Manufacturing of the Products Sample Clauses

Manufacturing of the Products. Bayer shall manufacture, process, store, distribute, test, transport, dispose, deliver and otherwise handle the Products and the Inputs at all times in full compliance with, as applicable, cGMPs (as defined in Section 5.1), other Regulations (as defined in Section 5.1), the Product Specifications, the Manufacturing Agreement (for manufacturing Fraction IV-I/PEG Paste into the Column Eluate), attached hereto as Exhibit F and incorporated herein by reference, the Manufacturing Agreement (for manufacturing Fraction IV-I Paste into ATIII), attached hereto as Exhibit G and incorporated herein by reference, and the SOPs (as defined in Section 2.13). The Manufacturing Agreements for manufacturing Fraction IV-I/PEG Paste into the Column Eluate and Fraction IV-I Paste into ATM shall be renewed annually, consistent with the Term of this Agreement, with each such renewal deemed attached hereto as Exhibit F and Exhibit G, respectively, and incorporated herein by reference. In the event of a conflict between the provisions of this Agreement and the provisions of either of the Manufacturing Agreements, the provisions of this Agreement shall prevail. Bayer shall maintain all records as are necessary and appropriate to demonstrate compliance with cGMPs and the Regulations. In no event shall any change to the batch production records be implemented until Bayer has received written approval from Purchaser which approval will not be unreasonably withheld. Bayer shall make no changes in the production equipment, production procedures, or testing methods existing as of the date of this Agreement. without providing reasonable notice to Purchaser in advance of the change and obtaining Purchaser’s prior written consent which consent will not be unreasonably withheld.
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Manufacturing of the Products. Greatbatch is responsible for material compliance with Applicable Laws regulating the manufacture of the Products by Greatbatch under this Agreement. Without limiting the generality of the foregoing, the Products delivered to NeuroPace under this Agreement will be manufactured in material conformance with current revisions of ISO 9001 or ISO13485, as applicable. Subject to the non-disclosure requirements of Section 10.1, Greatbatch will provide reasonable access, at a mutually agreed upon date and time, for NeuroPace’s regulatory and quality personnel to (a) the portion of Greatbatch’s facilities used for the manufacture of Products pursuant to this Agreement and (b) the records of Greatbatch related to Products manufactured under this Agreement. The purpose of this reasonable access is to confirm Greatbatch’s compliance in the manufacture of the Products under this Agreement with any applicable requirements noted in this Section 4.1. Greatbatch will advise NeuroPace promptly of any material written report, recommendation, violation, citation or other adverse information provided to Greatbatch by an agent or representative of any national or international authority visiting or inspecting Greatbatch’s operations related to assembly and manufacture of the Products. Greatbatch will keep all required manufacturing records for each lot of Products for the period of time required by Applicable Laws.
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Manufacturing of the Products. Greatbatch is responsible for compliance with Applicable Laws regulating the manufacture of the Products by Greatbatch under this Agreement. Without limiting the generality of the foregoing, the Products delivered to Customer under this Agreement will be manufactured in conformance with current revisions of ISO 9001. Subject to the non-disclosure requirements of Section 9.1, Greatbatch will provide reasonable access, at a mutually agreed upon date and time, for Customer’s regulatory and quality personnel to (a) the portion of Greatbatch’s facilities used for the manufacture of Products pursuant to this Agreement and (b) the records of Greatbatch related to Products manufactured under this Agreement. The purpose of this reasonable access is to confirm Greatbatch’s compliance in the manufacture of the Products under this Agreement with any applicable requirements noted in this Section 4.1. Greatbatch will advise Customer promptly of any written report, recommendation, violation, citation or other adverse information provided to Greatbatch by an agent or representative of any government authority visiting or inspecting Greatbatch’s operations related to assembly and manufacture of the Products. Greatbatch will keep all required manufacturing records for each lot of Products for the period of time required by Applicable Laws.
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Manufacturing of the Products. Procuring the Components necessary for the Manufacturing
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Manufacturing of the Products. Seller and its Affiliates shall Manufacture and supply the Products to Buyer at all times in full compliance with the Act, cGMP and any other applicable Regulatory Requirements. Seller and its Affiliates shall maintain during the Term of this Agreement and for a period thereafter consistent with Seller’s policies and standard cGMP requirements, all records as are necessary or appropriate to demonstrate compliance with the Act, cGMP and any other applicable quality control standards of any Regulatory Authority in the Territory. If Seller fails to comply with cGMPs in a manner, as demonstrated by an observation of a Regulatory Authority, Seller shall diligently proceed to remedy such deviation in accordance with Seller’s response to the observation.
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Manufacturing of the Products. Collegium shall exclusively (even as to Collegium) Manufacture and supply Hikma with, and Hikma shall exclusively purchase from Collegium, all of the quantities of the Products which Hikma requires to be sold in the Territory. As soon as reasonably practicable, and in [***], the Parties shall negotiate in good faith and enter into the Manufacturing Agreement, which will include provisions addressing remedies for failure to supply, supply deficiencies, and back-up/alternate manufacturing and other customary terms pertaining to the manufacturing and supply of the Products, and any and all agreements contemplated ​ ​ thereunder providing for manufacture and supply by Collegium of the Products to Hikma in finished dosage form, packaged and labeled for commercial sale in the Territory.
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Manufacturing of the Products. Subject to the provisions of Section 10 hereof, Xxxxxx will manufacture and package quality Products for sale to Xxxxxxx pursuant to the agreed upon formulations and specifications and will use its best efforts to control its cost of manufacturing consistent with the quality specifications for the Products. Xxxxxx will devote to such manufacturing all equipment owned or leased by Xxxxxx necessary for the production of the Products, and the services of all Xxxxxx employees necessary for such production.
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Manufacturing of the Products. 5.1 Manufacturing. Company agrees to manufacture and sell the Products to -------------- Distributor subject to the terms and conditions set forth herein.
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Manufacturing of the Products 
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Related to Manufacturing of the Products

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Supply of Products ‌‌ 3.1 The Supplier warrants that the Products shall: (a) correspond with their description and any applicable Product Specification; (b) conform in all respects with the Order and any relevant sample; (c) be of satisfactory quality and fit for any purpose held out by the Supplier or made known to the Supplier by Ornua, expressly or by implication, and in this respect Ornua relies on the Supplier's skill and judgement; (d) be manufactured by properly trained and qualified personnel using all reasonable skill, care and diligence and in a good and workmanlike manner;‌ (e) where they are manufactured products, be free from defects in design, materials and workmanship and remain so for the period set out in the Product Specification or, if none is specified, for at least 12 months after delivery; (f) comply with all applicable statutory and regulatory requirements relating to the manufacture, labelling, packaging, storage, handling and delivery of the Products;‌ (g) comply with all relevant standards including any UK Standards, European Standards or International Standards applicable in the UK and the country or State where the Products are to be used; and (h) in the case of Products containing food stuffs, when delivered to Ornua, comply with all applicable food and hygiene legislation and regulations and best industry practice.‌ 3.2 The Supplier shall ensure that at all times it has and maintains all licences, permissions, authorisations, consents and permits needed to carry out its obligations under the Contract in respect of the supply of Products. Breach of this Condition shall be deemed a material breach of the Contract. 3.3 Ornua may inspect and test the Products at any time before delivery. The Supplier shall remain fully responsible for the Products despite any such inspection or testing and any such inspection or testing shall not reduce or otherwise affect the Supplier's obligations under the Contract. 3.4 If following such inspection or testing Ornua considers that the Products do not comply or are unlikely to comply with the Supplier's undertakings at clause 3.1, Ornua shall inform the Supplier and the Supplier shall immediately take such remedial action as is necessary to ensure compliance.‌ 3.5 Ornua may conduct further inspections and tests after the Supplier has carried out its remedial actions.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • 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.

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Supply of Product 4.1 DAEWOONG shall manufacture and supply Product to AEON in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

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