FDA Approval Fee Sample Clauses

FDA Approval Fee. Promptly after the receipt by Xxxxxx of a written notification from the FDA of the approval of the applicable 510(k) or PMA submission, Xxxxxx shall pay to HDC a one-time FDA Approval Fee of Five-Hundred-Thousand U.S. Dollars ($500,000.00). This Fee shall also be irrevocable and non-creditable against any royalty obligation.
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FDA Approval Fee. Sublicensee shall pay to Sublicensor an FDA Approval Fee of *** for each Transgenic Product which constitutes, in whole or in part, a pharmaceutical and for which approval for commercial production is obtained from the Food and Drug Administration (the “FDA”). For each such Transgenic Product, the FDA Approval Fee shall be due *** Confidential Treatment Requested exactly one year from the date on which FDA approval is obtained for the Transgenic Product. FDA Approval Fees shall not be creditable against any other fees or earned royalties. As used in this provision, the term “pharmaceutical” shall not be construed, in any event, as including food products or nutritional ingredients (such as human milk proteins) for which approval is obtained from the FDA.
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Related to FDA Approval Fee

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • PRELIMINARY APPROVAL OF SETTLEMENT 3. 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. RELEASE OF CLAIMS

  • 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.

  • Preliminary Approval Within a reasonable time after execution of this Settlement Agreement by the Parties, Plaintiff shall apply to the Court for the entry of an Order:

  • Preliminary Approval Order “Preliminary Approval Order” means the order of the Court preliminarily approving this Settlement Agreement.

  • Authorization, Approval, etc No authorization, approval, or other action by, and no notice to or filing with, any governmental authority, regulatory body or any other Person is required either

  • Agency Approval The Servicer has been approved by FNMA or FHLMC and will remain approved as an "eligible seller/servicer" of conventional, residential mortgage loans as provided in FNMA or FHLMC guidelines and in good standing. The Servicer has not received any notification from FNMA or FHLMC that the Servicer is not in compliance with the requirements of the approved seller/servicer status or that such agencies have threatened the servicer with revocation of its approved seller/servicer status.

  • FCC Approval Notwithstanding anything to the contrary contained in this Agreement or in the other Loan Documents, neither the Administrative Agent nor any Lender will take any action pursuant to this Agreement or any of the other Loan Documents, which would constitute or result in a change in control of the Borrower or any of its Subsidiaries requiring the prior approval of the FCC without first obtaining such prior approval of the FCC. After the occurrence of an Event of Default, the Borrower shall take or cause to be taken any action which the Administrative Agent may reasonably request in order to obtain from the FCC such approval as may be necessary to enable the Administrative Agent to exercise and enjoy the full rights and benefits granted to the Administrative Agent, for the benefit of the Lenders by this Agreement or any of the other Loan Documents, including, at the Borrower’s cost and expense, the use of the Borrower’s best efforts to assist in obtaining such approval for any action or transaction contemplated by this Agreement or any of the other Loan Documents for which such approval is required by Law.

  • Application Approval Our representative will notify you (or one of you, if there are co-applicants) of the Application approval, execute the Lease agreements for signature prior to occupancy, and, once complete, credit the application deposit of all applicants toward the required security deposit.

  • 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.

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