NDA Submission definition

NDA Submission means the submission of an NDA to the applicable Regulatory Authority: (a) in the U.S., (b) as a centralized filing with the EMEA, or (c) in Japan, as applicable; provided in each case that such submission shall be deemed to have occurred when all required components of the NDA have been filed with the Regulatory Authority by (or on behalf of) the filing party.
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NDA Submission means the first submission by or on behalf of ViaCell or its Affiliates to the applicable Regulatory Agency of a Major Market of a completed application for Product Approval of the use of the applicable Product in the Field in that Major Market.
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NDA Submission means the submission of Technical Information, and other materials for review by the relevant governmental or regulatory authorities for evaluation for possible NDA Approval.
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Examples of NDA Submission in a sentence

  • KHK shall give DICERNA written notice of its intent to submit an NDA to the FDA with respect to each Licensed Product for the Initial Target at least [***] prior to the anticipated date of such submission (each, an “NDA Submission Notice”), which NDA Submission Notice shall include a written report setting forth in reasonable detail all Development Costs incurred by KHK with respect to such Licensed Product through the date of the NDA Submission Notice.

  • Following its receipt of the NDA Submission Notice, DICERNA shall have the right, upon written notice, to review all Drug Approval Applications prepared for such Licensed Product for the Initial Target, including the NDA, and all correspondence submitted or received with respect to such Licensed Product, at DICERNA’s sole cost and expense.

  • Matrix shall provide to HMR within one (1) month of HMR's request, copies of all regulatory correspondence, including, but not limited to, IND Information Amendments, IND Reports, IND Safety Reports, NDA Submission, NDA Post-marketing Reports, and reports of written/phone contacts to/from regulatory agencies, as well as the safety database (as applicable).

  • The ----------------- Option 1 Warrants shall be non-transferrable and may be exercised at any time during a period of five (5) years following the date of issuance thereof at a price equal to the OraPharma Stock FMV on such NDA Submission Achievement Date.

  • If ViaCell proceeds to NDA Submission without having made the Milestone Payment for milestone "a" (Commencement of Phase III Clinical Trial), e.g., because the data from a Phase II clinical trial is believed to be sufficient for registration, then such Milestone Payment for milestone "a" shall be made concurrently with the Milestone Payment for Milestone "b" (NDA Submission).

  • The principal amount of the NDA Submission Note shall be due and payable on the earlier to occur of either (a) five (5) business days following the consummation of a public offering by OraPharma of equity securities registered under the Securities Act of 1933 (as amended), if any, after the date of the NDA Submission Note, or (b) the date that is three (3) years following the date of the NDA Submission Note.

  • ACY shall also be entitled to receive warrants to purchase One Hundred Twenty Five Thousand Dollars ($125,000) of OraPharma Stock based upon the OraPharma Stock FMV as of such NDA Submission Achievement Date (the "Option 1 Warrants").

  • Interest shall accrue thereon at a fluctuating rate per annum equal to the prime rate of CitiBank, N.A. (or any successor thereto) in effect on the first business day of each calendar quarter, and shall be due and payable in arrears on the last business day of each calendar quarter during the term of the NDA Submission Note, with a final interest payment due and payable on the maturity date.

  • The number of shares of OraPharma Stock that ACY may purchase upon the exercise of the Option 1 Warrants shall be equal to the result of $125,000 divided by the ---------- OraPharma Stock FMV on such NDA Submission Achievement Date.

  • VIVUS Reports 2006 Fourth Quarter and Full-Year Financial ResultsPositive Phase 2 Data for Qnexa and FDA Acceptance of EvaMist NDA Submission Lead 2006 HighlightsMOUNTAIN VIEW, Calif., March 2, 2007 — VIVUS, Inc.


More Definitions of NDA Submission

NDA Submission means a request for approval to market a drug containing evidence of safety and efficacy which is demonstrated by extensive pre-clinical and clinical testing;
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NDA Submission means the submission of an NDA to the CFDA (or any equivalent agency or Regulatory Authority in the Territory) in writing.
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NDA Submission means notification from the FDA indicating acceptance for the filing of the NDA in the United States for the Product for use in the Indication. (ooo) "Net Sales" means collectively, the gross amount invoiced by Fujisawa or its Affiliates or by sublicensees granted a sublicense pursuant to Section 3.7(b) for sales of the Product in the Field to a Third Party for use in the Territory (other than sales of Products by Sublicensees in Mexico), less the following as they pertain to the Product: (i) any and all normal and customary trade and quantity discounts and customary allowances actually granted to purchasers of a Product for returns or credits, recalls (whether in the form of a credit or free replacement actually given in place of a returned or recalled Product), allowances to end users, which are reasonable and customary in accordance with generally accepted practices in the pharmaceutical industry (whether in the form of a credit or free Product), taxes (the legal incidence of which is on the purchaser and is shown separately on a Party's invoices) and transportation, insurance and postage charges (if billed on a Party's invoices as a separate item), and payments and rebates (including Medicaid rebates given pursuant to an agreement with U.S. Department of Health and Human Services and other rebates given pursuant to a government based rebate program, including local and state rebate programs), accrued, paid or deducted pursuant to agreements (including managed care agreements and group purchasing agreements) or Applicable Laws, chargebacks and reporting rebates paid to wholesalers and other distributors.
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NDA Submission means notification from the FDA indicating acceptance for the filing of the NDA in the United States for the Product for use in the Indication.
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Related to NDA Submission

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

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

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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.

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

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • 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.

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • IND means an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a clinical trial of pharmaceutical product.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Planning Submission or “CAPS” or “Community Accountability Planning Submission” means the HSP Board approved planning document submitted by the HSP to the Funder. The form, content and scheduling of the Planning Submission will be identified by the Funder;

  • JDC has the meaning set forth in Section 3.2.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • 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).

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.