Common use of Recalls and Market Withdrawals Clause in Contracts

Recalls and Market Withdrawals. (a) If at any time during the Exclusive Period (i) any governmental or regulatory authority in the Territory issues a request, directive, or order that the Product be recalled or withdrawn, or (ii) a court of competent jurisdiction orders such a recall or withdrawal in the Territory, or (iii) either Party determines in its sole discretion that the Product should be recalled or withdrawn, the Parties shall take all appropriate corrective actions. The final decision of a Party to recall pursuant to (iii) of this subsection shall not be subject to arbitration under Article 13 of this Agreement (or any other legal action, subject to Section 13(g)), although the consequences to the other Party of any improper decision shall be subject to arbitration. (b) If the negligent act or omission by one Party or the breach by one Party of an applicable product warranty (which, in the case of Product manufactured by ICN shall be the warranty contained in Section 8.4(a)) is the proximate cause of a recall or withdrawal under any provision of Section 3.7(a), that Party shall be solely responsible for such costs and expenses for its own account. If the negligent act or omission or breach of product warranty by one Party is not the proximate cause of such a recall or withdrawal, (i) the costs and expenses of notification and destruction or return of the recalled or withdrawn Product in connection with a recall or withdrawal resulting from a determination pursuant to Section 3.7(a)(iii), above shall be borne by the Party making such determination, and (ii) the costs and expenses of notification and destruction or return of the recalled or withdrawn Product in connection with a recall or withdrawal pursuant to Section 3.7(a)(i) or (ii) shall be borne equally by the Parties.

Appears in 7 contracts

Samples: Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc), Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc), Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc)

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