Common use of Product Manufacturing Clause in Contracts

Product Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company, to the extent applicable, is being conducted in compliance with the FDCA, including, without limitation, the FDA’s Quality System Regulation set forth at 21 CFR Part 820, and the respective counterparts thereof promulgated by governmental authorities in the United Kingdom and the European Union, except where failures to so comply, whether individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third-party manufacturer for the Company’s products) subject to a governmental authority (including FDA) shutdown or import or export prohibition.

Product Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company, to the extent applicable, is being conducted in compliance with the FDCAFederal Food, Drug, and Cosmetic Act, including, without limitation, the FDA’s Quality System Regulation set forth at 21 CFR Part 820, and the respective counterparts thereof promulgated by governmental authorities in the United Kingdom and the European Union, except where failures to so comply, whether individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third-party manufacturer for the Company’s products) subject to a governmental authority (including FDA) shutdown or import or export prohibition.