Initial NDA definition

Initial NDA means the NDA filed by Novartis on or about 19 January 1960 for the following indications: initial milk let-down, milk retention, incipient mastitis, impaired milk let-down.
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Initial NDA means the New Drug Application and all amendments and supplements thereto filed with the FDA relating to the Patents or for which the Know-How is being used.
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Initial NDA means the NDA (#******) [Confidential Information omitted and filed separately with the SEC] submitted by Pharmos to the FDA on March 30, 1995, including any amendments, supplements, schedules and exhibits thereto.
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Examples of Initial NDA in a sentence

  • Licensee shall be responsible for the preparation, submission and prosecution of all necessary Regulatory Authority filings and applications required to obtain all label extensions or label changes to the Initial NDA, to obtain any subsequent NDA for the Product and to Commercialise Product in the Territory.

  • For the avoidance of doubt, during the Manufacturing Period all decisions relating to the Specification and methods of manufacturing shall be made solely by Licensor provided that Licensor shall give Licensee reasonable notice in writing of any changes prior to effecting them and provided that such changed Specification is still in accordance with the Initial NDA and any subsequent NDA.

  • The Development Costs of any such additional Clinical Trial required in connection with the Initial NDA pre-NDA Approval Date shall be paid by the Licensor, provided that a sum equal to the first [*] dollars ($[*]) and [*] per cent ([*]%) of any Development Costs exceeding [*] dollars ($[*]) shall be reimbursed by the Licensee, by being paid in addition to the milestone payable under Clause 10.10, upon payment of such milestone.

  • Company may terminate this Agreement in its entirety upon delivery of [***] days’ prior written notice to Forma in the event that the Initial NDA is not approved by the FDA on or before [***].

  • Forma shall, within [***] days after Regulatory Approval of the Initial NDA, assign and transfer the Approved NDA and, in accordance with the Transition Plan, assign and transfer the corresponding Regulatory Filings, including the Forma INDs, to Company.

  • Figure 6-4 CPDLC Transfer Using FAN and FCN Messaging – Initial NDA not Delivered 6.2.4.11.9Figure 6-4 shows a CPDLC transfer in which the original Next Data Authority message uplinked by the transferring ATSU is not delivered to the aircraft.

  • BLP further agrees to continue to provide Pharmos with BLP Technical Documentation as Pharmos may reasonably deem necessary or appropriate solely in order for Pharmos to obtain and thereafter maintain FDA approval of the Initial NDA and any subsequent NDA as Pharmos may from time to time reasonably request during the Term.

  • See http://www.ghgprotocol.org/ and http://www.defra.gov.uk/environment/business/envrp/pdf/conversion­factors.pdf.

  • BLP shall allow Pharmos to continue to reference any DMF in the course of seeking and obtaining FDA approval of the Initial NDA and any subsequent NDA, and shall provide Pharmos with a DMF reference letter in each case; provided, however, that BLP shall have no obligation to disclose to Pharmos the contents of any DMF.

  • Prior to assignment of the Approved NDA, subject to the terms and conditions of this Agreement, including this Section 2.8 and Section 2.9, Forma shall be responsible for all regulatory matters relating to the Initial NDA, including overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, the FDA with respect to the Initial NDA (the “Forma Regulatory Activities”) as necessary for Regulatory Approval.


More Definitions of Initial NDA

Initial NDA means the NDA submitted to the FDA on February 15, 2022 by Forma for the Licensed Product in the Initial Indication with the identifier NDA 215814 and all Regulatory Filings submitted to the FDA by Forma in connection with such NDA, including any responses to complete response letters and any refiling, reapplication, additional filing or additional application.
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Initial NDA means, where appropriate, either (i) the MAA, or (ii) the New Drug Application (#*****) submitted by Pharmos to the United States Food and Drug Agency on March 30, 1995, including in either case any amendments, supplements, schedules and exhibits thereto.
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Initial NDA the NDA filed by the Licensor under the terms of Clause 5 for the Product in the Territory.
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Initial NDA. The term ‘Initial NDA’ means New Drug Application No. 021-892 as filed with the United States Food and Drug Administration.
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Related to Initial NDA

  • Initial Negotiation End Date has the meaning set forth in Section 12.2(a).

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Initial Notes means the first $500,000,000 aggregate principal amount of Notes issued under this Indenture on the date hereof.

  • Initial Note means each initial Governmental Lender Note registered by the Comptroller and subsequently canceled and replaced by a definitive Governmental Lender Note pursuant to this Funding Loan Agreement.

  • Initial Notice shall have the meaning set forth in Section 7.1.

  • Additional Indication means any indication other than the Initial Indication.

  • Initial Filing Date means the date on which the Initial Registration Statement is filed with the SEC.

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

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

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Registration Filing Date means the date that is ninety (90) calendar days after the Effective Date.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • 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.

  • 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.

  • 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).

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Additional Filing Date means the date on which the Additional Registration Statement is filed with the SEC.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • 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.

  • Additional Notes means additional Notes (other than the Initial Notes) issued from time to time under this Indenture in accordance with Sections 2.01 and 4.09 hereof.

  • 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).

  • Initial Note Holder means each of the Initial Note A-1 Holder, the Initial Note A-2 Holder, the Initial Note A-3-1 Holder, the Initial Note A-3-2 Holder, the Initial Note A-4 Holder, the Initial Note A-5-1 Holder, the Initial Note A-5-2 Holder, the Initial Note A-6 Holder and the Initial Note A-7 Holder.

  • Required Filing Date has the meaning assigned to such term in Section 2.1.1(b);

  • Original Registration Statement. As used in this Agreement, the terms “amendment” or “supplement” when applied to the Registration Statement or the Prospectus shall be deemed to include the filing by the Company with the Commission of any document under the Exchange Act after the date hereof that is or is deemed to be incorporated therein by reference. All references in this Agreement to financial statements and schedules and other information which is “contained,” “included” or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date; and all references in this Agreement to amendments or supplements to the Registration Statement or the Prospectus shall be deemed to mean and include, without limitation, the filing of any document under the Exchange Act which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date. At the time the Registration Statement was or will be originally declared effective and at the time the Company’s most recent annual report on Form 10-K was filed with the Commission, if later, the Company met the then-applicable requirements for use of Form S-3 under the Securities Act. During the Agency Period, each time the Company files an annual report on Form 10-K the Company will meet the then-applicable requirements for use of Form S-3 under the Securities Act.

  • Initial Filing Deadline means the date which is thirty (30) calendar days after the Closing Date.