NDA Approval Date definition

NDA Approval Date means date on which Evoke receives NDA Approval.
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NDA Approval Date means the date of the NDA Approval.
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NDA Approval Date means have the meaning set forth in Section 1.11(i)(v).
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Examples of NDA Approval Date in a sentence

  • The Acquiror agrees and acknowledges that, following the Closing until the Evamist NDA Approval Date, the Seller shall have the right to use any and all Purchased Assets solely and to the extent necessary for carrying out the Seller’s right hereunder to prosecute the Evamist NDA and obtain the Evamist NDA Approval.

  • The Agreement shall take into effect as of the Effective Date and shall remain in effect for a term of five (5) years from the NDA Approval Date unless earlier terminated as provided hereunder (the “Term”).

  • Completion of Deliverable E5.1 ensures that the format and content of E5.3 can be planned/sourced well in advance of completion to allow sufficient time to refine the business case to its best version.

  • Until the Evamist NDA Approval Date, the Seller shall control the prosecution of the Evamist NDA before the FDA, subject to the terms and conditions of this Section 8.5. Unless and until the Evamist FDA Submissions are assigned to the Acquiror pursuant to Section 8.5(b), the Seller shall use efforts (consistent with the past practices of the Seller with respect to the Evamist NDA and other NDAs of the Seller), at its expense, to obtain Evamist NDA Approval as soon as practicable.

  • Unless previously assigned to the Acquirorpursuant to S ection 8.5(b), the Seller shall transfer and assign, within five (5) Business Days of the NDA Approval Date, to the Acquiror(A) the Evamist FDA Submissions (including all associated rights) together with (B) all files related thereto.

  • As of the NDA Approval Date, Evoke shall maintain product liability insurance for the Product of at least ten million dollars ($10,000,000) naming Eversana as an additional insured under such policy, it being understood and agreed that Eversana shall not need to obtain any product liability insurance during the Term.

  • The manager can dynamically control hisoutside wealth allocation at discrete points in time, with a denotWT bXTþ cðXTX0Þþ þ YTð1Þing the fraction invested in the index fund.

  • A copy of the questions must be submitted to the chief diversity officer as part of the search records.The search committee chair will be responsible for contacting individuals to be interviewed and for thanking candidates who will not be interviewed for their interest in the position.Having reviewed the interview process and having reached an agreement on the nominees, the search committee will make its final recommendations to the appropriate vice president, dean, and/or the president.

  • Salix shall use all Due Diligence efforts to achieve Launch of the Xxxxxx Product as soon as reasonably practicable after the NDA Approval Date and to maximise Sales of the Xxxxxx Product in the Territory during the Xxxxxx Royalty Term.


More Definitions of NDA Approval Date

NDA Approval Date means the date of approval of the relevant NDA for a Product.
Sample 1
NDA Approval Date means date on which Zosano receives NDA Approval. 1.39. “Net Profit” means Net Sales, less the following: [***]. 1.40. “Net Sales” means the gross invoiced price (not including value added taxes, sales taxes or similar taxes) of Product actually sold to a Customer hereunder after deducting, if not previously deducted, from the amount invoiced or received: a. trade and quantity discounts other than early payment cash discounts that are actually allowed or granted; b. rebates, chargebacks and other allowances that are actually allowed or granted; c. credits or allowances actually given or made by Zosano to Customers for rejection or return of the Products to Zosano; 5
Sample 1

Related to NDA Approval Date

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

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

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • 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.

  • Preliminary Approval Date means the date the Preliminary Approval Order has been executed and entered by the Court.

  • Final Approval Date means the date on which the Court enters the Final Order and Judgment.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

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

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

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Shareholder Approval Date means the date on which this Plan is approved shareholders of the Company eligible to vote in the election of directors, by a vote sufficient to meet the requirements of Code Sections 162(m) (if applicable) and 422, Rule 16b-3 under the Exchange Act (if applicable), applicable requirements under the rules of any stock exchange or automated quotation system on which the Shares may be listed on quoted, and other laws, regulations and obligations of the Company applicable to the Plan.

  • Stockholder Approval Date means the date on which Stockholder Approval is received and deemed effective under Delaware law.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • 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.

  • Preliminary Approval Order means the proposed Order Granting Preliminary Approval of Class Action Settlement, Approving Form and Manner of Notice, and Setting Date for Hearing on Final Approval of Settlement, which, subject to the approval of the Court, shall be substantially in the form attached hereto as Exhibit A.

  • Disclosure Statement Approval Order means the Final Order approving, among other things, the adequacy of the Disclosure Statement pursuant to section 1125 of the Bankruptcy Code.

  • Preliminary Approval means the Court’s Order Granting Preliminary Approval of the Settlement.

  • 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.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that prevents the approval or marketing of any Biosimilar Product of such Licensed Product in such country.

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