Complaints Handling and Reporting Sample Clauses

Complaints Handling and Reporting. The Parties shall agree upon a procedure for handling complaints and device malfunction reports in the Quality Agreement.
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Complaints Handling and Reporting. Notifications, communications, handling and reporting of the Licensed Product complaints and adverse events shall be addressed under the Pharmacovigilance Agreement, provided that such Pharmacovigilance Agreement shall provide that Lian must (i) investigate any complaints or issues relating to the Licensed Products in the Territory and notify Nanobiotix thereof; (ii) not admit liability or settle any dispute or complaint that imposes any liability on or admits any fault of Nanobiotix without Nanobiotix’s prior written consent; and (iii) [***].
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Complaints Handling and Reporting. (a) Promptly following the Effective Date, the Parties shall coordinate to ensure that Teva shall be solely responsible in the U.S. for (i) receiving all Product complaints and reports of Product adverse events and malfunctions, and all communications with complainants and (ii) filing all required regulatory reports for the Product or the Regulatory Approvals in the U.S., including any medical device reports or other adverse event reports relating to the Product. To the extent either Party has or receives any information regarding any complaints or reports of adverse events or malfunctions relating to the Product, each Party shall provide the other Party with all such information in accordance with Section 4.4(d). [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (b) Promptly following Teva’s notification and documentation of a complaint or report related to the manufacture of the Product to Alexza, Alexza shall conduct an investigation for any complaint or report of the Product’s adverse event or malfunction that relates to the manufacture of the Product by Alexza in accordance with the Quality Agreement and cGMP. Alexza shall use Commercially Reasonable Efforts to provide Teva with a written report of investigation within [ * ] days, or other timeframe as agreed upon by both Parties. If Alexza is not able to complete the investigation within [ * ] days due to technical issues related to the investigation (e.g., extended testing of the complaint sample), Alexza shall issue an interim investigation report to Teva within [ * ] days (or other agreed timeframe), summarizing the investigation findings to date and plans to complete the investigation, including an estimated timeline.
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Complaints Handling and Reporting. (a) BLS shall be solely responsible for in the Field in the Territory (i) receiving all Product complaints and reports of Product adverse events and malfunctions, and all communications with complainants and (ii) filing all required regulatory reports for the Product or the Marketing Approvals in the Territory, including, without limitation, any medical device reports or other adverse event reports relating to the Product. To the extent Alexza has or receives any information regarding any complaints or reports of adverse events or malfunctions relating to the Product, Alexza shall immediately, and in no event later than [ * ] after receipt by Alexza, provide BLS with all such information. (b) Promptly following BLS’ notification and documentation of a complaint or report related to the Manufacture of Product to Alexza, Alexza shall conduct an investigation for any complaint or report of a Product’s adverse event or malfunction that relates to the Manufacture of the Product by Alexza in accordance with the Quality Agreement and cGMP. Alexza shall use Commercially Reasonable Efforts to provide BLS with a written report of investigation within [ * ], or other timeframe as agreed upon by both Parties. If Alexza is not able to complete the investigation within [ * ] due to technical issues related to the investigation (e.g., extended testing of the complaint sample), Alexza shall issue an interim investigation report to BLS within [ * ] (or other agreed timeframe), summarizing the investigation findings to date and plans to complete the investigation, including an estimated timeline.
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Complaints Handling and Reporting. (a) Xxxxxx shall be solely responsible in the Territory for (i) receiving all Product complaints and reports of Product adverse events and malfunctions, and all communications with complainants and (ii) filing all required regulatory reports for the Product or the Launch Authorizations in the Territory, including, without limitation, any medical device reports or other adverse event reports relating to the Product, and shall provide such information to Alexza promptly, and in no event later than [ * ] ([ * ]) days after receipt by Xxxxxx. To the extent Alexza has or receives any information regarding any complaints or reports of adverse events or malfunctions relating to the Product that it obtains other than pursuant to the preceding sentence, Alexza shall promptly, and in no event later than [ * ] after receipt of such information by Alexza, provide Xxxxxx with all such information. (b) Promptly following Xxxxxx’x notification and documentation of a complaint or report related to the manufacture of the Product to Alexza, Alexza shall conduct an investigation for any complaint or report of the Product’s adverse event or malfunction that relates to the manufacture of the Product by Alexza in accordance with the Quality Agreement [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Related to Complaints Handling and Reporting

  • 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.

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

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

  • Accounting and Reporting 5.1. Issuer agrees to furnish Custodian with the income tax cost basis and dates of acquisition of all Securities held in Issuer’s Account to be carried on its records. If Issuer does not furnish such information, Custodian shall carry the Securities at any such nominal value it determines, such value to be for bookkeeping purposes only. All statements and reporting of any matters requiring this information will use this nominal value. Custodian shall have no duty to verify the accuracy of the tax cost basis or dates of acquisition furnished by Issuer. 5.0. Xx the extent that Custodian has agreed to provide pricing or other information services, Custodian is authorized to utilize any vendor (including brokers and dealers of securities and pricing services embedded in Custodian’s securities processing or accounting systems) reasonably believed by Custodian to be reliable to provide such information. Issuer understands that certain pricing information with respect to complex financial instruments, including, without limitation, derivatives, may be based on calculated amounts rather than actual market transactions and may not reflect actual market values, and that the variance between such calculated amounts and actual market values may or may not be material. If Issuer does not provide such information, Custodian shall use the cost or nominal value for such Securities, solely for administrative convenience. Pursuant to Section 13 Issuer shall release, indemnify, defend and hold Custodian harmless, and Custodian shall be without liability, for any Losses incurred as a result of errors or omissions with respect to any pricing or other information utilized by Custodian hereunder. Custodian shall have no responsibility or duty to ascertain or authenticate the value of pricing applied to any Securities. 5.3. Custodian shall provide Issuer account statements for its Account at least monthly via electronic means or as otherwise as agreed to by Issuer and Custodian showing all income and Issuer transactions. Issuer may approve or disapprove any such statement within 10 days of its receipt, and if no written objections are received within the 10-day period, such statement of account shall be deemed approved by Issuer. 5.4. Issuer or its designee (at their sole cost and expense) shall have access upon reasonable prior notice to Custodian during regular business hours to the books and records relating to Issuer’s Account, or shall be given confirmation of the contents of the books and records maintained by Custodian to verify the accuracy of such books and records. Custodian shall notify Issuer promptly of any Law that would restrict such access or confirmation. Custodian shall not be under any obligation to retain records in paper form.

  • 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.

  • Documenting and Reporting Breaches 6.1 Business Associate shall report to Covered Entity any Breach of Unsecured PHI, including Breaches reported to it by a Subcontractor, as soon as it (or any of its employees or agents) becomes aware of any such Breach, and in no case later than two (2) business days after it (or any of its employees or agents) becomes aware of the Breach, except when a law enforcement official determines that a notification would impede a criminal investigation or cause damage to national security. 6.2 Business Associate shall provide Covered Entity with the names of the individuals whose Unsecured PHI has been, or is reasonably believed to have been, the subject of the Breach and any other available information that is required to be given to the affected individuals, as set forth in 45 CFR § 164.404(c), and, if requested by Covered Entity, information necessary for Covered Entity to investigate the impermissible use or disclosure. Business Associate shall continue to provide to Covered Entity information concerning the Breach as it becomes available to it. Business Associate shall require its Subcontractor(s) to agree to these same terms and conditions. 6.3 When Business Associate determines that an impermissible acquisition, use or disclosure of PHI by a member of its workforce is not a Breach, as that term is defined in 45 CFR § 164.402, and therefore does not necessitate notice to the impacted individual(s), it shall document its assessment of risk, conducted as set forth in 45 CFR § 402(2). When requested by Covered Entity, Business Associate shall make its risk assessments available to Covered Entity. It shall also provide Covered Entity with 1) the name of the person(s) making the assessment, 2) a brief summary of the facts, and 3) a brief statement of the reasons supporting the determination of low probability that the PHI had been compromised. When a breach is the responsibility of a member of its Subcontractor’s workforce, Business Associate shall either 1) conduct its own risk assessment and draft a summary of the event and assessment or 2) require its Subcontractor to conduct the assessment and draft a summary of the event. In either case, Business Associate shall make these assessments and reports available to Covered Entity. 6.4 Business Associate shall require, by contract, a Subcontractor to report to Business Associate and Covered Entity any Breach of which the Subcontractor becomes aware, no later than two (2) business days after becomes aware of the Breach.

  • 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.

  • Accounting and Reports (a) The Company shall adopt for tax accounting purposes any accounting method that the Board shall decide in its sole discretion is in the best interests of the Company. The Company’s accounts shall be maintained in U.S. currency. (b) After the end of each Taxable Year, the Company shall furnish to each Member such information regarding the operation of the Company and such Member’s Interest as is necessary for Members to complete U.S. federal and state income tax or information returns and any other tax information required by U.S. federal and state law. (c) Except as otherwise required by the 1940 Act, or as may otherwise be permitted by rule, regulation or order, within 60 days after the close of the period for which a report required under this Section 7.1 is being made, the Company shall furnish to each Member an unaudited semi-annual report and an audited annual report containing the information required by such Act. The Company shall cause financial statements contained in each annual report furnished hereunder to be accompanied by a certificate of independent public accountants based upon an audit performed in accordance with generally accepted accounting principles. The Company may furnish to each Member such other periodic reports as it deems necessary or appropriate in its discretion.

  • PERFORMANCE MONITORING AND REPORTING Performance indicators

  • Data Collection and Reporting 1. Grantee shall develop and use a local reporting unit that will provide an assigned location for all clients served within the Hospital. This information shall also be entered into Client Assignment and Registration (CARE)when reporting on beds utilized at the Hospital. 2. Grantee shall budget and report expenditure data on the CARE Report III, incorporated by reference and posted at: xxxxx://xxx.xxx.xxxxx.xxx/doing-business-hhs/provider- portals/behavioral-health-services-providers/behavioral-health-provider- resources/community-mental-health-contracts, within the Community Hospital strategy C.2.1.1 using line 764 - Project Private Beds. 3. Grantee shall ensure that patient registration, diagnostics, admission and discharge data is reported by using the CARE screens and action codes listed below: a. Screen: Campus-Based Assignments (Add/Change/Delete), Action Code: 305; b. Screen: Campus-Based Discharge/Community Placement (Add/Change/Delete), Action Code: 310; c. Screen: Joint Community Support Plan (Add/Change/Delete), Action Code: 312; d. Screen: Register Client, Action Code: 325; e. Screen: Diagnostics (Add/Change/Delete), Action Code: 330; f. Screen: Voluntary Admission and Commitment (Add/Change/Delete), Action Code 332; g. Screen: Campus-Based Residential Xxxx/Dorm (Add/Change/Delete), Action Code 615; and h. Screen: MH Bed Allocation Exception (Add/Change/Delete), Action Code 345. For details related to the use of these screens and action codes, Grantee can refer to the CARE Reference Manual which can be found under the CARE (WebCARE) section on the portal at: xxxxx://xxxxxxxxx.xxx.xxxxx.xx.xx/helpGuide/Content/16_CARE/CAREWebCARE%20Refere nce%20Manual.htm

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