Recall Matters Sample Clauses

Recall Matters. CKD shall observe and conform at all times with all legal requirements in order to maintain an effective system for the recall from the market in the Territory of any Licensed Product used or sold in the Territory. CKD will be responsible for conducting, in accordance with all Applicable Laws, all withdrawals or recalls of Licensed Products used or sold in the Territory (except as may be otherwise provided in the Supply Agreement between the Parties), and will provide Cara with reasonable notice under the circumstances of such intended withdrawal or recall in an appropriate time, to the extent practicable, for Cara and CKD to discuss such intended action. CKD shall be responsible for, and CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [*]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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Recall Matters. GSL shall observe and conform at all times with all legal requirements in order to maintain an effective system for the recall from the market in the United States and Canada of any Licensed Product used or sold in the United States and Canada. GSL will be responsible for conducting, in accordance with all Applicable Laws, all withdrawals or recalls of Licensed Product used or sold in the United States and Canada in the Field of Use, and will provide Lipocine with reasonable notice under the circumstances of such intended withdrawal or recall in an appropriate time, to the extent practicable, for Lipocine and GSL to discuss such intended action.
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Recall Matters. Maruishi shall observe and conform at all times with all legal requirements in order to maintain an effective system for the recall from the market in the Territory of any Licensed Product used or sold in the Territory. Maruishi will be responsible for conducting, in accordance with all Applicable Laws, all withdrawals or recalls of Licensed Products used or sold in the Territory (except as may be otherwise provided in the Supply Agreement between the Parties), and will provide Cara with reasonable notice under the circumstances of such intended withdrawal or recall in an appropriate time, to the extent practicable, for Cara and Maruishi to discuss such intended action. Maruishi shall be responsible for, and shall hold harmless and indemnify Cara and its Affiliates from and against, any and all Losses resulting from any such recall or withdrawal of the Licensed Product used or sold in the Territory, except that Cara shall be responsible for Maruishi’s Losses arising from or in connection with a recall or withdrawal that is caused by a manufacturing defect in CR-845 API supplied by Cara to Maruishi under the Supply Agreement resulting from Cara’s or its contracted manufacturers’ negligence or intentional misconduct, which may include recalls due to a safety issue that fundamentally originated in manufacturing defects in the CR-845 API which is contained in Finished Product.
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Recall Matters. Shionogi shall observe and conform at all times with all legal requirements in order to maintain an effective system for the recall from the market of any Licensed Product used or sold in the Territory. Shionogi will be responsible for conducting, in accordance with all applicable laws and regulations, all withdrawals or recalls of Licensed Products used or sold in the Territory (except as may be otherwise provided in a supply agreement between the Parties), and will provide Amylin with reasonable notice under the circumstances of such intended withdrawal or recall in an appropriate time, to the extent practicable, for Amylin and Shionogi to discuss such intended action.
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Related to Recall Matters

  • FDA Matters (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials.

  • Operational Matters 7.1 The LGB shall comply with the obligations set out in Appendix 2 which deals with the day-to-day operation of, and delegation of responsibilities to, the LGB.

  • Personnel Matters 7.1 Verbal or written complaints regarding an employee made to any member of the Administration by any parent, student or other person which is to be placed in any personnel file or which may be used to evaluate or discipline an employee shall be promptly investigated. The employee shall be given prompt notice of such complaint and shall be given the opportunity to respond to the complaint. Unsubstantiated complaints shall not be placed in an employee’s file.

  • Litigation and Environmental Matters (a) There are no actions, suits or proceedings by or before any arbitrator or Governmental Authority pending against or, to the knowledge of the Borrower, threatened in writing against or affecting the Borrower or any of its Restricted Subsidiaries which would reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect.

  • Privacy Matters (1) For the purposes of this section, “

  • Tax Matters It is intended that the assets with respect to which any REMIC election is to be made, as set forth in the Preliminary Statement, shall constitute, and that the conduct of matters relating to such assets shall be such as to qualify such assets as, a "real estate mortgage investment conduit" as defined in and in accordance with the REMIC Provisions. In furtherance of such intention, the Trustee covenants and agrees that it shall act as agent (and the Trustee is hereby appointed to act as agent) on behalf of any such REMIC and that in such capacity it shall: (a) prepare and file, or cause to be prepared and filed, in a timely manner, a U.S. Real Estate Mortgage Investment Conduit Income Tax Return (Form 1066 or any successor form adopted by the Internal Revenue Service) and prepare and file or cause to be prepared and filed with the Internal Revenue Service and applicable state or local tax authorities income tax or information returns for each taxable year with respect to any such REMIC, containing such information and at the times and in the manner as may be required by the Code or state or local tax laws, regulations, or rules, and furnish or cause to be furnished to Certificateholders the schedules, statements or information at such times and in such manner as may be required thereby; (b) within thirty days of the Closing Date, furnish or cause to be furnished to the Internal Revenue Service, on Forms 8811 or as otherwise may be required by the Code, the name, title, address, and telephone number of the person that the holders of the Certificates may contact for tax information relating thereto, together with such additional information as may be required by such Form, and update such information at the time or times in the manner required by the Code; (c) make or cause to be made elections that such assets be treated as a REMIC on the federal tax return for its first taxable year (and, if necessary, under applicable state law); (d) prepare and forward, or cause to be prepared and forwarded, to the Certificateholders and to the Internal Revenue Service and, if necessary, state tax authorities, all information returns and reports as and when required to be provided to them in accordance with the REMIC Provisions, including without limitation, the calculation of any original issue discount using the Prepayment Assumption; (e) provide information necessary for the computation of tax imposed on the transfer of a Residual Certificate to a Person that is not a Permitted Transferee, or an agent (including a broker, nominee or other middleman) of a Non-Permitted Transferee, or a pass-through entity in which a Non-Permitted Transferee is the record holder of an interest (the reasonable cost of computing and furnishing such information may be charged to the Person liable for such tax); (f) to the extent that they are under its control conduct matters relating to such assets at all times that any Certificates are outstanding so as to maintain the status as a REMIC under the REMIC Provisions; (g) not knowingly or intentionally take any action or omit to take any action that would cause the termination of either REMIC status; (h) pay, from the sources specified in the last paragraph of this Section 8.11, the amount of any federal or state tax, including prohibited transaction taxes as described below, imposed on any such REMIC prior to its termination when and as the same shall be due and payable (but such obligation shall not prevent the Trustee or any other appropriate Person from contesting any such tax in appropriate proceedings and shall not prevent the Trustee from withholding payment of such tax, if permitted by law, pending the outcome of such proceedings); (i) ensure that federal, state or local income tax or information returns shall be signed by the Trustee or such other person as may be required to sign such returns by the Code or state or local laws, regulations or rules; (j) maintain records relating to any such REMIC, including but not limited to the income, expenses, assets and liabilities thereof and the fair market value and adjusted basis of the assets determined at such intervals as may be required by the Code, as may be necessary to prepare the foregoing returns, schedules, statements or information; and (k) as and when necessary and appropriate, represent any such REMIC in any administrative or judicial proceedings relating to an examination or audit by any governmental taxing authority, request an administrative adjustment as to any taxable year of any such REMIC, enter into settlement agreements with any governmental taxing agency, extend any statute of limitations relating to any tax item of any such REMIC, and otherwise act on behalf of any such REMIC in relation to any tax matter or controversy involving it. In order to enable the Trustee to perform its duties as set forth herein, the Depositor shall provide, or cause to be provided, to the Trustee within ten (10) days after the Closing Date all information or data that the Trustee requests in writing and determines to be relevant for tax purposes to the valuations and offering prices of the Certificates, including, without limitation, the price, yield, prepayment assumption and projected cash flows of the Certificates and the Mortgage Loans. Thereafter, the Depositor shall provide to the Trustee promptly upon written request therefor, any such additional information or data that the Trustee may, from time to time, reasonably request in order to enable the Trustee to perform its duties as set forth herein. The Depositor hereby indemnifies the Trustee for any losses, liabilities, damages, claims or expenses of the Trustee arising from any errors or miscalculations of the Trustee that result from any failure of the Depositor to provide, or to cause to be provided, accurate information or data to the Trustee on a timely basis. In the event that any tax is imposed on "prohibited transactions" of any REMIC hereunder as defined in Section 860F(a)(2) of the Code, on the "net income from foreclosure property" of such REMIC as defined in Section 860G(c) of the Code, on any contribution to any REMIC hereunder after the Startup Day pursuant to Section 860G(d) of the Code, or any other tax is imposed, including, without limitation, any minimum tax imposed upon any REMIC hereunder pursuant to Sections 23153 and 24874 of the California Revenue and Taxation Code, if not paid as otherwise provided for herein, such tax shall be paid by (i) the Trustee, if any such other tax arises out of or results from a breach by the Trustee of any of its obligations under this Agreement, (ii) the Master Servicer, in the case of any such minimum tax, or if such tax arises out of or results from a breach by the Master Servicer or Seller of any of their obligations under this Agreement, (iii) the Seller, if any such tax arises out of or results from the Seller's obligation to repurchase a Mortgage Loan pursuant to Section 2.02 or 2.03 or (iv) in all other cases, or in the event that the Trustee, the Master Servicer or the Seller fails to honor its obligations under the preceding clauses (i),(ii) or (iii), any such tax will be paid with amounts otherwise to be distributed to the Certificateholders, as provided in Section 3.08(b).

  • Environmental Matters Except as, in the aggregate, could not reasonably be expected to have a Material Adverse Effect:

  • General Matters The parties hereto agree that they will, in good faith and with their best efforts, cooperate with each other to carry out the transactions contemplated by this Agreement and to effect the purposes hereof.

  • Fiscal Matters a. The School District will provide all required Course Materials (textbooks and electronic materials) and will be billed for applicable Instructional Materials charges embedded in courses requiring electronic materials in accordance with the College respective course agreement.

  • Procedural Matters The Trustee may maintain a proceeding even if it does not possess any of the Notes or does not produce any of them in such proceeding. A delay or omission by the Trustee or any Holder in exercising any right or remedy following an Event of Default will not impair the right or remedy or constitute a waiver of, or acquiescence in, such Event of Default. All remedies will be cumulative to the extent permitted by law.

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