Notice of PLA Filing for FDA Approval Sample Clauses

Notice of PLA Filing for FDA Approval. If, on or before December 18, 1996, LICENSEE or any SUBLICENSEE files with the FDA an NDA or a Product License Application ("PLA") seeking FDA Approval to market and sell a PEG-SOD Product, LICENSEE shall, immediately after it is aware of such filing, notify LICENSOR in writing of such filing. If LICENSOR becomes aware of such filing, LICENSOR shall immediately notify LICENSEE in writing of such filing. If neither LICENSEE nor LICENSOR has received notice by June 19, 1996 that the FDA has approved such NDA or PLA, the parties shall confirm that fact in writing between themselves, the earliest dated confirmation being hereafter referred to as the "Initiating Notice". If LICENSEE or any SUBLICENSEE files with the FDA an NDA or PLA seeking FDA approval to market and sell a PEG-SOD Product and such NDA or PLA is approved by the FDA on or before December 18, 1996, LICENSEE shall, immediately after it is aware of such approval, give LICENSOR written notice (the "Initiating Notice") of such approval. If LICENSOR becomes aware of such approval, LICENSOR shall immediately give LICENSEE written notice (the "Initiating Notice") of such approval.
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Related to Notice of PLA Filing for FDA Approval

  • Notice of a License Action Grantee shall notify their contract manager of any action impacting its license to provide services under this Contract within five days of becoming aware of the action and include the following: a. Reason for such action; b. Name and contact information of the local, state or federal department or agency or entity; x. Xxxx of the license action; and d. License or case reference number.

  • Waiver of Notice; Approval of Meeting; Approval of Minutes The transactions of any meeting of Limited Partners, however called and noticed, and whenever held, shall be as valid as if it had occurred at a meeting duly held after regular call and notice, if a quorum is present either in person or by proxy. Attendance of a Limited Partner at a meeting shall constitute a waiver of notice of the meeting, except when the Limited Partner attends the meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened; and except that attendance at a meeting is not a waiver of any right to disapprove the consideration of matters required to be included in the notice of the meeting, but not so included, if the disapproval is expressly made at the meeting.

  • PROCEDURE FOR APPROVAL OF SETTLEMENT Acceptance of this Settlement Agreement shall be sought at a hearing of the Central Regional Council of the MFDA on a date agreed to by counsel for Staff and the Respondent.

  • Approval of Plan Approval of the Plan by the Commissioner of Internal Revenue as referred to in 17.1 means a continuing approval sufficient to establish that the Plan and related trust(s) are at all times qualified and exempt from income tax under Section 401(a) and other applicable provisions of the Internal Revenue Code of 1986, and that contributions made by the Company under the Plan are deductible for income tax purposes in accordance with law. The cognizant governmental authorities referred to in 17.1 include, without limitation, the Department of Labor, the Pension Benefit Guaranty Corporation and the Securities and Exchange Commission, and their approval means their confirmation with respect to any matter within their regulatory authority that the Plan does not conflict with applicable law.

  • Waiver of Notice; Approval of Meeting Whenever notice to the Members is required to be given under this Agreement, a written waiver, signed by the Person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a Person at any such meeting of the Members shall constitute a waiver of notice of such meeting, except when the Person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the Members need be specified in any written waiver of notice unless so required by resolution of the Board. All waivers and approvals shall be filed with the Company records or made part of the minutes of the meeting.

  • Approval of Plans Landlord will not check Tenant drawings for building code compliance. Approval of the Final Plans by Landlord is not a representation that the drawings are in compliance with the requirements of governing authorities, and it shall be Tenant’s responsibility to meet and comply with all federal, state, and local code requirements. Approval of the Final Plans does not constitute assumption of responsibility by Landlord or its architect for their accuracy, sufficiency or efficiency, and Tenant shall be solely responsible for such matters.

  • Application for approval 3.1. The application for approval of a vehicle type with regard to the AEBS shall be submitted by the vehicle manufacturer or by his authorised representative. 3.2. It shall be accompanied by the documents mentioned below in triplicate: 3.2.1. A description of the vehicle type with regard to the items mentioned in paragraph 2.4., together with a documentation package which gives access to the basic design of the AEBS and the means by which it is linked to other vehicle systems or by which it directly controls output variables. The numbers and/or symbols identifying the vehicle type shall be specified. 3.3. A vehicle representative of the vehicle type to be approved shall be submitted to the Technical Service conducting the approval tests.

  • Renewal Notice; Notification of Changes Subject to governing law, XOOM can renew this Agreement with new or revised Terms. XOOM will send you written notice at least (30) days before the end of the Term. The notice will specify the date by which you must advise XOOM if you do not want to renew your Agreement. If you do not advise XOOM by the specified date, this Agreement will automatically renew at the fixed rate or variable rate then in effect in accordance with the notice. XOOM reserves the right, with fifteen (15) days’ notice, to amend this Agreement to adjust its service to accommodate any change in regulations, law, tariff or other change in procedure required by any third party that may affect XOOM’s ability to continue to serve you under this Agreement.

  • PRELIMINARY APPROVAL OF SETTLEMENT Promptly upon execution of this Stipulation, Lead Plaintiffs will move for preliminary approval of the Settlement, certification of the Settlement Class for settlement purposes only, and the scheduling of a hearing for consideration of final approval of the Settlement, which motion shall be unopposed by Defendants. Concurrently with the motion for preliminary approval, Lead Plaintiffs shall apply to the Court for, and Defendants shall agree to, entry of the Preliminary Approval Order, substantially in the form attached hereto as Exhibit A.

  • Notice of Proposed Actions (a) In case the Company, after the Distribution Date, shall propose (i) to effect any of the transactions referred to in Section 11(a)(i) or to pay any dividend to the holders of record of its Preferred Stock payable in stock of any class or to make any other distribution to the holders of record of its Preferred Stock (other than a regular periodic cash dividend), or (ii) to offer to the holders of record of its Preferred Stock or options, warrants, or other rights to subscribe for or to purchase shares of Preferred Stock (including any security convertible into or exchangeable for Preferred Stock) or shares of stock of any other class or any other securities, options, warrants, convertible or exchangeable securities or other rights, or (iii) to effect any reclassification of its Preferred Stock or any recapitalization or reorganization of the Company, or (iv) to effect any consolidation or merger with or into, or to effect any sale or other transfer (or to permit one or more of its Subsidiaries to effect any sale or other transfer), in one or more transactions, of more than 50% of the assets or earning power of the Company and its Subsidiaries (taken as a whole) to, any other Person or Persons, or (v) to effect the liquidation, dissolution or winding up of the Company, then, in each such case, the Company shall give to each holder of record of a Right Certificate, in accordance with Section 26 hereof, notice of such proposed action, which shall specify the record date for the purposes of such transaction referred to in Section 11(a)(i), or such dividend or distribution, or the date on which such reclassification, recapitalization, reorganization, consolidation, merger, sale or transfer of assets, liquidation, dissolution or winding up is to take place and the record date for determining participation therein by the holders of record of Preferred Stock, if any such date is to be fixed, and such notice shall be so given in the case of any action covered by clause (i) or (ii) above at least 10 days prior to the record date for determining holders of record of the Preferred Stock for purposes of such action, and in the case of any such other action, at least 10 days prior to the date of the taking of such proposed action or the date of participation therein by the holders of record of Preferred Stock, whichever shall be the earlier. (b) In case any of the transactions referred to in Section 11(a)(ii) or Section 13 of this Rights Agreement are proposed, then, in any such case, the Company shall give to each holder of Rights, in accordance with Section 26 hereof, notice of the proposal of such transaction at least 10 days prior to consummating such transaction, which notice shall specify the proposed event and the consequences of the event to holders of Rights under Section 11(a)(ii) or Section 13 hereof, as the case may be, and, upon consummating such transaction, shall similarly give notice thereof to each holder of Rights. (c) The failure to give notice required by this Section 25 or any defect therein shall not affect the legality or validity of the action taken by the Company or the vote upon any such action.

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