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. (ii) AcelRx shall use Commercially Reasonable Efforts to conduct development activities for all Post Approval Commitments in the U.S., including such Post Approval Commitments required by the FDA and any Regulatory Authorities in the Territory that overlap in whole or in parts. AcelRx shall bear all costs for Post Approval Commitments required by the FDA [ * ]. In the event that AcelRx is required to expand its development activities for Post Approval Commitments beyond FDA requirements and in order to meet additional requirements by Regulatory Authorities in the Territory, then Grünenthal shall bear any incremental costs beyond those costs for such FDA-required Post Approval Commitments, provided that the development activities applicable to the Territory and allocation of related costs shall be discussed and agreed by the JSC prior to their initiation.
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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.
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 Shared 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.
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.
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) 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 to clause (b). Licensee shall provide POZEN with quarterly updates on the status of such out-of-pocket expenses until such time as an aggregate amount of US$[* * *] of such expenses are incurred in connec...
Post-Approval Commitments 

Related to Post-Approval Commitments

  • Additional Commitments The Parties may negotiate commitments with respect to measures affecting trade in services not subject to scheduling under Article 106 (National Treatment) or Article 107 (Market Access), including those regarding qualifications, standards or licensing matters. Such commitments shall be inscribed in a Party's Schedule.

  • Incremental Commitments (a) The Company may from time to time notify the Administrative Agent that certain of the Lenders designated by the Company and/or that additional lenders shall be added to this Agreement as Incremental Lenders with Commitments for the purpose of increasing the existing Commitments under the Facility (a “Commitment Increase”) by executing and delivering to the Administrative Agent an Incremental Loan Activation Notice signed by such Lenders or such additional lenders and specifying (i) the respective Incremental Commitments of such Incremental Lenders and (ii) the applicable Commitment Increase Date; provided, that after giving effect to such Commitment Increase (including the incurrence of any Incremental Loans on the applicable Commitment Increase Date and use of proceeds thereof) (x) no Default or Event of Default shall be continuing and (y) the sum of the Total Commitments then in effect (including, for the avoidance of doubt, Incremental Commitments) shall not exceed $2 billion. (b) Each Incremental Lender that is a signatory to an Incremental Loan Activation Notice severally agrees, on the terms and conditions of this Agreement, to make revolving credit loans (each, an “Incremental Loan”) to the Company and/or the applicable Subsidiary Borrowers from time to time on or after the Commitment Increase Date specified in such Incremental Loan Activation Notice in an aggregate principal amount outstanding at any time up to but not exceeding the amount of the Incremental Commitment of such Incremental Lender specified in such Incremental Loan Activation Notice, subject to the terms of this Agreement and the applicable Incremental Loan Activation Notice. Nothing in this Section 2.27 shall be construed to obligate any Lender to execute an Incremental Loan Activation Notice. (c) On any Commitment Increase Date, in the event any Loans under the Facility are then outstanding, (i) each relevant Incremental Lender shall make available to the Administrative Agent such amounts in immediately available funds as the Administrative Agent shall determine are necessary in order to cause, after giving effect to such increased Commitments and the application of such amounts to prepay Loans under the Facility of other relevant Lenders, the Loans under the Facility to be held ratably by all Lenders with Commitments in the Facility in accordance with such Commitments after giving effect to such increase, (ii) the Company and any relevant Subsidiary Borrower shall be deemed to have prepaid and reborrowed all outstanding Loans under this Agreement and (iii) the Company and any relevant Subsidiary Borrower shall pay to the relevant Lenders the amounts, if any, payable under Section 2.22 as a result of such prepayment.

  • Additional Commitment Lenders The Borrower shall have the right to replace each Non-Extending Lender with, and add as “Lenders” under this Agreement in place thereof, one or more Eligible Assignees (each, an “Additional Commitment Lender”) as provided in Section 10.13; provided that each of such Additional Commitment Lenders shall enter into an Assignment and Assumption pursuant to which such Additional Commitment Lender shall, effective as of the Existing Maturity Date, undertake 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).

  • 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 (i) Subject to the terms and conditions hereof, each Lender with an Initial Tranche A Term Loan Commitment severally agrees to make, on the Closing Date, one or more term loans (each, an “Initial Tranche A Term Loan”) to the Borrower in Dollars in an amount equal to such Lender’s Initial Tranche A Term Loan Commitment. The Borrower may make only one borrowing under the Initial Tranche A Term Loan Commitment which shall be on the Closing Date. Any amount borrowed under this Section 2.1(a)(i) and subsequently repaid or prepaid may not be reborrowed. Subject to Sections 2.11(a) and 2.12, all amounts owed hereunder with respect to the Initial Tranche A Term Loans shall be paid in full no later than the Maturity Date applicable to such Initial Tranche A Term Loans. Each Lender’s Initial Tranche A Term Loan Commitment shall terminate immediately and without further action on the Closing Date after giving effect to the funding of such Lender’s Initial Tranche A Term Loan Commitment on such date. (ii) Subject to the terms and conditions hereof, each Lender with an Initial Tranche B Term Loan Commitment severally agrees to make, on the Closing Date one or more term loans (each, an “Initial Tranche B Term Loan”) to the Borrower in Dollars in an amount equal to such Lender’s Initial Tranche B Term Loan Commitment. The Borrower may make only one borrowing under the Initial Tranche B Term Loan Commitment which shall be on the Closing Date. Any amount borrowed under this Section 2.1(a)(ii) and subsequently repaid or prepaid may not be reborrowed. Subject to Sections 2.11(a) and 2.12, all amounts owed hereunder with respect to the Initial Tranche B Term Loans shall be paid in full no later than the Maturity Date applicable to such Initial Tranche B Term Loans. Each Lender’s Initial Tranche B Term Loan Commitment shall terminate immediately and without further action on the Closing Date after giving effect to the funding of such Lender’s Initial Tranche B Term Loan Commitment on such date.

  • Termination and Reduction of Revolving Commitments (a) Unless previously terminated, the Revolving Commitments shall terminate on the Maturity Date. (b) The Borrower may at any time terminate, or from time to time reduce, the Revolving Commitments; provided that (i) each partial reduction of the Revolving Commitments shall be in an amount that is an integral multiple of $1,000,000 and not less than $5,000,000 and (ii) the Borrower shall not terminate or reduce the Revolving Commitments if, after giving effect to any concurrent prepayment of the Loans in accordance with Section 2.08, the sum of the Aggregate Total Exposure would exceed the total Commitments. (c) The Borrower shall notify the Administrative Agent of any election to terminate or reduce the Revolving Commitments under paragraph (b) of this Section at least three Business Days prior to the effective date of such termination or reduction, specifying such election and the effective date thereof. Promptly following receipt of any notice, the Administrative Agent shall advise the Lenders of the contents thereof. Each notice delivered by the Borrower pursuant to this Section shall be irrevocable; provided that a notice of termination of the Revolving Commitments delivered by the Borrower may state that such notice is conditioned upon the effectiveness of other credit facilities or another transaction, in which case such notice may be revoked by the Borrower (by notice to the Administrative Agent on or prior to the specified effective date) if such condition is not satisfied. Any termination or reduction of the Revolving Commitments shall be permanent. Each reduction of the Revolving Commitments shall be applied to the Lenders in accordance with their respective Applicable Percentages. (d) If, after giving effect to any reduction of the Revolving Commitments, the Letter of Credit Sublimit exceeds the amount of the Revolving Commitments, such Letter of Credit Sublimit shall be automatically reduced by the amount of such excess.

  • Revolving Commitments (a) Subject to the terms and conditions hereof, each Lender severally agrees to make revolving credit loans (“Revolving Loans”) to the Borrower from time to time on any Business Day during the Commitment Period, at such times as the Borrower may request in accordance with Section 2.2, in an aggregate principal amount at any one time outstanding which, when added to such Lender’s Applicable Percentage of the aggregate principal amount of Swingline Loans then outstanding, does not exceed the amount of such Lender’s Commitment; provided, however, that (i) no Revolving Loan shall be made to the extent the aggregate unpaid principal amount of all Loans would exceed the Total Commitments, (ii) no Borrowing Base A Loans shall be made to the extent that the aggregate unpaid principal amount of all Borrowing Base A Loans would exceed the aggregate Loan Value of the Pledged Eligible Assets (including the Pledged Eligible Assets referred to in Section 2.2(a)(ii) with respect to such Revolving Loan) and (iii) no Borrowing Base B Loans shall be made to the extent that the aggregate amount of all Borrowing Base B Loans would exceed the Borrowing Base B Limit; provided further that Borrowing Base B Loans may not be borrowed on any date in any rolling period of 90 consecutive days if Borrowing Base B Loans have already been outstanding for 30 days during such period. During the Commitment Period, the Borrower may borrow, prepay the Revolving Loans in whole or in part, and reborrow, all in accordance with the terms and conditions hereof. (b) The Borrower shall repay all outstanding Revolving Loans on the Termination Date. (c) The failure of any Lender to make any Revolving Loan required to be made by it shall not relieve any other Lender of its obligations hereunder; provided that the Commitments of the Lenders are several and no Lender shall be responsible for any other Lender’s failure to make Revolving Loans as required.

  • Capital Commitments (a) The Partnership may from time to time, in the discretion of the Managing General Partner, issue additional Partnership Units and admit additional Limited Partners to the Partnership. Any Person that acquires Partnership Units for cash (an “Investor”) will acquire such Units pursuant to an agreement (a “Subscription Agreement”) between such Investor and the Partnership pursuant to which such Investor agrees to acquire, and the Partnership agrees to issue, Partnership Units in exchange for Capital Contributions in cash on such terms and conditions as are provided in this Agreement and as may be provided in such Subscription Agreement. A Subscription Agreement shall become effective as of the date it has been executed and delivered by the Investor party thereto and accepted by the Managing General Partner on behalf of the Partnership. Units issuable pursuant to a Subscription Agreement may be issuable in installments, with each installment being issuable, and the Capital Contribution therefor being payable, in accordance with calls for capital (“Capital Calls”) issued pursuant to written notice (the “Capital Call Notice”) to the Investor party to such Subscription Agreement. The total purchase price payable by any Investor under a Subscription Agreement for the Units issuable pursuant thereto is referred to as such Investor’s “Capital Commitment”. Each Investor which acquires any Units pursuant to a Subscription Agreement shall be deemed to be admitted to the Partnership as a Partner immediately upon the payment of the purchase price for the first Units so issued to such Investor. The aggregate amount of Capital Contributions made by a Partner (in cash or property) is referred to herein as such Partner’s “Funded Commitment”, and the portion of the Capital Commitment provided for in any Subscription Agreement that remains unpaid after any closing of a purchase and issuance of Units thereto shall be referred to as the “Unfunded Commitment” of the Partner party to such Subscription Agreement. Except as provided in Section 11.4(c), in no event will any Partner be required to contribute any capital to the Partnership in excess of such Partner’s Capital Commitment. (b) If at any time the Managing General Partner determines to raise capital by issuing Capital Calls to Partners having Unfunded Commitments, it shall generally issue such Capital Calls pro rata to each such Partner in proportion to the Unfunded Commitment of each such Partner. However, the Managing General Partner may, in its discretion, issue Capital Calls other than pro rata to the extent required by the terms of any Subscription Agreement or other agreement between the Partnership or the Managing General Partner and one or more Partners, or if the Managing General Partner otherwise deems it advisable to issue Capital Calls in some manner other than pro rata (for example, to assist in achieving or maintaining the status of any REIT in which the Partnership has a direct or indirect interest as a “domestically controlled” REIT). Each Capital Call Notice issued by the Managing General Partner shall specify the account to which Capital Contributions are to be delivered pursuant thereto and the date on which such Capital Contributions are due (“Payment Date”), which date shall be no sooner than ten Business Days after the date such Capital Call Notice is issued. All Capital Contributions made on or before the Payment Date specified in a Capital Call Notice shall be deemed to have been made on such Payment Date.

  • Financing Commitments Parent has delivered to the Company a true and complete copy as of the date hereof of the executed financing commitment letter, dated September 9, 2015, by and among Parent and Xxxxxx Xxxxxxx Senior Funding, Inc. and the other financial institutions party thereto from time to time, including all exhibits, schedules, annexes and amendments to such letter in effect on the date hereof (the “Commitment Letter”) and a true and correct copy of any related fee letter (collectively, the “Ancillary Letters”) (provided that percentages and amount of (i) the fees, (ii) the economic provisions of the market flex, (iii) the fee-related provisions of the alternate transaction provisions and (iv) the successful syndication definition in the Ancillary Letters may be redacted). The Commitment Letter is in full force and effect as of the date of this Agreement, and the commitments contained in the Commitment Letter have not been withdrawn, modified, rescinded or terminated or otherwise amended, supplemented or modified in any respect prior to the date of this Agreement. The Commitment Letter, in the form so delivered, is a legal, valid and binding obligation of Parent and, to the knowledge of Parent, the other parties thereto (subject to applicable bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other laws affecting creditors’ rights generally and general principles of equity whether considered in a proceeding in equity or at law). Assuming the Financing is received as contemplated by the Commitment Letter, the aggregate amount of net proceeds from the Financing, together with cash, cash equivalents and current financial assets of Parent and its Subsidiaries on hand, will be, as of the Closing Date, sufficient to satisfy all of the Parent’s obligations under this Agreement, including the payment of any Subject Indebtedness required to be repaid, redeemed, retired, cancelled, terminated or otherwise satisfied or discharged in connection with the Offer or the Merger and all other costs and expenses required to be paid or satisfied by Parent in connection with the transactions contemplated by this Agreement. There are no side letters or other agreements, contracts or arrangements relating to the Financing contemplated by the Commitment Letter other than the Ancillary Letters and customary engagement letters, which engagement letters do not contain any condition to the availability or timing of the Financing contemplated by the Commitment Letter. As of the date of this Agreement, (A) no event has occurred that, with or without notice, lapse of time or both, would constitute a default or breach by the Parent and (B) subject to the satisfaction of the conditions contained in Section 5.1 and Annex A hereof, Parent does not have any reason to believe that the Financing contemplated by the Commitment Letter will not be available to Parent or Merger Sub at the Closing. Parent has fully paid all commitment fees or other fees, if any, required by the Commitment Letter to be paid prior to the date of this Agreement. There are no conditions precedent or other contingencies related to the funding of the full amount of the Financing, other than as expressly set forth in the Commitment Letter.

  • Fees Commitments 36 4.1. Fees 36 4.2. Voluntary Reduction of Term Loan Commitments 37 4.3. Mandatory Termination of Commitments 37 6.4. Opinions of Counsel 41 6.5. Promissory Notes 41 6.6. Fees 42 6.7. Collateral 42 6.8. Perfection Certificate 42 6.9. Intercompany Subordination Agreement 42 6.10. Petition Date 42 6.11. Final DIP Order 42 6.12. First Day Orders 42 6.13. Trustee 42 6.14. Material Adverse Effect 42 6.15. Patriot Act 43 6.16. Liens 43

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