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.
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 | |
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 | |
| | | | | | | | | |
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 | | | |
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
“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
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
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