Amendment 1, dated November 14, 2024, to Amended and Restated License and Collaboration Agreement, dated July 27, 2021, by and between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

​

Exhibit 10.28

​

Amendment 1 to AMENDED AND RESTATED LICENSE AND COLLABORATION AGREEMENT BY AND BETWEEN JANSSEN BIOTECH, INC. AND PROTAGONIST THERAPEUTICS, INC

Reference is made to the Amended and Restated License and Collaboration Agreement of July 27, 2021 (“the Agreement”) by and between the Janssen Biotech, Inc. (hereafter “Janssen”), and Protagonist Therapeutics, Inc. (hereafter “Protagonist”), or individually as “Party” or collectively as “Parties.” This Amendment is effective as of November 14, 2024 between Janssen and Protagonist.

In general, the Parties agreed to amend the Milestone Events D, E, and L under section 7.3.  

NOW THEREFORE, for valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree to amend Section 7.3 as follows:

7.3. Development and Approval Milestones.

​

7.3.1. Development and Approval Milestone Events. Janssen will notify Protagonist in writing within [***] after the first achievement by Janssen or any of its Affiliates or sublicensees of any of the milestone events set forth in the table below (each, a “Milestone Event”). In consideration of the rights and licenses granted to Janssen hereunder, Janssen shall pay to Protagonist the applicable milestone payment set forth in the table below (each, a “Milestone Payment”) within [***] after receipt of an invoice from Protagonist with respect to achievement of each Milestone Event that occurs prior to or on the date of database lock for the PTG-200 Phase 2A Clinical Trial and [***] after receipt of an invoice from Protagonist with respect to achievement of each Milestone Event that occurs after such date.

​

​

​

​

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

​

​

7.3.2. Milestone Rules.

​

(a) Each Milestone Payment shall be payable only once, even if the corresponding Milestone Event occurs more than once or with respect to more than one Licensed Product of the applicable type (i.e., if a Milestone Event occurs with respect to more than one Initial Product or a Milestone Event occurs with respect to more than one 2^nd Generation Product). Each Milestone Payment shall be nonrefundable and non-creditable.

(b) The Milestone Payment for Milestone Event C-1 shall be payable one time only, upon the first occurrence of Milestone Event C-1 with respect to the Initial Product or any 2^nd Generation Product. For example, if Milestone Event C-1 occurs for the Initial Product before the dosing of the 3^rd patient in a Phase 3 Clinical Trial of a 2^nd Generation Product for any Indication, then (x) the Milestone Payment for Milestone Event C-1 will be payable for occurrence of Milestone Event C-1 for the Initial Product, and (y) dosing of the 3^rd patient in a Phase 3 Clinical Trial of a 2^nd Generation Product will not cause any obligation to pay the Milestone Payment for Milestone Event C-1 a second time.

​

​

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

​

(c) For purposes of Milestone Event D, a Phase 3 Clinical Trial of a Licensed Product for an Indication will be deemed to meet its primary clinical endpoint on the first date when all of the following have occurred:

(1) The statistical analysis of the data from such trial is complete;

(2) The top-line results from such trial have become available to Janssen; and

(3) The top-line results demonstrate that the primary clinical endpoint (as described in the protocol for such trial) is formally statistically significant, where “statistically significant” is defined as achieving a prespecified level of significance value using the procedure defined in the protocol and statistical analysis plan for such trial.

7.3.3. [***].

7.3.4. Definition of Second Indication. A “Second Indication” means:

(a) [***];

(b) with respect to a 2nd Generation Product,

(1) [***];

(2) as used in Milestone Event J, an Indication other than the Indication with respect to which Milestone Event F occurred for a 2nd Generation Product; and

(3) as used in Milestone Event K, an Indication other than the Indication with respect to which Milestone Event C occurred for a 2nd Generation Product; and

(4) as used in Milestone Event L, either: (x) if Milestone Event C-1 occurs for a 2nd Generation Product before the dosing of the 3rd patient in a Phase 3 Clinical Trial of the Initial Product, an Indication other than the Indication with respect to which Milestone Event C-1 occurred or (y) if Milestone Event C-1 occurs for the Initial Product before the dosing of the 3rd patient in a Phase 3 Clinical Trial of a 2nd Generation Product, an Indication with respect to which Milestone Event C-1 occurred.

7.3.5. [***].

​

​

​

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

​

7.3.6. Skipped Milestones. With respect to the Milestone Events set forth in the table above in
Section 7.3.1 and subject to Section 7.3.2, if for any reason:

​

(a) Milestone Event B does not occur for a 2nd Generation Product before the

occurrence of Milestone Event C for a 2nd Generation Product, then Milestone Event B shall be deemed to occur for a 2nd Generation Product concurrently with the occurrence of Milestone Event C;

​

(b) Milestone Event C does not occur for a 2nd Generation Product before the

occurrence of Milestone Event C-1 for a 2nd Generation Product, then Milestone

Event C shall be deemed to occur for a 2nd Generation Product concurrently with the occurrence of Milestone Event C-1 for a 2nd Generation Product; and

​

(c) Milestone Event C does not occur for a 2nd Generation Product before the occurrence of Milestone Event D for a 2nd Generation Product, then Milestone Event C shall be deemed to occur for a 2nd Generation Product concurrently with the occurrence of Milestone Event D;.

​

[***]

​

(e) Milestone Event K for the Initial Product or a 2nd Generation Product, respectively, does not occur before the occurrence of Milestone Event L for the Initial Product or a 2nd Generation Product, respectively, then Milestone Event K shall be deemed to occur for the applicable product concurrently with the occurrence of Milestone Event L for the applicable product; and

​

[***]

​

Except as otherwise expressly provided herein, the Agreement shall remain in full force and effect without any amendments or modifications.

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their duly authorized representative, effective as of the date above written.

Parties explicitly agree to execute this Agreement by way of an electronic signature, and agree this shall constitute a valid and enforceable agreement between the parties. The present Agreement is made in pdf-version which is signed electronically by each party.

​

​

​

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

​

​

​