Document:

Exhibit 10.12

 

AMENDMENT NO. 2

TO 
 EXCLUSIVE LICENSE AGREEMENT

BETWEEN

NATIONWIDE CHILDREN’S HOSPITAL

AND

AVEXIS, INC. (formerly known as BIOLIFE CELL BANK, INC.)

 

This Second Amendment (“Amendment No. 2”) to the Exclusive License Agreement dated October 9, 2013 and Amendment No. 1 dated January 13, 2014 (collectively hereafter “Agreement”) is entered into effective as of April 1, 2014 (the “Amendment Date”) by and between Nationwide Children’s Hospital, a nonprofit Ohio corporation (“Children’s”), and AveXis, Inc., formerly known as BioLife Cell Bank, Inc., a Delaware corporation (“Licensee”) (each a “Party” and collectively the “Parties”). In the event of any conflict between the terms of the Agreement and the terms of this Amendment No. 2, the terms of this Amendment No. 2 will control. Capitalized terms used but not defined herein shall have the respective meanings set forth in the Agreement.

 

RECITALS

 

WHEREAS, the Parties entered into the Agreement with respect to the development and marketing of the Licensed Technology;

 

WHEREAS, the Licensee has effected a name change from BioLife Cell Bank, Inc. to AveXis, Inc. on January 30, 2014 pursuant to Section 7.4 of the Agreement and has relocated its principal place of business to One Energy Square, 4925 Greenville Avenue, Suite 604, Dallas, Texas 75206 on March 14, 2014;

 

WHEREAS, the Licensee provided and Children’s accepted a written development report for the License Year 2013 set forth in Section 3.3 of the  Agreement and such development report includes information substantially affecting that certain current development plan set forth in Exhibit C of the Agreement;

 

WHEREAS, the scAAV9-SMN gene therapy product was not released for clinical use by January 1, 2014 and the Phase 1/2 trial is now to start in March/April 2014, delaying the projected clinical development pathway by at least two months;

 

WHEREAS, the Licensee has substantially revised its ongoing work plan as related to manufacturing; and

 

WHEREAS, the Parties now desire to revise certain provisions of the Agreement and the development plan set forth in Exhibit C of the Agreement.

 

NOW, THEREFORE, in consideration of the mutual promises and covenants herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby mutually agree as follows:

 

1.                                      The preamble of the Agreement is amended and restated to read in its entirety as follows:

 

This Exclusive License Agreement (this “Agreement”) is entered into as of the last date of the signatures below (the “Effective Date”) by and between Nationwide Children’s Hospital, a nonprofit Ohio corporation (“Children’s”) and AveXis, Inc., formerly known as BioLife Cell Bank, Inc., a Delaware corporation having offices at One Energy Square, 4925 Greenville Avenue, Suite 604, Dallas, Texas 75206 (“Licensee”).

 

 

2.                                      Notice to Licensee in Section 12.1 of the Agreement is amended and restated to read in its entirety as follows:

 

To Licensee:                                                                           AveXis, Inc.

Attention:  John A. Carbona, CEO

One Energy Square

4925 Greenville Avenue, Suite 604

Dallas, Texas 75206

Phone:  972.725.7797

Email:  jc@avexisinc.com

cc:  nch@avexisinc.com

 

3.                                      All references in the Agreement to “BioLife Cell Bank, Inc.” shall be amended to read “AveXis, Inc.”

 

4.                                      Exhibit C of the Agreement shall be deleted in its entirety and replaced with the attached “Exhibit C – Development Plan, Revised January 2014” attached hereto as Exhibit 1.

 

5.                                      Except as expressly set forth in this Amendment No. 2, all other agreements, terms, and conditions of the Agreement shall remain in full force and effect.

 

IN WITNESS WHEREOF, the Parties have respectively duly executed this Amendment No. 2 as of the Amendment Date.

 

	
NATIONWIDE CHILDREN’S HOSPITAL
    	
 
    	
AVEXIS, INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Amy Roscoe
    	
 
    	
By:
    	
/s/ John A. Carbona
    
	
 
    	
Amy Roscoe,
    	
 
    	
 
    	
John   A. Carbona,
    
	
 
    	
Vice President,   Strategic Planning and Finance
    	
 
    	
 
    	
Chief   Executive Officer
    

 

 

EXHIBIT 1

 

Exhibit C – Development Plan

Revised January 2014

 

****

 

****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.Exhibit 10.13

 

AMENDMENT NO.3

TO

EXCLUSIVE LICENSE AGREEMENT

 

This Third Amendment (this “Amendment No. 3”) is entered into effective as of April 23, 2015 (the “Amendment Date”) by and between NATIONWIDE CHILDREN’S HOSPITAL, a nonprofit Ohio corporation (“Children’s”), and AVEXIS, INC., a Delaware corporation formerly known as BioLife Cell Bank, Inc. (“Licensee”) (each a “Party” and collectively the “Parties”).  This Amendment amends that certain Exclusive License Agreement dated October 9, 2013 between the Parties as the same was amended by Amendment No. 1 thereto dated January 13, 2014 and Amendment No. 2 thereto dated April 1, 2014 (as so amended, the “Original Agreement”).  In the event of any conflict between the terms of the Original Agreement and the terms of this Amendment, the terms of this Amendment will control.  Capitalized terms used but not defined herein shall have the respective meanings set forth in the Original Agreement.

 

RECITALS

 

WHEREAS, the Parties entered into the Original Agreement with respect to the development and marketing of the Licensed Technology; and

 

WHEREAS, the Parties now desire to extend certain deadlines set forth in Section 7.4 of the Original Agreement.

 

NOW, THEREFORE, in consideration of the mutual promises and covenants herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby mutually agree as follows:

 

1.                                      The second sentence of Section 7.4 of the Original Agreement is amended and restated to read in its entirety as follows:

 

On or before ****, Licensee will complete an asset sell-off of its existing operating cell banking business, file for a name change to AveXis, Inc. (“AveXis”), and complete a Class B capital raise (the “Internal Restructuring”); in addition, within **** (the “Filing Deadline”) after Children’s provides written notice to Licensee that the Research Institute has delivered a dosage of the scAAV9-SMN gene therapy product for the treatment of spinal muscular atrophy type 1 under the Licensed Technology to the **** patient, Licensee will file a registration statement with the U.S. Securities and Exchange Commission for the purpose of becoming a publicly­trading company; provided, however, that:

 

(a)                     Licensee may extend the Filing Deadline to **** by providing written notice of such extension to Children’s on or before the Filing Deadline, and an extension payment in the amount of **** within **** thereafter.

 

2.                                      Except as expressly set forth in this Amendment, all other agreements, terms, and conditions of the Original Agreement shall remain in full force and effect.

 

**** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

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IN WITNESS WHEREOF, the Parties have respectively duly executed this Amendment as of the Amendment Date.

 

 

	
NATIONWIDE CHILDREN’S HOSPITAL
    	
 
    	
AVEXIS, INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Timothy C. Robinson
    	
 
    	
By:
    	
/s/ John D. Harkey Jr.
    
	
Name:
    	
Timothy C. Robinson
    	
 
    	
Name:
    	
John D. Harkey Jr.
    
	
Title:
    	
Executive Vice   President & Chief
    	
 
    	
Title:
    	
Chairman of the Board
    
	
 
    	
Financial &   Administrative Officer
    	
 
    	
 
    

 

2Exhibit 10.14

 

AMENDMENT NO. 4
 TO
 EXCLUSIVE LICENSE AGREEMENT

 

This Fourth Amendment (this “Amendment No. 4”)  is entered into effective as of October 14th, 2015 (the “Amendment Date”)  by and between Nationwide Children’s Hospital, a nonprofit Ohio corporation (“Children’s”),  and AveXis, Inc., a Delaware corporation formerly known as BioLife Cell Bank, Inc. (“Licensee”) (each a  “Party”  and collectively the “Parties”).  This Amendment amends that certain Exclusive License Agreement dated October 9, 2013 between the Parties as the same was amended by Amendment No. 1 thereto dated January 13, 2014, Amendment No. 2 thereto dated April 1, 2014, and Amendment No. 3 thereto dated April 23, 2015 (as so amended, the “Original Agreement”).  In the event of any conflict between the terms of the Original Agreement and the terms of this Amendment, the terms of this Amendment will control. Capitalized terms used but not defined herein shall have the respective meanings set forth in the Original Agreement.

 

RECITALS

 

WHEREAS, the Parties entered into the Original Agreement with respect to the development and marketing of the Licensed Technology; and

 

WHEREAS, the Parties now desire to allow Licensee to become the sponsor of the IND and to transfer the IND and associate regulatory filing from Children’s to the Licensee.

 

NOW, THEREFORE, in consideration of the mutual promises and covenants herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby mutually agree as follows:

 

1.                                      Section 2.1.5 shall be deleted entirely and replaced with the following:

 

2.1.5 IND License. An Investigational New Drug application for the scAAV9-SMN gene therapy product for the treatment of spinal muscular atrophy type 1 (the “IND”) will be initially filed and sponsored by Children’s. Within **** days of the Effective Date, Children’s shall provide Licensee with continual, read-only access to the IND. Children’s shall store and maintain pre-clinical study records, specimens, samples, and data related to the IND, in accordance with FDA regulations 21CFR 58.195(b), which in summary states data, specimens, and records will be stored for **** after FDA marketing approval or **** after submission to FDA for marketing approval. On ****, Licensee shall have the right (the “IND Option”) to become the sponsor of the IND. Within ****  of exercise of the IND Option, Children’s shall complete the transfer of the IND and associated regulatory filings from Children’s to Licensee. Thereafter, Licensee shall have exclusive access to all information owned by Children’s with respect to satisfying Licensee’s obligations as the sponsor of the IND. Furthermore, in the event that Licensee exercises the IND Option, Children’s shall thereafter have the right to file for a change in the sponsorship of the IND to remove Licensee and redesignate Children’s if (i) any act or omission of Licensee constituting negligence or willful misconduct with respect to Licensee’s control of the IND has or could reasonably be expected to have a material adverse effect on the clinical trials conducted under the IND, (ii) Licensee has not cured such act or omission within **** of its receipt of written notice and demand from Children’s or (iii) Licensee has failed to comply with any applicable law, regulation, or guideline, including but not limited to, any applicable FDA or other governmental requirement, where such failure to comply has or could reasonably be expected to have a material adverse effect on the clinical trials conducted under the IND. If delays in curing such act or omission occur without fault by Licensee while Licensee is in the process of curing such act or omission, the time to cure such act or omission shall be extended, upon written approval of Children’s, which approval shall not be unreasonably withheld.

 

**** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

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2.                                      Except as expressly set forth in this Amendment No.4, all other agreements, terms, and conditions of the Original Agreement shall remain in full force and effect.

 

IN WITNESS WHEREOF, the Parties have respectively duly executed this Amendment as of the Amendment Date.

 

	
NATIONWIDE CHILDREN’S HOSPITAL
    	
 
    	
AVEXIS, INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Timothy C.   Robinson
    	
 
    	
By:
    	
/s/ Sean P. Nolan
    
	
Name:
    	
Timothy C. Robinson
    	
 
    	
Name:
    	
Sean P. Nolan
    
	
Title:
    	
Executive Vice President & Chief Financial 
    	
 
    	
Title:
    	
President and Chief Executive Officer
    
	
 
    	
& Administrative Officer
    	
 
    	
 
    	
 
    

 

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