Manufacturing for ROW Administration. Prior to Regulatory Approval of Licensed Product in any country in the ROW, Celgene will provide to the JGC a Manufacturing plan for the ROW in form and substance at least as detailed as the applicable section of the U.S. Commercialization Plan (including covering the applicable three-year time period) (the “ROW Post-Approval Manufacturing Plan”). Celgene (itself or by or through any others, including any Affiliates or Sublicensees) will not materially deviate from the then current ROW Post-Approval Manufacturing Plan when Manufacturing Licensed Product for Commercialization for ROW Administration without first notifying the JGC in writing and providing an updated ROW Post-Approval Manufacturing Plan.
Appears in 7 contracts
Samples: Co Development, Co Promote and Profit Share Agreement (2seventy Bio, Inc.), Master Collaboration Agreement (2seventy Bio, Inc.), Co Development, Co Promote and Profit Share Agreement (Bluebird Bio, Inc.)
