Exhibit 10.1
CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (this “Agreement”), made as of July 26, 2022 (the “Effective Date”), is by and between Amgen Inc., a Delaware corporation, having its principal place of business at One Amgen Center Drive, Thousand Oaks, CA 91362 (“Amgen”), and IDEAYA Biosciences, Inc., having its principal place of business at 7000 Shoreline Court, Suite 350, South San Francisco, California 94080 (“Ideaya”). Amgen and Ideaya are sometimes each referred to herein individually as “Party” and collectively “Parties”.
RECITALS
A. Amgen and Ideaya are both research–based pharmaceutical companies involved in the research, development, manufacture and sale of medicines for use in humans and are particularly interested in cancer research.
B. Ideaya is developing the Ideaya Compound (as defined below) for the treatment of cancer.
C. Amgen is developing the Amgen Compound (as defined below) for the treatment of cancer.
D. The Parties desire to collaborate for the conduct of a certain clinical trial in which the Amgen Compound and the Ideaya Compound (collectively, “Compounds”) would be dosed concurrently or in combination in accordance with the Development Plan (as defined below), the Protocol (as defined below) and the terms of this Agreement.
E. Amgen and Ideaya desire to agree on various terms and conditions to govern the Parties’ respective rights and obligations in connection with the collaboration, including with regard to the performance of the clinical trial, supply of Compounds for the trial and the ownership, use and publication of the results of such trial.
NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions, the Parties, intending to be legally bound, mutually agree as follows:
For all purposes of this Agreement, and all amendments hereto, the capitalized terms, whether used in the singular or plural, defined in this Article 1 and throughout this Agreement will have the meanings herein specified.
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Ideaya will supply Amgen with Ideaya Compound for the Study, that conform to the Ideaya Compound specifications and Ideaya’s IND for the Ideaya Compound and have been manufactured in accordance with the provisions of this Agreement, cGMP and all applicable laws and regulations relating to drugs intended for investigational use in humans, and Ideaya will, upon request, provide Amgen with all related and necessary documentation pursuant to the following terms and conditions:
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Notwithstanding the foregoing, if a Party is required or otherwise intends to make a disclosure of any other Party’s Confidential Information pursuant to Section 9.3.2 or Section 9.3.3, it shall give advance notice to such other Party of such impending disclosure and endeavor in good faith to secure confidential treatment of such Confidential Information or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment. Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of Section 9.1, and the Party disclosing Confidential Information pursuant to Applicable Law shall take all steps reasonably necessary, including obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.
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If to Ideaya, to:
7000 Shoreline Court, Suite 350
South San Francisco, CA 94080
Attention: Legal Department
Email: legal@ideayabio.com
If to Amgen, to:
One Amgen Center Drive
Thousand Oaks, California 91320-1799
Attention: Corporate Secretary
Facsimile: 805-499-4531
Email: transactionslaw@amgen.com
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IN WITNESS WHEREOF, the respective representatives of the Parties have executed this Clinical Trial Collaboration and Supply Agreement as of the Effective Date.
IDEAYA BIOSCIENCES, INC.
/s/ Yujiro Hata
Signature
Yujiro Hata
Name
Chief Executive Officer
Title
AMGEN Inc.
/s/ Jean-Charles Soria
Signature
Jean-Charles Soria
Name
SVP, Global Development Oncology
Title
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Appendix A
Protocol Outline
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Appendix B
Development Plan
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Appendix C
JOINT CONTROLLER ADDENDUM
Under this JCA, the Parties agree that the terms “Personal Data Breach”, “Data Subject”, “Controller”, “processing”, “Processor”, “Supervisory Authority” and “Third Party(ies)” shall have the meaning assigned to them in the GDPR.
“Joint Controller” means a Controller which, jointly with one or several other Controller(s), determines the purpose(s) and means of the Processing as set out in Article 26 of the GDPR and/or UK GDPR. Ideaya, on the one hand, and Amgen on the other hand, are Joint Controllers of the Processing, the purpose of which is detailed in Exhibit 1 to this JCA;
“Regulator” means a data protection supervisory authority which has jurisdiction over the Data Controller or the Data Processor’s Processing of Personal Data; and
"Subprocessor" means any natural or legal person engaged by a Processor for the performance of all or part of the Processing operated on behalf of either of the Joint Controllers.
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Exhibit 1 to Appendix C
Description of the Processing of Personal Data
Purpose(s) of the Processing
Conduct of the Study in accordance with the Agreement and the Protocol.
Categories of Data Subjects
The personal data transferred concern the following categories of data subjects:
Type of Personal Data
The personal data transferred concern the following categories of data:
Terms of retention of the categories of Personal Data
Personal Data will be retained for the duration of the Agreement and as required or permitted to fulfill legal requirements and in line with Applicable Laws.
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Appendix D
Information Security Requirements Schedule
This Information Security Requirements Schedule (“Information Security Schedule”) supplements (and is not intended, and shall not be interpreted, to limit the terms of the Agreement) and is governed by the terms and conditions of the Agreement to which it is attached. Any defined terms not otherwise defined herein shall have the meanings set forth in the Agreement. In addition to requirements set forth in the Agreement, each Party shall handle, treat, store, access (or limit access), and otherwise protect (1) the other Party’s Confidential Information (or similarly defined term in the Agreement); and (2) Personal Data disclosed, transferred, or otherwise made available by the other Party (collectively “Protected Information”) in accordance with the terms of this Information Security Schedule.
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Without limiting any rights and remedies hereunder, each Party shall have the right to audit and monitor the other Party’s compliance with the requirements of this Information Security Schedule. Upon reasonable notice to the other Party, once per year during the Term of the Agreement (and except as otherwise stated in this Information Security Schedule), each Party (or any vendor selected by such Party) may
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undertake an assessment and audit of the audited Party’s Security and the audited Party’s compliance with all Applicable Laws as relevant to the audited Party’s actions related to the auditing Party’s Protected Information in connection with this Agreement. The auditing Party shall have the right to revoke or limit the audited Party’s access to the auditing Party’s Protected Information or to EIS at any time for any reason. In addition to its other obligations hereunder, upon the auditing Party’s request, the audited Party shall immediately return to the auditing Party any hardware and software provided to the audited Party by or on behalf of the auditing Party.
Without limiting each Party’s obligations regarding the other Party’s Protected Information, with respect to each Incident, each Party shall:
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Appendix E
Standard Contractual Clauses
Each, a “Party”; together, “the Parties”.
SECTION I
Clause 1
Purpose and scope
have agreed to these standard data protection clauses (hereinafter “Clauses”).
Clause 2
Effect and invariability of the Clauses
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Clause 3
Third party beneficiaries
Clause 4
Interpretation
Clause 5
Hierarchy
In the event of a contradiction between these Clauses and the provisions of related agreements between the Parties, existing at the time these Clauses are agreed or entered into thereafter, these Clauses shall prevail.
Clause 6
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Description of the transfer(s)
The details of the transfer(s), and in particular the categories of personal data that are transferred and the purpose(s) for which they are transferred, are specified in Annex I.B.
Clause 7
Docking Clause
SECTION II – OBLIGATIONS OF THE PARTIES
Clause 8
Data protection safeguards
The data exporter warrants that it has used reasonable efforts to determine that the data importer is able, through the implementation of appropriate technical and organisational measures, to satisfy its obligations under these Clauses.
8.1 Purpose limitation
The data importer shall process the personal data only for the specific purpose(s) of the transfer, as set out in Annex I.B. It may only process the personal data for another purpose:
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8.2 Transparency
8.3 Accuracy and data minimisation
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8.4 Storage limitation
The data importer shall retain the personal data for no longer than necessary for the purpose(s) for which it is processed. It shall put in place appropriate technical or organisational measures to ensure compliance with this obligation, including erasure or anonymisation of the data and all back-ups at the end of the retention period.
8.5 Security of processing
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8.6 Sensitive data
Where the transfer involves personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, or biometric data for the purpose of uniquely identifying a natural person, data concerning health or a person’s sex life or sexual orientation, or data relating to criminal convictions or offences (hereinafter “sensitive data”), the data importer shall apply specific restrictions and/or additional safeguards adapted to the specific nature of the data and the risks involved. This may include restricting the personnel permitted to access the personal data, additional security measures (such as pseudonymisation) and/or additional restrictions with respect to further disclosure.
8.7 Onward transfers
The data importer shall not disclose the personal data to a third party located outside the European Union (in the same country as the data importer or in another third country, hereinafter “onward transfer”) unless the third party is or agrees to be bound by these Clauses, under the appropriate Module. Otherwise, an onward transfer by the data importer may only take place if:
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Any onward transfer is subject to compliance by the data importer with all the other safeguards under these Clauses, in particular purpose limitation.
8.8 Processing under the authority of the data importer
The data importer shall ensure that any person acting under its authority, including a processor, processes the data only on its instructions.
8.9 Documentation and compliance
Clause 9
Intentionally omitted.
Clause 10
Data subject rights
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Clause 11
Redress
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Clause 12
Liability
Clause 13
Supervision
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SECTION III – LOCAL LAWS AND OBLIGATIONS IN CASE OF ACCESS BY PUBLIC AUTHORITIES
Clause 14
Local laws and practices affecting compliance with the Clauses
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Clause 15
Obligations of the data importer in case of government access requests
15.1 Notification
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15.2 Review of legality and data minimisation
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SECTION III – FINAL PROVISIONS
Clause 16
Non-compliance with the Clauses and termination
In these cases, it shall inform the competent supervisory authority of such non-compliance. Where the contract involves more than two Parties, the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise.
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Clause 17
Governing law
These Clauses shall be governed by the law of one of the EU Member States, provided such law allows for third-party beneficiary rights. The Parties agree that this shall be the law of the Netherlands.
Clause 18
Choice of forum and jurisdiction
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APPENDIX to Appendix E
ANNEX 1
A. LIST OF PARTIES
Data exporter(s):
Name: Amgen Inc.
Address: One Amgen Center Drive, Thousand Oaks, California 91320-1799
Contact person’s name, position and contact details: privacyoffice@amgen.com
Activities relevant to the data transferred under these Clauses: Collection of personal data of the categories of data subjects listed below for the purposes of conducting clinical trials.
Role: Controller
Data importer(s):
Name (written out in full): Ideaya Biosciences, Inc.
Address: 7000 Shoreline Court, Suite 350, South San Francisco, California 94080
Contact person’s name, position and contact details: privacy@ideayabio.com.
Activities relevant to the data transferred under these Clauses: N/A
Role: Controller
B. DESCRIPTION OF THE TRANSFER
Categories of data subjects whose personal data is transferred
The personal data transferred concern the following categories of data subjects:
Categories of personal data transferred
The personal data transferred concern the following categories of data:
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Sensitive data transferred and applied restrictions or safeguards that fully takes into consideration the nature of the data and the risks involved, such as for instance strict purpose limitation, access restrictions (including access only for staff having followed specialised training), keeping a record of access to the data, restrictions for onward transfers or additional security measures.
The special categories of Patient Personal Data transferred may include patient health data (encoded with subject ID) (including pharmacovigilance data).
Data importer, taking into account the nature, scope, context, and purposes of the Processing, as well as the risk for the rights and freedoms of natural persons, takes appropriate technical and organizational measures that meet or exceed the requirements set forth in Appendix D to the Agreement (“Information Security Requirements Schedule”). Specific technical and organizational measures can be requested from data importer.
The frequency of the transfer
Continuous basis.
Nature of the transfer, Purpose(s) of the transfer and further processing
The transfer of Personal Data is made to comply with its reporting regulatory obligations and to ensure high standards of quality and safety of health care and of medicinal products; and, if applicable, for other purposes required or allowed by law or consented to by the data subjects.
The period for which the personal data will be retained, or, if that is not possible, the criteria used to determine that period
Personal Data will be retained for the duration of the Agreement and as required or permitted to fulfill legal requirements and in line with applicable law.
For transfers to (sub-) processors, also specify subject matter, nature and duration of the processing
The subject matter, nature, and duration of the Processing is defined under the Agreement and this Appendix to Appendix E.
C. COMPETENT SUPERVISORY AUTHORITY
Identify the competent supervisory authority/ies in accordance with Clause 13:
Autoriteit Persoonsgegevens.
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ANNEX 2
TECHNICAL AND ORGANISATIONAL MEASURES INCLUDING TECHNICAL AND ORGANISATIONAL MEASURES TO ENSURE THE SECURITY OF THE DATA
Description of the technical and organizational measures implemented by the data importer, including any relevant certifications:
Data importer, taking into account the nature, scope, context, and purposes of the Processing, as well as the risk for the rights and freedoms of natural persons, takes appropriate technical and organizational measures that meet or exceed the requirements set forth in Appendix D to the Agreement (“Information Security Requirements Schedule”). Specific technical and organizational measures can be requested from data importer.
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SUPPLEMENTARY PROVISIONS
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UK Addendum to the EU Commission Standard Contractual Clauses
This Addendum | This Addendum to the Clauses |
The Annex | The Standard Contractual Clauses set out in the Annex of Commission Implementing Decision (EU) 2021/914 of 4 June 2021 |
UK Data Protection Laws | All laws relating to data protection, the processing of personal data, privacy and/or electronic communications in force from time to time in the UK, including the UK GDPR and the Data Protection Act of 2018. |
UK GDPR | The United Kingdom General Data Protection Regulation, as it forms part of the law of England and Wales, Scotland and Northern Ireland by virtue of section 3 of the European Union (Withdrawal) Act of 2018 |
UK | The United Kingdom of Great Britain and Northern Ireland |
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“The details of the transfers(s) and in particular the categories of personal data that are transferred and the purpose(s) for which they are transferred) are those specified in Annex I.B where UK Data Protection Laws apply to the data exporter’s processing when making that transfer.”
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“Any dispute arising from these Clauses shall be resolved by the courts of England and Wales. A data subject may also bring legal proceedings against the data exporter and/or data importer before the courts of any country in the UK. The Parties agree to submit themselves to the jurisdiction of such courts.”
“By signing we agree to be bound by the UK Addendum to the EU Commission Standard Contractual Clauses dated:” and add the date (where all transfers are under the Addendum)
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“By signing we also agree to be bound by the UK Addendum to the EU Commission Standard Contractual Clauses dated” and add the date (where there are transfers both under the Clauses and under the Addendum) (or words to the same effect) and executing the Clauses; or
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