Common use of Complaint Handling Clause in Contracts

Complaint Handling. Except as otherwise provided below in Section 11.2, in the event that PLANTEX or NOVACEA receives any complaint, claims or adverse reaction reports regarding Finished Product, including notices from the FDA regarding any alleged regulatory non-compliance of the Finished Product, each party shall, within five (5) business days, provide the other with all information contained in the complaint, report, or notice and such additional information regarding the Finished Product as may be reasonably requested, except that notification by NOVACEA to PLANTEX shall be required only in those instances where any such complaint, claim or adverse reaction report appears to be related to API or where in the exercise of reasonable judgment NOVACEA concludes or should conclude that such report contains information that may bear upon or relate to the possibility of prospective liability on the part of PLANTEX (or any Affiliate thereof). NOVACEA and PLANTEX shall comply, at a minimum, with FDA and cGMP requirements for complaint handling.

Complaint Handling. Except as otherwise provided below in Section 11.2, in the event that PLANTEX or NOVACEA D-NOVO receives any complaint, claims or adverse reaction reports regarding Finished Product, including notices from the FDA regarding any alleged regulatory non-compliance of the Finished Product, each party shall, within five (5) business days, provide the other with all information contained in the complaint, report, or notice and such additional information regarding the Finished Product as may be reasonably requested, except that notification by NOVACEA D-NOVO to PLANTEX shall be required only in those instances where any such complaint, claim or adverse reaction report appears to be related to API or where in the exercise of reasonable judgment NOVACEA D-NOVO concludes or should conclude that such report contains information that may bear upon or relate to the possibility of prospective liability on the part of PLANTEX (or any Affiliate thereof). NOVACEA D-NOVO and PLANTEX shall comply, at a minimum, with FDA and cGMP requirements for complaint handling.