AMENDMENT NO. 2 TO GLOBAL COLLABORATION AND LICENSE AGREEMENT
Exhibit 10.1
Certain identified information, marked by [***], has been excluded from the exhibit because it is both not material and is the type that the Company treats as private or confidential.
AMENDMENT NO. 2 TO GLOBAL COLLABORATION AND LICENSE AGREEMENT
This Amendment No. 2 to Global Collaboration and License Agreement (this "Amendment No. 2") is dated as of April 7, 2022, by and between INCYTE CORPORATION, a Delaware corporation, having its principal place of business at 0000 Xxxxxxxxx Xxx-Xxx, Xxxxxxxxxx, XX 00000 (hereinafter "Incyte"), and MACROGENICS, INC., a Delaware corporation, having its principal place of business at 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxxxxxx, XX 00000 ("MacroGenics", together with Incyte, the "Parties" and each separately, a "Party"), and is meant to amend that certain Global Collaboration and License Agreement, dated as of October 24, 2017, between Incyte and MacroGenics and amended on March 15, 2018 ("Amendment No. 1"). The Global Collaboration and License Agreement and Amendment No. 1, the "Agreement". Capitalized terms used and not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement.
WHEREAS, the Parties wish to add a Milestone to the Agreement specifically for receipt of a Regulatory Approval in the U.S. in the Indication of [***] but do not wish for such Regulatory Approval and Clinical Studies in and regulatory filings for such Indication to qualify as (i) a Development Milestone for [***] under Section 8.2(b); (ii) a Regulatory Filing Milestone for the filing of a BLA in the U.S. under Section 8.2(c); or (iii) an Approval Milestone for the receipt of a Regulatory Approval in the U.S. under Section 8.2(d);
NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained herein, and for other good and valuable consideration the receipt and adequacy of which are hereby acknowledged, the Parties agree as follows:
8.2(f) | [***] Milestone. A payment of [***] dollars ($[***]) shall be payable for receipt of the Regulatory Approval in the U.S. by Incyte, its Affiliates, or sublicensees (excluding Collaborators) for a Monotherapy Regimen or Incyte Combination Regimen in the Indication of [***] (the "[***] Milestone Payment"). For clarity, the [***] Milestone Payment shall be in addition to the existing Approval Milestones such that the [***] Milestone Payment plus the aggregate of the potential Approval Milestones shall equal a total of [***] dollars ($[***]). |
(i) | The filing of a BLA in the U.S. by Incyte, its Affiliates, or sublicensees (excluding Collaborators) for a Monotherapy Regimen or Incyte Combination Regimen in the Indication of [***] shall not qualify as a Regulatory Filing Milestone under Section 8.2(c). |
(ii) | The receipt of a Regulatory Approval in the U.S. by Incyte, its Affiliates, or sublicensees (excluding Collaborators) for a Monotherapy Regimen or Incyte Combination Regimen in the Indication of [***] shall not qualify as an Approval Milestone under Section 8.2(d). |
(iii) | The Development Milestone under Section 8.2(b), "Treatment of [***] cumulative subjects across all Incyte Clinical Studies (including Incyte Monotherapy Studies and Incyte Combination Studies) in a single Indication for greater than [***] continuously at a recommended Phase II or Phase III defined dose and schedule" shall not apply to Clinical Studies in the Indication of [***], and no payment for such Development Milestone shall be due with respect to the Indication of [***], whether by reason of actually treating [***] cumulative subjects in the Indication of [***] or by reason of the occurrence of any of the events set forth in the final sentence in the first paragraph of Section 8.2 stating, "In addition, except with respect to the Breakthrough Designation Milestone, if for any reason any other Development Milestone corresponding to a Milestone payment does not occur prior to the occurrence of Regulatory Approval, then such prior non-occurring Development Milestone shall be deemed to occur concurrently with Regulatory Approval, and the applicable Milestone payments for the applicable Development Milestones shall become due and payable in accordance with this Section 8.2." For clarity, receipt of Regulatory Approval in the U.S., the EU, or Japan by Incyte, its Affiliates, or sublicensees (excluding Collaborators) for a Monotherapy Regimen or Incyte Combination Regimen in the Indication of [***] shall not trigger any such Milestone payment. |
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IN WITNESS WHEREOF, the parties hereto have caused this Amendment No. 2 to Global Collaboration and License Agreement to be duly executed by their respective authorized signatories effective as of the date first indicated above.
MACROGENICS, INC.
By: /s/ Xxxxx Xxxxxx
Name: Xxxxx Xxxxxx
Title: President and Chief Executive Officer
INCYTE CORPORATION
By: /s/ Xxxxx Xxxxxxx
Name: Xxxxx Xxxxxxx
Title: EVP, Global Strategy & Corporate Development
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