Common use of Obligations of Corium Clause in Contracts

Obligations of Corium. Without limiting the foregoing, Corium shall be responsible for, directly or through a Third Party Manufacturer: (a) filing and qualifying with the FDA the manufacturing site of Corium; (b) filing and maintaining distribution shipping records for the Product; irrespective of the Party selected to manufacture the Product: (c) conducting all required testing including, without limitation, stability testing for each batch of Product manufactured for use in bioequivalence studies contemplated under this Agreement; and conducting, as required by the ANDA, cGMPs, and FDA regulations, as amended, any and all such testing for all validation batches and all commercial batches of Product; and (d) manufacturing and packaging the Product according to any guidelines provided reasonably required by Xxxx and consistent with the ANDA and all applicable FDA regulations, as amended. Xxxx shall have the exclusive right to define (i) the shape, color, size, embossing and imprinting of each Unit or Product, and (ii) packaging, cartoning, labeling, including package inserts, and all related artwork for containers and any advertising.

Obligations of Corium. Without limiting the foregoing, Corium shall be responsible for, directly or through a Third Party Manufacturer: (a) filing and qualifying with the FDA the manufacturing site of Corium; (b) filing and maintaining distribution shipping records for the ProductProducts; irrespective of the Party selected to manufacture the Product: (c) conducting all required testing including, without limitation, stability testing for each batch of Product manufactured for use in bioequivalence studies contemplated under this Agreement; and conducting, as required by the ANDA, cGMPs, and FDA regulations, as amended, any and all such testing for all validation batches and all commercial batches of Product; and (d) manufacturing and packaging the Product Products according to any guidelines provided reasonably required by Xxxx and consistent with the ANDA and all applicable FDA regulations, as amended. Xxxx shall have the exclusive right to define (i) the shape, color, size, embossing and imprinting of each Unit or Product, and (ii) packaging, cartoning, labeling, including package inserts, and all related artwork for containers and any advertising.

Obligations of Corium. Without limiting the foregoing, Corium shall be responsible for, directly or through a Third Party Manufacturer: (a) filing and qualifying with the FDA the manufacturing site of Corium; (b) filing and maintaining distribution shipping records for the ProductProducts; irrespective of the Party selected to manufacture the Product: (c) conducting all required testing including, without limitation, stability testing for each batch of Product manufactured for use in bioequivalence studies contemplated under this Agreement; and conducting, as required by the ANDA, cGMPs, and FDA regulations, as amended, any and all such testing for all validation batches and all commercial batches of Product; andand *Confidential Treatment Requested. (d) manufacturing and packaging the Product Products according to any guidelines provided reasonably required by Xxxx and consistent with the ANDA and all applicable FDA regulations, as amended. Xxxx shall have the exclusive right to define (i) the shape, color, size, embossing and imprinting of each Unit or Product, and (ii) packaging, cartoning, labeling, including package inserts, and all related artwork for containers and any advertising.