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.
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.
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.