UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10‑Q/A
(Amendment No. 1)
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2017
or
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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: 001‑37350
InVivo Therapeutics Holdings Corp.
(Exact name of registrant as specified in its charter)
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Nevada |
36‑4528166 |
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(State or other jurisdiction of |
(I.R.S. Employer |
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incorporation or organization) |
Identification Number) |
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One Kendall Square, Suite B14402 |
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Cambridge, MA |
02139 |
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(Address of principal executive offices) |
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(617) 863‑5500
(Registrant’s telephone number, including area code)
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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes ☒ No ☐
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 definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b‑2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
☐ (Do not check if a smaller reporting company) |
Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying 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 in Rule 12b‑2 of the Exchange Act). Yes ☐ No ☒
As of October 28, 2017, 34,238,044 shares of the registrant’s common stock, $0.00001 par value, were issued and outstanding.
EXPLANATORY NOTE
The sole purpose of this Amendment No. 1 (this “Amendment No. 1”) to the Quarterly Report on Form 10‑Q for the quarterly period ended September 30, 2017 (the “Quarterly Report on Form 10‑Q”) of InVivo Therapeutics Holdings Corp. (the “Company”) is to amend and restate “Part II - Item 6” (Exhibits) of the Quarterly Report on Form 10‑Q, filed with the Securities and Exchange Commission (the “SEC”) on October 30, 2017 in its entirety to add Exhibit 10.2, which was inadvertently omitted from the original filing. The agreement filed as Exhibit 10.2 amends the exclusive license agreement dated July 2, 2007 and filed as Exhibit 10.1 to Amendment No. 2 to the Company’s Quarterly Report on Form 10 ‑ Q/A for the quarter ended March 31, 2011, as filed with the SEC on July 18, 2011, as amended by Amendment Number One, dated May 12, 2011 and filed as Exhibit 10.22 to the Amendment No. 4 to the Company’s Registration Statement on Form S‑1/A (File No 333‑171998), as filed with the SEC on July 19, 2011.
Other than the foregoing and the recently-dated certifications of the Company, as required by Rule 12b‑15 under the Securities Exchange Act of 1934, no other changes have been made to the Company’s Quarterly Report on Form 10‑Q. This Amendment No. 1 does not reflect events occurring after the filing on October 30, 2017 of the original Quarterly Report on Form 10‑Q with the SEC, or modify or update the disclosures presented in the original Quarterly Report on Form 10‑Q, except to reflect the revisions described above.
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PART II. OTHER INFORMATION
Item 6. Exhibits
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Exhibit |
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Number |
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Description |
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10.1 |
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10.2* |
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31.1** |
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31.2** |
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31.3* |
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31.4* |
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32.1** |
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32.2** |
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101.INS** |
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XBRL Instance Document |
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101.SCH** |
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XBRL Taxonomy Extension Schema Document |
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101.CAL** |
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XBRL Taxonomy Calculation Linkbase Document |
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101.DEF** |
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XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB** |
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XBRL Taxonomy Label Linkbase Document |
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101.PRE** |
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XBRL Taxonomy Presentation Linkbase Document |
* Filed herewith
** Previously filed with the Quarterly Report on Form 10‑Q for the quarterly period ended September 30, 2017
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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INVIVO THERAPEUTICS HOLDINGS CORP. |
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Date: January 3, 2017 |
By: |
/s/ Christopher McNulty |
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Name: |
Christopher McNulty |
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Title: |
Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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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.
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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.
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CHILDREN’S MEDICAL CENTER CORPORATION |
INVIVO THERAPEUTICS CORPORATION |
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By |
/s/ August Cervini |
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By |
/s/ Mark D. Perrin |
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August Cervini |
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Mark D. Perrin |
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VP, Research Administration |
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Chief Executive Officer and Chairman |
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Date |
8/29/17 |
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Date |
August 9, 2017 |
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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):
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Serial Number |
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Filing Date |
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Status |
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Issue Date |
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U.S. |
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60/794,986 |
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4/25/2006 |
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Expired |
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U.S. |
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11/789,538 |
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4/25/2007 |
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Issued |
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8,377,463 |
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U.S. |
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12/186,346 |
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8/5/2008 |
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Issued |
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9,173,732 |
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U.S. |
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14/496,742 |
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09/25/2014 |
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Issued |
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9,101,695 |
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U.S. |
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14/177,888 |
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02/11/2014 |
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Issued |
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8,858,966 |
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U.S. |
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14/694,466 |
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04/23/2015 |
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Issued |
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9,440,008 |
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U.S. |
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13/741,901 |
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01/15/2013 |
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Issued |
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8,685,434 |
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U.S. |
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15/229,551 |
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08/05/2016 |
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Pending |
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PCT |
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PCT/US08/72226 |
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8/5/2008 |
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Expired |
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Australia |
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2008360388 |
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8/5/2008 |
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Surrendered |
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Brazil |
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PI0709638‑0 |
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8/5/2008 |
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Pending |
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Canada |
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2733252 |
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8/5/2008 |
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Surrendered |
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China |
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200880131305.9 |
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8/5/2008 |
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Surrendered |
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India |
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201648000170 |
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8/5/2008 |
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Pending |
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Japan |
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2009‑507940 |
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8/5/2008 |
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Issued |
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5340917 |
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Singapore |
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201100824‑0 |
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Surrendered |
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Singapore |
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200807854‑5 |
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South Korea |
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10‑2011‑7005148 |
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8/5/2008 |
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Surrendered |
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00/00/00 |
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EPO |
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EP-TBA |
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8/5/2008 |
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Pend |
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00/00/00 |
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PCT |
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PCT/US07/067403 |
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4/25/2007 |
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Expired |
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Australia |
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2007244813 |
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4/25/2007 |
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Issued |
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2007244813 |
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Brazil |
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PI 0709638‑0 |
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10/23/2008 |
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Pending |
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Canada |
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2650804 |
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4/25/2007 |
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Pending |
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China |
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200780022752.6 |
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4/25/2007 |
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Lapsed |
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India |
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5785/CHENP/2008 |
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10/24/2008 |
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Pending |
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Japan |
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2013‑086578 |
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10/23/2008 |
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Issued |
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5746726 |
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EPO |
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7761270.3 |
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4/25/2007 |
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Pending |
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Hong Kong |
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9106081.8 |
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4/25/2007 |
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Pending |
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Korea |
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10‑2015‑7005577 |
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03/03/2015 |
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Pending |
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Japan |
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2015‑095932 |
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05/08/2015 |
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Pending |
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Australia |
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2012227370 |
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09/27/2012 |
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Issued |
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2012227370 |
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Korea |
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10‑2014‑7024979 |
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09/04/2014 |
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Pending |
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Australia |
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2015271864 |
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Pending |
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Korea |
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10‑2008‑7028672 |
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Lapsed |
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Korea |
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10‑2013‑7032762 |
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Lapsed |
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Japan |
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2011‑522037 |
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Surrendered |
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Korea |
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2016‑7004639 |
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Pending |
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Canada |
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2936333 |
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Pending |
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Korea |
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20167024587 |
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Pending |
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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
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“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
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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
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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
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Exhibit 31.3
CERTIFICATION
I, Richard Toselli, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q/A (Amendment No. 1) of InVivo Therapeutics Holdings Corp.;
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;
Date: January 3, 2018
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/s/ Richard Toselli |
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Richard Toselli |
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Acting Chief Executive Officer |
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(principal executive officer) |
Exhibit 31.4
CERTIFICATION
I, Christopher McNulty, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q/A (Amendment No. 1) of InVivo Therapeutics Holdings Corp.;
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;
Date: January 3, 2018
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/s/ Christopher McNulty |
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Christopher McNulty |
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Chief Financial Officer |
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(principal financial officer) |