Form 10-K/A Cell Source, Inc. For: Dec 31

June 19, 2019 4:14 PM EDT

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D. C. 20549
 
FORM 10-K/A
(Amendment No. 1)
 
 
 
 
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the years ended December 31, 2018
 
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from _____________ to _____________
 
 
Commission file number 000-55413
 
 
Cell Source, Inc.
(Exact name of registrant as specified in its charter)

Nevada
 
32-0379665
(State or other jurisdiction of incorporation or organization)
 
(I.R.S. Employer Identification No.)
     
57 West 57th Street, Suite 400
New York, New York
 
10019
(Address of principal executive offices)
 
(Zip Code)

Registrant’s telephone number, including area code: (646) 416-7896

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
         
None
 
 
 
Securities registered pursuant to Section 12(g) of the Act: Common stock, $0.001 par value
 
Indicate by check mark whether the registrant is a well-known seasoned issuer as defined in Rule 405 of the Securities Act. ☐  Yes    ☒ No
 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  ☐  Yes    ☒ No
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  ☒  Yes  ☐ No
 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  ☒  Yes  ☐ No
 
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K . ☐
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.  See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer   ☒
Smaller reporting company ☒

Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for completing with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act) ☐  Yes    ☒ No
 
As of June 30, 2018, the aggregate market value of the issued and outstanding common stock held by non-affiliates of the registrant was $14,303,937 based on the closing sale price as reported on the OTC Markets.

As of March 27, 2019, there were 26,077,611 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE - None.


EXPLANATORY NOTE

This Amendment No. 1 on Form 10-K/A (the “Amendment”) amends Cell Source Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (the “Form 10-K”), as filed with the Securities and Exchange Commission on April 1, 2019, and is being filed solely to re-file Exhibit 10.39 and Exhibit 10.40 in compliance with Regulation S-K Item 601(b). This Amendment includes new certifications by our Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 attached as Exhibits 31.1, 31.2, 32.1 and 32.2 hereto.

PART IV

ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES.

Financial Statements

See Index to Financial Statements immediately following the signature page of this Annual Report.

Financial Statement Schedules

All financial statement schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto.

Exhibits

The following exhibits are included as part of this Annual Report:

Exhibit
   
Number
 
Description
     
2.1 (1)
 
Share Exchange Agreement, dated June 30, 2014, by and between Cell Source, Ltd., and Ticket to See, Inc.
3.1 (1)
 
Articles of Association of Cell Source Limited, dated August 14, 2011, as amended on November 11, 2013
3.2 (2)
 
Articles of Incorporation of Ticket to See, Inc., dated June 6, 2012
3.3 (3)
 
Certificate of Amendment to Articles of Incorporation of Ticket to See, Inc., dated June 23, 2014
3.3 (4)
 
Certificate of Amendment to Articles of Incorporation of Ticket to See, Inc., dated May 20, 2014
3.4 (2)
 
Bylaws of Cell Source, Inc., dated June 6, 2012
3.5 (18)
 
Certificate of Designation with respect to Series A Preferred Stock dated November 14, 2016
10.1 (1)
 
Form of Subscription Agreement
10.2 (1)
 
Form of Registration Rights Agreement
10.3 (1)
 
Form of Investor Warrant
10.4 (1)
 
Form of Consultant Warrant(8)
10.5 (1)
 
Form of Researcher Company Warrant
10.6 (1)
 
Form of Company Warrant
10.7 (1)
 
Form of Lockup Agreement (included in Exhibit 2.1)
10.8 (1)
 
Research and License Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited, dated October 3, 2011
10.9 (1)
 
Amendment to Research and License Agreement
10.10 (1)
 
Evaluation and Exclusive Option Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited, dated Oct. 3, 2011 (included in Exhibit 10.7)
10.11 (1)
 
Amendment dated April 1, 2014 to Evaluation and Exclusive Option Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited
10.12 (1)
 
Second Amendment dated June 22, 2014 to Evaluation and Exclusive Option Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited
10.13 (1)
 
Consulting Agreement by and between Cell Source Limited and Professor Yair Reisner
10.14 (6)
 
Form of Amendment No. 1 to Registration Rights Agreement
10.15 (7)
 
Bridge Funding Agreement
10.16 (5)
 
Third Amendment dated June 22, 2014 to Evaluation and Exclusive Option Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited
10.17 (8)
 
Form of Consulting Agreement pursuant to which the Company issued warrants to purchase an aggregate of 2,000,000 shares of the Company’s common stock
10.18 (9)
 
Form of Promissory Note issued to the Company’s Chief Executive Officer
10.19(10)
 
Form of March 2015 Promissory Note
10.20(10)
 
Form of March 2015 Warrant

2


10.21(11)
 
Form of Note Amendment Letter Agreement
10.22(11)
 
Form of May 2015 Note
10.23(11)
 
Form of May 2015 Warrant
10.24(12)
 
Form of Advisory/Consulting Agreement
10.25(13)
 
Zolty Promissory Note
10.26(13)
 
Zolty Warrant
10.27(13)
 
Form of July 2015 Convertible Promissory Note
10.28(13)
 
Form of July 2015 Warrant
10.29(15)
 
Form of Bridge Note Subscription Agreement
10.30(15)
 
Form of Convertible Note
10.31(15)
 
Form of March 2016 Note
10.32(15)
 
Form of March 2016 Warrant
10.33(18)
 
Form of July 2016 Warrants
10.34(18)
 
Second Amendment to Research and License Agreement dated as of November 28, 2016 between the Company and Yeda Research and Development Company Limited
10.35(18)
 
Third Amendment to Research and License Agreement dated as of March 29, 2018 between the Company and Yeda Research and Development Company Limited
10.36(18)
 
Fourth Amendment to Research and License Agreement dated as of March 30, 2018 between the Company and Yeda Research and Development Company Limited
10.37(16)
 
Convertible Note due July 27, 2016
10.38(17)
 
Promissory Note dated May 10, 2016
10.39(19)
 
Sponsored Research Agreement dated November 28, 2018 between The University of Texas M.D. Anderson Cancer Center and Cell Source Limited
10.40(19)
 
Agreement for Veto Cell Production and Clinical Trial Program dated February 19, 2019 between The University of Texas M.D. Anderson Cancer Center and Cell Source Limited
16.1(1)
 
Letter from Paritz & Company, P.A.
21(14)
 
Subsidiaries
31.1
 
Certification of principal executive and principal financial officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
 
Certification of principal executive and principal financial officer pursuant to Section 906 of the Sarbanes-Oxley Act                  of 2002
101.INS *
 
XBRL Instance Document
101.SCH *
 
XBRL Taxonomy Extension Schema Document
101.CAL *
 
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF *
 
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB *
 
XBRL Taxonomy Extension Label Linkbase Document
101.PRE *
 
XBRL Taxonomy Extension Presentation Linkbase Document


(1)
Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 1, 2014.
(2)
Incorporated by reference to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on June 6, 2012.
(3)
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 26, 2014.
(4)
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 6, 2014.
(5)
Incorporated by reference to the Company’s Form 10-Q filed with the Securities and Exchange Commission on August 19, 2014.
(6)
Incorporated by reference to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 8, 2014.
(7)
Incorporated by reference to the Company’s Registration Statement Form S-1/A filed with the Securities and Exchange Commission on September 23, 2014.
(8)
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 30, 2014.
(9)
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on December 2, 2014.
(10)
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on April 1, 2015.
(11)
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 3, 2015.
(12)
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 10, 2015.
(13)
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on July 28, 2015.
(14)
Incorporated by reference to the Company’s Form 10-K filed with the Securities and Exchange Commission on March 13, 2015.
(15)
Incorporated by reference to the Company’s Form 10-K filed with the Securities and Exchange Commission on April 14, 2016.
(16)
Incorporated by reference to the Company’s Form 10-Q filed with the Securities and Exchange Commission on May 13, 2016.
(17)
Incorporated by reference to the Company’s Form 10-Q filed with the Securities and Exchange Commission on August 15, 2016.
(18)
Incorporated by reference to the Company’s Form 10-K filed with the Securities and Exchange Commission on July 25, 2018.
(19)
Certain information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.
*
Filed with Form 10-K filed with the Securities and Exchange Commission on April 1, 2019


3

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
CELL SOURCE, INC.
       
       
Dated:  June 19, 2019
By:
/s/ Itamar Shimrat
   
Name: 
Itamar Shimrat
   
Title:
Chief Executive Officer and
     
Chief Financial Officer
     
(Principal Executive, Financial and Accounting Officer)
 
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
 
SIGNATURE
 
TITLE
 
DATE
           
           
By: 
/s/ Dennis Brown  
Chairman
 
June 19, 2019
 
Dennis Brown
       
           
           
By:
/s/ Itamar Shimrat  
Chief Executive Officer, Chief Financial Officer and Director
 
June 19, 2019
 
Itamar Shimrat
 
(Principal Executive, Financial and Accounting Officer)
   
           
           
By:
/s/ Ben Friedman  
Director
 
June 19, 2019
 
Ben Friedman
       
           
           
By:
/s/ David Zolty  
Director
 
June 19, 2019
 
David Zolty
       



4
Exhibit 10.39

Certain information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.

Veto Cell Production and Clinical Trial Program

This agreement is entered into between
The University of Texas M. D. Anderson Cancer Center
located at  1515 Holcombe Blvd, Houston, TX 77030, USA

Hereunder called  MD Anderson

and

Cell Source Limited
a company duly registered under the laws of the State of Israel, Company Number 514669761 having its principal place of business at 5 Kineret Street, Bnei Brak  5126237

- hereinafter called Cell Source –

This Veto Cell Production and Clinical Trial Sponsorship Agreement ("Agreement"), is effective as of the 19th day of February, 2019 (the "Effective Date").

§ 1 – Subject matter

(1)
Subject to MD Anderson receiving the necessary approvals, including without limitation, the approval of the applicable institutional review board (“IRB”) overseeing the Program, MD Anderston will use reasonable efforts to undertake to implement  the protocol “Anti-viral central memory CD8 veto cells in haploidentical HSCT” (attached hereto as Exhibit A), such protocol as may be further revised pending approval by the applicable IRB (the “Program”).

(2)
As outlined in the initial budget , MDA  undertakes to perform 4  production validation runs  and a Phase I/II clincial trial using veto cells in [   ] patients. Based on the assessment of  results in the first [   ] patients further continuation of the study in up to [   ] patients will be considered.

(3)
MD Anderson, under the supervision of its Principal Investigator Richard Champlin, M.D.,   shall perform the Program in close co-operation with Cell Source and shall keep Cell Source informed of the Program’s progress and all major developments concerning the Program.

(4)
Upon completion of each quarter  MDA  shall submit a written report to Cell Source describing the results of the Program.

(5)
Cell Source represents and warrants that it exclusively licenses proprietary scientific knowledge developed at the Weizmann Institute of Science by a team headed by Prof. Yair Reisner, including without limitation, the Anti-viral central memory CD8 veto cells, from Yeda Research and Development Limited (“Yeda”). The Program will be conducted in cooperation with Prof. Riesner.

(6)
The rights to any outcomes of the treatments performed on behalf of Cell Source, to the extent that they may be protected by patent laws, will belong exclusively to Yeda and fall under the existing exclusive license that Cell Source has from the Weizmann Institute through its agreement with Yeda, provided, however, MD Anderson shall have the right to use such outcomes for MD Anderson’s internal academic, research and patient care purposes.

(7)
MD Anderson and Cell Source will promptly notify each other upon identifying any aspect of the protocol for the Program or the Program results that may adversely affect the safety, well-being, or medical care of Program subjects, or that may affect the willingness of subjects to continue participation of the Program, influence the conduct of the Program, or may alter the IRB’s approval to continue the Program; when possible, such findings shall be submitted to MD Anderson electronically.  MD Anderson shall promptly notify the IRB of any such events.  When Program subject safety or medical care could be directly affected by Program results, then notwithstanding any other provision of this Agreement, MD Anderson will send Program subjects a written communication about the results.
 

§ 2 – Payment

In support of  MD Anderson’s participation in the Program hereunder, Cell Source shall pay to  MD Anderston  the sums as described in the attached budget (attached hereto as Exhibit B).

§ 3 – Confidentiality
 
(1)
Any Confidential Information that will be exchanged between the Parties, whether orally, in writing or by any other medium, during the course of the Program under this agreement, shall be treated confidential by the receiving Party. The receiving Party shall not use such Confidential Information for any purpose other than performance of this agreement, and shall not make available such Confidential Information to any third party.

(2)
For the purposes of this agreement, “Confidential Information” shall mean any information that is expressly marked as confidential by appropriate means, or clearly identifiable as being confidential by its nature. However, “Confidential Information” shall not include any information that

-
was known to the receiving Party prior to its disclosure, or
-
was known to the public or was generally available prior to its disclosure, or
-
became known to the public or became generally available after disclosure through no wrongful act or omission of the receiving Party, or
-
essentially corresponds to information that was disclosed or made available to the receiving Party at any time by a third party, who, to the knowledge of the receiving Party, had the legal right to disclose the information to the receiving Party (it is agreed that Prof. Reisner, his team or anyone from the Weizmann Institute deriving its information from the technology developed by Prof. Reisner while at the Weizmann Institute are not considered third party to this matter),
-
was developed independently by the receiving Party without knowledge of the Confidential Information,
-
is required to be disclosed in order to obtain the informed consent from subjects who may wish to enroll in the Program, provided, however, that the Confidential Information will be disclosed only to the extent necessary and will not be provided in answer to unsolicited inquiries by telephone or to individuals who are not eligible Program candidates,
-
is disclosed to a Program subject for the safety or well-being of the Program subject.

(3)
Notwithstanding the foregoing, each receiving Party will be permitted to disclose Confidential Information as required by law or regulation, provided to the extent practicable, prior to such disclosure, the receiving Party will provide reasonable advance notice to the disclosing Party to allow the disclosing Party an opportunity to obtain a protective order.

(4)
Each Party shall ensure that its respective employees will be bound by these confidentiality obligations.

§ 4 – Publications

(1)
Notwithstanding anything to the contrary herein, Cell Source ackowledges that MDA has the first right to publishe the results of Program. Any publication in whatever form on the data and results of the Program by MD Anderson, shall be submitted to Cell Source in advance. Cell Source will review the manuscript and provide comments within 30 days. If Cell Source does not react within such 30 days, Cell Source shall be deemed to not have any comments on the publication. Cell Source will also have the right to publish press releases regarding the Program, provided, however, all press releases including the name of MD Anderson requires prior written approval from MD Anderson’s Department of External Communications. All such publication and press releases shall be in accordance with generally acceptable scientific research and/or academic standards.

(2)
Cell Source may request a delay of the publication for a period not to exceed sixty (60) days, or changes to its content, only insofar as necessary to avoid undue disclosure of Cell Source’s Confidential Information, provided, in no case shall MD Anderson be required to remove any data or results of the Program. Should Cell Source or Yeda elect to file a patent regarding a new invention that results from this Program, Cell Source may request a delay of the publication for a period not to exceed sixty (60) days if the publication discloses the content of such patent application.

2

§ 5 – Liability

(1)
MDA shall perform the Program hereunder with its usual care and on the basis of the current state of the art in science and technology research and in accordance with  all relevant laws and regulations required in the MDA’s domicile. With respect to the Results, no warranty of any kind is given, neither express nor implied, as to the Results’ fitness for any particular purpose or to the non-infringement of any third party’s rights by the Results.

(2)
Any liability among the contracting parties shall be limited to gross negligence and willful misconduct. Except in cases of willful misconduct, neither party shall be liable for any remote or incidental damage or loss (such as loss of profit or loss of contract).

(3)
This Agreement does not obligate any of the contracting parties to provide medical treatment, except to the extent required by applicable law, nor does this Agreement obligate either party to provide reimbursement for medical treatment if a Program subject requires medical treatment for physical illness or injury sustained as a direct result of the treatment of such Program subject in accordance with this Agreement and the protocol for the Program.

§ 6 – Term

(1)
This agreement shall enter into force upon signature by both parties.

(2)
This agreement may not be terminated prematurely by either Party, except in case of “good cause for termination” as per the pertinent regulations in MDA’s domicile.

§ 7 – Miscellaneous

(1)
This agreement may only be amended by written agreement of the Parties.

Signatures

THE UNIVERSITY OF TEXAS
M.D. ANDERSON CANCER CENTER
Houston, Texas


Name
Title

Read and Understood:


__________________________
Principal Investigator
Richard Champlin

CELL SOURCE LIMITED
Israel


__________________________
Itamar Shimrat
Chief Executive Officer

 
Brackets ( [   ] ) indicate that certain information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.

3

Exhibit A
Protocol

[   ]







Brackets ( [   ] ) indicate that certain information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.

4


EXHIBIT B- BUDGET
 
Funding Agency:
 
 
Cell Source Limited
   
Principal Investigator:
Champlin, Richard
 
Title:
Role of Veto Cells in Haploidentical Transplantation for Myeloma
 
Project Dates:
TBD
     
Protocol(s)
2018-0221
     
Total Patients
       [    ]
     
 
[    ]
       

 

      Year 1       Year 2
      Grand Total  
                         
Total Costs
 
$
1,162,760.38
   
$
889,624.93
   
$
2,052,385.31
 


PAYMENT SCHEDULE
Payment Plan
Milestone/Deliverable
[    ]
    Payment (USD)  
[    ]
 
$   473,288.26
 
[    ]
 
$   258,144.93
 
[    ]
 
$   384,456.83
 
[    ]
 
$   468,247.65
 
[    ]
 
$   468,247.65
 
        Total
 
$2,052,385.31
 



Brackets ( [   ] ) indicate that information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.

5
Exhibit 10.40

Certain information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.

SPONSORED RESEARCH AGREEMENT

This Sponsored Research Agreement (“Agreement”), effective as of the 28th day of November, 2018 (the “Effective Date”) is made by and between The University of Texas M. D. Anderson Cancer Center, (“MD Anderson”), a member institution of The University of Texas System (“System”), with a place of business at 1515 Holcombe Blvd., Houston, Texas, 77030, and Cell Source, a corporation with a place of business at 57 West 57th Street, Suite 400, New York, NY 10019. (“Sponsor”).   MD Anderson and Sponsor hereinafter may be referred to each as a “Party” and collectively as the “Parties.”

RECITALS

A.  MD Anderson and Sponsor are interested in pursuing research in the area of stem cells.

B.  Sponsor desires to collaborate with MD Anderson and is willing to sponsor MD Anderson’s research study entitled “Tolerance Induction by Veto Cells” (“Study”), as described in Exhibit A, attached hereto.

C.  Sponsor and MD Anderson are entering into this Agreement to set forth the rights and obligations of the Parties with respect to the Study.

NOW THEREFORE, in consideration of the mutual covenants and promises herein contained, MD Anderson and Sponsor agree as follows:

1. TERM

This Agreement shall be effective as of the Effective Date, and shall continue in effect for a period of three (3) years following the Effective Date (“Term”) unless such Term is extended by mutual written agreement of the Parties, or the Agreement is earlier terminated in accordance with Section 11 of this Agreement.

2. STUDY CONDUCT

2.1  MD Anderson will use its own facilities and its reasonable best efforts to conduct the Study under the direction of Dr. Yair Reisner, or his/her successor as mutually agreed to by the Parties (the “Principal Investigator”) in accordance with Exhibit A and applicable laws and regulations.  In the event of any conflict between Exhibit A and this Agreement, this Agreement shall control.  Unless expressly set forth herein, MD Anderson shall provide all necessary personnel, equipment, supplies, facilities and resources to perform the Study, and shall be fully responsible for the activities of any MD Anderson personnel to whom Study activities are delegated.

2.2  Sponsor understands and acknowledges that MD Anderson’s primary mission is the development and dissemination of scientific knowledge, and that MD Anderson makes no representations, warranties, or guarantees with respect to any specific results of the Study.


2.3  Sponsor understands and acknowledges that MD Anderson may be involved in similar research through other researchers on behalf of itself and others. Nothing in this Agreement will limit or prohibit MD Anderson or any of its personnel, including the Principal Investigator, from conducting any research or for performing research for or with any entity or person, including any other outside sponsors.  Sponsor acknowledges that this provision is intended to preserve the academic freedom and integrity of MD Anderson and its faculty and to ensure that MD Anderson and its faculty are not regarded as captive researchers for Sponsor. Despite the above, it is agreed that if the Principal Investigator conducts any research or if any other research is conducted at MD Anderson that breaches this agreement inasmuch as such research uses confidential materials or information as defined below as “Confidential Information” in Paragraph 6.1 of this agreement that is provided by Sponsor and that is associated with the Study outside of the Study without Sponsor’s written permission, Sponsor shall then be entitled to all the rights it has under this agreement with respect to the results of such research.

2.4  . MD Anderson will provide a written report every [   ] months to the Sponsor in terms of progress in the Research being conducted. Furthermore, MD Anderson will provide a current annual advance work plan [   ] for each annual period which must be approved in advanced in writing by the Sponsor. In the event that MD Anderson wishes to propose curtailing or modifying an existing research stream between update periods, any change of this kind must be pre-approved in writing by the Sponsor.

3. STUDY BUDGET

3.1  Sponsor agrees to pay MD Anderson an amount equal to its expenditures and reasonable overhead in conducting the Study in the amount of US$1,507,352.33 (“Budget”). The schedule and procedure of payments under the Budget shall be made as set forth in Exhibit B, attached hereto.  In the event of any conflict between Exhibit B and this Agreement, this Agreement shall control.

4. DATA

4.1  MD Anderson shall own all data and results generated in the conduct of the Study (“Data”), and shall have the right to use such Data for any purpose, and to publish such Data as set forth in Section 5 hereunder.

4.2  MD Anderson shall provide Data to Sponsor in the form of Study reports as described in section 2.4 above.  Sponsor shall have the right to use Data for its own purposes, provided that Sponsor shall maintain such Data in confidence until the earlier of: (a) publication or public disclosure of such Data by MD Anderson and/or Principal Investigator; or (b) twelve (12) months following the completion of the Study; or (c) under non-disclosure agreements with business associates or regulatory bodies as needed.

5. PUBLICATION AND PUBLICITY

5.1  MD Anderson and Principal Investigator shall have the right to publish or present Data in scientific journals and/or at scientific meetings at MD Anderson’s and/or the Principal Investigator’s sole discretion, and to submit Data to a public data registry.  MD Anderson and Principal Investigator shall provide Sponsor with a copy of a proposed publication or presentation for review and comment sixty (60) days prior to publication by the publishing source or at least forty (40) days prior to presentation at a scientific meeting or conference.  MD Anderson and Principal Investigator shall have the final authority to determine the scope and content of any presentation and/or publication of Data. At Sponsor’s request, MD Anderson will delay the publication or presentation for up to sixty (60) additional days in order to allow Sponsor to protect its proprietary interests.

2

5.2  Except for MD Anderson’s right to publish the Data as set forth in Section 5.1 and subject to applicable law and regulations, neither Party will reference the other party’s name or disclose the results (including interim findings) of the Study in a press release or any written statement except as agreed in advance by both parties. In the event that the Sponsor wishes to issue a press release sharing findings and/or status of the Study, a draft press release will be circulated to MD Anderson for approval or editorial comments and MD Anderson will respond promptly. In any permitted statements, the Parties shall describe the scope and nature of their participation accurately and appropriately.

6. CONFIDENTIAL INFORMATION

6.1  In conjunction with the Study, the Parties may wish to disclose certain of their respective confidential and/or proprietary information (“Confidential Information”) to each other. Each Party will use Confidential Information of the other Party solely for the purpose of conducting the Study, and shall use reasonable efforts to prevent the disclosure of such other Party's Confidential Information to third parties during the Term and for a period of three (3) years after expiration or termination of this Agreement, provided that the receiving Party's obligation of confidentiality and nonuse hereunder shall not apply to information that: (a)  is already in the receiving Party's possession at the time of disclosure; (b)  is or later becomes part of the public domain through no fault of the receiving Party; (c)  is received from a third party having no obligations of confidentiality or nonuse to the disclosing Party; (d)  independently developed by the receiving Party; (e)  is required by law or regulation to be disclosed;  (f) is published in accordance with Section 5 of this Agreement; (g) is necessary to disclose in order to file a patent application or enforce a patent related to this Agreement; or (h) is communicated to MD Anderson's scientific and/or institutional review committees.

6.2  In the event that information is required to be disclosed pursuant to Section 6.1(e), the Party required to make disclosure shall notify the other Party to allow the other Party to assert whatever exclusions or exemptions may be available to such Party under applicable law or regulation.

6.3  In the event that Sponsor shall come into contact with any “Protected Health Information” (as such term is defined under HIPAA) of MD Anderson or any information which could be used to identify any of MD Anderson’s patients or research subjects, Sponsor shall maintain any such Protected Health Information or other information confidential in accordance with laws and regulations as applicable to MD Anderson, including without limitation HIPAA, and shall not use or disclose any such Protected Health Information or other information in any manner that would constitute a violation of any applicable law or regulation if such use or disclosure was made by MD Anderson.

7. INTELLECTUAL PROPERTY

7.1  Sponsor and MD Anderson understand and agree that the performance of the Study may require use of information and/or materials that may be protected by patents or other proprietary rights owned by or licensed to either Party (“Background Intellectual Property”).    Nothing in this Agreement will be deemed or construed to convey or transfer to either Party any rights or license with respect to the Background Intellectual Property of the other Party except insofar as contemplated by this Agreement.

7.2  Title to any inventions or discoveries arising from the performance of the Study (“Inventions”) and conceived and reduced to practice solely by MD Anderson employees shall be owned by MD Anderson and shall be disclosed in writing to Sponsor.  Title to any Inventions conceived and reduced to practice jointly by MD Anderson and Sponsor shall be owned jointly by MD Anderson and Sponsor.   [   ].

3

8. INDEMNIFICATION

8.1  Sponsor agrees to indemnify, hold harmless, and subject to the statutory duties of the Texas State Attorney General defend MD Anderson, System, their Regents, officers, agents and employees (“MD Anderson Indemnitees”) from any liability, loss or damage they may suffer as a result of claims, demands, costs or judgments against them arising out of Sponsor’s rights and obligations under this Agreement, including but not limited to Sponsor’s use of Data; provided, however, that Sponsor shall not be obligated to hold harmless any MD Anderson Indemnitee from claims arising out of the negligence or willful malfeasance of any MD Anderson Indemnitee.

8.2  To the extent authorized by the constitution and laws of the State of Texas, MD Anderson agrees to indemnify and hold harmless Sponsor, its officers, agents and employees (“Sponsor Indemnitees”) from any liability, loss or damage they may suffer as a result of claims, demands, costs or judgments against them arising out of MD Anderson’s negligence in conducting the Study, provided, however, that MD Anderson shall not be obligated to hold harmless any Sponsor Indemnitee from claims arising out of the negligence or willful malfeasance of any Sponsor Indemnitee.

8.3  Both Parties agree that upon receipt of a notice of claim or action arising out of the Study, the Party receiving such notice will notify the other Party promptly.

9. INDEPENDENT CONTRACTOR

For the purposes of this Agreement and the Study, the Parties shall be, and shall be deemed to be, independent contractors and not agents or employees of the other Party. Neither Party shall have authority to make any statements, representations or commitments of any kind, or to take any action which shall be binding on the other Party, except as may be expressly provided for herein or authorized in writing.

10. TERMINATION

10.1  This Agreement may be terminated: (a) immediately by the written agreement of both Parties; (b) by the Sponsor at the end of each twelve month period following the commencement of the Study, with sixty (60) days' notice to MD Anderson; (c) by MD Anderson for health, safety or regulatory reasons or if Sponsor breaches this Agreement and fails to cure such breach within fifteen (15) business days of notice of such breach by MD Anderson; or (d) immediately by either Party if at any time Principal Investigator becomes unable to conduct the Study, and the Parties cannot agree upon a mutually acceptable successor to the Principal Investigator.

10.2  In the event that either Party shall be in default of its material obligations under this Agreement and shall fail to remedy such default within thirty (30) days after receipt of written notice thereof, this Agreement shall terminate upon expiration of the thirty (30) day period.

10.3  Termination or cancellation of this Agreement shall not affect the rights and obligations of the Parties accrued prior to termination. Upon termination: (a) Sponsor shall pay MD Anderson for all reasonable expenses incurred or committed to be expended as of the effective termination date, including salaries for appointees for the remainder of the current quarter, for the proportion of their appointment allocated to the Sponsor  as applicable; and (b) each Party shall return to the other Party or destroy any Confidential Information of such other Party remaining in the Party’s possession, provided that such Party may retain one (1) copy of such Confidential Information for purposes of compliance with this Agreement and with applicable laws and regulations.

4

10.4  Any provisions of this Agreement which by their nature extend beyond expiration or termination of the Agreement shall survive such termination.

11. MISCELLANEOUS PROVISIONS

11.1  This Agreement may not be assigned by either Party without the prior written consent of the other Party.

11.2  This Agreement constitutes the entire and only agreement between the Parties relating to the Study, and all prior negotiations, representations, agreements and understandings are superseded hereby. No agreements altering or supplementing the terms hereof may be made except by means of a written document signed by the duly authorized representatives of the Parties.

11.3  Principal Investigator and Sponsor may be parties to a consulting agreement or other outside agreement to which MD Anderson is not a party. Sponsor acknowledges and agrees that MD Anderson has no involvement with or responsibility for these consulting or outside agreements.

11.4  Any notice required by this Agreement shall be given by prepaid, first class, certified mail, return receipt requested, addressed in the case of MD Anderson to:

The University of Texas
M. D. Anderson Cancer Center
1515 Holcombe Blvd., Unit 1436
Office of Research Administration
Attn: Executive Director, Research Administration
Houston, TX 77030

With a copy to:

The University of Texas System
M. D. Anderson Cancer Center
1515 Holcombe Blvd., 1674
Legal Services
ATTN: Chief Legal Officer
Houston, TX 77030

or in the case of Sponsor to:

Cell Source, Inc.
57 West 57th Street, Suite 400
New York, NY 10019
     ATTN: ITAMAR SHIMRAT, Chief Executive Officer)
     FAX: 1 646 416-8006
     PHONE: 1 646 416-7896

or at such other addresses as may be given from time to time in accordance with the terms of this notice provision.

11.5  This Agreement shall be governed by, construed, and enforced in accordance with the laws of the State of Texas.

5


11.6  MD Anderson is an agency of the State of Texas and under the Constitution and laws of the State of Texas possesses certain rights and privileges and only such authority as is granted to it under the Constitution and laws of the State of Texas. Notwithstanding any provision hereof, nothing herein is intended to be, nor will it be construed to be, a waiver of the sovereign immunity of the State of Texas or a prospective waiver or restriction of any of the rights, remedies, claims, and privileges of the State of Texas. Moreover, notwithstanding the generality or specificity of any provision hereof, the provisions of this agreement as they pertain to MD Anderson are enforceable only to the extent authorized by the Constitution and laws of the State of Texas.

11.7  Neither MD Anderson nor Sponsor will be required to perform any act or to refrain from any act or be bound to any act that would violate any state or federal law applicable to it.  In this regard, this Agreement is subject to, and MD Anderson and Sponsor agree to comply with, all applicable local, state, federal, national and international laws, statutes, rules and regulations.  Any provision of any law, statute, rule or regulation that invalidates any provision of this Agreement, that is inconsistent with any provision of this Agreement, or that would cause one or any of the Parties hereto to be in violation of law will be deemed to have superseded the terms of this Agreement.  MD Anderson and Sponsor, however, will use all reasonable efforts to accommodate the terms and intent of this Agreement to the greatest extent possible consistent with the requirements of the law and negotiate in good faith toward amendment of this Agreement in such respect.  If the Parties cannot reach agreement on an appropriate amendment, then this Agreement may be immediately terminated by either Party.

6


IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.

SPONSOR
THE UNIVERSITY OF TEXAS
 
M. D. ANDERSON CANCER CENTER
   
 By
By
      Name: Itamar Shimrat
Name: Jaime Farias
     Title: Chief Executive Officer
Title: Assistant Director of Sponsored Programs
   
   
   

READ AND UNDERSTOOD BY:
   
   

Dr. Yair Reisner

Principal Investigator




Brackets ([   ]) indicate that certain information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.

7

EXHIBIT A


[     ]








Brackets ([   ]) indicate that certain information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.

8


EXHIBIT B

STUDY BUDGET

Funding Agency: Cell Source
Principal Investigator: Yari Reisner
Title:
Project Dates: TBD
Protocol(s): N/A
Total Patients: N/A
[   ]
*

Total Costs
 
Year 1
   
Year 2
   
Year 3
   
Grand Total
 
                         
   
$
499,673.60
   
$
499,703.81
   
$
507,974.92
   
$
1,507,352.33
 


PAYMENT PLAN (Effective 01/01/2019)

   
YEAR 01
   
YEAR 02
   
YEAR 03
 
                   
Quarterly payments*
 
$
124,918.40
   
$
124,925.95
   
$
126,993.73
 
Total
 
$
499,673.60
   
$
499,703.81
   
$
507,974.92
 

* Payments to be made quarterly by first of each quarter



Brackets ( [   ] ) indicate that information has been excluded from this exhibit because (i) it is not material and (ii) would be competitively harmful if publicly disclosed.


9
Exhibit 31.1
 
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
 
I, Itamar Shimrat, certify that:
 
1.    I have reviewed this report on Form 10-K/A of Cell Source, Inc.;
 
2.    Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.    Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.    The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
 
a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
 
b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
 
c)
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
 
d)
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.     The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
 
a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
 
b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. 
 

Dated:  June 19, 2019
By:
/s/ Itamar Shimrat
 
 
 Itamar Shimrat
 
 
 Chief Executive Officer and Chief
 
 
 Financial Officer
 
 
 (Principal Executive, Financial and
 
 
 Accounting Officer)


Exhibit 32.1
 
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Annual Report of Cell Source, Inc. (the “Company”) on Form 10-K/A for the year ended December 31, 2018 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Itamar Shimrat, Chief Executive Officer and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
 
 
(1)
  The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
 
(2)
  The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 

Date: June 19, 2019
By:
/s/ Itamar Shimrat
 
 
 Itamar Shimrat
 
 
 Chief Executive Officer and Chief
 
 
 Financial Officer (Principal Executive,
 
 
 Financial and Accounting Officer)
 



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