Examples of Material Communication in a sentence
Within [***] after receipt of any Material Communication from a Regulatory Authority with respect to any Collaboration Product, Voyager will provide Genzyme, through its Alliance Manager, with a brief written description of the principal issues raised in such Material Communication.
Upon Voyager’s reasonable request after receiving a notice from Genzyme in accordance with the immediately preceding sentence, Genzyme will provide to Voyager complete copies of such correspondence of any such Material Communication within a reasonable period of time following such request.
Upon the Noticed Party’s reasonable request after receiving a notice from the Noticing Party in accordance with the immediately preceding sentence, the Noticing Party will provide to the Noticed Party complete copies of correspondence of relating to such Material Communication in original language without translation within a reasonable period of time following such request.
Each Regulatory Lead Party will provide to the other Party for review and discussion a copy of each Material Communication with any Regulatory Authorities with respect to any Licensed Product for which such Party is the Regulatory Lead Party.
Any Material Communication to a Regulatory Authority with respect to any Licensed Product in the Profit-Share Territory must be consistent with the Profit-Share Regulatory Strategy for such Licensed Product approved by the JSC.
With respect to any Material Communication with the FDA or the EMA or a Regulatory Authority in [**] related to a Licensed Product, the Regulatory Lead Party will allow the other Party [**].
Ono will allow Repare a reasonable opportunity to review and comment on Ono’s proposed response to any Material Communications with PMDA with respect to any Licensed Product, and Ono will reasonably consider all comments timely provided by Repare in connection therewith; provided, that Ono may designate a reasonable time and date by which Repare must respond to a Material Communication by the PMDA in light of the requirements of the PMDA.
Notwithstanding the foregoing, Otsuka shall not be required to provide a brief written description or a translation of any Material Communication that is conveyed at any meeting, teleconference or videoconference that is attended by any Perception representative.
Upon Perception’s request after receiving such description from Otsuka, Otsuka shall translate such Material Communication, [***] as soon as practically possible and shall provide to Perception such translated Material Communication promptly after completion of such translation into English.
Each Party will provide the JSC for its review and discussion a brief description in English of the principal issues raised in each Material Communication with Regulatory Authorities in the EU/Japan with respect to the Distribution Product in the Field.