Assumption of Regulatory Commitments Sample Clauses

Assumption of Regulatory Commitments. From and after the Closing Date, Buyer will assume control of and responsibility for all costs, obligations and Liabilities arising from or related to, any commitments or obligations to any Governmental Entity involving the ANDAs and any of the other Purchased Assets.
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Assumption of Regulatory Commitments. From and after the Closing Date, except as set forth in the terms set forth in Appendix III or the pharmacovigilance agreement to be entered into by the parties pursuant to the Supply Agreement, Buyer will assume control of, and responsibility for all costs and Liabilities arising from or related to any commitments or obligations to any Governmental Entity involving the Products, only to the extent arising from or relating to Product sold by Buyer after the Closing Date, and in the case of any Products that are subject to obtaining FDA approval of any unapproved Product ANDA, transferred to Buyer on the Closing Date.
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Assumption of Regulatory Commitments. Subject to the terms and conditions of the Commercial Agreement, from and after the Closing Date, Buyer will assume control of, and responsibility for all costs, obligations and Liabilities arising from or related to any requirements, commitments or obligations to any Governmental Entity involving Fanapt and the Fanapt Development Stage Products.
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Assumption of Regulatory Commitments. From and after the Closing Date, except as set forth in the terms set forth in Appendix III or the pharmacovigilance agreement to be entered into by the parties pursuant to the Supply Agreement, Buyer will assume control of, and responsibility for all costs and Liabilities arising from or related to any commitments or obligations to any Governmental Entity involving the Products, only to the extent arising from or relating to Product sold by Buyer after the Closing [****] = 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. Confidential treatment has been requested with respect to the omitted portions. Date, and in the case of any Products that are subject to obtaining FDA approval of any unapproved Product ANDA, transferred to Buyer on the Closing Date.
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Assumption of Regulatory Commitments. From and after the Closing Date and in accordance with the transition plan, Buyer will assume control of, and responsibility for all costs, obligations and Liabilities arising from or related to any commitments or obligations to any Governmental Authority involving the Product, but only to the extent such Liabilities (i) arise from facts and circumstances occurring after the Closing Date and (ii) do not arise from or relate to any breach by Seller of its obligations or any of its Affiliates obligations. Notwithstanding the foregoing, from and after the Closing Date, Seller shall be responsible for certain regulatory commitments in accordance with the transition plan until such regulatory commitments become the responsibility of Buyer or, if earlier, are fulfilled.
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Assumption of Regulatory Commitments. From and after the Closing Date, and subject to the terms hereof, Cumberland will assume control of, and responsibility for all costs, obligations and Liabilities arising from or related to, any commitments, requirements or obligations to, or any requests or orders from, any Governmental Authority involving the Product, to the extent arising from Product sold by or on behalf of Cumberland or related to the Product ANDA owned by Cumberland after the Closing Date.
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Assumption of Regulatory Commitments. (a) From and after the Effective Date, Buyer will be in control of, and responsible for, all costs and Liabilities arising from or related to any commitments or obligations to any Governmental Entity relating to the Product or the Product ANDA, or otherwise related to the Purchased Assets with respect to the period following the Effective Date. (b) From and after the Effective Date, Buyer will be responsible for communications with any Governmental Entity involving the Product ANDA or any batches of Product manufactured after the Effective Date. Ingenus will forward to Buyer any correspondence received by Ingenus after the Effective Date from the FDA solely to the extent related to the Purchased Assets within one ( 1) business day of receipt by Ingenus. (c) From and after the Effective Date, Buyer shall be responsible for all adverse experience reporting to the FDA in respect of the Products; provided, however, that Ingenus shall cooperate with Buyer's requests regarding adverse experience information with respect to the Product to ensure that all adverse experience data and documentation for the Product are transferred to Buyer. Legacy adverse experience data and documentation will be transferred to the Buyer no later than 30 calendar days following the date hereof. Any new adverse experience reports, any follow-up adverse experience reports or medical inquiries received by Ingenus will be forwarded to Buyer in accordance with quality agreement , together with any source documents within one (1) Business Day. (d) Ingenus covenants and agrees that it shall deliver electronic copies of the ANDA and all materials, information or data related to the manufacture of the Product included therein (including any such information included in the Chemistry, Manufacturing and Controls section of the ANDA), to Buyer by mail or FTP site no later than the earlier of five (5) business days following the date hereof and two (2) days following delivery of FDA Notice of Transfer pursuant to Section 11 below, with complete paper copies thereof to follow by mail no later than 30 days following the Closing Date. Ingenus shall continue to maintain the drug listing for the Product, including the annual drug listing certifications under 21 C.F.R. 207. Ingenus will work with Buyer to update the drug listing in the event that there are any corrections or labeling updates required under regulations the drug listing will be delisted promptly following the date upon which the last mar...
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Assumption of Regulatory Commitments. Subject to ARTICLE IX, from and after the Closing Date, Buyer shall assume control of, and responsibility for, all costs, obligations and Liabilities arising from or related to any commitments or obligations to any Governmental Entities first arising on or after the Closing Date solely in connection with the Product in the Territory.
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Assumption of Regulatory Commitments. From and after the Closing Date, except as set forth in the pharmacovigilance agreement to be entered into by the parties pursuant to the Supply Agreement, Buyer will assume control of, and responsibility for all costs and Liabilities arising from or related to any commitments or obligations to any Governmental Entity involving the Products, only to the extent arising from or relating to Product sold by Buyer after the Closing Date.
Sample 1

Related to Assumption of Regulatory Commitments

  • Manner of Requesting a Letter of Credit The Borrower shall provide at least five (5) Business Days’ advance written notice to the Administrative Agent of each request for the issuance of a Letter of Credit, such notice in each case to be accompanied by an Application for such Letter of Credit properly completed and executed by the Borrower and, in the case of an extension or amendment or an increase in the amount of a Letter of Credit, a written request therefor, in a form acceptable to the Administrative Agent and the L/C Issuer, in each case, together with the fees called for by this Agreement. The Administrative Agent shall promptly notify the L/C Issuer of the Administrative Agent’s receipt of each such notice (and the L/C Issuer shall be entitled to assume that the conditions precedent to any such issuance, extension, amendment or increase have been satisfied unless notified to the contrary by the Administrative Agent or the Required Lenders) and the L/C Issuer shall promptly notify the Administrative Agent and the Lenders of the issuance of the Letter of Credit so requested.

  • Extension of Commitments The Commitments may be extended in the manner and amount set forth in this subsection (b), for a period of 364 days measured from the Termination Date then in effect. If the Company wishes to request an extension of each Bank's Commitment, it shall give notice to that effect to the Agent not less than 45 days and not more than 60 days prior to the Termination Date then in effect, whereupon the Agent shall promptly notify each of the Banks of such request. Each Bank will use its best efforts to respond to such request, whether affirmatively or negatively, as it may elect in its discretion, within 30 days of such notice to the Agent. If any Bank shall not have responded affirmatively within such 30-day period, such Bank shall be deemed to have rejected the Company's proposal to extend its Commitment, and only the Commitments of those Banks which have responded affirmatively shall be extended, subject to receipt by the Agent of counterparts of an Extension Agreement in substantially the form of Exhibit H hereto duly completed and signed by the Borrower, the Company, the Agent and all of the Banks which have responded affirmatively. The Agent shall provide to the Company, no later than 10 days prior to the Termination Date then in effect, a list of the Banks which have responded affirmatively. The Extension Agreement shall be executed and delivered no later than five days prior to the Termination Date then in effect, and no extension of the Commitments pursuant to this subsection (b) shall be legally binding on any party hereto unless and until such Extension Agreement is so executed and delivered. The Company and the Borrower may decline to execute and deliver such Extension Agreement if any Bank has rejected the Company's proposal to extend its Commitment or has failed to execute and deliver such Extension Agreement, and will promptly notify the Agent and the Banks if it so declines.

  • Extension of Revolving Credit Commitments The Borrower may at any time and from time to time request that all or a portion of the Revolving Credit Commitments of a given Class (each, an “Existing Revolver Tranche”) be amended to extend the Maturity Date with respect to all or a portion of any principal amount of such Revolving Credit Commitments (any such Revolving Credit Commitments which have been so amended, “Extended Revolving Credit Commitments”) and to provide for other terms consistent with this Section 2.16. In order to establish any Extended Revolving Credit Commitments, the Borrower shall provide a notice to the Administrative Agent (who shall provide a copy of such notice to each of the Lenders under the applicable Existing Revolver Tranche) (each, a “Revolver Extension Request”) setting forth the proposed terms of the Extended Revolving Credit Commitments to be established, which shall (x) be identical as offered to each Lender under such Existing Revolver Tranche (including as to the proposed interest rates and fees payable) and offered pro rata to each Lender under such Existing Revolver Tranche and (y) be identical to the Revolving Credit Commitments under the Existing Revolver Tranche from which such Extended Revolving Credit Commitments are to be amended, except that: (i) the Maturity Date of the Extended Revolving Credit Commitments may be delayed to a later date than the Maturity Date of the Revolving Credit Commitments of such Existing Revolver Tranche, to the extent provided in the applicable Extension Amendment; (ii) the Effective Yield with respect to extensions of credit under the Extended Revolving Credit Commitments (whether in the form of interest rate margin, upfront fees, commitment fees, original issue discount or otherwise) may be different than the Effective Yield for extensions of credit under the Revolving Credit Commitments of such Existing Revolver Tranche, in each case, to the extent provided in the applicable Extension Amendment; (iii) the Extension Amendment may provide for other covenants and terms that apply solely to any period after the Latest Maturity Date that is in effect on the effective date of the Extension Amendment (immediately prior to the establishment of such Extended Revolving Credit Commitments); and (iv) all borrowings under the applicable Revolving Credit Commitments (i.e., the Existing Revolver Tranche and the Extended Revolving Credit Commitments of the applicable Revolver Extension Series) and repayments thereunder shall be made on a pro rata basis (except for (I) payments of interest and fees at different rates on Extended Revolving Credit Commitments (and related outstandings) and (II) repayments required upon the Maturity Date of the non-extending Revolving Credit Commitments); provided, further, that (A) no Default shall have occurred and be continuing at the time a Revolver Extension Request is delivered to Lenders, (B) in no event shall the final maturity date of any Extended Revolving Credit Commitments of a given Revolver Extension Series at the time of establishment thereof be earlier than the then Latest Maturity Date of any other Revolving Credit Commitments hereunder, (C) any such Extended Revolving Credit Commitments (and the Liens securing the same) shall be permitted by the terms of the Intercreditor Agreements (to the extent any Intercreditor Agreement is then in effect) and (D) all documentation in respect of such Extension Amendment shall be consistent with the foregoing. Any Extended Revolving Credit Commitments amended pursuant to any Revolver Extension Request shall be designated a series (each, a “Revolver Extension Series”) of Extended Revolving Credit Commitments for all purposes of this Agreement; provided that any Extended Revolving Credit Commitments amended from an Existing Revolver Tranche may, to the extent provided in the applicable Extension Amendment, be designated as an increase in any previously established Revolver Extension Series with respect to such Existing Revolver Tranche. Each Revolver Extension Series of Extended Revolving Credit Commitments incurred under this Section 2.16 shall be in an aggregate principal amount that is not less than $5,000,000.

  • Reduction of Commitment On the last Trading Day of each Pricing Period, the Investor’s Total Commitment under this Agreement automatically (and without the need for any amendment to this Agreement) shall be reduced, on a dollar-for-dollar basis, by the total amount of the Fixed Request Amount and the Optional Amount Dollar Amount, if any, for such Pricing Period paid to the Company at the Settlement Date.

  • Notification by Administrative Agent; Additional Lenders The Administrative Agent shall notify the Borrower and each Lender of the Lenders’ responses to each request made hereunder. To achieve the full amount of a requested increase and subject to the approval of the Administrative Agent, the L/C Issuer and the Swing Line Lender (which approvals shall not be unreasonably withheld), the Borrower may also invite additional Eligible Assignees to become Lenders pursuant to a joinder agreement in form and substance satisfactory to the Administrative Agent and its counsel.

  • 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.

  • Termination of Commitment On the service of a notice under paragraph (a) of Clause 18.2, the Commitment and all other obligations of the Lender to the Borrower under this Agreement shall terminate.

  • Application to Term Loans With respect to each prepayment of Term Loans required by Section 5.2(a), the Borrower may, if applicable, designate the Types of Loans that are to be prepaid and the specific Borrowing(s) pursuant to which made; provided, that if any Lender has provided a Rejection Notice in compliance with Section 5.2(f), such prepayment shall be applied with respect to the Term Loans to be prepaid on a pro rata basis across all outstanding Types of such Term Loans in proportion to the percentage of such outstanding Term Loans to be prepaid represented by each such Class. In the absence of a Rejection Notice or a designation by the Borrower as described in the preceding sentence, the Administrative Agent shall, subject to the above, make such designation in its reasonable discretion with a view, but no obligation, to minimize breakage costs owing under Section 2.11.

  • Conditions Precedent to Initial Loans and Letters of Credit The obligation of each Lender to make the Loans requested to be made by it on the Closing Date and the obligation of each Issuer to Issue Letters of Credit on the Closing Date is subject to the satisfaction or due waiver in accordance with Section 11.1 (

  • Conditions Precedent to Loans and Letters of Credit 32 Section 3.1 Conditions To Effectiveness.................................................32 Section 3.2 Each Credit Event...........................................................33 Section 3.3 Delivery of Documents.......................................................34

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