Regulatory Delay Clause Samples

Regulatory Delay. No provision of this License Agreement shall be affected by any delay in the approval of the Actavis ANDA by the FDA, or the failure of Actavis to obtain FDA approval of the Actavis ANDA, except to the extent that such provision is affected by the delay of the Launch Date.

Regulatory Delay. Notwithstanding the foregoing, to the extent that the Buyer is delayed in obtaining any of the Approvals necessary to construct Buyer’s Project due solely to the actions or inactions of a permit granting authority, the Buyer may request, and the Seller, in its reasonable discretion may grant, an extension to the Time of Closing without requiring the Buyer to pay any additional deposit for the period of time that Seller determines, based on the records maintained in connection with the Approvals hearings, that Buyer has been delayed by such permit granting authority. Alternatively, or if the Seller elects not to extend the Time of Closing as requested by ▇▇▇▇▇, Buyer may terminate this Agreement and the Deposit shall be refunded to Buyer by Escrow Agent and neither party shall have any further obligations hereunder except for those obligations that specifically survive termination.

Regulatory Delay. (a) If CUSTOMER has reason to believe that Regulatory Approval will be delayed, CUSTOMER shall provide POLYPEPTIDE with prompt written notice of such delay. In such case, if CUSTOMER has already issued the Commercial Launch Authorization Notice, Initial Quarterly Forecast and any Firm Purchase Orders (including the first Firm Purchase Order for quantities of PRODUCT specified by CUSTOMER for delivery by POLYPEPTIDE for the first [**] full calendar quarters of the Initial Quarterly Forecast), CUSTOMER may request that POLYPEPTIDE suspend production of PRODUCT quantities contained in any such Firm Purchase Order. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. (b) If CUSTOMER makes a suspension request, POLYPEPTIDE shall as promptly as possible suspend all production of PRODUCT, and the parties shall discuss in good faith and determine an efficient process for mitigating related costs, which process shall be implemented by POLYPEPTIDE in a timely manner. Subject to such discussion, during any period of regulatory delay, POLYPEPTIDE may invoice CUSTOMER for [**]; provided that all such amounts paid by CUSTOMER shall be credited by POLYPEPTIDE against the purchase price for finished PRODUCT subsequently delivered to CUSTOMER. If, in accordance with the agreed upon suspension process and a Firm Purchase Order, POLYPEPTIDE completes any PRODUCT batches in progress at the time of receipt of notice of regulatory delay, POLYPEPTIDE shall deliver and invoice CUSTOMER for any such finished PRODUCT no earlier than [**] months following the delivery date specified in the applicable Firm Purchase Order. CUSTOMER agrees to pay any such invoices within [**] days of its receipt thereof. In the event that CUSTOMER requests that POLYPEPTIDE delay delivery of PRODUCT to CUSTOMER, POLYPEPTIDE shall apply such payment to the purchase price due for the PRODUCT so delayed. POLYPEPTIDE agrees to use commercially reasonable efforts to mitigate the costs that are to be borne by CUSTOMER under this Section 3.12. Section 5.1 with respect to the transfer of title notwithstanding, in the event of delayed delivery of PRODUCT at the request of CUSTOMER, CUSTOMER agrees to obtain insurance for PRODUCT upon delivery of invoices to CUSTOMER under this Section 3.12(b).

Regulatory Delay. Notwithstanding any other terms in this Agreement to the contrary, in the event that: (a) the PCAOB Audited Financial Statements are not delivered on or before September 30, 2023 and Purchaser, in its sole discretion, elects to extend the time for receipt thereof (an “Audit Delay”), (b) any other necessary financial or regulatory or governmental Consent (including those set forth on Schedule 7.1(d) of the Company Disclosure Schedules) is not completed or obtained prior to December 22, 2023 (“Regulatory Delay”) (as determined by Purchaser in its reasonable discretion based on representations made by the Company to Purchaser about such completion date), or (c) if the Company fails to achieve any of the Quarterly Financial Targets (“Quarterly Shortfall”), the Company shall be responsible for paying any extension fees and all other fees or expenses actually incurred by or on behalf of Purchaser, the Company or any of their Affiliates in connection with such Audit Delay, Regulatory Delay or Quarterly Shortfall, to the extent that (i) caused by any reasons not attributable to Purchaser, including as a result of the Company breaching its obligations to provide information to Purchaser in accordance with the terms of this Agreement, the Company failing to respond to the request of any regulatory authority or the Company failing to obtain governmental Consent set forth on Schedule 7.1(d) prior to December 22, 2023, for whatever reason, and (ii) such extension fees and any other fees or expenses are actually incurred by or on behalf of Purchaser, the Company or any of their Affiliates after the date of such Audit Delay, Regulatory Delay or Quarterly Shortfall.

Regulatory Delay. Notwithstanding Section 11.3 above and any other terms in this Agreement to the contrary, in the event that: (a) the Audited Financial Statements are not delivered on or before 31 August 2022 and Purchaser in its sole discretion elects to extend the time for receipt (“Audit Delay”) or (b) any other necessary financial or regulatory or governmental approval not being completed prior to April 24, 2023 (“Regulatory Delay”) (as determined by Purchaser in its reasonable discretion based on representations made by Company to Purchaser about such completion date), Company shall be responsible for paying any extension fees and all other Expenses actually incurred by or on behalf of Purchaser or any of its Affiliates and any other Party in connection with such Audit Delay or Regulatory Delay, to the extent that (i) such Audit Delay or Regulatory Delay is caused by the Company, including as a result of the Company breaching its obligations to provide information to Purchaser in accordance with the terms of this Agreement or the Company failing to respond to the request of any regulatory authority and (ii) such extension fees and any other Expenses are actually incurred by or on behalf of Purchaser or any of its Affiliates and any other Party after the date of such Audit Delay or Regulatory Delay. All deliverables and time periods for actions set forth herein shall be extended by the Audit Delay or Regulatory Delay at the sole option of Purchaser.

Regulatory Delay. No provision of this Settlement Agreement shall be affected by any delay in the approval of the Paddock ANDA by the FDA, or the failure of Perrigo to obtain FDA approval of the Paddock ANDA.

Regulatory Delay. No provision of this Settlement Agreement shall be affected by any delay in the approval of either of the Actavis ANDAs by the FDA, or the failure of Actavis to obtain FDA approval of either of the Actavis ANDAs.

Regulatory Delay. No provision of this Settlement Agreement shall be affected by any delay in the approval of the Lupin ANDA by the FDA, or the failure of Lupin to obtain FDA approval of the Lupin ANDA.

Regulatory Delay. No provision of this Settlement Agreement shall be affected by any delay in the approval of the Taro ANDA by the FDA, or the failure of Taro to obtain FDA approval of the Taro ANDA.