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. 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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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.
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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. 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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Related to GOVERNMENTAL CONTACT REPORTING

  • 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.

  • Information Reporting (a) The Fund agrees that, during the Current Special Rate Period and so long as BANA or any Affiliate thereof is the beneficial owner of any Outstanding VRDP Shares, it will deliver, or direct the Tender and Paying Agent to deliver, to BANA and any such Affiliate:

  • 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.

  • Governmental Reporting Nothing in this Agreement is intended to interfere with or discourage the Executive’s good faith disclosure related to a suspected violation of federal or state law or regulation to any governmental agency or entity or making other disclosures that are protected under the whistleblower provisions of federal or state law or regulation. The Executive cannot and will not be held criminally or civilly liable under any federal or state trade secret law for disclosing otherwise protected trade secrets and/or confidential or proprietary information so long as the disclosure is made in (1) confidence to a federal, state, or local government official, directly or indirectly, or to an attorney and solely for the purpose of reporting or investigating a suspected violation of law; or (2) a complaint or other document filed in a lawsuit or other proceeding, so long as such filing is made under seal. Company will not retaliate against the Executive in any way for a disclosure made pursuant to this Section. Further, in the event the Executive makes such a disclosure, and files a lawsuit against the Company alleging that the Company retaliated against the Executive because of the disclosure, the Executive may disclose the relevant trade secret or confidential information to the Executive’s attorney, and may use the same in the court proceeding only if (1) the Executive ensures that any court filing that includes the trade secret or confidential information at issue is made under seal; and (2) the Executive does not otherwise disclose the trade secret or confidential information except as required by court order.

  • 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.

  • Tax Reporting (1) Prepare and file on a timely basis appropriate federal and state tax returns including, without limitation, Forms 1120/8613, with any necessary schedules.

  • Transaction Reports Subadviser shall provide Investment Manager a daily trade file with information relating to all transactions concerning the allocated portion of the Fund’s assets for which Subadviser is responsible and shall provide Investment Manager with such other information regarding the Fund upon Investment Manager’s reasonable request. Subadviser shall affirm or send a trade file of these transactions as instruction to the custodian of the Fund.

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