FDA Meetings/Communications Clause Samples

FDA Meetings/Communications. All formal meetings with the FDA concerning any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix C clinical trial 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. The Sponsor will provide the other Party with copies of 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 or dissemination is prohibited by law. Add a new Article 3.12 as follows:

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 meetings with the FDA concerning any clinical trial within the scope of the Research Plan will be discussed by Collaborator and IC in advance. Each Party reserves the right to take part in setting the agenda for, to attend, and to participate in these meetings. IC will provide Collaborator with copies of 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 or dissemination is prohibited by law. PHS ICT-CRADA Agreement Ref. No. NCI # 03111 MODEL ADOPTED June 18, 2009 Page 7 of 42 Revised May 15, 2014

FDA Meetings/Communications. All meetings with the FDA concerning any clinical trial 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 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 in which case ICD shall redact those portions of Confidential Information proprietary to a third party, or dissemination is prohibited by law. A new Article 3.12 is added as follows:

FDA Meetings/Communications. 4.1 With respect to any discussions with the FDA involving data obtained from this Clinical Trial under IND# 13967, the CTSN DCC and NHLBI, in consultation with the Company, will take the initiative in arranging meetings or conference calls with the FDA. Formal meetings with the FDA concerning the Clinical Trial design and/or data will be discussed and agreed upon in advance by the Company and the CTSN DCC and NHLBI. The Company will have the right to participate in all formal meetings with the FDA. The Company agrees not to contact the FDA independent of the CTSN DCC and NHLBI concerning this Clinical Trial. However, the Company may contact the FDA on separate product-related issues. 4.2 The Company will in a timely manner notify NHLBI and CTSN DCC of any FDA correspondence related to the Protocol that is received by the Company, or its Affiliates, any FDA enforcement actions directed toward the Company or its Affiliates, including but not limited to the following but only if these would impact the safety of Human Subjects in the Clinical Trial: warning letters, seizures, recalls, injunctions/consent decrees, rejection of regulatory submissions or withdrawal of approval for Test Article; criminal investigations, and proceedings to debar the Company or its Affiliates or individuals employed under a contract to the Company and/or its Affiliates. 4.3 The Company will also promptly notify NHLBI and CTSN DCC of any action taken by the FDA regarding manufacturing of the Test Article that would impact the safety of Human Subjects in the Clinical Trial.

FDA Meetings/Communications. 4.1 With respect to any discussions with the FDA involving data obtained from this Clinical Trial under NHLBI’s IND, NHLBI, in consultation with Company, will take the initiative in arranging meetings or conference calls with the FDA. Formal meetings with the FDA concerning the Clinical Trial design and/or data will be discussed and agreed upon in advance by Company and NHLBI. Company will have the right to participate in all formal meetings with the FDA. Company agrees not to contact the FDA independent of NHLBI concerning this Clinical Trial. However, Company may contact the FDA on separate product-related issues. Intramural Clinical Trial Agreement Page 9 of 22 Document Printed February 4, ▇▇▇▇ […***…] 4.2 Company will promptly notify NHLBI of any FDA correspondence related to the Protocol that is received by Company, or its Affiliates; any FDA enforcement actions directed toward Company or its Affiliates, including but not limited to: warning letters, seizures, recalls, injunctions/consent decrees, rejection of regulatory submissions or withdrawal of approval for a Test Article, criminal investigations, and proceedings to debar Company or its Affiliates or individuals employed under a contract to Company and/or its Affiliates. 4.3 Company will also promptly notify NHLBI of any action taken by the FDA regarding manufacturing of the Test Article that would impact the safety of Human Subjects in the Clinical Trial.

FDA Meetings/Communications. 4.1 With respect to any discussions with the FDA involving data obtained from the Studies under Institution’s IND, the Institution will be responsible for arranging meetings or conference calls with the FDA. The Company agrees not to contact the FDA independent of the Institution concerning the Studies. The Institution will inform the Company of any proposed meetings or conference calls with the FDA and Company will have the option of participating either in person or via teleconference. The Institution will promptly provide the Company with copies of all IND submissions, AE reporting, FDA correspondence/communication reports, meeting briefing documents and minutes, IND annual reports and formal questions and responses that have been submitted to the FDA, except to the extent that those documents contain Confidential Information (as defined by the CRCA) of another party. 4.2 Company will promptly notify Institution of: a) Any FDA correspondence related to the Studies that is received by the Company, or its Affiliates; b) FDA enforcement actions directed toward the Company or its Affiliates, including but not limited to, warning letters, seizures, recalls; injunctions/consent decrees; rejection of regulatory submissions or withdrawal of approval for a product; c) Criminal investigations; and d) Proceedings to debar Company or its Affiliates or individuals employed under a contract to Company and/or its Affiliates. 4.3 Company will also promptly notify Institution of any action taken by the FDA regarding manufacturing of the Study Drug that would impact the safety of Human Subjects in the Studies.

FDA Meetings/Communications. All meetings with the FDA concerning any clinical trial 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. The Sponsor will provide the other Party with copies of 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 or dissemination is prohibited by law. PHS ECT-CRADA Case Ref. No. DK-10-0109 MODEL ADOPTED June 18, 2009 Portions of this Exhibit, indicated by the ▇▇▇▇ “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

FDA Meetings/Communications. All meetings with the FDA concerning any clinical trial within the scope of the Research Plan will be discussed by Collaborator and IC in advance. Each Party reserves the right to take part in setting the agenda for, to attend, and to participate in these meetings and IC agrees not to object to Collaborator’s attendance at any meetings with the FDA with an established agenda directed to and within the scope of the Research Plan. IC agrees to provide Collaborator with copies of FDA meeting minutes after such meetings, regardless of whether Collaborator attends, as well as copies of all transmittal letters for IND submissions, IND safety reports, formal questions and responses that will be 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 a reasonable time period prior to submittal to the FDA to allow Collaborator to review prior to submittal, when practicable, except to the extent that those documents contain the proprietary information of a third party or dissemination is prohibited by law. IC will consider Collaborator’s comments with regard to any response or letters sent to the FDA prior to their submittal. [*****] Raptor Pharmaceutical Corp. has requested confidential treatment of certain portions of this offer letter which have been omitted and filed separately with the U.S. Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.