Common use of Packaging and Artwork Clause in Contracts

Packaging and Artwork. Patheon will package the Products in accordance with the Specifications. If applicable, Client will be responsible for the cost of artwork development. Patheon will determine and imprint the batch numbers and expiration dates for each Product shipped. The batch numbers and expiration dates will be affixed to the Products on each Product’s label and on the shipping carton of each Product as outlined in the Specifications and as required by cGMP. Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the Products. Those changes will be submitted by Client to all applicable Regulatory Authorities and other third parties responsible for the approval of the Products. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.4; provided, that Patheon has promptly implemented any changes to labels, product inserts and other packaging for Products requested by Client. Patheon’s name will not appear on the label or anywhere else on the Products unless: (i) required by any Applicable Laws; or (ii) Patheon consents in writing to the use of its name. At least 120 days prior to the Delivery Date of Product for which new or modified artwork is required, Client will provide at no cost to Patheon, final camera ready artwork for all packaging Components to be used in the manufacture of the Product that meet the Specifications. For the avoidance of doubt, the parties acknowledge and agree that Client will be responsible for complying with any and all regulatory requirements for the labeling of the Product.

Appears in 1 contract

Samples: Product Agreement (Baudax Bio, Inc.)

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Packaging and Artwork. Patheon will package the Products in accordance with the Specifications. If applicable, Client will be responsible for the cost of artwork Artwork development. Patheon will determine and imprint the batch numbers Batch numbers, manufacturing and expiration dates as well as any other information required by authorities (e.g. DSCSA or serialization number) for each Product shipped. The batch numbers Batch numbers, manufacturing, and expiration dates will be affixed to on the Products on each Product’s label and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPcGMPs and other applicable laws and regulations. Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the Products. Those changes will be submitted by Client to all applicable Regulatory Authorities and other third parties responsible for the approval of the Products. Client will be responsible for the demonstrated cost of labelling obsolescence when changes occur, as contemplated in Section 4.4; provided, that Patheon has promptly implemented any changes to labels, product inserts and other packaging for Products requested by Client. Patheon’s name will not appear on the label or anywhere else on the Products unless: (i) required by any Applicable Laws; or (ii) Patheon consents in writing to the use of its name. At least 120 [***] days prior to the Delivery Date of Product for which new or modified artwork Artwork is required, Client will provide at no cost to Patheon, final camera ready artwork Artwork for all packaging Components to be used in the manufacture of the Product that meet the Specifications. For the avoidance of doubt, the parties acknowledge and agree that Client will be responsible for complying with any and all regulatory requirements for the labeling of the Product.

Appears in 1 contract

Samples: Product Agreement (ChemoCentryx, Inc.)

Packaging and Artwork. At Client’s election (if requested in writing by Client), Patheon will package the Products as set out in accordance with the Specifications. If applicable, Client will be responsible for the cost of artwork development. Patheon will determine and imprint the batch numbers and expiration dates for each Product shipped. The batch numbers and expiration dates will be affixed to on the Products on each Product’s label and on the shipping carton of each Product as outlined in the Specifications Specifications, the Quality Agreement and as required by cGMPcGMPs and any other Applicable Laws. Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the Products. Those changes will be submitted by Client to all applicable Regulatory Authorities and other third parties responsible for the approval of the Products, to the extent required by Applicable Laws. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.4; provided, that Patheon has promptly implemented any changes to labels, product inserts and other packaging for Products requested by Client. Patheon’s name will not appear on the label or anywhere else on the Products unless: (i) required by any Applicable Laws; or (ii) Patheon consents in writing to the use of its name. At least 120 days prior to the Delivery Date of Product for which new or modified artwork is requiredrequired (unless a sooner date is required for compliance with Applicable Laws), Client will provide at no cost to Patheon, final camera ready artwork for all packaging Components to be used in the manufacture of the Product that meet the Specifications. For the avoidance of doubt, the parties acknowledge and agree that Client will be responsible for complying with any and all regulatory requirements for the labeling of the Product, except to the extent such requirements are embodied in the Specifications or the Quality Agreement and Patheon has failed to comply therewith.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Synageva Biopharma Corp)

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Packaging and Artwork. Patheon will package the Products in accordance with the Specifications. If applicable, Client will be responsible for the cost of artwork development. Patheon will determine and imprint the batch numbers and expiration dates for each Product shipped. The batch numbers and expiration dates will be affixed to the Products on each Product’s label and on the shipping carton of each Product as outlined in the Specifications and as required by cGMP. Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the Products. Those changes will be submitted by Client to all applicable Regulatory Authorities and other third parties responsible for the approval of the Products. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.4; provided, that Patheon has promptly implemented any changes to labels, product inserts and other packaging for Products requested by Client. Patheon’s 's name will not appear on the label or anywhere else on the Products unless: (i) required by any Applicable Laws; or (ii) Patheon consents in writing to the use of its name. At least 120 days prior to the Delivery Date of Product for which new or modified artwork is required, Client will provide at no cost to Patheon, final camera ready artwork for all packaging Components to be used in the manufacture of the Product that meet the Specifications. For the avoidance of doubt, the parties acknowledge and agree that Client will be responsible for complying with any and all regulatory requirements for the labeling of the Product.

Appears in 1 contract

Samples: Product Agreement (Recro Pharma, Inc.)

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