Blueprint





 







Exhibit 10.1






 



Facility Improvement and Process Validation Agreement


 




This
facility improvement and process validation agreement
("Agreement") is effective
this 26th day of August, 2019 ("Effective Date") and is between Duke
University, a tax-exempt research and educational institution
located in Durham, North Carolina, acting for and on behalf of its
School of Medicine (“Duke”), and Cellular Biomedicine
Group, Inc. ("Sponsor") a
corporation with offices in 1345 Avenue of the Americas,
15th
Floor, New York, New York 10105. The parties represented in this
Agreement shall be referred to individually as a
“Party” and collectively as the
“Parties”.


 



WHEREAS, Duke has established a
biological manufacturing facility capable of producing cellular
products under current Good Manufacturing Practice regulations
(“Core
Lab”) to promote and
support scientific research and;


 



WHEREAS, Duke requires facility improvements to provide for
greater Core Lab capacity anticipated to be used by Duke in future
research funded by Sponsor;


 



WHEREAS, both Parties desire
for such Core Lab to collaborate on a clinical trial of tumor
infiltrating lymphocytes (TIL cells) that will be performed at Duke
and funded by Sponsor; and


 



WHEREAS, the facility improvements contemplated by this
Agreement are of mutual interest and benefit to Duke and Sponsor and will further the instructional
and research objectives of Duke
in a manner consistent with its status as a non-profit education
and health care institution.


 



NOW, THEREFORE, the Parties agree as follows:


 



1. 

Duke
shall conduct the project described in Exhibit A, attached (the
“Project”).






 



2. 

Duke’s Investigator ("Investigator") shall be Joanne
Kurtzberg, M.D., who will oversee the Project. If the Investigator
is unable to continue to serve and a successor acceptable to both
Duke and Sponsor is not available, this Agreement
will be terminated in accordance with Article 7.






 



3. 

In consideration of
the performance of the Project, and as detailed in the budget
included as Exhibit B, Sponsor shall pay Duke a fixed-price total
of [***]. Upon submission of an invoice by Duke, Sponsor will pay
the full amount within forty-five (45) days of the Effective
Date.






 



4. 

Duke’s relationship to Sponsor under this Agreement shall be that
of an independent contractor and not an agent, joint venturer,
employee, or partner of Sponsor.






 



5. 

The Project will
commence of the Effective Date and will terminate upon completion
of the Project or twenty-four (24) months from the Effective Date,
whichever is sooner (the “Term”). The Parties may extend the
Term of this Agreement upon execution of a written amendment to
this Agreement.






 




 

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6. 

Confidential
information shall mean all information provided by one Party (the
“Disclosing
Party”) to the other (the “Receiving Party”) that is clearly
identified in writing as confidential by the Disclosing Party at
the time of disclosure (“Confidential Information”). The
Receiving Party agrees to hold the Disclosing Party’s
Confidential Information in trust and confidence, using the same
care and discretion that the Receiving Party uses with information
that it considers confidential. The Receiving Party will not use
the Disclosing Party’s Confidential Information for purposes
other than those contemplated by this Agreement. The Receiving
Party shall not be bound by confidentiality obligations hereunder
with respect to the Confidential Information, or any part thereof,
that:






(a) is
already known to the Receiving Party at the time of the
disclosure;


(b) is
or becomes publicly known without the wrongful act or breach of
this Agreement by the Receiving Party;


(c) is
rightfully received by the Receiving Party from a third party on a
non-confidential basis;


(d) is
approved for release by written authorization of the Disclosing
Party; or


(e) is
subsequently and independently developed by employees of the
Receiving Party without use of or reliance upon the Confidential
Information.


 


Nothing
herein shall prevent the Receiving Party from disclosing
Confidential Information to the extent required pursuant to a
judicial or government request, requirement or order. In such
instances, the Receiving Party shall take reasonable steps to
provide the Disclosing Party sufficient prior written notice in
order for the Disclosing Party to contest such request, requirement
or order.


 



7. 

[***] developed by
Duke in the performance of the
Project (the “Results”) shall be promptly and
fully disclosed to Sponsor, and
may be used by Sponsor for any
legitimate purpose. Duke shall
have the right to retain copies of and use all Results for its
own research, educational, clinical,
and publication purposes subject to the confidentiality and
publication review obligations of this Agreement. [***]
shall remain the property of Duke whether developed prior to or during
the Project. During performance of the Project and performance of a
future clinical trial funded by
Sponsor, [***] will be implemented and disclosed to Sponsor.
[***] To the extent Duke has rights in such [***], Duke grants
Sponsor the fully paid-up, non-exclusive, world-wide right to make,
have made, use, have used, and sublicense such [***] for any
legitimate purpose.






 


THE
RESULTS ARE PROVIDED BY DUKE TO SPONSOR “AS IS”. DUKE
MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE,
OR THAT THE USE OF THE RESULTS WILL NOT INFRINGE ANY PATENT,
COPYRIGHT, TRADEMARK, OR OTHER RIGHTS.


 



8. 

Sponsor agrees to
indemnify, hold harmless, and defend Duke, its officers, employees,
and agents against any and all claims, suits, losses, damages,
costs, fees, and expenses asserted by third parties, both
government and non-government, resulting from or arising out of
this Agreement; provided, however, that Sponsor shall not be
responsible for Duke's gross negligence or willful misconduct.
Sponsor shall maintain in force at its sole cost and expense, with
reputable insurance companies, insurance of a type and in an amount
reasonably sufficient to protect against liability hereunder. Duke
shall have the right to request the appropriate certificates of
insurance from Sponsor for the purpose of ascertaining the
sufficiency of such coverage.






 




 

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9. 

Neither Party will,
without the prior written consent of the other Party: (a) use in
advertising, publicity or otherwise, the name of any employee or
agent, any trade-name, trademark, trade device, service mark,
symbol, or any abbreviation, contraction or simulation thereof
owned by the other Party, or (b) represent, either directly or
indirectly, that any product or service of the other Party is a
product or service of the representing Party or that it is made in
accordance with or utilizes the information or documents of the
other Party. Notwithstanding the foregoing, Duke may acknowledge
the contributions of Sponsor in academic publications prepared in
accordance with Article 9 and shall have the right to post
Sponsor’s name, the Project name, and the Project period on
Duke’s publically accessible lists of research conducted at
Duke and as may be required in submissions to funding
agencies.






 



10. 

Any notice or other
communication required or permitted under this Agreement will be in
writing and will be deemed given as of the date it is: (a)
delivered by hand, or (b) mailed, postage prepaid, first class,
certified mail, return receipt requested, to the Party at the
address listed below or subsequently specified in writing, or (c)
sent, shipping prepaid, return receipt requested, by national
courier service, to the Party at the address listed below or
subsequently specified in writing:






 


	


As to Duke:

	


Office of Research Contracts


	
 

	


Duke University,


	
 

	


2200 West Main St. Suite 900,


	
 

	


Durham, N.C. 27705


	
 

	


Attn: Director


	
 

	
 


	


As to Company:

	


Cellular Biomediciane Group, Inc.


	
 

	


1345 Avenue of the Americas, 15th Floor


	
 

	


New York, New York 10105


	
 

	


Chief Legal Officer










11. 

Termination







(a) 

This Agreement will
terminate upon completion of the Project or expiration of the Term,
whichever is sooner.





 



(b) 

The Parties agree
that the provisions of this Agreement are intended to be
interpreted and implemented so as to comply with all applicable
laws, governmental rules and regulations; however, if it is
determined that any provision of this Agreement is not in such
compliance, then the Parties agree to modify that provision or this
Agreement so as to be in compliance. If such modification is not
possible, or practical, or if the Parties are unable to agree upon
the modification to be made, then either Party may immediately
terminate this Agreement.





 



(c) 

Either Party may
terminate this Agreement upon thirty (30) days written notice i) if
the other Party’s breach of this Agreement remains uncured
for such thirty (30) day period, or ii) if the Duke Investigator is
unable to complete the Project and the Parties are unable to agree
upon a successor.





 



(d) 

Either Party may
terminate this Agreement immediately if the other Party engages in
fraud or illegal conduct during the performance of the
Project.





 



(e) 

In the event of
early termination, Sponsor will compensate Duke for i) all
uncompensated milestones met and ii) portions of each milestone
undertaken but not met, on a pro-rated basis, prior to the date of
written notice of termination by Sponsor.





 



(f) 

Upon termination
for any reason, a Party, at the other Party’s discretion,
shall return or destroy all Confidential Information received from
the other Party. A Party may retain in its office of counsel one
(1) copy of the Disclosing Party’s Confidential Information
as record of obligation.





 


 




 

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12. 

Nonperformance by
either Party shall be excused to the extent that performance is
rendered impossible by strike, fire, earthquake, flood,
governmental acts or orders or restrictions, failure of suppliers
or any other reason where failure to perform is beyond the
reasonable control of the non-performing Party. In such event the
affected Party, as the case may be, shall promptly notify the other
Party of such inability and of the period for which such inability
is anticipated to continue. Without limiting the foregoing, the
Party subject to such inability shall use reasonable efforts to
minimize the duration of any force majeure event.






 



13. 

Any and all
provisions of this Agreement which by their nature or effect are
required or intended to be observed, kept or performed after
termination or expiration of this Agreement will survive the
termination or expiration of this Agreement, as the case may be,
and remain binding upon and for the benefit of the Parties
hereto.






 



14. 

This Agreement and
its attached Exhibits represent the entire understanding between
the Parties, and supersedes all agreements, express or implied,
between the Parties as to its subject matter. Any alteration,
modification, or amendment to this Agreement must be in writing and
signed by both Parties.






 



15. 

This Agreement is
binding upon and will inure to the benefit of the Parties hereto
and their respective successors and assigns. This Agreement shall
not be assignable in whole or in part by a Party without the prior
written consent of the other Party, such consent not to be
unreasonably withheld. Notwithstanding the foregoing, Sponsor may
assign its rights or obligations under this Agreement in connection
with a merger or similar reorganization or the sale of all or
substantially all of its assets or of the Sponsor’s subject
matter of this Agreement, without the prior written consent of
Duke. Upon completion of such an event, Sponsor will provide Duke
with written notification disclosing the name and address of the
third party that has assumed Sponsor’s rights and obligations
under this Agreement.






 



16. 

This Agreement
shall be governed by the laws of the State of North Carolina,
without reference to its choice of law provisions. The Parties
hereby submit to the jurisdiction of the courts of North Carolina
in all matters concerning this Agreement.






 




 

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      WHEREFORE,
the Parties hereto agree:


 


	

             
DUKE UNIVERSITY


 


 


By:                  
  /s/ W. Gavin
Foltz


Printed
Name:    W. Gavin Foltz, J.D.


Title:
                
Assoc. Dean


                                      
  Office of Research Contracts


Date
executed:  August 26, 2019


 

	

CELLULAR
BIOMEDICINE GROUP, INC.:


 

 


By:                  
/s/ Bizuo (Tony)
Liu


Printed
Name:  Bizuo (Tony) Liu


Title:                
Chief Executive Officer


 

 


Date
executed:  August 27, 2019 


 

 


 







 


 




 

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EXHIBIT A

 



Scope of Work

 


 


[***]


 


 


 


 




 

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EXHIBIT B


 



Budget


 


 



[***]


 


 


 


 




 

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