Amendment No. 1 to the CIRM Award, dated August 8, 2017

EX-10.1 2 tv478386_ex10-1.htm EXHIBIT 10.1

 

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, Inc