FDA Approvals definition

FDA Approvals has the meaning set forth in Section 7.42.
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FDA Approvals shall have the meaning ascribed to such term in Section 3.1(oo). “GAAP” shall have the meaning ascribed to such term in Section 3.1(h). “GM” means Grushko & M▇▇▇▇▇▇, P.C., with offices located at 5▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇. “Harvard Trials” shall have the meaning ascribed to such term in Section 3.1(oo). “Indebtedness” shall have the meaning ascribed to such term in Section 3.1(aa).
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FDA Approvals means approvals obtained from the FDA, including without limitation, 510(k)s, NDAs and PMAs, necessary to the operation of the business of SDI as it relates to the Two Products.
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Examples of FDA Approvals in a sentence

  • The Parties intend to establish this strategic collaboration for the design, development, marketing and support of the Magnus Analyzer and its subsystems, including obtaining the necessary Approvals for its use, sale and marketing, specifically FDA Approvals.

  • Elan shall be responsible for the compilation and filing of the Regulatory Filings in respect of the Product with the FDA and shall be the holder of any FDA Approvals granted for the Product and the Party principally responsible for interaction with the FDA.

  • Non- Standard Reporting Intervals Per Hour $100 In addition to Custom Reports, includes non-RxInsider reports such as FDA Approvals, pending approvals, pending generics, etc, that are included in this Contract, but may be requested more frequently than monthly or quarterly as specified in this Contract.

  • By: /s/ ▇▇▇ ▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Name: ▇▇▇ ▇▇▇▇▇▇▇ Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Title: EVP & CFO Title: Chief Financial Officer Date: August 18, 2020 Date: August 17, 2020 Subject to Vendor obtaining appropriate FDA Approvals for the LumiraDx Instrument and COVID-19 Test Strips and the other terms and conditions set forth in the Agreement, CVS shall be entitled to purchase LumiraDx Instruments, COVID-19 Test Strips and Ancillary Equipment in monthly amounts no less than what is outlined below.

  • If at any point during the Term, Vendor fails to maintain the appropriate and required FDA Approval(s), CVS, or its designated distributor on its behalf, as applicable, retains the right to return any purchased unused Products to Vendor and receive a full refund for any amounts paid to Vendor for such unused Products.

  • The Company will make all Regulatory Filings and obtain and maintain all required Regulatory Approvals (including all required FDA Approvals) for the Products in the Designated Jurisdictions.

  • If Vendor fails to obtain the appropriate and required FDA Approval(s) prior to August 31, 2020, CVS, or its designated distributor on its behalf, as applicable, retains the right to return any purchased unused Products to Vendor and receive a full refund for any amounts paid to Vendor for such unused Products.

  • Licensee shall pay Cellegy a milestone payment of ten million dollars ($10,000,000) in cash no later than thirty (30) days after Cellegy certifies in writing to Licensee that the Licensed Product has all FDA Approvals required to promote, sell and distribute the Licensed Product in the United States.

  • The obligations set forth in this Agreement are subject to Vendor obtaining and maintaining the appropriate FDA Approvals now and in the future for the LumiraDx Instrument and COVID-19 Test Strips as well as the ancillary equipment, including collection supplies (“Ancillary Equipment”) necessary to administer the tests (collectively the “Products”) that expressly authorizes use of the LumiraDx Instrument and COVID-19 Tests strips in patient care settings outside of the clinical laboratory environment.

  • If not earlier terminated as provided in this Article 10, the term of this Agreement (the “Term”) shall commence on the Effective Date and expire seven (7) years after FDA Approvals are obtained for the marketing and sale of the Magnus Analyzer in the United States; provided, however, that this Agreement may be renewed for subsequent five (5) year terms upon mutual agreement of the Parties.