Post-Marketing Commitments Sample Clauses

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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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, Xxx X’Xxxx shall not manufacture, import, distribute, sell or offer the Products for sale in the State of California unless they are Reformulated Products pursuant to Section 2.1 above or carry the Proposition 65 warnings specified in Section 2.3 below.

  • Incremental Term Loan Commitments (a) Each Borrower shall have the right, in consultation and coordination with the Administrative Agent but without requiring the consent of any of the Lenders, to request, at any time and from time to time prior to the then latest Maturity Date, that one or more Lenders (and/or one or more other Persons which are Eligible Transferees and which will become Lenders) provide Incremental Term Loan Commitments to such Borrower and, subject to the terms and conditions contained in this Agreement and in the respective Incremental Term Loan Commitment Agreement, 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, (ii) each Tranche of Incremental Term Loan Commitments shall be made available to a single Incremental Term Loan Borrower and shall be denominated in Dollars, (iii) the amount of each Tranche of Incremental Term Loan Commitments shall be in a minimum aggregate amount of $25,000,000, (iv) the aggregate amount of all Incremental Term Loan Commitments provided pursuant to this Section 1.14 shall not exceed the Maximum Incremental Term Loan Commitment Amount, (v) the up-front fees and, if applicable, any unutilized commitment fees and/or other fees payable in respect of each Incremental Term Loan Commitment shall be separately agreed to by the respective Incremental Term Loan Borrower and each Incremental Term Loan Lender (and with all such fees to be disclosed in writing by the respective Incremental Term Loan Borrower to the Administrative Agent), (vi) each Tranche of Incremental Term Loans shall have (I) (x) an Incremental Term Loan Maturity Date of no earlier than the then latest Maturity Date as then in effect, and (y) 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 Loans with the longest Weighted Average Life to Maturity and (II) an “interest rate” or “interest rates” applicable to such Tranche of Incremental Term Loans (which, for such purposes only, shall be determined by the Administrative Agent and deemed to include all upfront or similar fees or original issue discount (amortized over the life of such Incremental Term Loans) payable to all Lenders providing such Incremental Term Loans, but exclusive of any arrangement, structuring or other fees payable in connection therewith that are not shared with all Lenders providing such Tranche of Incremental Term Loans) that may (at such time or from time to time thereafter) exceed the “interest rates” applicable to the Term Loans; provided that, in the event that the “interest rate” excess applicable to such Tranche of Incremental Term Loans shall at such time be greater than 0.50%, the Applicable Margin for the Tranche B-2 Term Loans, the Tranche C-2 Term Loans and each other then existing Tranche of Incremental Term Loans shall be increased by such amounts, and for such time periods, as are needed so that at no time shall the “interest rate” for the respective new Tranche of Incremental Term Loans (calculated as described above) exceed the relevant interest rates applicable to the then existing Tranches of Term Loans by more than 0.50%, (vii) the proceeds of all Incremental Term Loans shall be used only for the purposes permitted by Section 7.05(a), (viii) each Incremental Term Loan Commitment Agreement shall specifically designate, with the approval of the Administrative Agent, the Tranche of the Incremental Term Loan Commitments being provided thereunder (which Tranche may 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) or an increase in a previously established Tranche), (ix) all Incremental Term Loans (and all interest, fees and other amounts payable thereon) shall be Obligations under this Agreement and the other applicable Credit Documents and shall be secured by the relevant Security Documents, and guaranteed under each relevant Guaranty, on a pari passu basis with all other Loans of the applicable Borrower secured by each such Security Agreement and guaranteed under each such Guaranty, and (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 Commitment Agreement 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 Commitment Agreement as provided in Section 1.01(c) and such 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. (b) At the time of the provision of Incremental Term Loan Commitments pursuant to this Section 1.14, the applicable Incremental Term Loan Borrower, 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 Commitment Agreement substantially in the form of Exhibit I (appropriately completed), with the effectiveness of the Incremental Term Loan Commitment provided therein to occur on the date set forth in such Incremental Term Loan Commitment Agreement, which date in any event shall be no earlier than the date on which all Incremental Term Loan Commitment Requirements are satisfied. The Administrative Agent shall promptly notify each Lender as to the effectiveness of each Incremental Term Loan Commitment Agreement.

  • 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.

  • Service Level Commitment IBM provides the following service level commitment (“SLA”) for the Cloud Service, after IBM makes the Cloud Service available to you.

  • 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 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.

  • Revolving Commitment Subject to the terms and conditions hereof and in reliance upon the representations and warranties set forth herein, each Lender severally agrees to make available to the Borrower such Lender's Revolving Commitment Percentage of revolving credit loans requested by the Borrower in Dollars ("REVOLVING LOANS") from time to time from the Closing Date until the Maturity Date, or such earlier date as the Revolving Commitments shall have been terminated as provided herein; PROVIDED, HOWEVER, that the sum of the aggregate outstanding principal amount of Revolving Loans shall not exceed ONE HUNDRED MILLION DOLLARS ($100,000,000) (as such aggregate maximum amount may be reduced from time to time as provided in Section 3.4, the "REVOLVING COMMITTED AMOUNT"); PROVIDED, FURTHER, (A) with regard to each Lender individually, such Lender's outstanding Revolving Loans shall not exceed such Lender's Revolving Commitment Percentage of the Revolving Committed Amount, and (B) the sum of the aggregate outstanding principal amount of Revolving Loans PLUS LOC Obligations PLUS Swingline Loans shall not exceed the Revolving Committed Amount. The initial advance of the Revolving Loans on the Closing Date shall consist solely of Base Rate Loans. Thereafter, Revolving Loans may consist of Base Rate Loans or Eurodollar Loans, or a combination thereof, as the Borrower may request; PROVIDED, HOWEVER, that no more than 15 Eurodollar Loans shall be outstanding hereunder at any time (it being understood that, for purposes hereof, Eurodollar Loans with different Interest Periods shall be considered as separate Eurodollar Loans, even if they begin on the same date, although borrowings, extensions and conversions may, in accordance with the provisions hereof, be combined at the end of existing Interest Periods to constitute a new Eurodollar Loan with a single Interest Period). Revolving Loans hereunder may be repaid and reborrowed in accordance with the provisions hereof.

  • 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.

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