a company headquartered in this District, and provided services pursuant
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`to those contracts in this District. And Hyloris entered into relevant contracts to supply
`
`
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`3 About Us, Hyloris.com, https://hyloris.com/about-us/ (last visited Aug. 30, 2022).
`4 Our Strategy, Hyloris.com, https://hyloris.com/our-strategy/ (last visited Aug. 30, 2022).
`8
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`

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`AltaThera, a company headquartered in this District, with a medical drug and did supply the drug
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`to AltaThera in this District.
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`30.
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`To the extent Hyloris is not deemed to reside in this District for any particular
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`claim or claims, venue is proper as to Hyloris under 28 U.S.C. § 1391(c)(3), which provides that
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`defendants not resident in the United States may be sued in any judicial district.
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`BACKGROUND
`
`31.
`
`AltaThera is a specialty pharmaceutical and precision medicine company which
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`manufactures, markets, sells and distributes in the United States a class III antiarrhythmic drug:
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`Sotalol IV.
`
`32.
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`Sotalol IV is administered for the management of atrial fibrillation—a quivering
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`or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other
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`heart-related complications—exclusively to patients in hospitals under supervision.
`
`33.
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`Through years of focused effort, AltaThera has developed an extensive network
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`of doctors and hospitals that need intravenous antiarrhythmic drugs, special understanding of the
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`needs of these doctors and hospitals and how to tailor a product and outreach to meet those
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`needs, and an experienced full-time hospital-focused field force, consisting of sales
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`representatives and doctorate-level (MD, PhD, PharmD) medical science liaisons who meet with
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`physicians for scientific discussions on Sotalol IV. AltaThera has invested substantial money,
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`time, and effort in understanding the antiarrhythmic drug market and the best way to serve that
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`market.
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`34.
`
`As a company operating in the highly competitive and quickly evolving
`
`pharmaceuticals market, where being the first to obtain FDA approval and/or patent protection is
`
`often the difference between a company thriving or failing, AltaThera’s business depends on
`
`9
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`

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`maintaining the confidentiality of its information, in particular information about new drugs or
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`methods and the business and commercial plans supporting their development and launch.
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`AltaThera therefore goes to great lengths to protect the confidentiality of its information,
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`particularly from competitors or potential competitors.
`
`35.
`
`AltaThera regularly requires those it does business with—including all employees
`
`and consultants—to enter non-disclosure and confidentiality agreements. Access to company
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`information is restricted and provided even to AltaThera employees on a need-to-know
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`basis. Employees and consultants are periodically reminded that all of AltaThera’s information is
`
`considered confidential and proprietary. No one can access AltaThera’s office without a keycard,
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`and all AltaThera computers are required to be password protected.
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`EARLY DISCUSSIONS REGARDING SOTALOL IV
`
`36.
`
`Approximately a decade ago, AltaThera was looking for a new drug product that
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`fit the company’s strategic goals. To that end, it entered into confidential discussions with Dr.
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`Somberg and API regarding the commercialization of Sotalol IV.5
`
`37.
`
`At the time, API owned assets relating to Sotalol IV, including a New Drug
`
`Application (“Sotalol IV NDA”) (NDA #022306), which had been approved by the FDA on July
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`2, 2009.
`
`38.
`
`In
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`, AltaThera entered an agreement with Dr. Somberg and API
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`(the “Term Sheet”), which provided that API would
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`
`
`
`
`
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`
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`5 Unless otherwise noted, this complaint treats API and Dr. Somberg—API’s sole owner, CEO,
`President, and decision-maker—interchangeably.
`10
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`

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`Case: 1:22-cv-04620 Document #: 1 Filed: 08/30/22 Page 11 of 67 PagelD #:11
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`ee API agreedthat it would notPe
`SE:: :::s
`39.
`Nonetheless, Dr. Somberg (iii secretly engaging in discussions
`with a Belgian company—Hyloris—tegardingee
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`a 4
`
`0.|When AltaThera threatened to take legal action against API based on violations of
`
`the Term Sheet, Dr. Somberg introduced AltaThera onii
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`a 4
`
`1. Po APItransferred all existing interest in the Sotalol IV
`
`assets to Hyloris, which in turn granted AltaThera an exclusivelicense to those assets, including
`
`the Sotalol TV NDA.
`
`Hyloris License Agreement
`
`42.
`
`AltaThera entered into the Licensing, Development, and Supply Agreement
`
`(“Hyloris License Agreement”) with Hyloris on December 1, 2014, and becamethe exclusive
`
`licensee
`
`
`SS:
`Pt Hyloris agreed to supply AltaThera with Sotalol IV. And AltaThera
`
`and Hyloris agreed to cooperate in any potential reformulation of Sotalol IV and its development
`
`for new indications. Under the License Agreement,Pe
`
`
`9
`
`
`Term Sheet (emphasis added).
`6
`
`Term Sheet (emphasis added).
`7
`® Hyloris License Agreement, Recitals, Art. 1.2
`
`° Hyloris License Agreement, Art. 10.2.
`
`11
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`

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`43.
`
`Becausethe parties would be sharing valuable confidential informationin the
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`course of their relationship, the Hyloris License Agreement imposedstringent obligations
`
`44.
`
`Eachparty agreed not toee
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`unlesscertain limited exceptions applied.!°
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`an Po was defined broadly as
`
`10 Hyloris License Agreement, Art. 13.1.
`1! Hyloris License Agreement, Art. 13.3.
`” Hyloris License Agreement, Art. 1.2
`13 Hyloris License Agreement, Art. 1.2
`
`_ w
`
`12
`
`_ _
`
`_ Ne
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`;
`;
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`

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`Case: 1:22-cv-04620 Document #: 1 Filed: 08/30/22 Page 13 of 67 PageID #:13
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`47.
`
`The parties acknowledged that there was no
`
`14 They also agreed that
`
`15
`
`
`
`
`
`
`
`
`
`
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`DEVELOPMENT OF A NEW METHOD FOR DOSING
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`48. When AltaThera licensed the Sotalol IV assets in 2014, the FDA-approved
`
`indication for Sotalol IV called for at least three days of hospital monitoring in connection with
`
`the administration of the product. While this extended hospital stay was effective at reducing risk
`
`for patients, it made Sotalol IV a less desirable choice for doctors and patients, as long hospital
`
`stays can be expensive and uncomfortable. This limited Sotalol IV’s potential, commercially and
`
`otherwise.
`
`49.
`
`After licensing the Sotalol IV assets, AltaThera developed a novel idea to reduce
`
`the length of the required hospital stay through a new method of more rapidly initiating or
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`escalating the sotalol dosage safely. Indeed, using AltaThera’s method, Sotalol IV could be
`
`administered in approximately one hour prior to a switch to oral sotalol. AltaThera’s one-day
`
`method would reduce the required hospital stay from three days to one. This innovation gave
`
`doctors and patients a new option for managing a dangerous condition in a safe, efficient way. It
`
`also increased Sotalol IV’s commercial potential. AltaThera hired Dr. Somberg to assist in its
`
`efforts to develop and commercialize this method as more fully described herein.
`
`
`
`14 Hyloris License Agreement, Art. 13.4.
`15 Hyloris License Agreement, Art. 13.4.
`
`13
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`

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`Case: 1:22-cv-04620 Document #: 1 Filed: 08/30/22 Page 14 of 67 PageID #:14
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`50.
`
`AltaThera’s one-day method was originally conceived by AltaThera’s founder,
`
`Brandon Kashfian.
`
`51.
`
`The value of the technical innovation of AltaThera’s one-day method was
`
`reinforced by highly valuable AltaThera confidential and trade secret information regarding,
`
`among other things, the commercial value of the innovation, the strategy for deploying the
`
`innovation in the marketplace, and the regulatory and intellectual property strategy supporting
`
`that commercial strategy. For example, AltaThera recognized, but did not disclose to the public,
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`an opportunity to seek patent protection for its technical innovation and FDA approval for a new
`
`indication for Sotalol IV based on that innovation, which would ensure that AltaThera would
`
`have a competitive advantage in the market for IV antiarrhythmic agents over others without
`
`access to AltaThera’s confidential and proprietary information.
`
`52.
`
`AltaThera did not disclose its ideas to others who could derive economic value
`
`from them, and closely guarded its technical innovations in connection with the one-day method
`
`as valuable company trade secrets until AltaThera was granted a public patent describing its one-
`
`day method in December 2019. Much of AltaThera’s related information—for example, its
`
`strategy for deploying the innovation in the marketplace—remains confidential.
`
`53.
`
`AltaThera did disclose the technical innovations to Dr. Somberg, however. Based
`
`on Dr. Somberg’s background and experience with Sotalol IV, AltaThera had retained him as an
`
`advisor and consultant via his consulting business, API, and Mr. Kashfian and Dr. Somberg
`
`worked together to refine AltaThera’s novel one-day method and ultimately reduce the idea to
`
`practice.
`
`54.
`
`In view of the critical importance of Sotalol IV to AltaThera and the value of
`
`AltaThera’s trade secrets and confidential information, AltaThera was careful to protect its rights
`
`14
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`

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`in connection with its relationship with Dr. Somberg and API throughout the parties’
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`relationship.
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`Dr. Somberg and API Confidentiality Agreement
`
`55.
`
`In April 2016, AltaThera, Dr. Somberg, and API agreed to a Confidentiality and
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`Non-Disclosure Agreement (“2016 API Confidentiality Agreement”).16
`
`56.
`
`The parties acknowledged that they would disclose confidential information to
`
`each other in the course of their relationship, and recognized that “such Confidential Information
`
`… has been developed or obtained … by the investment of significant time, effort, and expense,
`
`and that such Confidential Information provides the Disclosing Party with a significant
`
`competitive advantage in its business.”17
`
`57.
`
`The parties agreed that “[n]either party shall use, or allow any third party to use,
`
`any confidential information obtained from the other party for any purpose, whether business,
`
`commercial, or otherwise, unless agreed upon in writing by the parties.”18
`
`58.
`
`The parties would “not copy, alter, modify, disassemble, reverse engineer, or
`
`decompile any materials received from [the other party] without prior written consent” and
`
`would “return … or destroy Confidential Information or any materials prepared by [the receiving
`
`party] that incorporate any Confidential Information, promptly upon the request of Disclosing
`
`Party or after the purpose for which they were furnished or made ha[s] been accomplished or
`
`abandoned.”19
`
`
`
`16 The 2016 API Confidentiality Agreement is nearly identical to another Confidentiality and
`Non-Disclosure Agreement among AltaThera, Somberg, and API executed in 2011 (the “2011
`API Confidentiality Agreement,” together with the 2016 API Confidentiality Agreement, the
`“API Confidentiality Agreements”).
`17 API Confidentiality Agreements, p. 2, § 1.
`18 API Confidentiality Agreements, p. 2, § 3.
`19 API Confidentiality Agreements, p. 3, § 5.
`
`15
`
`

`

`Case: 1:22-cv-04620 Document #: 1 Filed: 08/30/22 Page 16 of 67 PageID #:16
`
`59.
`
`Each party “represent[ed] that it ha[d] not and w[ould] not in the future (except as
`
`provided in this Agreement), provide[] or communicate any of [the other party’s] Confidential
`
`information to any third party.”20 Instead, the parties would “hold in confidence and [agree] not
`
`to disclose or reveal Confidential Information received hereunder to any person except for [the
`
`receiving party’s] employees, directors, counsel, and advisors (collectively ‘Representatives’)
`
`who are required to have such Confidential Information in order to perform their functions in
`
`connection with the limited purposes of this Agreement.”21 And “[e]ach permitted
`
`Representative to whom Confidential Information is disclosed shall adhere to all aspects of this
`
`Agreement.”22
`
`60.
`
`The agreement defines “Confidential Information” broadly, as “any information
`
`or material which [the receiving party] may obtain knowledge of through or as a result of the
`
`relationship established hereunder with the Disclosing Party, access to Disclosing Party’s
`
`premises, or communications with the Disclosing Party’s employees or independent
`
`contractors.”23 It includes, without limitation, “designs, concepts, drawings, ideas, inventions,
`
`specifications, techniques, discoveries, models, data, content material, sources, documentation,
`
`diagrams, flow charts, research, development, manufacturing processes and sources, procedures,
`
`know-how, new product or new technology information, marketing techniques and materials,
`
`marketing plans, timetables, strategies and development plans, and any other information related
`
`to the discovery, manufacture, production, development, and marketing.”24
`
`
`
`20 API Confidentiality Agreements, p. 3, § 6.
`21 API Confidentiality Agreements, p. 2, § 2.
`22 API Confidentiality Agreements, p. 2, § 2.
`23 API Confidentiality Agreements, p. 1, § 2 (“Confidential Information”).
`24 API Confidentiality Agreements, p. 1–2.
`
`16
`
`

`

`Case: 1:22-cv-04620 Document #: 1 Filed: 08/30/22 Page 17 of 67 PageID #:17
`
`61.
`
`The definition is subject to limited exceptions, including for information that later
`
`becomes generally known to the public other than as a result of a breach of the agreement.
`
`Consultant Agreements
`
`62.
`
`AltaThera and API also executed a Consultant Agreement on January 8, 2018,
`
`and Amended and Restated Consultant Agreements on June 1, 2018 and August 22, 2019 (the
`
`“Consultant Agreements”). Through these agreements, AltaThera engaged API “to provide
`
`medical affairs, regulatory affairs, clinical affairs, and business expertise” related to Sotalol IV.25
`
`63.
`
`Again, the agreements contained broad protections regarding the use or disclosure
`
`of AltaThera’s information.
`
`64.
`
`The Consultant Agreements treat all information pertaining to the affairs of
`
`AltaThera as confidential. API “recognize[d] and acknowledge[d] that all information pertaining
`
`to the affairs, business, clients, customers or other relationships of [AltaThera], as hereinafter
`
`defined, is confidential and is a unique and valuable asset of [AltaThera].”26 And “[a]ll records,
`
`memoranda, etc. relating to the business of [AltaThera] whether made by [API] or otherwise
`
`coming into [its] possession are confidential and will remain the property of [AltaThera].”27
`
`65.
`
`API agreed that it would “not make use of this type of information for [its] own
`
`purposes or for the benefit of any person or organization other than [AltaThera].”28 API would
`
`“not at any time use or exploit any of the confidential information of [AltaThera] for any purpose
`
`other than for the benefit of [AltaThera].”29 Thus, for example, Dr. Somberg and API agreed that
`
`any work “relating to” AltaThera’s business, even if “made by” Dr. Somberg, was AltaThera’s
`
`
`
`25 Consultant Agreements, Preamble.
`26 Consultant Agreements, § VI.B (emphases added).
`27 Consultant Agreements, § VI.B.
`28 Consultant Agreements, § VI.B.
`29 Consultant Agreements, § VI.E.
`
`17
`
`

`

`Case: 1:22-cv-04620 Document #: 1 Filed: 08/30/22 Page 18 of 67 PageID #:18
`
`confidential information, and the property of AltaThera, which Dr. Somberg and API could not
`
`use for any purpose other than for the benefit of AltaThera.
`
`66.
`
`API also agreed that it would not “give to any person, firm, association,
`
`corporation or governmental agency any information concerning the affairs, business, clients,
`
`customers or other relationships of [AltaThera] except as required by law.”30 Further, API would
`
`“use reasonable efforts to prevent the disclosure of this information by others.”31
`
`67.
`
`The Consultant Agreements were also clear that anything API developed as a
`
`result of, or relating to, its services during its engagement with AltaThera would belong to
`
`AltaThera:
`
`The results and proceeds of [API’s] services [under the Consultant Agreements],
`including, without limitation, any works of authorship resulting from or relating to
`[AltaThera’s] business and/or [API’s] services during [its] engagement with [AltaThera]
`and/or any of [AltaThera’s] affiliates and any works in progress, will be works-made-for
`hire and [AltaThera] will be deemed the sole owner throughout the universe of any and
`all rights of whatsoever nature therein, whether or not now or hereafter known, existing,
`contemplated, recognized or developed, with the right to use the same in perpetuity in
`any manner [AltaThera] determines in its sole discretion without any further payment to
`[API] whatsoever.
`
`If, for any reason, any of such results and proceeds will not legally be a work-for-hire
`and/or there are any rights which do not accrue to [AltaThera] under the preceding
`sentence, then [API] hereby irrevocably assigns and agrees to assign any and all of [its]
`right, title and interest thereto, including, without limitation, any and all copyrights,
`patents, trade secrets, trademarks and/or other rights of whatsoever nature therein,
`whether or not now or hereafter known, existing, contemplated, recognized or developed,
`to [AltaThera], and [AltaThera] will have the right to use the same in perpetuity
`throughout the universe in any manner [AltaThera] determines without any further
`payment to [API] whatsoever.
`
`[API] will, from time to time, as may be requested by [AltaThera], do any and all things
`which [AltaThera] may reasonably deem useful or desirable to establish or document
`[AltaThera’s] exclusive ownership of any and al

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