Regulatory Delay. No provision of this Settlement Agreement shall be affected by any delay in the approval of the Par ANDA by the FDA, or the failure of Par to obtain FDA approval of the Par ANDA.
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. 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.
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 Agreement shall be affected by any delay in the approval of the Par ANDA by the FDA, […***…], except to the extent that such provision is affected by the delay of Par’s Commercial Marketing.
Regulatory Delay. The parties acknowledge that during the Clinical Trial Phase and Pre-Commercial Phase, IDEC's clinical development of Labelled Drug is subject to regulatory oversight and that regulatory requirements may result in delay or suspension of clinical development and patient treatment, while such matters are resolved. If such delay or suspension occurs or if there are no active Clinical Trial protocols and it is not then necessary for IDEC to receive its supply of Isotope [CONFIDENTIAL TREATMENT REQUESTED], IDEC shall promptly notify Nordion in writing to temporarily suspend manufacture of Isotope. During such suspension, Nordion shall remain in a state of readiness to recommence supply of Isotope upon [CONFIDENTIAL TREATMENT REQUESTED] written notice from IDEC. In consideration of Nordion maintaining the facility in a state of readiness during such suspension, IDEC shall, in lieu of IDEC's purchase obligations set forth in Section 6.3, [CONFIDENTIAL TREATMENT REQUESTED] until such time as Isotope supply is resumed and shall [CONFIDENTIAL TREATMENT REQUESTED]. Nordion shall provide to IDEC reasonable documentation [CONFIDENTIAL TREATMENT REQUESTED]. In the event Nordion is sourcing radiochemical grade yttrium-90 in house, IDEC shall in lieu of [CONFIDENTIAL TREATMENT REQUESTED], until such time as Isotope supply is resumed. Except in the event that delay in Nordion obtaining its NDA for Isotope is caused by the acts or omissions of IDEC, if Nordion does not receive NDA approval in accordance with Exhibit 1, or if Nordion during Clinical Trials or Pre-Commercial Phase, is prevented from supplying Isotope due to FDA regulatory requirements, [CONFIDENTIAL TREATMENT REQUESTED] applicable under this section shall be suspended until such time as NDA approval is obtained by Nordion or the FDA lifts any requirement preventing Nordion from supplying Isotope, as the case may be.
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. No provision of this Settlement Agreement shall be affected by any delay in the approval of either of the Teva ANDA by the FDA, or the failure of Teva to obtain FDA approval of the Teva 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. 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 Xxxxx, 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.
