Examples of Pivotal Registration Study in a sentence
Initiation of the first study designed as a Pivotal Registration Study in any country in the Territory with respect to a Drug Product for a Hematology Indication.
During the Pivotal Registration Study and thereafter, Astellas shall use Diligent Efforts to perform Medical Affairs Activities for each Collaboration Product [*] and to the extent appropriate [*].
Astellas shall establish, at its own cost and prior to the Initiation of the first Pivotal Registration Study for the applicable Collaboration Product, the global safety database for the Collaboration Products, and shall maintain such global safety database for so long as such Collaboration Product is under Development and/or Commercialization hereunder.
At (i) any time after [ * ] Indication or [ * ] Indication, or (ii) any time in connection with [ * ] Indication or any [ * ] Indication, Cytokinetics shall have the right to field its own MSLs in the Co-Promotion Territory (for Licensed Indications) or Shared Territory (for [ * ] Indications and [ * ] Indications), in connection with such Pivotal Registration Study.
The Medical Affairs Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ MSLs’ activities during such Pivotal Registration Study and any subsequent Pivotal Registration Study for such Collaboration Product (and thereafter if Cytokinetics exercises its Co-Promotion option for such Collaboration Product), as well as a budget therefor, which shall be consistent with Section 9.5 below.