Packaging and Artwork. Patheon will package the Products in accordance with the Specifications. Client will own all artwork and shall be responsible for the cost of artwork development. Specifically, Client will be responsible for supplying Patheon with digital artwork necessary to enable Patheon to supply Products fully finished ready for sale by the Client, incorporating Client’s trademark(s), livery and text. The Client will also be responsible for the cost of proofing and of production of the printing plates required by Patheon to assemble, package and supply the Products and for the approval of final proofs generated by the printer. All such artwork, trademarks, livery and text shall be the property of Client and Patheon shall obtain no rights therein. 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 all applicable Regulatory Authorities and other third parties responsible for the approval of the Products to the extent required by Applicable Law. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated 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. If necessary, at least [**] 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 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.
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Samples: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)
Packaging and Artwork. Patheon will package perform the Products Packaging Services in accordance with the Specifications. Client will own all artwork and shall be responsible for the cost of artwork development. Specifically, Client will be responsible for supplying Patheon with digital artwork necessary to enable Patheon to supply Products fully finished ready for sale by the Client, incorporating Client’s trademark(s), livery and text. The Client will also be responsible for the cost of proofing and of production of the printing plates required by Patheon to assemble, package and supply the Products and for the approval of final proofs generated by the printer. All such artwork, trademarks, livery and text shall be the property of Client and Patheon shall obtain no rights therein. 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 all applicable Regulatory Authorities and other third parties responsible for the approval of the Products to the extent required by Applicable LawProducts. 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. If necessary, at At least [***] 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. Notwithstanding anything to the contrary set forth in this Agreement, Client shall have the right, upon [***] prior written notice to Patheon, to terminate the Packaging Services under a Product Agreement in whole or in part and to transfer such Packaging Services to a third party service provider. Upon the expiration of such [***] notice period, the Manufacturing Services and the Specifications under the applicable Product Agreement shall no longer include the Packaging Services that were subject to Client’s written notice. If the portion of the Price attributable to the terminated Packaging Services is not reasonably apparent (either by reference to Exhibit B to the applicable Product Agreement or otherwise), the parties shall negotiate in good faith an amendment to the Product Agreement decreasing the Price to account for the value of the terminated Packaging Services.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (TESARO, Inc.)
Packaging and Artwork. Patheon will package the Products in accordance with the Specifications. If applicable, Client will own all artwork and shall be responsible for the cost of artwork development. Specifically, Client will be responsible for supplying Patheon with digital artwork necessary to enable Patheon to supply Products fully finished ready for sale by the Client, incorporating Client’s trademark(s), livery and text. The Client will also be responsible for the cost of proofing and of production of the printing plates required by Patheon to assemble, package and supply the Products and for the approval of final proofs generated by the printer. All such artwork, trademarks, livery and text shall be the property of Client and Patheon shall obtain no rights therein. 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 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 cGMPscGMP. 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 LawProducts. 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. If necessary, at 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: Master Manufacturing Services Agreement (Baudax Bio, Inc.)
Packaging and Artwork. Patheon will package the Products in accordance with the Specifications. Client will own all artwork and shall be responsible for the cost of artwork development. Specifically, Client will be responsible for supplying Patheon with digital artwork necessary to enable Patheon to supply Products fully finished ready for sale by the Client, incorporating Client’s trademark(s), livery and text. The Client will also be responsible for the cost of proofing and of production of the printing plates required by Patheon to assemble, package and supply the Products and for the approval of final proofs generated by the printer. All such artwork, trademarks, livery and text shall be the property of Client and Patheon shall obtain no rights therein. 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 all applicable Regulatory Authorities and other third parties responsible for the approval of the Products to the extent required by Applicable LawProducts. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.44.4 unless labelling obsolescence is due to Patheon requested amendments to the Specifications, the Quality Agreement or the Manufacturing Site, or Patheon’s failure to provide the Manufacturing Services in accordance with this Agreement, in which case Patheon will be responsible for the cost of labeling obsolescence. Both parties will work in good faith to minimize the cost of obsolescence. 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 and Client consent in writing to the use of its name. If necessaryTo the extent not previously provided, 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 Manufacture of the Product that meet the Specifications; however, in the event that any new or modified artwork is urgently required by a Regulatory Authority or at initial Product launch, the parties will work together in good faith to have camera ready artworks procured within the said target of 120 days, but it is hereby understood that (i) this may not be achievable due to factors outside either party’s control and (ii) Patheon may delay the shipment of Product by the same number of days as equate to the delay in receipt of the new Packaging Components, to the extent the same are due to the said changes in artwork and bona fide commercial constraints imposed by its third party print supply vendor, provided in each case that it gives advance written notice to Client. 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 labelling of the Product.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)
Packaging and Artwork. The provisions of Sections 3.5(a)-(d) below will only apply if Client requires that Patheon will package the Products in accordance with the Specifications. undertake any secondary packaging and/or labelling services.
(a) Client will own all artwork and shall be responsible for the cost of artwork developmentdevelopment and approval of all artwork. Specifically, Client will be responsible for supplying Patheon with digital artwork necessary to enable Patheon to supply Products fully finished ready for sale by the Client, incorporating Client’s trademark(s), livery and text. The Client will also be responsible for the cost of proofing and of production of the printing plates required by Patheon to assemble, package and supply the Products and for the approval of final proofs generated by the printer. All such artwork, trademarks, livery and text shall be the property of Client and Patheon shall obtain no rights therein. 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 Product inserts, and other packaging for the Products. Those changes will be submitted by Client to Product, including obtaining all applicable Regulatory Authorities and other third parties responsible for the approval of the Products to the extent required by Applicable Lawapprovals. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.45.2. Patheon's name will not appear on the label or anywhere else on the Products Product unless: (i) required by any Applicable Laws; or (ii) Patheon consents in writing to the use of its name. If necessary, at At least [***] days prior to the anticipated Delivery Date of Product for which new or modified artwork is required, Client will provide at no cost to PatheonPatheon and in accordance with the applicable Specifications, final artwork in electronic format for all packaging Components to be used in the manufacture of the Product that meet the SpecificationsProduct. For the avoidance of doubt, the parties acknowledge and agree that Client will be responsible for complying the accuracy of all information contained on all labels and compliance of all labels with Applicable Laws.
(b) For the packaging of Product, Patheon will make arrangements for and implement the imprinting of lot numbers and expiration dates on the packaging of each Product shipped. These lot numbers and expiration dates will be affixed on the Product packaging and on the shipping carton of each Product as is required by cGMPs, Applicable Laws and consistent with the Specifications. If applicable, electronic on-line verification of lot number/expiration date and serialization will be performed by Patheon. If Patheon places an internal lot number on a Product package and/or shipping carton that is different from the Client lot number referenced in any and all regulatory requirements purchase order for that batch of Product, Patheon will provide a cross-reference for the labeling Client lot number on all documents associated with that batch of Product.
(c) If applicable, Patheon will make arrangements for the imprinting of the Productproduct identifier (i.e. global trade identification number and serial number) on the packaging of each Product shipped. The product identifier and serial number will be affixed on the Product packaging and on the shipping carton of each Product as required cGMPs, Applicable Laws and consistent with the Specifications. Electronic on-line verification of the product identifier and serial number will be performed by Patheon.
(d) If applicable, Patheon will make arrangements for the imprinting of the data carrier (i.e. 2D Data Matrix or barcode) on the packaging of each Product shipped. The data carrier will encode the lot number, expiration date, product identifier and serial number. The data carriers will be affixed on the Product packaging and on the shipping carton of each Product as required by cGMPs, Applicable Laws and consistent with the Specifications. Electronic verification of the data carrier will be performed by Patheon.
Appears in 1 contract
Packaging and Artwork. Patheon will package the Products in accordance with the Specifications. Client will own all artwork and shall be responsible for the cost of artwork development. Specifically, Client will be responsible for supplying Patheon with digital artwork necessary to enable Patheon to supply Products fully finished ready for sale by the Client, incorporating Client’s trademark(s), livery and text. The Client will also be responsible for the cost of proofing and of production of the printing plates required by Patheon to assemble, package and supply the Products and for the approval of final proofs generated by the printer. All such artwork, trademarks, livery and text shall be the property of Client and Patheon shall obtain no rights therein. 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. Patheon will ensure that the final package for each Product complies with the agreed Specification. 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 LawProducts. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.44.5. 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. If necessary, at At least [** * *] 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 Parties acknowledge and agree that that, as between the Parties, Client will be responsible for complying with any and all regulatory requirements for the labeling of the Product.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Paratek Pharmaceuticals, Inc.)
Packaging and Artwork. Patheon will package the Products in accordance with the Specifications. Client will own all artwork and shall be responsible for the cost of artwork development. Specifically, Client will be responsible for supplying Patheon with digital artwork necessary to enable Patheon to supply Products fully finished ready for sale by the Client, incorporating Client’s trademark(s), livery and text. The Client will also be responsible for the cost of proofing and of production of the printing plates required by Patheon to assemble, package and supply the Products and for the approval of final proofs generated by the printer. All such artwork, trademarks, livery and text shall be the property of Client and Patheon shall obtain no rights therein. Patheon *** Confidential Treatment Requested 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 as the case may be, to labels, product inserts, and any other packaging for the Products. Those changes will be submitted by Client to all applicable Regulatory Authorities as required and other third parties responsible for the approval of the Products to the extent required by Applicable LawProducts. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.44.3. 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. If necessary, at At least […***…] 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: Master Manufacturing Services Agreement (Neurocrine Biosciences Inc)