Finished Product. Cipher shall Manufacture, Test and release finished Product in accordance with the Regulatory Requirements at Cipher’s sole cost and expense, any additional Tests that THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Distributor may require to ensure the quality of the incoming goods shall be conducted by Distributor at Distributor’s sole cost and expense. Distributor shall be responsible for contracting for and providing ongoing, appropriate oversight as to compliance with Regulatory Approvals and applicable Law of finished Product and Product sample Packaging.
Finished Product. Collaborator shall be responsible for, at its own cost, the formulation, filling, finishing, testing and final release of the Finished Products for Development and Commercialization in the Licensed Territory. Collaborator shall have the right to pursue in its sole discretion the formulation for the Product, including a formulation which is different from that utilized for the Product by Affymax and/or its Third Party Partners for use in the Affymax Territory. Collaborator shall be solely responsible for obtaining, at its expense, any licenses deemed by it to be necessary or desirable to such formulation and/or any aspect of the Finished Manufacture which is different from that utilized for the Product by Affymax and/or its Third Party Partners for use in the Affymax Territory.
Finished Product. 2.4.1. Specification for Batch(s) Each batch of OCS Lung Solution will be manufactured using predetermined specifications. The specifications are defined in Table 2. Table 2: Raw Material Specification for OCS Lung Solution Components Component Formula Quantity (gm/L) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
Finished Product. All finished Product supplied by Vertical shall be Manufactured, Tested and released by the Approved Manufacturer in accordance with the Regulatory Requirements, as between Vertical and Sub-Distributor, at Vertical’s sole cost and expense. Any additional Tests that Sub-Distributor may require to ensure the quality of the incoming goods shall be conducted by Sub-Distributor at Sub-Distributor’s sole cost and expense. Vertical hereby represents and warrants to Sub-Distributor that the Product, at the time of shipment to Sub-Distributor hereunder, (a) shall conform to the Specifications and not be adulterated or misbranded under Applicable Law, (b) shall have been Manufactured in accordance with Applicable Law, including but not limited to current Good Manufacturing Practices (“GMP”), and (c) shall not infringe or misappropriate any patent or other Intellectual Property rights of any Third Party. Except with respect to Sub-Distributor’s initial purchase order or as otherwise agreed to in writing by Sub-Distributor, all Product shipped to Sub-Distributor, on the date of shipment shall have a shelf-life of at least 24 months.
Finished Product. The Purchaser shall be responsible for obtaining and maintaining all Regulatory Approvals with respect to the Finished Product in the Territory other than those Regulatory Approvals relating to the Product and Supplier’s manufacture thereof, which shall be the responsibility of Supplier. The Purchaser shall provide the Supplier with (i) a copy of its NDA approval letter for Finished Product within a reasonable time after Purchaser’s receipt thereof from the FDA, and (ii) copies of any equivalent Regulatory Approval notices for Finished Product from other applicable Regulatory Agencies within a reasonable time after receipt thereof; provided that in each case Purchaser may redact any of its proprietary information from such copy. Supplier shall cooperate and provide reasonable assistance to Purchaser in connection with Purchaser’s obtainment and maintenance of Regulatory Approvals for Finished Product.
Finished Product. Patheon hereby covenants that all Finished Product manufactured and supplied to Santarus under this Agreement: (a) shall have been manufactured, packaged, tested and stored in compliance with the Specifications, GMP, Applicable Laws and the terms and conditions of this Agreement and the Quality Agreement; (b) shall not be adulterated, or misbranded within the meaning of the FFDCA or other Applicable Laws as of the time that the Finished Product is transferred to the carrier at Patheon's shipping point; and (c) will have been shipped to Santarus not later than *** days after the date of its manufacture (unless any delay in shipment beyond such *** day period is due solely to a delay by Santarus in conducting its review for the final release of the Finished Product). The foregoing obligations are referred to in this Agreement as the "PATHEON MANUFACTURING RESPONSIBILITIES."
Finished Product. Notwithstanding anything to the contrary contained herein, in accordance with the procedures set forth in the Quality Agreement, with respect to the supply of Finished Product, Amarin or its designated Third Party shall be responsible (at its sole cost and expense, which shall be included in the Cost of Goods and Supply Price) for all final product labeling and packaging (whether in commercial or clinical packaging presentation, and, if not already qualified by Amarin’s existing stability program, including a new stability program, which shall be included in Cost of Goods and Supply Price), including insertion of materials such as patient inserts, patient medication guides, professional inserts and any other written, printed or graphic materials accompanying the Product, considered to be part of the Finished Product, and handling, storage, quality control, quality assurance, and the testing and release aspects of Territory-Specific Analytical Release Testing and related activities, of the Finished Product in connection with the foregoing (collectively, “Packaging and Labeling”). With respect to the supply of Finished Product, Amarin or its designated Third Party shall ensure that all such Packaging and Labeling shall comply with Applicable Laws, GMPs and the Regulatory Approvals for the Product in the Territory, including the Product Specifications; provided, that Licensee shall be responsible for compliance with Applicable Laws, GMPs and the Regulatory Approvals with respect to approved and camera-ready artwork for such Packaging and Labeling and all other printed components and materials, which camera-ready artwork Licensee shall prepare and deliver to Amarin (in electronic files in a native electronic format) at least [***] prior to issuing a firm Purchase Order.
Finished Product. The term “
Finished Product. Patheon hereby covenants that all Finished Product manufactured and supplied to Santarus under this Agreement: (a) shall have been manufactured, packaged, tested and stored in compliance with the Specifications, GMP, Applicable Laws and the terms and conditions of this Agreement and the Quality Agreement; (b) shall not be adulterated, or misbranded within the meaning of the FFDCA or other Applicable Laws as of the time that the Finished Product is transferred to the carrier at Patheon’s shipping point; and (c) will have been shipped to Santarus not later than [***] days after the date of its manufacture (unless any delay in shipment beyond such [***] day period is due solely to a delay by Santarus in conducting its review for the final release of the Finished Product). The foregoing obligations are referred to in this Agreement as the “Patheon Manufacturing Responsibilities.” *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Finished Product. At Contractor’s then current Production Fees; provided, however, that Allergan shall not be obligated to purchase any Product that is nonconforming to Specification or written procedures due to Contractor’s fault.
