Complaints, Adverse Reactions, Recalls. 6.3.1 Distributor will inform TMC promptly of any information concerning complaints involving the Product or adverse drug experiences (as defined in 21 CFR § 314.80), injury, toxicity, sensitivity reaction associated with the clinical use of the Product by any Ship-To Customer or other third party .
6.3.2 If there is a recall, withdrawal or replacement of the Product imposed by TMC or the FDA (“Recall”), Distributor will stop shipping recalled Product lots after Distributor receives written notification of such Recall. TMC will notify Distributor of any proposed Recall as soon as possible and, in any event, will do so within forty-eight (48) hours of initiating a Recall. Distributor shall cooperate fully in any such Recall.
6.3.3 TMC will reimburse Distributor for any documented reasonable costs or expenses that Distributor actually may incur due to a Recall. For all Product held by Distributor, such Recall costs and expenses include TMC’s reimbursement to Distributor of its original acquisition cost or, if higher, at the then-current purchase price in the Commercial Price List. Each Party will use best efforts to minimize Recall costs and expenses. Distributor shall prepare a detailed invoice of such costs or expenses, which invoice shall be paid by TMC within thirty (30) days of its receipt of such invoice. TMC will be liable for late fees equal to 1.5% per month (or any portion thereof) on all amounts not paid within thirty (30) days of the date of billing, except for any portion of any xxxx that is the subject of any dispute raised by TMC in good faith. If any dispute is resolved in favor of Distributor, TMC will pay the applicable late fee on such amount from the original due date.
Complaints, Adverse Reactions, Recalls. 6.3.1 Each Party agrees to inform the other Party promptly (but in no event later than [**] after becoming aware) of any information concerning complaints involving a Product complaint (as defined in 21 CFR ss. 211.198). Distributor shall supply the name of the drug product, lot number, name of complainant, and nature of complaint.
6.3.2 Each Party agrees to inform the other Party promptly (but in no event later than [**] after becoming aware) of any information concerning adverse drug experiences (as defined in 21 CFR ss. 314.80), injury, toxicity, sensitivity reaction associated with the clinical use of a Product, whether or not considered related to a Product, or adulteration or misbranding of a Product by any distributor, wholesaler or other third party. All notifications under this Section shall be made by calling 0-000-000-0000 and shall, upon request, be confirmed by facsimile on Cytogen's designated adverse event forms (FDA Med Watch Form, 3500A).
6.3.3 If there is a recall or withdrawal of a Product, Distributor agrees to stop shipping recalled lots immediately, and in no event later than [**] after Distributor receives written notification of such recalls. Distributor shall cooperate fully in any such recall.
6.3.4 Cytogen agrees to reimburse Distributor for any documented reasonable costs or expenses (including reasonable attorneys' fees) that Distributor actually may incur due to recalls, withdrawals, or replacements of any Product imposed by Cytogen or the FDA. Distributor shall prepare a detailed invoice of such costs or expenses, and undisputed amounts shall be paid by Cytogen within thirty (30) days of its receipt of such invoice. Pursuant to Section 8, Cytogen shall have the right to conduct an audit, or have an independent auditor conduct and audit, of Distributor's books and records to verify that such costs and expenses are properly chargeable in accordance with generally accepted accounting principles.
