AMENDMENT #3 TO EXCLUSIVE LICENSE AGREEMENT # 2
EXHIBIT 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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AMENDMENT #3
TO EXCLUSIVE LICENSE AGREEMENT # 2
WHEREAS Xxxx Medical Inc. (“XXXX”) and Rutgers, The State University of New Jersey (“Rutgers”), referred to collectively herein as “the Parties”, entered into an EXCLUSIVE LICENSE AGREEMENT NUMBER 2 (“License #2) effective July 1, 2010; and,
WHEREAS Section 6.3 (i)(b) of License #2, as amended by the signed Request for Extension letter dated July 1, 2014, requires XXXX to file an application with the USFDA or a comparable agency in another Major Market Country no later than the end of 2015; and
WHEREAS Section 6.3 (ii) (b), as amended by Amendment #2, requires XXXX to Pay Rutgers an annual amount of $[***] in order to extend REVA’s rights in the field of Non-Stent Products for as long as the necessary regulatory filing for Non-Stent Product has not been effected;
THEREFORE, the Parties hereby mutually agree to amend License #2 as of August 31, 2016 as follows:
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Section 6.3 (i)(b) will be replaced with the following: |
“Licensee or its Sublicensees will submit a complete application to either an appropriate regulatory body in the European Community or to the USFDA for a CE Marking or a Pre-Market Approval for at least one Coronary Stent Product, not later than by September 1, 2016.”
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The following language will be added at the end of the first paragraph of Section 6.3 (ii)(b): |
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.
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“Starting on June 30, 2016, for each annual filing extension desired by Licensee, Licensee will pay Rutgers an amount of $[***] on July 1 of the year for which the extension is granted, and an additional amount of $[***] immediately upon the earliest to occur of the following events:
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Termination of License #2 for any reason |
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Change of Control as defined in License #2 |
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January 1, 2019” |
IN WITNESS HEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.
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RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY |
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XXXX MEDICAL, INC. |
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/s/ S. Xxxxx Xxxxxxx |
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/s/ Xxxxxx X. Xxxxxxx |
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Signature |
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Signature |
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S. Xxxxx Xxxxxxx, Ph.D. |
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Xxxxxx X. Xxxxxxx, Ph.D. |
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Associate Vice President |
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President & COO |
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Office of Research Commercialization |
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Date: 9/12/2016 |
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Date: 9-8-16 |
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.
