Common use of Product Events, Withdrawals, Field Corrections and Field Alerts Clause in Contracts

Product Events, Withdrawals, Field Corrections and Field Alerts. In the event Prometheus deems it necessary or is otherwise required by a Governmental Authority to initiate a recall, withdrawal or field correction of, field alert report or comparable report with respect to any Product manufactured by GSK pursuant to this Agreement (in each instance, a "Product Event"), Prometheus shall notify GSK and GSK shall fully cooperate with Prometheus to address, as appropriate, such Product Event. The costs and expense of such Product Event shall be borne by Prometheus except to the extent GSK is required to bear such costs and expenses under Section 6.9. Without limiting the generality of the foregoing, with respect to product recalls each Party: (a) Shall immediately notify the other Party of any defect found, subsequent to release, which may be grounds to initiate a recall; (b) Maintain a procedure to handle Product recalls, including contact arrangements for hours falling outside the typical Business Day; and (c) Provide all support reasonably necessary to support any Product recall investigation and subsequent actions. In any event, Prometheus will be responsible for leading all Product Event investigations and for all associated communications with Governmental Authorities.

Appears in 5 contracts

Samples: Supply Agreement (Prometheus Laboratories Inc), Asset Purchase and Sale Agreement (Prometheus Laboratories Inc), Supply Agreement (Prometheus Laboratories Inc)

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