Post-Approval Commitments Sample Clauses

Post-Approval Commitments. (i) Grünenthal shall use Commercially Reasonable Efforts to conduct (at its cost) development activities for Territory-specific Post Approval Commitments for the Licensed Product in the Field that are not also required by the FDA in the U.S. for the Licensed Product in the Field. Grünenthal shall not be required to obtain AcelRx’s consent to conduct such development activities but shall provide, through the JSC, reasonable detail regarding these Post Approval Commitments. [ * ] = 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.
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Post-Approval Commitments. Jazz shall be solely responsible for conducting, at its sole expense, any post-approval commitment or requirement studies or Clinical Trials (collectively, “Post-Approval Commitments”) that are requested or required by any Regulatory Authority in the Territory with respect to any Regulatory Approval of a Licensed Product based on the Zymeworks Ongoing Studies. Zymeworks shall (i) upon Jazz’s request and expense, reasonably cooperate with Jazz to prepare a Clinical Trial design, protocol and schedule that satisfies the applicable Regulatory Authority’s requests or requirements with respect to the Post-Approval Commitments and (ii) supply Licensed Antibody and Licensed Product to Jazz for use in such Post-Approval Commitments, in accordance with Article 7.
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Post-Approval Commitments. Cell Genesys agrees to provide Takeda technical assistance in the form of personnel to support the conduct of studies in regards to the manufacturing, nonclinical or clinical area that may be required to meet post-approval commitments in the ROW Territory. Takeda shall bear the cost incurred by either Party in connection with the performance and conduct of post-approval commitments, including any Internal FTE Costs, Out-of-Pocket Cost and Clinical Supply Costs for such studies.
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Post-Approval Commitments. In the event that the FDA shall require any Post-Approval Commitment in connection with the Initial Approval of the Existing Licensed Product, the Parties shall mutually agree which Party shall conduct such Post-Approval Commitment. In the event that Licensor is conducting any Post-Approval Commitment, the JCC shall establish a budget with respect to such Post-Approval Commitment (each such budget, a "POST-APPROVAL BUDGET"). Each Post-Approval Budget shall include line item estimates of expenses with respect to such Post-Approval Commitments broken down on a Calendar Year basis, which costs and expenses shall include only external, out-of-pocket costs and expenses (such costs and expenses collectively, the "POST-APPROVAL COSTS"). Licensee shall bear [REDACTED] [Exclusion of confidential information relating to cost-sharing] of the actual Post-Approval Costs incurred by Licensor, to the extent that such expenses do not exceed in the aggregate [REDACTED] [Exclusion of confidential information relating to cost-sharing] of the applicable Post-Approval Budget. All Post-Approval Commitments shall be conducted under the oversight of the JCC.
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Post-Approval Commitments. Following NDA Approval, in the event that the FDA requires any Post-Approval Commitments, Licensee shall, subject to the provisions of this Section 2.2, use Commercially Reasonable Efforts to conduct such Post-Approval Commitments. Licensee and POZEN shall [* * *] any out-of-pocket expenses incurred in connection with such Post-Approval Commitments up to an aggregate amount of US$[* * *]. POZEN’s share of the expenses incurred in connection with such Post-Approval Commitments, which, for the avoidance of doubt, shall not in any case [* * *], shall be [* * *]; provided, that [* * *]; provided, further, [* * *]. If Licensee reasonably determines that the expenses of such Post-Approval Commitments will [* * *] then Licensee shall, within sixty (60) days of NDA Approval of the Initial Products either (a) THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. terminate this Agreement pursuant to Section 13.7 hereof or (b) agree to pay when due all such expenses that are [* * *] in respect of such Post-Approval Commitment. Notwithstanding the foregoing, if Licensee cannot reasonably determine whether the costs of such Post-Approval Commitments will [* * *] at the time of receipt of the NDA Approval for the Initial Products, then Licensee will request a meeting with the FDA within thirty (30) days after NDA Approval of the Initial Products to finalize the scope, timing and extent of the Post-Approval Commitments (the “Post-Approval Meeting”), and Licensee’s right to terminate this Agreement under this Section 2.2 shall be extended until the earlier of (x) ten (10) days following the Post Approval Meeting, or (y) one hundred twenty (120) days following Licensee’s request to the FDA for the Post-Approval Meeting; provided if Licensee does not request a Post-Approval Meeting with the FDA within thirty (30) days of the NDA Approval for the Initial Products, then Licensee’s right to terminate this Agreement shall expire sixty (60) days following NDA Approval for the Initial Products. If Licensee does not make an election within sixty (60) days of the NDA Approval of the Initial Products, or if applicable, pursuant to the preceding sentence following the Post-Approval Meeting, Licensee shall be deemed to have elected to pay all such expenses [* * *] in expenses incurred in respect of such Post-Approval Commitment pursuant t...
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Post-Approval Commitments 
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Related to Post-Approval Commitments

  • Additional Commitments If applicable, the Participant agrees, prior to the vesting of the Restricted Stock Units granted pursuant to this Award Agreement that he or she shall deliver to the Secretary of the Company or the Secretary’s office, or such other place as may be determined by the Committee, payment in cash (via cashier’s check or such other form acceptable to the Company), or such other method as the Committee may approve, for the Withholding Obligation, if the Participant desires to pay the Withholding Obligation in lieu of the Company exercising its entitlement in the first sentence of Section 6 hereof.

  • Incremental Commitments (a) The Borrower may, by written notice to the Administrative Agent from time to time, request Incremental Term Loan Commitments and/or Incremental Revolving Facility Commitments, as applicable, in an amount not to exceed the Incremental Amount available at the time such Incremental Commitments are established (or at the time any commitment relating thereto is entered into or, at the option of the Borrower, at the time of incurrence of the Incremental Loans thereunder) from one or more Incremental Term Lenders and/or Incremental Revolving Facility Lenders (which may include any existing Lender) willing to provide such Incremental Term Loans and/or Incremental Revolving Facility Commitments, as the case may be, in their own discretion; provided, that each Incremental Revolving Facility Lender providing a commitment to make revolving loans shall be subject to the approval of the Administrative Agent and, to the extent the same would be required for an assignment under Section 9.04, the Issuing Banks and the Swingline Lender (which approvals shall not be unreasonably withheld) unless such Incremental Revolving Facility Lender is a Revolving Facility Lender. Such notice shall set forth (i) the amount of the Incremental Term Loan Commitments and/or Incremental Revolving Facility Commitments being requested (which shall be in minimum increments of $5,000,000 and a minimum amount of $10,000,000, or equal to the remaining Incremental Amount or, in each case, such lesser amount approved by the Administrative Agent), (ii) the date on which such Incremental Term Loan Commitments and/or Incremental Revolving Facility Commitments are requested to become effective, (iii) in the case of Incremental Revolving Facility Commitments, whether such Incremental Revolving Facility Commitments are to be (x) commitments to make additional Revolving Facility Loans on the same terms as the Initial Revolving Loans or (y) commitments to make revolving loans with pricing terms, final maturity dates, participation in mandatory prepayments or commitment reductions and/or other terms different from the Initial Revolving Loans (“Other Revolving Loans”) and (iv) in the case of Incremental Term Loan Commitments, whether such Incremental Term Loan Commitments are to be (x) commitments to make term loans with terms identical to Term B Loans or (y) commitments to make term loans with pricing, maturity, amortization, participation in mandatory prepayments and/or other terms different from the Term B Loans (“Other Term Loans”).

  • Additional Commitment Lenders The Company shall have the right, but shall not be obligated, on or before the applicable Maturity Date for any Non-Extending Lender to replace such Non-Extending Lender with, and add as “Lenders” under this Agreement in place thereof, one or more financial institutions that are not Ineligible Institutions (each, an “Additional Commitment Lender”) approved by the Administrative Agent in accordance with the procedures provided in Section 2.19(b), each of which Additional Commitment Lenders shall have entered into an Assignment and Assumption (in accordance with and subject to the restrictions contained in Section 9.04, with the Company or replacement Lender obligated to pay any applicable processing or recordation fee) with such Non-Extending Lender, pursuant to which such Additional Commitment Lenders shall, effective on or before the applicable Maturity Date for such Non-Extending Lender, assume a Commitment (and, if any such Additional Commitment Lender is already a Lender, its Commitment shall be in addition to such Lender’s Commitment hereunder on such date). Prior to any Non-Extending Lender being replaced by one or more Additional Commitment Lenders pursuant hereto, such Non-Extending Lender may elect, in its sole discretion, by giving irrevocable notice thereof to the Administrative Agent and the Company (which notice shall set forth such Lender’s new Maturity Date), to become an Extending Lender. The Administrative Agent may effect such amendments to this Agreement as are reasonably necessary to provide for any such extensions with the consent of the Company but without the consent of any other Lenders.

  • Term Commitments Subject to the terms and conditions hereof, each Term Lender severally agrees to make a term loan (a “Term Loan”) to the Borrower on the Closing Date in an amount not to exceed the amount of the Term Commitment of such Lender. The Term Loans may from time to time be Eurodollar Loans or ABR Loans, as determined by the Borrower and notified to the Administrative Agent in accordance with Sections 2.2 and 2.12.

  • Loan Commitments Subject to the terms and conditions hereof,

  • Termination and Reduction of Revolving Commitments (a) Unless previously terminated, the Revolving Commitments shall terminate on the Maturity Date.

  • Revolving Commitments If for any reason the Total Revolving Outstandings at any time exceed the Aggregate Revolving Commitments then in effect, the Borrower shall immediately prepay Revolving Loans and/or Swing Line Loans and/or Cash Collateralize the L/C Obligations in an aggregate amount equal to such excess; provided, however, that the Borrower shall not be required to Cash Collateralize the L/C Obligations pursuant to this Section 2.05(b)(i) unless after the prepayment in full of the Revolving Loans and Swing Line Loans the Total Revolving Outstandings exceed the Aggregate Revolving Commitments then in effect.

  • Incremental Revolving Commitments (a) The Borrower may on one or more occasions, by written notice to the Administrative Agent, request during the Revolving Commitment Period the establishment of Incremental Revolving Commitments, provided that the aggregate amount of all the Incremental Revolving Commitments to be established hereunder on any date shall not exceed the Incremental Amount as of such date. Each such notice shall specify (i) the date on which the Borrower proposes that the Incremental Revolving Commitments shall be effective, which shall be a date not less than 10 Business Days (or such shorter period as may be agreed to by the Administrative Agent) after the date on which such notice is delivered to the Administrative Agent, (ii) the amount of the Incremental Revolving Commitments being requested (which shall be an amount not less than $5,000,000) and (iii) the identity of each Person proposed to become an Incremental Revolving Lender in connection therewith (it being agreed that (x) any Lender approached to provide any Incremental Revolving Commitment may elect or decline, in its sole discretion, to provide such Incremental Revolving Commitment and (y) any Person that the Borrower proposes to become an Incremental Revolving Lender, if such Person is not then a Lender, must be an Eligible Assignee and, if such approval would then be required under Section 10.6(c) for an assignment to such Person of a Commitment or Loan, must be approved by the Administrative Agent, each Issuing Bank and the Swing Line Lender (such approval not to be unreasonably withheld or delayed)).

  • Capital Commitments No Credit Party shall relieve, excuse, delay, postpone, compromise or xxxxx any Investor from the making of any Capital Contribution pursuant to a Capital Call by the applicable Credit Party, provided that the Credit Parties may excuse any Investor from funding a Capital Call with respect to which an Investor Exclusion Event applies.

  • Financing Commitments Pinnacle has obtained written commitments (the "Financing Commitments") for the financing necessary to consummate the Merger and the other transactions contemplated hereby (including any refinancing of indebtedness of Aztar or Pinnacle or any of their respective subsidiaries which Pinnacle deems it advisable to refinance in connection with the consummation of the Merger and the other transactions contemplated hereby) and to pay all associated fees, costs and expenses (the "Financing"). Pinnacle has provided true, accurate and complete copies of such commitments to Aztar. None of the Financing Commitments has been amended, modified or terminated prior to the date of this Agreement, and the respective commitments contained in the Financing Commitments have not been withdrawn or rescinded in any respect. As of the date hereof, the Financing Commitments are in full force and effect and (based on and assuming the accuracy of the representations and warranties of Aztar in this Agreement and the compliance by Aztar with its obligations hereunder) no event has occurred which, with or without notice, lapse of time (other than the expiration of the term thereof) or both, would constitute a default on the part of Pinnacle under any of the Financing Commitments. There are no conditions precedent or other contingencies related to the funding of the full amount of the Financing, other than as set forth in or contemplated by the Financing Commitments. The aggregate proceeds to be disbursed pursuant to the agreements contemplated by the Financing Commitments, together with Pinnacle's and Aztar's cash and cash equivalents, will be sufficient for Pinnacle to pay the aggregate Merger Consideration and to consummate the Consent/Tender Offers, if any (and any other repayment or refinancing of debt contemplated in this Agreement or the Financing Commitments), and to pay all related fees and expenses. Based on and assuming the accuracy of the representations and warranties of Aztar in this Agreement and the compliance by Aztar with its obligations hereunder, Pinnacle has no reason as of the date hereof to believe that any of the conditions to the Financing contemplated by the Financing Commitments will not be satisfied or that the Financing will not be made available to Pinnacle on or prior the Closing Date. Nothing in this Agreement shall prevent Pinnacle from amending or modifying the Financing Commitments or from seeking to raise equity or other alternative sources of funds prior to the Closing, as long as such amendment or modification or other action does not prevent, delay or reduce the likelihood of the consummation of the Merger.

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