Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. Amendment No. 1 to Amended...
Exhibit 10.40
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Amendment No. 1 to Amended and Restated License Agreement
This Amendment No. 1 to the AMENDED AND RESTATED LICENSE AGREEMENT (this “Amendment No. 1”) is entered into as of this 17th day of July, 2024 (the “Amendment No. 1 Effective Date”), by and between Zikani Therapeutics, Inc., a Delaware corporation with a principal office at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇ (“Licensee”), and President and Fellows of Harvard College, an educational and charitable corporation existing under the laws and the constitution of the Commonwealth of Massachusetts, having a place of business at ▇▇▇▇▇▇▇ ▇. and ▇▇▇▇▇ ▇. ▇▇▇▇▇ Campus Center, Suite 727E, ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (“Harvard”). Harvard, on the one hand, and Licensee, on the other, each shall be referred to herein as a “Party” and together as the “Parties”.
WHEREAS, Harvard and Licensee entered into an Amended and Restated License Agreement dated as of March 26, 2020 (the “License Agreement”); and
WHEREAS, Harvard and Licensee desire to amend the License Agreement in accordance with Section 11.10 thereof for the purposes of modifying the terms relating to Non-Royalty Sublicense Income and Priority Review Vouchers (as defined herein), as set forth below;
NOW, THEREFORE, for good and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties agree as follows:
“Priority Review Voucher” means a priority review voucher awarded by the FDA under Section 524 or Section 529 of the Federal Food, Drug and Cosmetic Act (“FFDCA”) or awarded under any successor or comparable government program in the United States or another country.
“Priority Review Voucher Income” means all consideration, in any form, received by Licensee, a Sublicensee, or any of their Affiliates, as the case may be, in connection with the sale or transfer to an unrelated third party in a bona fide arm’s-length transaction of a Priority Review Voucher awarded in connection with a Licensed Product.
“PRV Fair Market Value” means, with respect to each Priority Review Voucher, the average of the sale price of the most recent three (3) Priority Review Vouchers sold in the U.S. in publicly announced, bona fide arm’s-length transactions prior to the issuance of such Priority Review Voucher.
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“For clarity, all Priority Review Voucher Income received by Licensee or its Affiliates shall be excluded from Non-Royalty Sublicense Income and will be treated separately pursuant to Section 4.5 of this Agreement.”
“If Licensee or any of its Affiliates receives Non-Royalty Sublicense Income with respect to a Sublicensee’s achievement of any milestone listed in Section 4.2.1, the amounts paid by Licensee to Harvard under this Section 4.2 with respect to achievement of such milestone may be deducted from the aggregate amount of Non-Royalty Sublicense Income received from such Sublicensee on which Licensee must pay fees to Harvard under Section 4.4.”
“4.4 Non-Royalty Sublicense Income. Licensee will pay Harvard a fee on Non-Royalty Sublicense Income as follows:
“4.5. Priority Review Voucher Income.
[Signature Page Follows]
IN WITNESS WHEREOF, the parties hereto have caused this Amendment No. 1 to be executed by their duly authorized representatives.
Exhibit 10.40
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
President and Fellows of Harvard College
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Title: Chief Technology Development Officer
7/24/2023
5
Exhibit 10.40
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Zikani Therapeutics, Inc.
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Title: President and CEO
7/24/2023
6
