Failure to take action. (1) An appli- cant agrees to extend the review period under section 505(c)(1) or (j)(5)(A) of the act until it takes any of the actions listed in paragraph (b) of this section. For an application or abbreviated ap- plication, FDA may consider an appli- cant’s failure to take any of such ac- tions within 1 year after issuance of a complete response letter to be a re- quest by the applicant to withdraw the application, unless the applicant has requested an extension of time in
Failure to take action. The failure of the Planning Commission to act on the Final Plat within 60 days shall be deemed approval of this plat, provided, however, that the applicant, with the Commission’s approval, may waive this requirement and consent to the extension of such period. Walk through checklist prior to Final Approval
Failure to take action. (1) An appli- cant agrees to extend the review period under section 505(c)(1) or (j)(5)(A) of the act until it takes any of the actions listed in paragraph (b) of this section. For an application or abbreviated ap- plication, FDA may consider an appli- cant’s failure to take any of such ac- tions within 1 year after issuance of a complete response letter to be a re- quest by the applicant to withdraw the application, unless the applicant has requested an extension of time in which to resubmit the application. FDA will grant any reasonable request for such an extension. FDA may con- sider an applicant’s failure to resubmit the application within the extended time period or to request an additional extension to be a request by the appli- cant to withdraw the application.
(2) If FDA considers an applicant’s failure to take action in accordance with paragraph (c)(1) of this section to be a request to withdraw the applica- tion, the agency will notify the appli- cant in writing. The applicant will have 30 days from the date of the noti- fication to explain why the application should not be withdrawn and to request an extension of time in which to resub- mit the application. FDA will grant any reasonable request for an exten- sion. If the applicant does not respond to the notification within 30 days, the application will be deemed to be with- drawn. [73 FR 39609, July 10, 2008]
(a) An abbreviated new drug applica- tion that refers to, or a petition under section 505(j)(2)(C) of the act and § 314.93 that relies on, a listed drug that has been voluntarily withdrawn from sale in the United States must be ac- companied by a petition seeking a de- termination whether the listed drug was withdrawn for safety or effective- ness reasons. The petition must be sub- mitted under §§ 10.25(a) and 10.30 of this chapter and must contain all evidence available to the petitioner concerning the reasons for the withdrawal from sale.
(b) When a petition described in para- graph (a) of this section is submitted, the agency will consider the evidence in the petition and any other evidence before the agency, and determine whether the listed drug is withdrawn from sale for safety or effectiveness reasons, in accordance with the proce- dures in § 314.161.
(c) An abbreviated new drug applica- tion described in paragraph (a) of this section will be disapproved, under
Failure to take action. Failure of the Planning Commission to act on the Preliminary Plat within 60 days shall be deemed approval of this plat.
Failure to take action. The Seller shall not (i) take any action, or fail to take any action, if such action or failure to take action may interfere with the enforcement of any rights under this Contribution Agreement or any of the other Loan Documents; (ii) take any action, or fail to take any action, if such action or failure to take action may interfere with the enforcement of any rights with respect to the Transferred Receivables; or (iii) fail to pay any tax, assessment, charge, fee or other obligation of the Seller with respect to the Transferred Receivables, or fail to defend any action, if such failure to pay or defend may adversely affect the validity or enforceability of the assignment of the Transferred Receivables to the Purchaser hereunder or the right, title or interest which the Seller had in the Transferred Receivables prior to its sale and assignment of the Transferred Receivables to the Purchaser hereunder.
Failure to take action. No General Partner will be liable to the Partnership or any of the Partners for its failure to take any action, including, but not limited to, any action on behalf of the Partnership which may prevent the foreclosure of all or any portion of the property of the Partnership, including, without limitation, the Facility, due to the Partnership's lack of sufficient funds therefor. The Managing General Partner shall have the power, but shall not be obligated, to (i) sell all or any portion of the property of the Partnership in order to raise such funds, or (ii) cause the dissolution of the Partnership or the abandonment of all or any portion of its property or both, without any liability whatsoever and without prejudice to any claim that any General Partner or the Partnership may have against the Limited Partners for the breach of any provisions of this Agreement.
Failure to take action. None of Bevexxx xx Capstone or their respective Subsidiaries will take any action, or fail to take any action, if such action (or failure to act) would reasonably be expected to cause the Merger to fail to qualify as a reorganization within the meaning of Section 368(a) of the Code.
Failure to take action. Neither Seller nor Buyer will take any action, or fail to take any action, if such action (or failure to act) would reasonably be expected to cause this Agreement, or any of its provisions, to fail.
Failure to take action. The Originator shall not fail to pay any tax, assessment, charge, fee or other obligation of the Originator with respect to the Purchased Assets, or fail to defend any action, if such failure to pay or defend may adversely affect the validity or enforceability of the assignment of the Purchased Assets to the Buyer hereunder or the right, title or interest which the Originator had in the Purchased Assets prior to their assignment to the Buyer hereunder.
Failure to take action. If Guarantor fads to take any such action within the time periods set forth herein, Lender may pursue any remedies at law or in equity against Guarantor, without having to proceed first against Borrower, and may itself take such action, and Guarantor shall be liable to Lender for all expenses, including attorneys’ fees incurred by Lender, and all amounts paid by Lender in taking any such action, subject to Section 1.4 above.
