Common use of Communications with Regulatory Agencies Clause in Contracts

Communications with Regulatory Agencies. MSK will, to the extent permitted by law and MSK policy, and after review by MSK’s legal counsel (a) notify Company of any communications from or to any regulatory authority having an impact on the Study; (b) include Company in any discussions or meetings with the FDA regarding the Study; (c) supply Company with a copy of any correspondence from the FDA regarding the Study, including any IND, approval letter, and any other IND-related correspondence; and (d) allow Company a reasonable opportunity to comment on any correspondence being sent to the FDA by MSK or Investigator-Sponsor regarding the Study, including any submitted IND and IND annual reports.

Communications with Regulatory Agencies. MSK will, to the extent permitted by law and MSK policy, and after review by MSK’s legal counsel (a) notify Company of any communications from or to any regulatory authority having an impact on the Study; (b) include Company in any discussions or meetings with the FDA regarding the Study; (c) supply Company with a copy of any correspondence from the FDA regarding the Study, including any IND, approval letter, and any other IND-related correspondence; and (d) allow Company a reasonable opportunity to comment on any correspondence being sent to the FDA by MSK or Investigator-Sponsor regarding the Study, including any submitted IND ; and IND annual reports(d) allow Company a reasonable opportunity to review copies of the “Safe to Proceed” letter from the FDA.”