Expedited Reporting Sample Clauses

Expedited Reporting. 1.1 Each party shall report to the other party Serious Adverse Drug Reactions regarding the Product within a maximum of [ * ] from being received by either party.
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Expedited Reporting. SUSARs are subject to expedited reporting. The process will be further described in the Study Specific Safety Management Plan. The Sponsor has authorised the CRO to execute its responsibilities for expedited safety report submission to the appropriate regulatory authorities within specific time periods of being notified of the event (within 7 or 15 calendar days depending the character of the SUSAR); therefore, it is important that the Investigator submit additional information requested as soon as it becomes available.
Expedited Reporting. ‌ All SAEs must be reported to Philips within 24 hours of the Investigator becoming aware of the event. Additionally, any medical device deficiencies that might have led to a SAE if: • suitable action had not been taken; • intervention had not been made; or • circumstances had been less fortunate must also be reported to Philips within 24 hours of the Investigator becoming aware of the event. Furthermore, any new findings or updates in relation to previously reported SAE or device deficiencies which may have potentially led to SAE must be reported to Philips within 24 hours of the Investigator becoming aware of the new findings or updates.
Expedited Reporting. Supplier is responsible for determining seriousness, expectedness per the package insert and the company's opinion of relatedness. Supplier is responsible for preparing any regulatory forms for submission in the Territory. Teva will make the determination as to whether a report meets criteria for expedited reporting to regulatory authorities in the Territory. Teva will be responsible for submission of expedited reports to the regulatory authorities in the Territory. Both parties will submit the appropriate reports of individual case reports to the regulatory authorities of the countries in their territories within the time frames required by the current legislation in each ountry.
Expedited Reporting. The responsibility for expedited reporting of AEs relating to the Product(s) covered by this SDEA to regulatory authority in the Territory, as per applicable regulatory requirements in the Territory, will be that of SUNCMS and/or its delegate where the Product is available to patients and/or with the written Letter of Authorization/Delegation from the MAH SUN requested by applicable regulations in the Territory. Periodic Safety Reporting SUNCMS will be responsible for generation and submission of Periodic Safety Reports with the Product(s) covered by this SDEA as per applicable regulatory requirements in the Territory. SUN will be provided promptly, on request, with all the required information e.g. sales data to generate the report by CMS.. Information contained in Periodic Safety Report is the property of the Party generating them and proprietary rights will be respected. Each Party will keep the other informed of any recall related to Product(s) covered under the Business Contracts and any safety-related queries from regulatory authorities and co-operate in responding promptly. Risk Management Plan SUN will be responsible for preparing, maintaining, and updating and submitting Risk Management Plan in the territories as per applicable regulatory requirements. CMS will provide inputs to SUN for development and submission of a Risk Management Plan within the timelines in which information is requested by SUN. Signal Management SUN will be responsible for global safety signal management, as per international regulations, and CMS will be responsible for local safety signal management as per applicable regulatory requirements in the Territory. SUN will communicate any important identified risk with the Product(s) to CMS upon its confirmation. If CMS identifies any identified risk with the Product(s), it will promptly inform SUN and will provide reasonable further assistance in the signal evaluation, if needed. Major Safety Issues For actions relating to major safety issues (e.g. regulatory action, recall, suspension or stopping of clinical studies due to safety reasons) with the productProduct(s) covered by the agreementSDEA, SUN and CMS will inform each other immediately within TWO (2) business days. Each party will arrange to have ready access, at all times, to detailed distribution information on the product(s), in order to facilitate recalls/withdrawals, if this should become necessary. Any public statement, if required, shall be issued at the discretion ...

Related to Expedited Reporting

  • Record Keeping and Reporting 15.01 The Accredited Entity shall ensure that:

  • Inspection and Reporting Each Grantor shall permit the Collateral Agent, or any agent or representatives thereof or such attorneys, accountant or other professionals or other Persons as the Collateral Agent may designate (at Grantors’ sole cost and expense) (i) to examine and make copies of and abstracts from any Grantor’s Records and books of account, (ii) to visit and inspect its properties, (iii) to verify materials, leases, Instruments, Accounts, Inventory and other assets of any Grantor from time to time, and (iv) to conduct audits, physical counts, appraisals, valuations and/or examinations at the locations of any Grantor. Each Grantor shall also permit the Collateral Agent, or any agent or representatives thereof or such attorneys, accountants or other professionals or other Persons as the Collateral Agent may designate to discuss such Grantor’s affairs, finances and accounts with any of its directors, officers, managerial employees, attorneys, independent accountants or any of its other representatives. Without limiting the foregoing, the Collateral Agent may, at any time, in the Collateral Agent’s own name, in the name of a nominee of the Collateral Agent, or in the name of any Grantor communicate (by mail, telephone, facsimile or otherwise) with the Account Debtors of such Grantor, parties to contracts with such Grantor and/or obligors in respect of Instruments or Pledged Debt of such Grantor to verify with such Persons, to the Collateral Agent’s satisfaction, the existence, amount, terms of, and any other matter relating to, Accounts, Instruments, Pledged Debt, Chattel Paper, payment intangibles and/or other receivables.

  • Information and Reporting The Adviser shall provide the Trust and its respective officers with such periodic reports concerning the obligations the Adviser has assumed under this Agreement as the Trust may from time to time reasonably request.

  • IRS Reporting Ultimus will prepare and distribute appropriate Internal Revenue Service (“IRS”) forms for shareholder income and capital gains (including the calculation of qualified income), sale of fund shares, distributions from retirement accounts and education savings accounts, fair market value reporting on IRAs, contributions, rollovers and conversions to IRAs and education savings accounts and required minimum distribution notifications and issue tax withholding reports to the IRS.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower's part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower's part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Monitoring and Reporting 3.1 The Contractor shall provide workforce monitoring data as detailed in paragraph 3.2 of this Schedule 8. A template for data collected in paragraphs 3.2, 3.3 and 3.4 will be provided by the Authority. Completed templates for the Contractor and each Sub-contractor will be submitted by the Contractor with the Diversity and Equality Delivery Plan within six (6) Months of the Commencement Date and annually thereafter. Contractors are required to provide workforce monitoring data for the workforce involved in delivery of the Contract. Data relating to the wider Contractor workforce and wider Sub-contractors workforce would however be well received by the Authority. Contractors and any Sub-contractors are required to submit percentage figures only in response to paragraphs 3.2(a), 3.2(b) and 3.2(c).

  • Information and Reporting Requirements 63 7.1 Financial and Business Information.........................................................63 7.2

  • 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:

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

  • 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.

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