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
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:
[***] 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.”
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. | ||
| /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