Common use of Packaging and Artwork Clause in Contracts

Packaging and Artwork. Patheon will package the Products as set out in the Specifications. 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 on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs. 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 ail -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 set forth in Section 4.4. Patheon’s name will not appear on the label or anywhere else on the Products unless: (i) required by any 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 ail 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 3 contracts

Samples: Product Agreement (Osmotica Pharmaceuticals PLC), Product Agreement (Osmotica Pharmaceuticals LTD), Product Agreement (Osmotica Pharmaceuticals LTD)

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Packaging and Artwork. Patheon will package the Products as set out in the Specifications. 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 numbers, expiration dates, serialization numbers, and expiration dates 2D bar codes will be affixed on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs. 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 ail -applicable 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 set forth contemplated in Section 4.4. Patheon’s 's name will not appear on the label or anywhere else on the Products unless: (i) required by any Laws; or (ii) Patheon consents in writing to the use of its name. At least 120 90 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 ail 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 2 contracts

Samples: Product Agreement (Keryx Biopharmaceuticals Inc), Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.)

Packaging and Artwork. Patheon will package the Products as set out in accordance with the Specifications. Client Indivior 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 on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs. Client Indivior may, in its sole discretion, make changes to labels, product Product inserts, and other packaging for the Products. Those changes will be submitted by Client Indivior to ail -applicable all applicable Regulatory Authorities and other third parties responsible for the approval of the Products. Client Indivior will be responsible for the cost of labelling obsolescence when changes occur, as set forth contemplated in Section 4.4. Patheon’s 's name will not appear on the label or anywhere else on the Products unless: (i) required by any 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 Indivior will provide at no cost to Patheon, final camera camera-ready artwork for ail 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 Indivior will be responsible for complying with any and all regulatory requirements for the labeling of the Product.

Appears in 2 contracts

Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)

Packaging and Artwork. Patheon will package the Products as set out in accordance with the Specifications. Client will be responsible for the cost of artwork development. Patheon with consent of Client, will determine and imprint the batch numbers and expiration dates for each Product shipped. The batch numbers, the serialization numbers and expiration dates will be affixed on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs. 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 ail -applicable 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 set forth contemplated in Section 4.4. Patheon’s 's name will not appear on the label or anywhere else on the Products unless: (i) required by any 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, Manufacturing Services Agreement Client will provide at no cost to Patheon, final camera ready artwork for ail 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: Services Agreement (Evoke Pharma Inc)

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Packaging and Artwork. Patheon will package the Products as set out Product in accordance with the Specifications. 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 on the Products Product and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs. Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the ProductsProduct. Those changes will be submitted by Client to ail -applicable all applicable Regulatory Authorities and other third parties responsible for the approval of the ProductsProduct. Client will be responsible for the cost of labelling obsolescence when changes occur, as set forth contemplated in Section 4.4. Patheon’s name will not appear on the label or anywhere else on the Products Product unless: (i) required by any 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 ail 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: Manufacturing Services Agreement (Nabriva Therapeutics PLC)

Packaging and Artwork. Patheon will package the Products as set out in accordance with the Specifications. Client will be responsible for the cost of artwork development. Patheon will determine and imprint the batch Batch numbers and expiration dates for each Product shipped. The batch Batch numbers expiration dates, and expiration dates when agreed upon by the Parties, serial numbers will be affixed on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs. 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 ail -applicable 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 set forth contemplated in Section 4.4. Patheon’s 's name will not appear on the label or anywhere else on the Products unless: (i) required by any 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 ail all packaging Components to be used in the manufacture of the Product that meet the Specifications. But if this new or modified artwork is required in connection with a Product Master Manufacturing Services Agreement launch or is due to changes in safety information or Regulatory Authority requirements, then Patheon will use commercially reasonable efforts to implement the changes to the artwork on an expedited basis. 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 (Jazz Pharmaceuticals PLC)

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