Regulatory Responsibility. The responsibilities of the Parties with respect to communication and filings with Regulatory Authorities related to the Compounds supplied hereunder in connection with the Sub-Study will be as set forth in this Agreement, the Pharmacovigilance Agreement and the Clinical Quality Agreement entered into by the Parties or their Affiliates in connection herewith.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (SpringWorks Therapeutics, Inc.)
Regulatory Responsibility. The responsibilities of the Parties with respect to communication and filings with Regulatory Authorities related to the Compounds supplied hereunder in connection with the Sub-Study will be as set forth in this Agreement, the Pharmacovigilance Agreement and the Clinical Quality Agreement entered into by the Parties or their Affiliates in connection herewith.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Advaxis, Inc.)
Regulatory Responsibility. The responsibilities of the Parties with respect to communication and filings with Regulatory Authorities related to the supply of Compounds supplied hereunder in connection with the Sub-Study will be as set forth in this Agreement, the Pharmacovigilance Agreement and the Clinical Quality Agreement entered into by the Parties or their Affiliates in connection herewith.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (IDEAYA Biosciences, Inc.)
Regulatory Responsibility. The responsibilities of the Parties with respect to communication and filings with Regulatory Authorities related to the Compounds supplied hereunder in connection with the Sub-Study activities under the Development Plan will be as set forth in this Agreement, the Pharmacovigilance Agreement and the Clinical Quality Agreement entered into by the Parties or their Affiliates in connection herewith.. 12.16
Appears in 1 contract
Samples: Collaboration and License Agreement (SpringWorks Therapeutics, Inc.)
Regulatory Responsibility. The responsibilities of the Parties with respect to communication and filings with Regulatory Authorities related to the Compounds supplied hereunder in connection with the Sub-Study will be as set forth in this Agreement, the Pharmacovigilance Agreement and the Clinical Quality Agreement entered into by the Parties or their Affiliates in connection herewith, except that Advaxis will separately submit any CMC information with respect to the Advaxis Compound directly to any Regulatory Authorities as may be necessary.
Appears in 1 contract
Samples: Clinical Study Collaboration Agreement (Advaxis, Inc.)
