Document:

Exhibit 10.1

 

AMENDMENT TO NOTICE OF AWARD –
CLIN 2 - CIRM Clinical Trial Stage Projects

California Institute for Regenerative
Medicine

 

Amendment Number: 01

Amendment Date: 8/8/17

 

	Award Number:	CLIN2-08334	Total Award Amount:	$3,376,259
	Awardee Name:	Capricor, Inc	Project Period Start Date:	04/01/2016
	 	 	Project Period End Date:	10/31/2018
	Principal Investigator or Program Director:	
        Deborah Davis Ascheim

         
	 	 
	Project Title:	Allogeneic Cardiosphere-Derived Cells for Duchenne Muscular Dystrophy Cardiomyopathy

 

	Authorized Organization Official and Address:	Official and Address to Receive Payments:
	AJ Bergmann	AJ Bergmann
	VP of Finance	8840 Wilshire Blvd., 2nd Floor
	8840 Wilshire Blvd. 2nd Floor	Beverly Hills, CA 90211
	Beverly Hills, CA 90211	 

 

This Amendment responds to the Prior Approval Request (PAR)
dated and/or received by CIRM on 07/14/2017. The terms and conditions of the original NGA and any prior Amendments to the NGA continue
in full force and effect except for those changes specified in this amendment. The Principal Investigator and Authorized Organizational
Official must sign and return this Amendment to CIRM within 30 days of the Amendment date stated above. CIRM may hold future payments
on this Award until the fully signed Amendment is received. The following changes are effective immediately:

 

		A.	Change in Scope, Specific Aims, or Milestones

 

Request to use existing project funds for tech transfer
of manufacture of the CAP-1002 product to designated CMO, approved by CIRM, which will enable them to offer access to CAP-1002
to patients from the control arm of the ongoing study (HOPE) via an open-label extension protocol (subject to regulatory approval),
is approved.

 

By continuing to accept and use CIRM funds provided under
this award, Grantee and Principal Investigator accept the modified terms reflected in this Amendment.

 

	/s/ Maria Millan, M.D. 	 
	Maria Millan, M.D.	 
	Vice President, Therapeutics, CIRM	 
	 	 
	/s/ Deborah Davis Ascheim	 
	Deborah Davis Ascheim	 
	Principal Investigator, Capricor, Inc	 
	 	 
	/s/ AJ Bergmann	 
	AJ Bergmann	 
	Authorized Organization Official, Capricor, IncExhibit 10.2

 

FIRST AMENDMENT TO

 FACILITIES
LEASE

 

This First
Amendment to Facilities Lease (“Amendment”) effective as of August 1, 2017, and is made by and between CEDARS-SINAI
MEDICAL CENTER, a California nonprofit public benefit corporation (“Landlord”) and CAPRICOR, INC., a Delaware
corporation (“Tenant”), with reference to the facts and circumstances set forth below.

 

A. Landlord
and Tenant executed that certain Facilities Lease dated June 1, 2014 (the “Lease”), for the Buildings and Premises
described therein. Capitalized words and phrases contained in this Amendment shall have the same meanings ascribed to them in the
Lease.

 

B. The Lease
expired on May 31, 2017 and since such date, Tenant has been occupying the Premises on a month-to-month basis as Landlord and Tenant
have engaged in discussions with respect to the extension of the term thereof and other terms to be included therein.

 

C. With the
consent of Landlord, Tenant has been occupying that certain manufacturing space identified as Suites 1056 and 1057 in the Davis
Building (“Suites 1056 and 1057”), which is owned by Landlord. Landlord and Tenant have engaged in discussions
and reached an understanding whereby Suites 1056 and 1057 shall be added to the definition of “Premises Area” set forth
in Sections 1.3 and 2.1 of the Lease.

 

NOW, THEREFORE, for
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Landlord and Tenant agree to amend
the Lease in the following manner:

 

1.         PREMISES. Article
II of the Lease is hereby modified to include the following:

 

“Suites 1056 and
1057 in the Davis Building shall be added to the definition of “Premises Area” set forth in Sections 1.3 and
2.1 of the Lease without any further monetary compensation to Landlord. Exhibit B of the Lease is hereby deleted in its entirety
and replaced with Exhibit B hereto; such modified Exhibit B shows the Premises Area as modified by this Amendment to include Suites
1056 and 1057 of the Davis Building. The parties agree that Suites 1056 and 1057 may be utilized by Tenant for the purpose of (a)
manufacturing Tenant’s cell and exosome products for purposes determined by Tenant, and (b) manufacturing cells and/or exosomes
that may from time to time be requested for certain of Landlord’s pre-clinical and clinical studies, and with respect to
this subsection (b), subject to separate agreements to be negotiated between the parties. The parties further acknowledge and agree
that all applicable terms and conditions of the Lease, other than those pertaining to Rent, shall apply to Tenant’s use of
Suites 1056 and 1057 (including the term and termination provisions set forth therein).”

 

2.        TERM. Article III of the Lease is
hereby modified to include the following:

 

“The Term of the
Lease shall be extended for an additional twelve (12) month period commencing August 1, 2017 and terminating (unless otherwise
extended) July 31, 2018 (“First Term Extension”). Tenant is hereby granted and shall, if not then in default
under this Lease, have an option to extend the term of this Lease for an additional twelve (12) month period (the “Second
Term Extension”) on the same terms, covenants, and conditions contained in this Lease, except that the rent to be paid
by Tenant to Landlord shall be as set forth in Section 3 below.”

 

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3.       RENT.
Article IV of the Lease is hereby modified to include the following:

 

“(a) Commencing
August 1, 2017 and continuing through the end of the Term Extension, with the exception of
Suites 1056 and 1057, (i) as described in Section 4.2 of the Lease, the Basic Annual Rent is hereby increased by the relevant CPI
rate of 2.1% to the amount of $8.17 per square foot per month, thereby increasing the total monthly Basic Annual Rent payment from
$15,480 to $15,808.95; and (ii) as described in Section 4.3 of the Lease, the Additional Rent is hereby increased as follows: the
Base Operating Expense (as such term is defined in the Lease) is hereby increased by the relevant CPI rate of 2.1% to the amount
of $2.04 per square foot per month, thereby increasing the total monthly Additional Rent payment from $3,870 to $3,947.40. As a
result of such increases, Tenant’s Total Monthly Payment is hereby increased from $19,350 to $19,756.”

 

“(b) In consideration
for the lease of Suites 1056 and 1057 by Landlord to Tenant hereunder, the parties agree that, in lieu of increasing any of the
rental payments set forth in the Lease beyond the amounts identified in Section 3(a) of this Amendment, Tenant shall, for the duration
of the Lease term, as may be extended by the parties, continue to provide investigative product and support services to Landlord
at levels subject to the mutual satisfaction of the parties determined at the end of each 12-month period of the Lease term. In
the event that Landlord becomes unsatisfied with the level of support received from Tenant and the parties are unable to come to
a mutually satisfactory arrangement, Landlord shall have the right to terminate the Lease (but only with respect to Suites 1056
and 1057) in accordance with the applicable terms and conditions included in Article 18 thereof. Should Landlord wish to terminate
this arrangement, it shall give Tenant at least 180 days’ prior written notice of its decision.”

 

4.        SAFETY REQUIREMENTS.
Article VI of the Lease is hereby modified to add the following new Section 6.7:

 

“6.7       Safety
Requirements. In addition to complying with all Applicable Laws (as required by Section 6.2 hereof) and Landlord’s Rules
and Regulations (as required by Article XIX) and participating in Landlord’s safety training program (as required by Section
6.4 hereof), Tenant shall comply with the following additional safety requirements of Landlord: (a) Tenant shall develop, implement,
practice and maintain best laboratory safety practices; (b) Tenant shall allow regulatory agencies to visit its laboratory spaces,
offices and other support space for the purpose of general or focused inspections upon seven (7) days’ advanced written notice
from Landlord, where possible, unless such notice is not permitted by the regulatory agency; (c) Tenant shall participate in the
review and oversight of its activities by Landlord’s Institutional Biosafety Committee, Institutional Review Board, Institutional
Animal Care and Use Committee and other safety-oriented committees and shall adhere to directives given to it by any such
committees; (d) all of Tenant’s personnel who require access to Landlord’s research buildings shall participate in
all safety trainings mandated by Landlord and demonstrate comprehension thereof; (e) Tenant shall participate in Landlord’s
safety inspection program, help identify safety deficiencies and make all corrections required by Landlord to be compliant with
regulations, including regulations and guidance promulgated by state and federal Occupational Safety and Health agencies; (f) Tenant
shall promptly report any unsafe conditions, hazards, releases and exposures, as well as serious injuries and illnesses, to Landlord’s
Environmental Health and Safety Department; and (g) Tenant shall use all materials and equipment supplied by Landlord, as well
as all Landlord-provided utilities and facilities, in a safe and proper manner, and immediately report all breakdowns thereof to
Landlord. Tenant acknowledges that any breach of these requirements and/or Landlord’s Rules and Regulations shall be deemed
to be a default under the Lease in accordance with Article XVII hereof, subject to the cure provisions set forth therein.”

 

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5.        RULES
& REGULATIONS. Exhibit E of the Lease is hereby deleted in its entirety and replaced with Exhibit E hereto.

 

6.        REAFFIRMATION.
As modified hereby, the Lease is reaffirmed and ratified by the parties in its entirety.

 

IN WITNESS WHEREOF,
the parties have executed this Agreement as of the date set forth above.

 

	Cedars-Sinai Medical Center	 	Capricor, Inc.
	 	 	 
	By:	/s/ Edward M. Prunchunas	 	By:	/s/ Karen Krasney
	 	 	 
	Name: Edward M. Prunchunas	 	Name: Karen Krasney
	 	 	 
	Title: Executive Vice President, Finance & Chief Financial Officer	 	Title: EVP, General Counsel
	 	 	 
	By:	/s/ Nicole A. Leonard, JD, MBA	 	 
	 	 	 
	Name: Nicole A. Leonard, JD, MBA	 	 
	 	 	 
	Title: Vice President, Research	 	 

 

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EXHIBIT B

 

FLOOR PLAN OF THE DAVIS BUILDING PREMISES

 

 

 

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EXHIBIT E

 

RULES & REGULATIONS

 

		1.	Filming/Taking Pictures/Voices Recording of Patients and Health System Employees of the Health System Policy: Corporate Integrity
Program

		2.	Equal Employment Opportunity: Equal Employment Opportunity Policy: Human Resources/Organizational Development

		3.	Acceptable Use Guidelines: EIS

		4.	Confidentiality of Patient, Business, and Employee Information Policy: Corporate Integrity Program

		5.	Expectations: Drug Free and Alcohol Free Workplace Policy: Human Resources/Organization Development

		6.	Davis Building Rules and Regulations

		7.	All policies of Landlord’s Environmental Health and Safety Department

 

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