Transfer of Regulatory Approval Sample Clauses

Transfer of Regulatory Approval. On and promptly after the Effective Date (or the exercise of the Options, as applicable), Inpharma shall (a) use its Reasonable Best Efforts to effect the transfer of ownership of the Regulatory Approval for the Territory to Cytogen, including the filing with the FDA and any other relevant Governmental or Regulatory Authorities all information required in order to transfer such (including any authorization letters or notices, and letters of acceptance) Regulatory Approvals as set forth in Section 6.03, (b) provide Cytogen a complete copy of the 510(k) K030802 for the Product, including all correspondence with the FDA relating to such 510(k), and (c) de-list the Product from the medical device listing files with the FDA and use its Reasonable Best Efforts to assist Cytogen to file a medical device listing form for the Product with the FDA.
Sample 1
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Transfer of Regulatory Approval. Promptly after receipt of any Regulatory Approval by the FDA for a Licensed Product in the SCLC Initial Indication, PharmaMar shall, transfer and assign to Jazz such Regulatory Approval and all Regulatory Filings for a Licensed Product in the Jazz Territory and shall transfer to Jazz all Licensed Product Data and PharmaMar Know-How not previously transferred to Jazz, except for the DMF, which shall be maintained by and in the name of PharmaMar. For these purposes, Jazz shall promptly submit the required Regulatory Filings to the FDA for such transfer, documenting Jazz´s commitment to agreements, promises, and conditions made by PharmaMar in the NDA or IND and the effective date of the change in ownership of the Regulatory Approval. Cost of such transfer shall be borne by both Parties equally. After transfer of the Regulatory Approval to Jazz pursuant to this Section 5.2 on a NDA Approval that is not a Full Approval, Jazz shall use Commercially Reasonable Efforts to achieve the next Regulatory Milestone that is based on Full Approval.
Sample 1

Related to Transfer of Regulatory Approval

  • No Regulatory Approval By the Company or Parent, if its Board of Directors so determines by a vote of a majority of the members of its entire Board, in the event any Requisite Regulatory Approval shall have been denied by final, nonappealable action by such Governmental Authority or a Governmental Authority shall have requested the permanent withdrawal of an application therefor.

  • Regulatory Approval Any waiting period applicable to the Transactions under the HSR Act shall have been terminated or shall have expired.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • Approvals of Regulatory Authorities Niagara Bancorp shall have received all required approvals of Regulatory Authorities of the Merger (without the imposition of any conditions that are in Niagara Bancorp's reasonable judgment unduly burdensome); and all notice and waiting periods required thereunder shall have expired or been terminated;

  • Listing Approval The Shares to be delivered on the Closing Date or any Additional Closing Date, as the case may be, shall have been approved for listing on the Exchange, subject to official notice of issuance. If (i) any of the conditions specified in this Section 5 shall not have been fulfilled when and as provided in this Agreement, or (ii) any of the opinions and certificates mentioned above or elsewhere in this Agreement shall not be reasonably satisfactory in form and substance to the Representative and its counsel, this Agreement and all obligations of the Underwriters hereunder may be cancelled on, or at any time prior to, the Closing Date or any Additional Closing Date, as the case may be, by the Representative. Notice of such cancellation shall be given to the Company in writing or by telephone or facsimile confirmed in writing.

  • Required Regulatory Approvals Certain transactions required, permitted or otherwise contemplated by this Agreement may under certain circumstances require prior filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner. Such transactions include: (a) issuance or purchase of any additional capital stock of the Company or other securities convertible into or exchangeable or exercisable for capital stock of the Company pursuant to Sections 1.2 or 3.4; (b) transfer of Shares to a wholly owned subsidiary of a Shareholder, to another Shareholder or to a wholly owned subsidiary of another Shareholder pursuant to Sections 3.1(a) or 3.4; (c) exercise of preemptive rights by a Shareholder pursuant to Section 3.2; and (d) exercise of call rights by the Company or a Shareholder pursuant to Section 3.3 (including pursuant to the two provisos in Section 3.1(b)). Notwithstanding anything to the contrary contained in this Agreement, any such transactions requiring filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner shall not, to the extent within the control of a party hereto, be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained, and to the extent not within the control of an applicable party hereto, such party shall use best efforts to cause such transactions not to be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained.

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

  • 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.

  • Approval of Stockholders If an option is granted by this Agreement prior to approval of the stockholders of the Plan, the option granted shall be null and void unless stockholder approval is obtained within twelve months after the Plan was adopted.

  • Government Approval, Regulation, etc No authorization or approval or other action by, and no notice to or filing with, any governmental authority or regulatory body or other Person is required for the due execution, delivery or performance by the Borrower of this Amendment.

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