FDA Approval Event definition

FDA Approval Event means the FDA Approval Date occurs on or before the Fifty-Four Month Anniversary Date.
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FDA Approval Event means the public disclosure, as part of a Quarterly Report on Form 10-Q or on a Current Report on Form 8-K or otherwise, of the occurrence of an approval or clearance for commercial sale of any of the Company’s ovarian cancer tests by the U.S. Food and Drug Administration of the U.S. Department of Health and Human Services.
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FDA Approval Event means the approval by the Food and Drug Administration of the Borrower’s pre-market approval applications for the use of its cryoablation system to treat atrial flutter.
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Examples of FDA Approval Event in a sentence

  • If an FDA Approval Event has not occurred by September 1, 2009, the Notes shall be purchased in cash in whole or in part (which must be equal to $1,000 principal amount or any integral multiple thereof) by the Company, at the option of Holders, in accordance with the provisions of Section 11.3 of the Indenture for cash at a purchase price equal to 100% of the principal amount of the surrendered Notes together with accrued but unpaid interest, if any, to but excluding the Put Right Purchase Date.

  • The “Interest Rate” shall be equal to 7.00% per annum unless and until an FDA Approval Event shall have occurred, and thereafter, as of the date of public disclosure of such FDA Approval Event, 4.00% per annum.

  • If an FDA Approval Event (as defined in the Indenture) shall have occurred, the interest rate on this Note shall be reduced to 4.00% per annum at all times thereafter.

  • In the event the interest rate is reduced to 4.00% because of an FDA Approval Event, the Company shall provide notice of such reduction to the Trustee in accordance with Section 13.2 of this Indenture.

  • The Committee believes that, in accordance with section 11.3 of the 7% Notes Indenture, the 7% Notes are redeemable by each holder at any time because an FDA Approval Event (as defined in the 7% Notes Indenture) failed to occur by September 1, 2009.


More Definitions of FDA Approval Event

FDA Approval Event means the date that the FDA Approval has been received by the Borrower (or as relevant, any member of the Group), as certified by an officer of the Borrower to the Lenders (or as applicable, the Agent), on or before 31 March 2023.
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FDA Approval Event is the final approval by the FDA of a companion diagnostics test involving the Borrower’s CELsignia diagnostics by the FDA.
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Related to FDA Approval Event

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Non-Approval Event means, in respect of the Benchmark:

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Milestone Event has the meaning set forth in Section 8.4.

  • Medical event means an event that meets the criteria in 12VAC5-481-2080.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Approval Date means the date on which the Plan is approved by the Company’s stockholders.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).