Active Materials and Client-Supplied Components. At least [***] before the scheduled production date (such date to be communicated to Client by Patheon), Client will deliver the Active Materials and any Client-Supplied Components to [***], at no cost to Patheon, with any VAT paid by Client, in sufficient quantity to enable Patheon to manufacture the desired quantities of Product and to ship Product on the Delivery Date. If the Active Materials and/or Client-Supplied Components are not received [***] before the scheduled production date, Patheon may delay the shipment of Product by the same number of days as the delay in receipt of the Active Materials and/or Client-Supplied Components. But if Patheon is unable, despite using commercially reasonable efforts, to manufacture Product to meet this new shipment date due to prior third party production commitments, Patheon may 71086739_10 delay the shipment until a later date as agreed to by the Parties. All shipments of Active Material will be accompanied by certificate(s) of analysis from the Active Material manufacturer and Client, confirming the identity and purity of the Active Materials and its compliance with the Active Material Specifications. For Active Materials or Client-Supplied Components which may be subject to import or export, Client agrees that its vendors and carriers will comply with applicable requirements of the U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism. If any Active Materials or Client-Supplied Components are imported, then Client will pay any applicable customs duties or VAT and act as importer of record for such imported materials in compliance with the local Customs and VAT requirements applicable in the country of importation. On the date of shipment, the API or Client-Supplied Components will conform to their specifications that Client has given to Patheon and the API and Client-Supplied Components will be adequately contained, packaged, and labeled and will conform to the affirmations of fact on the container.
Appears in 1 contract
Samples: Manufacturing Agreement (Paratek Pharmaceuticals, Inc.)
Active Materials and Client-Supplied Components. At least [***] before the scheduled production date (provided Client has received adequate advance notice of such date to be communicated to Client by Patheondate), Client will deliver the Active Materials and any Client-Supplied Components to the Manufacturing Site DDP (Incoterms 2010), [***], at no cost to Patheon, with any VAT paid by Client, in sufficient quantity to enable Patheon to manufacture the desired quantities of Product and to ship Product on the Delivery Date. If Client becomes aware of any potential delay in the delivery of the Active Materials or/and any Client-Supplied Components, it shall promptly notify Patheon of such potential delay and the parties shall jointly evaluate the impact, if any, of such delay on the scheduled production date. If Patheon has provided Client adequate advance notice of the scheduled production date, the Active Materials and/or Client-Supplied Components are not received [***] before the scheduled production date, Patheon may delay date and the shipment of Product by the same number of days as the delay in receipt of the Active Materials and/or Client-Supplied Components. But if Patheon is unable, despite using commercially reasonable efforts, to manufacture Product to meet this new shipment date due to prior third party production commitments, Patheon may 71086739_10 delay the shipment until a later date as agreed to by the Partiesparties are [**]. All shipments of Active Material will be accompanied by certificate(s) of analysis from the Active Material manufacturer and the Client, confirming the identity and purity of the Active Materials and its compliance with the Active Material Specificationsspecifications. For Client shall retain title to all Active Materials and Client-Supplied Components. Unless so authorized by (a) Client; (b) a court appointed administrator, receiver or other insolvency specialist; or (c) otherwise under a judicial proceeding or a court decision, Patheon shall not at any time sell or offer for sale, assign, mortgage, lease or allow any lien or other security interest to be created upon, or permit any seizure or confiscation of, the Active Materials or the Client Supplied Components while in Patheon’s possession. Patheon will not use the Active Materials or Client-Supplied Components which may be subject except to import or exportperform the Manufacturing Services. Patheon represents, warrants and covenants that, unless otherwise agreed in writing by Client, it will (i) store the Active Materials and Client agrees that Supplied Components only at the Manufacturing Site, and (ii) without prejudice to the provisions under Section 8.4(d), store and maintain the Active Materials and Client Supplied Components at its vendors cost and carriers will comply with applicable requirements expense only in the quantity necessary during the performance of the U.S. Customs Manufacturing Services pursuant to Section 5.2(a), in [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. accordance with Applicable Laws (including cGMP), the Specifications, the Quality Agreement and Border Protection Service and the Customs Trade Partnership Against Terrorismthis Agreement, as well as Client’s reasonable prior written instructions. If any Each Calendar Quarter, Patheon will provide Client with a quarterly Active Materials or Client-Supplied Components are imported, then Client will pay any applicable customs duties or VAT and act as importer of record for such imported materials in compliance with the local Customs and VAT requirements applicable in the country of importation. On the date of shipment, the API or Client-Supplied Components will conform to their specifications that Client has given to Patheon and the API and Client-Supplied Components will be adequately contained, packaged, and labeled and will conform to the affirmations of fact on the containerinventory report.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Synageva Biopharma Corp)
Active Materials and Client-Supplied Components. At If Patheon has advised Client of the scheduled production date, then, at least [***] days before the scheduled production date (such date to be communicated to Client by Patheon)date, Client will deliver the Active Materials and any Client-Supplied Components to the Manufacturing Site [***]] (Incoterms 2010), at no cost to Patheon, with any VAT paid by Client, in sufficient quantity to enable Patheon to manufacture the desired quantities of Product and to ship Product on the Delivery Date. If the Active Materials and/or Client-Supplied Components are not received [***] days before the scheduled production date, Patheon may delay the shipment of Product by the same number of days as the delay in receipt of the Active Materials and/or Client-Supplied Components. But if Patheon is unable, despite using commercially reasonable efforts, unable to manufacture Product to meet this new shipment date due to prior third party production commitments, Patheon may 71086739_10 delay the shipment until a later date as agreed to by the Partiesparties. All shipments of Active Material will be accompanied by certificate(s) of analysis from the Active Material manufacturer and Client, confirming the identity and purity of the Active Materials and its compliance with the Active Material Specificationsspecifications. For Active Materials or Client-Supplied Components which may be subject to import or export, Client agrees that it will use reasonable efforts to ensure that its vendors and carriers will comply with applicable requirements of the U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism. If any Active Materials or ClientTerrorism (“C-Supplied Components are imported, then Client will pay any applicable customs duties or VAT and act as importer of record for such imported materials in compliance with the local Customs and VAT requirements applicable in the country of importation. On the date of shipment, the API or Client-Supplied Components will conform to their specifications that Client has given to Patheon and the API and Client-Supplied Components will be adequately contained, packaged, and labeled and will conform to the affirmations of fact on the containerTPAT”).
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Jazz Pharmaceuticals PLC)
Active Materials and Client-Supplied Components. At If Patheon has advised Client of the scheduled production date, then, at least [***] days before the scheduled production date (such date to be communicated to Client by Patheon)date, Client will deliver the Active Materials and any Client-Supplied Components to the Manufacturing Site [***]] (Incoterms 2010), at no cost to Patheon, with any VAT paid by Client, in sufficient quantity to enable Patheon to manufacture the desired quantities of Product and to ship Product on the Delivery Date. If the Active Materials and/or Client-Supplied Components are not received [***] days before the scheduled production date, Patheon may delay the shipment [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. of Product by the same number of days as the delay in receipt of the Active Materials and/or Client-Supplied Components. But if Patheon is unable, despite using commercially reasonable efforts, unable to manufacture Product to meet this new shipment date due to prior third party production commitments, Patheon may 71086739_10 delay the shipment until a later date as agreed to by the Partiesparties. All shipments of Active Material will be accompanied by certificate(s) of analysis from the Active Material manufacturer and Client, confirming the identity and purity of the Active Materials and its compliance with the Active Material Specificationsspecifications. For Active Materials or Client-Supplied Components which may be subject to import or export, Client agrees that it will use reasonable efforts to ensure that its vendors and carriers will comply with applicable requirements of the U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism. If any Active Materials or ClientTerrorism (“C-Supplied Components are imported, then Client will pay any applicable customs duties or VAT and act as importer of record for such imported materials in compliance with the local Customs and VAT requirements applicable in the country of importation. On the date of shipment, the API or Client-Supplied Components will conform to their specifications that Client has given to Patheon and the API and Client-Supplied Components will be adequately contained, packaged, and labeled and will conform to the affirmations of fact on the containerTPAT”).
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Jazz Pharmaceuticals PLC)