Document:

Exhibit 10.20

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.

 

AMENDMENT TO THE DEVELOPMENT AGREEMENT AND TO THE SECOND AMENDED AND RESTATED LICENSE, PRODUCT DEVELOPMENT AND SUPPLY UMBRELLA AGREEMENT

 

This Amendment (“Amendment”) to the Development Agreement dated as of 16 July 2015 (“Development Agreement”) and the Second Amended and Restated License, Product Development and Supply Umbrella Agreement dated as of 16 July 2015 (the “Umbrella Agreement”), is made as of 26 November 2015 by and between TELA Bio, Inc (“TELA Bio”) and Aroa Biosurgery Limited (“Aroa”).

 

The parties desire to amend certain provisions of the Development Agreement and the Umbrella Agreement as set forth in this Amendment.

 

Now, Therefore, in consideration of the covenants and agreements set forth herein, the parties hereto, intending to be legally bound, agree as follows:

 

1.                                      The Development Agreement is hereby amended as follows:

 

a.                                      The Completion Date for the products described in items 2 and 3 of the first page of the Development Agreement, [***].

 

b.                                      The payment schedule set forth on page two of the Development Agreement is hereby amended to [***].

 

2.                                      The parties confirm that the condition for the payment of the Final Payment Amount (as amended herein) has been satisfied.  Accordingly, the payment of the Final Payment Amount is due and payable as of the date of the signing of this Amendment TelaBio agrees to sign the “Escrow Funds Payment Instructions” attached as the Appendix hereto contemporaneously with the signing of this Amendment.

 

3.                                      As a consequence of the amendments to the Development Agreement as set forth herein, the Umbrella Agreement is hereby amended as follows:

 

a.                                      The October 31. 2015 deadline for the completion of the [***] (as defined above) is hereby extended to [***].

 

4.                                      Aroa and TELA agree that the Goal Deadline for the Abdominal Wall/Hernia Repair Products is not amended and remains unaffected by any of the provisions of this Amendment.

 

5.                                      For the avoidance of doubt and for the purposes of clarification, the parties agree that the extension of the Completion Date hereunder shall not constitute “a delay in the development of the Abdominal Wall/Hernia Products under the Development Agreement due to a failure of Aroa or the failure of Aroa to deliver the Products to TELA Bio for a commercial launch pursuant to a Purchase Order provided in accordance with Section 8.3” under section 8.12 of the Umbrella Agreement.

 

Capitalised terms in this Amendment have the meanings given to those terms in the Development Agreement and the Umbrella Agreement.

 

 

Except as otherwise amended herein, the other provisions of the Development Agreement and the Umbrella Agreement continue to be in full force and effect.

 

The parties agree that this Amendment shall be governed by and construed in accordance with the laws of the State of Delaware, excluding its conflict of laws provisions. This Amendment may be executed in counterparts, each of which shall be deemed an original and all of which taken together shall constitute one and the same agreement.  Executed signature pages to this Amendment may be delivered by facsimile or pdf electronic transmission and such signature pages shall be deemed for all purposes to be originally signed signature pages.

 

IN WITNESS WHEREOF, each of the parties has caused this Amendment to be executed by its duly authorized representative.

 

 

	
TELA BIO, INC.
    	
 
    	
AROA BIOSURGERY LIMITED
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Antony Koblish
    	
 
    	
By:
    	
/s/ Brian Ward
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Antony Koblish
    	
 
    	
Name:
    	
Brian Ward
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
President & CEO
    	
 
    	
Title:
    	
CEO
    

 

 

APPENDIX

 

ESCROW FUNDS PAYMENT INSTRUCTIONS

 

See attached

 

 

ESCROW FUNDS PAYMENT INSTRUCTIONS

 

In accordance with clause 9.1.1 of the Escrow Agreement between the TELA Bio Inc. (“TELA Bio”), Aroa Biosurgery Limited (“Aroa”) and Duncan Cotterill (the Escrow Agent”) dated 17 July 2015 (“Escrow Agreement”), the undersigned, on behalf of each of TELA Bio and Aroa instruct the Escrow Agent to release the amount of [***] from the Escrow Funds on the date of these instructions, in accordance with the Payment Schedule (as that term is defined in the Escrow Agreement), less any deductions permitted under the Escrow Agreement, into the bank account of Aroa as set out below.

 

The parties confirm that any conditions in the Payment Schedule for the payment of the amount instructed herein has been satisfied.

 

	
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DATE:          26 November 2015

 

SIGNED BY:

 

	
TELA BIO, INC.
    	
 
    	
AROA BIOSURGERY LIMITED
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Antony Koblish
    	
 
    	
By:
    	
/s/ Brian Ward
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Antony Koblish
    	
 
    	
Name:
    	
Brian Ward
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
President & CEO
    	
 
    	
Title:
    	
CEOExhibit 10.21

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.

 

ADDENDUM TO THE SECOND AMENDED AND RESTATED LICENSE, PRODUCT DEVELOPMENT AND SUPPLY UMBRELLA AGREEMENT

 

TELA Bio, Inc. (“TELA Bio”) and Aroa Biosurgery Limited (“Aroa”) entered into the Second Amended and Restated License, Product Development and Supply Umbrella Agreement (the “Umbrella Agreement”) on 16 July 2015.

 

TELA Bio and Aroa are parties to (i) a Development Agreement, effective as of September 21, 2017 (“Contour Product Development Agreement”), that sets forth the terms and conditions relating to the development of the Endoform® Contoured Reconstructive Template (“Contour Product”), which was subsequently amended on June 1, 2018 (‘Contour Product Amendment”), (ii) Product Exhibit 2, effective as of September 21, 2017 (“Contour Product Exhibit”), to the Second Amended and Restated License, Product Development and Supply Agreement dated July 16, 2015, as amended (“Umbrella Agreement”) and (iii) Addendum to the Umbrella Agreement, dated as of September 21, 2017, with respect to the Endoform® Contour Reconstructive Template (“Contour Product Addendum”).

 

The parties wish to replace the Contour Product with the Endoform® Restella Reconstructive Template (“Restella Product”).

 

This addendum to the Umbrella Agreement (“Addendum”), is made as of the 3rd day of January 2019, and sets out the terms of the parties’ agreements with respect to the Restella Product. This Addendum also cancels and replaces the Contour Product Addendum and the Contour Product Exhibit.

 

1.                                      TELA Bio and Aroa will, effective as of the date of this Addendum, enter into a development agreement relating to the development of the Restella Product and each party’s responsibilities in connection with the development of the Restella Product (“Restella Product Development Agreement”). Such development agreement and the Product Exhibit (set out in the development agreement) shall constitute the Product Exhibit for the Restella Product (“Restella Product Exhibit”), for the purposes of the Umbrella Agreement. The Restella Product Development Agreement and the Restella Product Exhibit shall cancel and replace the Contour Product Development Agreement, and the Contour Product Exhibit.

 

2.                                      The Restella Product:

 

a.                                      Will use Aroa’s existing 510(k) clearances ([***]) as the predicate and ([***]) as the reference; and

 

b.                                      Will have, based on TELA Bio’s use of clearances described in a. above, the intended use for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery; and

 

c.                                       Will, based on TELA Bio’s use of clearances described in a. above, be indicated for use as an extracellular matrix scaffold to reinforce or elevate soft tissue where weakness or a

 

 

void exists and for the surgical repair of damaged or ruptured tissue membranes which require the use of reinforcing material to obtain the desired surgical outcome.

 

(Clauses 2a. to 2c. together being the “Claims, Intended Use and Indications for Use of the Restella Product”.)

 

d.                                      Will include a combination of Aroa Technology (forestomach tissue) and synthetic sutures which are indicated in the Restella Product Exhibit.

 

3.                                      [***]

 

a.                                      [***]

 

b.                                      [***]

 

c.                                       [***]

 

d.                                      Aroa and its Affiliates shall not and shall not grant any other person or entity any rights to market, promote, sell or otherwise commercialize the Restella Product in any of the Indications in the Territory.

 

e.                                       Aroa will be the sole and exclusive owner of any regulatory approvals/clearances with respect to the Restella Product.

 

4.                                      The Restella Product can only be in the shapes, sizes and forms approved in writing by Aroa and all changes, variations or improvements to the Restella Product shall require the prior written approval of Aroa. [***].

 

5.                                      The parties acknowledge and agree that the Goal for a breast reconstruction product in the North American Territory has been satisfied. For the avoidance of doubt, the development and commercial launch of the Restella Product will not satisfy, amend or vary the Goal or Goal Deadline relating to a breast reconstruction product for the European Territory under Section 8.12 of the Umbrella Agreement.

 

6.                                      TELA Bio’s rights herein to use Aroa’s 510(k) regulatory clearance for the Restella Product and the Claims, Intended Use and Indications for Use of the Restella Product, as set out herein or in the 510(k) regulatory clearance for the Restella Product, shall terminate when:

 

a.                                      [***]

 

b.                                      [***].

 

Capitalised terms used but not defined in this Addendum have the meanings given to those terms in the Umbrella Agreement.

 

This Addendum shall cancel, replace and supersede the Contour Product Addendum and Restella Product Exhibit shall cancel, replace and supersede the Contour Product Exhibit. Accordingly, the Contour Product Addendum and the Contour Product Exhibit are hereby cancelled as at the date of this Addendum.

 

 

Except as agreed herein, the provisions of the Umbrella Agreement are not amended and continue to be in full force and effect.

 

This Addendum shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to any conflict of law provisions.

 

This Addendum may be executed in separate counterparts, each of which shall be an original and all of which taken together shall constitute one and the same agreement.

 

Executed signature pages to this Addendum may be delivered by facsimile or electronic mail and any signature page so delivered shall be deemed to be an original.

 

 

IN WITNESS WHEREOF, each of the parties has caused this Addendum to be executed by its duly authorized representative as of the date first above written.

 

 

	
TELA   BIO, INC.
    	
 
    	
ARO   BIOSURGERY LIMITED
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Antony Koblish
    	
 
    	
By:
    	
/s/ Brian Ward
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Antony Koblish
    	
 
    	
Name:
    	
Brian Ward
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
President
    	
 
    	
Title:
    	
CEO
    

 

 

APPENDIX

 

Modified Restella Shapes

 

(Section 4)

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