Status Quo Period definition

Status Quo Period means a period beginning the day Indivior begins Marketing a Follow-on Drug Product in the United States and ends on the earlier of (i) six (6) months after a Third Party begins Marketing a Drug Product approved under an ANDA or 505(b )(2) Application for which the Original Drug Product is the reference listed drug, or (ii) three (3) years after the day
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Status Quo Period means a period beginning the day Defendant begins Marketing a Follow-on Drug Product in the United States and ends on the earlier of (i) 6 months after a Third Party begins Marketing a Drug Product approved under an ANDA or 505(b)(2) Application for which the Original Drug Product is the reference listed drug, or (ii) 3 years after the day Defendant or a licensee of Defendant begins Marketing the Follow-on Drug Product in the United States. For clarity, if a Third Party began Marketing a Drug Product as described in (i) of this definition six months or more before Defendant begins Marketing a Follow-on Drug Product in the United States, then there is no applicable Status Quo Period, and the restrictions of Paragraph II.C do not apply.
Sample 1Sample 2
Status Quo Period means a period beginning the day Indivior begins Marketing a Follow-on Drug Product in the United States and ends on the earlier of (i) six (6) months after a Third Party begins Marketing a Drug Product approved under an ANDA or 505(b )(2)
Sample 1

Examples of Status Quo Period in a sentence

  • Indivior may recall and destroy products consistent with21 C.F.R. Part 7, Subpart C; may take reasonable steps to protect safety in the event of manufacturing defects; and may take any action that is requested by FDA;Provided further, for clarity, this Section II.C does not apply to Sublocade because any relevant Status Quo Period with respect to that Drug Product has ended.

  • The orders also require drivers who tell carriers they need a rest to receive at least 10 hours off before returning to service.Rail Union Extends Status Quo Period To Delay Potential StrikeOn November 9, the Brotherhood of Maintenance of Way Employees Division (BMWED) extended its negotiations with the railroads to delay a potential strike until December 4.

  • Table 2-3 Environmental Sensitive Spots of Status Quo Period Road Name Sensitive Object Note: 1.

Related to Status Quo Period

  • Start-up Period means up to 7 Academy Financial Years and covers the period up to and including the first Academy Financial Year in which all age groups are present at the Academy (that is, all the pupil cohorts relevant to the age range of the Academy will have some pupils present).

  • Peak Period means the time between 6 a.m. and 10 p.m. (April through September) or between 7 a.m. and 11 p.m. (October through March) on all days except Saturdays and Sundays, which daily time period will be subject to change from time to time at the Company's option. This change would occur after no less than ten (10) days notice has been given to all Customers who would be affected, and to the Commission.

  • Ramp Period The Ramp Period shall begin on the Effective Date and continue for a period of 3 months following the Effective Date. Commencing with the Effective Date and at all times during the Ramp Period thereafter, Customer will receive the rates, discounts, charges and credits set forth herein and will not be subject to the AVC. Annual Volume Commitment (“AVC”): $360,000 in Total Service Charges (“AVC”) during each contract year of the Term (following the expiration of the Ramp Period).

  • Overlap Period means any taxable year or other taxable period beginning on or before and ending after the Closing Date.

  • Ramp-Up Period means the period from and including the Effective Date to, but excluding, September 23, 2016.

  • Delivery Period Termination Date Has the meaning specified in the Related Pass Through Trust Supplement.

  • Offering Termination Date means the last day of each March, June, September and December following an Offering Commencement Date, or such other Offering Termination Date established in connection with a Terminating Event.

  • Minimum Hire Period means the Minimum Hire Period as described on the invoices, quotation, authority to hire, or any other forms as provided by the Supplier to the Client.

  • Free period means any Period other than the Prohibited Period.

  • Lock-up Period means the period beginning on the date hereof and continuing through the close of trading on the date that is 90 days after the date of the Prospectus (as defined in the Underwriting Agreement).

  • Three-Year Period means, with respect to a Restatement, the three completed fiscal years immediately preceding the date that the Board, a committee of the Board, or the officer or officers of the Company authorized to take such action if Board action is not required, concludes, or reasonably should have concluded, that the Company is required to prepare such Restatement, or, if earlier, the date on which a court, regulator or other legally authorized body directs the Company to prepare such Restatement. The “Three-Year Period” also includes any transition period (that results from a change in the Company’s fiscal year) within or immediately following the three completed fiscal years identified in the preceding sentence. However, a transition period between the last day of the Company’s previous fiscal year end and the first day of its new fiscal year that comprises a period of nine to 12 months shall be deemed a completed fiscal year.

  • Affiliation period means a period which, under the terms of the health insurance coverage offered

  • Extended Period As defined in Section 9.04(b).

  • Final Termination Date means the last date of the final year in which the Applicant is required to Maintain Viable Presence and as further identified in Section 2.3.E of this Agreement.

  • Off-Peak Period means the period during which the demand on an electric utility system is not at or near its maximum. For the purpose of this section, the off-peak period includes all hours that are not in the peak period.

  • Hire Period means the period commencing when the Customer holds the Hire Goods on hire (including Saturdays Sundays and Bank Holidays) and ending upon the happening of any of the following events:

  • Termination Period means the period of time beginning with a Change in Control and ending on the earlier to occur of:

  • Contract Transition Period means the 90 day transition as defined in Section F of this Contract.

  • Qualifying Period means 12 continuous Calendar Weeks during the whole or part of which the Agency Worker is supplied by one or more Temporary Work Agencies to the relevant Hirer to work temporarily for and under the supervision and direction of the relevant Hirer in the same role, and as further defined in the Schedule to these Terms;

  • extended reduction period means the period for which a person is in receipt of an extended reduction in accordance with paragraph 89, 96 or 101;

  • Initial Termination Date has the meaning set forth in Section 8.2(a).

  • Run-Out Period means a period after the close of a Plan Year or other period during which Participants in a flexible spending arrangement (FSA) may request reimbursement for expenses incurred during the Period of Coverage.

  • Service Termination Date means the last Day in a month upon which Service shall terminate, as set forth in a Schedule of Service and subject to any renewal thereof.

  • Service Period has the meaning given to it in Framework Schedule 4 (Template Order Form and Template Call Off Terms) as refined by a Contracting Body in a Call Off Agreement between that Contracting Body and the Supplier;

  • ROFO Period is defined in Section 6.1(a).

  • Outside Termination Date shall have the meaning set forth in Section 8.01(f).