Attached files

file filename
EX-31.4 - EX-31.4 - INVIVO THERAPEUTICS HOLDINGS CORP.ex-31d4.htm
EX-31.3 - EX-31.3 - INVIVO THERAPEUTICS HOLDINGS CORP.ex-31d3.htm
10-Q/A - 10-Q/A - INVIVO THERAPEUTICS HOLDINGS CORP.f10-qa.htm

Exhibit 10.2

AMENDMENT TWO TO THE

EXCLUSIVE LICENSE

(CMCC Agreement #6748)

This second amendment (“Amendment Two”) is made and entered into as of August 29, 2017 (the “Effective Date”) by and between Children’s Medical Center Corporation, a corporation duly organized and existing under the laws of the Commonwealth of Massachusetts and having offices located at 300 Longwood Avenue, Boston, MA (“CMCC”) and InVivo Therapeutics Corporation, a business corporation organized and existing under the laws of the State of Delaware and having its principal office at One Kendall Square, Suite B14402, Cambridge, MA 02139 (“Licensee”).

WHEREAS, CMCC and Licensee have entered into that certain Exclusive License Agreement with an effective date of July 2, 2007 and Amendment Number One on May 12, 2011 (collectively the “Agreement”);

WHEREAS CMCC and Licensee wish to amend such Agreement as set forth in this Amendment Two; and

WHEREAS the Agreement otherwise remains unchanged.

In consideration of these premises and of the mutual promises set forth below, the parties agree to amend the Agreement as follows:

Amendment to the Agreement:

1.           Appendix 1A shall be deleted in its entirety and replaced with Appendix 1A of this Amendment Two.

2.          Appendix 1B shall be deleted in its entirety and replaced with Appendix 1B of this Amendment Two.

3.           Licensee has declined to pay the patent annuities and maintenance fees for certain licensed patent applications contained under Patent Rights as identified in Appendix IA of this Amendment Two. CMCC and MIT acknowledge Licensee’s surrender of rights in such patent applications pursuant to Amendment One, Paragraph 6 replacing Article VI Paragraph B of the Agreement, and acknowledge that Licensee has no further obligations with respect to such surrendered patent applications. For the avoidance of doubt, a license to US Patent No. 9,173,732 remains subsisting under the Agreement, the ‘732 patent being the U.S. counterpart of several foreign applications that were surrendered by the Licensee pursuant to the Agreement. Rights in the surrendered patent application in Appendix II shall be governed by Amendment One, Paragraph 6 amending Article VI Patent Prosecution, Paragraph B. of the Agreement.

1


 

4.          The parties agree that as of the Effective Date of the Second Amendment, the $100,000 Milestone payment referenced in Article IV(c) of the Agreement is hereby due to CMCC and shall be paid by Licensee to CMCC within thirty (30) days of the Effective Date of the Second Amendment.

5.          The parties acknowledge that Licensee has provided to CMCC the Commercialization Plan as defined in Article III, Paragraph B of the Agreement.

6.          Upon execution, this Amendment Two shall be made a part of the Agreement and shall be incorporated therein. Except as provided herein, all other terms and conditions of the Agreement shall remain in full force and effect.

7.          This Amendment Two may be executed by facsimile or a portable document format (PDF) and in any number of counterparts, each of which shall be deemed to be an original, and all of which together will constitute one and the same instrument.

IN WITNESS WHEREOF, the parties hereunto have duly executed this Amendment Two by their respective authorized signatory.

 

 

 

 

 

 

CHILDREN’S MEDICAL CENTER CORPORATION

INVIVO THERAPEUTICS CORPORATION

 

 

 

 

By

/s/ August Cervini

 

By

/s/ Mark D. Perrin

 

 

August Cervini

 

Mark D. Perrin

 

VP, Research Administration

 

Chief Executive Officer and Chairman

 

 

 

 

 

 

 

 

 

 

 

 

Date

8/29/17

 

Date

August 9, 2017

 

 

2


 

Appendix 1A: Patent Rights

The following patents and patent applications based on CMCC case 1455 (M.I.T. Case

Number 12084) and CMCC case 1456 (M.I.T. Case 13490Q):

 

 

 

 

 

 

 

 

 

 

Country

    

Serial Number

    

Filing Date

    

Status

    

Issue Date

 

U.S.

 

60/794,986

 

4/25/2006

 

Expired

 

 

 

U.S.

 

11/789,538

 

4/25/2007

 

Issued

 

8,377,463

 

U.S.

 

12/186,346

 

8/5/2008

 

Issued

 

9,173,732

 

U.S.

 

14/496,742

 

09/25/2014

 

Issued

 

9,101,695

 

U.S.

 

14/177,888

 

02/11/2014

 

Issued

 

8,858,966

 

U.S.

 

14/694,466

 

04/23/2015

 

Issued

 

9,440,008

 

U.S.

 

13/741,901

 

01/15/2013

 

Issued

 

8,685,434

 

U.S.

 

15/229,551

 

08/05/2016

 

Pending

 

 

 

PCT

 

PCT/US08/72226

 

8/5/2008

 

Expired

 

 

 

Australia

 

2008360388

 

8/5/2008

 

Surrendered

 

 

 

Brazil

 

PI0709638‑0

 

8/5/2008

 

Pending

 

 

 

Canada

 

2733252

 

8/5/2008

 

Surrendered

 

 

 

China

 

200880131305.9

 

8/5/2008

 

Surrendered

 

 

 

India

 

201648000170

 

8/5/2008

 

Pending

 

 

 

Japan

 

2009‑507940

 

8/5/2008

 

Issued

 

5340917

 

Singapore

 

201100824‑0

 

 

 

Surrendered

 

 

 

Singapore

 

200807854‑5

 

 

 

 

 

 

 

South Korea

 

10‑2011‑7005148

 

8/5/2008

 

Surrendered

 

00/00/00

 

EPO

 

EP-TBA

 

8/5/2008

 

Pend

 

00/00/00

 

 

3


 

 

 

 

 

 

 

 

 

 

 

 

PCT

 

PCT/US07/067403

 

4/25/2007

 

Expired

 

 

 

Australia

 

2007244813

 

4/25/2007

 

Issued

 

2007244813

 

Brazil

 

PI 0709638‑0

 

10/23/2008

 

Pending

 

 

 

Canada

 

2650804

 

4/25/2007

 

Pending

 

 

 

China

 

200780022752.6

 

4/25/2007

 

Lapsed

 

 

 

India

 

5785/CHENP/2008

 

10/24/2008

 

Pending

 

 

 

Japan

 

2013‑086578

 

10/23/2008

 

Issued

 

5746726

 

EPO

 

7761270.3

 

4/25/2007

 

Pending

 

 

 

Hong Kong

 

9106081.8

 

4/25/2007

 

Pending

 

 

 

Korea

 

10‑2015‑7005577

 

03/03/2015

 

Pending

 

 

 

Japan

 

2015‑095932

 

05/08/2015

 

Pending

 

 

 

Australia

 

2012227370

 

09/27/2012

 

Issued

 

2012227370

 

Korea

 

10‑2014‑7024979

 

09/04/2014

 

Pending

 

 

 

Australia

 

2015271864

 

 

 

Pending

 

 

 

Korea

 

10‑2008‑7028672

 

 

 

Lapsed

 

 

 

Korea

 

10‑2013‑7032762

 

 

 

Lapsed

 

 

 

Japan

 

2011‑522037

 

 

 

Surrendered

 

 

 

Korea

 

2016‑7004639

 

 

 

Pending

 

 

 

Canada

 

2936333

 

 

 

Pending

 

 

 

Korea

 

20167024587

 

 

 

Pending

 

 

 

 

4


 

Appendix 1B: Additional Patent Rights

I.          United States Patents and Applications

CMCC Case No. 23 (M.I.T. Case No. 4973) (Expired)

United States of America Patent No. 5804178, Issued September 8, 1998

“IMPLANTATION OF CELL-MATRIX STRUCTURE ADJACENT MESENTERY, OMENTUM OR PERITONEUM TISSUE”

by Linda G. Griffith, Lynt Johnson, Robert S. Langer and Joseph P. Vacanti

CMCC Case No. 25 (M.I.T. Case No. 5573) (Expired)

United States of America Patent No. 5514378, Issued May 7, 1996

“BIOCOMPATIBLE POLYMER MEMBRANES AND METHODS OF PREPARATION OF THREE DIMENSIONAL MEMBRANE STRUCTURES”

by Linda G. Griffith, Robert S. Langer, Antonios G. Mikos, Georgios Sarakinos and Joseph P. Vacanti

CMCC Case Nos. 20 and 30 (M.I.T. Case No. 4279) (Expired)

United States of America Patent No. 5759830, Issued June 2, 1998

United States of America Patent No. 5770417, Issued June 23, 1998

“THREE-DIMENSIONAL FIBROUS SCAFFOLD CONTAINING ATTACHED CELLS FOR PRODUCING VASCULARIZED TISSUE IN VIVO”

by Robert S. Langer and Joseph P. Vacanti

United States of America Patent No. 5770193, Issued June 23, 1998

“PREPARATION OF THREE-DIMENSIONAL FIBROUS SCAFFOLD CONTAINING ATTACHED CELLS FOR PRODUCING VASCULARIZED TISSUE IN VIVO”

by Robert S. Langer and Joseph P. Vacanti

CMCC Case No. 26 (M.I.T. Case No. 5729)

United States of America Patent No. 6309635, Issued October 30, 2011 (Expires December 30, 2018)

“PREVASCULARIZED POLYMERIC IMPLANTS FOR ORGAN TRANSPLANTATION”

by James C. Gilbert, Donald E. Ingber, Robert S. Langer, James E. Stein and Joseph P. Vacanti

CMCC Case No. 389 (M.I.T. Case No. 6560) (Expired)

United States of America Patent No. 7462471, Issued December 9, 2008

5


 

“POROUS BIODEGRADABLE POLYMERIC MATERIALS FOR CELL TRANSPLANTATION”

by Linda G. Griffith, Robert S. Langer, Antonios G. Mikos, Georgios Sarakinos and Joseph P. Vacanti

CMCC Case No. 415 (M.I.T. Case No. 6798)

United States of America Patent No. 6281015, Issued August 28, 2001 (Expires August 28, 2018)

“LOCALIZED DELIVERY OF FACTORS ENHANCING SURVIVAL OF TRANSPLANTED CELLS”

by Robert S. Langer, David J. Mooney and Joseph P. Vacanti

CMCC Case No. 505 (M.I.T. Case No. 7138) (Expired)

United States of America Patent No. 6095148, Issued August 1, 2000

“NEURONAL STIMULATION USING ELECTRICALLY CONDUCTING POLYMERS”

by Robert S. Langer, Christine E. Schmidt, Venkatram P. Shastri and Joseph P. Vacanti

M.I.T. Case No. 6984 (Expired)

United States of America Patent No. 5654381, Issued August 5, 1997

“FUNCTIONALIZED POLYESTER GRAFT COPOLYMERS”

by Jeffrey S. Hrkach, Robert S. Langer and Noah Lotan

M.I.T. Case No. 13525 (CMCC Case No. 26) (Expired)

United States of America Patent No. 6689608, Issued February 10, 2004

United States of America Serial No. 12/218448, Filed July 15, 2008

“POROUS BIODEGRADABLE POLYMERIC MATERIALS FOR CELL TRANSPLANTATION”

by Linda G. Griffith, Robert S. Langer, Antonios G. Mikos, Georgios Sarakinos and Joseph P. Vacanti

II.         International (non-U.S.) Patents and Applications

CMCC Case No. 26 (M.I.T. Case No. 5729) (Expired)

European Patent Convention Patent No. 0610423, Issued May 7, 1997

Japan Patent No. 3524919, Issued February 20, 2004

Austria Patent No. 0610423, Issued May 7, 1997

Belgium Patent No. 0610423, Issued May 7, 1997

France Patent No. 0610423, Issued May 7, 1997

Germany Patent No. 69219613, Issued May 7, 1997

Italy Patent No. 0610423, Issued May 7, 1997

6


 

Luxembourg Patent No. 0610423, Issued May 7, 1997

Netherlands Patent No. 0610423, Issued May 7, 1997

Sweden Patent No. 0610423, Issued May 7, 1997

United Kingdom Patent No. 0610423, Issued May 7, 1997

“PREVASCULARIZED POLYMERIC IMPLANTS FOR ORGAN TRANSPLANTATION”

by James C. Gilbert, Donald E. Ingber, Robert S. Langer, James E. Stein and Joseph P. Vacanti

CMCC Case No. 30 (M.I.T. Case No. 4279) (Expired)

Canada Patent No. 1340581, Issued June 8, 1999

“CHIMERIC NEOMORPHOGENESIS OF ORGANS BY CONTROLLED CELLULAR IMPLANTATION USING ARTIFICIAL MATRICES”

by Robert S. Langer and Joseph P. Vacanti

CMCC Case No. 415 (M.I.T. Case No. 6798) (Expired)

European Patent Convention Patent No. 0794790, Issued April 17, 2002

Japan Patent No. 4361134, Issued August 21, 2009

Canada Patent No. 2207286, Issued October 7, 2003

Ireland Patent No. 0794790, Issued April 17, 2002

Belgium Patent No. 0794790, Issued April 17, 2002

Switzerland Patent No. 0794790, Issued April 17, 2002

Germany Patent No. 0794790, Issued April 17, 2002

Denmark Patent No. 0794790, Issued April 17, 2002

Spain Patent No. 0794790, Issued April 17, 2002

France Patent No. 0794790, Issued April 17, 2002

Austria Patent No. 0794790, Issued April 17, 2002

Greece Patent No. 3039884, Issued April 17, 2002

Sweden Patent No. 0794790, Issued April 17, 2002

Italy Patent No. 0794790, Issued April 17, 2002

Luxembourg Patent No. 0794790, Issued April 17, 2002

Monaco Patent No. 0794790, Issued April 17, 2002

Netherlands Patent No. 0794790, Issued April 17, 2002

Portugal Patent No. 0794790, Issued April 17, 2002

United Kingdom Patent No. 0794790, Issued April 17, 2002

“LOCALIZED DELIVERY OF FACTORS ENHANCING SURVIVAL OF TRANSPLANTED CELLS”

by Robert S. Langer, David J. Mooney and Joseph P. Vacanti

CMCC Case No. 505 (M.I.T. Case No. 7138) (Expired)

New Zealand Patent No. 321886, Issued June 8, 2000

Japan Patent No. 4451929, Issued February 5, 2010

7


 

South Korea Serial No. 98‑703320, Filed October 31, 1996

Australia Patent No. 720275, Issued September 11, 2000

Canada Serial No. 2236749, Filed October 31, 1996

Japan Serial No. 2008‑287194, Filed October 31, 1996

Japan Serial No. 2009‑244981, Filed October 31, 1996

“NEURONAL STIMULATION USING ELECTRICALLY CONDUCTING POLYMERS”

by Robert S. Langer, Christine E. Schmidt, Venkatram P. Shastri and Joseph P. Vacanti

8