Amendment No. 1 to Clinical Trial Collaboration and Supply Agreement (Second Pfizer Agreement), dated as of May 12, 2023, by and between Pfizer Inc. and IDEAYA Biosciences, Inc

EX-10.2 3 idya-ex10_2.htm EX-10.2 EX-10.2

Exhibit 10.2

Amendment No. 1 to Agreement

(“Amendment No. 1”)

 

Amendment No. 1 Date: May 10, 2023

 

 

Name of Original Agreement: Clinical Trial Collaboration and Supply Agreement (the “Agreement”)

 

Effective Date of Original Agreement: March 9, 2022

 

Parties: Pfizer Inc. (“Pfizer”) and Ideaya Biosciences, Inc. (“Ideaya”)

 

 

WHEREAS, the Parties entered into the Agreement, for the Global Phase 2, registration enabling study in Metastatic Uveal Melanoma (MUM) and GNAQ/11-mutated Solid Tumors (non-MUM) pertaining to the clinical evaluation of the Ideaya Compound in combination with the Pfizer Compound;

 

WHEREAS, the Parties entered into a Clinical Trial Collaboration and Supply Agreement dated March 9, 2022, for a Global Phase 2, (proof of concept) study in cMET / HGF driven tumors pertaining to the clinical evaluation of the Ideaya Compound in combination with the Pfizer Compound (the “CMET CTCSA”);

 

WHEREAS, the Parties desire to terminate the CMET CTCSA;

 

WHEREAS, the Parties desire to amend the Agreement, including the Supply Schedule, to provide for additional supply of the Pfizer Compound for the Study.

 

NOW, THEREFORE, in order to accommodate the desired amendment(s), the parties hereby agree as follows:

 

1.
Defined Terms. Capitalized terms used but not defined herein shall have the respective meanings ascribed to such terms in the Agreement.

 

2.
Termination. The Parties hereby agree to terminate the CMET CTCSA effective as of the Amendment No. 1 Date. The Parties stipulate and agree that there was no Compound Delivered under the CMET CTCSA as contemplated by Section 6.11 of the Agreement.

 

3.
Amendment(s) to the Agreement.

 

3.1.
Section 7 of the Agreemenht is revised to read, in its entirety, as follows:

 

[***] 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.1


Exhibit 10.2

“7 Cost of Study. The Parties agree that (i) Pfizer shall provide the Pfizer Compound for use in the Study, as described in Article 8 below, at the cost to Ideaya specified on the Supply Schedule (except as provided in Section 6.11); and (ii) Ideaya shall provide the Ideaya Compound for use in the Study, as described in Article 8 below, at no cost to Pfizer. The Study costs will be paid fully by Ideaya.”

 

3.2.
Appendix B of the Agreement is revised to read, in its entirety, as set forthing in Appendix B of this Amendment No 1.

 

4.
Ratification of the Agreement. Except as expressly set forth in Article 2 above, the Agreement shall remain unmodified and in full force and effect. The execution, delivery and effectiveness of this Amendment No. 1 shall not, except as expressly provided herein, operate as a waiver of any right, power or remedy of the parties to the Agreement, nor constitute a waiver of any provision of the Agreement.

 

5.
Counterparts. This Amendment No. 1 may be executed in any number of counterparts, each of which shall be an original instrument and all of which, when taken together, shall constitute one and the same agreement.

 

 

SIGNATURES IMMEDIATELY FOLLOWING ON NEXT PAGE

 

[***] 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.2


Exhibit 10.2

IN WITNESS WHEREOF, the duly authorized representatives of Pfizer and Ideaya have executed this Amendment No. 1 as of the date first above written.

 

 

 

[***] 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.3


Exhibit 10.2

Ideaya Biosciences, Inc.

 

By: /s/ Yujiro Hata

 

Print Name: Yujiro Hata

Title: President and Chief Executive Officer

Date: 5/12/2023

(Duly authorized)

 



[***] 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.4


Exhibit 10.2

Pfizer Inc.

By: /s/ Chris Boshoff

 

Print Name: Chris Boshoff

Title: Chief Development Officer

Date: May 12, 2023

(Duly authorized)

[***] 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.5


Exhibit 10.2

 

[***] 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.6


Exhibit 10.2

Appendix B– Supply Schedule

 

SUPPLY OF COMPOUNDS

 

Ideaya will provide Pfizer written orders [***] days before delivery of the crizotinib Drug Product. Pfizer will provide Ideaya with [***].

 

Delivery timelines and Compound quantities are based on the Phase II study plan in place at the time of the Effective Date. Compound quantities are subject to modification based on Study conduct (due, for example, to the addition of Study sites or countries, patients with durable responses, etc). If the quantity of compounds set forth are not sufficient to complete the Study, Ideaya shall so notify Pfizer and the Parties shall discuss in good faith regarding additional quantities of Compounds to be provided and the schedule on which such additional quantities may be provided.

 

Following are estimates of the demand for the supply of the Pfizer Compound for the Study. The supply chain teams from Pfizer and Ideaya will meet regularly to review demand and supply requirements and adjust the delivery schedule to ensure continuous supply for the Study.

 

Study Assumptions

 

[***]

 

The source of the Compounds to be provided by the Parties during the Term may change. In such event, the supplying Party will ensure that all Compounds supplied by such Party will be from an approved source .

 

 

[***] 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.7


Exhibit 10.2

The responsibilities of both parties are summarised in table below:

 

CLINICAL SUPPLIES TABLE OF ROLES AND RESPONSIBILITIES

Documentation will be transferred between the Clinical Supply Chain contacts or designee.

[***]

This Supply Schedule is binding on the final date of approval. The Supply Schedule can be reviewed at any time by mutual consent of each party to determine if changes will be considered minor or major. Any minor changes to the content of the Supply Schedule will be documented in the Revision History box and no re-routing for signatures will be required. A major change will necessitate the document to be revised, re-routed for signatures and be assigned the next sequential version number.

 

 

[***] 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.8


Exhibit 10.2

IN WITNESS HEREOF, Ideaya and Pfizer hereby approves this Supply Schedule, Version 1 as of the dates set forth below:


 

Ideaya Biosciences, Inc.

 

Pfizer, Inc.


Signature

/s/ Yujiro Hata

 

Signature

/s/ Patrick Furcolo

 

Name

Yujiro Hata

 

Name

Patrick Furcolo

 

Title

President and Chief Executive Officer

 

Title

Senior Director, Global Clinical Supply

 

Date

5/12/2023

 

Date

11-May-2023

 

 

[***] 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.9