Field Corrective Actions Clause Samples

Field Corrective Actions. 17.2.1. The parties hereby acknowledge and agree that field corrective actions, market withdrawals and/or recalls may be initiated by a Governmental or Regulatory Authority or by Insmed. Each party shall promptly notify (and in any event, within [***]) the other party of all facts or circumstances which could precipitate the need for implementing a field corrective action, market withdrawal and/or recall (“Corrective Action”) with respect to ARIKACE. Such facts or circumstances may include product complaints received by a party or other information regarding ARIKACE which comes to the attention of a party, including information regarding the Manufacturing process or its output. Reported information shall include, but not be limited to: (i) the date the information was received; (ii) lot number(s); and (iii) the reported terms(s) seriousness, and any other relevant outcome information. 17.2.2. Therapure shall make available any necessary batch records or other analysis of its Manufacturing operations for ARIKACE which may be necessary in order for Insmed to fully investigate the matter. Neither party shall unreasonably withhold any information from the other party involving patient safety, efficacy of ARIKACE or efficacy of a Corrective Action. Insmed shall develop and issue any statements to be made to any third parties (including, without limitation, Governmental or Regulatory Authorities or the general public) relating to a Corrective Action in compliance with all applicable Laws and shall provide Therapure with reasonable opportunity for review prior to the publication or release of such statements.
View SourceView Similar (2)
Field Corrective Actions. In the event of a field corrective action, Hyperfine shall have full control and authority over the coordination of the action, and Manufacturer shall use diligent efforts and cooperate in good faith. If the action arises out of a manufacturing nonconformance, Manufacturer’s responsibility is as stated in Section 11, Warranty. If the action arises out of a design or regulatory nonconformance directly attributable to Hyperfine, Hyperfine shall be responsible for all costs related to the action. If Manufacturer becomes aware of a nonconformance during the manufacturing process that might affect product already shipped, Manufacturer shall immediately inform Hyperfine and shall cooperate in determining the extent of the nonconformance. ​
View SourceView Similar (2)
Field Corrective Actions. In the event of a field corrective action, Butterfly shall have full control and authority over the coordination of the action, and Manufacturer shall use diligent efforts and cooperate in good faith. If the action arises out of a manufacturing nonconformance, Manufacturer’s responsibility is as stated in Section 11, Warranty. If the action arises out of a design or regulatory nonconformance directly attributable to Butterfly, Butterfly shall be responsible for all costs related to the action. If Manufacturer becomes aware of a nonconformance during the manufacturing process that might affect product already shipped, Manufacturer shall immediately inform Butterfly and shall cooperate in determining the extent of the nonconformance.
View Source

Related to Field Corrective Actions

  • Corrective Actions The Government will use its best efforts to ensure that each Covered Provider (i) takes, where necessary, appropriate and timely corrective actions in response to audits, (ii) considers whether the results of the Covered Provider’s audit necessitates adjustment of the Government’s records, and (iii) permits independent auditors to have access to its records and financial statements as necessary.

  • Corrective Action Despite its right to terminate this Agreement pursuant to this Article, the LHIN may choose not to terminate this Agreement and may take whatever corrective action it considers necessary and appropriate, including suspending Funding for such period as the LHIN determines, to ensure the successful completion of the Services in accordance with the terms of this Agreement.

  • Corrective Action Plans If the OAG finds deficiencies in ▇▇▇▇▇▇▇’s performance under this Grant Contract, the OAG, at its sole discretion, may impose one or more of the following remedies as part of a corrective action plan: increase of monitoring visits; require additional or more detailed financial and/or programmatic reports be submitted; require prior approval for expenditures; require additional technical or management assistance and/or make modifications in business practices; reduce the contract amount; and/or terminate this Grant Contract. The foregoing are not exclusive remedies, and the OAG may impose other requirements that the OAG determines will be in the best interest of the State.

  • Mitigation and Corrective Action Business Associate shall mitigate, to the extent practicable, any harmful effect that is known to it of an impermissible use or disclosure of PHI, even if the impermissible use or disclosure does not constitute a Breach. Business Associate shall draft and carry out a plan of corrective action to address any incident of impermissible use or disclosure of PHI. If requested by Covered Entity, Business Associate shall make its mitigation and corrective action plans available to Covered Entity. Business Associate shall require a Subcontractor to agree to these same terms and conditions.

  • Proposed Corrective Action Plan Simultaneously with the submission of the Audit, the District will submit to OCR for its review and approval a proposed Corrective Action Plan to address all inaccessible content and functionality identified during the District’s Audit. The proposed Corrective Action Plan will set out a detailed schedule for: (1) addressing problems, taking into account identified priorities, with all corrective actions to be completed within 18 months of the date OCR approved the Corrective Action Plan; (2) setting up systems of accountability and verifying claims of accessibility by vendors or open sources; and setting up a system of testing and accountability to maintain the accessibility of all online content and functionality on an ongoing basis. In its Corrective Action Plan, the District will acknowledge that if all inaccessible content and functionality identified during the Audit is not removed or made accessible on a timely basis, the District will be in violation of this Agreement, Section 504, and Title II and OCR may initiate administrative enforcement or judicial proceedings to enforce the specific terms and obligations of the Agreement.