Regulatory Commitment Activities definition

Regulatory Commitment Activities means any study or trial of Product that is required by the applicable Regulatory Agency in the Territory to be conducted after MAA Approval, or [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. that Alvogen (or its designee) agrees at the written request of the applicable Regulatory Agency in the Territory will be conducted following such approval.
Regulatory Commitment Activities means any study of Product required by a Regulatory Agency to be conducted as a condition of Regulatory Approval by such Regulatory Agency.
Regulatory Commitment Activities means any study, trial or monitoring activity of Product or its components that is required by the FDA to be conducted after NDA Approval, or that the sponsor of the NDA agrees at the written request of FDA will be conducted following such approval, including pediatric studies if applicable.

Related to Regulatory Commitment Activities

  • Designated Revolving Commitments means the amount or amounts of any commitments to make loans or extend credit on a revolving basis to the Company or any of its Restricted Subsidiaries by any Person other than the Company or any of its Restricted Subsidiaries that has or have been designated (but only to the extent so designated) in an Officers’ Certificate delivered to the Trustee as “Designated Revolving Commitments” until such time as the Company subsequently delivers an Officers’ Certificate to the Trustee to the effect that the amount or amounts of such commitments shall no longer constitute “Designated Revolving Commitments.”

  • Replacement Revolving Commitments shall have the meaning assigned to such term in Section 2.22.

  • Other Revolving Commitments means one or more Classes of revolving credit commitments hereunder or extended Revolving Commitments that result from a Refinancing Amendment or a Loan Modification Agreement.

  • U.S. Revolving Commitment means the commitment of a Lender to make or otherwise fund any U.S. Revolving Loan and to acquire participations in U.S. Letters of Credit and Swing Line Loans hereunder and “U.S. Revolving Commitments” means such commitments of all Lenders in the aggregate. The amount of each Lender’s U.S. Revolving Commitment, if any, is set forth on Schedule 1.01(c) or in the applicable Assignment Agreement or Joinder Agreement, as applicable, subject to any adjustment or reduction pursuant to the terms and conditions hereof. The aggregate amount of the U.S. Revolving Commitments as of the Closing Date is $265,000,000.

  • Additional Commitments means any commitments hereunder added pursuant to Section 2.22, 2.23 or 9.02(c).

  • Extended Revolving Commitments has the meaning specified in Section 2.16(2).

  • New Revolving Commitments has the meaning assigned to such term in Section 2.04.

  • Extended Revolving Commitment shall have the meaning assigned to such term in Section 2.19(a).

  • Available Revolving Commitment as to any Revolving Lender at any time, an amount equal to the excess, if any, of (a) such Lender’s Revolving Commitment then in effect over (b) such Lender’s Revolving Extensions of Credit then outstanding; provided, that in calculating any Lender’s Revolving Extensions of Credit for the purpose of determining such Lender’s Available Revolving Commitment pursuant to Section 2.8(a), the aggregate principal amount of Swingline Loans then outstanding shall be deemed to be zero.

  • Incremental Revolving Commitment has the meaning assigned to such term in Section 2.14(a).

  • Incremental Revolving Commitments has the meaning specified in Section 2.14(a).

  • Existing Revolving Commitments has the meaning specified in Section 2.17(b).

  • Ancillary Commitment means, in relation to an Ancillary Lender and an Ancillary Facility, the maximum Base Currency Amount which that Ancillary Lender has agreed (whether or not subject to satisfaction of conditions precedent) to make available from time to time under an Ancillary Facility and which has been authorised as such under Clause 7 (Ancillary Facilities), to the extent that amount is not cancelled or reduced under this Agreement or the Ancillary Documents relating to that Ancillary Facility.

  • Total Revolving Commitments at any time, the aggregate amount of the Revolving Commitments then in effect.

  • Total Revolving Commitment means the sum of the Revolving Commitments of the Revolving Lenders as the same may be decreased pursuant to Section 2.12(c) or increased pursuant to Section 2.19. As of the Closing Date, the amount of the Total Revolving Commitment is $100,000,000.

  • Revolving Commitment Period the period from and including the Closing Date to the Revolving Termination Date.

  • Aggregate Revolving Commitment means the aggregate of the Revolving Commitments of all of the Revolving Lenders, as reduced or increased from time to time pursuant to the terms and conditions hereof. As of the Effective Date, the Aggregate Revolving Commitment is $1,000,000,000.

  • Aggregate Revolving Commitments means the Revolving Commitments of all the Lenders. The amount of the Aggregate Revolving Commitments in effect on the Closing Date is SIX HUNDRED MILLION DOLLARS ($600,000,000).

  • Additional Commitment means any commitment hereunder added pursuant to Sections 2.22, 2.23 or 9.02(c).

  • Total Utilization of Revolving Commitments means, as at any date of determination, the sum of (i) the aggregate principal amount of all outstanding Revolving Loans (other than Revolving Loans made for the purpose of repaying any Refunded Swing Line Loans or reimbursing Issuing Bank for any amount drawn under any Letter of Credit, but not yet so applied), (ii) the aggregate principal amount of all outstanding Swing Line Loans, and (iii) the Letter of Credit Usage.

  • Revolving Commitment Increase has the meaning set forth in Section 2.14(a).

  • Total Utilization of Revolving Loan Commitments means, as at any date of determination, the sum of (i) the aggregate principal amount of all outstanding Revolving Loans (other than Revolving Loans made for the purpose of repaying any Refunded Swing Line Loans or reimbursing the applicable Issuing Lender for any amount drawn under any Letter of Credit but not yet so applied) plus (ii) the aggregate principal amount of all outstanding Swing Line Loans plus (iii) the Letter of Credit Usage.

  • Group Commitment means with respect to any Purchaser Group the aggregate of the Commitments of each Purchaser within such Purchaser Group.

  • Revolving Committed Amount shall have the meaning set forth in Section 2.1(a).

  • Initial Term Loan Commitment means the commitment of a Lender to make or otherwise fund an Initial Term Loan and “Initial Term Loan Commitments” means such commitments of all of the Lenders in the aggregate. The amount of each Lender’s Initial Term Loan Commitment, if any, is set forth on Appendix A-1 or in the applicable Assignment Agreement, subject to any adjustment or reduction pursuant to the terms and conditions hereof. The aggregate amount of the Initial Term Loan Commitments as of the Closing Date is $200,000,000.

  • Existing Commitment shall have the meaning provided in Section 2.17.