Common use of FDA Meetings/Communications Clause in Contracts

FDA Meetings/Communications. All formal meetings with the FDA concerning any clinical trial studies to be conducted within the scope of the Research Plan will be discussed by Collaborator and ICD in advance. Each Party reserves the right to take part in setting the agenda for, to attend, and to participate in these meetings. ICD will provide Collaborator with copies of all FDA meeting minutes, all transmittal letters for IND submissions, IND safety reports, formal questions and responses that have been submitted to the FDA, Annual Reports, and official FDA correspondence, pertaining either to the INDs under this CRADA or to the Clinical Investigators on Protocols performed in accordance with the Research Plan, except to the extent that those documents contain the proprietary information of a third party (provided that, to the extent reasonably practicable, ICD will redact such third party proprietary information and provide such redacted documents to Collaborator) or dissemination is prohibited by applicable law. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

FDA Meetings/Communications. All formal meetings with the FDA concerning any clinical trial studies to be conducted within the scope of the Research Plan will be discussed by Collaborator and ICD in advance. Each Party reserves the right to take part in setting the agenda for, to attend, and to participate in these meetings. ICD will provide Collaborator with copies of all FDA meeting minutes, all transmittal letters for IND submissions, IND safety reports, formal questions and responses that have been submitted to the FDA, Annual Reports, and official FDA correspondence, pertaining either to the INDs under this CRADA or to the Clinical Investigators on Protocols performed in accordance with the Research Plan, except to the extent that those documents contain the proprietary information of a third party (provided that, to the extent reasonably practicable, ICD will redact such third party proprietary information and provide such redacted documents to Collaborator) or dissemination is prohibited by applicable law. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended.. Add the following Article 3.12:

FDA Meetings/Communications. All formal meetings with the FDA concerning any clinical trial studies to be conducted within the scope of the Research Plan will be discussed by Collaborator and ICD in advance. Each Party reserves the right to take part in setting the agenda for, to attend, and to participate in these meetings. ICD will provide Collaborator with copies of all FDA meeting minutes, all transmittal letters for IND submissions, IND safety reports, formal questions and responses that have been submitted to the FDA, Annual Reports, and official FDA correspondence, pertaining either to the INDs under this CRADA or to the Clinical Investigators on Protocols performed in accordance with the Research Plan, except to the extent that those documents contain the proprietary information of a third party (provided that, to the extent reasonably practicable, ICD will redact such third party proprietary information and provide such redacted documents to Collaborator) or dissemination is prohibited by applicable law. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended.