Exhibit 10.1

 

***Text Omitted and Filed Separately with the Securities and Exchange

Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

FOURTH AMENDMENT

TO AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT

 

THIS FOURTH AMENDMENT TO AMENDED AND RESTATED LICENSE AGREEMENT (this “CDCs Fourth Amendment”) is made and entered into as of June 20, 2018 (“Fourth Amendment Date”) by and between CEDARS-SINAI MEDICAL CENTER, a California nonprofit public benefit corporation (“CSMC”) and CAPRICOR, INC., a Delaware corporation (“Licensee”), under the following circumstances:

 

A.CSMC and Licensee entered into the Amended and Restated Exclusive License Agreement dated December 30, 2013, as amended by the First Amendment dated March 20, 2015, the Second Amendment dated August 5, 2016, and the Third Amendment dated December 26, 2017 (collectively, the “CDCs License Agreement”).

 

B.CSMC filed additional solely-owned patent application as listed under Section 2(a)(i) and a co-owned patent application as listed under Section 2(b)(i) below (collectively, the “New Applications”).

 

C.The parties desire to amend the CDCs License Agreement as further described herein to incorporate the rights to the New Applications pertaining to various therapeutic applications with cardiosphere-derived cells (CDCs).

 

D.Rights to the New Applications pertaining to various therapeutic applications with extracellular vesicles (EVs), which the parties acknowledge are defined by the International Society for Extracellular Vesicles as including exosomes, microvesicles, microparticles, ectosomes, oncosomes and prostasomes, are concurrently being exclusively licensed by CSMC to Licensee in that certain Fifth Amendment to Exclusive License Agreement (the “Exosomes Fifth Amendment”) executed concurrently herewith.

 

E.It is the intent of the parties that all rights embodied in the New Applications are being exclusively licensed from CSMC to Licensee through the combination of this CDCs Fourth Amendment and Exosomes Fifth Amendment.

 

F.For the avoidance of doubt, any other subject matter contained in the New Applications which is not covered by the Exosomes Fifth Amendment is covered by this CDCs Fourth Amendment.

 

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein and in the CDCs License Agreement and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

 

 

 

  

***Text Omitted and Filed Separately with the Securities and Exchange

Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

1.         Defined Terms. Terms not otherwise defined herein shall have the meaning ascribed to them in the CDCs License Agreement.

 

2.          Amendments to the CDCs License Agreement.

 

(a)         The following New Application, which is solely owned by CSMC, is hereby added to Revised Schedule A (Patent Rights) to the CDCs License Agreement:

 

(i)

[***]

 

(b)         The following technology, which is co-owned by CSMC and Licensee, is hereby added to Revised Schedule A (Patent Rights) to the CDCs License Agreement:

 

(i)

[***]

 

3.          Co-Owned Patent Rights. With respect to the Patent Rights that are co-owned by CSMC and Licensee (including the New Application listed in Section 2(b)(i) of this CDCs Fourth Amendment and the Patent Rights with respect thereto), the following provisions shall apply:

 

(a)          Licensee shall not grant any license, assignment or other rights whatsoever to any co-owned interest that Licensee may have in the Patent Rights to any third party, unless such third party is an Acceptable Assignee (as such term is defined in the CDCs License Agreement) to whom a sublicense or assignment (as applicable) of CSMC’s rights is concurrently being granted under Section 2.2 of the CDCs License Agreement. Any license, assignment or other conveyance of any rights in Licensee’s co-owned interest in the Patent Rights in violation of the immediately preceding sentence shall be null and void ab initio and shall be deemed a material breach of the CDCs License Agreement.

 

(b)          Notwithstanding the foregoing, in the event that Licensee initiates and/or undergoes any of the events listed in Section 6.2(a) of the CDCs License Agreement, any co-owned interest that Licensee may have in the Patent Rights shall not be assigned or licensed to any third party without CSMC’s prior written consent.

 

(c)          Licensee represents and warrants to CSMC that, with respect to any co-owned interest that Licensee may have in the Patent Rights: (i) it has not granted licenses to or otherwise in any way encumbered the Patent Rights, and (ii) there are no claims, judgments or settlements to be paid by Licensee with respect the Patent Rights or pending claims or litigation relating to the Patent Rights. Licensee is not aware that any additional rights or licenses are necessary for Licensee to exercise its licensed rights granted by CSMC under this CDCs License Agreement.

 

 

 

  

***Text Omitted and Filed Separately with the Securities and Exchange

Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(d)         Licensee shall be obligated to pay CSMC a Royalty (as such term is defined in the CDCs License Agreement) for the duration of the term of the CDCs License Agreement (as outlined in Section 6.1 of the CDCs License Agreement), regardless of co-ownership of the Patent Rights between the parties and any early termination of the CDCs License Agreement.

 

(e)         Upon any early termination of the CDCs License Agreement for any of the events listed in Section 6.2(a), Licensee’s entire right, title and interest in and to the Patent Rights, including any ownership or co-ownership interest, shall be automatically assigned to CSMC without any further action of the parties and without any further consideration to Licensee.

 

4.          Other Provisions. This CDCs Fourth Amendment is a revision to the CDCs License Agreement only, it is not a novation thereof. Except as otherwise provided herein, the terms and conditions of the CDCs License Agreement shall remain in full force and effect.

 

5.        Further Assurances. Each of the parties hereto shall execute such further documents and instruments and do all such further acts as may be necessary or required in order to effectuate the intent and accomplish the purposes of this CDCs Fourth Amendment.

 

6.        Counterparts. This CDCs Fourth Amendment may be executed in any number of counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument.

 

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***Text Omitted and Filed Separately with the Securities and Exchange

Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

IN WITNESS WHEREOF, the parties have executed this CDCs Fourth Amendment as of the day and year first above written.

 

Dated:  June 20, 2018 CAPRICOR, INC.
     
  By: /s/ Anthony Bergmann
    Anthony Bergmann
    Chief Financial Officer
     
Dated:  June 20, 2018 CEDARS-SINAI MEDICAL CENTER
     
  By: /s/ James D. Laur, JD
    James D. Laur, JD
    Vice President, Technology Transfer & Business Affairs
     
  By: /s/ Edward M. Prunchunas
    Edward M. Prunchunas
    Executive Vice President, Finance & Chief Financial Officer