Regulatory Decisions Clause Samples
Regulatory Decisions. MannKind may terminate this Agreement upon a thirty (30) day written notice to AFP if a controlling regulatory authority withdraws approval of the MannKind Product.
Regulatory Decisions. Any Governmental Authority shall have issued a final decision that could reasonably be likely to result in a Material Adverse Effect.
Regulatory Decisions. 45 7.11 Consequences of an Event of Default.................................................................45
Regulatory Decisions. Without prejudice to Section 10.1 above, a Party may terminate this Agreement upon written notice to the other Party in the event that ANVISA makes a final, non-appealable decision to not approve the Authorization or withdraws approval of the Authorization.
Regulatory Decisions. Any Governmental Authority shall have issued a decision that could reasonably be likely to result in a Material Adverse Effect on the Borrower.
Regulatory Decisions. MannKind may terminate this Agreement upon a thirty (30) day written notice to Organon in the event that the FDA, EMEA and/or JP either fail to approve or withdraws approval of the End Product.