FDA Type C Meeting definition

FDA Type C Meeting means a meeting with the FDA regarding the development and review of the Iclaprim Assets pursuant to the FD&C Act.

Examples of FDA Type C Meeting in a sentence

  • Prior to the Closing, Nuprim Shareholders shall have provided all the information in their possession required to be produced for purposes of the FDA Type C Meeting and all of the reports and disclosure memoranda owned or controlled by Nuprim that may be necessary to timely complete the FDA Type C Meeting.

  • To the Nuprim Shareholder’s knowledge, the Nuprim Shareholders have provided all the information in their possession required to be produced during the FDA Type C Meeting and all of the reports and disclosure memoranda owned or controlled by Nuprim that are necessary for the Business as of the Closing Date.

  • From and after the Closing, Nuprim Shareholders shall continue to provide any requested information in their possession required to be produced for purposes of the FDA Type C Meeting and all of the reports and disclosure memoranda owned or controlled by Nuprim that may be necessary to timely complete the FDA Type C Meeting.

  • During the Pre-Closing Period, upon Motif’s request, Nuprim Shareholders shall authorize the transfer of up to 1 kilogram of drug substance solely to allow Motif to undertake development work intended to be completed prior to the FDA Type C Meeting, and for no other purpose, in such quantities as requested by Motif.

  • By or before February 15, 2017, so long as Nuprim Shareholders have provided all the information in their possession required to be produced during the FDA Type C Meeting and all of the reports and disclosure memoranda owned or controlled by Nuprim necessary to timely complete the FDA Type C Meeting, Motif must commence clinical development of the Iclaprim Product, time being of the essence.