Effectiveness Notice definition

Effectiveness Notice means a notice and certificate of Borrower properly executed by an Authorized Officer of Borrower, addressed to the Lenders and delivered to the Administrative Agent whereby Borrower certifies satisfaction and/or waiver of all the conditions precedent to the effectiveness under Section 4.1 and Section 4.2 of this Agreement.
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Effectiveness Notice means a notice and certificate of APA properly executed by an Authorized Officer of APA addressed to the Lenders and delivered to the Administrative Agent, whereby APA certifies satisfaction of all the conditions precedent to the effectiveness under Section 4.1 of this Agreement.
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Effectiveness Notice means a notice and certificate of the Borrower properly executed by an Authorized Officer of the Borrower addressed to the Lenders and delivered to the Administrative Agent, whereby the Borrower certifies satisfaction of all the conditions precedent to the effectiveness under Section 4.1 of this Agreement.
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Examples of Effectiveness Notice in a sentence

  • The Administrative Agent shall have received the Effectiveness Notice.

  • The summary can be a simple statement naming the drug product, listing the indication(s), and stating your reliance on the PET Safety and Effectiveness Notice, which provides the basis for the determination of safety and effectiveness required for FDA approval.

  • Based on the findings elucidated in the March 2000 PET Safety and Effectiveness Notice, FDA has determined that you are not required to conduct clinical trials or submit new safety and effectiveness information to obtain approval for fludeoxyglucose F 18 injection, ammonia N 13 injection, or sodium fluoride F 18 injection used in PET imaging.

  • Here is an example of an application summary for fludeoxyglucose F 18 injection for all three indications: In accordance with FDA’s PET Safety and Effectiveness Notice published in the Federal Register of March 10, 2000 (65 FR 12999), (Name of applicant) is submitting this new drug application, as described in section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, for fludeoxyglucose F 18 injection for the following indications: 1.

  • Effectiveness: Notice of other compliance with this Rule shall not invalidate the Proceedings or any fine or sanction imposed.

  • The information published in the PET Safety and Effectiveness Notice will form the basis for approval of 505(b)(2) NDAs for the three PET products discussed in this guidance.

  • Note: If FDA approves other applications for fludeoxyglucose F 18 injection submitted in accordance with the PET Safety and Effectiveness Notice, it is possible that these products could become alternative RLDs. For sodium fluoride F 18 injection, the RLD should be listed as one of the following: NDA 17-042, (18 F) as Fluoride Ion in Saline Solution, held by GE Healthcare.

  • Petitioners are correct that Sections 262(d)(1) and (e) only required that the Effectiveness Notice and statement of shares be sent to “holders of record,” but it does not follow that sending such correspondence to beneficial owners such as petitioners was an implicit waiver.

  • Again, Section 262 did not require respondent to refrain from sending the Effectiveness Notice and statement of shares to stockholders who made defective appraisals, including appraisals like petitioners that were defective for failure to comply with the “holder of record” requirement.

  • Because there is no approved NDA for ammonia N 13 injection at this time, the FDA can accept only NDAs for that PET drug product based on the Agency's findings in the PET Safety and Effectiveness Notice.


More Definitions of Effectiveness Notice

Effectiveness Notice means a notice and certificate of Apache properly executed by an Authorized Officer of Apache addressed to the Lenders and delivered to the Administrative Agent, whereby Apache certifies satisfaction of all the conditions precedent to the effectiveness under Section 4.1 of this Agreement.
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Effectiveness Notice means a notice and certificate of Borrower properly executed by an Authorized Officer of Borrower addressed to the Lenders and delivered to the Administrative Agent, in sufficient number of counterparts to provide one for each such lender and each agent under this Agreement, whereby Borrower certifies satisfaction of all the conditions precedent to the effectiveness under Section 4.1 of this Agreement.
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Effectiveness Notice shall have the meaning given to such term in Section 6.1.
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Effectiveness Notice means an irrevocable written notice from the Company to the Investor informing of effectiveness of the Registration Statement and directing the Investor to purchase the Securities as referenced in Exhibit A of this Agreement.
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Effectiveness Notice has the meaning specified in Section 2.5(a).
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Related to Effectiveness Notice

  • Effectiveness Target Date As defined in Section 5.

  • Effectiveness Deadline Date has the meaning set forth in Section 2(a) hereof.

  • Effectiveness Deadline As defined in Section 3(a) and 4(a) hereof.

  • Initial Effectiveness Deadline means the date which is (i) in the event that the Initial Registration Statement is not subject to a full review by the SEC, sixty (60) calendar days after the Closing Date or (ii) in the event that the Initial Registration Statement is subject to a full review by the SEC, ninety (90) calendar days after the Closing Date.

  • Effectiveness Date means, with respect to the Initial Registration Statement required to be filed hereunder, the 90th calendar day following the date hereof (or, in the event of a “full review” by the Commission, the 120th calendar day following the date hereof) and with respect to any additional Registration Statements which may be required pursuant to Section 2(c) or Section 3(c), the 90th calendar day following the date on which an additional Registration Statement is required to be filed hereunder (or, in the event of a “full review” by the Commission, the 120th calendar day following the date such additional Registration Statement is required to be filed hereunder); provided, however, that in the event the Company is notified by the Commission that one or more of the above Registration Statements will not be reviewed or is no longer subject to further review and comments, the Effectiveness Date as to such Registration Statement shall be the fifth Trading Day following the date on which the Company is so notified if such date precedes the dates otherwise required above, provided, further, if such Effectiveness Date falls on a day that is not a Trading Day, then the Effectiveness Date shall be the next succeeding Trading Day.

  • Additional Effectiveness Deadline means the date which is the earlier of (x) (i) in the event that the Additional Registration Statement is not subject to a full review by the SEC, thirty (30) calendar days after the earlier of the Additional Filing Date and the Additional Filing Deadline or (ii) in the event that the Additional Registration Statement is subject to a full review by the SEC, fifty (50) calendar days after the earlier of the Additional Filing Date and the Additional Filing Deadline and (y) the fifth (5th) Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that such Additional Registration Statement will not be reviewed or will not be subject to further review; provided, however, that if the Additional Effectiveness Deadline falls on a Saturday, Sunday or other day that the SEC is closed for business, the Additional Effectiveness Deadline shall be extended to the next Business Day on which the SEC is open for business.

  • Amendment Effectiveness Deadline Date has the meaning set forth in Section 2(d) hereof.

  • Required Effectiveness Date As defined in Section 2.1.

  • Registration Notice has the meaning specified in Section 2.1(a).

  • Piggyback Notice has the meaning specified in Section 2.02(a).

  • Shelf Effectiveness Period shall have the meaning set forth in Section 2(b) hereof.

  • Shelf Filing Deadline As defined in Section 4(a) hereof.

  • Initial Registration Statement means the initial Registration Statement filed pursuant to this Agreement.

  • Rule 462(b) Registration Statement means any registration statement prepared by the Company registering additional Securities, which was filed with the Commission on or prior to the date hereof and became automatically effective pursuant to Rule 462(b) promulgated by the Commission pursuant to the Securities Act.

  • IPO Registration Statement means the Registration Statement on Form S-1 (File No. 333-196099), as amended, filed by the Partnership with the Commission under the Securities Act to register the offering and sale of the Common Units in the Partnership’s initial public offering of such Common Units to the public.

  • Additional Registration Statement means a registration statement or registration statements of the Company filed under the 1933 Act covering any Additional Registrable Securities.

  • Demand Registration Statement has the meaning set forth in Section 2.01(a).

  • Filing Deadline As defined in Sections 3(a) and 4(a) hereof.

  • Special Registration Statement means (i) a registration statement relating to any employee benefit plan or (ii) with respect to any corporate reorganization or transaction under Rule 145 of the Securities Act, any registration statements related to the issuance or resale of securities issued in such a transaction or (iii) a registration related to stock issued upon conversion of debt securities.

  • 10-K Filing Deadline As defined in Section 11.05(a).

  • Effectiveness Period shall have the meaning set forth in Section 2(a).

  • Exchange Offer Registration Statement has the meaning set forth in the Registration Rights Agreement.

  • Resale Registration Statement means a registration statement meeting the requirements set forth in the Registration Rights Agreement and covering the resale of the Warrant Shares by each Purchaser as provided for in the Registration Rights Agreement.

  • New Registration Statement has the meaning set forth in Section 2(a).