PREA Commitment Study definition

PREA Commitment Study means that certain Selected Mandated Study commitment required to be performed by the FDA [****] including (a) the activities set forth in the PREA Commitment Study Clinical Protocol, (b) the Toxicology Study, and (c) subject to Section 7.2.9, any subsequent amendments and modifications to the scope of such PREA Commitment Study, or any additional Studies as determined by the JDC, on the one hand, and the FDA, on the other hand.”
Sample 1

Examples of PREA Commitment Study in a sentence

  • The institutions, financial holding companies and mixed financial holding companies that are required to comply with the requirements referred to in Section 1 of this Chapter on the basis of their consolidated situation shall carry out a full consolidation of all institutions and financial institutions that are their subsidiaries.

  • SRIPANWA may consider any factor SRIPANWA deems appropriate, including but not limited to SPM’s performance and other business operators’ performance in the same industry.

  • Notwithstanding the fact that Impax shall at any time perform the PREA Commitment Study, the PREA Commitment Study shall not for any purposes in this Agreement [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  • Nicholas Hawkins BCom, FCA – Executive Director and Chief Financial Officer, age 41Insurance industry experienceNicholas Hawkins was appointed as a director of IAG Finance (New Zealand) Limited on 31 August 2008 and as Chief Financial Officer of IAG in July 2008.

  • Except as provided herein, Impax shall be responsible for all costs and expenses in connection with (i) all Impax Studies and (ii) Impax’s performance of the PREA Commitment Study.

  • For clarity, any completion by Impax of the PREA Commitment Study prior to the date of application of the last PREA Royalty Reduction shall not in any way reduce the aggregate PREA Royalty Reduction set forth in the table above, or in way vary the dates of application thereof as set forth herein this Section 7.2.8.

  • Reasonable Efforts to complete and prepare the final clinical study report for the PREA Commitment Study within the timeframe set forth in the PREA Development Plan; provided, however, [****].

  • Solely for the purposes of the conduct of the PREA Commitment Study, the Parties shall establish a joint development committee (the “Joint Development Committee” or “JDC”) by the date that is thirty (30) days after the Effective Date.

  • The Nodal Officer shall report to NDR or to any other person assigned by the President, NAR.

  • In such case TENANT will obtain a construction permit and a franchise from the government authorized agencies.

Related to PREA Commitment Study

  • Facility A Commitment means, with respect to each Facility A Lender, the commitment, if any, of such Lender to make Facility A Revolving Loans and to acquire participations in Facility A Letters of Credit, Facility A Protective Advances and Facility A Swingline Loans, expressed as an amount representing the maximum possible aggregate amount of such Lender’s Facility A Revolving Exposure hereunder, as such commitment may be reduced or increased from time to time pursuant to (a) Section 2.09 and (b) assignments by or to such Lender pursuant to Section 9.04. The initial amount of each Lender’s Facility A Commitment is set forth on the Commitment Schedule, or in the Assignment and Assumption pursuant to which such Lender shall have assumed its Facility A Commitment, as applicable. The initial aggregate amount of the Lenders’ Facility A Commitments is $150,000,000.

  • Initial Term Loan Commitment means, in the case of each Lender that is a Lender on the Closing Date, the amount set forth opposite such Lender’s name on Schedule 1.1(b) as such Lender’s Initial Term Loan Commitment. The aggregate amount of the Initial Term Loan Commitments as of the Closing Date is $820,000,000.

  • Revolving Commitment Amount means $125,000,000, as reduced from time to time pursuant to Section 6.1.

  • 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.”

  • Revolving Loan Commitment Amount means, on any date, $30,000,000, as such amount may be reduced from time to time pursuant to Section 2.2.

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

  • Total Initial Term Loan Commitment means the sum of the Initial Term Loan Commitments of all Lenders.

  • Initial Commitment means, in relation to an Initial Senior Noteholder, the amount set out in the relevant Senior Noteholder Fee Letter.

  • 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.

  • Aggregate Revolving Commitment Amount means the aggregate principal amount of the Aggregate Revolving Commitments from time to time. On the Closing Date, the Aggregate Revolving Commitment Amount is $300,000,000.

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

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

  • Aggregate Revolving Commitment means the sum of the Revolving Commitments of all the Revolving Lenders.

  • Aggregate Revolving Loan Commitment means the aggregate of the Revolving Loan Commitments of all the Revolving Lenders, as may be reduced or increased from time to time pursuant to the terms hereof. The initial Aggregate Revolving Loan Commitment is Two Hundred Fifty Million and 00/100 Dollars ($250,000,000.00).

  • Total Revolving Loan Commitment means, at any time, the sum of the Revolving Loan Commitments of each of the Lenders at such time.

  • Total Loan Commitment means as to any Lender the aggregate commitments of such Lender with respect to its Revolving Loan Commitment and Term Loan Commitment.

  • Term Loan Commitment Amount means, with respect to each Lender, the sum of such Lender’s Term Loan Tranche 1 Commitment Amount and Term Loan Tranche 2 Commitment Amount.

  • Total Term Loan Commitment means the sum of the amounts of the Lenders’ Term Loan Commitments.

  • Term A Commitment means, as to each Term A Lender, its obligation to make Term A Loans to the Borrower pursuant to Section 2.01(a) in an aggregate principal amount at any one time outstanding not to exceed the amount set forth opposite such Term A Lender’s name on Schedule 2.01 under the caption “Term A Commitment” or opposite such caption in the Assignment and Assumption pursuant to which such Term A Lender becomes a party hereto, as applicable, as such amount may be adjusted from time to time in accordance with this Agreement.

  • Revolving Loan Commitment means the commitment of a Revolving Lender to make Revolving Loans to Company pursuant to subsection 2.1A(ii), and “Revolving Loan Commitments” means such commitments of all Revolving Lenders in the aggregate.

  • Total Revolving Commitment means, at any time, the sum of the Revolving Commitments at such time.

  • Revolving Commitment means, as to each Lender, its obligation to (a) make Revolving Loans to the Borrower pursuant to Section 2.01, (b) purchase participations in L/C Obligations and (c) purchase participations in Swing Line Loans, in an aggregate principal amount at any one time outstanding not to exceed the amount set forth opposite such Lender’s name on Schedule 2.01 or in the Assignment and Assumption pursuant to which such Lender becomes a party hereto, as applicable, as such amount may be adjusted from time to time in accordance with this Agreement.

  • Term Loan A Commitment means, with respect to each Lender, its Term Loan A Commitment, and, with respect to all Lenders, their Term Loan A Commitments, in each case as such Dollar amounts are set forth beside such Lender's name under the applicable heading on Schedule C-1 or on the signature page of the Assignment and Acceptance pursuant to which such Lender became a Lender hereunder in accordance with the provisions of Section 14.1.

  • Tranche C Term Loan Commitment means the commitment of a Lender to make a Tranche C Term Loan to Company pursuant to subsection 2.1A(iii), and "Tranche C Term Loan Commitments" means such commitments of all Lenders in the aggregate.

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

  • Initial Term Commitment means, as to each Term Lender, its obligation to make an Initial Term Loan to the Borrower pursuant to Section 2.01(a) in an aggregate principal amount not to exceed the amount set forth opposite such Term Lender’s name in Schedule 1.01A under the caption “Initial Term Commitment.” The initial aggregate principal amount of the Initial Term Commitments as of the Closing Date was $2,670,000,000.