GOVERNMENTAL CONTACT REPORTING Sample Clauses

GOVERNMENTAL CONTACT REPORTING. Each Party shall promptly notify the other Party upon being contacted by the FDA or any other competent governmental authority or agency in the Territories for any material regulatory purpose pertaining to this Agreement or to the Product. Neither Party shall respond to the FDA or such other authority or agency before consulting with the other Party, unless under the circumstances pursuant to which FDA or such other authority or agency contacts such Party, it is not practical or lawful for the contacted Party to give the other Party advance notice, in which event the contacted Party shall inform the other Party of such contact as soon as practical and lawful. In addition, each Party shall keep the other Party advised with respect to information concerning the safety or efficacy of the Product, including but not limited to providing, within three (3) business days of the creation or receipt thereof, all information regarding such safety, efficacy and medical information issues and copies of safety reports filed with the FDA or any other authority or agency.
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GOVERNMENTAL CONTACT REPORTING. Triangle shall promptly notify Abbott upon being contacted by the FDA or any other federal, state or local governmental agency in the Territory for any regulatory purpose pertaining to this Agreement or to the Products. Triangle shall not respond to the FDA or such governmental agency before consulting with Abbott, unless under the circumstances pursuant to which FDA or such other federal, state or local governmental agency contacts Triangle, it is not practical or lawful for Triangle to give Abbott advance notice, in which event Triangle shall inform Xxxxxx of such contact as soon as practical and lawful. In addition, each Party shall keep the other Party advised with respect to information concerning the safety or efficacy of the Products. On Triangle's written request with respect to any Product, Abbott shall supply detailed information regarding such safety, efficacy and medical information issues, including, if requested, copies of safety reports filed with the FDA or any other governmental agency.
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GOVERNMENTAL CONTACT REPORTING. Each Party shall promptly notify the other Party, as well as such other Party's general counsel, as from time to time made know to such Party, upon being contracted by the FDA or any other federal, state or local governmental agency for any regulatory purpose pertaining to this Agreement or to the Products. If practical the Party receiving such contact shall notify the other Party within twenty-four (24) hours. The Party receiving notice from such agency shall provide the other Party with prompt written notice of any inquiries from, or positions taken by, the FDA or any other federal, state or local governmental agencies which may affect the co- promotion or distribution of any Product.
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GOVERNMENTAL CONTACT REPORTING. EuroGen shall promptly notify SuperGen upon being contacted by the FDA, or any other competent governmental authority or agency within the Territory, for any material regulatory purpose pertaining to this Agreement or to any Product for which Regulatory Approval has been obtain. Excepting routine matters and matters relating to applications for Regulatory Approval, EuroGen shall not respond to the authority or agency before consulting with the SuperGen, unless under the circumstances pursuant to which the authority or agency contacts such Party, it is not practical or lawful for EuroGen to give SuperGen advance notice. In any event, EuroGen shall inform SuperGen of such contact as soon as practical and lawful. Each Party shall keep the other Party advised with respect to information concerning the safety or efficacy of any Product, including but not limited to providing, within three (3) business days of the creation or receipt thereof, all information regarding such safety, efficacy and medical information issues and copies of safety reports filed with the FDA or any other authority or agency.
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GOVERNMENTAL CONTACT REPORTING. Each party shall notify the other within twenty four (24) hours in writing upon being contacted by the FDA or any other Federal, state, or local governmental agency for any regulatory purpose pertaining to this Agreement or to the Product, including any audit regarding safety or surveillance. Cephalon shall not respond to the FDA or such governmental agency before consulting with Xxxxxx'x Vice President, Corporate Quality Assurance and Regulatory Affairs and Xxxxxx'x Medical Services Director, unless, under the circumstances pursuant to which FDA or such other Federal, state, or local governmental agency contacts Cephalon, it is not practical or lawful for Cephalon to give Xxxxxx advance notice, in which event Cephalon shall inform Xxxxxx of such contact as soon as practical and lawful. Xxxxxx shall provide Cephalon with prompt written notice of any inquiries from, or positions taken by, the FDA or any other Federal, state, or local governmental agencies which may affect the co-promotion, sale or distribution of the Product. In addition, Xxxxxx shall keep Cephalon advised with respect to information concerning the safety or efficacy of the Products. Xxxxxx shall supply detailed information regarding such safety, efficacy, and medical information issues, and shall provide copies of safety reports as and when filed with the FDA.
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GOVERNMENTAL CONTACT REPORTING. Otsuka shall promptly notify ISTA upon being contacted by the FDA, or any competent governmental authority or agency within the Territory, for any regulatory purpose pertaining to this Agreement. Excepting routine matters and matters relating to applications for Regulatory Approval, Otsuka shall not respond to the authority or agency before consulting with ISTA, unless, under the circumstances pursuant to which the authority or agency contacts Otsuka, it is not practical or lawful for Otsuka to give ISTA advance notice. In any event, Otsuka shall inform ISTA of such contact as soon as practical and lawful. Each Party shall keep the other Party advised with respect to information concerning the safety or efficacy of any Product, including but not limited to providing, within five (5) business days or seven (7) calendar days, whichever is greater, of the creation or receipt thereof, all information regarding such safety, efficacy and medical information issues and copies of safety reports filed with the FDA or any authority or agency inside or outside the Territory.
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GOVERNMENTAL CONTACT REPORTING. Each Party shall notify the other in writing no later than three (3) business days (earlier if necessary to permit the other Party to consult in accordance with the terms of this Agreement) of being contacted by the FDA or any other Governmental Authority for any purpose pertaining to this Agreement or to the marketing or promotion of the Product, including without limitation any audit regarding safety or surveillance. Sirtex shall not respond to the FDA or such other Governmental Authority before consulting with OncoSec, unless, under the circumstances pursuant to which FDA or such other Governmental Authority contacts Sirtex, it is not lawful or practicable to give OncoSec advance notice, in which event Sirtex shall inform OncoSec of such contact as soon as lawful or practicable. Except where precluded by any deadline imposed by FDA or any other Governmental Authority, and in such case, as soon as reasonably practicable, OncoSec will consult with Sirtex with respect to matters that relate to the Product and are reasonably likely to have a material impact on Sirtex’s activities and obligations under this Agreement prior to any meeting or other contact with FDA or any other Governmental Authority, and shall forward to Sirtex a copy of any letter notification or report relating to such matter that is sent by OncoSec to FDA or any other Governmental Authority upon submission or earlier if permissible as provided herein. All reporting to and consultation with each Party relating to regulatory matters shall be made to such individual as designated by such Party to the other in writing. To the extent lawful, OncoSec shall have the right to participate in any communication or meeting required of Sirtex by FDA or any other Governmental Authority relating to any Product co-promoted pursuant to this Agreement.
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GOVERNMENTAL CONTACT REPORTING. Each Party shall promptly notify the other Party, as well as such other Party's general counsel, as from time to time made know to such Party, upon being contracted by the FDA or any other federal, state or local governmental agency for any regulatory purpose pertaining to this Agreement or to the Products. If practical the Party receiving such contact shall notify the other Party within twenty-four (24) hours. The Party receiving notice from such agency shall provide the other Party with prompt written notice of any inquiries from, or positions taken by, the FDA or any other federal, state or local governmental agencies which may affect the co-promotion or distribution of any Product. Product Registration. During the Term, the holder of the ANDA shall, at its own expense, obtain and thereafter maintain all regulatory approvals necessary for the marketing of each of the Products in the Territory. The holder of the ANDA shall maintain product and establishment regulations under 21 C.F.R. Part 207, Subparts C and D, for the Products. Records Retention. Each Party shall keep for five (5) years (or longer, if required by any regulatory authorities) after termination of this Agreement records of all Product sales and customers sufficient to adequately administer a recall of any Product and to fully cooperate in any decision by the Parties to recall, retrieve and/or replace any Product.
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Related to GOVERNMENTAL CONTACT REPORTING

  • Contract Reporting The Contractor shall report information on orders received from Customers associated with this Contract. No price adjustments will be considered for any Contractor who has outstanding reports, or any other documentation required under this Contract. The Contractor shall submit reports in accordance with the following schedule: MFMP Transaction Fee Report Calendar month 15 calendar days after the end of each month Quarterly Sales Report State’s Fiscal Quarter 30 calendar days after close of the period Diversity Report(submitted to the Customer) State Fiscal Year 30 Business Days after close of the period Preferred Pricing Affidavit (in accordance with the Special Contract Conditions) Annual Contract Anniversary Date

  • Governmental Compliance The Tenant Improvements shall comply in all respects with the following: (i) the Code and other state, federal, city or quasi-governmental laws, codes, ordinances and regulations, as each may apply according to the rulings of the controlling public official, agent or other person; (ii) applicable standards of the American Insurance Association (formerly, the National Board of Fire Underwriters) and the National Electrical Code; and (iii) building material manufacturer’s specifications.

  • Litigation Reporting If Contractor is served with a pleading or other document in connection with an action before a court or other administrative decision making body, and such pleading or document relates to this Participating Addendum or may affect Contractor’s ability to perform its obligations under this Participating Addendum, Contractor shall, within 10 days after being served, notify the State of such action and deliver copies of such pleading or document to the State’s primary contact identified in §5 of the Participating Addendum .

  • Information Reporting We may report your performance under this Agreement to credit reporting agencies, including your failure to make minimum payments on time. A negative credit report may significantly harm your ability to obtain credit from other sources. We may also obtain follow-up credit reports on you (for example, when we review your Account for a credit line increase). We may exchange information about you or your Account with our affiliates, and, to the extent permitted by law, with other third parties. However, if you prefer that we not share such information with our affiliate companies, just call us at (000) 000-0000 or outside the Albuquerque area, 0-000-000-0000. You may also write to us at Nusenda Federal Credit Union, P.O. Box 8530, Albuquerque, New Mexico 87198. Closing Your Account. You may close your Account at any time by notifying us in writing. However, you remain responsible to pay the balance according to the terms of this Agreement. We may close your Account or suspend your Account privileges at any time without prior notice. We may also reissue a different Card, Account number, or different checks at any time. You must return the Card or the checks to us upon request. Lost or Stolen Cards. If any Card, Account Number or PIN is lost or stolen, or if you think someone used or may use them without your permission, notify us at once by calling the telephone number shown on the billing statement or by calling 0-000-000-0000. We may require you to provide certain information in writing to help us find out what happened. Do not use the Card after we've been notified, even if it is found or returned. You will not be liable for any unauthorized purchases or cash advances made after we've been notified of the loss or the theft; however, you must identify for us the charges on the billing statement that were not made by you or someone authorized by you, and from which you received no benefit. Credit Authorizations. We are not responsible if we do not approve a purchase or cash advance on your Account, or if a third party refuses to accept or honor the Card, even if you have sufficient credit available. We may limit the number of purchases or cash advances which may be approved in one day. If we detect unusual or suspicious activity on your Account, we may temporarily suspend your credit privileges until we can verify the activity. We may approve purchases or cash advances that cause the balance to exceed your credit line without waiving any of our rights under the Agreement. Waiver. Our failure to exercise, or our delay in exercising any of our rights under this Agreement for any reason does not mean that we will be unable to exercise these rights later.

  • Commission Reporting (a) The Trust Administrator, each Servicer and the Master Servicer shall reasonably cooperate with the Depositor in connection with the Trust’s satisfying the reporting requirements under the Exchange Act. The Trust Administrator shall prepare on behalf of the Depositor any Forms 8-K and 10-K customary for similar securities as required by the Exchange Act and the rules and regulations of the Commission thereunder, and the Depositor shall sign and the Trust Administrator shall file (via XXXXX) such Forms on behalf of the Depositor. The Depositor hereby grants to the Trust Administrator a limited power of attorney to execute and file each such document on behalf of the Depositor. Such power of attorney shall continue until the earlier of (i) receipt by the Trust Administrator from the Depositor of written termination of such power of attorney and (ii) the termination of the Trust. (b) Each Form 8-K shall be filed by the Trust Administrator within 15 days after each Distribution Date, with a copy of the statement to the Certificateholders for such Distribution Date as an exhibit thereto. Prior to March 31st of the calendar year following the calendar year during which the Closing Date occurs (or such earlier date as may be required by the Exchange Act and the rules and regulations of the Commission), the Trust Administrator shall file a Form 10-K, in substance as required by applicable law or applicable Commission staff’s interpretations. Such Form 10-K shall include as exhibits, each Servicer’s and the Master Servicer’s annual statement of compliance described under Section 3.16 and the accountant’s report described under Section 3.17, in each case to the extent they have been timely delivered to the Trust Administrator. If they are not so timely delivered, the Trust Administrator shall file an amended Form 10-K including such documents as exhibits promptly after they are delivered to the Trust Administrator. The Trust Administrator shall have no liability with respect to any failure to properly or timely prepare or file such periodic reports resulting from or relating to the Trust Administrator’s inability or failure to obtain any information not resulting from its own negligence or willful misconduct. The Form 10-K shall also include a certification in the form attached hereto as Exhibit T (the “Depositor Certification”), which shall be signed by the senior officer of the Depositor in charge of securitization. The Trust Administrator shall have no responsibility to file any items other than those specified in this Section 10.13. (c) Not later than 15 calendar days before the date on which the Depositor’s annual report on Form 10-K is required to be filed in accordance with the Exchange Act and the rules and regulations of the Commission (or, if such day is not a Business Day, the immediately preceding Business Day), the Trust Administrator shall sign a certification in the form attached hereto as Exhibit U (the “Trust Administrator Certification”) for the benefit of the Depositor and its officers, directors and affiliates regarding certain aspects of items 1 through 3 of the Depositor Certification. In addition, the Trust Administrator shall, subject to the provisions of Sections 10.01 and 10.02 hereof, indemnify and hold harmless the Depositor and each Person, if any, who “controls” the Depositor within the meaning of the 1933 Act and its officers, directors and affiliates from and against any losses, damages, penalties, fines, forfeitures, reasonable and necessary legal fees and related costs, judgments and other costs and expenses arising out of or based upon a breach of the Trust Administrator’s obligations under this Section 10.13 or any inaccuracy made in the Trust Administrator Certification. If the indemnification provided for in this Section 10.13(c) is unavailable or insufficient to hold harmless such Persons, then the Trust Administrator shall contribute to the amount paid or payable by such Persons as a result of the losses, claims, damages or liabilities of such Persons in such proportion as is appropriate to reflect the relative fault of the Depositor on the one hand and the Trust Administrator on the other. The Trust Administrator acknowledges that the Depositor is relying on the Trust Administrator’s performance of its obligations under this Section 10.13 in order to perform its obligations under Section 10.13(b) above. (d) (i) Not later than 15 calendar days before the date on which the Depositor’s annual report on Form 10-K is required to be filed in accordance with the Exchange Act and the rules and regulations of the Commission (or, if such day is not a Business Day, the immediately preceding Business Day), the Master Servicer will deliver to the Depositor and the Trust Administrator an Officer’s Certificate for the prior calendar year in substantially the form of Exhibit W-1 to this Agreement. The Master Servicer agrees to indemnify and hold harmless each of the Depositor, the Trust Administrator and each Person, if any, who “controls” the Depositor or the Trust Administrator within the meaning of the 1933 Act and their respective officers and directors against any and all losses, penalties, fines, forfeitures, legal fees and related costs, judgments and any other costs, fees and expenses that such Person may sustain arising out of third party claims based on (i) the failure of the Master Servicer to deliver or cause to be delivered when required any Officer’s Certificate required pursuant to this Section 10.13(d)(i), or (ii) any material misstatement or omission contained in any Officer’s Certificate provided pursuant to this Section 10.13(d)(i). If an event occurs that would otherwise result in an indemnification obligation under clauses (i) or (ii) above, but the indemnification provided for in this Section 10.13(d)(i) by the Master Servicer is unavailable or insufficient to hold harmless such Persons, then the Master Servicer shall contribute to the amount paid or payable by such Persons as a result of the losses, claims, damages or liabilities of such Persons in such proportion as is appropriate to reflect the relative fault of the Depositor or Trust Administrator on the one hand and the Master Servicer on the other. The Master Servicer acknowledges that the Depositor and the Trust Administrator are relying on the Master Servicer’s performance of its obligations under this Agreement in order to perform their respective obligations under this Section 10.13.

  • Project Reports The Recipient shall monitor and evaluate the progress of the Project and prepare Project Reports in accordance with the provisions of Section 4.08 of the General Conditions and on the basis of the indicators agreed with the Association. Each Project Report shall cover the period of one calendar semester, and shall be furnished to the Association not later than one month after the end of the period covered by such report.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Informational Tax Reporting The Assuming Institution agrees to perform all obligations of the Failed Bank with respect to Federal and State income tax informational reporting related to (i) the Assets and the Liabilities Assumed, (ii) deposit accounts that were closed and loans that were paid off or collateral obtained with respect thereto prior to Bank Closing, (iii) miscellaneous payments made to vendors of the Failed Bank, and (iv) any other asset or liability of the Failed Bank, including, without limitation, loans not purchased and Deposits not assumed by the Assuming Institution, as may be required by the Receiver.

  • Progress Reporting 5. The IP will submit to UNICEF narrative progress reports against the planned activities contained in the Programme Document, using the PDPR. Unless otherwise agreed between the Parties in writing, these reports will be submitted at the end of every Quarter. The final report will be submitted no later than thirty (30) calendar days after the end the Programme and will be provided together with the FACE form.

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