Second Amendment to the Amended and Restated License Agreement with Albert Einstein College of Medicine dated January 13, 2024
EXHIBIT 10.38
Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.
SECOND AMENDMENT TO THE AMENDED AND RESTATED LICENSE AGREEMENT
This Second Amendment to the Amended and Restated License Agreement (“Second Amendment”) is by and between Albert Einstein College of Medicine, a New York education corporation, having an office and place of business at 1300 Morris Park Avenue, Bronx, New York 10461 (“Licensor”) and Cue Biopharma, Inc., a corporation organized and existing under the laws of the State of Delaware, having an office and place of business at 40 Guest Street, Boston, MA 02135 (“Licensee”). The effective date of this Second Amendment is January 13, 2024 (“Second Amendment Effective Date”).
WHEREAS, Albert Einstein College of Medicine, Inc. and Cue Biopharma, Inc. are parties to that certain Amended and Restated License Agreement entered into July 31, 2017, as amended by that certain First Amendment To The Amended And Restated License Agreement dated October 30, 2018 (the “Agreement”);
WHEREAS, Licensor is successor to the Albert Einstein College of Medicine, Inc.’s interest under the Agreement effective January 1, 2019, by virtue of a merger made effective by an Order issued by the New York State Education Department’s Board of Regents;
WHEREAS, Section 12.15(e) of the Agreement sets forth Licensee's diligence obligation to “Initiate an FDA approved Phase III clinical trial for a Licensed Product within [**] of the Original Effective Date”, i.e., by [**]; and
WHEREAS, despite its best efforts, Licensee is unable to initiate an FDA approve Phase III clinical trial by [**], but intends to diligently continue clinical development of CUE-101 with the goal of initiating a clinical trial designed to support an application to the FDA for approval to market and sell CUE-101; and
NOW, THEREFORE, in consideration of the mutual covenants contained in the Agreement and in this Second Amendment and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Licensor and Licensee hereby agree as follows:
(e) Initiate an FDA approved Phase III clinical trial or an FDA approved clinical trial designed to support a biologics license application (BLA) for a Licensed Product within [**] of the Original Effective Date.
12.17 If any one of the due diligence requirements in Section 12.15 and/or 12.16 is not met, Licensor shall have the right to terminate pursuant to Section 10.03 and all rights will revert to Licensor, after providing Licensee with written notice of failure to meet such requirements and thirty (30) days from the date of such written notice to cure such failure. Notwithstanding the foregoing, in the event that Licensee provides Licensor with prior written notice that Licensee, despite its best efforts, is unable to fulfill the due diligence requirement for Section 12.16 12.15(d), (e), (f), (g) and/or (h), the deadline for fulfilling such requirement shall be extended by [**]. No further extensions shall be granted for such diligence requirement without Einstein’s prior written consent. In the event Licensee is unable to fulfill a due diligence requirement for Section 12.16 12.15(d), (e), (f), (g) or (h) after an extension has been granted, Licensor shall have the right to terminate pursuant to Section 10.03 and all rights will revert to Licensor, after providing Licensee with written notice of failure to meet such requirements and thirty (30) days from the date of such written notice to cure such failure.
To Licensee
Cue Biopharma, Inc.
40 Guest Street
Boston, MA 02135
Attn: Chief Executive Officer
with copies to:
[**]
and
Wilmer Cutler Pickering Hale and Dorr LLP
60 State Street
Boston, MA 02109
Attn: [**]
To Licensor
Albert Einstein College of Medicine
1300 Morris Park Avenue
Bronx, New York 10461
Attention: Office of Biotechnology
with copy to:
[**]
Senior Counsel
Albert Einstein College of Medicine
1300 Morris Park Avenue
Belfer 310
Bronx, New York 10461
Tel. [**]
Fax [**]
Email: [**]
IN WITNESS WHEREOF, the Parties hereto have executed this Second Amendment as of the Second Amendment Effective Date.
ALBERT EINSTEIN COLLEGE OF MEDICINE
By: _/s/ Janis Paradiso_______________________________________
Name: Janis Paradiso, MBA
Title: Director, Office of Biotechnology & Business Development
CUE BIOPHARMA, INC.
By: _/s/ Colin Sandercock_______________________________________
Name: Colin Sandercock
Title: SVP & General Counsel