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.
Sample 1

Related to FDA Approval Fee

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

  • 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.

  • Milestone Payment Within thirty (30) days following the first Patent Issuance, Eton shall give written notice to Imprimis and shall pay to Imprimis a non-refundable and noncreditable payment of fifty thousand dollars ($50,000).

  • Commercial Milestone Payments Green Cross shall pay to MacroGenics the Net Sales milestone payments set forth below, which shall be due and payable within *** after the end of the first Calendar Year during which such milestone is triggered.

  • 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.

  • Development Milestone Payments In partial consideration for the rights and licenses granted to Coya hereunder, within ten days after the first achievement of each milestone event in a given Indication set forth in this Section 5.2 (Development Milestone Payments) with respect to a Product (each, a “Development Milestone Event”) by or on behalf of Coya or any of its Affiliates or Sublicensees, Coya shall provide ARScience Bio written notice to ARScience Bio identifying the Development Milestone Event achieved. Upon receipt of any such notice of first achievement of a Development Milestone Event by Coya or its Affiliates or Sublicensees, ARScience Bio will promptly invoice Coya for the applicable Development Milestone Event and Coya will make a milestone payment to ARScience Bio in the amount set forth in this Section 5.2 (Development Milestone Payments) corresponding to such Development Milestone Event (each, a “Development Milestone Payment”) within 45 days of receipt of such invoice. On an Indication-by-Indication basis, each Development Milestone Payment shall be payable only upon the first achievement of the corresponding Development Milestone Event by a Product, in any given Indication for which the Development Milestone Events have not been previously achieved (each such Indication, a “New Indication”). No amounts shall be due for subsequent or repeated achievements of such Development Milestone Event with respect to the same or different Mono Product or Combination Product, as applicable, in such Indication. Accordingly and for clarity, the Development Milestone Payment shall be paid only once, when first achieved by Coya, an Affiliate or a Sublicensee, but no payment shall be due if the same milestone is subsequently achieved by one of Coya, an Affiliate or a Sublicensee. For clarity, the amounts owed in Column (a) below shall be due for the first Combination Product to achieve the Development Milestone Events in a New Indication and the amounts owned in Column (c) below shall be due for the first Mono Product to achieve the Development Milestone Events in a New Indication. Any Combination Product or Mono Product to achieve the Development Milestone Events in a New Indication after the first achievement of the Development Milestone Events as described in the foregoing sentence will cause the amounts in Column (b) with respect to a Combination Product and Column (d) with respect to a Mono Product to be due and payable by Coya upon each such occurrence. If the first Product to achieve a Development Milestone Event in any Indication is a Combination Product, the amounts in Column (a) below shall be due and payable by Coya. If the next Product to achieve a Development Milestone Event in a New Indication is a Mono Product, the amounts in Column (c) below would be due and payable by Coya; provided, that if such next Product to achieve a Development Milestone Event in a New Indication is a Combination Product, the amounts in Column (b) would be due and payable by Coya. By way of example, if a Combination Product achieves IND Acceptance in ALS, and is the first Product to achieve a Development Milestone Event under this Agreement, [***] will be due and payable by Coya. If subsequently a Mono Product achieves IND Acceptance in ALS, no Development Milestone Payments will be due and payable by Coya under this Agreement. However, if subsequently any Combination Product achieves IND Acceptance in Alzheimer’s disease, [***] would be due and payable by Coya.

  • HSR Approval The applicable waiting period under the HSR Act shall have expired or been terminated.

  • Development Fee The fee for the packaging of a Company Property, including negotiating and approving plans and assisting in obtaining zoning and necessary variances and financing for a specific Company Property to be developed or under development, either initially or at a later date.

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