Duty to Report Incidents Sample Clauses

Duty to Report Incidents. GEMS-IT and Supplier shall inform each other in writing, within 5 business days from knowledge of a reportable event, of all incidents relating to the subject matter of the Agreement that must be reported according to the FDA Medical Device Reporting regulation (21 CFR Part 803) or the European Medical Device Vigilance regulations or that must be registered according to other national regulations such as Canadian medical device regulations, including without limitation incidents involving death or serious injury, malfunctions that, if recurrent, may cause or contribute to death or serious injury or other material quality problems or concerns. GEMS-IT will be responsible for reporting such incidents to the appropriate regulatory authority. Supplier shall fully cooperate with GEMS-IT as may be necessary to comply with any reporting obligations regarding such incidents or quality concerns.
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Duty to Report Incidents. Trinity Center shall immediately report to the City: (i) all incidences of observed or alleged criminal activity occurring at the Armory, or at any other location in connection with its performance of this Agreement, including the discovery of any illegal drugs or weapons. (ii) all incidents requiring any emergency response to the Armory (e.g. police, fire, ambulance, County health); and (iii) all incidents required to be reported to the National Guard in accordance with the attached Operating Plan.
Sample 1
Duty to Report Incidents. Without limiting the obligations of CoTherix and the Specialty Pharmacy Company under Section 4.8 above to notify Profile of all Device/Consumables Complaints (as defined in Section 4.8), CoTherix, the Specialty Pharmacy Company and Profile shall promptly inform each other of incidents, whether occurring in clinical trials or in patient use after the Commercial Availability Date, involving death or serious injury, malfunctions that, if recurrent, may cause or contribute to death or serious injury, or other material quality problems or material quality concerns. Each party shall fully cooperate with the other party to enable each party to comply with any reporting obligations regarding such incidents or quality concerns.
Sample 1
Duty to Report Incidents. Buyer and Seller shall inform each other in writing, within two (2) business days of becoming aware of a reportable event, in accordance with FDA Medical Device Reporting regulation (21 CFR Part 803) or the European Medical Device Vigilance regulations or that must be registered according to other national regulations such as Canadian medical devices regulations (SOR/98-282), including without limitation incidents involving death or serious injury, malfunctions that, if recurrent, may cause or contribute to death or serious injury or other material quality problems or concerns, of all incidents relating to the subject matter of the Agreement. Buyer will be responsible for reporting such incidents to the appropriate regulatory authority for the Custom Sensors. Seller will be responsible for reporting such incidents to the appropriate regulatory authority for all other Products. Both parties shall fully cooperate with each other as may be necessary to comply with any reporting obligations regarding such incidents or quality concerns. If FDA or other authorities contact either party to inquire about or investigate the Products sold to Buyer under this Agreement, the contacted party, unless required to maintain confidentiality by such authorities, shall inform the other party immediately thereof. The parties shall cooperate closely to clear any regulatory issues or potential regulatory issues promptly.
Sample 1

Related to Duty to Report Incidents

  • Duty to Report Tenant immediately shall report any problems immediately to Landlord. Even a few bedbugs can rapidly multiply to create a major infestation that can spread to other premises. Manager will then be given access to the leased premises for inspection within 24 hours of Tenant being given notice.

  • Duty to report Force Majeure Event 21.5.1 Upon occurrence of a Force Majeure Event, the Affected Party shall by notice report such occurrence to the other Party forthwith. Any notice pursuant hereto shall include full particulars of: (a) the nature and extent of each Force Majeure Event which is the subject of any claim for relief under this Article 21 with evidence in support thereof; (b) the estimated duration and the effect or probable effect which such Force Majeure Event is having or will have on the Affected Party’s performance of its obligations under this Agreement; (c) the measures which the Affected Party is taking or proposes to take for alleviating the impact of such Force Majeure Event; and (d) any other information relevant to the Affected Party’s claim. 21.5.2 The Affected Party shall not be entitled to any relief for or in respect of a Force Majeure Event unless it shall have notified the other Party of the occurrence of the Force Majeure Event as soon as reasonably practicable, and in any event no later than 10 (ten) days after the Affected Party knew, or ought reasonably to have known, of its occurrence, and shall have given particulars of the probable material effect that the Force Majeure Event is likely to have on the performance of its obligations under this Agreement. 21.5.3 For so long as the Affected Party continues to claim to be materially affected by such Force Majeure Event, it shall provide the other Party with regular (and not less than weekly) reports containing information as required by Clause 21.5.1, and such other information as the other Party may reasonably request the Affected Party to provide.

  • Failure to Report No compensation shall be granted for the total period of standby if the employee is unable to report for duty when required.

  • PROCEDURE FOR DEALING WITH SAFETY ISSUES OR INCIDENTS 11.1 The Employer, the Employees and the Union agree that for the purposes of s. 81 of the WHS Act matters about work health and safety arising at the workplace shall be resolved in accordance with this procedure. 11.2 The Parties agree that for the purposes of this procedure and s. 81(3) of the WHS Act the following persons shall be the representatives of the following parties: (a) the Principal Contractor (as defined in the WHS Act) - Site Manager or any other person nominated by the Principal Contractor (b) the Employers - the Site Manager or any other person nominated by the Employer(s) (c) The Employees - the Union or other representatives. (Collectively referred to as "Nominated Parties”) 11.3 The Nominated Parties agree that representatives shall be entitled to: (a) inspect any work system, plant, substance, structure, or other thing relevant to resolving the issue (b) consult with relevant Employees in relation to resolving the issue (c) consult with the relevant PCBU (as defined in the WHS Act) about resolving the issue (d) inspect and take copies of any document that is directly relevant to resolving the issue; and (e) advise any person whom the representative reasonably believes to be exposed to a serious risk to his or her health and safety, emanating from an immediate and imminent exposure to a hazard of that risk. 11.4 The Nominated Parties and/or their representatives may commence the procedure by informing, either by themselves or their representative, the other Parties and/or representatives that: (a) there is an issue to be resolved; and (b) the nature and scope of the issue. 11.5 As soon as the Parties and/or their representatives are informed of the issue, the Nominated Parties and/or their representatives must meet or communicate with each other to attempt to resolve the issue. 11.6 The Nominated Parties and/or their representatives must have regard to all relevant matters including: (a) the degree and imminent risk to the Employees or other persons affected by the issue. (b) the number and location of Employees and other persons affected by the issue. (c) the measures both temporary and permanent that must be implemented to resolve the issue. (d) who will be responsible for implementing the resolution measures. (e) whether the hazard or risk can be isolated; and (f) the time that may elapse before the hazard or risk is permanently corrected. 11.7 Once the issue is resolved details of the issue and its resolution must be set out in writing with all Nominated Parties and/or their representatives to be satisfied that the agreement reflects the resolution of the issue with a copy given to all Nominated Parties and/or their representatives to the issue. The issue, once resolved, shall be recorded in the next safety committee meeting minutes with the agreed resolution. 11.8 The Nominated Parties and/or their representatives must make reasonable efforts to achieve a timely and final resolution of the issue. If within a reasonable time there is still no resolution, any of the Nominated Parties attempting to resolve the issue may then ask Work Health and Safety Queensland, and/or the QBCC, where applicable, to arrange for an inspector to attend the workplace to assist in resolving the issue. 11.9 Direction to cease work (a) If - (i) an issue concerning health or safety arises at a workplace or from the conduct of the undertaking of the Employer; and (ii) the issue concerns work which involves an immediate threat to the health or safety of any person; and (iii) given the nature of the threat and degree of risk, it is not appropriate to adopt the processes set out in clause 11.7 above (b) the Employer and/or the health and safety representative for the designated work group in relation to which the issue has arisen may, after consultation between them, direct that the work is to cease. (c) During any period for which work has ceased in accordance with such a direction, the Employer may assign any Employees whose work is affected to suitable and safe alternative work. 11.10 Fundamental to this process is a standing invitation for Union representatives to attend site to assist with all matters relating to health and safety. 11.11 Employees are not required to work in circumstances where the employee or a Union representative reasonably believes a safety law is being, or will be, contravened. Consultation between the relevant parties will occur throughout this procedure including with senior representatives of the Employer and the Union.

  • Determination of Responsiveness 28.1 The Procuring Entity's determination of a Tender's responsiveness is to be based on the contents of the Tender itself, as defined in ITT28.2.

  • Failure to Respond If you fail to respond by the date given above, your application will be refused under Section 3A(4)(a) of the Registered Designs Act 1949.

  • What to report You must report the information about each obligating action that the submission instructions posted at xxxx://xxx.xxxx.xxx specify.

  • Notification of Results Within 10 days after satisfactory inspection and/or testing of Interconnection Facilities built by the Interconnection Customer (including, if applicable, inspection and/or testing after correction of defects or failures), the Interconnected Transmission Owner shall confirm in writing to the Interconnection Customer and Transmission Provider that the successfully inspected and tested facilities are acceptable for energization.

  • RESPONDING TO REQUESTS FOR INFORMATION To the extent authorized by the Participating Consumer(s) and to the extent such individual permission is required by law, the Competitive Supplier shall, during normal business hours (as set forth above), respond promptly and without charge therefore to reasonable requests of the Town for information or explanation regarding the matters covered by this ESA and the supply of electricity to Participating Consumers. Competitive Supplier agrees to designate a service representative or representatives (the “Service Contacts”) who shall be available for these purposes, and shall identify the office address and telephone number of such representative(s). Whenever necessary to comply with this Article 5.3, the Service Contacts shall call upon other employees or agents of the Competitive Supplier to obtain such information or explanation as may be reasonably requested. Nothing in this Article 5.3 shall be interpreted as limiting the obligation of the Competitive Supplier to respond to complaints or inquiries from Participating Consumers, or to comply with any regulation of the Department or AG regarding customer service.

  • Right to Review Tax Returns Upon request, each party shall make available to the other party the portion of Pre-Separation Period Tax Returns that relates to the ALC Group that the first party is responsible for preparing under this Article III.

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