gtbp_ex107





 





 



Exhibit 10.7

 


 

 



Clinical Trial Agreement

 


 



This Clinical Trial Agreement (“Agreement”) is made as
of this ___ day of September 2019 (the “Effective
Date”) by and between Regents of
the University of
Minnesota, a non-profit,
educational, and research (“Institution”) with an
address at Sponsored Projects Administration, 450 McNamara Alumni
Center, 200 Oak Street S.E., Minneapolis, MN 55455 and
GT Biopharma,
Inc., a Delaware corporation
having its principal place of business 9350 Wilshire Blvd., Suite
203, Beverly Hills, CA 90212 (“Sponsor”). Sponsor and
Institution are herein referred to collectively as
“Parties.” Individually, each of Sponsor and
Institution is a “Party”.

 


WHEREAS, Sponsor is a for-profit organization that
intends to fund a single center clinical trial, in accordance with
Sponsor’s FDA authorized investigational new drug application
(“IND”) number 136205 and further described in Section
1.1 below, involving the use of certain diagnostic(s), drug(s),
device(s), or biologic(s);

 


WHEREAS, the Institution has appropriate facilities and
personnel with the qualification, training, knowledge, and
experience necessary to conduct such a clinical trial;
and

 


WHEREAS, the Study contemplated by this Agreement is of
mutual interest and benefit to Institution and Sponsor, and will
further the instructional and research objectives of Institution in
a manner consistent with its status as a nonprofit educational,
research and health care institution;

 


NOW,
THEREFORE, in consideration for
the mutual promises made in this Agreement and for valid
consideration, the Parties agree as follows:

 



1. Scope of
Agreement

 



1.1.            

Institution will undertake a sponsored single
center clinical trial (“Study”) in accordance with
Sponsor’s FDA authorized IND No. 136205 and described in the
protocol HM2015-39 (CPRC # 2015LS167) (“Protocol”)
entitled, “CD16/IL-15/CD33 (161533) Tri-Specific
Killer Engagers (TriKEs) for the Treatment of High Risk
Myelodysplastic Syndromes, Refractory/Relapsed Acute Myeloid
Leukemia and Advanced Systemic Mastocytosis” incorporated herein as Exhibit A. Institution will only recruit subjects in
accordance with the Protocol. The Study will be conducted at the
Institution under the direction of Erica Warlick, MD, an employee
of Institution (“Principal
Investigator”).






 



1.2.            

In
the event of any conflict between the terms and conditions of this
Agreement and the Protocol or between this Agreement and any of its
Exhibits, the terms and conditions of the Protocol shall control
with respect to matters of the clinical conduct of the Study, and
the terms of this Agreement shall control with respect to all other
matters.





 



1.3.            

Institution
agrees to provide all reasonable personnel, facilities, and
resources, as required, to perform responsibilities under the
Study. University shall manufacture and provide the required
quantities of properly-labeled drug(s) (“Study Drug”)
under the terms of a separate agreement between the parties.
Receipt, storage, and handling of Study Drug will be in compliance
with all applicable laws and regulations and the
Protocol.





 


 




 

1








 






 


 

 



1.4.            

Sponsor
and Institution shall comply with and conduct all aspects of the
Study in compliance with all applicable federal, state, and local
laws and regulations, including generally accepted standards of
good clinical practice as adopted by current FDA regulations and
statutes and regulations of the U.S. Government relating to
exportation of technical data, computer software, laboratory
prototypes, and other commodities as applicable to academic
institutions. Institution will only allow individuals who are
appropriately trained and qualified to assist in the conduct of the
Study.





 



1.5.            

Institution
shall obtain Institutional Review Board (“IRB”)
approval for this Study and proof thereof shall be provided to
Sponsor. Initiation of the Protocol and Institution’s
obligation to conduct the Study shall not begin until IRB approval
is obtained. Institution shall obtain from each subject, prior to
the subject's participation in the Study, a signed informed consent
and necessary authorization to disclose health information to
Sponsor in a form approved in writing by the IRB or a waiver of
consent as directed by the IRB and further provided that the
informed consent is consistent with Institution's
policies.





 



1.6.            

Sponsor
agrees to provide Institution with all data and safety monitoring
reports related to the Study to the extent such information is made
available to Sponsor by the PI and Institution, and Institution
agrees to submit such information to the IRB as required. During
the Study and for at least two (2) years following the completion
of the Study, Sponsor shall promptly provide Institution and
Principal Investigator with the written report of any findings,
including Study results and any routine monitoring findings in site
monitoring reports, and data safety monitoring committee reports
including, but not limited to, data and safety analyses, and any
Study information that may (i) affect the safety and welfare of
current or former Study subjects, or (ii) influence the conduct of
the Study. Institution and/or Principal Investigator will
communicate findings to the IRB and Study subjects, as
appropriate.





 



1.7.            

Institution
and the Principal Investigator shall promptly inform Sponsor of any
urgent safety measures as instructed in the Protocol or breaches of
the Protocol of which Institution or Principal Investigator becomes
aware.





 



2. Payments

 



2.1            

Sponsor agrees to pay Institution in accordance
with the budget attached as Exhibit B (“Budget”) on a fixed-fee prorated
basis, according to the actual work completed and any
non-cancelable obligated expenses, for subjects who are enrolled
into the Study. Sponsor acknowledges and agrees that some expenses
on Exhibit B may represent costs incurred by Institution prior to
the Effective Date of this Agreement. Such costs shall be limited
to those related directly to the Study, and specifically described
in Exhibit B. The Parties acknowledge that the Budget amounts
represent an equitable exchange for the conduct of the Study in
light of the professional time and expenses required for the
performance of the Study.





 


 




 

2








 






 


 

 



2.2            

In
addition to other necessary routing information detailed in Exhibit
B, each payment shall clearly reference the: Study Protocol Number
and PI name. The Institution’s tax identification number is:
41-6007513.





 



3. Confidentiality

 



3.1.            

It
is anticipated that in the performance of this Agreement, Sponsor
or Institution may need to disclose (“Disclosing
Party”) to the other party (“Receiving Party”)
information which is considered confidential. The rights and
obligations of the Parties with respect to such information are as
follows:





 



“Confidential Information” refers to information of any
kind which is disclosed by the Disclosing Party to the Receiving
Party for purposes of conducting the Study or Data (as defined
below in Section 4) which:

 



a) 

by
appropriate marking, is identified as confidential and proprietary
at the time of disclosure;





 



b) 

if
disclosed orally, is identified in a marked writing within thirty
(30) days as being confidential; or





 



c) 

is
of such a nature that a reasonable person familiar with the Study
would consider it to be confidential or proprietary from the
context or circumstances of disclosure.





 



Each party agrees, for a period of five (5) years following the
termination or expiration of this Agreement, to use reasonable
efforts, no less than the protection given their own confidential
information, to use Confidential Information received from the
other party in accordance with this Section.

 



Receiving Party agrees to use Disclosing Party’s Confidential
Information solely as allowed under the terms of this Agreement,
and for the purpose of conducting the Study. Receiving Party agrees
to make Disclosing Party’s Confidential Information available
only to their and their affiliate’s respective employees,
personnel, agents, consultants, and vendors, and approved
subcontractors, as applicable, who require access to such
Confidential Information in the performance of this Study, and are
subject to similar terms of confidentiality.

 



3.2.            

The
obligation of nondisclosure does not apply with respect to any of
the Confidential Information that:





 



a) 

is
or becomes public knowledge through no breach of this Agreement by
Receiving Party;





 



b) 

is
disclosed to Receiving Party by a third party entitled to disclose
such information without known obligation of
confidentiality;





 



c) 

is
already known or is independently developed by Receiving Party
without use of the other party’s Confidential Information as
shown by Receiving Party’s contemporaneous written
records;





 



d) 

is
necessary to obtain IRB approval of Study or required to be
included in the written information summary provided to Study
subject(s) and/or informed consent form;





 



e) 

is
released with the prior written consent of the Disclosing Party;
or





 



f) 

is
required to support the medical care of a Study
Subject.





 


 




 

3








 






 



3.3.            

Receiving
Party may disclose Confidential Information to the extent that it
is required to be produced pursuant to a requirement of applicable
law, IRB, government agency, an order of a court of competent
jurisdiction, or a facially valid administrative, Congressional, or
other subpoena, provided that Receiving Party, subject to the
requirement, order, or subpoena, promptly notifies Disclosing
Party. Disclosing Party may seek to limit the scope of such
disclosure and/or seek to obtain a protective order. Receiving
Party will disclose only the minimum amount of Confidential
Information necessary to comply with law or court order as advised
by legal counsel.





 



3.4.            

No
license or other right is created or granted hereby, except the
specific right to conduct the Study as set forth by Protocol and
under terms of this Agreement, nor shall any license or other right
with respect to the subject matter hereof be created or granted
except by the prior written agreement of the Parties duly signed by
their authorized representatives.





 



3.5.            

Upon
Disclosing Party's written request, Receiving Party agrees to
return all Confidential Information supplied to it by Disclosing
Party at Disclosing Party’s expense pursuant to this
Agreement except that Receiving Party may retain one (1) copy of
any such Confidential Information in a secure location for purposes
of identifying and satisfying its obligations and exercising its
rights under this Agreement.





 



3.6            

Institution and
Sponsor may each disclose the existence of this Agreement and any
additional information necessary to ensure compliance with
applicable Federal, State and Institutional policies, regulations,
and laws.





 



4. Data Use and Ownership

 



4.1.            

“Data”
shall mean all data and information generated by Institution as a
result of conducting the Study in accordance with the IRB approved
Protocol.





 



4.2.            

Sponsor
shall own and have the right to use the Data in accordance with the
signed informed patient consent and authorization form, applicable
laws, and the terms of this Agreement.





 



4.3.            

Data
does not include original Study subject or patient medical records,
research notebooks, source documents, or other routine internal
documents kept in the Institution’s ordinary course of
business operations, which shall remain the sole and exclusive
property of the Institution or medical provider.





 


 




 

4








 






 


 

 



4.4            

Notwithstanding
any licenses or other rights granted to Sponsor herein, but in
accordance with the confidentiality and publication sections
herein, Institution shall retain the right to use the Data and
results for its publication, IRB, regulatory, legal, clinical,
educational, and research purposes. The foregoing is not intended
to grant to the University any right to use the following
Sequence:





 



NWVNVISDLKKIEDLIQSMHIDATLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIHDTVENLIILANDSLSSNGNVTESGCKECEELEEKNIKEFLQSFVHIVQMFINTS

 



(“Altor Sequence”) to which Altor Bioscences and its
owner, ImmunityBio, Inc. claims ownership for any purpose other
than to perform the Study.

 



5. HIPAA/HIPAA Privacy

 



5.1.            

Institution
shall comply with applicable laws and regulations, as amended from
time to time, including without limitation, the Health Insurance
Portability and Accountability Act of 1996 and it’s
implementing regulations (HIPAA) with respect to the collection,
use, storage, and disclosure of Protected Health Information (PHI)
as defined in HIPAA. Sponsor shall collect, use, store, access, and
disclose PHI collected from Study subjects only as permitted by the
IRB approved informed consent form or HIPAA authorization form
obtained from a Study subject. Sponsor will collect, use, store,
and disclose any Subject Material, defined in Section 15, it
receives only in accordance with the informed consent form and, in
any event, will not collect, use, store, or disclose any PHI
attached to or contained within the Subject Material in any manner
that would violate this Section of the Agreement.





 



Institution acknowledges that, pursuant to Section 111 of the
Medicare, Medicaid, and SCHIP Extension Act of 2007 ("MMSEA"),
Sponsor has an obligation to submit certain reports to the Centers
for Medicare & Medicaid Services with respect to Medicare
beneficiaries who participate in the Study and experience a
research injury for which diagnosis or treatment costs are
incurred. Sponsor recognizes that Institution and Sponsor are
subject to laws and regulations protecting the confidentiality of
research subject information. Accordingly: (1) Institution agrees
upon prior written request to provide to Sponsor, or a third-party
vendor as designated by Sponsor, certain identifiable patient
information required by MMSEA for Study subjects who are Medicare
beneficiaries and incur medical costs in association with a
research injury and whose costs are reimbursed by Sponsor pursuant
to this Agreement; and (2) Institution further agrees to otherwise
cooperate with Sponsor (and any third-party vendors as designated
by Sponsor) to the extent necessary for Sponsor to meet its MMSEA
reporting obligations.

 



5.2.            

Sponsor’s
ability to review the Study subjects’ Study-related
information contained in the Study subject’s medical record
shall be subject to reasonable safeguards for the protection of
Study subject confidentiality and the Study subjects’
informed consent form or HIPAA authorization form.





 



5.3.            

Sponsor
shall not attempt to identify, or contact, any Study subject unless
permitted by the informed consent form.





 


 




 

5








 






 



6. Record Retention

 



As applicable by law, Institution shall retain and preserve a copy
of the Study records for the longer of:

 



a) 

two
(2) years after a marketing authorization for Study Drug, or Study
Device has been approved for the indication for which it was
investigated or Sponsor has discontinued research on the Study Drug
or Study Device;





 



b) 

such
longer period as required by federal regulatory requirements;
or





 



c) 

as
requested by Sponsor at Sponsor’s reasonable storage
expense.





 



7. Monitoring and Auditing

 



7.1.            

Site
visits by Sponsor and/or its authorized designee (e.g., Study
monitor) will be scheduled in advance for times mutually acceptable
to the Parties during normal business hours. Sponsor’s and/or
authorized designee’s access is subject to reasonable
safeguards to ensure confidentiality of medical records and
systems.





 



7.2.            

Upon
becoming aware of an audit or investigation by a regulatory agency
with jurisdiction over the Study, Institution agrees to provide
Sponsor with prompt notice of the auditor investigation. If legally
permissible or allowable by the regulatory agency and permissible
in accordance with the Institution’s policy, Sponsor may be
available or request to be present with approval from auditor
during such audit, but Sponsor agrees not to alter or interfere
with any documentation or practice of Institution. Institution
shall be free to respond to any regulatory agency inquiries and
will provide Sponsor with a copy of any formal response or
documentation to the regulatory agency regarding the
Study.





 



8. Inventions, Discoveries and Patents

 



8.1.            

It
is recognized and understood that certain existing inventions and
technologies, and those arising outside of the research conducted
under this Agreement, are the separate property of Sponsor or
Institution and are not affected by this Agreement, and neither
Party shall have any claims to or rights in such separate
inventions and technologies.





 



8.2.            

Any
new patentable inventions, developments, or discoveries made during
and in the performance of the Study (“Inventions”)
shall be promptly disclosed to Sponsor. Title to Inventions shall
reside with Sponsor if Sponsor personnel are the sole inventors,
with Institution if Institution personnel are the sole inventors,
and shall be held jointly if both Institution and Sponsor personnel
are inventors. The foregoing is not intended to grant to either
party any invention that necessarily uses or incorporates the Altor
Sequence.





 



8.3.            

To
the extent that Institution owns sole or joint title in any
Inventions, Sponsor is hereby granted, without option fee other
than consideration of the Study sponsored herein, (i) a
non-exclusive, perpetual, irrevocable, fully-paid up, royalty-free,
worldwide license for all purposes; and (ii) an exclusive option to
obtain an exclusive license to such Inventions for all purposes,
whereby upon Sponsor’s exercise of the option within twelve
(12) months of Institution’s notifying Sponsor of such
Inventions, and payment of $15,000 license fee to Institution,
Institution’s rights in such Inventions will be added to and
become a “Licensed Patent” under the Exclusive License
Agreement with Sponsor as Licensee, dated July 18, 2016, a copy of
which is attached to this Clinical Trial Agreement.





 


 




 

6








 






 


 

 





8.4.

Nothing
contained in this Agreement shall be deemed to grant either
directly by implication, estoppel, or otherwise any license under
any patents, patent applications, or other proprietary interest to
any other inventions, discovery or improvement of either
Party.





 





8.5.

The
Parties agree that the provisions of this Agreement are intended to
be interpreted and implemented so as to comply with all applicable
federal laws, rules, and regulations, including without limitation
the requirements of Rev. Proc. 2007-47; provided, however, if it is
determined by the Internal Revenue Service or any other federal
agency or instrumentality (the "Government") that the provisions of
this Agreement are not in such compliance, then the Parties agree
to modify the provisions and the implementation of this Agreement
so as to be in compliance with all applicable federal laws, rules,
and regulations as determined by the Government.





 





8.6.

The
Institution retains on behalf of itself and all other non-profit
research institutions, to practice the Licensed Patent for any
non-profit purpose, including research, teaching, and educational
purposes. Licensee agrees that, notwithstanding any other provision
of this Agreement, it has no right to enforce the Licensed Patent
against any such institution using the Licensed Patent for
non-profit purposes. The foregoing is not intended to grant to
University any rights with respect to the Altor Sequence, except to
perform the Study.





 



9. Publication

 





9.1.

Institution
can publish and present Data and results arising out of its
performance of the Protocol (individually, a
“Publication”). At least 30 days prior to submission
for Publication, Institution shall submit to Sponsor for review and
comment any proposed oral or written Publication ("Review Period").
Institution shall consider any such Sponsor comments in Good Faith.
“Good Faith” in this context means that the
Institution’s researcher will consider Sponsor’s
comments in light of the researcher’s academic and scientific
understanding, and determine based on that understanding whether
the proposed publication should be revised to reflect the
Sponsor’s comments. If during the Review Period, one party
notifies the other party in writing that it desires patent
applications to be filed on any inventions disclosed or contained
in the disclosures, the parties shall assist each other and will
defer Publication for a period not to exceed 60 days to permit the
party’s respective patent counsels sufficient time to
evaluate patentability, prepare and file any desired patent
applications. If the Publication contains Sponsor’s
Confidential Information as defined in Section 3 and Sponsor
requests Institution in writing to delete such Sponsor’s
Confidential Information, the Institution agrees to delete such
Sponsor’s Confidential Information (with the exception of
Data and results).





 



10. Use of Name

 





10.1.

Neither
Institution nor Sponsor may use the name, trademark, logo, symbol,
or other image or trade name of the other Party or its employees
and agents in any advertisement, promotion, or other form of
publicity or news release or that in any way implies endorsement
without the prior written consent of an authorized representative
of the Party whose name is being used. Such approval will not be
unreasonably withheld.





 


 




 

7








 






 


 

 





10.2.

The
Parties understand that the amount of any payment made hereunder
may be disclosed and made public by a Party as required by law or
regulation, including the Patient Protection and Affordable Care
Act of 2010, provided that the disclosure clearly designates the
payment as having been made to Institution for research and not to
the physician.





 





10.3.

Institution
may acknowledge the Sponsor’s support, including but not
limited to financial support as may be required by academic
journals, professional societies, funding agencies, and applicable
regulations. Notwithstanding anything to the contrary in this
Agreement, Sponsor agrees to allow publicly registered information
about the Study to appear on Institution’s clinical trials
directory/website. Additionally, notwithstanding anything herein to
the contrary, Institution shall have the right to post
Sponsor’s name, the Study title, and the Study period, and
funding amount, on Institution publicly accessible lists of
research conducted by the Institution.





 



11. Indemnification and Limitation of Liability

 




11.1

Sponsor agrees to defend,
indemnify, and hold harmless the Institution and its medical
affiliates and affiliated hospitals, and each of their trustees,
officers, directors, governing bodies, subsidiaries, affiliates,
investigators, employees, IRB members, agents, successors,
heirs and assigns  (collectively referred to as
"Institution’s Indemnitees"), from and against any third
party claims, loss, damage, cost and expense of claims (including
reasonable attorney’s fees) and suits alleged to be caused by
or arising from the conduct of the Study or use of the Study Drug
or Study Device under this Agreement or from the use of the Study
results ("Claims"), regardless of the legal theory
asserted.





 





11.2.


Sponsor shall have no obligation to provide such indemnification to
the extent that such Claim is solely caused by Institution’s
Indemnitee(s)’:  (1) failure to adhere to and comply
with all material and substantive specifications and directions set
forth in the Protocol (except to the extent such deviation is
reasonable to protect the rights, safety and welfare of the Study
subjects); (2) failure to comply with all applicable laws and
regulations in the performance of the Study, or (3) if such claim
is directly caused by the negligent acts or omissions of
Institution’s Indemnitees(s).





 




11.3.

Subject to the limits and without waiving any
immunities provided under applicable law (including constitutional provisions,
statutes and case law) regarding the status, powers and authority
of the Institution or the Institution’s principal(s),
Institution shall indemnify, hold harmless and defend
Sponsor, its directors, officers, employees and agents,
(“Sponsor’s Indemnitees”) from and against only
those third party Claims to the extent directly attributable to
Institution’s negligence in its conduct of the Study.
Notwithstanding the above, Institution shall have no obligation to
indemnify Sponsor for any other Claims (including, but not limited
to, infringement or product liability Claims).





 


 




 

8








 






 


 

 

 




11.4.

The indemnified
Party shall give notice to the indemnifying Party promptly upon
receipt of written notice of a Claim for which indemnification may
be sought under this Agreement, provided, however, that failure to provide such
notice shall not relieve indemnifying Party of its indemnification obligations except to the
extent that the indemnifying Party’s ability to defend
such Claim is materially, adversely affected by such failure.
Indemnifying Party shall not make any settlement admitting fault or
incur any liability on the part of the indemnified Party without
indemnified Party’s prior written consent, such consent not
to be unreasonably withheld or delayed.  The indemnified Party
shall cooperate with indemnifying Party in all reasonable respects
regarding the defense of any such Claim, at indemnifying
Party’s expense.  The indemnified Party shall be
entitled to retain counsel of its choice at its own expense. In the
event a Claim falls under this indemnification clause, in no event
shall the indemnified Party compromise, settle or otherwise admit
any liability with respect to any Claim without the prior written
consent of the indemnifying Party, and such consent not to be
unreasonably withheld or delayed.





 




11.5.

EXCEPT FOR THE PARTIES’ OBLIGATIONS TO
INDEMNIFY EACH OTHER PURSUANT TO THIS AGREEMENT, NEITHER PARTY
SHALL BE LIABLE FOR SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES
ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, EVEN IF
ADVISED OF THE POSSIBILITY OF THE SAME.





 



12. Subject Injury

 





12.1.


If a Study subject suffers an adverse reaction, illness, or injury
which, in the reasonable judgment of the Principal Investigator,
Sponsor’s Chief Medical Officer and Institution, was directly
caused by the Study Drug or Study Device or any properly performed
procedures required by the Protocol, Sponsor shall reimburse
Institution to the extent such costs are not reimbursed by Study
subject’s private insurance or Medicare/Medicaid insurance
for all reasonable and necessary costs of diagnosis and treatment
of any Study subject’s injury, including hospitalization, but
only to the extent such expenses are not attributable to (i)
Institution's negligence or willful misconduct, or (ii) the natural
progression of an underlying or pre-existing condition or events,
unless exacerbated by participating in the Study.






 



13. Insurance

 




13.1.   

Institution shall,
at its sole cost and expense maintain a policy or program of
insurance or self-insurance at the level of at least $1,000,000 per
occurrence (or per claim) and $3,000,000 annual aggregate to
support its obligations assumed in this Agreement. However, if
Institution is a public entity entitled to governmental immunity
protections under applicable state law, then Institution may
provide liability coverage in accordance with any limitations
associated with the applicable law.





 


 




 

9








 






 

 


 

 




13.2.

Sponsor shall, at
its sole cost and expense, procure and maintain commercial general
liability insurance, clinical trial insurance and products
liability insurance or equivalent self-insurance, unless otherwise
indicated in an attachment, in amounts not less than $3,000,000 per
occurrence and $10,000,000 annual aggregate.  Such commercial
general liability insurance, clinical trial insurance and products
liability insurance or equivalent self-insurance shall provide
contractual liability coverage for Sponsor’s indemnification
obligations herein. 







 




13.3.

Upon written
request, either Party will provide evidence of its insurance or
self-insurance acceptable to the other Party.  Either Party
will provide the other Party with written notice of material change
in its coverage which would affect such Party’s ability to
meet its obligations under this Agreement. A Party’s
inability to meet its insurance obligation constitutes material
breach of this Agreement.






 



14. Term and Termination

 





14.1.


This term of this Agreement shall commence upon the Effective Date
and terminate upon the completion of the Parties’
Study-related activities under the Agreement, unless terminated
early as further described in this Section.





 





14.2.


Sponsor has the right to terminate the Study upon thirty (30) days
prior written notice to the Institution. This Study may be
terminated immediately at any time for any reason by the
Institution or Sponsor when, in their judgment or that of the
Principal Investigator, the Institution’s IRB, Scientific
Review Committee, if applicable, or the Food and Drug
Administration, it is determined to be inappropriate, impractical,
or inadvisable to continue, in order to protect the Study subjects'
rights, welfare, and safety, or the IRB otherwise disapproves the
Study. If for any reason Principal Investigator becomes unavailable
to direct the performance of the work under this Agreement,
Institution shall notify Sponsor. If the Parties are unable to
identify a mutually acceptable successor, this Agreement may be
terminated by either Party upon thirty (30) days written
notice.





 





14.3.


Notwithstanding the above, any Party may, in addition to any other
available remedies:





 



a) 


immediately terminate this Agreement upon the other Party’s
material failure to adhere to the Protocol, except for deviation
required to protect the rights, safety, and welfare of Study
subjects; and/or





 



b) 


terminate this Agreement upon the other Party’s material
default or breach of this Agreement, provided that the
defaulting/breaching Party fails to remedy such material default,
breach, or failure to adhere to the Protocol within thirty (30)
business days after written notice thereof.





 





14.4


In addition to any other available remedies, the Institution may
immediately suspend enrollment of new subjects under this Agreement
if Sponsor fails to make any payment under the terms of this
Agreement or that certain payment plan in the letter, dated August
27, 2019 from the Institution and countersigned by Sponsor on
August 28, 2019 by the due date indicated therein and attached
hereto as Exhibit C.





 


 




 

10








 






 


 

 





14.4.


In the event that this Agreement is terminated prior to completion
of the Study, for any reason, Institution shall:





 



a) 


notify the IRB that the Study has been terminated;





 



b) 


cease enrolling subjects in the Study;





 



c) 


cease treating Study subjects under the Protocol to the extent
medically permissible and appropriate;





 



d) 


terminate, as soon as practicable, all other Study activities;
and





 



e) 


furnish to Sponsor any required final report for the Study in the
form reasonably acceptable to Sponsor.





 



Promptly following any such termination, Institution will provide
to Sponsor copies of Data collected pursuant to the Study Protocol.
Upon written request, the Parties shall return all Confidential
Information of the other Party provided under this Agreement
provided, however, that the Parties may retain one (1) copy of
Confidential Information for record keeping purposes, monitoring
its obligations, and exercising its rights hereunder, subject to
its ongoing compliance with the confidentiality and non-use
obligations set forth in this Agreement.

 





14.5.


If this Study is terminated early by either Party, the Institution
shall be reimbursed for all work completed, on a pro rata basis,
and reasonable costs of bringing the Study to termination incurred
through the date of termination, and for non-cancelable commitments
properly incurred through that date. Upon receipt of notice of
termination, Institution will use reasonable efforts to reduce or
eliminate further costs and expenses and will cooperate with
Sponsor to provide for an orderly wind-down of the
Study.





 





14.6.


Subsections 1.4, 1.6, and 14.6, and Sections 2, 3, 4, 5, 6, 7, 8,
9, 10, 11, 12, 13, 15, 19 and 23, shall survive any termination or
expiration of this Agreement, except that Section 3 shall survive
for the period stated in Section 3.1. Any provision of this
Agreement that by its nature and intent remains valid after
termination will survive termination.





 



15. Subject Material

 


15.1. Subject
Material means any biologic material of human origin including,
without limitation, tissues, blood, plasma, urine, spinal fluid, or
other fluids derived from the Study subjects in accordance with and
pursuant to the Protocol (“Subject
Material”).

 


15.2.
Institution agrees to make the Subject Material available to the
Sponsor in accordance with the Protocol for the purposes of the
Study. The Subject Material may be used by the Sponsor, central
lab, or other contracted party only as allowed by the Study
subject’s informed consent form or pertinent institutional
review board(s).  Sponsor agrees that any use of Subject
Materials, other than as allowed by the Study subject’s
informed consent form, will require additional IRB review and
approval.

 


 




 

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16. Subcontract

 



Institution has the right to subcontract to other sites to conduct
the Study in accordance with the Protocol with terms consistent
with this Agreement with written approval of the Sponsor, which
approval shall not be unreasonably withheld. If Institution
subcontracts any Study related duties, Institution shall contract
with such subcontractors incorporating terms substantially similar
to the terms herein. Such subcontracts may be provided to the
Sponsor upon written request. The Sponsor has the right to
subcontract to a third-party CRO or Academic Research Organization
(ARO) and assign Study-related duties and rights to any Sponsor
affiliate. If Sponsor subcontracts any Study-related duties and
rights, Sponsor remains responsible for any of those duties and
rights.

 



17. Notices

 



Any notice, authorization, approval, consent or other communication
will be in writing and deemed given:



a. Upon delivery in person;



b. Upon delivery by courier;



c. Upon delivery date by a nationally-recognized overnight delivery
service such as FedEx.


 



If to Sponsor:



GT Biopharma, Inc.



9350 Wilshire Blvd., Suite 203



Beverly Hills, CA 90212



Attn: Anthony Cataldo



Chairman and Chief Executive Officer


 



With a Copy to:



Steven Weldon



Chief Financial Officer



GT Biopharma, Inc.



9350 Wilshire Blvd., Suite 203



Beverly Hills, CA 90212


 



If to Institution:



Regents of the University of Minnesota



Sponsored Projects Administration



450 McNamara Alumni Center



200 Oak Street S.E.



Minneapolis, MN 55455



Attn: Bridget Foss



Principal Grant and Contract Administrator


 



With a copy to Principal Investigator:



Erica Warlick, MD



University of Minnesota



Division of Hematology, Oncology and Transplantation



420 Delaware Street SE



MMC 480Minneapolis, MN 55455


 




 

12








 






 


 



18. Independent Contractor

 



It is mutually understood and agreed that the relationship between
Parties is that of independent contractors. Neither Party is the
agent, employee, partner, joint venturer, or servant of the other.
Except as specifically set forth herein, neither Party shall have
nor exercise any control or direction over the methods by which the
other Party performs work or obligations under this Agreement.
Further, nothing in this Agreement is intended to create any
partnership, joint ventures, lease, or equity relationship,
expressly or by implication, between the Parties.

 



19. Clinical Trial Registry

 



Prior to enrollment of the first subject in the Study, Sponsor
agrees to ensure that the Study is fully registered on
www.clinicaltrials.gov in accordance with the requirements of the
International Committee of Medical Journal Editors (ICMJE) and
Public Law 110-85. Results of this Study will be reported in
compliance with applicable laws.

 



20. Non-Referral/Anti-Corruption Language

 





20.1.


The Parties agree that it is not their intent under this Agreement
to induce or encourage the unlawful referral of subjects or
business between the Parties, and there shall not be any
requirement under this Agreement that either Party, its employees
or affiliates, including its medical staff, engage in any unlawful
referral of subjects to, or order or purchase products or services
from, the other Party.






 





20.2.


Each Party shall require that their employees, who are involved in
the conduct of the Study, will not offer, pay, request or accept
any bribe, inducement, kickback or facilitation payment, and shall
not make or cause another to make any offer or payment to any
individual or entity for the purpose of influencing a decision for
the benefit of the other Party.





 



21. Force Majeure

 



If either Party hereto shall be delayed or hindered in, or
prevented from, the performance of any act required hereunder for
any reason beyond such Party’s direct control, including but
not limited to, strike, lockouts, labor troubles, governmental or
judicial actions or orders, riots, insurrections, war, acts of God,
inclement weather, or other reason beyond the Party’s control
(a “Disability”) then such Party’s performance
shall be excused for the period of the Disability. Any Study
timelines affected by a Disability shall be extended for a period
equal to the delay and any affected Budget shall be adjusted to
account for cost increases or decreases resulting from the
Disability. The Party affected by the Disability shall notify the
other Party of such Disability as provided for herein.

 


 




 

13








 






 


 

 



22. Counterparts

 



This Agreement may be executed in any number of counterparts, each
of which shall be an original and all of which together shall
constitute one and the same document, and is binding on all Parties
notwithstanding that each of the Parties may have signed different
counterparts. Facsimiles or scanned copies of signatures or
electronic images of signatures shall be considered original
signature unless prohibited by applicable law.

 



23. Debarment

 



The Institution certifies that to its knowledge neither it, nor any
of its employees, agents or other persons performing the Study
under its direction, is currently debarred, suspended, or excluded
under the Federal Food, Drug and Cosmetic Act, as amended, or
disqualified under the provisions of 21 CFR §312.70. In the
event that the Principal Investigator or any Study personnel
becomes debarred or disqualified during the term of this Agreement
or within 1 year after termination of the Study, the Institution
agrees to promptly notify Sponsor after learning of such event.
Institution certifies that it is not excluded from a federal health
care program, including Medicare and Medicaid. In the event an
Institution becomes excluded during the term of this Agreement or
within 1 year after termination of the Study, the Institution
agrees to promptly notify Sponsor after learning of such
event.

 



24. Choice of Law – Any action brought against the
Institution shall only be brought in the courts of Hennepin County,
Minnesota, USA, without regard to conflict of laws
principles.

 



25. Entire Agreement

 



Section and clause headings are used herein solely for convenience
of reference and are not intended as substantive parts of the
Parties’ agreement. This Agreement incorporates the Exhibits
referenced herein. This written Agreement constitutes the entire
agreement between the Parties concerning the subject matter, and
supersedes all other or prior agreements or understandings, whether
written or oral, with respect to that subject matter. Any changes
made to the terms, conditions or amounts cited in this Agreement
require the written approval of each Party's authorized
representative.


 


 


 


 


 



[Remainder of page intentionally blank. Signatures begin on next
page]


 


 


 




 

14








 






 


 



SIGNATURE PAGE

 



The authorized representatives of the Parties have signed this
Agreement as set forth below:

 



REGENTS OF THE UNIVERSITY OF MINNESOTA


 


 



By: ___________________________________________


      
Bridget Foss 


 



Title: Principal Grant and Contract Administrator


 



Date: __________________________________


 



GT BIOPHARMA, INC.


 


 



By: _________________________________________


Anthony
Cataldo


 



Title: Chairman & Chief Executive Officer


 



Date: _______________________________________


 


 



READ AND ACKNOWLEDGED


 


 



By: __________________________________________


Erica
Warlick, M.D.


 



Title: Principal Investigator


 



Date: _______________________________________


 


 


 



Attachments


 



Exhibit A – GTB-3550 Clinical Trial Protocol and
Responsibilities



Exhibit B – Budget



Exhibit C – Payment Plan Letter Agreement


 

 


 

 




 

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