Active Materials and Client-Supplied Components. As soon as possible and at least before the scheduled production date, 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 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 to manufacture Product to meet this new shipment date due to prior third party production commitments, Patheon may 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 the 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 (“C-TPAT”).
Client shall supply to Catalent for Processing, at Client’s cost, all Client-supplied Materials, in quantities sufficient to meet Client’s requirements for Product. Client shall deliver such items and associated certificates of analysis to the Facility no later than 60 days (but not earlier than 90 days) before the Processing Date. Client shall be responsible at its cost for securing necessary export or import, or similar clearances, permits or certifications required in respect of such supply. Catalent shall use such items solely for Processing. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Product, and shall promptly provide any updates thereto.
Client-supplied Materials. Catalent shall have no liability under this Agreement for any and all claims for lost, damaged or destroyed Client-supplied Materials, whether or not such Client-supplied Materials are incorporated into Product.
Client shall supply to Catalent for Processing, at Client’s cost (except as otherwise set forth in this Agreement), all Client-supplied Materials, in quantities sufficient to meet Client’s Purchase Orders for Product under this Agreement. Client shall deliver such items and associated EXECUTION VERSION
Acorda-Supplied Components/Materials. Manufacturer shall obtain from Acorda, and Acorda shall supply to Manufacturer at no cost to Manufacturer, all Acorda-Supplied Components/Materials. Manufacturer will be responsible for ordering Acorda-Supplied Components/Materials from Acorda as necessary to ensure availability of Acorda-Supplied Components/Materials at the Manufacturing Site in sufficient quantity and on such schedule as is required to enable Manufacturer to manufacture and deliver to Acorda as contemplated herein the desired quantities of Supplied Product covered by Purchase Orders by the applicable Delivery Dates. Acorda shall be responsible for any required governmental clearance, permit or certification, packaging, shipping, insuring, carriage, importing and exporting of Acorda-Supplied Components/Materials for delivery to the Manufacturing Site. Prior to delivery of any Acorda-Supplied Components/Materials, Acorda shall provide to Manufacturer a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any governmental certification or authorization that may be required under Applicable Laws relating to the Active Materials and Supplied Product, and thereafter shall provide promptly any update thereto.
Acorda-Supplied Components/Materials. Title and risk of loss (except in the case of a breach of this Agreement by Manufacturer or Manufacturer’s gross negligence or intentional misconduct, which shall be subject to [Section 10.1]) to Acorda-Supplied Components/Materials will at all times remain with Acorda. To the extent that any right, title or interest in or to such Components/Materials should at any time, contrary to the provisions of this [Section 2.1(f)(vi)], become vested in Manufacturer, Manufacturer shall, and does hereby, assign all of its right, title and interest to such Components/Materials to Acorda. Without limiting the foregoing, Manufacturer shall take all such actions as may be required in order to vest good title to such Components/Materials in Acorda, including by executing, delivering, or filing such instruments or documents as may from time to time be requested by Acorda to more fully vest in Acorda good title to such Components/Materials. Manufacturer shall make such entries in its books and records, and shall post such notices in those portions of the Manufacturing Site in which Acorda-Supplied Components/Materials are stored, as are necessary or appropriate under Applicable Laws to reflect and preserve Acorda’s good title to the Acorda-Supplied Materials.
API and Client-Supplied Components. Client, at its cost, must deliver the API not already in Safety Stock (as defined below) pursuant to [Section 2.1(i)] and any Client-Supplied Components to the Manufacturing Site DDP (Incoterms 2010) at least days before the scheduled manufacture date for Product covered by a Firm Order in sufficient quantity to enable [[Organization A:Organization]] to manufacture the agreed quantities of Product and to ship Product on the Delivery Date. If Client fails to deliver the API or Client-Supplied Components in accordance with this [Section 2.1(f)] then # [[Organization A:Organization]] will immediately advise Client of this failure, and # if despite making commercially reasonable efforts, [[Organization A:Organization]] is unable to manufacture Product on the scheduled date because of the delay, the parties will reschedule the Firm Order and establish a new Delivery Date for the Firm Order as agreed between the parties. If [[Organization A:Organization]] would have been ready to manufacture the Product on the scheduled date and is unable to reschedule the manufacturing slot for another client’s product after using reasonable efforts to do so, Client will . Client will: # deliver API that meets the specifications for the API, which will be confirmed by [[Organization A:Organization]]’s identity testing procedures; and # ensure that all shipments of API are accompanied by the required documentation as specified in the applicable Quality Agreement. For API 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 (“C-TPAT”).
The following materials will be supplied by AADI to FRESENIUS KABI to enable product manufacturing (“Supplied Materials”):
Conversion of Active Materials and Components. Patheon will convert Active Materials and Components into Products.
Conversion of Active Materials and Components. [[Organization A:Organization]] will convert Active Materials and Components into Product.
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