Applicable Regulatory Agency definition

Applicable Regulatory Agency means any supra-national, federal, national, regional, state, provincial or local regulatory agency, department, bureau, commission, council or other Governmental Authority regulating or otherwise exercising authority with respect to the Manufacturing, import and/or commercialization of the Products, including, as applicable, the FDA (as such term is hereinafter defined), Health Canada, the TGA (Australia) and the CFDA (China).
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Applicable Regulatory Agency means the FCC, the IUB, the MPUC or any other Governmental Authority that regulates any of the Grantors’ business.
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Examples of Applicable Regulatory Agency in a sentence

  • In the event: (a) Purchaser reasonably determines that any Product should be recalled due to its non-conformance with the terms of this Agreement; (b) any Applicable Regulatory Agency issues a request, directive or order that any Product be recalled; or (c) a court of competent jurisdiction orders such a recall (either (b) or (c) together, an “Order”), each Party shall take all appropriate corrective actions reasonably requested by the other Party or any Applicable Regulatory Agency.

  • Except as otherwise set forth herein with regard to Raw Materials, Supplier shall conduct all required quality control and other tests required to ensure that Products as Manufactured meet the mutually agreed upon Specifications and the cGMPs or other Manufacturing quality control regulations of the FDA or any other Applicable Regulatory Agency in the relevant jurisdiction.

  • In the event that Supplier wishes to propose any material change to the Manufacturing process or the Specifications, it shall provide all relevant details related to such proposed change for review by Purchaser, but shall not implement any such change prior to Purchaser’s approval, which approval Purchaser shall not reasonably withhold or delay, and any necessary approval by the Applicable Regulatory Agency.

  • Each of the Grantors shall cooperate fully and use its best efforts in obtaining the consent and approval of each Applicable Regulatory Agency required to effectuate the foregoing.

  • Each of the Grantors agrees to take any and all necessary and appropriate commercially reasonable actions to preserve the Operating Licenses and to otherwise prevent any modification, revocation, suspension, cancellation, or refusal by any Applicable Regulatory Agency to renew any of the Operating Licenses held by it except to the extent such modification, revocation, suspension, cancellation or refusal could not reasonably be expected to have a Material Adverse Effect.

  • Each of the Grantors agrees, at such Grantor’s own cost and expense, to cooperate with any such purchaser and with the Collateral Agent in the preparation, execution and filing of any applications and other documents and providing any information that may be necessary or helpful in obtaining the consent of the Applicable Regulatory Agency to the assignment or transfer to such purchaser of the Collateral or any of the Operating Licenses.