Regulatory Dependencies Clause Samples
The Regulatory Dependencies clause establishes that certain obligations or actions under the agreement are contingent upon obtaining necessary approvals, licenses, or clearances from relevant regulatory authorities. In practice, this means that parties may not be required to perform specific duties, such as closing a transaction or launching a product, until all required regulatory permissions are secured. This clause helps manage legal and compliance risks by ensuring that contractual commitments are not enforced until all regulatory hurdles are cleared, thereby protecting parties from potential legal violations or penalties.
Regulatory Dependencies. Annex AA-2 sets forth those ▇▇▇▇▇▇▇ Countries in which a Marketing Approval for a Territory Combination Product relies upon or references a Marketing Approval for such Territory Combination Product for the European Union or any Gilead Country (each such ▇▇▇▇▇▇▇ Country, a “▇▇▇▇▇▇▇ Reliant Country”). Gilead shall provide ▇▇▇▇▇▇▇ [*] notice of any voluntary withdrawal or abandonment of a Marketing Approval in any country that is specified in Annex AA-2 as a country that is referenced or relied upon by any ▇▇▇▇▇▇▇ Reliant Country (a “Gilead Marketing Approval”). [*]. Notwithstanding the foregoing, this Section 4.8 shall not apply to preclude Gilead from engaging in any withdrawal of a Gilead Marketing Approval due to safety, efficacy or public health reasons or as required or requested by a Regulatory Authority.