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COMPLAINT
Christina N. Goodrich (SBN 261722)
christina.goodrich@klgates.com
Cassidy T. Young (SBN 342891)
cassidy.young@klgates.com
K&L Gates LLP
10100 Santa Monica Boulevard
Eighth Floor
Los Angeles, CA 90067
Telephone: 310.552.5000
Facsimile: 310.552.5001
Attorneys for Plaintiff
ENOCHIAN BIOSCIENCES, INC.
SUPERIOR COURT OF THE STATE OF CALIFORNIA
FOR THE COUNTY OF LOS ANGELES
ENOCHIAN BIOSCIENCES, INC., a
Delaware corporation,
Plaintiff,
v.
SERHAT GUMRUKCU, an individual; W.
ANDERSON WITTEKIND, an individual;
G TECH BIO LLC, a California limited
liability company; SG & AW HOLDINGS
LLC, a California limited liability
company; SERAPH RESEARCH
INSTITUTE, a California nonprofit
corporation; and DOES 1 through 50,
inclusive;
Defendants.
Case No. _____________
COMPLAINT FOR:
(1)BREACH OF CONTRACT;
(2)BREACH OF IMPLIED
COVENANT OF GOOD
FAITH AND FAIR
DEALING;
(3)INTENTIONAL
MISREPRESENTATION
(FRAUD);
(4)FRAUDULENT
CONCEALMENT;
(5)FRAUDULENT
NONDISCLOSURE;
(6)NEGLIGENT
MISREPRESENTATION;
(7)CIVIL CONSPIRACY;
(8)UNJUST ENRICHMENT;
(9)UNFAIR BUSINESS
PRACTICES (CAL. BUS.
CODE §§ 17200, et seq.).
DEMAND FOR JURY TRIAL
Electronically FILED by Superior Court of California, County of Los Angeles on 10/21/2022 03:01 PM Sherri R. Carter, Executive Officer/Clerk of Court, by R. Perez,Deputy Clerk
Assigned for all purposes to: Stanley Mosk Courthouse, Judicial Officer: Christopher Lui
22STCV34071
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COMPLAINT
Plaintiff Enochian Biosciences, Inc. (“Plaintiff” or “Enochian”), brings this
action against Defendants Serhat Gumrukcu (“Gumrukcu”), W. Anderson Wittekind
(“Wittekind”), G Tech Bio LLC (“G Tech”), SG & AW Holdings LLC (“SG & AW
Holdings”), Seraph Research Institute (“SRI”), and Does 1 through 50 (collectively,
“Defendants”), and alleges as follows:
NATURE OF THE ACTION
1. This action arises out of the relationship between Enochian and Defendants
to research and develop prospective gene and immune therapy interventions to treat
devastating diseases. Together, Enochian and Defendants collaborated on a number of
product candidates (or “pipelines”) for the treatment of HIV/AIDS and certain cancers.
Enochian continues to pursue its promising HIV/AIDS and cancer pipelines.
2. As the relationship between Enochian and Defendants progressed, the
parties also began to research and develop pipelines for the treatment of Hepatitis B
(“HBV”) and coronaviruses and influenza viruses.
3. Specifically, in or around 2019, Enochian and Defendants began research
and development into the use of a novel cell-based gene therapy, “Hijack RNA,” which
is based on viral replication mechanisms applied in a novel way to “trick” a virus to
induce the death of the cells that harbor them instead of inducing replication and spread
of infection to other cells. In theory, the Hijack RNA approach could be applied to any
RNA virus, including HBV, coronaviruses, and influenza viruses.
4. Around the time Defendants began researching and developing Hijack
RNA, Enochian entered into a Framework Agreement (the “Framework Agreement”)
with G Tech and SRI “to collaboratively conduct research with the aim to discover new
treatments in [the] field of gene and cell therapy,” including those based on the Hijack
RNA approach. The Framework Agreement contemplates that Enochian, G Tech, and
SRI would regularly propose and potentially develop new opportunities for pre-clinical
research and execute an individual statement of work detailing the work to be
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COMPLAINT
performed, deliverables, timeline, and responsibilities for each new opportunity.
5. After entering into the Framework Agreement, Enochian entered into two
separate agreements with G Tech and SRI to pursue the Hijack RNA approach for its
HBV and SARS-CoV-2 (the coronavirus that causes COVID-19)/influenza pipelines.
Through these agreements, G Tech and SRI agreed to perform pre-clinical experiments,
studies, tests, and other research and development, including IND-enabling studies, to
advance the pre-clinical science to the point of being ready for the first encounter with
the FDA (typically through a pre-IND meeting1
), at which point the research would be
transferred to Enochian for submission to the FDA and Enochian would take over
further research and development.
6. Throughout 2020 and 2021, Defendants reported to Enochian positive
results from numerous studies relating to its HBV and SARS-CoV-2/influenza
pipelines.
7. It was not until late June 2022—following the arrest of Gumrukcu and a
subsequent internal review of primary data underlying Enochian’s HBV and SARS-
CoV-2/influenza pipelines—that Enochian uncovered evidence that Defendants had
engaged in a concerted, deliberate scheme to alter, falsify, and misrepresent to Enochian
the results of multiple studies supporting its HBV and SARS-CoV-2/influenza pipelines
in order to extract millions of dollars from Enochian. Defendants manipulated negative
results to reflect positive outcomes from various studies, and even fabricated studies out
of whole cloth. Defendants’ conduct amounts to nothing short of brazen fraud, which
has caused Enochian substantial harm.
8. Upon information and belief, at all relevant times, Defendants (1) acted
together to carry out this scheme to defraud Enochian; (2) had knowledge of the
1
In 1988, the U.S. Food and Drug Administration (“FDA”) established the Pre-Investigational New
Drug Application (“pre-IND”) Consultation Program, which was designed to provide an opportunity
for sponsors of new drugs or therapies in pre-clinical development to request and receive early
feedback and advice on scientific, regulatory, or safety issues relating to the development of the new
drug or therapy.
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COMPLAINT
aforementioned data manipulation and falsification; and (3) engaged in such data
manipulation and falsification with the intent to injure and defraud Enochian.
9. Enochian paid Defendants and third parties nearly $25 million based on
Defendants’ misrepresentation of results related to Enochian’s HBV and SARS-CoV-
2/influenza pipelines. Moreover, the funds Enochian ultimately paid to Defendants
were retained and used for the personal benefit of defendants Gumrukcu and Wittekind,
who, upon information and belief, together owned, managed, and controlled G Tech,
SG & AW Holdings, and SRI.2
10. Through this action, Enochian intends to hold Defendants responsible for
their conduct and recover the damages resulting therefrom.
PARTIES
11. Plaintiff Enochian Biosciences, Inc. is a Delaware corporation with its
principal place of business in Los Angeles, California. Enochian is a pre-clinical
biotechnology company dedicated to identifying, researching, developing, and
commercializing gene-modified cell and immune therapies. Enochian is committed to
using its integrated platforms, which encompass innovative gene-modified cell and
immune therapy interventions, to seek treatment and cures for devastating diseases.
Enochian’s therapies can potentially be applied to multiple indications.
12. Defendant Serhat Gumrukcu is an individual who, upon information and
belief, resides in Los Angeles, California. Gumrukcu is a former scientific advisor to
Enochian who invented certain technologies and approaches to be used in various
Enochian pipelines.
13. Defendant W. Anderson Wittekind is an individual who, upon information
and belief, resides in Los Angeles, California. Wittekind is Gumrukcu’s husband.
14. Defendant G Tech Bio, LLC is a California limited liability company with
2
For example, upon information and belief, the funds Enochian paid to Defendants were used by
Gumrukcu and Wittekind, through their holding companies, to facilitate the purchase of an $18 million
property in Los Angeles in August 2021.
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COMPLAINT
its principal place of business located at 8605 Santa Monica Boulevard, Suite 36381,
West Hollywood, California 90069. Upon information and belief, G Tech is owned,
managed, and/or controlled by Gumrukcu and Wittekind. According to G Tech’s
corporate filings with the California Secretary of State, SG & AW Holdings and
Wittekind are the managers and/or members of G Tech.
15. Defendant SG & AW Holdings LLC is a California limited liability
company with its principal place of business located at 8605 Santa Monica Boulevard,
Suite 36381, West Hollywood, California 90069. Upon information and belief, SG &
AW Holdings is owned, managed, and/or controlled by Gumrukcu and Wittekind.
According to SG & AW Holdings’ corporate filings with the California Secretary of
State, Wittekind is the sole manager and/or member of SG & AW Holdings. Upon
information and belief, the “SG” and “AW” in the name of SG & AW Holdings are the
initials of Serhat Gumrukcu and Anderson Wittekind.
16. Defendant Seraph Research Institute, formerly known as G Health
Research Foundation, is a California nonprofit corporation with its principal place of
business located at 8605 Santa Monica Boulevard, Suite 36381, West Hollywood,
California 90069. Upon information and belief, SRI is owned, managed, and/or
controlled by Gumrukcu and Wittekind. According to SRI’s corporate filings with the
California Secretary of State, Gumrukcu is the Chief Executive Officer of SRI and
Wittekind is the Secretary and Chief Financial Officer of SRI.
17. Enochian is unaware of the true names and capacities of the remaining
defendants, identified as Does 1 through 50, and therefore sues such defendants by such
fictitious names. Enochian reserves its right to amend this Complaint to allege true
names and capacities when ascertained. Enochian is informed and believes, and on that
basis alleges, that each of the fictitiously named defendants are in some manner
responsible for the harm Enochian has incurred and will incur if injunctive relief is not
allowed or damages are not awarded.
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COMPLAINT
18. At all relevant times, each Defendant (1) was aware of all other
Defendants’ intent to manipulate and falsify data, and (2) similarly intended that the
data manipulation and falsification be committed. Upon information and belief,
Gumrukcu and Wittekind, along with G Tech, SG & AW Holdings, and SRI, managed
and/or controlled by them, acted together to carry out this fraudulent scheme.
JURISDICTION AND VENUE
19. This Court has jurisdiction over all causes of action asserted in this
Complaint pursuant to the California Constitution, Article VI, Section X; section 410.10
of the California Code of Civil Procedure; and section 17203 of the California Business
and Professions Code.
20. This Court has general personal jurisdiction over all Defendants.
Defendants Gumrukcu and Wittekind reside in the State of California. Defendant
Seraph Research Institute is a California nonprofit corporation that maintains its
principal place of business in California. Defendants G Tech and SG & AW Holdings
are California limited liability companies that maintain principal places of business in
California. Defendant SRI is a California nonprofit corporation that maintains its
principal place of business in California. Additionally, Defendants G Tech and SRI are
subject to personal jurisdiction in the State of California because they entered into
agreements that identify courts in Los Angeles County, California as the exclusive
forum for resolution of disputes with Enochian.
21. This Court has subject matter jurisdiction over this dispute because the
amount in controversy, exclusive of interest and costs, exceeds $25,000, and the
conduct at issue occurred in, or had its effects in, Los Angeles County, California.
22. Venue is proper in this action pursuant to Cal. Code Civ. Proc. § 395(a)
because (1) Defendants reside in Los Angeles County; (2) the contracts governing the
conduct of certain parties to this action were intended to be and were performed in Los
Angeles County; and (3) the acts and/or omissions of Defendants giving rise to this
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COMPLAINT
action took place in Los Angeles County, and the effects of which were felt by Enochian
in Los Angeles County.
FACTUAL BACKGROUND
23. In or around 2019, Enochian and Defendants began research and
development into the use of the novel Hijack RNA approach for the treatment and cure
of RNA viruses. Following Defendants’ presentations of proof-of-concept studies at
key scientific conferences, Enochian entered into two agreements with Defendants to
develop the Hijack RNA approach for its HBV and SARS-CoV-2/influenza pipelines.
As discussed herein, Enochian has since learned that Defendants intentionally altered,
falsified, and misrepresented to Enochian certain data related to Enochian’s HBV and
SARS-CoV-2/influenza pipelines in a scheme to defraud Enochian of millions of
dollars.
A. The Framework Agreement
24. Enochian, G Tech, and SRI entered into the Framework Agreement with
an Effective Date of November 15, 2019. The Framework Agreement is signed by Dr.
Mark Dybul (on behalf of Enochian), Wittekind (on behalf of G Tech), and Gumrukcu
(on behalf of SRI).3
25. The Framework Agreement memorialized Enochian, G Tech, and SRI’s
intention to “collaboratively conduct research with the aim to discover new treatments
in [the] field of gene and cell therapy.” Specifically, Enochian, G Tech, and SRI entered
into the Framework Agreement to establish “the framework of contractual conditions
under which the Parties may collaborate and how [Enochian] may [] provide support to
SRI for each Project and for [Enochian] to license Technology from G Tech.”
26. To this end, as set forth in Section 2(a) of the Framework Agreement,
Enochian, G Tech, and SRI would meet, no less than once a quarter, to “review the
activities of G Tech and SRI and identify new opportunities related to specific avenues
3
G Tech and SRI are referred to as the “Research Parties” in the Framework Agreement.
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COMPLAINT
of pre-clinical research that directly contribute to the scientific foundation of
[Enochian].”4
27. For each project Enochian, G Tech, and SRI intended to pursue, the parties
agreed to execute a separate statement of work. The statement of work, together with
the Framework Agreement, would constitute a separate agreement5
governing the
objectives and work to be performed for that specific project.
28. Section 2(b) of the Framework Agreement states, in relevant part:
If a Party becomes aware of any unforeseen or unusual events
or assumptions, factors, and criteria not taken into
consideration that would affect the outcome of the budget,
timeline or other aspects of the Project set forth in an
applicable Funding Agreement, or would require additional
services not originally contemplated, such Party shall
promptly notify the other Parties and the Parties shall discuss
in good faith, and, upon mutual written agreement in
conformity with the internal approval policies of the
Company in place at the time of the Funding Agreement,
amend the applicable Funding Agreement (a “Project
Amendment Order”) accordingly.
29. Further, pursuant to Section 3(a), G Tech and SRI agreed to “comply, in
all material respects, with all United States laws and regulations of any state, federal or
local governmental or regulatory agency.”
30. Additionally, Section 9(c)(i) of the Framework Agreement provides, in
relevant part:
Each Research Party hereby covenants to the Company that
4
Each such opportunity is referred to as a “Project” in the Framework Agreement.
5
Such an agreement is referred to as a “Funding Agreement” in the Framework Agreement.
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COMPLAINT
at all times until this Framework Agreement and each
Funding Agreement is terminated pursuant to Section 10
hereof… it shall, and shall cause all of its employees to,
cooperate with the Company, during and following the
completion of a Project in all matters related to proof-of-
concept, validation, IND and pre-IND applications and other
studies in furtherance of the Company’s Business as it relates
to each Project that is under a Funding Agreement….
31. Subject to the Framework Agreement, and as discussed herein, Enochian,
G Tech, and SRI executed two statements of work and license agreements related to its
HBV and SARS-CoV-2/influenza pipelines in 2020 and 2021, respectively.
B. HBV Pipeline
i. The December 2019 HEP DART Conference
32. On November 22, 2019, Enochian, G Tech, and SRI entered into a letter
of intent memorializing their agreement in principle for Enochian to acquire an
exclusive license for Defendants’ Hijack RNA approach to treat and cure HBV (the
“HBV Letter of Intent”). The HBV Letter of Intent set forth the general parameters of
the parties’ agreement and provided that Enochian, G Tech, and SRI would further
memorialize the full terms of their agreement by January 31, 2020. The HBV Letter of
Intent is signed by Dr. Mark Dybul (on behalf of Enochian), Wittekind (on behalf of G
Tech), and Gumrukcu (on behalf of SRI).
33. Shortly after the HBV Letter of Intent but before signing an agreement,
Gumrukcu—through SRI and in collaboration with Dr. Phillippe Gallay (“Dr. Gallay”)
of The Scripps Research Institute in La Jolla, California (“Scripps”)—presented results
of Defendants’ novel approach to the treatment and cure of HBV during the December
2019 HEP DART Conference. The HEP DART Conference is an internationally
recognized biennial conference that provides an important platform for scientists,
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COMPLAINT
healthcare workers, and clinicians to share and discuss the latest advancements in the
field of viral hepatitis and liver cancer.
34. Dr. Gallay was the senior author, performed pivotal in vitro and in vivo
proof-of-concept studies,6
and attended the presentation with Gumrukcu.
35. Gumrukcu’s presentation was well received. In fact, Defendants’
approach was selected as one of the best new therapies/innovative strategies to
potentially treat and cure HBV.
36. Dr. Carol Brosgart (“Dr. Brosgart”), a leader in the viral hepatitis and liver
cancer field, met with Gumrukcu and Dr. Gallay at the HEP DART Conference. Dr.
Brosgart was so impressed by Defendants’ approach that she joined Enochian’s Board
of Directors and later became the Chairperson of Enochian’s HBV Scientific Advisory
Board (“SAB”).7
ii. The HBV Agreement
37. Following Defendants presentation at the December 2019 HEP DART
Conference, and based on the publicly presented results and substantial interest the
results generated, Enochian executed a Statement of Work & License Agreement with
an Effective Date of January 31, 2020 with G Tech and SRI (the “HBV Agreement”).
The HBV Agreement incorporated by reference the terms of the Framework
Agreement. The HBV Agreement is signed by Dr. Mark Dybul (on behalf of Enochian),
Wittekind (on behalf of G Tech), and Gumrukcu (on behalf of SRI).
38. Through the HBV Agreement, Enochian acquired a perpetual,
sublicensable, exclusive license to develop, manufacture, and commercialize
6
In vitro procedures, tests, and experiments are those that researchers perform outside of a living
organism, in a controlled environment, such as a test tube or petri dish. In vivo tests, experiments, and
procedures are those that researchers perform in or on a whole living organism, like a mouse.
7
As Enochian’s pipelines advanced, SABs were established with leaders in the relevant fields for the
pipelines. The SAB would hold meetings where data, experimental plans, and methods and controls
for experiments were presented and questioned. The SAB would review and question data, give advice
on experimental plans, and review any FDA feedback. The HBV SAB was created in July 2020.
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COMPLAINT
Defendants’ prospective HBV treatment. Pursuant to the HBV Agreement, G Tech and
SRI were to perform, or contract with third-parties to perform, pre-clinical experiments,
studies, tests, and other research and development, including IND-enabling studies.
39. The HBV Agreement provided that G Tech and SRI would advance the
pipeline until it reached the first encounter with the FDA. All research G Tech and SRI
contracted out to have conducted, or conducted themselves, would be transferred to
Enochian during the process of preparing a submission to the FDA, after which
Enochian would assume the research and development.
40. As set forth in Section 4.1 of the HBV Agreement, during the “Funding
Term” (commencing February 2020 and continuing for 24 months thereafter), pre-
clinical research and development (including IND-enabling studies) were the sole
responsibility of G Tech and SRI until ready for the first encounter with the FDA. G
Tech and SRI had the ability to utilize any facilities that they determined would be
appropriate for the performance of their obligations and were permitted to collaborate
or subcontract obligations if appropriate.
41. Pursuant to Section 4.2 of the HBV Agreement, G Tech and SRI were
required to perform their obligations using “Commercially Reasonable Efforts,” as
defined in the HBV Agreement. Specifically, “Commercially Reasonable Efforts” were
defined in Article I, Section H as:
[T]he level of reasonable, diligent, good faith efforts that
biopharmaceutical, pharmaceutical or other life sciences
companies of similar size and a[t] a similar stage in their
development as such Party typically devote to the
development and/or commercialization of products and/or
therapies owned by them that are at a similar stage in their
development or life cycle and are of similar market potential
taking into account efficacy, safety, approved labeling, the
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competitiveness of alternative products or therapies in the
marketplace, the patent and other proprietary position of the
product and/or therapy, the likelihood of regulatory approval,
and other relevant factors.
42. In consideration for the exclusive license and the work to be performed by
G Tech and SRI, Enochian agreed to make certain payments to G Tech.
43. Section 2.4 of the HBV Agreement provided for various “Benchmark
Payments,” including, among others, a one-time payment of $1.2 million upon the
execution of the HBV Agreement8
and a one-time payment of $1.5 million within 30
days of a pre-IND meeting with the FDA for the prospective HBV treatment.
44. Under the HBV Agreement, Enochian also agreed to fund the pre-clinical
research and development and the purchase of certain property (mostly lab equipment)
as set forth in Section 2.1 and Schedule B. Specifically, Schedule B called for Enochian
to pay G Tech:
a. up to $825,000 for “R&D Studies”
b. up to $820,000 for “IND-Enabling Studies”
c. up to $750,000 for “Lab Equipment”
d. $144,500 per month during the Funding Term for “Staffing”
iii. Defendants Manipulated Results of Chimeric Mice Study
45. Based on the results from the in vitro and in vivo proof-of-concept studies
conducted by Defendants in collaboration with Dr. Gallay and Scripps, and pursuant to
the HBV Agreement with Enochian, Defendants proceeded with more advanced
studies, including a study on chimeric mice, to support Enochian’s pre-IND meeting
request to the FDA. Chimeric mice studies are considered by some experts to be the
premier animal model to evaluate HBV treatments and cures. At Defendants’ direction,
the chimeric mice study was conducted by Dr. Gallay at the Scripps vivarium.
8
Enochian made its initial Benchmark Payment of $1.2 million to G Tech on February 6, 2020.
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46. The chimeric mice study involved a treatment product candidate (ENOB-
HB-01) that could potentially eliminate HBV-infected liver cells by Hijack RNA, which
would enter the cells through a vector9
(in this case, an adeno-associated virus or
“AAV” particle), and “trick” the virus to induce the death of infected cells rather than
the virus reproducing and causing more infection and liver disease.
47. Based on Defendants’ representations regarding the preliminary results
from the chimeric mice study and the timing of its completion, Enochian submitted a
request for a pre-IND meeting to the FDA on April 9, 2021. The FDA agreed to a pre-
IND meeting and indicated it would provide a “Written Response Only” or “WRO.” 10
48. As part of the pre-IND consultation, Enochian was required to submit a
package of supporting material to the FDA thirty (30) days prior to the date of the WRO.
However, Gumrukcu informed Enochian that the chimeric mice study data would not
be completed in time to submit the package to the FDA as required. Therefore,
Enochian requested that the FDA postpone the response date. The FDA subsequently
agreed to provide a WRO on September 10, 2021, which required Enochian to submit
its pre-IND meeting package by August 11, 2021.
49. The chimeric mice study was completed in or around early July 2021.
50. On July 6, 2021, Dr. Gallay provided the primary data from the chimeric
mice study to Defendants. Specifically, Dr. Gallay sent the primary data from the
chimeric mice study to Gumrukcu in a single MS Excel file attached to an e-mail.
51. Gumrukcu presented what he claimed to be summaries of the data from
the chimeric mice study to Enochian’s HBV SAB (attending in-person and via Zoom)
on July 19, 2021. According to Gumrukcu, the results showed a 98% clearance in HBV
DNA.
9
Viral vectors are tools designed to deliver genetic materials into cells.
10
WROs are sent to requesters in lieu of meetings conducted face-to-face or by
teleconference/videoconference.
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52. Following a request by Enochian for an Enochian senior scientist to review
and graph the primary data, Gumrukcu sent what he represented to be the primary data
from the chimeric mice study to Dr. Lu Chen (“Dr. Chen”), who was then Enochian’s
Head of Chemistry, Manufacturing, and Controls and Product Development, on July
19, 2021. Notably, Gumrukcu did not forward the single MS Excel file containing the
primary data provided by Dr. Gallay to Dr. Chen. Instead, in his e-mail to Dr. Chen,
Gumrukcu attached three individual MS Excel files purporting to reflect the study’s
results.
53. The results reported by Defendants to Enochian were impressive.
Specifically, the data reported to Enochian showed that one dose of ENOB-HB-01:11
a. Provided a 98.6% reduction in HBV DNA after eleven (11) weeks:
11
The graphs presented in the following paragraphs were taken directly from Gumrukcu’s July 19,
2021 presentation to Enochian’s HBV SAB.
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b. Provided a near complete reduction of HBV antigens after eleven
(11) weeks:
c. Had little to no rebound in HBV DNA after fourteen (14) weeks:
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d. Had little to no rebound in HBV antigens after fourteen (14) weeks:
e. Had an effect on liver enzymes after eleven (11) weeks,
demonstrating a substantial drop in HBV DNA and the effectiveness
of ENOB-HB-01:
54. Enochian submitted the results provided by Defendants as part of its pre-
IND meeting submission to the FDA on August 11, 2021.
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55. Following the submission of Enochian’s pre-IND meeting package to the
FDA, Enochian made the $1.5 million “Benchmark Payment” to G Tech on August 19
and 20, 2021, as required under Section 2.4(b) of the HBV Agreement.
56. At the time, Enochian had no reason to question the data presented by
Defendants. However, as part of its late-June 2022 internal review, Enochian compared
the primary data Gumrukcu reported to Enochian with the original primary data
provided to Defendants by Dr. Gallay, which revealed that Defendants intentionally
manipulated the results of the chimeric mice study performed by Dr. Gallay and Scripps.
57. Rather than a 98.6% reduction in HBV DNA after eleven (11) weeks,
infected mice given one dose of ENOB-HB-01 only showed a 25.14% reduction in
HBV DNA after sixteen (16) weeks:12
58. Rather than a complete reduction in HBV antigens after eleven (11) weeks,
infected mice given one dose of ENOB-HB-01 showed only slightly reduced HBV
antigens after sixteen (16) weeks:
12
The graphs presented in the following paragraphs were re-created using the raw excel data provided
by Dr. Gallay to Gumrukcu.
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59. Defendants also altered the original data provided by Dr. Gallay by
switching the control group and one of the test groups from the original study, as shown
in the below comparison. Rather than no rebound in HBV DNA after fourteen (14)
weeks, as reported by Defendants, infected mice rebounded after ten (10) and
twelve (12) weeks, respectively:
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60. Rather than no rebound in HBV antigens after fourteen (14) weeks,
infected mice given one dose of ENOB-HB-01 showed rebound in HBV antigens after
twelve (12) weeks:
61. Rather than an effect on liver enzymes after eleven (11) weeks, one dose
of ENOB-HB-01 had no effect on liver enzymes after sixteen (16) weeks:
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62. This final alteration reveals a conscious and deliberate effort by
Defendants to manipulate the data to make it more believable. Defendants altered the
data to show that stopping treatment with nucleoside inhibitors, which prevent HBV
replication and, therefore, the ability of ENOB-HB-01 to kill HBV-infected cells (viral
replication is required for the Hijack RNA to function) led to increases in key liver
enzymes (AST and ALT) that indicate damage to liver cells, presumably to be
consistent with the manipulation to show a more substantial drop in HBV DNA (i.e.,
more HBV-infected cells killed). Because one of the significant concerns with Hijack
RNA is rapid death of liver cells infected with HBV, this dual manipulation—HBV
DNA and liver enzymes—was required to maintain consistency between the various
results.
63. Defendants intentionally misrepresented the results of the chimeric mice
study for the HBV treatment to induce Enochian to pay Defendants the $1.5 million
“Benchmark Payment” tied to the pre-IND meeting with the FDA under the HBV
Agreement.
64. Enochian would not have submitted its pre-IND meeting package to the
FDA based upon only an approximately 25% reduction in HBV DNA found in the
chimeric mice. While the progressive, sustained decrease in HBV DNA of 25% is
indicative of possible positive impact, the limited decrease combined with the lack of
decrease in antigens would have required additional chimeric mice studies, likely with
additional doses, or a shift from AAV to other delivery mechanisms (because AAV
induces antibodies that can limit effectiveness of subsequent doses), before proceeding
with a pre-IND meeting. But for Defendants’ misrepresentations, additional research
and development potentially leading to greater positive results could have continued
pursuant to the terms of the Framework Agreement and HBV Agreement.
65. In addition to the $1.5 million Benchmark Payment, Enochian made the
following payments to G Tech pursuant to Schedule B of the HBV Agreement:
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 R&D Studies: $825,000
 IND-Enabling Studies: $150,000
 Staffing: $3,468,000
66. All of these payments were made by Enochian with the intent and belief
that Defendants would progress and were progressing the pre-clinical research and
development of the prospective HBV treatment to the pre-IND stage in good faith and
in accordance with the HBV Agreement.
67. Following Enochian’s internal review, however, it has been revealed that
Defendants failed to do so. Instead, Defendants manipulated the results of the critical
chimeric mice study while inducing Enochian to make such payments.
C. SARS-CoV-2 and Influenza Pipelines
68. At the same time it was pursuing its HBV pipeline, Enochian became
interested in pursuing Defendants’ Hijack RNA approach for SARS-CoV-2 and
influenza. Specifically, Enochian sought to research and develop inhaled SARS-CoV-
2 treatment (ENOB-CV-01) and prophylaxis13
(ENOB-CV-1114
) product candidates
and, eventually, inhaled influenza treatment (ENOB-FL-01) and prophylaxis (ENOB-
FL-11) product candidates.
69. As a preliminary matter, Enochian believed that positive data from the
proof-of-concept HBV studies Defendants presented at the December 2019 HEP DART
Conference, and subsequent, confirmatory data presented at other key scientific
conferences, were highly suggestive of potential success of the Hijack RNA approach
with SARS-CoV-2 and influenza. Although the data related to HBV, the general
approach is the same for any RNA virus and, therefore, data from HBV was indicative
of potential success with SARS-CoV-2 and influenza.
13
Prophylaxis refers to the prevention of or guarding against the occurrence of a disease. Treatment,
on the other hand, is administered after the occurrence of a disease.
14
ENOB-CV-11 uses the same product as ENOB-CV-01 but for prophylaxis rather than treatment.
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i. Preliminary SARS-CoV-2/Influenza Data Presented by Defendants
70. In addition to promising HBV data, Enochian also received and reviewed
data provided by Defendants specific to SARS-CoV-2 and influenza.
71. As it relates to SARS-CoV-2, the data included the results of an in vitro
study performed by Defendants that was accepted for presentation at the March 7-10,
2021 Conference on Retroviruses and Opportunistic Infections (“CROI”) and
subsequent in vivo data generated by Dr. Gallay that was ultimately incorporated into
the presentation given by Defendants at CROI. CROI is an exclusive scientific meeting
that requires an application to attend and is known to have rigorous standards for
accepting abstracts for presentation.
72. Gumrukcu’s abstract, submitted and accepted for presentation at CROI,
only included in vitro data, but the ultimate presentation at CROI included both
Defendants’ in vitro data and Dr. Gallay’s in vivo data. The results were, effectively,
the same as the proof-of-concept HBV studies and suggested that, because the
conceptual framework of Hijack RNA could be reproduced with different infectious
agents, the approach appeared solidly grounded. Enochian also was informed by
Defendants that Dr. Gallay was enthusiastic about this approach to SARS-CoV-2 and
had similar in vitro data that showed Hijack RNA killed infected, but not uninfected
cells.
73. Gumrukcu ultimately presented the in vitro and in vivo data as a “spotlight
of science” presentation at CROI. The following slides were included in Gumrukcu’s
CROI presentation:
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74. Prior to CROI, Gumrukcu provided updates relating to the in vitro and in
vivo SARS-CoV-2 proof-of-concept studies at Enochian Board of Directors meetings
in May, September, and November 2020 and ultimately previewed a draft copy of the
CROI presentation at the February 2021 Board of Directors meeting. At the February
2021 meeting, Gumrukcu explained that Hijack RNA, which was shown to be effective
in Defendants’ HBV studies, had also been shown to be effective to treat SARS-CoV-
2.
75. As it relates to influenza, Gumrukcu presented in vitro data to the Enochian
research and development team that showed the killing of multiple subtypes of
influenza-infected cells but not uninfected cells. The data was accepted for presentation
at another key scientific conference, the Annual Conference of the American Society of
Gene and Cell Therapy (“ASGCT”), which was held virtually on May 12-15, 2020.
76. Based upon the SARS-CoV-2 and influenza data developed by Gumrukcu,
SRI, and their collaborators, and presented to Enochian, and pursuant to the Framework
Agreement, Enochian began negotiations with Defendants to acquire an exclusive
license for the application of the Hijack RNA approach to the treatment of and
prophylaxis for coronaviruses, including SARS-CoV-2, and influenza viruses in
February and March 2021.
77. As Enochian considered the terms and conditions under which it would
acquire the license, Gumrukcu reported to Enochian preliminary results of an in vivo
study involving ENOB-CV-11 (the prophylaxis product candidate) in hACE2 mice15
that was purportedly then underway. Specifically, at an ad hoc meeting of Enochian’s
Board of Directors held on March 30, 2021—specifically convened to discuss
Defendants’ Hijack RNA approach to SARS-CoV-2 and influenza prophylaxis and
treatment and the possibility of Enochian licensing the approach—Gumrukcu reported
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hACE2 mice are the most commonly used animal model to study potential COVID-19 therapies,
prophylaxis, and vaccines.
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that mice treated with ENOB-CV-11 were challenged nine (9) days after treatment with
SARS-CoV-2 and showed no infection:
78. At the March 30, 2021 meeting, based upon Gumrukcu’s presentation of
these promising results, Enochian’s Board of Directors authorized and directed
Enochian to proceed to finalize the license agreement with Defendants.
79. On April 5, 2021, Gumrukcu provided what he described as “updated”
results of the same in vivo ENOB-CV-11 study to Enochian. Gumrukcu reported that
the same mice were again challenged with SARS-CoV-2 thirty (30) days after treatment
and still showed no sign of infection two (2) weeks after this second challenge:
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80. Upon information and belief, the in vivo ENOB-CV-11 study reported to
Enochian in late March and early April 2021 was never performed and the results
showing a successful outcome were entirely fabricated. Upon information and belief,
Defendants also fabricated successful sixty (60) and ninety (90) day results.
ii. The COVID Agreement
81. Enochian entered into a Statement of Work and License Agreement for
Influenza and Coronavirus Indications with an Effective Date of April 18, 2021, as
amended on June 16, 2021, with G Tech and SRI (the “COVID Agreement”). The
COVID Agreement incorporated by reference the terms of the Framework Agreement.
The COVID Agreement was signed by Dr. Mark Dybul (on behalf of Enochian),
Wittekind (on behalf of G Tech), and Gumrukcu (on behalf of SRI).
82. Like the HBV Agreement, the COVID Agreement provided that G Tech
and SRI would advance the pipeline until it reached the first encounter with the FDA.
All research G Tech and SRI contracted out to have conducted, or conducted
themselves, would be transferred to Enochian during the process of preparing a
submission to the FDA, after which Enochian would assume the research and
development.
83. As set forth in Section 4.1 of the COVID Agreement, during the “Funding
Term” (commencing as of the Effective Date of the COVID Agreement and continuing
for 24 months), pre-clinical research and development (including IND-enabling studies)
were the sole responsibility of G Tech and SRI. G Tech and SRI had the ability to
utilize any facilities that they determined would be appropriate for the performance of
their obligations and were permitted to collaborate or subcontract obligations if
appropriate.
84. Pursuant to Section 4.2 of the COVID Agreement, G Tech and SRI were
required to perform their obligations under “Commercially Reasonable Efforts,” as
defined in the COVID Agreement. Specifically, “Commercially Reasonable Efforts”
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were defined in Article I, Section L as:
[T]he level of reasonable, diligent, good faith efforts that
biopharmaceutical, pharmaceutical or other life sciences
companies of similar size and at a similar stage in their
development as such Party typically devote to the
development or commercialization of products, therapies,
services or solutions owned by them that are at a similar stage
in their development or life cycle and are of similar market
potential taking into account efficacy, safety, approved
labeling, the competitiveness of alternative product,
therapies, services, or solutions in the marketplaces, the
patent and other proprietary position of the product, therapy,
service or solution or the likelihood of regulatory approval
and other relevant factors.
85. In consideration for the exclusive license and the work to be performed by
G Tech and SRI, Enochian agreed to make several payments to G Tech.
86. Under Section 2.1(a) of the COVID Agreement, Enochian agreed to pay
an “Upfront Payment” of $10 million to G Tech within sixty (60) days of the Effective
Date. The sixty (60) day period was extended to July 31, 2021 by an amendment
executed by the parties on June 16, 2021.
87. Pursuant to Section 8.9 of the COVID Agreement, if Enochian declined to
pay the Upfront Payment within the agreed time period, the COVID Agreement and the
license granted therein would terminate without penalty.
88. In addition, Enochian agreed to provide certain cash funding for research
costs and equipment and certain other in-kind funding during the Funding Period,
including “Costs to Date of Vector Research” and “Costs to Date of Non-Vector
Research,” as these terms are defined in Section 2.1(b) and Schedule B of the COVID
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Agreement. These amounts totaled $760,000.00.
89. These “Costs to Date” purportedly included the costs associated with
initial experiments, studies, tests, and other research performed by Defendants in
cooperation with third-parties.
90. All of these payments were made with the intent and the belief that
Defendants were progressing and would continue to progress the pre-clinical research
and development of Enochian’s SARS-CoV-2/influenza pipelines to the pre-IND stage
in good faith and in accordance with the COVID Agreement.
91. Following Enochian’s late-June 2022 internal review, however, it has been
revealed that Defendants failed to do so. Instead, it has become clear that Defendants
manipulated and falsified the results of multiple studies to induce Enochian to make
such payments.
iii. Defendants Received Results of Failed ENOB-CV-11 AAV Study
92. In or around March 2021, Defendants approached Texas Biomedical
Research Institute (“Texas Biomed”) to perform a study involving ENOB-CV-11 (the
candidate prophylaxis product) in hACE2 mice. In the study, the Hijack RNA was
encapsulated and delivered by an AAV particle.
93. Texas Biomed’s ENOB-CV-11 AAV study was performed in or around
May 2021. It was the only study performed by Texas Biomed in connection with
Enochian’s SARS-CoV-2 and influenza pipelines.
94. In the study, mice were treated with ENOB-CV-11, a mock product, or a
control. The mice were then challenged with SARS-CoV-2 nine (9) days later.
95. Notably, this study was performed after Defendants reported day nine (9)
and day thirty (30) results of the in vivo ENOB-CV-11 study to Enochian in late March
and early April 2021. As such, the in vivo ENOB-CV-11 study reported by Defendants
to Enochian in March and April 2021 could not have been performed by Texas Biomed.
As explained above, upon information and belief, the in vivo ENOB-CV-11 study
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reported by Defendants to Enochian was never performed and the results showing a
successful outcome were entirely fabricated.
96. On June 8, 2021, Gumrukcu attended a Zoom meeting with Dr. Luis
Martinez-Sobrido and Dr. Jun-Gyu Park, DVM Ph.D. (“Dr. Park”) of Texas Biomed
presumably to discuss the findings of the ENOB-CV-11 AAV study.
97. On June 14, 2021, Gumrukcu received an e-mail from Dr. Park attaching
results of the study, including the primary data and a slide deck (with pictures).
98. The results demonstrated that ENOB-CV-11 was ineffective and had no
prophylactic effect. All but one of the mice died by day eight (8) after being challenged
with SARS-CoV-2.16
In short, the study had failed and no follow-up challenges to the
same (now dead) mice could be done.
99. Notably, on or before the June 8, 2021 Zoom meeting, and no later than
June 14, 2021, Defendants knew of the results of the failed ENOB-CV-11 AAV study.
Two days later, on June 16, 2021, Enochian made the $10 million Upfront Payment to
G Tech. In other words, as Enochian and Defendants were discussing moving forward
with the $10 million Upfront Payment to G Tech and negotiating an amendment to the
COVID Agreement to provide for such payment, Defendants were in possession of
results demonstrably confirming that the ENOB-CV-11 AAV study failed and
concealed those results from Enochian.
100. If Defendants had reported to Enochian the true, accurate results of the
ENOB-CV-11 AAV study provided to Defendants by Texas Biomed, which
demonstrated failure of the ENOB-CV-11 treatment, Enochian would not have made
the Upfront Payment and the COVID Agreement would have terminated.
101. Defendants never reported the actual results of the failed ENOB-CV-11
AAV study to Enochian.
16
Upon information and belief, the sixth mouse was not effectively challenged with SARS-CoV-2 and
did not contract the virus. As such, the survival of the sixth mouse did not and does not indicate
success of ENOB-CV-11.
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iv. Defendants Fabricated Multiple ENOB-CV-01 Studies
102. Not only did Defendants fail to disclose the results of the failed ENOB-
CV-11 AAV study, Defendants fabricated four ENOB-CV-01 studies out of whole cloth
and reported fake results from those never-performed studies to Enochian. These
studies include:
(1) an in vivo ENOB-CV-01 AAV study;
(2) an in vivo ENOB-CV-01 pDNA study;
(3) an in vitro ENOB-CV-01 pDNA cytotoxicity study; and
(4) a second in vivo ENOB-CV-01 pDNA study.
103. Enochian relied on each of these studies to move forward with the research
and development of ENOB-CV-01 (and its other SARS-CoV-2 and influenza pipelines)
and to prepare and submit its pre-IND meeting request and submission package for
ENOB-CV-01 to the FDA, thereby incurring millions of dollars of damages. Each of
these never-performed studies is addressed, in turn, below.
104. First, in or around July or August 2021, Defendants used the results of the
failed ENOB-CV-11 AAV study to fabricate a purportedly successful ENOB-CV-01
AAV study. To do so, Defendants isolated the sole surviving mouse from the ENOB-
CV-11-treated group to make the data appear that there was a 100% survival in the
purported ENOB-CV-01-treated group:
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Original Data17
Manipulated Data18
105. In presenting the “results” to Enochian, Defendants attributed the
fabricated ENOB-CV-01 AAV study to Texas Biomed.
106. Further, to make the fabricated ENOB-CV-01 AAV study appear 100%
successful, Defendants renamed the “Mock-infected, mock-treated (PBS)” control
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Red box added.
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Red box added.
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group from the failed ENOB-CV-11 AAV study as the “1e4 PFU SARS-CoV-2, test
AAV treated” group in the fabricated ENOB-CV-01 AAV study. Because the mice in
the “Mock-infected, mock-treated (PBS)” control group in the failed ENOB-CV-11
AAV study were neither infected with SARS-CoV-2 nor prophylaxed with ENOB-CV-
11, the group showed 100% survival after eight (8) days. By using the control group
from the failed ENOB-CV-11 AAV study as the test group in the fabricated ENOB-
CV-01 AAV study, Defendants were able to make the fabricated ENOB-CV-01 AAV
study appear fully successful after eight (8) days:19
Original Data20
Manipulated Data21
107. Defendants further represented to Enochian that the mice challenged with
SARS-CoV-2 and treated with ENOB-CV-01 had a survival rate of 100% up to thirty
(30) days post-infection (blue line in the image below), whereas the mice not treated or
mock treated after infection all died by eight (8) days post-infection:
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The test group from the failed ENOB-CV-11 AAV study, “AAV-hijacking-treated, SARS-CoV-
2/NLuc,” which showed 25% survival after eight (8) days, was renamed the infected and mock-treated
group, “1ef PFU SARS-CoV-2, mock AAV treated,” in the fabricated ENOB-CV-01 AAV study.
20
Red boxes and black arrow added.
21
Red boxes and black arrow added.
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108. Enochian relied upon Defendants’ fabricated ENOB-CV-01 AAV study—
including the results presented by Defendants above—in preparing and submitting its
pre-IND meeting request and submission package for ENOB-CV-01 to the FDA on
September 7, 2021.
109. Enochian would not have submitted a pre-IND meeting request to the FDA
had it known that Defendants fabricated the ENOB-CV-01 AAV study.
110. Additionally, had Enochian known that the ENOB-CV-11 AAV study had
failed and/or that Defendants had manufactured from that failed ENOB-CV-11 AAV
study a fabricated ENOB-CV-01 AAV study, it would have reconsidered conducting
further research and development of its SARS-CoV-2 and influenza pipelines.
111. Second, due to then-recently expressed FDA concerns regarding AAV
vector-based products, Enochian and Defendants decided to shift away from an AAV
vector to a pDNA vector encapsulated in a lipid nanoparticle (“LNP”). Enochian began
working with Acuitas Therapeutics (“Acuitas”) to provide LNP formulations for further
study.
112. On or around August 22, 2021, Gumrukcu reported the results of an in vivo
ENOB-CV-01 pDNA study to Enochian. This study was never performed and the
results are fake.
113. Instead, Defendants used the failed ENOB-CV-11 AAV study to fabricate
a purportedly successful in vivo ENOB-CV-01 pDNA study. To do so, Defendants
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simply copied certain data from the failed ENOB-CV-11 AAV study and attributed it
to certain control and test groups in the fabricated ENOB-CV-01 pDNA study. For
example, Defendants used the results for the “PBS control, mock-infected” control
group from the ENOC-CV-11 AAV study, which showed 100% survival, and attributed
it to the “Group #1 = Test Plasmid 0.5ug, SARS-CoV-2 infected” test group in the
ENOB-CV-01 pDNA study:
Original AAV Data22
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Red and green boxes and annotation added.
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Manipulated pDNA Data23
114. In addition to transposing certain data from the failed ENOB-CV-11 AAV
study, Defendants also falsified data out of whole cloth to fabricate the purportedly
successful in vivo ENOB-CV-01 pDNA study.
115. The fabricated ENOB-CV-01 pDNA study was also used in Enochian’s
September 7, 2021 pre-IND meeting request and submission package to the FDA for
ENOB-CV-01.
116. Enochian would not have submitted a pre-IND meeting request and
submission package to the FDA had it known that Defendants fabricated the ENOB-
CV-01 pDNA study.
117. Moreover, following Defendants’ report of the purportedly successful
ENOB-CV-01 pDNA study to Enochian and in reliance thereon, in or around August
2021 Enochian entered into a $3.7 million agreement with Aldevron, LLC (“Aldevron”)
to manufacture GMP plasmid for the pDNA vector.
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Red and green boxes and annotation added.
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118. Had Enochian known that Defendants had fabricated the results of the
ENOB-CV-01 pDNA study, it would have not incurred these additional costs paid to
Aldevron to further the research and development of ENOB-CV-01.
119. Third, on August 24, 2021, Gumrukcu reported the results of an in vitro
ENOB-CV-01 pDNA cytotoxicity study to Enochian’s Head of Molecular Biology,
Tung Nguyen, so that those results could be included in Enochian’s pre-IND meeting
request and submission package for ENOB-CV-01. Defendants attributed the study and
the results to Texas Biomed. This study was not performed by Texas Biomed and, upon
information and belief, was never performed, and the results of the study are fake.
120. As noted above, Texas Biomed only conducted one study in connection
with Enochian’s SARS-CoV-2 and influenza pipelines—the failed ENOB-CV-11 AAV
study. In addition, Texas Biomed has confirmed that it has never worked with pDNA
on behalf of Enochian. Therefore, Texas Biomed could not have conducted the in vitro
ENOB-CV-01 pDNA cytotoxicity study reported to Enochian by Defendants.
121. Upon information and belief, Defendants entirely fabricated the results
from the in vitro ENOB-CV-01 pDNA cytotoxicity study.
122. The falsified data for the in vitro ENOB-CV-01 pDNA cytotoxicity study
was also used in Enochian’s September 7, 2021 pre-IND meeting request and
submission package to the FDA for ENOB-CV-01.
123. Enochian would not have submitted a pre-IND meeting request and
submission package to the FDA had it known that Defendants falsified the in vitro
ENOB-CV-01 pDNA cytotoxicity study.
124. Fourth, Defendants fabricated a second in vivo ENOB-CV-01 pDNA
study—but this time attributed it to Dr. Gallay and Scripps—to validate the efficacy of
the ENOB-CV-01 pDNA LNP formulations.
125. Notably, in or around October 2021, certain LNP formulations were
shipped to Scripps for such a study, leading Enochian to believe that this study was
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being conducted by Defendants.
126. On April 11, 2022, Gumrukcu reported the results for the second ENOB-
CV-01 pDNA study to Enochian. The data Defendants shared with Enochian showed
survival, although with loss of some body weight, with one formulation of the LNP at
a dose of 3ug:
127. This second ENOB-CV-01 pDNA study was not performed by Scripps
and, upon information and belief, was never performed, and the results of the study are
fake.
128. Dr. Gallay has since confirmed that his Scripps lab never tested the LNP
formulations. While Dr. Gallay’s lab received the LNP formulations, the formulations
were still in his Scripps lab’s freezer as of late June 2022. In other words, the LNP
formulations shipped to Scripps were never used and, therefore, the second ENOB-CV-
01 pDNA study could not have been performed by Scripps as indicated by Defendants.
129. Defendants’ inclusion of body weight loss, a side effect of the treatment,
in the results of the fabricated study again reveals a conscious and deliberate effort by
Defendants to manipulate the data to make it more believable. Defendants intentionally
incorporated certain side effects in the falsified results to further conceal their fraud.
130. The data from this study, as well as the first fabricated ENOB-CV-01
pDNA study attributed to Texas Biomed (discussed above), were the basis for two (2)
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additional in vivo studies coordinated by Enochian.
131. Following Defendants’ transfer of data to Enochian to facilitate its pre-
IND meeting request and submission package to the FDA for ENOB-CV-01, Enochian
undertook additional, subsequent pre-clinical studies to replicate and further study the
results reported by Defendants to Enochian. Beginning in April 2022, Enochian
coordinated with IIT Research Institute (“IITRI”), a well-respected contract research
organization, to replicate Defendants’ results. However, no study performed by IITRI
(with any version of LNP formulation, ug dosage, or number of doses) showed any
success similar to the fabricated studies presented to Enochian by Defendants.
132. In total, Enochian agreed to pay IITRI $1.9 million over several months to
attempt to replicate Defendants’ results.
133. Enochian would not have engaged and paid IITRI had it known that
Defendants falsified the ENOB-CV-01 pDNA studies, as described above, and falsified
the results.
134. As a result of Defendants’ manipulation and falsification of numerous
studies and corresponding data in Enochian’s HBV and SARS-CoV-2/influenza
pipelines, Enochian ultimately paid approximately $25 million to Defendants and third-
parties that it would not otherwise have paid.24
FIRST CAUSE OF ACTION
BREACH OF CONTRACT – FRAMEWORK AGREEMENT
(Against G Tech and SRI)
135. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
136. Enochian entered into a written contract, the Framework Agreement, with
an Effective Date of November 15, 2019.
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Enochian’s investigation is ongoing, and Enochian reserves the right to amend or supplement its
total damages claimed.
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137. The Framework Agreement was a valid and binding contract between and
among Enochian and G Tech and SRI. Subject to the Framework Agreement, Enochian,
G Tech, and SRI subsequently executed the HBV Agreement and COVID Agreement,
which incorporated by reference the terms of the Framework Agreement.
138. Enochian fully performed its material obligations under the Framework
Agreement at all relevant times.
139. Among other things, G Tech and SRI materially breached the Framework
Agreement by falsifying and misrepresenting data from studies performed pursuant to
the Framework Agreement with the intent to induce Enochian to make payments
thereunder.
140. Pursuant to Section 2(b) of the Framework Agreement, G Tech and SRI
were required to notify Enochian of any “unforeseen or unusual events or
assumptions… that would affect the outcome of the budget, timeline or other aspects of
the Project.”
141. Pursuant to Section 3(a) of the Framework Agreement, G Tech and SRI
agreed to “comply, in all material respects, with all United States laws and regulations
of any state, federal or local governmental or regulatory agency.”
142. Pursuant to Section 9(c) of the Framework Agreement, G Tech and SRI
covenanted to “cooperate with [Enochian], during and following the completion of a
Project in all matters related to proof-of-concept, validation, IND and pre-IND
applications and other studies in furtherance of [Enochian’s] Business as it relates to
each Project.”
143. By falsifying and misrepresenting data from studies performed pursuant to
the Framework Agreement, G Tech and SRI materially breached Sections 2(b), 3(a),
and 9(c) of the Framework Agreement, which were incorporated by reference in both
the HBV Agreement and COVID Agreement.
144. In light of Enochian’s internal review and resulting discovery of G Tech’s
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and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s
actions were intentional and designed to induce Enochian to make payments under the
Framework Agreement. G Tech’s and SRI’s conduct was at all times willful,
intentional, malicious, and reckless in its disregard for their obligations to Enochian.
145. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian
has been and continues to be injured and has sustained significant damages in an amount
to be determined by the evidence at trial.
146. G Tech’s and SRI’s conduct was the sole or substantial cause of
Enochian’s harm.
147. Enochian is entitled to and seeks to recover all available contract damages
including consequential damages, lost profits, loss of future earnings, and attorney’s
fees where allowed by contract or statute.
SECOND CAUSE OF ACTION
BREACH OF THE IMPLIED COVENANT OF GOOD FAITH AND FAIR
DEALING – FRAMEWORK AGREEMENT
(Against G Tech and SRI)
148. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
149. Implied in the business relationship between and among Enochian and G
Tech and SRI, including, but not limited to, the covenants implied in the language of
the Framework Agreement, is a promise of good faith and fair dealing. This forms a
covenant to refrain from doing anything that would unfairly interfere with the right of
the other party to receive the benefit(s) of the contract.
150. As a result of negotiations between the parties prior to entering the
Framework Agreement, and impliedly included in the resulting agreement, Enochian
was entitled to rely on G Tech’s and SRI’s representations that they would execute their
duties under the Framework Agreement in good faith. Good faith required, among other
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things, that G Tech and SRI accurately report any and all experiments, studies, tests,
and other research performed pursuant to the Framework Agreement to Enochian.
151. G Tech and SRI did not act in good faith, insofar as they falsified and
misrepresented data from studies performed pursuant to the Framework Agreement
with the intent to induce Enochian to make payments thereunder.
152. In light of Enochian’s internal review and resulting discovery of G Tech’s
and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s
actions were intentional and designed to induce Enochian to make payments under the
Framework Agreement. G Tech’s and SRI’s conduct was at all times willful,
intentional, malicious, and reckless in their disregard for their obligations to Enochian.
153. Enochian fully performed its material obligations under the Framework
Agreement at all relevant times.
154. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian
has been and continues to be injured and has sustained significant damages in an amount
to be determined by the evidence at trial.
155. G Tech’s and SRI’s conduct was the sole or substantial cause of
Enochian’s harm.
156. Enochian is entitled to and seeks to recover all available damages in tort
including special damages, general damages, consequential damages, lost profits, loss
of future earnings, punitive damages, and attorney’s fees where allowed by contract or
statute.
THIRD CAUSE OF ACTION
BREACH OF CONTRACT – HBV AGREEMENT
(Against G Tech and SRI)
157. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
158. Enochian entered into a written contract, the HBV Agreement, with an
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Effective Date of January 31, 2020. The HBV Agreement incorporated by reference
the terms of the Framework Agreement.
159. The HBV Agreement was a valid and binding contract between and among
Enochian and G Tech and SRI.
160. Enochian fully performed its material obligations under the HBV
Agreement at all relevant times.
161. Among other things, G Tech and SRI materially breached the HBV
Agreement by failing to use “Commercially Reasonable Efforts” to perform its
responsibilities under the agreement.
162. Pursuant to Section 4.2 of the HBV Agreement, G Tech and SRI were
required to perform their obligations under “Commercially Reasonable Efforts,” as
defined in the HBV Agreement. Specifically, “Commercially Reasonable Efforts” were
defined as in Article I, Section H:
[T]he level of reasonable, diligent, good faith efforts that
biopharmaceutical, pharmaceutical or other life sciences
companies of similar size and a[t] a similar stage in their
development as such Party typically devote to the
development and/or commercialization of products and/or
therapies owned by them that are at a similar stage in their
development or life cycle and are of similar market potential
taking into account efficacy, safety, approved labeling, the
competitiveness of alternative products or therapies in the
marketplace, the patent and other proprietary position of the
product and/or therapy, the likelihood of regulatory approval,
and other relevant factors.
163. By falsifying and misrepresenting data from studies performed pursuant to
the HBV Agreement with the intent to induce Enochian to make payments thereunder,
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G Tech and SRI did not act with “the level of reasonable, diligent, good faith efforts”
required by the HBV Agreement.
164. In light of Enochian’s internal review and resulting discovery of G Tech’s
and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s
actions were intentional and designed to induce Enochian to make payments under the
HBV Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional,
malicious, and reckless in its disregard for their obligations to Enochian.
165. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian
has been and continues to be injured and has sustained significant damages in an amount
to be determined by the evidence at trial.
166. Enochian is entitled to and seeks to recover all available contract damages
including consequential damages, lost profits, loss of future earnings, and attorney’s
fees where allowed by contract or statute.
FOURTH CAUSE OF ACTION
BREACH OF THE IMPLIED COVENANT OF GOOD FAITH AND FAIR
DEALING – HBV AGREEMENT
(Against G Tech and SRI)
167. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
168. Implied in the business relationship between and among Enochian and G
Tech and SRI, including, but not limited to, the covenants implied in the language of
the HBV Agreement, is a promise of good faith and fair dealing. This forms a covenant
to refrain from doing anything that would unfairly interfere with the right of the other
party to receive the benefit(s) of the contract.
169. As a result of negotiations between the parties prior to entering the HBV
Agreement, and impliedly included in the resulting agreement, Enochian was entitled
to rely on G Tech’s and SRI’s representations that they would execute their duties under
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the HBV Agreement in good faith. Good faith required, among other things, that G
Tech and SRI accurately report any and all experiments, studies, tests, and other
research performed pursuant to the HBV Agreement to Enochian.
170. G Tech and SRI did not act in good faith, insofar as they falsified and
misrepresented data from studies performed pursuant to the HBV Agreement with the
intent to induce Enochian to make payments thereunder.
171. In light of Enochian’s internal review and resulting discovery of G Tech’s
and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s
actions were intentional and designed to induce Enochian to make payments under the
HBV Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional,
malicious, and reckless in their disregard for their obligations to Enochian.
172. Enochian fully performed its material obligations under the HBV
Agreement at all relevant times.
173. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian
has been and continues to be injured and has sustained significant damages in an amount
to be determined by the evidence at trial.
174. Enochian is entitled to and seeks to recover all available damages in tort
including special damages, general damages, consequential damages, lost profits, loss
of future earnings, punitive damages, and attorney’s fees where allowed by contract or
statute.
FIFTH CAUSE OF ACTION
BREACH OF CONTRACT – COVID AGREEMENT
(Against G Tech and SRI)
175. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
176. Enochian entered into a written contract, the COVID Agreement, with an
Effective Date of April 18, 2021. The COVID Agreement incorporated by reference
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the terms of the Framework Agreement.
177. The COVID Agreement was a valid and binding contract between and
among Enochian and G Tech and SRI.
178. Enochian fully performed its material obligations under the COVID
Agreement at all relevant times.
179. Among other things, G Tech and SRI materially breached the COVID
Agreement by failing to use “Commercially Reasonable Efforts” to perform its
responsibilities under the agreement.
180. Pursuant to Section 4.2 of the COVID Agreement, G Tech and SRI were
required to perform its obligations under “Commercially Reasonable Efforts,” as
defined in the COVID Agreement. Specifically, “Commercially Reasonable Efforts”
were defined as in Article I, Section L:
[T]he level of reasonable, diligent, good faith efforts that
biopharmaceutical, pharmaceutical or other life sciences
companies of similar size and at a similar stage in their
development as such Party typically devote to the
development or commercialization of products, therapies,
services or solutions owned by them that are at a similar stage
in their development or life cycle and are of similar market
potential taking into account efficacy, safety, approved
labeling, the competitiveness of alternative product,
therapies, services, or solutions in the marketplaces, the
patent and other proprietary position of the product, therapy,
service or solution or the likelihood of regulatory approval
and other relevant factors.
181. By falsifying and misrepresenting data from studies performed pursuant to
the COVID Agreement with the intent to induce Enochian to make payments
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thereunder, G Tech and SRI did not act with “the level of reasonable, diligent, good
faith efforts” required by the COVID Agreement.
182. In light of Enochian’s internal review and resulting discovery of G Tech’s
and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s
actions were intentional and designed to induce Enochian to make payments under the
COVID Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional,
malicious, and reckless in its disregard for their obligations to Enochian.
183. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian
has been and continues to be injured and has sustained significant damages in an amount
to be determined by the evidence at trial.
184. Enochian is entitled to and seeks to recover all available contract damages
including consequential damages, lost profits, loss of future earnings, and attorney’s
fees where allowed by contract or statute.
SIXTH CAUSE OF ACTION
BREACH OF THE IMPLIED COVENANT OF GOOD FAITH AND FAIR
DEALING – COVID AGREEMENT
(Against G Tech and SRI)
185. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
186. Implied in the business relationship between and among Enochian and G
Tech and SRI, including, but not limited to, the covenants implied in the language of
the COVID Agreement, is a promise of good faith and fair dealing. This forms a
covenant to refrain from doing anything that would unfairly interfere with the right of
the other party to receive the benefit(s) of the contract.
187. As a result of negotiations between the parties prior to entering the COVID
Agreement, and impliedly included in the resulting agreement, Enochian was entitled
to rely on G Tech’s and SRI’s representations that they would execute their duties under
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the COVID Agreement in good faith. Good faith required, among other things, that G
Tech and SRI accurately report any and all experiments, studies, tests, and other
research performed pursuant to the COVID Agreement to Enochian.
188. G Tech and SRI did not act in good faith, insofar as they falsified and
misrepresented data from studies performed pursuant to the COVID Agreement with
the intent to induce Enochian to make payments thereunder.
189. In light of Enochian’s internal review and resulting discovery of G Tech’s
and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s
actions were intentional and designed to induce Enochian to make payments under the
COVID Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional,
malicious, and reckless in their disregard for their obligations to Enochian.
190. Enochian fully performed its material obligations under the COVID
Agreement at all relevant times.
191. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian
has been and continues to be injured and has sustained significant damages in an amount
to be determined by the evidence at trial.
192. Enochian is entitled to and seeks to recover all available damages in tort
including special damages, general damages, consequential damages, lost profits, loss
of future earnings, punitive damages, and attorney’s fees where allowed by contract or
statute.
SEVENTH CAUSE OF ACTION
INTENTIONAL MISREPRESENTATION/FRAUD
(Against All Defendants)
193. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
194. Defendants made multiple false representations to, and concealed
information from, Enochian concerning material facts, including, but not limited to: (1)
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the validity and/or success of certain studies performed relating to the HBV pipeline;
and (2) the validity and/or success of certain studies performed relating to the SARS-
CoV-2 and influenza pipelines.
195. Both prior to and during the period that Defendants contracted with
Enochian to provide services and licenses to Enochian, Defendants represented to
Enochian that it would act in good faith, which included, but was not limited to,
accurately reporting any and all experiments, studies, tests, and other research
performed pursuant to the HBV Agreement and the COVID Agreement to Enochian.
196. Instead, Defendants, with the intent to induce Enochian to make the
“Benchmark Payment” and subsequent payments pursuant to the HBV Agreement,
misrepresented, falsified, and concealed data from studies performed pursuant to the
HBV Agreement, as discussed herein.
197. Similarly, Defendants, with the intent to induce Enochian to make the
“Upfront Payment,” “Costs to Date” payments, and additional payments contemplated
by the COVID Agreement, misrepresented, falsified, and concealed data from studies
performed pursuant to the COVID Agreement, as discussed herein.
198. Defendants’ representations were false, and Defendants knew that they
were false at all relevant times, including all times in which Defendants made such
representations. Furthermore, Defendants’ conduct was at all times willful, intentional,
malicious, and reckless in its disregard for its obligations to Enochian.
199. Defendants intended for Enochian to rely upon Defendants’
representations to make payments to Defendants pursuant to the HBV Agreement and
COVID Agreement.
200. Enochian reasonably relied on Defendants’ misrepresentations when
deciding to make payments to Defendants pursuant to the HBV Agreement and COVID
Agreement.
201. As a direct and proximate result of Defendants’ misrepresentations,
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Enochian has been and continues to be injured and has sustained significant damages in
an amount to be determined by the evidence at trial.
202. Defendants’ conduct was the sole or substantial cause of Enochian’s harm.
203. Enochian is entitled to and seeks to recover all available damages in tort
including special damages, general damages, consequential damages, lost profits, loss
of future earnings, punitive damages, and attorney’s fees where allowed by contract or
statute.
EIGHTH CAUSE OF ACTION
FRAUDULENT CONCEALMENT
(Against All Defendants)
204. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
205. Defendants concealed information from Enochian concerning material
facts, including, but not limited to: (1) the validity and/or success of certain studies
performed relating to the HBV pipeline; and (2) the validity and/or success of certain
studies performed relating to the SARS-CoV-2 and influenza pipelines.
206. Defendants had a duty to disclose the concealed facts based on the terms
of the Framework Agreement, the HBV Agreement, and the COVID Agreement.
207. Both prior to and during the period that Defendants contracted with
Enochian to provide services and licenses to Enochian, Defendants represented to
Enochian that Defendants would, among other things, accurately report any and all
experiments, studies, tests, and other research performed pursuant to the HBV
Agreement and the COVID Agreement to Enochian.
208. However, Defendants concealed true data from studies performed pursuant
to the HBV Agreement and COVID Agreement and instead presented false and/or
manipulated data to Enochian, as described herein. Defendants knew that their
representations were false at all relevant times, including all times in which Defendants
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made such representations. Furthermore, Defendants’ conduct was at all times willful,
intentional, malicious, and reckless in its disregard for its obligations to Enochian.
209. Enochian could not have otherwise discovered the true data from the
research performed pursuant to the HBV Agreement and the COVID Agreement.
210. Defendants intentionally concealed the true data from Enochian to induce
Enochian to make payments to Defendants pursuant to the HBV Agreement and
COVID Agreement, as described herein.
211. Enochian reasonably relied on Defendants’ misrepresentations when
deciding to make payments to Defendants pursuant to the HBV Agreement and COVID
Agreement. As explained above, if Enochian had knowledge of the true data, it would
have behaved differently.
212. As a direct and proximate result of Defendants’ fraudulent concealment,
Enochian has been and continues to be injured and has sustained significant damages in
an amount to be determined by the evidence at trial.
213. Enochian is entitled to and seeks to recover all available damages in tort
including special damages, general damages, consequential damages, lost profits, loss
of future earnings, punitive damages, and attorney’s fees where allowed by contract or
statute.
NINTH CAUSE OF ACTION
FRAUDULENT NONDISCLOSURE
(Against All Defendants)
214. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
215. Defendants failed to disclose material facts to Enochian, including, but not
limited to: (1) the validity and/or success of certain studies performed relating to the
HBV pipeline; and (2) the validity and/or success of certain studies performed relating
to the SARS-CoV-2 and influenza pipelines.
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216. Defendants had a duty to disclose the withheld facts based on the terms of
the Framework Agreement, the HBV Agreement, and the COVID Agreement.
217. Both prior to and during the period that Defendants contracted with
Enochian to provide services and licenses to Enochian, Defendants represented to
Enochian that Defendants would, among other things, accurately report any and all
experiments, studies, tests, and other research performed pursuant to the HBV
Agreement and the COVID Agreement to Enochian.
218. However, Defendants failed to disclose the true data from studies
performed pursuant to the HBV Agreement and COVID Agreement and instead
presented false data to Enochian, as described herein. Defendants knew that their
representations were false at all relevant times, including all times in which Defendants
made such representations. Furthermore, Defendants’ conduct was at all times willful,
intentional, malicious, and reckless in its disregard for its obligations to Enochian.
219. Enochian could not have otherwise discovered the true data from the
research performed pursuant to the HBV Agreement and the COVID Agreement.
220. Defendants intentionally withheld the true data from Enochian to induce
Enochian to make payments to Defendants pursuant to the HBV Agreement and
COVID Agreement, as described herein.
221. Enochian reasonably relied on Defendants’ misrepresentations when
deciding to make payments to Defendants pursuant to the HBV Agreement and COVID
Agreement. As explained above, if Enochian had knowledge of the true data, it would
have behaved differently.
222. As a direct and proximate result of Defendants’ fraudulent nondisclosure,
Enochian has been and continues to be injured and has sustained significant damages in
an amount to be determined by the evidence at trial.
223. Enochian is entitled to and seeks to recover all available damages in tort
including special damages, general damages, consequential damages, lost profits, loss
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COMPLAINT
of future earnings, punitive damages, and attorney’s fees where allowed by contract or
statute.
TENTH CAUSE OF ACTION
NEGLIGENT MISREPRESENTATION
(Against All Defendants)
224. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
225. Defendants made multiple false representations to, and concealed
information from, Enochian concerning material facts, including, but not limited to: (1)
the validity and/or success of certain studies performed relating to the HBV pipeline;
and (2) the validity and/or success of certain studies performed relating to the SARS-
CoV-2 and influenza pipelines.
226. Both prior to and during the period that Defendants contracted with
Enochian to provide services and licenses to Enochian, Defendants represented to
Enochian that it would act in good faith, which included, but was not limited to,
accurately reporting any and all experiments, studies, tests, and other research
performed pursuant to the HBV Agreement and the COVID Agreement to Enochian.
227. Instead, Defendants, with the intent to induce Enochian to make the
“Benchmark Payment” and subsequent payments pursuant to the HBV Agreement,
misrepresented, falsified, and concealed data from studies performed pursuant to the
HBV Agreement, as discussed herein.
228. Similarly, Defendants, with the intent to induce Enochian to make the
“Upfront Payment,” “Costs to Date” payments, and additional payments contemplated
by the COVID Agreement, misrepresented, falsified, and concealed data from studies
performed pursuant to the COVID Agreement, as discussed herein.
229. Defendants’ representations were false. Defendants knew, or should have
known, that the statements were false at all relevant times, including all times in which
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COMPLAINT
Defendants made such representations.
230. Defendants intended for Enochian to rely on their representations, and
Enochian did so rely.
231. Defendants knew, or should have known, that their statements were
material to Enochian’s decision to make payments to Defendants pursuant to the HBV
Agreement and the COVID Agreement.
232. Enochian reasonably relied on Defendants’ misrepresentations when
deciding to make payments to Defendants pursuant to the HBV Agreement and COVID
Agreement.
233. As a direct and proximate result of Defendants’ misrepresentations,
Enochian has been and continues to be injured and has sustained significant damages in
an amount to be determined by the evidence at trial.
234. Defendants’ conduct was the sole or substantial cause of Enochian’s harm.
235. Enochian is entitled to and seeks to recover all available damages in tort
including special damages, general damages, consequential damages, lost profits, loss
of future earnings, punitive damages, and attorney’s fees where allowed by contract or
statute.
ELEVENTH CAUSE OF ACTION
CIVIL CONSPIRACY
(Against All Defendants)
236. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
237. Whether or not each Defendant actively participated in or committed the
wrongful acts alleged hereinabove, Defendants knowingly and willfully conspired
between and among themselves pursuant to an express, or tacit, agreement to commit
overt acts to intentionally or negligently misrepresent experiments, studies, tests, and
other research performed pursuant to the HBV Agreement and the COVID Agreement
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COMPLAINT
to Enochian. Defendants committed such acts with the intent to induce Enochian to
make certain payments, including, but not limited to, those contemplated by the HBV
Agreement and the COVID Agreement.
238. First, Defendants, with the intent to induce Enochian to make the
“Benchmark Payment” and subsequent payments pursuant to the HBV Agreement,
expressly, or tacitly, agreed to misrepresent and falsify data from studies performed
pursuant to the HBV Agreement, as discussed herein.
239. In furtherance of their scheme, Defendants committed the fraudulent acts
described herein, including, misrepresenting and falsifying data from studies performed
pursuant to the HBV Agreement.
240. Second, Defendants, with the intent to induce Enochian to make the
“Upfront Payment,” “Cost to Date” payments, and additional payments contemplated
by the COVID Agreement, expressly, or tacitly, agreed to misrepresent and falsify data
from studies performed pursuant to the COVID Agreement, as discussed herein.
241. In furtherance of their scheme, Defendants committed the fraudulent acts
described herein, including, misrepresenting and falsifying data from studies performed
pursuant to the COVID Agreement.
242. Defendants were acting to advance their own personal interests.
243. As a direct and proximate result of Defendants’ conspiracy, Enochian has
been and continues to be injured and has sustained significant damages in an amount to
be determined by the evidence at trial.
244. Defendants’ conduct was the sole or substantial cause of Enochian’s harm.
245. Enochian is entitled to and seeks to recover all available damages in tort
including special damages, general damages, consequential damages, lost profits, loss
of future earnings, punitive damages, and attorney’s fees where allowed by contract or
statute.
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COMPLAINT
TWELFTH CAUSE OF ACTION
UNJUST ENRICHMENT
(Against All Defendants)
246. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
247. Defendants have been unjustly enriched by virtue of their acceptance of
payments Enochian made pursuant to the HBV and COVID Agreements as a result of
Defendants’ misrepresentation and falsification of data from studies performed
pursuant to the agreements.
248. Defendants knowingly and voluntarily received and accepted a benefit
from Enochian equal to the amount of payments made pursuant to the HBV and COVID
Agreements as a result of Defendants’ misrepresentation and falsification of data from
studies performed pursuant to the agreements.
249. Defendants retained the benefit received from Enochian by failing to return
the payments made pursuant to the HBV and COVID Agreements upon Enochian’s
discovery of Defendants’ misrepresentation and falsification of data from studies
performed pursuant to the agreements.
250. Defendants will be measurably and unjustly enriched at the expense of
Enochian if Defendants are permitted to retain the payments made by Enochian to
Defendants pursuant to the HBV and COVID Agreements as a result of Defendants’
misrepresentation and falsification of data from studies performed pursuant to the
agreements.
251. Equity demands that Defendants repay the amount they have been unjustly
enriched at the expense of Enochian.
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COMPLAINT
THIRTEENTH CAUSE OF ACTION
UNFAIR BUSINESS PRACTICES (CAL. BUS. CODE §§ 17200, et seq.)
(Against All Defendants)
252. Enochian hereby incorporates and re-alleges each and every allegation
contained in the foregoing paragraphs as if fully set forth herein.
253. California Business & Professions Code §§ 17200, et seq., commonly
referred to as California’s Unfair Competition Law (“UCL”), prohibits any unlawful,
unfair, or fraudulent business act or practice.25
254. By perpetrating systemic fraud and failing to execute its duties under the
HBV Agreement and the COVID Agreement in good faith, as alleged herein,
Defendants have misled Enochian, committed common law fraud, and thus their
conduct is and has been unlawful.
255. Defendants’ conduct described herein, including, but not limited to,
misrepresenting and falsifying data from studies performed pursuant to the HBV and
COVID Agreements has resulted in unfair competition in that it is and was fraudulent,
unethical, and substantially injurious to Enochian.
256. Defendants have perpetuated a fraud; therefore, Defendants have engaged
in a fraudulent business practice for purposes of the UCL.
257. Ultimately, by reason of Defendants’ fraudulent, deceptive, unfair,
unlawful, and/or otherwise wrongful conduct as alleged herein, Defendants have
violated the UCL by developing, consummating, ratifying, and conspiring to commit
an unlawful, unfair, and fraudulent business practice. As such, Defendants’ conduct
satisfies all three elements of the UCL, collectively and individually.
258. As a result of Defendants’ unfair, unlawful, fraudulent, and/or other
wrongful conduct, Defendants have been unjustly enriched.
25
Each of the three UCL prongs provides a “separate and distinct theory of liability” and an
independent basis for relief. Rubio v. Capital One Bank, 613 F.3d 1195, 1203 (9th
Cir. 2010) (internal
quotation marks omitted).
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COMPLAINT
259. Enochian seeks restitution from Defendants for the value of all payments
made to Defendants and third parties, including, but not limited to, those made pursuant
to the HBV Agreement and the COVID Agreement, as a result of the fraudulent
misrepresentations made by Defendants to Enochian, plus pre- and post-judgment
interest. Enochian is further entitled to and seek statutory damages per UCL.
PRAYER FOR RELIEF
WHEREFORE, Plaintiff Enochian Biosciences, Inc. prays for judgment in its
favor and against Defendants as to each of its claims providing for the following relief:
A. Award Enochian its damages suffered as a result of Defendants’ acts or
omissions;
B. Order that Defendants specifically perform under the Framework
Agreement, HBV Agreement, and COVID Agreement;
C. Order such equitable relief, including, but not limited to, a perpetual,
sublicenseable, exclusive (even as to Defendants) license pursuant Section
3.1 to the HBV Agreement and Section 3.1 of the COVID Agreement, so
that Enochian may continue the research and development of the HBV,
SARS-CoV-2, and influenza pipelines;
D. Award Enochian interest at the maximum rate per annum on the amounts
found to be due and owing to Enochian, from the date of breach or
wrongful conduct until the date of judgment;
E. Award Enochian attorneys’ fees and costs of suit herein incurred; and
F. Award Enochian such other and further relief as the Court may deem just
and proper.
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COMPLAINT
DEMAND FOR JURY TRIAL
Plaintiff Enochian hereby demands a trial by jury on every issue on which it is
entitled.
Dated: October 21, 2022
K&L GATES LLP
By: /s/ Christina N. Goodrich
Christina N. Goodrich
Cassidy T. Young
Attorneys for Plaintiff,
ENOCHIAN BIOSCIENCES, INC.

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Enochian v Serhat Gumrukcu Complaint.pdf

  • 1. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -1- COMPLAINT Christina N. Goodrich (SBN 261722) christina.goodrich@klgates.com Cassidy T. Young (SBN 342891) cassidy.young@klgates.com K&L Gates LLP 10100 Santa Monica Boulevard Eighth Floor Los Angeles, CA 90067 Telephone: 310.552.5000 Facsimile: 310.552.5001 Attorneys for Plaintiff ENOCHIAN BIOSCIENCES, INC. SUPERIOR COURT OF THE STATE OF CALIFORNIA FOR THE COUNTY OF LOS ANGELES ENOCHIAN BIOSCIENCES, INC., a Delaware corporation, Plaintiff, v. SERHAT GUMRUKCU, an individual; W. ANDERSON WITTEKIND, an individual; G TECH BIO LLC, a California limited liability company; SG & AW HOLDINGS LLC, a California limited liability company; SERAPH RESEARCH INSTITUTE, a California nonprofit corporation; and DOES 1 through 50, inclusive; Defendants. Case No. _____________ COMPLAINT FOR: (1)BREACH OF CONTRACT; (2)BREACH OF IMPLIED COVENANT OF GOOD FAITH AND FAIR DEALING; (3)INTENTIONAL MISREPRESENTATION (FRAUD); (4)FRAUDULENT CONCEALMENT; (5)FRAUDULENT NONDISCLOSURE; (6)NEGLIGENT MISREPRESENTATION; (7)CIVIL CONSPIRACY; (8)UNJUST ENRICHMENT; (9)UNFAIR BUSINESS PRACTICES (CAL. BUS. CODE §§ 17200, et seq.). DEMAND FOR JURY TRIAL Electronically FILED by Superior Court of California, County of Los Angeles on 10/21/2022 03:01 PM Sherri R. Carter, Executive Officer/Clerk of Court, by R. Perez,Deputy Clerk Assigned for all purposes to: Stanley Mosk Courthouse, Judicial Officer: Christopher Lui 22STCV34071
  • 2. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -2- COMPLAINT Plaintiff Enochian Biosciences, Inc. (“Plaintiff” or “Enochian”), brings this action against Defendants Serhat Gumrukcu (“Gumrukcu”), W. Anderson Wittekind (“Wittekind”), G Tech Bio LLC (“G Tech”), SG & AW Holdings LLC (“SG & AW Holdings”), Seraph Research Institute (“SRI”), and Does 1 through 50 (collectively, “Defendants”), and alleges as follows: NATURE OF THE ACTION 1. This action arises out of the relationship between Enochian and Defendants to research and develop prospective gene and immune therapy interventions to treat devastating diseases. Together, Enochian and Defendants collaborated on a number of product candidates (or “pipelines”) for the treatment of HIV/AIDS and certain cancers. Enochian continues to pursue its promising HIV/AIDS and cancer pipelines. 2. As the relationship between Enochian and Defendants progressed, the parties also began to research and develop pipelines for the treatment of Hepatitis B (“HBV”) and coronaviruses and influenza viruses. 3. Specifically, in or around 2019, Enochian and Defendants began research and development into the use of a novel cell-based gene therapy, “Hijack RNA,” which is based on viral replication mechanisms applied in a novel way to “trick” a virus to induce the death of the cells that harbor them instead of inducing replication and spread of infection to other cells. In theory, the Hijack RNA approach could be applied to any RNA virus, including HBV, coronaviruses, and influenza viruses. 4. Around the time Defendants began researching and developing Hijack RNA, Enochian entered into a Framework Agreement (the “Framework Agreement”) with G Tech and SRI “to collaboratively conduct research with the aim to discover new treatments in [the] field of gene and cell therapy,” including those based on the Hijack RNA approach. The Framework Agreement contemplates that Enochian, G Tech, and SRI would regularly propose and potentially develop new opportunities for pre-clinical research and execute an individual statement of work detailing the work to be
  • 3. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -3- COMPLAINT performed, deliverables, timeline, and responsibilities for each new opportunity. 5. After entering into the Framework Agreement, Enochian entered into two separate agreements with G Tech and SRI to pursue the Hijack RNA approach for its HBV and SARS-CoV-2 (the coronavirus that causes COVID-19)/influenza pipelines. Through these agreements, G Tech and SRI agreed to perform pre-clinical experiments, studies, tests, and other research and development, including IND-enabling studies, to advance the pre-clinical science to the point of being ready for the first encounter with the FDA (typically through a pre-IND meeting1 ), at which point the research would be transferred to Enochian for submission to the FDA and Enochian would take over further research and development. 6. Throughout 2020 and 2021, Defendants reported to Enochian positive results from numerous studies relating to its HBV and SARS-CoV-2/influenza pipelines. 7. It was not until late June 2022—following the arrest of Gumrukcu and a subsequent internal review of primary data underlying Enochian’s HBV and SARS- CoV-2/influenza pipelines—that Enochian uncovered evidence that Defendants had engaged in a concerted, deliberate scheme to alter, falsify, and misrepresent to Enochian the results of multiple studies supporting its HBV and SARS-CoV-2/influenza pipelines in order to extract millions of dollars from Enochian. Defendants manipulated negative results to reflect positive outcomes from various studies, and even fabricated studies out of whole cloth. Defendants’ conduct amounts to nothing short of brazen fraud, which has caused Enochian substantial harm. 8. Upon information and belief, at all relevant times, Defendants (1) acted together to carry out this scheme to defraud Enochian; (2) had knowledge of the 1 In 1988, the U.S. Food and Drug Administration (“FDA”) established the Pre-Investigational New Drug Application (“pre-IND”) Consultation Program, which was designed to provide an opportunity for sponsors of new drugs or therapies in pre-clinical development to request and receive early feedback and advice on scientific, regulatory, or safety issues relating to the development of the new drug or therapy.
  • 4. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -4- COMPLAINT aforementioned data manipulation and falsification; and (3) engaged in such data manipulation and falsification with the intent to injure and defraud Enochian. 9. Enochian paid Defendants and third parties nearly $25 million based on Defendants’ misrepresentation of results related to Enochian’s HBV and SARS-CoV- 2/influenza pipelines. Moreover, the funds Enochian ultimately paid to Defendants were retained and used for the personal benefit of defendants Gumrukcu and Wittekind, who, upon information and belief, together owned, managed, and controlled G Tech, SG & AW Holdings, and SRI.2 10. Through this action, Enochian intends to hold Defendants responsible for their conduct and recover the damages resulting therefrom. PARTIES 11. Plaintiff Enochian Biosciences, Inc. is a Delaware corporation with its principal place of business in Los Angeles, California. Enochian is a pre-clinical biotechnology company dedicated to identifying, researching, developing, and commercializing gene-modified cell and immune therapies. Enochian is committed to using its integrated platforms, which encompass innovative gene-modified cell and immune therapy interventions, to seek treatment and cures for devastating diseases. Enochian’s therapies can potentially be applied to multiple indications. 12. Defendant Serhat Gumrukcu is an individual who, upon information and belief, resides in Los Angeles, California. Gumrukcu is a former scientific advisor to Enochian who invented certain technologies and approaches to be used in various Enochian pipelines. 13. Defendant W. Anderson Wittekind is an individual who, upon information and belief, resides in Los Angeles, California. Wittekind is Gumrukcu’s husband. 14. Defendant G Tech Bio, LLC is a California limited liability company with 2 For example, upon information and belief, the funds Enochian paid to Defendants were used by Gumrukcu and Wittekind, through their holding companies, to facilitate the purchase of an $18 million property in Los Angeles in August 2021.
  • 5. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -5- COMPLAINT its principal place of business located at 8605 Santa Monica Boulevard, Suite 36381, West Hollywood, California 90069. Upon information and belief, G Tech is owned, managed, and/or controlled by Gumrukcu and Wittekind. According to G Tech’s corporate filings with the California Secretary of State, SG & AW Holdings and Wittekind are the managers and/or members of G Tech. 15. Defendant SG & AW Holdings LLC is a California limited liability company with its principal place of business located at 8605 Santa Monica Boulevard, Suite 36381, West Hollywood, California 90069. Upon information and belief, SG & AW Holdings is owned, managed, and/or controlled by Gumrukcu and Wittekind. According to SG & AW Holdings’ corporate filings with the California Secretary of State, Wittekind is the sole manager and/or member of SG & AW Holdings. Upon information and belief, the “SG” and “AW” in the name of SG & AW Holdings are the initials of Serhat Gumrukcu and Anderson Wittekind. 16. Defendant Seraph Research Institute, formerly known as G Health Research Foundation, is a California nonprofit corporation with its principal place of business located at 8605 Santa Monica Boulevard, Suite 36381, West Hollywood, California 90069. Upon information and belief, SRI is owned, managed, and/or controlled by Gumrukcu and Wittekind. According to SRI’s corporate filings with the California Secretary of State, Gumrukcu is the Chief Executive Officer of SRI and Wittekind is the Secretary and Chief Financial Officer of SRI. 17. Enochian is unaware of the true names and capacities of the remaining defendants, identified as Does 1 through 50, and therefore sues such defendants by such fictitious names. Enochian reserves its right to amend this Complaint to allege true names and capacities when ascertained. Enochian is informed and believes, and on that basis alleges, that each of the fictitiously named defendants are in some manner responsible for the harm Enochian has incurred and will incur if injunctive relief is not allowed or damages are not awarded.
  • 6. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -6- COMPLAINT 18. At all relevant times, each Defendant (1) was aware of all other Defendants’ intent to manipulate and falsify data, and (2) similarly intended that the data manipulation and falsification be committed. Upon information and belief, Gumrukcu and Wittekind, along with G Tech, SG & AW Holdings, and SRI, managed and/or controlled by them, acted together to carry out this fraudulent scheme. JURISDICTION AND VENUE 19. This Court has jurisdiction over all causes of action asserted in this Complaint pursuant to the California Constitution, Article VI, Section X; section 410.10 of the California Code of Civil Procedure; and section 17203 of the California Business and Professions Code. 20. This Court has general personal jurisdiction over all Defendants. Defendants Gumrukcu and Wittekind reside in the State of California. Defendant Seraph Research Institute is a California nonprofit corporation that maintains its principal place of business in California. Defendants G Tech and SG & AW Holdings are California limited liability companies that maintain principal places of business in California. Defendant SRI is a California nonprofit corporation that maintains its principal place of business in California. Additionally, Defendants G Tech and SRI are subject to personal jurisdiction in the State of California because they entered into agreements that identify courts in Los Angeles County, California as the exclusive forum for resolution of disputes with Enochian. 21. This Court has subject matter jurisdiction over this dispute because the amount in controversy, exclusive of interest and costs, exceeds $25,000, and the conduct at issue occurred in, or had its effects in, Los Angeles County, California. 22. Venue is proper in this action pursuant to Cal. Code Civ. Proc. § 395(a) because (1) Defendants reside in Los Angeles County; (2) the contracts governing the conduct of certain parties to this action were intended to be and were performed in Los Angeles County; and (3) the acts and/or omissions of Defendants giving rise to this
  • 7. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -7- COMPLAINT action took place in Los Angeles County, and the effects of which were felt by Enochian in Los Angeles County. FACTUAL BACKGROUND 23. In or around 2019, Enochian and Defendants began research and development into the use of the novel Hijack RNA approach for the treatment and cure of RNA viruses. Following Defendants’ presentations of proof-of-concept studies at key scientific conferences, Enochian entered into two agreements with Defendants to develop the Hijack RNA approach for its HBV and SARS-CoV-2/influenza pipelines. As discussed herein, Enochian has since learned that Defendants intentionally altered, falsified, and misrepresented to Enochian certain data related to Enochian’s HBV and SARS-CoV-2/influenza pipelines in a scheme to defraud Enochian of millions of dollars. A. The Framework Agreement 24. Enochian, G Tech, and SRI entered into the Framework Agreement with an Effective Date of November 15, 2019. The Framework Agreement is signed by Dr. Mark Dybul (on behalf of Enochian), Wittekind (on behalf of G Tech), and Gumrukcu (on behalf of SRI).3 25. The Framework Agreement memorialized Enochian, G Tech, and SRI’s intention to “collaboratively conduct research with the aim to discover new treatments in [the] field of gene and cell therapy.” Specifically, Enochian, G Tech, and SRI entered into the Framework Agreement to establish “the framework of contractual conditions under which the Parties may collaborate and how [Enochian] may [] provide support to SRI for each Project and for [Enochian] to license Technology from G Tech.” 26. To this end, as set forth in Section 2(a) of the Framework Agreement, Enochian, G Tech, and SRI would meet, no less than once a quarter, to “review the activities of G Tech and SRI and identify new opportunities related to specific avenues 3 G Tech and SRI are referred to as the “Research Parties” in the Framework Agreement.
  • 8. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -8- COMPLAINT of pre-clinical research that directly contribute to the scientific foundation of [Enochian].”4 27. For each project Enochian, G Tech, and SRI intended to pursue, the parties agreed to execute a separate statement of work. The statement of work, together with the Framework Agreement, would constitute a separate agreement5 governing the objectives and work to be performed for that specific project. 28. Section 2(b) of the Framework Agreement states, in relevant part: If a Party becomes aware of any unforeseen or unusual events or assumptions, factors, and criteria not taken into consideration that would affect the outcome of the budget, timeline or other aspects of the Project set forth in an applicable Funding Agreement, or would require additional services not originally contemplated, such Party shall promptly notify the other Parties and the Parties shall discuss in good faith, and, upon mutual written agreement in conformity with the internal approval policies of the Company in place at the time of the Funding Agreement, amend the applicable Funding Agreement (a “Project Amendment Order”) accordingly. 29. Further, pursuant to Section 3(a), G Tech and SRI agreed to “comply, in all material respects, with all United States laws and regulations of any state, federal or local governmental or regulatory agency.” 30. Additionally, Section 9(c)(i) of the Framework Agreement provides, in relevant part: Each Research Party hereby covenants to the Company that 4 Each such opportunity is referred to as a “Project” in the Framework Agreement. 5 Such an agreement is referred to as a “Funding Agreement” in the Framework Agreement.
  • 9. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -9- COMPLAINT at all times until this Framework Agreement and each Funding Agreement is terminated pursuant to Section 10 hereof… it shall, and shall cause all of its employees to, cooperate with the Company, during and following the completion of a Project in all matters related to proof-of- concept, validation, IND and pre-IND applications and other studies in furtherance of the Company’s Business as it relates to each Project that is under a Funding Agreement…. 31. Subject to the Framework Agreement, and as discussed herein, Enochian, G Tech, and SRI executed two statements of work and license agreements related to its HBV and SARS-CoV-2/influenza pipelines in 2020 and 2021, respectively. B. HBV Pipeline i. The December 2019 HEP DART Conference 32. On November 22, 2019, Enochian, G Tech, and SRI entered into a letter of intent memorializing their agreement in principle for Enochian to acquire an exclusive license for Defendants’ Hijack RNA approach to treat and cure HBV (the “HBV Letter of Intent”). The HBV Letter of Intent set forth the general parameters of the parties’ agreement and provided that Enochian, G Tech, and SRI would further memorialize the full terms of their agreement by January 31, 2020. The HBV Letter of Intent is signed by Dr. Mark Dybul (on behalf of Enochian), Wittekind (on behalf of G Tech), and Gumrukcu (on behalf of SRI). 33. Shortly after the HBV Letter of Intent but before signing an agreement, Gumrukcu—through SRI and in collaboration with Dr. Phillippe Gallay (“Dr. Gallay”) of The Scripps Research Institute in La Jolla, California (“Scripps”)—presented results of Defendants’ novel approach to the treatment and cure of HBV during the December 2019 HEP DART Conference. The HEP DART Conference is an internationally recognized biennial conference that provides an important platform for scientists,
  • 10. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -10- COMPLAINT healthcare workers, and clinicians to share and discuss the latest advancements in the field of viral hepatitis and liver cancer. 34. Dr. Gallay was the senior author, performed pivotal in vitro and in vivo proof-of-concept studies,6 and attended the presentation with Gumrukcu. 35. Gumrukcu’s presentation was well received. In fact, Defendants’ approach was selected as one of the best new therapies/innovative strategies to potentially treat and cure HBV. 36. Dr. Carol Brosgart (“Dr. Brosgart”), a leader in the viral hepatitis and liver cancer field, met with Gumrukcu and Dr. Gallay at the HEP DART Conference. Dr. Brosgart was so impressed by Defendants’ approach that she joined Enochian’s Board of Directors and later became the Chairperson of Enochian’s HBV Scientific Advisory Board (“SAB”).7 ii. The HBV Agreement 37. Following Defendants presentation at the December 2019 HEP DART Conference, and based on the publicly presented results and substantial interest the results generated, Enochian executed a Statement of Work & License Agreement with an Effective Date of January 31, 2020 with G Tech and SRI (the “HBV Agreement”). The HBV Agreement incorporated by reference the terms of the Framework Agreement. The HBV Agreement is signed by Dr. Mark Dybul (on behalf of Enochian), Wittekind (on behalf of G Tech), and Gumrukcu (on behalf of SRI). 38. Through the HBV Agreement, Enochian acquired a perpetual, sublicensable, exclusive license to develop, manufacture, and commercialize 6 In vitro procedures, tests, and experiments are those that researchers perform outside of a living organism, in a controlled environment, such as a test tube or petri dish. In vivo tests, experiments, and procedures are those that researchers perform in or on a whole living organism, like a mouse. 7 As Enochian’s pipelines advanced, SABs were established with leaders in the relevant fields for the pipelines. The SAB would hold meetings where data, experimental plans, and methods and controls for experiments were presented and questioned. The SAB would review and question data, give advice on experimental plans, and review any FDA feedback. The HBV SAB was created in July 2020.
  • 11. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -11- COMPLAINT Defendants’ prospective HBV treatment. Pursuant to the HBV Agreement, G Tech and SRI were to perform, or contract with third-parties to perform, pre-clinical experiments, studies, tests, and other research and development, including IND-enabling studies. 39. The HBV Agreement provided that G Tech and SRI would advance the pipeline until it reached the first encounter with the FDA. All research G Tech and SRI contracted out to have conducted, or conducted themselves, would be transferred to Enochian during the process of preparing a submission to the FDA, after which Enochian would assume the research and development. 40. As set forth in Section 4.1 of the HBV Agreement, during the “Funding Term” (commencing February 2020 and continuing for 24 months thereafter), pre- clinical research and development (including IND-enabling studies) were the sole responsibility of G Tech and SRI until ready for the first encounter with the FDA. G Tech and SRI had the ability to utilize any facilities that they determined would be appropriate for the performance of their obligations and were permitted to collaborate or subcontract obligations if appropriate. 41. Pursuant to Section 4.2 of the HBV Agreement, G Tech and SRI were required to perform their obligations using “Commercially Reasonable Efforts,” as defined in the HBV Agreement. Specifically, “Commercially Reasonable Efforts” were defined in Article I, Section H as: [T]he level of reasonable, diligent, good faith efforts that biopharmaceutical, pharmaceutical or other life sciences companies of similar size and a[t] a similar stage in their development as such Party typically devote to the development and/or commercialization of products and/or therapies owned by them that are at a similar stage in their development or life cycle and are of similar market potential taking into account efficacy, safety, approved labeling, the
  • 12. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -12- COMPLAINT competitiveness of alternative products or therapies in the marketplace, the patent and other proprietary position of the product and/or therapy, the likelihood of regulatory approval, and other relevant factors. 42. In consideration for the exclusive license and the work to be performed by G Tech and SRI, Enochian agreed to make certain payments to G Tech. 43. Section 2.4 of the HBV Agreement provided for various “Benchmark Payments,” including, among others, a one-time payment of $1.2 million upon the execution of the HBV Agreement8 and a one-time payment of $1.5 million within 30 days of a pre-IND meeting with the FDA for the prospective HBV treatment. 44. Under the HBV Agreement, Enochian also agreed to fund the pre-clinical research and development and the purchase of certain property (mostly lab equipment) as set forth in Section 2.1 and Schedule B. Specifically, Schedule B called for Enochian to pay G Tech: a. up to $825,000 for “R&D Studies” b. up to $820,000 for “IND-Enabling Studies” c. up to $750,000 for “Lab Equipment” d. $144,500 per month during the Funding Term for “Staffing” iii. Defendants Manipulated Results of Chimeric Mice Study 45. Based on the results from the in vitro and in vivo proof-of-concept studies conducted by Defendants in collaboration with Dr. Gallay and Scripps, and pursuant to the HBV Agreement with Enochian, Defendants proceeded with more advanced studies, including a study on chimeric mice, to support Enochian’s pre-IND meeting request to the FDA. Chimeric mice studies are considered by some experts to be the premier animal model to evaluate HBV treatments and cures. At Defendants’ direction, the chimeric mice study was conducted by Dr. Gallay at the Scripps vivarium. 8 Enochian made its initial Benchmark Payment of $1.2 million to G Tech on February 6, 2020.
  • 13. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -13- COMPLAINT 46. The chimeric mice study involved a treatment product candidate (ENOB- HB-01) that could potentially eliminate HBV-infected liver cells by Hijack RNA, which would enter the cells through a vector9 (in this case, an adeno-associated virus or “AAV” particle), and “trick” the virus to induce the death of infected cells rather than the virus reproducing and causing more infection and liver disease. 47. Based on Defendants’ representations regarding the preliminary results from the chimeric mice study and the timing of its completion, Enochian submitted a request for a pre-IND meeting to the FDA on April 9, 2021. The FDA agreed to a pre- IND meeting and indicated it would provide a “Written Response Only” or “WRO.” 10 48. As part of the pre-IND consultation, Enochian was required to submit a package of supporting material to the FDA thirty (30) days prior to the date of the WRO. However, Gumrukcu informed Enochian that the chimeric mice study data would not be completed in time to submit the package to the FDA as required. Therefore, Enochian requested that the FDA postpone the response date. The FDA subsequently agreed to provide a WRO on September 10, 2021, which required Enochian to submit its pre-IND meeting package by August 11, 2021. 49. The chimeric mice study was completed in or around early July 2021. 50. On July 6, 2021, Dr. Gallay provided the primary data from the chimeric mice study to Defendants. Specifically, Dr. Gallay sent the primary data from the chimeric mice study to Gumrukcu in a single MS Excel file attached to an e-mail. 51. Gumrukcu presented what he claimed to be summaries of the data from the chimeric mice study to Enochian’s HBV SAB (attending in-person and via Zoom) on July 19, 2021. According to Gumrukcu, the results showed a 98% clearance in HBV DNA. 9 Viral vectors are tools designed to deliver genetic materials into cells. 10 WROs are sent to requesters in lieu of meetings conducted face-to-face or by teleconference/videoconference.
  • 14. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -14- COMPLAINT 52. Following a request by Enochian for an Enochian senior scientist to review and graph the primary data, Gumrukcu sent what he represented to be the primary data from the chimeric mice study to Dr. Lu Chen (“Dr. Chen”), who was then Enochian’s Head of Chemistry, Manufacturing, and Controls and Product Development, on July 19, 2021. Notably, Gumrukcu did not forward the single MS Excel file containing the primary data provided by Dr. Gallay to Dr. Chen. Instead, in his e-mail to Dr. Chen, Gumrukcu attached three individual MS Excel files purporting to reflect the study’s results. 53. The results reported by Defendants to Enochian were impressive. Specifically, the data reported to Enochian showed that one dose of ENOB-HB-01:11 a. Provided a 98.6% reduction in HBV DNA after eleven (11) weeks: 11 The graphs presented in the following paragraphs were taken directly from Gumrukcu’s July 19, 2021 presentation to Enochian’s HBV SAB.
  • 15. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -15- COMPLAINT b. Provided a near complete reduction of HBV antigens after eleven (11) weeks: c. Had little to no rebound in HBV DNA after fourteen (14) weeks:
  • 16. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -16- COMPLAINT d. Had little to no rebound in HBV antigens after fourteen (14) weeks: e. Had an effect on liver enzymes after eleven (11) weeks, demonstrating a substantial drop in HBV DNA and the effectiveness of ENOB-HB-01: 54. Enochian submitted the results provided by Defendants as part of its pre- IND meeting submission to the FDA on August 11, 2021.
  • 17. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -17- COMPLAINT 55. Following the submission of Enochian’s pre-IND meeting package to the FDA, Enochian made the $1.5 million “Benchmark Payment” to G Tech on August 19 and 20, 2021, as required under Section 2.4(b) of the HBV Agreement. 56. At the time, Enochian had no reason to question the data presented by Defendants. However, as part of its late-June 2022 internal review, Enochian compared the primary data Gumrukcu reported to Enochian with the original primary data provided to Defendants by Dr. Gallay, which revealed that Defendants intentionally manipulated the results of the chimeric mice study performed by Dr. Gallay and Scripps. 57. Rather than a 98.6% reduction in HBV DNA after eleven (11) weeks, infected mice given one dose of ENOB-HB-01 only showed a 25.14% reduction in HBV DNA after sixteen (16) weeks:12 58. Rather than a complete reduction in HBV antigens after eleven (11) weeks, infected mice given one dose of ENOB-HB-01 showed only slightly reduced HBV antigens after sixteen (16) weeks: 12 The graphs presented in the following paragraphs were re-created using the raw excel data provided by Dr. Gallay to Gumrukcu.
  • 18. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -18- COMPLAINT 59. Defendants also altered the original data provided by Dr. Gallay by switching the control group and one of the test groups from the original study, as shown in the below comparison. Rather than no rebound in HBV DNA after fourteen (14) weeks, as reported by Defendants, infected mice rebounded after ten (10) and twelve (12) weeks, respectively:
  • 19. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -19- COMPLAINT 60. Rather than no rebound in HBV antigens after fourteen (14) weeks, infected mice given one dose of ENOB-HB-01 showed rebound in HBV antigens after twelve (12) weeks: 61. Rather than an effect on liver enzymes after eleven (11) weeks, one dose of ENOB-HB-01 had no effect on liver enzymes after sixteen (16) weeks:
  • 20. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -20- COMPLAINT 62. This final alteration reveals a conscious and deliberate effort by Defendants to manipulate the data to make it more believable. Defendants altered the data to show that stopping treatment with nucleoside inhibitors, which prevent HBV replication and, therefore, the ability of ENOB-HB-01 to kill HBV-infected cells (viral replication is required for the Hijack RNA to function) led to increases in key liver enzymes (AST and ALT) that indicate damage to liver cells, presumably to be consistent with the manipulation to show a more substantial drop in HBV DNA (i.e., more HBV-infected cells killed). Because one of the significant concerns with Hijack RNA is rapid death of liver cells infected with HBV, this dual manipulation—HBV DNA and liver enzymes—was required to maintain consistency between the various results. 63. Defendants intentionally misrepresented the results of the chimeric mice study for the HBV treatment to induce Enochian to pay Defendants the $1.5 million “Benchmark Payment” tied to the pre-IND meeting with the FDA under the HBV Agreement. 64. Enochian would not have submitted its pre-IND meeting package to the FDA based upon only an approximately 25% reduction in HBV DNA found in the chimeric mice. While the progressive, sustained decrease in HBV DNA of 25% is indicative of possible positive impact, the limited decrease combined with the lack of decrease in antigens would have required additional chimeric mice studies, likely with additional doses, or a shift from AAV to other delivery mechanisms (because AAV induces antibodies that can limit effectiveness of subsequent doses), before proceeding with a pre-IND meeting. But for Defendants’ misrepresentations, additional research and development potentially leading to greater positive results could have continued pursuant to the terms of the Framework Agreement and HBV Agreement. 65. In addition to the $1.5 million Benchmark Payment, Enochian made the following payments to G Tech pursuant to Schedule B of the HBV Agreement:
  • 21. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -21- COMPLAINT  R&D Studies: $825,000  IND-Enabling Studies: $150,000  Staffing: $3,468,000 66. All of these payments were made by Enochian with the intent and belief that Defendants would progress and were progressing the pre-clinical research and development of the prospective HBV treatment to the pre-IND stage in good faith and in accordance with the HBV Agreement. 67. Following Enochian’s internal review, however, it has been revealed that Defendants failed to do so. Instead, Defendants manipulated the results of the critical chimeric mice study while inducing Enochian to make such payments. C. SARS-CoV-2 and Influenza Pipelines 68. At the same time it was pursuing its HBV pipeline, Enochian became interested in pursuing Defendants’ Hijack RNA approach for SARS-CoV-2 and influenza. Specifically, Enochian sought to research and develop inhaled SARS-CoV- 2 treatment (ENOB-CV-01) and prophylaxis13 (ENOB-CV-1114 ) product candidates and, eventually, inhaled influenza treatment (ENOB-FL-01) and prophylaxis (ENOB- FL-11) product candidates. 69. As a preliminary matter, Enochian believed that positive data from the proof-of-concept HBV studies Defendants presented at the December 2019 HEP DART Conference, and subsequent, confirmatory data presented at other key scientific conferences, were highly suggestive of potential success of the Hijack RNA approach with SARS-CoV-2 and influenza. Although the data related to HBV, the general approach is the same for any RNA virus and, therefore, data from HBV was indicative of potential success with SARS-CoV-2 and influenza. 13 Prophylaxis refers to the prevention of or guarding against the occurrence of a disease. Treatment, on the other hand, is administered after the occurrence of a disease. 14 ENOB-CV-11 uses the same product as ENOB-CV-01 but for prophylaxis rather than treatment.
  • 22. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -22- COMPLAINT i. Preliminary SARS-CoV-2/Influenza Data Presented by Defendants 70. In addition to promising HBV data, Enochian also received and reviewed data provided by Defendants specific to SARS-CoV-2 and influenza. 71. As it relates to SARS-CoV-2, the data included the results of an in vitro study performed by Defendants that was accepted for presentation at the March 7-10, 2021 Conference on Retroviruses and Opportunistic Infections (“CROI”) and subsequent in vivo data generated by Dr. Gallay that was ultimately incorporated into the presentation given by Defendants at CROI. CROI is an exclusive scientific meeting that requires an application to attend and is known to have rigorous standards for accepting abstracts for presentation. 72. Gumrukcu’s abstract, submitted and accepted for presentation at CROI, only included in vitro data, but the ultimate presentation at CROI included both Defendants’ in vitro data and Dr. Gallay’s in vivo data. The results were, effectively, the same as the proof-of-concept HBV studies and suggested that, because the conceptual framework of Hijack RNA could be reproduced with different infectious agents, the approach appeared solidly grounded. Enochian also was informed by Defendants that Dr. Gallay was enthusiastic about this approach to SARS-CoV-2 and had similar in vitro data that showed Hijack RNA killed infected, but not uninfected cells. 73. Gumrukcu ultimately presented the in vitro and in vivo data as a “spotlight of science” presentation at CROI. The following slides were included in Gumrukcu’s CROI presentation:
  • 24. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -24- COMPLAINT 74. Prior to CROI, Gumrukcu provided updates relating to the in vitro and in vivo SARS-CoV-2 proof-of-concept studies at Enochian Board of Directors meetings in May, September, and November 2020 and ultimately previewed a draft copy of the CROI presentation at the February 2021 Board of Directors meeting. At the February 2021 meeting, Gumrukcu explained that Hijack RNA, which was shown to be effective in Defendants’ HBV studies, had also been shown to be effective to treat SARS-CoV- 2. 75. As it relates to influenza, Gumrukcu presented in vitro data to the Enochian research and development team that showed the killing of multiple subtypes of influenza-infected cells but not uninfected cells. The data was accepted for presentation at another key scientific conference, the Annual Conference of the American Society of Gene and Cell Therapy (“ASGCT”), which was held virtually on May 12-15, 2020. 76. Based upon the SARS-CoV-2 and influenza data developed by Gumrukcu, SRI, and their collaborators, and presented to Enochian, and pursuant to the Framework Agreement, Enochian began negotiations with Defendants to acquire an exclusive license for the application of the Hijack RNA approach to the treatment of and prophylaxis for coronaviruses, including SARS-CoV-2, and influenza viruses in February and March 2021. 77. As Enochian considered the terms and conditions under which it would acquire the license, Gumrukcu reported to Enochian preliminary results of an in vivo study involving ENOB-CV-11 (the prophylaxis product candidate) in hACE2 mice15 that was purportedly then underway. Specifically, at an ad hoc meeting of Enochian’s Board of Directors held on March 30, 2021—specifically convened to discuss Defendants’ Hijack RNA approach to SARS-CoV-2 and influenza prophylaxis and treatment and the possibility of Enochian licensing the approach—Gumrukcu reported 15 hACE2 mice are the most commonly used animal model to study potential COVID-19 therapies, prophylaxis, and vaccines.
  • 25. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -25- COMPLAINT that mice treated with ENOB-CV-11 were challenged nine (9) days after treatment with SARS-CoV-2 and showed no infection: 78. At the March 30, 2021 meeting, based upon Gumrukcu’s presentation of these promising results, Enochian’s Board of Directors authorized and directed Enochian to proceed to finalize the license agreement with Defendants. 79. On April 5, 2021, Gumrukcu provided what he described as “updated” results of the same in vivo ENOB-CV-11 study to Enochian. Gumrukcu reported that the same mice were again challenged with SARS-CoV-2 thirty (30) days after treatment and still showed no sign of infection two (2) weeks after this second challenge:
  • 26. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -26- COMPLAINT 80. Upon information and belief, the in vivo ENOB-CV-11 study reported to Enochian in late March and early April 2021 was never performed and the results showing a successful outcome were entirely fabricated. Upon information and belief, Defendants also fabricated successful sixty (60) and ninety (90) day results. ii. The COVID Agreement 81. Enochian entered into a Statement of Work and License Agreement for Influenza and Coronavirus Indications with an Effective Date of April 18, 2021, as amended on June 16, 2021, with G Tech and SRI (the “COVID Agreement”). The COVID Agreement incorporated by reference the terms of the Framework Agreement. The COVID Agreement was signed by Dr. Mark Dybul (on behalf of Enochian), Wittekind (on behalf of G Tech), and Gumrukcu (on behalf of SRI). 82. Like the HBV Agreement, the COVID Agreement provided that G Tech and SRI would advance the pipeline until it reached the first encounter with the FDA. All research G Tech and SRI contracted out to have conducted, or conducted themselves, would be transferred to Enochian during the process of preparing a submission to the FDA, after which Enochian would assume the research and development. 83. As set forth in Section 4.1 of the COVID Agreement, during the “Funding Term” (commencing as of the Effective Date of the COVID Agreement and continuing for 24 months), pre-clinical research and development (including IND-enabling studies) were the sole responsibility of G Tech and SRI. G Tech and SRI had the ability to utilize any facilities that they determined would be appropriate for the performance of their obligations and were permitted to collaborate or subcontract obligations if appropriate. 84. Pursuant to Section 4.2 of the COVID Agreement, G Tech and SRI were required to perform their obligations under “Commercially Reasonable Efforts,” as defined in the COVID Agreement. Specifically, “Commercially Reasonable Efforts”
  • 27. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -27- COMPLAINT were defined in Article I, Section L as: [T]he level of reasonable, diligent, good faith efforts that biopharmaceutical, pharmaceutical or other life sciences companies of similar size and at a similar stage in their development as such Party typically devote to the development or commercialization of products, therapies, services or solutions owned by them that are at a similar stage in their development or life cycle and are of similar market potential taking into account efficacy, safety, approved labeling, the competitiveness of alternative product, therapies, services, or solutions in the marketplaces, the patent and other proprietary position of the product, therapy, service or solution or the likelihood of regulatory approval and other relevant factors. 85. In consideration for the exclusive license and the work to be performed by G Tech and SRI, Enochian agreed to make several payments to G Tech. 86. Under Section 2.1(a) of the COVID Agreement, Enochian agreed to pay an “Upfront Payment” of $10 million to G Tech within sixty (60) days of the Effective Date. The sixty (60) day period was extended to July 31, 2021 by an amendment executed by the parties on June 16, 2021. 87. Pursuant to Section 8.9 of the COVID Agreement, if Enochian declined to pay the Upfront Payment within the agreed time period, the COVID Agreement and the license granted therein would terminate without penalty. 88. In addition, Enochian agreed to provide certain cash funding for research costs and equipment and certain other in-kind funding during the Funding Period, including “Costs to Date of Vector Research” and “Costs to Date of Non-Vector Research,” as these terms are defined in Section 2.1(b) and Schedule B of the COVID
  • 28. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -28- COMPLAINT Agreement. These amounts totaled $760,000.00. 89. These “Costs to Date” purportedly included the costs associated with initial experiments, studies, tests, and other research performed by Defendants in cooperation with third-parties. 90. All of these payments were made with the intent and the belief that Defendants were progressing and would continue to progress the pre-clinical research and development of Enochian’s SARS-CoV-2/influenza pipelines to the pre-IND stage in good faith and in accordance with the COVID Agreement. 91. Following Enochian’s late-June 2022 internal review, however, it has been revealed that Defendants failed to do so. Instead, it has become clear that Defendants manipulated and falsified the results of multiple studies to induce Enochian to make such payments. iii. Defendants Received Results of Failed ENOB-CV-11 AAV Study 92. In or around March 2021, Defendants approached Texas Biomedical Research Institute (“Texas Biomed”) to perform a study involving ENOB-CV-11 (the candidate prophylaxis product) in hACE2 mice. In the study, the Hijack RNA was encapsulated and delivered by an AAV particle. 93. Texas Biomed’s ENOB-CV-11 AAV study was performed in or around May 2021. It was the only study performed by Texas Biomed in connection with Enochian’s SARS-CoV-2 and influenza pipelines. 94. In the study, mice were treated with ENOB-CV-11, a mock product, or a control. The mice were then challenged with SARS-CoV-2 nine (9) days later. 95. Notably, this study was performed after Defendants reported day nine (9) and day thirty (30) results of the in vivo ENOB-CV-11 study to Enochian in late March and early April 2021. As such, the in vivo ENOB-CV-11 study reported by Defendants to Enochian in March and April 2021 could not have been performed by Texas Biomed. As explained above, upon information and belief, the in vivo ENOB-CV-11 study
  • 29. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -29- COMPLAINT reported by Defendants to Enochian was never performed and the results showing a successful outcome were entirely fabricated. 96. On June 8, 2021, Gumrukcu attended a Zoom meeting with Dr. Luis Martinez-Sobrido and Dr. Jun-Gyu Park, DVM Ph.D. (“Dr. Park”) of Texas Biomed presumably to discuss the findings of the ENOB-CV-11 AAV study. 97. On June 14, 2021, Gumrukcu received an e-mail from Dr. Park attaching results of the study, including the primary data and a slide deck (with pictures). 98. The results demonstrated that ENOB-CV-11 was ineffective and had no prophylactic effect. All but one of the mice died by day eight (8) after being challenged with SARS-CoV-2.16 In short, the study had failed and no follow-up challenges to the same (now dead) mice could be done. 99. Notably, on or before the June 8, 2021 Zoom meeting, and no later than June 14, 2021, Defendants knew of the results of the failed ENOB-CV-11 AAV study. Two days later, on June 16, 2021, Enochian made the $10 million Upfront Payment to G Tech. In other words, as Enochian and Defendants were discussing moving forward with the $10 million Upfront Payment to G Tech and negotiating an amendment to the COVID Agreement to provide for such payment, Defendants were in possession of results demonstrably confirming that the ENOB-CV-11 AAV study failed and concealed those results from Enochian. 100. If Defendants had reported to Enochian the true, accurate results of the ENOB-CV-11 AAV study provided to Defendants by Texas Biomed, which demonstrated failure of the ENOB-CV-11 treatment, Enochian would not have made the Upfront Payment and the COVID Agreement would have terminated. 101. Defendants never reported the actual results of the failed ENOB-CV-11 AAV study to Enochian. 16 Upon information and belief, the sixth mouse was not effectively challenged with SARS-CoV-2 and did not contract the virus. As such, the survival of the sixth mouse did not and does not indicate success of ENOB-CV-11.
  • 30. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -30- COMPLAINT iv. Defendants Fabricated Multiple ENOB-CV-01 Studies 102. Not only did Defendants fail to disclose the results of the failed ENOB- CV-11 AAV study, Defendants fabricated four ENOB-CV-01 studies out of whole cloth and reported fake results from those never-performed studies to Enochian. These studies include: (1) an in vivo ENOB-CV-01 AAV study; (2) an in vivo ENOB-CV-01 pDNA study; (3) an in vitro ENOB-CV-01 pDNA cytotoxicity study; and (4) a second in vivo ENOB-CV-01 pDNA study. 103. Enochian relied on each of these studies to move forward with the research and development of ENOB-CV-01 (and its other SARS-CoV-2 and influenza pipelines) and to prepare and submit its pre-IND meeting request and submission package for ENOB-CV-01 to the FDA, thereby incurring millions of dollars of damages. Each of these never-performed studies is addressed, in turn, below. 104. First, in or around July or August 2021, Defendants used the results of the failed ENOB-CV-11 AAV study to fabricate a purportedly successful ENOB-CV-01 AAV study. To do so, Defendants isolated the sole surviving mouse from the ENOB- CV-11-treated group to make the data appear that there was a 100% survival in the purported ENOB-CV-01-treated group:
  • 31. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -31- COMPLAINT Original Data17 Manipulated Data18 105. In presenting the “results” to Enochian, Defendants attributed the fabricated ENOB-CV-01 AAV study to Texas Biomed. 106. Further, to make the fabricated ENOB-CV-01 AAV study appear 100% successful, Defendants renamed the “Mock-infected, mock-treated (PBS)” control 17 Red box added. 18 Red box added.
  • 32. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -32- COMPLAINT group from the failed ENOB-CV-11 AAV study as the “1e4 PFU SARS-CoV-2, test AAV treated” group in the fabricated ENOB-CV-01 AAV study. Because the mice in the “Mock-infected, mock-treated (PBS)” control group in the failed ENOB-CV-11 AAV study were neither infected with SARS-CoV-2 nor prophylaxed with ENOB-CV- 11, the group showed 100% survival after eight (8) days. By using the control group from the failed ENOB-CV-11 AAV study as the test group in the fabricated ENOB- CV-01 AAV study, Defendants were able to make the fabricated ENOB-CV-01 AAV study appear fully successful after eight (8) days:19 Original Data20 Manipulated Data21 107. Defendants further represented to Enochian that the mice challenged with SARS-CoV-2 and treated with ENOB-CV-01 had a survival rate of 100% up to thirty (30) days post-infection (blue line in the image below), whereas the mice not treated or mock treated after infection all died by eight (8) days post-infection: 19 The test group from the failed ENOB-CV-11 AAV study, “AAV-hijacking-treated, SARS-CoV- 2/NLuc,” which showed 25% survival after eight (8) days, was renamed the infected and mock-treated group, “1ef PFU SARS-CoV-2, mock AAV treated,” in the fabricated ENOB-CV-01 AAV study. 20 Red boxes and black arrow added. 21 Red boxes and black arrow added.
  • 33. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -33- COMPLAINT 108. Enochian relied upon Defendants’ fabricated ENOB-CV-01 AAV study— including the results presented by Defendants above—in preparing and submitting its pre-IND meeting request and submission package for ENOB-CV-01 to the FDA on September 7, 2021. 109. Enochian would not have submitted a pre-IND meeting request to the FDA had it known that Defendants fabricated the ENOB-CV-01 AAV study. 110. Additionally, had Enochian known that the ENOB-CV-11 AAV study had failed and/or that Defendants had manufactured from that failed ENOB-CV-11 AAV study a fabricated ENOB-CV-01 AAV study, it would have reconsidered conducting further research and development of its SARS-CoV-2 and influenza pipelines. 111. Second, due to then-recently expressed FDA concerns regarding AAV vector-based products, Enochian and Defendants decided to shift away from an AAV vector to a pDNA vector encapsulated in a lipid nanoparticle (“LNP”). Enochian began working with Acuitas Therapeutics (“Acuitas”) to provide LNP formulations for further study. 112. On or around August 22, 2021, Gumrukcu reported the results of an in vivo ENOB-CV-01 pDNA study to Enochian. This study was never performed and the results are fake. 113. Instead, Defendants used the failed ENOB-CV-11 AAV study to fabricate a purportedly successful in vivo ENOB-CV-01 pDNA study. To do so, Defendants
  • 34. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -34- COMPLAINT simply copied certain data from the failed ENOB-CV-11 AAV study and attributed it to certain control and test groups in the fabricated ENOB-CV-01 pDNA study. For example, Defendants used the results for the “PBS control, mock-infected” control group from the ENOC-CV-11 AAV study, which showed 100% survival, and attributed it to the “Group #1 = Test Plasmid 0.5ug, SARS-CoV-2 infected” test group in the ENOB-CV-01 pDNA study: Original AAV Data22 22 Red and green boxes and annotation added.
  • 35. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -35- COMPLAINT Manipulated pDNA Data23 114. In addition to transposing certain data from the failed ENOB-CV-11 AAV study, Defendants also falsified data out of whole cloth to fabricate the purportedly successful in vivo ENOB-CV-01 pDNA study. 115. The fabricated ENOB-CV-01 pDNA study was also used in Enochian’s September 7, 2021 pre-IND meeting request and submission package to the FDA for ENOB-CV-01. 116. Enochian would not have submitted a pre-IND meeting request and submission package to the FDA had it known that Defendants fabricated the ENOB- CV-01 pDNA study. 117. Moreover, following Defendants’ report of the purportedly successful ENOB-CV-01 pDNA study to Enochian and in reliance thereon, in or around August 2021 Enochian entered into a $3.7 million agreement with Aldevron, LLC (“Aldevron”) to manufacture GMP plasmid for the pDNA vector. 23 Red and green boxes and annotation added.
  • 36. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -36- COMPLAINT 118. Had Enochian known that Defendants had fabricated the results of the ENOB-CV-01 pDNA study, it would have not incurred these additional costs paid to Aldevron to further the research and development of ENOB-CV-01. 119. Third, on August 24, 2021, Gumrukcu reported the results of an in vitro ENOB-CV-01 pDNA cytotoxicity study to Enochian’s Head of Molecular Biology, Tung Nguyen, so that those results could be included in Enochian’s pre-IND meeting request and submission package for ENOB-CV-01. Defendants attributed the study and the results to Texas Biomed. This study was not performed by Texas Biomed and, upon information and belief, was never performed, and the results of the study are fake. 120. As noted above, Texas Biomed only conducted one study in connection with Enochian’s SARS-CoV-2 and influenza pipelines—the failed ENOB-CV-11 AAV study. In addition, Texas Biomed has confirmed that it has never worked with pDNA on behalf of Enochian. Therefore, Texas Biomed could not have conducted the in vitro ENOB-CV-01 pDNA cytotoxicity study reported to Enochian by Defendants. 121. Upon information and belief, Defendants entirely fabricated the results from the in vitro ENOB-CV-01 pDNA cytotoxicity study. 122. The falsified data for the in vitro ENOB-CV-01 pDNA cytotoxicity study was also used in Enochian’s September 7, 2021 pre-IND meeting request and submission package to the FDA for ENOB-CV-01. 123. Enochian would not have submitted a pre-IND meeting request and submission package to the FDA had it known that Defendants falsified the in vitro ENOB-CV-01 pDNA cytotoxicity study. 124. Fourth, Defendants fabricated a second in vivo ENOB-CV-01 pDNA study—but this time attributed it to Dr. Gallay and Scripps—to validate the efficacy of the ENOB-CV-01 pDNA LNP formulations. 125. Notably, in or around October 2021, certain LNP formulations were shipped to Scripps for such a study, leading Enochian to believe that this study was
  • 37. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -37- COMPLAINT being conducted by Defendants. 126. On April 11, 2022, Gumrukcu reported the results for the second ENOB- CV-01 pDNA study to Enochian. The data Defendants shared with Enochian showed survival, although with loss of some body weight, with one formulation of the LNP at a dose of 3ug: 127. This second ENOB-CV-01 pDNA study was not performed by Scripps and, upon information and belief, was never performed, and the results of the study are fake. 128. Dr. Gallay has since confirmed that his Scripps lab never tested the LNP formulations. While Dr. Gallay’s lab received the LNP formulations, the formulations were still in his Scripps lab’s freezer as of late June 2022. In other words, the LNP formulations shipped to Scripps were never used and, therefore, the second ENOB-CV- 01 pDNA study could not have been performed by Scripps as indicated by Defendants. 129. Defendants’ inclusion of body weight loss, a side effect of the treatment, in the results of the fabricated study again reveals a conscious and deliberate effort by Defendants to manipulate the data to make it more believable. Defendants intentionally incorporated certain side effects in the falsified results to further conceal their fraud. 130. The data from this study, as well as the first fabricated ENOB-CV-01 pDNA study attributed to Texas Biomed (discussed above), were the basis for two (2)
  • 38. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -38- COMPLAINT additional in vivo studies coordinated by Enochian. 131. Following Defendants’ transfer of data to Enochian to facilitate its pre- IND meeting request and submission package to the FDA for ENOB-CV-01, Enochian undertook additional, subsequent pre-clinical studies to replicate and further study the results reported by Defendants to Enochian. Beginning in April 2022, Enochian coordinated with IIT Research Institute (“IITRI”), a well-respected contract research organization, to replicate Defendants’ results. However, no study performed by IITRI (with any version of LNP formulation, ug dosage, or number of doses) showed any success similar to the fabricated studies presented to Enochian by Defendants. 132. In total, Enochian agreed to pay IITRI $1.9 million over several months to attempt to replicate Defendants’ results. 133. Enochian would not have engaged and paid IITRI had it known that Defendants falsified the ENOB-CV-01 pDNA studies, as described above, and falsified the results. 134. As a result of Defendants’ manipulation and falsification of numerous studies and corresponding data in Enochian’s HBV and SARS-CoV-2/influenza pipelines, Enochian ultimately paid approximately $25 million to Defendants and third- parties that it would not otherwise have paid.24 FIRST CAUSE OF ACTION BREACH OF CONTRACT – FRAMEWORK AGREEMENT (Against G Tech and SRI) 135. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 136. Enochian entered into a written contract, the Framework Agreement, with an Effective Date of November 15, 2019. 24 Enochian’s investigation is ongoing, and Enochian reserves the right to amend or supplement its total damages claimed.
  • 39. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -39- COMPLAINT 137. The Framework Agreement was a valid and binding contract between and among Enochian and G Tech and SRI. Subject to the Framework Agreement, Enochian, G Tech, and SRI subsequently executed the HBV Agreement and COVID Agreement, which incorporated by reference the terms of the Framework Agreement. 138. Enochian fully performed its material obligations under the Framework Agreement at all relevant times. 139. Among other things, G Tech and SRI materially breached the Framework Agreement by falsifying and misrepresenting data from studies performed pursuant to the Framework Agreement with the intent to induce Enochian to make payments thereunder. 140. Pursuant to Section 2(b) of the Framework Agreement, G Tech and SRI were required to notify Enochian of any “unforeseen or unusual events or assumptions… that would affect the outcome of the budget, timeline or other aspects of the Project.” 141. Pursuant to Section 3(a) of the Framework Agreement, G Tech and SRI agreed to “comply, in all material respects, with all United States laws and regulations of any state, federal or local governmental or regulatory agency.” 142. Pursuant to Section 9(c) of the Framework Agreement, G Tech and SRI covenanted to “cooperate with [Enochian], during and following the completion of a Project in all matters related to proof-of-concept, validation, IND and pre-IND applications and other studies in furtherance of [Enochian’s] Business as it relates to each Project.” 143. By falsifying and misrepresenting data from studies performed pursuant to the Framework Agreement, G Tech and SRI materially breached Sections 2(b), 3(a), and 9(c) of the Framework Agreement, which were incorporated by reference in both the HBV Agreement and COVID Agreement. 144. In light of Enochian’s internal review and resulting discovery of G Tech’s
  • 40. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -40- COMPLAINT and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s actions were intentional and designed to induce Enochian to make payments under the Framework Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional, malicious, and reckless in its disregard for their obligations to Enochian. 145. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 146. G Tech’s and SRI’s conduct was the sole or substantial cause of Enochian’s harm. 147. Enochian is entitled to and seeks to recover all available contract damages including consequential damages, lost profits, loss of future earnings, and attorney’s fees where allowed by contract or statute. SECOND CAUSE OF ACTION BREACH OF THE IMPLIED COVENANT OF GOOD FAITH AND FAIR DEALING – FRAMEWORK AGREEMENT (Against G Tech and SRI) 148. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 149. Implied in the business relationship between and among Enochian and G Tech and SRI, including, but not limited to, the covenants implied in the language of the Framework Agreement, is a promise of good faith and fair dealing. This forms a covenant to refrain from doing anything that would unfairly interfere with the right of the other party to receive the benefit(s) of the contract. 150. As a result of negotiations between the parties prior to entering the Framework Agreement, and impliedly included in the resulting agreement, Enochian was entitled to rely on G Tech’s and SRI’s representations that they would execute their duties under the Framework Agreement in good faith. Good faith required, among other
  • 41. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -41- COMPLAINT things, that G Tech and SRI accurately report any and all experiments, studies, tests, and other research performed pursuant to the Framework Agreement to Enochian. 151. G Tech and SRI did not act in good faith, insofar as they falsified and misrepresented data from studies performed pursuant to the Framework Agreement with the intent to induce Enochian to make payments thereunder. 152. In light of Enochian’s internal review and resulting discovery of G Tech’s and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s actions were intentional and designed to induce Enochian to make payments under the Framework Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional, malicious, and reckless in their disregard for their obligations to Enochian. 153. Enochian fully performed its material obligations under the Framework Agreement at all relevant times. 154. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 155. G Tech’s and SRI’s conduct was the sole or substantial cause of Enochian’s harm. 156. Enochian is entitled to and seeks to recover all available damages in tort including special damages, general damages, consequential damages, lost profits, loss of future earnings, punitive damages, and attorney’s fees where allowed by contract or statute. THIRD CAUSE OF ACTION BREACH OF CONTRACT – HBV AGREEMENT (Against G Tech and SRI) 157. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 158. Enochian entered into a written contract, the HBV Agreement, with an
  • 42. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -42- COMPLAINT Effective Date of January 31, 2020. The HBV Agreement incorporated by reference the terms of the Framework Agreement. 159. The HBV Agreement was a valid and binding contract between and among Enochian and G Tech and SRI. 160. Enochian fully performed its material obligations under the HBV Agreement at all relevant times. 161. Among other things, G Tech and SRI materially breached the HBV Agreement by failing to use “Commercially Reasonable Efforts” to perform its responsibilities under the agreement. 162. Pursuant to Section 4.2 of the HBV Agreement, G Tech and SRI were required to perform their obligations under “Commercially Reasonable Efforts,” as defined in the HBV Agreement. Specifically, “Commercially Reasonable Efforts” were defined as in Article I, Section H: [T]he level of reasonable, diligent, good faith efforts that biopharmaceutical, pharmaceutical or other life sciences companies of similar size and a[t] a similar stage in their development as such Party typically devote to the development and/or commercialization of products and/or therapies owned by them that are at a similar stage in their development or life cycle and are of similar market potential taking into account efficacy, safety, approved labeling, the competitiveness of alternative products or therapies in the marketplace, the patent and other proprietary position of the product and/or therapy, the likelihood of regulatory approval, and other relevant factors. 163. By falsifying and misrepresenting data from studies performed pursuant to the HBV Agreement with the intent to induce Enochian to make payments thereunder,
  • 43. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -43- COMPLAINT G Tech and SRI did not act with “the level of reasonable, diligent, good faith efforts” required by the HBV Agreement. 164. In light of Enochian’s internal review and resulting discovery of G Tech’s and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s actions were intentional and designed to induce Enochian to make payments under the HBV Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional, malicious, and reckless in its disregard for their obligations to Enochian. 165. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 166. Enochian is entitled to and seeks to recover all available contract damages including consequential damages, lost profits, loss of future earnings, and attorney’s fees where allowed by contract or statute. FOURTH CAUSE OF ACTION BREACH OF THE IMPLIED COVENANT OF GOOD FAITH AND FAIR DEALING – HBV AGREEMENT (Against G Tech and SRI) 167. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 168. Implied in the business relationship between and among Enochian and G Tech and SRI, including, but not limited to, the covenants implied in the language of the HBV Agreement, is a promise of good faith and fair dealing. This forms a covenant to refrain from doing anything that would unfairly interfere with the right of the other party to receive the benefit(s) of the contract. 169. As a result of negotiations between the parties prior to entering the HBV Agreement, and impliedly included in the resulting agreement, Enochian was entitled to rely on G Tech’s and SRI’s representations that they would execute their duties under
  • 44. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -44- COMPLAINT the HBV Agreement in good faith. Good faith required, among other things, that G Tech and SRI accurately report any and all experiments, studies, tests, and other research performed pursuant to the HBV Agreement to Enochian. 170. G Tech and SRI did not act in good faith, insofar as they falsified and misrepresented data from studies performed pursuant to the HBV Agreement with the intent to induce Enochian to make payments thereunder. 171. In light of Enochian’s internal review and resulting discovery of G Tech’s and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s actions were intentional and designed to induce Enochian to make payments under the HBV Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional, malicious, and reckless in their disregard for their obligations to Enochian. 172. Enochian fully performed its material obligations under the HBV Agreement at all relevant times. 173. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 174. Enochian is entitled to and seeks to recover all available damages in tort including special damages, general damages, consequential damages, lost profits, loss of future earnings, punitive damages, and attorney’s fees where allowed by contract or statute. FIFTH CAUSE OF ACTION BREACH OF CONTRACT – COVID AGREEMENT (Against G Tech and SRI) 175. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 176. Enochian entered into a written contract, the COVID Agreement, with an Effective Date of April 18, 2021. The COVID Agreement incorporated by reference
  • 45. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -45- COMPLAINT the terms of the Framework Agreement. 177. The COVID Agreement was a valid and binding contract between and among Enochian and G Tech and SRI. 178. Enochian fully performed its material obligations under the COVID Agreement at all relevant times. 179. Among other things, G Tech and SRI materially breached the COVID Agreement by failing to use “Commercially Reasonable Efforts” to perform its responsibilities under the agreement. 180. Pursuant to Section 4.2 of the COVID Agreement, G Tech and SRI were required to perform its obligations under “Commercially Reasonable Efforts,” as defined in the COVID Agreement. Specifically, “Commercially Reasonable Efforts” were defined as in Article I, Section L: [T]he level of reasonable, diligent, good faith efforts that biopharmaceutical, pharmaceutical or other life sciences companies of similar size and at a similar stage in their development as such Party typically devote to the development or commercialization of products, therapies, services or solutions owned by them that are at a similar stage in their development or life cycle and are of similar market potential taking into account efficacy, safety, approved labeling, the competitiveness of alternative product, therapies, services, or solutions in the marketplaces, the patent and other proprietary position of the product, therapy, service or solution or the likelihood of regulatory approval and other relevant factors. 181. By falsifying and misrepresenting data from studies performed pursuant to the COVID Agreement with the intent to induce Enochian to make payments
  • 46. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -46- COMPLAINT thereunder, G Tech and SRI did not act with “the level of reasonable, diligent, good faith efforts” required by the COVID Agreement. 182. In light of Enochian’s internal review and resulting discovery of G Tech’s and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s actions were intentional and designed to induce Enochian to make payments under the COVID Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional, malicious, and reckless in its disregard for their obligations to Enochian. 183. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 184. Enochian is entitled to and seeks to recover all available contract damages including consequential damages, lost profits, loss of future earnings, and attorney’s fees where allowed by contract or statute. SIXTH CAUSE OF ACTION BREACH OF THE IMPLIED COVENANT OF GOOD FAITH AND FAIR DEALING – COVID AGREEMENT (Against G Tech and SRI) 185. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 186. Implied in the business relationship between and among Enochian and G Tech and SRI, including, but not limited to, the covenants implied in the language of the COVID Agreement, is a promise of good faith and fair dealing. This forms a covenant to refrain from doing anything that would unfairly interfere with the right of the other party to receive the benefit(s) of the contract. 187. As a result of negotiations between the parties prior to entering the COVID Agreement, and impliedly included in the resulting agreement, Enochian was entitled to rely on G Tech’s and SRI’s representations that they would execute their duties under
  • 47. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -47- COMPLAINT the COVID Agreement in good faith. Good faith required, among other things, that G Tech and SRI accurately report any and all experiments, studies, tests, and other research performed pursuant to the COVID Agreement to Enochian. 188. G Tech and SRI did not act in good faith, insofar as they falsified and misrepresented data from studies performed pursuant to the COVID Agreement with the intent to induce Enochian to make payments thereunder. 189. In light of Enochian’s internal review and resulting discovery of G Tech’s and SRI’s falsified research and misrepresentations, it is clear that G Tech’s and SRI’s actions were intentional and designed to induce Enochian to make payments under the COVID Agreement. G Tech’s and SRI’s conduct was at all times willful, intentional, malicious, and reckless in their disregard for their obligations to Enochian. 190. Enochian fully performed its material obligations under the COVID Agreement at all relevant times. 191. As a direct and proximate result of G Tech’s and SRI’s actions, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 192. Enochian is entitled to and seeks to recover all available damages in tort including special damages, general damages, consequential damages, lost profits, loss of future earnings, punitive damages, and attorney’s fees where allowed by contract or statute. SEVENTH CAUSE OF ACTION INTENTIONAL MISREPRESENTATION/FRAUD (Against All Defendants) 193. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 194. Defendants made multiple false representations to, and concealed information from, Enochian concerning material facts, including, but not limited to: (1)
  • 48. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -48- COMPLAINT the validity and/or success of certain studies performed relating to the HBV pipeline; and (2) the validity and/or success of certain studies performed relating to the SARS- CoV-2 and influenza pipelines. 195. Both prior to and during the period that Defendants contracted with Enochian to provide services and licenses to Enochian, Defendants represented to Enochian that it would act in good faith, which included, but was not limited to, accurately reporting any and all experiments, studies, tests, and other research performed pursuant to the HBV Agreement and the COVID Agreement to Enochian. 196. Instead, Defendants, with the intent to induce Enochian to make the “Benchmark Payment” and subsequent payments pursuant to the HBV Agreement, misrepresented, falsified, and concealed data from studies performed pursuant to the HBV Agreement, as discussed herein. 197. Similarly, Defendants, with the intent to induce Enochian to make the “Upfront Payment,” “Costs to Date” payments, and additional payments contemplated by the COVID Agreement, misrepresented, falsified, and concealed data from studies performed pursuant to the COVID Agreement, as discussed herein. 198. Defendants’ representations were false, and Defendants knew that they were false at all relevant times, including all times in which Defendants made such representations. Furthermore, Defendants’ conduct was at all times willful, intentional, malicious, and reckless in its disregard for its obligations to Enochian. 199. Defendants intended for Enochian to rely upon Defendants’ representations to make payments to Defendants pursuant to the HBV Agreement and COVID Agreement. 200. Enochian reasonably relied on Defendants’ misrepresentations when deciding to make payments to Defendants pursuant to the HBV Agreement and COVID Agreement. 201. As a direct and proximate result of Defendants’ misrepresentations,
  • 49. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -49- COMPLAINT Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 202. Defendants’ conduct was the sole or substantial cause of Enochian’s harm. 203. Enochian is entitled to and seeks to recover all available damages in tort including special damages, general damages, consequential damages, lost profits, loss of future earnings, punitive damages, and attorney’s fees where allowed by contract or statute. EIGHTH CAUSE OF ACTION FRAUDULENT CONCEALMENT (Against All Defendants) 204. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 205. Defendants concealed information from Enochian concerning material facts, including, but not limited to: (1) the validity and/or success of certain studies performed relating to the HBV pipeline; and (2) the validity and/or success of certain studies performed relating to the SARS-CoV-2 and influenza pipelines. 206. Defendants had a duty to disclose the concealed facts based on the terms of the Framework Agreement, the HBV Agreement, and the COVID Agreement. 207. Both prior to and during the period that Defendants contracted with Enochian to provide services and licenses to Enochian, Defendants represented to Enochian that Defendants would, among other things, accurately report any and all experiments, studies, tests, and other research performed pursuant to the HBV Agreement and the COVID Agreement to Enochian. 208. However, Defendants concealed true data from studies performed pursuant to the HBV Agreement and COVID Agreement and instead presented false and/or manipulated data to Enochian, as described herein. Defendants knew that their representations were false at all relevant times, including all times in which Defendants
  • 50. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -50- COMPLAINT made such representations. Furthermore, Defendants’ conduct was at all times willful, intentional, malicious, and reckless in its disregard for its obligations to Enochian. 209. Enochian could not have otherwise discovered the true data from the research performed pursuant to the HBV Agreement and the COVID Agreement. 210. Defendants intentionally concealed the true data from Enochian to induce Enochian to make payments to Defendants pursuant to the HBV Agreement and COVID Agreement, as described herein. 211. Enochian reasonably relied on Defendants’ misrepresentations when deciding to make payments to Defendants pursuant to the HBV Agreement and COVID Agreement. As explained above, if Enochian had knowledge of the true data, it would have behaved differently. 212. As a direct and proximate result of Defendants’ fraudulent concealment, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 213. Enochian is entitled to and seeks to recover all available damages in tort including special damages, general damages, consequential damages, lost profits, loss of future earnings, punitive damages, and attorney’s fees where allowed by contract or statute. NINTH CAUSE OF ACTION FRAUDULENT NONDISCLOSURE (Against All Defendants) 214. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 215. Defendants failed to disclose material facts to Enochian, including, but not limited to: (1) the validity and/or success of certain studies performed relating to the HBV pipeline; and (2) the validity and/or success of certain studies performed relating to the SARS-CoV-2 and influenza pipelines.
  • 51. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -51- COMPLAINT 216. Defendants had a duty to disclose the withheld facts based on the terms of the Framework Agreement, the HBV Agreement, and the COVID Agreement. 217. Both prior to and during the period that Defendants contracted with Enochian to provide services and licenses to Enochian, Defendants represented to Enochian that Defendants would, among other things, accurately report any and all experiments, studies, tests, and other research performed pursuant to the HBV Agreement and the COVID Agreement to Enochian. 218. However, Defendants failed to disclose the true data from studies performed pursuant to the HBV Agreement and COVID Agreement and instead presented false data to Enochian, as described herein. Defendants knew that their representations were false at all relevant times, including all times in which Defendants made such representations. Furthermore, Defendants’ conduct was at all times willful, intentional, malicious, and reckless in its disregard for its obligations to Enochian. 219. Enochian could not have otherwise discovered the true data from the research performed pursuant to the HBV Agreement and the COVID Agreement. 220. Defendants intentionally withheld the true data from Enochian to induce Enochian to make payments to Defendants pursuant to the HBV Agreement and COVID Agreement, as described herein. 221. Enochian reasonably relied on Defendants’ misrepresentations when deciding to make payments to Defendants pursuant to the HBV Agreement and COVID Agreement. As explained above, if Enochian had knowledge of the true data, it would have behaved differently. 222. As a direct and proximate result of Defendants’ fraudulent nondisclosure, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 223. Enochian is entitled to and seeks to recover all available damages in tort including special damages, general damages, consequential damages, lost profits, loss
  • 52. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -52- COMPLAINT of future earnings, punitive damages, and attorney’s fees where allowed by contract or statute. TENTH CAUSE OF ACTION NEGLIGENT MISREPRESENTATION (Against All Defendants) 224. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 225. Defendants made multiple false representations to, and concealed information from, Enochian concerning material facts, including, but not limited to: (1) the validity and/or success of certain studies performed relating to the HBV pipeline; and (2) the validity and/or success of certain studies performed relating to the SARS- CoV-2 and influenza pipelines. 226. Both prior to and during the period that Defendants contracted with Enochian to provide services and licenses to Enochian, Defendants represented to Enochian that it would act in good faith, which included, but was not limited to, accurately reporting any and all experiments, studies, tests, and other research performed pursuant to the HBV Agreement and the COVID Agreement to Enochian. 227. Instead, Defendants, with the intent to induce Enochian to make the “Benchmark Payment” and subsequent payments pursuant to the HBV Agreement, misrepresented, falsified, and concealed data from studies performed pursuant to the HBV Agreement, as discussed herein. 228. Similarly, Defendants, with the intent to induce Enochian to make the “Upfront Payment,” “Costs to Date” payments, and additional payments contemplated by the COVID Agreement, misrepresented, falsified, and concealed data from studies performed pursuant to the COVID Agreement, as discussed herein. 229. Defendants’ representations were false. Defendants knew, or should have known, that the statements were false at all relevant times, including all times in which
  • 53. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -53- COMPLAINT Defendants made such representations. 230. Defendants intended for Enochian to rely on their representations, and Enochian did so rely. 231. Defendants knew, or should have known, that their statements were material to Enochian’s decision to make payments to Defendants pursuant to the HBV Agreement and the COVID Agreement. 232. Enochian reasonably relied on Defendants’ misrepresentations when deciding to make payments to Defendants pursuant to the HBV Agreement and COVID Agreement. 233. As a direct and proximate result of Defendants’ misrepresentations, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 234. Defendants’ conduct was the sole or substantial cause of Enochian’s harm. 235. Enochian is entitled to and seeks to recover all available damages in tort including special damages, general damages, consequential damages, lost profits, loss of future earnings, punitive damages, and attorney’s fees where allowed by contract or statute. ELEVENTH CAUSE OF ACTION CIVIL CONSPIRACY (Against All Defendants) 236. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 237. Whether or not each Defendant actively participated in or committed the wrongful acts alleged hereinabove, Defendants knowingly and willfully conspired between and among themselves pursuant to an express, or tacit, agreement to commit overt acts to intentionally or negligently misrepresent experiments, studies, tests, and other research performed pursuant to the HBV Agreement and the COVID Agreement
  • 54. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -54- COMPLAINT to Enochian. Defendants committed such acts with the intent to induce Enochian to make certain payments, including, but not limited to, those contemplated by the HBV Agreement and the COVID Agreement. 238. First, Defendants, with the intent to induce Enochian to make the “Benchmark Payment” and subsequent payments pursuant to the HBV Agreement, expressly, or tacitly, agreed to misrepresent and falsify data from studies performed pursuant to the HBV Agreement, as discussed herein. 239. In furtherance of their scheme, Defendants committed the fraudulent acts described herein, including, misrepresenting and falsifying data from studies performed pursuant to the HBV Agreement. 240. Second, Defendants, with the intent to induce Enochian to make the “Upfront Payment,” “Cost to Date” payments, and additional payments contemplated by the COVID Agreement, expressly, or tacitly, agreed to misrepresent and falsify data from studies performed pursuant to the COVID Agreement, as discussed herein. 241. In furtherance of their scheme, Defendants committed the fraudulent acts described herein, including, misrepresenting and falsifying data from studies performed pursuant to the COVID Agreement. 242. Defendants were acting to advance their own personal interests. 243. As a direct and proximate result of Defendants’ conspiracy, Enochian has been and continues to be injured and has sustained significant damages in an amount to be determined by the evidence at trial. 244. Defendants’ conduct was the sole or substantial cause of Enochian’s harm. 245. Enochian is entitled to and seeks to recover all available damages in tort including special damages, general damages, consequential damages, lost profits, loss of future earnings, punitive damages, and attorney’s fees where allowed by contract or statute.
  • 55. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -55- COMPLAINT TWELFTH CAUSE OF ACTION UNJUST ENRICHMENT (Against All Defendants) 246. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 247. Defendants have been unjustly enriched by virtue of their acceptance of payments Enochian made pursuant to the HBV and COVID Agreements as a result of Defendants’ misrepresentation and falsification of data from studies performed pursuant to the agreements. 248. Defendants knowingly and voluntarily received and accepted a benefit from Enochian equal to the amount of payments made pursuant to the HBV and COVID Agreements as a result of Defendants’ misrepresentation and falsification of data from studies performed pursuant to the agreements. 249. Defendants retained the benefit received from Enochian by failing to return the payments made pursuant to the HBV and COVID Agreements upon Enochian’s discovery of Defendants’ misrepresentation and falsification of data from studies performed pursuant to the agreements. 250. Defendants will be measurably and unjustly enriched at the expense of Enochian if Defendants are permitted to retain the payments made by Enochian to Defendants pursuant to the HBV and COVID Agreements as a result of Defendants’ misrepresentation and falsification of data from studies performed pursuant to the agreements. 251. Equity demands that Defendants repay the amount they have been unjustly enriched at the expense of Enochian.
  • 56. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -56- COMPLAINT THIRTEENTH CAUSE OF ACTION UNFAIR BUSINESS PRACTICES (CAL. BUS. CODE §§ 17200, et seq.) (Against All Defendants) 252. Enochian hereby incorporates and re-alleges each and every allegation contained in the foregoing paragraphs as if fully set forth herein. 253. California Business & Professions Code §§ 17200, et seq., commonly referred to as California’s Unfair Competition Law (“UCL”), prohibits any unlawful, unfair, or fraudulent business act or practice.25 254. By perpetrating systemic fraud and failing to execute its duties under the HBV Agreement and the COVID Agreement in good faith, as alleged herein, Defendants have misled Enochian, committed common law fraud, and thus their conduct is and has been unlawful. 255. Defendants’ conduct described herein, including, but not limited to, misrepresenting and falsifying data from studies performed pursuant to the HBV and COVID Agreements has resulted in unfair competition in that it is and was fraudulent, unethical, and substantially injurious to Enochian. 256. Defendants have perpetuated a fraud; therefore, Defendants have engaged in a fraudulent business practice for purposes of the UCL. 257. Ultimately, by reason of Defendants’ fraudulent, deceptive, unfair, unlawful, and/or otherwise wrongful conduct as alleged herein, Defendants have violated the UCL by developing, consummating, ratifying, and conspiring to commit an unlawful, unfair, and fraudulent business practice. As such, Defendants’ conduct satisfies all three elements of the UCL, collectively and individually. 258. As a result of Defendants’ unfair, unlawful, fraudulent, and/or other wrongful conduct, Defendants have been unjustly enriched. 25 Each of the three UCL prongs provides a “separate and distinct theory of liability” and an independent basis for relief. Rubio v. Capital One Bank, 613 F.3d 1195, 1203 (9th Cir. 2010) (internal quotation marks omitted).
  • 57. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -57- COMPLAINT 259. Enochian seeks restitution from Defendants for the value of all payments made to Defendants and third parties, including, but not limited to, those made pursuant to the HBV Agreement and the COVID Agreement, as a result of the fraudulent misrepresentations made by Defendants to Enochian, plus pre- and post-judgment interest. Enochian is further entitled to and seek statutory damages per UCL. PRAYER FOR RELIEF WHEREFORE, Plaintiff Enochian Biosciences, Inc. prays for judgment in its favor and against Defendants as to each of its claims providing for the following relief: A. Award Enochian its damages suffered as a result of Defendants’ acts or omissions; B. Order that Defendants specifically perform under the Framework Agreement, HBV Agreement, and COVID Agreement; C. Order such equitable relief, including, but not limited to, a perpetual, sublicenseable, exclusive (even as to Defendants) license pursuant Section 3.1 to the HBV Agreement and Section 3.1 of the COVID Agreement, so that Enochian may continue the research and development of the HBV, SARS-CoV-2, and influenza pipelines; D. Award Enochian interest at the maximum rate per annum on the amounts found to be due and owing to Enochian, from the date of breach or wrongful conduct until the date of judgment; E. Award Enochian attorneys’ fees and costs of suit herein incurred; and F. Award Enochian such other and further relief as the Court may deem just and proper.
  • 58. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -58- COMPLAINT DEMAND FOR JURY TRIAL Plaintiff Enochian hereby demands a trial by jury on every issue on which it is entitled. Dated: October 21, 2022 K&L GATES LLP By: /s/ Christina N. Goodrich Christina N. Goodrich Cassidy T. Young Attorneys for Plaintiff, ENOCHIAN BIOSCIENCES, INC.