Common use of Field Action Clause in Contracts

Field Action. (a) Distributor shall have the right, at Distributor’s sole expense, to conduct a health hazard evaluation to determine whether any Product poses a “risk to health” as defined in 21 C.F.R. Part 806. In connection with such health hazard evaluation, Manufacturer shall have the right to participate in Distributor’s quality board process and in connection therewith, shall promptly provide Distributor with complaint investigation and other data reasonably requested by Distributor to determine the potential for risk to health posed by a Product. Distributor shall have the right to determine, in its sole and absolute discretion, that a Product poses a risk to health requiring a Correction, Removal or Recall as defined in 21 C.F.R. Part 7 or any other recalls, collective actions or market actions (each action, a “Field Action”). (b) Distributor shall be responsible for administering all Field Actions with respect to the Product(s) in the Territory, whether suggested, requested or ordered by any Governmental Entity or whether Distributor, in its sole and absolute discretion, shall have determined to undertake such Field Action. Distributor shall have final and sole authority to make all decisions with respect to the initiation and administration of any such Field Action. (c) In the event any Governmental Entity having jurisdiction shall suggest, request or order, or if Distributor shall determine, in its sole and absolute discretion, to undertake, any Field Action with respect to any Product (or any finished product containing or contained in any Product) and the cause or basis of such Field Action is attributable to (i) (A) a breach by Manufacturer of any of its warranties, guarantees, representations, obligations or covenants contained herein or (B) Manufacturer’s negligence or willful misconduct, then Manufacturer shall be liable, and shall reimburse Distributor for the reasonable costs of such Field Action, including the cost of any Product (or any finished product containing or contained in any Product) which is affected thereby whether or not any such specific unit of Product shall be established to be in breach of any warranty by Manufacturer hereunder or (ii) (A) a breach by Distributor of any of its warranties, guarantees, representations, obligations or covenants contained herein or (B) Distributor’s negligence or willful misconduct, then Distributor shall be liable, and shall reimburse Manufacturer for the reasonable costs of such Field Action, including the cost of any Product (or any finished product containing or contained in any Product) which is affected thereby whether or not any such specific unit of Product shall be established to be in breach of any representation or warranty by Distributor hereunder. In the event of any Field Action other than those attributable to (x) a breach by either Party of any of its warranties, guarantees, representations, obligations or covenants contained herein or (y) either Party’s negligence or willful misconduct, the Parties shall negotiate Manufacturer’s liability for the costs associated with such Field Action in good faith and agree upon the extent of such liability (such agreement not to be unreasonably withheld, conditioned or delayed).