BLA/MAA definition
BLA/MAA means a Biologics License Application (“BLA”) submitted to the FDA or a Market Authorization Application (“MAA”) submitted to the EMA or MHLW, or any supplemental filing to a BLA or MAA.
Examples of BLA/MAA in a sentence
In addition to the Clinical Trials specifically allocated to IGM and to Sanofi, respectively, pursuant to Section 4.3.1 (Development Responsibilities), (a) prior to the First BLA/MAA Approval, Sanofi will [***] provided [***] and (b) following the First BLA/MAA Approval for each Oncology Collaboration Target, IGM will [***] (each such study, an “Additional Development Activity”).
BI will cooperate with RVDC and provide RVDC with such information, documentation and cooperation regarding the Media (internal coding “[***]”) used to manufacture Product as is reasonably requested by regulatory authorities for RVDC to submit, obtain, maintain and update BLA/MAA regulatory filings and to otherwise comply with applicable law with respect thereto.