Product Manufacture Sample Clauses
The Product Manufacture clause defines the standards and requirements for how a product must be produced under the agreement. It typically outlines specifications such as quality control measures, approved materials, manufacturing processes, and compliance with relevant laws or industry standards. For example, it may require that products be manufactured in certified facilities or meet certain safety certifications. The core function of this clause is to ensure that the products delivered meet agreed-upon expectations and regulatory requirements, thereby reducing the risk of defects or non-compliance.
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Product Manufacture. (i) Ingenus shall be responsible for the timely manufacture and supply of the Product in accordance with Athenex Purchase Orders and Section 5.1(b) of this Agreement.
(ii) Ingenus shall be responsible for procuring all Materials and performing all applicable analytical release testing to process the quantity of Product for which firm Purchase Orders have been issued by Athenex in accordance with the Forecasts.
(iii) At the time of the Product being made available to Athenex for EXW shipment, the Product shall have a minimum shelf-life of 75% of the approved Product expiry dating.
Product Manufacture. LICENSEE undertakes to manufacture PRODUCT and FINISHED PRODUCT in the TERRITORY in accordance with prevailing "Good Manufacturing Practice" in the TERRITORY.
Product Manufacture. (a) During the term of this Agreement, SPECTRUM shall from time to time, place orders with EPRO . EPRO shall process and deliver the Product pursuant to such orders, in compliance with the Specifications as defined in Exhibit A attached hereto. EPRO shall have the right to require SPECTRUM to pay 10% of the price for that amount of the Minimum Quantities of Product which have not been ordered by SPECTRUM.
(b) EPRO shall manufacture and have ready for shipment the ordered quantities of the Product within ninety (90) days from receipt of a written purchase order from SPECTRUM hereunder. SPECTRUM shall furnish EPRO with its three (3) year forecast on the Effective Date and every three (3) months with its rolling forecast for the following twelve (12) month period for the Product, however, any such estimates shall not be binding or otherwise limit or obligate SPECTRUM in any way except for the first six (6) months which shall be binding and shall be referred to as the “Minimum Quantities.”
(c) From time to time during the term of this Agreement, the Parties by mutual consent, may add to or modify the Specifications attached hereto as Exhibit A by reasonable advance written notice. EPRO will update its drug master file (DMF) every time the drug substance specifications are changed.
(d) EPRO shall not actively manufacture the Product for any third party for the Field of Use in the Territory and shall cooperate in good faith with Spectrum to insure that Product sold to any third party shall not be re-sold or used by that Party in the Field of Use in the Territory.
(e) SPECTRUM shall purchase its Product requirements exclusively from EPRO during the term of this Agreement.
(f) EPRO shall not manufacture or sell any product using the Technology or license its knowledge of the Technology to enable other manufacturers to make available the Product in the Field of Use in the Territory.
(g) EPRO shall manufacture the Product at its facility located at Schaffhausen, Switzerland (“EPRO’s Facility”), which facility will have to be inspected and approved by SPECTRUM prior to shipment of any commercial Product, and meets with all FDA requirements. EPRO will use commercially reasonable efforts to file a Drug Master File (“DMF”) for the manufacture of the Product before November 1st, 2006 and will be responsible for all associated costs. EPRO hereby represents and warrants that EPRO’s Facility, including the real estate on which it is situated and all equipment located therei...
Product Manufacture. Pursuant to the provisions of this Agreement, BVL shall Manufacture Customer’s Purchase Order quantities of Product in finished packaged dosage form as defined in each Attachment “A#.1” (i.e., A1.
1) For the avoidance of doubt, notwithstanding anything in this Agreement to the contrary, such Product shall meet the Specification, the requirements of cGMP and all Applicable Law. BVL, its Agents and Bedford (and any business, operations, personnel or assets owned or controlled by BVL and such Agents and any successors thereto, as the same may be reorganized from time to time) shall not during the term Manufacture for any Third Party, directly or through any Third Party any Relevant Product or provide or cause to be or assist in providing any products or services (including in manufacturing, development, or procurement) any Relevant Product, only in each case with the prior written consent of Customer (which may be given at its sole discretion).
Product Manufacture. Seller agrees to promptly provide Buyer written information on upgrades or modifications to existing Products and new product development for products similar to any of the Products. Seller shall continuously supply each Product for a minimum period of two (2) years following the end of the term of the last issued PO entered into between Buyer and Seller (the “Supply Period”). In the event that Seller intends to discontinue the manufacture and sale of any Product after the end of the Supply Period, Seller shall provide at least six (6) months prior written notice to Buyer. During such six-month period (the “Discontinuance Period”), Buyer may place PO’s for such Product pursuant to this Agreement; provided however, the last delivery date for such Product shall not be more than twelve (12) months after the end of such Discontinuance Period. In no event shall Seller sell such Product to any other of its customers after it stops selling such Product to Buyer.
Product Manufacture. ArthroCare shall manufacture and sell to Collagen, and Collagen agrees to exclusively purchase from ArthroCare, Collagen's requirements for Licensed Products in the Field. ArthroCare will manufacture Licensed Products in accordance with ISO 9000 Standards, EN 46000 Standards, FDA Quality Systems Regulations (including Current Good Manufacturing Practices), and requirements of the Medical Device Directives ("MDD") and the then-current product specifications, as may be modified from time to time by the mutual written consent of the parties hereto.
Product Manufacture. Pursuant to the provisions of this Agreement and subject to the limitations set forth in Article 5, BVL shall Manufacture and deliver to Customer the quantities of Product ordered by Customer under this Agreement in finished packaged dosage form as defined in each Attachment “A#.2” (i.e., A1.
Product Manufacture. 6.9.1 Pursuant to the terms of this Agreement, QIAGEN shall be responsible for, and shall use Commercially Reasonable Efforts to manufacture a sufficient amount of Product necessary to fully support the successful launch of the Product in each country or region in the Territory and to fully support efforts to maximize commercial sales of Product and market adoption in each such country or region in the Territory.
Product Manufacture. KHK shall have sole responsibility and authority regarding manufacture of the Licensed Product. KHK shall be entitled to [***].
Product Manufacture. Data Critical or its licensed agent shall manufacture the Products, Software and Parts in conformity with their Manufacturing and Design Documentation and this Agreement, and sell, provide, and ship such in new, undamaged condition. Data Critical or its licensed agent shall continue to manufacture and make the Parts available to Medtronic for purchase hereunder or otherwise transfer the appropriate technology and know-how to Medtronic, free of charge and without prohibitions on use for such manufacturing and availability purposes, to facilitate Medtronic's manufacture thereof, in each case for a period of five (5) years after any termination or expiration of this Agreement or, in the case of government supply contracts, as otherwise required by law. The prices payable by Medtronic for all parts shall be [*]. [*]. -------------------- * Confidential Treatment Requested