Supply Strategy. Commencing not later than the *** anniversary of the Effective Date, Halozyme shall be responsible for implementing a commercially reasonable supply strategy for API to meet ViroPharma’s reasonably anticipated forecasts provided pursuant to Section 7.3. Halozyme shall review such supply strategy with ViroPharma at least ***, and prior to implementing any material change required by a CBE-30, a Prior Approval Supplement or equivalent regulatory filing. Halozyme shall notify ViroPharma of any annual reportable changes within *** (***) days after their submission to FDA.
Appears in 3 contracts
Samples: Collaboration and License Agreement, Licensing Agreement, Collaboration and License Agreement (Viropharma Inc)
Supply Strategy. Commencing not later than the [*** ***] anniversary of the Effective Date, Halozyme shall be responsible for implementing a commercially reasonable supply strategy for API to meet ViroPharmaIntrexon’s reasonably anticipated forecasts provided pursuant to Section 7.3. Halozyme shall review such supply strategy with ViroPharma Intrexon at least [*****], and prior to implementing any material change required by a CBE-30, a Prior Approval Supplement or equivalent regulatory filing. Halozyme shall notify ViroPharma Intrexon of any annual reportable changes within *** ([***) **] days after their submission to FDA.
Appears in 3 contracts
Samples: Collaboration and License Agreement (Intrexon Corp), Collaboration and License Agreement (Intrexon Corp), Collaboration and License Agreement (Intrexon Corp)
Supply Strategy. Commencing not later than the *** first anniversary of after the Effective Date, Halozyme shall be responsible for implementing a commercially reasonable supply strategy for API to meet ViroPharma’s Bxxxxx’x reasonably anticipated forecasts provided pursuant to Section 7.36.3.1. Halozyme shall review such supply strategy with ViroPharma Bxxxxx at least ***annually, and prior to implementing any material change required by changes requiring a CBE-30, a Prior Approval Supplement CBE-30 or equivalent regulatory filing. Halozyme shall notify ViroPharma of any annual reportable changes within *** (***) days after their submission to FDA.
Appears in 1 contract
Samples: Enhanze™ License and Collaboration Agreement (Halozyme Therapeutics Inc)