FIRST APPROVAL DATE definition

FIRST APPROVAL DATE has the meaning set forth in Section 5.6(b).
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FIRST APPROVAL DATE means the date on which CURA or SPECTRUM first obtains approval from a Regulatory Authority in the Territory to market a Product.
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FIRST APPROVAL DATE shall have the meaning set forth by Article 6.3;
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Examples of FIRST APPROVAL DATE in a sentence

  • If the approving Party fails to respond within First Approval Date period, the requesting Party may resend its initial notice together with a Federal Express package to the approving Party’s designated contacts in Section 25(a), in each case with a prominent header that says “FINAL NOTICE FOR APPROVAL” or words substantially similar thereto.

  • With respect to any approvals relating to MS Rights, the First Approval Date shall be five (5) Business Days instead of three (3) as set forth above and the Final Approval Date will be five (5) additional Business Days instead of four (4) as set forth above.

  • In the event that the JSC shall not, for whatsoever reason (including cessation by the Parties of discussions relating thereto), have established a Development Plan for any given potential Product on or prior to the date falling one (1) year after the later to occur of (a) the First Approval Date and (b) the date on which the proposal therefor shall first have been submitted to the JSC, then the provisions of Sections 5.4.3 and 5.4.4 shall apply with respect to such potential Product.

  • In the event that the Qualification Date of the [*] Facility shall not have occurred on or prior to the date falling six (6) months after the First Approval Date, MediGene shall, at Bxxxxxx’x request, exercise commercially reasonable efforts to have [*] fully involve Bxxxxxx and its consultants in the attempt to correct or ameliorate any obstacles or issues being encountered and, ultimately, to obtain such Qualification.

  • Notwithstanding any other provision hereof, in the event that the [*] Qualification Date shall not have occurred on or prior to the date falling [*] months after the First Approval Date, [*] shall have the right to suspend any or all purchases of API hereunder until the later of (a) the [*] Qualification Date and (b) the date on which [*] shall have informed [*] that the [*] Qualification Date shall have occurred.

  • If the POC does not set such target for any year (measured from the First Approval Date) by such date, then (i) the Minimum Purchase target shall be US$ [**] for the fourth (4th) year; (ii) the Minimum Purchase target shall be US$ [**] for the fifth (5th) year; and (iii) thereafter, the Minimum Purchase target shall be equal to the greater of: (A) US$ [**]; or (B) [**] percent ( [**]%) of the actual purchases of the Product by Nycomed from TMC during the immediately preceding year.

  • Either Party may terminate this Agreement in its entirety forthwith by notice in writing to the other in the event that the First Approval Date shall not have occurred on or prior to the fourth (4th) anniversary of the Effective Date.

  • If the First Approval Date does not occur within [*] from the Effective Date, either Party may terminate this Agreement by [*] days written notice to the other Party, unless otherwise agreed by the Parties.

  • For each year subsequent to the third anniversary of the First Approval Date, the POC shall set a new Minimum Purchase target.


More Definitions of FIRST APPROVAL DATE

FIRST APPROVAL DATE means the date on which DUSA first obtains approval to market a Product from a Regulatory Authority in the Territory.
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FIRST APPROVAL DATE means the date on which the First Approved Product shall have received Market Approval in the Territory.
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FIRST APPROVAL DATE means the [*]. For the avoidance of doubt, the First Approval Date shall only occur once.
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FIRST APPROVAL DATE means the first date on which the Product is eligible for sale in one or more countries of the Territory based on receipt of all necessary Approvals from Government Authorities of one or more countries of the Territory.
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FIRST APPROVAL DATE means the date of grant or approval of the first Drug Approval Application in either the United States or any country or region in Europe.
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FIRST APPROVAL DATE means the date on which DUSA, or D&D, as the case may be, first obtains approval to market a Product from a Regulatory Authority in the Territory.
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Related to FIRST APPROVAL DATE

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

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

  • 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.

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

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

  • 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.

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

  • 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).

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • 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.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • 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.

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

  • Requisite Approval means the affirmative vote of the holders of at least a majority of the shares of outstanding Company Common Stock and outstanding Company Preferred Stock voting as a single class.

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

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

  • Offer Closing Date has the meaning set forth in Section 1.01(f).

  • Requisite Shareholder Approval shall have the meaning set forth in Section 4.3(a).

  • 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.

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

  • Option Closing Date shall have the meaning ascribed to such term in Section 2.2(c).

  • Required Shareholder Approval has the meaning in Section 2.20.

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

  • FCC Approval means the FCC’s grant of the FCC Applications; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.