Common use of Regulatory Collaboration Clause in Contracts

Regulatory Collaboration. Upon Jazz’s request, Pfenex shall provide reasonable support with respect to CMC (including writing applicable M3 modules of the International Conference on Harmonisation Common Technical Document specifically related to the production strains with respect to the applicable Product), pharmacovigilance, and other matters for the HemOnc Products in connection with Jazz’s regulatory activities. Without limiting the foregoing, at the direction of Jazz, the Parties shall collaborate and work together to prepare CMC related Regulatory Materials for the HemOnc Products and the JDC may establish a Working Group to coordinate and oversee such regulatory work.