Post-Marketing Commitments Clause Samples

Post-Marketing Commitments. If the FDA or other Competent Authority requires a Post Marketing Commitment for the Product, then Strata shall use Commercially Reasonable Efforts to implement such Post Marketing Commitment at Strata’s expense.
View SourceView Similar (3)
Post-Marketing Commitments. Each Party shall perform all activities necessary to satisfy any post-marketing requirements imposed by a Regulatory Authority with respect to a Single Agent Product in such Party’s Field, in accordance with the timelines established by such Regulatory Authority.
View Source
Post-Marketing Commitments. The Parties acknowledge that Fresenius’ rights and responsibilities hereunder in respect of Commercialization of the Distribution Product in the Field in the Territory, including under Section 9.1.1 and Section 9.1.2.1, include such rights and responsibilities in respect of the design and conduct of (a) Post-Marketing Commitments in respect of the Distribution Product in the Field and (b) other post-approval Clinical Studies in respect of the Distribution Product in the Field not required to obtain, support, or maintain Regulatory Approval (other than Pricing Approval) for the Distribution Product, and agree that the design and conduct of any corresponding Clinical Study will be determined [***] if such Clinical Study is in the Field. However, Fresenius will not conduct any such Clinical Study outside of the Field without obtaining Humacyte’s prior written consent.
View Source
Post-Marketing Commitments. If the FDA or other Competent Authority requires any post-approval commitments for the Licensed Product, then the Company shall use commercially reasonable efforts to implement such post marketing commitment(s) at the Company’s expense.
View Source
Post-Marketing Commitments. Within 90 days after the Effective Date, Daiichi shall post or make available information on its company website about post-marketing commitments (PMCs). The Daiichi website or links included therein shall provide access to general information about the PMC process, descriptions of ongoing Daiichi studies related to PMCs, and information about the nature and status of FDA PMCs. Daiichi shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.
View Source
Post-Marketing Commitments. Within 30 days after the first date when Shire engages in any FDA post-marketing commitment (PMC), Shire shall post or make available information on its company website about PMCs. The Shire website or links included therein shall provide access to general information about the PMC process, descriptions of ongoing Shire studies, and information about the nature and status of FDA post-marketing commitments. Shire shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.
View Source
Post-Marketing Commitments. In the case where both Parties have sought a labeled indication based on the Combined Therapy, if post-marketing commitments are required by a Regulatory Authority (e.g.: US post-marketing commitments and post marketing requirements, EU post approval commitments etc), the Parties shall negotiate in good faith.
View Source
Post-Marketing Commitments. Buyer acknowledges that from and after Closing, Buyer shall be, and hereby is, responsible to the FDA and any or all other applicable Governmental Entities for full performance of all the Post-Marketing Commitments. Buyer has the necessary expertise to properly perform all of the Post-Marketing Commitments. Buyer acknowledges, and the Parties agree, that, from and after Closing, Seller will have no further obligations whatsoever for, or in connection with, the Post-Marketing Commitments.
View Source
Post-Marketing Commitments. Schedule 4.19 describes all of the post-marketing commitments related to the Products or the Purchased Assets that have been imposed by a Governmental Authority as of the Effective Date.
View Source

Related to Post-Marketing Commitments

  • 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.

  • 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.

  • Reformulation Commitment As of the Effective Date all Products manufactured, imported, distributed, sold, and/or offered for sale in the State of California by, or on behalf of, Gekkeikan via SFI or otherwise shall be Products that qualify as Reformulated Products as defined in Section 2.1 above.

  • Incremental Term Loan Commitments (a) Lead Borrower may at any time and from time to time request that one or more Lenders (or one or more Eligible Transferees who will become Lenders) provide Incremental Term Loan Commitments to the Borrowers and, subject to the terms and conditions contained in this Agreement and in the relevant Incremental Term Loan Amendment, make Incremental Term Loans pursuant thereto; it being understood and agreed, however, that (i) no Lender shall be obligated to provide an Incremental Term Loan Commitment as a result of any such request by Lead Borrower, (ii) any Lender (including any Eligible Transferee who will become a Lender) may so provide an Incremental Term Loan Commitment without the consent of any other Lender, (iii) each Tranche of Incremental Term Loan Commitments shall be denominated in U.S. Dollars, (iv) the amount of Incremental Term Loan Commitments made available pursuant to a given Incremental Term Loan Amendment shall be in a minimum aggregate amount for all Lenders which provide an Incremental Term Loan Commitment thereunder (including Eligible Transferees who will become Lenders) of at least $25,000,000, (v) the aggregate principal amount of any Incremental Term Loans on the date of the incurrence thereof shall not exceed, when taken together with any incurrence of Permitted Pari Passu Notes or Permitted Junior Debt pursuant to Section 10.04(xxvii)(A)(1) on such date, (x) the then-remaining Fixed Dollar Incremental Amount as of the date of incurrence plus (y) subject to the satisfaction of the applicable Incurrence-Based Incremental Facility Test, any Incurrence-Based Incremental Amount that may be incurred thereunder on such date, (vi) the proceeds of all Incremental Term Loans incurred by the Borrowers may be used for any purpose not prohibited under this Agreement, (vii) Lead Borrower shall specifically designate, in consultation with the Administrative Agent, the Tranche of the Incremental Term Loan Commitments being provided thereunder (which Tranche shall be a new Tranche (i.e., not the same as any existing Tranche of Incremental Term Loans, Incremental Term Loan Commitments or other Term Loans), unless the requirements of Section 2.15(c) are satisfied), which designation shall be set forth in the applicable Incremental Term Loan Amendment, (viii) if to be incurred as a new Tranche of Incremental Term Loans, such Incremental Term Loans shall have the same terms as each other Tranche of Term Loans as in effect immediately prior to the effectiveness of the relevant Incremental Term Loan Agreement, except as to purpose (which is subject to the requirements of the preceding clause (vi)) and optional prepayment provisions and mandatory prepayment provisions (which are governed by Section 5.02; provided that each new Tranche of Incremental Term Loans shall be entitled to share in mandatory prepayments on a ratable basis with the other Tranches of Term Loans (unless the holders of the Incremental Term Loans of any Tranche agree to take a lesser share of any such prepayments)); provided, however, that (I) the maturity and amortization of such Tranche of Incremental Term Loans may differ, so long as such Tranche of Incremental Term Loans shall have (a) a Maturity Date of no earlier than the Latest Maturity Date as of the date such Indebtedness was incurred and (b) a Weighted Average Life to Maturity of no less than the Weighted Average Life to Maturity as then in effect for the Tranche of then outstanding Term Loans with the then longest Weighted Average Life to Maturity (in each case of the foregoing clauses (a) and (b), excluding for this purpose, interim loan financings that provide for automatic rollover, subject to customary conditions, to Indebtedness otherwise meeting the requirements of this clause (I)), (II) the Effective Yield applicable to such Tranche of Incremental Term Loans may differ from that applicable to the then outstanding Tranches of Term Loans, with the Effective Yield applicable thereto to be specified in the respective Incremental Term Loan Amendment; provided, however, that if the Effective Yield for any such Incremental Term Loans incurred prior the date that is six (6) months after the First Restatement Effective Date, exceeds the Effective Yield then applicable to any then outstanding Initial Term Loans by more than 0.75% per annum, the Applicable Margins for all then outstanding Initial Term Loans shall be increased as of such date in accordance with the requirements of the definition of “Applicable Margin” and (III) such Tranche of Incremental Term Loans may have other terms (other than those described in preceding clauses (I) and (II)) that may differ from those of other Tranches of Term Loans, including, without limitation, as to the application of optional or voluntary prepayments among the Incremental Term Loans and the existing Term Loans, in each case, taken as a whole, that are not materially more favorable to the lenders providing such Incremental Term Loans than the provisions applicable to the existing Term Loans or as are otherwise reasonably satisfactory to the Administrative Agent, (ix) all Incremental Term Loans (and all interest, fees and other amounts payable thereon) incurred by the Borrowers shall be Obligations of the Borrowers under this Agreement and the other applicable Credit Documents and shall be secured by the Security Agreements, and guaranteed under each relevant Guaranty, on a pari passu basis with all other Term Loans secured by the Security Agreement and guaranteed under each such Guaranty, (x) each Lender (including any Eligible Transferee who will become a Lender) agreeing to provide an Incremental Term Loan Commitment pursuant to an Incremental Term Loan Amendment shall, subject to the satisfaction of the relevant conditions set forth in this Agreement, make Incremental Term Loans under the Tranche specified in such Incremental Term Loan Amendment as provided in Section 2.01(b) and such Term Loans shall thereafter be deemed to be Incremental Term Loans under such Tranche for all purposes of this Agreement and the other applicable Credit Documents and (xi) all Incremental Term Loan Commitment Requirements are satisfied. (b) At the time of the provision of Incremental Term Loan Commitments pursuant to this Section 2.15, the Borrowers, the Administrative Agent and each such Lender or other Eligible Transferee which agrees to provide an Incremental Term Loan Commitment (each, an “Incremental Term Loan Lender”) shall execute and deliver to the Administrative Agent an Incremental Term Loan Amendment (which shall not require the consent of any other Lender), with the effectiveness of the Incremental Term Loan Commitment provided therein to occur on the date on which (w) a fully executed copy of such Incremental Term Loan Amendment shall have been delivered to the Administrative Agent, (x) all fees required to be paid in connection therewith at the time of such effectiveness shall have been paid (including, without limitation, any agreed upon upfront or arrangement fees owing to the Administrative Agent to the extent it served as the arranger for the Incremental Term Loan Commitments), (y) all Incremental Term Loan Commitment Requirements are satisfied, and (z) all other conditions set forth in this Section 2.15 shall have been satisfied. The Administrative Agent shall promptly notify each Lender as to the effectiveness of each Incremental Term Loan Amendment, and at such time, (i) Schedule 2.01 shall be deemed modified to reflect the revised Incremental Term Loan Commitments of the affected Lenders and (ii) to the extent requested by any Incremental Term Loan Lender, Term Notes will be issued at the Borrowers’ expense to such Incremental Term Loan Lender, to be in conformity with the requirements of Section 2.05 (with appropriate modification) to the extent needed to reflect the new Incremental Term Loans made by such Incremental Term Loan Lender. (c) Notwithstanding anything to the contrary contained above in this Section 2.15, the Incremental Term Loan Commitments provided by an Incremental Term Loan Lender or Incremental Term Loan Lenders, as the case may be, pursuant to each Incremental Term Loan Amendment shall constitute a new Tranche, which shall be separate and distinct from the existing Tranches pursuant to this Agreement; provided that, with the consent of the Administrative Agent, the parties to a given Incremental Term Loan Amendment may specify therein that the Incremental Term Loans made pursuant thereto shall constitute part of, and be added to, an existing Tranche of Term Loans, in any case so long as the following requirements are satisfied: (i) the Incremental Term Loans to be made pursuant to such Incremental Term Loan Amendment shall have the same Borrowers, the same Maturity Date and the same Applicable Margins as the Tranche of Term Loans to which the new Incremental Term Loans are being added; (ii) the new Incremental Term Loans shall have the same Scheduled Repayment Dates as then remain with respect to the Tranche to which such new Incremental Term Loans are being added (with the amount of each Scheduled Repayment applicable to such new Incremental Term Loans to be the same (on a proportionate basis)) as is theretofore applicable to the Tranche to which such new Incremental Term Loans are being added, thereby increasing the amount of each then remaining Scheduled Repayment of the respective Tranche proportionately; and (iii) on the date of the making of such new Incremental Term Loans, and notwithstanding anything to the contrary set forth in Section 2.09, such new Incremental Term Loans shall be added to (and form part of) each Borrowing of outstanding Term Loans of the applicable Tranche on a pro rata basis (based on the relative sizes of the various outstanding Borrowings), so that each Lender holding Term Loans under the respective Tranche of Term Loans participates in each outstanding Borrowing of Term Loans of the respective Tranche (after giving effect to the incurrence of such new Incremental Term Loans pursuant to Section 2.01(b)) on a pro rata basis. To the extent the provisions of the preceding clause (iii) require that Incremental Term Loan Lenders making new Incremental Term Loans add such Incremental Term Loans to the then outstanding Borrowings of Term SOFR Term Loans of such Tranche, it is acknowledged that the effect thereof may result in such new Incremental Term Loans having irregular Interest Periods (i.e., an Interest Period that began during an Interest Period then applicable to outstanding Term SOFR Term Loans of such Tranche and which will end on the last day of such Interest Period), which irregular interest periods shall be permitted notwithstanding anything to the contrary in this Agreement. All determinations by any the Administrative Agent of Term SOFR in such circumstances pursuant to the immediately preceding sentence shall, absent manifest error, be final and conclusive and binding on all parties hereto.

  • 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.