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. 1.2 The same time frames apply to the follow-up reports. 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 [ * ] = 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. 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. 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. 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 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 
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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 The Accredited Entity shall ensure that:

  • Inspection and Reporting Each Grantor shall permit the Collateral Agent, or any agent or representatives thereof or such professionals or other Persons as the Collateral Agent may designate, not more than once a year in the absence of an Event of Default, (i) to examine and make copies of and abstracts from such 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 such Grantor from time to time, (iii) to conduct audits, physical counts, appraisals and/or valuations, examinations at the locations of such Grantor. Each Grantor shall also permit the Collateral Agent, or any agent or representatives thereof or such professionals or other Persons as the Collateral Agent may designate to discuss such Grantor's affairs, finances and accounts with any of its officers subject to the execution by the Collateral Agent or its designee(s) of a mutually agreeable confidentiality agreement.

  • 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.

  • Safeguards Monitoring and Reporting The Borrower shall do the following or cause the Project Executing Agency to do the following:

  • 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 The Programme Operator shall monitor, record and report on progress towards the programme’s outcomes in accordance with the provisions contained in the legal framework. The Programme Operator shall ensure that suitable and sufficient monitoring and reporting arrangements are made with the project promoters in order to enable the Programme Operator and the National Focal Point to meet its obligations to the Donors. When reporting on progress achieved in Annual and Final Programme Reports, the Programme Operator shall disaggregate results achieved as appropriate and in accordance with instructions received from the FMO.

  • 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.

  • 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.

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