Manufacture. 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements.
2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.
Manufacture. Seller reserves the right to discontinue the manufacture of, or change or modify the design and/or construction of the Products sold pursuant to these terms and conditions, without incurring any obligation to Buyer.
Manufacture. 3.3.1. Filament lamp bulbs shall exhibit no scores or spots which might impair their efficiency and their optical performance.
3.3.2. Filament lamps shall be equipped with standard caps complying with the cap data sheets of IEC Publication 60061, third edition, as specified on the individual data sheets of Annex 1.
3.3.3. The cap shall be strong and firmly secured to the bulb.
3.3.4. To ascertain whether filament lamps conform to the requirements of paragraphs 3.3.1. to 3.3.3. above, a visual inspection, a dimension check and, where necessary, a trial fitting shall be carried out.
Manufacture. (a) Manufacturer shall only manufacture the specific number of Licensed Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Licensed Products bearing the Trademarks to any third parties without the express written consent of the Company.
(b) Manufacturer shall manufacture the Licensed Products and packaging to conform in quality and specifications to the prototypes as defined in Paragraph 1, above.
(c) All Licensed Products and packaging manufactured by Manufacturer shall be delivered to locations specified by Company or directly to the Company, whichever Company may direct.
Manufacture. For purposes of this Article 11 above, Section 5.E. and Articles 12 and 18 below, "manufacture" shall include without limitation the manufacturing process for the product, bulk solution manufacturing, filling, filtering, inspection, testing, Labeling and packaging of Product.
Manufacture. (a) Nektar shall Manufacture the Product, and prior to shipment to Amgen, store at the Facility, Release and Deliver the Product, as specified in Orders, all in compliance with the terms of this Supply Agreement including without limitation the terms of the Quality Agreement. Nektar shall meet the Standard of Care in the performance of its obligations under this Supply Agreement. Nektar shall provide all that is required or necessary to perform its obligations under this Supply Agreement including without limitation providing all permits, licenses, authorizations, registrations, labor, supervision, facilities, machinery, equipment, materials (including without limitation Raw Materials), supplies, intellectual property rights, maintenance, calibration, validation and resources. Nektar has submitted to Amgen, and Amgen has approved in writing concurrently with entering into this Supply Agreement, copies of the Manufacturing Documents.
(b) Subject to the provisions of this Section 4.1, including without limitation the provisions governing Agreed Improvements and Agreed Change Costs, Amgen shall have the right, in its reasonable discretion, to make changes to any of the Amgen-Approved Manufacturing Documents and Specifications. Amgen shall submit to Nektar a Change Notification with respect to [***] that, on the Effective Date, is set forth in the Specification on Appendix G to the Quality Agreement. No later than [***] after Nektar’s receipt of each Change Notification or such longer period as specified, or agreed to (such agreement not to be unreasonably withheld or delayed), in writing by Amgen, Nektar shall revise pursuant to the Change Notification the documents that are the subject to the Change Notification and submit such revised documents to Amgen for review and approval. Concurrently and in addition, Nektar shall notify Amgen (each a “Response Notice”) of (i) any Proposed Improvements (including the schedule for undertaking and completing any Proposed Improvements which schedule may take into consideration Nektar’s other manufacturing activities at the Facility to the extent that implementation of the Proposed Improvements would result in [***] interruption of or interference with such other activities) and Proposed Change Costs and (ii) any and all intellectual property rights of Third Parties of which Nektar has knowledge that might be relevant to the Change Notification. Unless Amgen specifies or agrees in writing to a longer period, within [***] ...
Manufacture. Best Theratronics shall manufacture and produce the Medical Cobalt-60 Sources for ViewRay in accordance with the terms set forth herein and shall ensure that all Medical Cobalt-60 Sources conforms to the Specifications. ViewRay will be supplied a Sealed Source Test Certificate for Medical Cobalt-60 Sources purchased. In the event that Best Theratronics should fail to comply with such standards and Specifications, Best Theratronics shall bear all direct and reasonable costs and expenses of remedial action so as to meet such standards and Specifications.
Manufacture. For the avoidance of doubt, the parties acknowledge and agree that manufacture of product, packaging, or materials by or on behalf of a party in a country in which such party is not permitted to use a Trademark for such product hereunder for shipment to a country in which such party is permitted to use a Trademark for such product hereunder shall not be deemed to be in violation of this Agreement provided that such activity is not publicized by such party in such country and such product, packaging, and materials are not distributed or sold in a manner that is inconsistent with the terms and conditions of this Agreement.
Manufacture. The Party responsible for the Manufacture of the Licensed Compounds or Licensed Products and placebo or other comparators pursuant to Section 3.5.1 shall Manufacture pursuant to GMP.
Manufacture. (a) During the Term and subject to this Section 3.4. CDI (and its Affiliates) shall have the exclusive right to manufacture and supply iPSC to Century for [***] beginning on the Effective Date. If at any time following [***] of the Effective Date, Century wishes to have a Third Party manufacture human iPSC (including TiPSC), Century shall discuss with CDI in good faith the possibility of using such Third Party to manufacture human iPSC (including TiPSC), provided that Century shall have the sole discretion to determine whether to use CDI or such Third Party for such manufacture of iPSC (including TiPSC). In the event that Century elects to use a Third Party manufacturer, CDI hereby agrees to amend the terms of this Agreement without delay to provide Century, its Affiliates and Sublicensees with the necessary licenses under the Licensed Patent Rights for the Exploitation of such products, including amending the definition of “Licensed Product” to remove the limitation that iPSC be exclusive manufactured by CDI. The Parties shall negotiate in good faith as soon as reasonably practical the terms of a manufacturing and supply agreement under which CDI or its Affiliate would itself manufacture and supply iPSC (a “Supply Agreement”) and the terms of a quality agreement which would provide the responsibilities of Century and CDI or its Affiliates for quality assurance of human iPSC (including TiPSC) and the Licensed Products referenced in the Supply Agreement (a “Quality Agreement”).
(b) The Supply Agreement and Quality Agreement shall each contain terms and conditions that are commercially reasonable given the terms of the Parties’ collaboration under this Agreement, including manufacturing capacity, quantity, forecasting, timeliness of delivery, quality, cost, and failure of supply that are consistent with prevailing industry standards for Third Party contract manufacturing agreements for comparable products.
(c) The Supply Agreement shall provide:
(i) CDI’s (and its Affiliates) exclusive right to manufacture and supply human iPSC (including TiPSC) to Century and its Sublicensees:
(ii) CDI’s (and its Affiliates or contractors) obligations to perform manufacturing activities in a good scientific manner and in compliance in all material respects with all applicable Law; and
(iii) Century’s ability to manufacture by itself or through its Affiliate, or to grant to a Third Party manufacturer the right to manufacture, the Licensed Products in minimal quantities neces...
