Definition of TB Regulatory Approval

  1. TB Regulatory Approval means all approvals necessary for the manufacture, marketing, importation and sale of a TB Product in the TB Field in a country or regulatory jurisdiction, which may include, without limitation, satisfaction of all applicable regulatory and notification requirements, but which shall exclude any pricing and reimbursement approvals.

Definition of TB Regulatory Approval in Option and License Agreement

TB Regulatory Approval means all approvals necessary for the manufacture, marketing, importation and sale of a TB Product in the TB Field in a country or regulatory jurisdiction, which may include, without limitation, satisfaction of all applicable regulatory and notification requirements, but which shall exclude any pricing and reimbursement approvals.