Expedited Reporting Sample Clauses

The Expedited Reporting clause requires parties to promptly notify each other of certain significant events or developments, often within a shortened or specifically defined timeframe. This typically applies to situations such as adverse events, breaches, or regulatory issues, where rapid communication is critical. By mandating swift disclosure, the clause ensures that all parties can respond quickly to urgent matters, thereby minimizing risks and facilitating timely decision-making.
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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.
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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. 1.2 The same time frames apply to the follow-up reports. [ * ] = 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. 1.3 The Licensee will report to its Authorities all Serious Adverse Drug Reactions occurring in the DUSA Territory regarding the Product, and will send copies to the Licensor. 1.4 The Licensor will report to the Licensee all Serious Adverse Drug Reactions occurring in the Photonamic Territory and [ * ] regarding any other Photonamic medicines containing the same active compound as the Product when transmitted by Photonamic's Licensees, for purposes of information. 1.5 The Licensor will send to the Licensee copies of all reports of Serious Adverse Drug Reactions (expected and unexpected) occurring outside the European Union regarding any other Photonamic medicines containing the same active compound as the Product. The Licensee will report the Unexpected Serious Adverse Drug Reactions to its Authorities, using medac's case number. 1.6 Each party shall ensure parallel reporting to the Regulatory Authorities of all local and foreign expedited reports in their respective countries in which a marketing authorization or a marketing license is granted, according to the requirements of the applicable laws and regulations in such countries. 1.7 Expedited reporting between the parties shall be conducted according to the definitions of The Rules Governing Medicinal Products in the European Union Volume 9 - Pharmacovigilance; provided, however, that if a Regulatory Authority has a requirement which is stricter than the requirements of The Rules Governing Medicinal Products in the European Union Volume 9 - Pharmacovigilance, the parties will comply with such stricter requirement. The parties shall promptly inform each other in writing about such stricter requirements applicable in their respective territory, especially after the requirements have been changed. 1.8 Both parties have agreed upon the format of the suspected Adverse Drug Reaction report and an e-mail or fax transmission mode. 1.9 The safety reference Product Information used for determining the labeling of a reaction is the current version of the Su...
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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. 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. 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. 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. 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 of SUN. SUN will have the responsibility of maintaining and updating Product label (P...
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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.
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Expedited Reporting. The Sponsor will report all relevant information about SUSARs that are fatal or life-threatening as soon as possible to the FDA and in any case no later than 7 days after knowledge by the Sponsor/designee of such a case, and the relevant follow-up information will subsequently be communicated within an additional 8 days. All other SUSARs will be reported to the FDA as soon as possible but within a maximum of 15 days of first knowledge by the Sponsor/designee. The Sponsor/designee will also inform all Investigators as required.
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Expedited Reporting 
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Related to Expedited Reporting

  • Required Reporting Pursuant to RCW 67.28.1816(2)(c)(i): All recipients must submit a report to the COUNTY by December 15, 2020 describing the actual number of people traveling for business or pleasure on a trip during 2020: (A) Away from their place of residence or business and staying overnight in Pacific County in paid accommodations; (B) To a place fifty miles or more one way from their place of residence or business to Pacific County for the day or staying overnight; or (C) From another country or state outside of their place of residence or their business to Pacific County. The ORGANIZATION is also required to submit a final actual expenditure report completed to the best of your ability by December 15, 2020 with the final voucher to receive full payment.

  • 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 .

  • Record Keeping and Reporting 7.1 The Supplier must ensure that suitably qualified representatives attend progress meetings with the Buyer and provide progress reports when specified in the Order Form. 7.2 The Supplier must keep and maintain full and accurate records and accounts on everything to do with the Contract for 7 years after the date of expiry or termination of the Contract and in accordance with the UK GDPR or the EU GDPR as the context requires. 7.3 The Supplier must allow any auditor appointed by the Buyer access to its premises to verify all contract accounts and records of everything to do with the Contract and provide copies for the Audit. 7.4 During an Audit, the Supplier must provide information to the auditor and reasonable co-operation at their request. 7.5 The Parties will bear their own costs when an Audit is undertaken unless the Audit identifies a material default by the Supplier, in which case the Supplier will repay the Buyer's reasonable costs in connection with the Audit. 7.6 If the Supplier is not providing any of the Deliverables, or is unable to provide them, it must immediately: (a) tell the Buyer and give reasons; (b) propose corrective action; and (c) provide a deadline for completing the corrective action. 7.7 If the Buyer, acting reasonably, is concerned as to the financial stability of the Supplier such that it may impact on the continued performance of the Contract then the Buyer may: (a) require that the Supplier provide to the Buyer (for its approval) a plan setting out how the Supplier will ensure continued performance of the Contract and the Supplier will make changes to such plan as reasonably required by the Buyer and once it is agreed then the Supplier shall act in accordance with such plan and report to the Buyer on demand; and (b) if the Supplier fails to provide a plan or fails to agree any changes which are requested by the Buyer or fails to implement or provide updates on progress with the plan, terminate the Contract immediately for material breach (or on such date as the Buyer notifies). 7.8 If there is a material default, the Supplier must notify the Buyer within 3 Working Days of the Supplier becoming aware of the material default. The Buyer may request that the Supplier provide a Rectification Plan within 10 Working Days of the Buyer’s request alongside any additional documentation that the Buyer requires. Once such Rectification Plan is agreed between the Parties (without the Buyer limiting its rights) the Supplier must immediately start work on the actions in the Rectification Plan at its own cost.

  • 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.