Manufacturing of Product. 3.1 JAGOTEC shall manufacture the Product for marketing and sale by NITEC in the Manufacturing Site in strict compliance with the Specifications and the approved Manufacturing Process and in accordance with the Quality Agreement. Furthermore, JAGOTEC shall only use such equipment and personnel which are appropriate or duly qualified for the manufacturing of Product in accordance with the provisions of this Agreement and the Quality Agreement. It is acknowledged and agreed between the parties that the final dissolution specification for the Product is not approved by the regulatory authorities at signing this contract but will be approved by the regulatory authorities during the approval process. Therefore, JAGOTEC shall only be liable for failing to manufacture the Product in accordance with such preliminary dissolution specification (as per annex 2) until agreement of the Joint Product Committee as set out below. After approval by the regulatory authorities of a final dissolution specification, JAGOTEC shall use Commercially Reasonable Best Efforts to implement such final dissolution specification such that the Product may be manufactured at the Manufacturing Site in accordance therewith. If, having used such efforts, JAGOTEC is able to manufacture in accordance with such final dissolution specification, it shall notify the Joint Product Committee. Upon the unanimous agreement of the Joint Product Committee that such final dissolution specification has been implemented, the Specifications and/or the
Manufacturing of Product. Arkados will be responsible for the manufacturing of the Product; provided, that GDA, acting on behalf of Arkados, will be responsible for (i) negotiating (subject to Arkados' approval) the terms of a foundry agreement with the Foundry under which the Product would be manufactured, including without limitation any pricing terms, (ii) monitoring and managing the Foundry's performance under the foundry agreement; and (iii) accepting, packaging and testing Product delivered by the Foundry.
Manufacturing of Product. 2.4.1 Isis will have the first right to manufacture the Product, at mutually agreeable, commercially reasonable terms and conditions, and pursuant to a supply agreement to be agreed to by the Parties containing standard terms regarding quality control, ordering, delivery, title and risk of loss, warranties and indemnification.
2.4.2 If Isis is unable or unwilling to manufacture the Product, or if the Parties cannot reach agreement on the terms and conditions within 60 days of a request for transfer pricing quote by OncoGenex, OncoGenex may: have the Product manufactured by a manufacturer licensed under Isis’ proprietary manufacturing and analytical technology; or have the Product manufactured using a process not covered by Isis’ proprietary manufacturing and analytical technology.
Manufacturing of Product. Ambrx shall manufacture and supply a limited (research-scale) quantity of each Product that is not manufactured in accordance with Good Manufacturing Practices, as set forth in the Product Development Plan, at no additional expense to Elanco unless agreed to in writing by the Steering Committee. Elanco will have the exclusive right in the Field to manufacture, or have manufactured, Product for clinical trial material and commercial supply. Elanco will assume all responsibility and related expense for manufacturing and supply of commercial quantities of Product to Elanco customers.
Manufacturing of Product. 2.5.1 Isis will have the first right to manufacture the API for the Product, on mutually agreeable, commercially reasonable terms and conditions, and pursuant to a supply agreement to be agreed to by the Parties containing terms customary in the industry regarding quality control, ordering, delivery, title and risk of loss, warranties and indemnification.
2.5.2 If Isis is unable or unwilling to manufacture the API for the Product, or if the Parties cannot reach agreement on the terms and conditions for a supply agreement within 60 days of a request for transfer pricing quote by OncoGenex, OncoGenex may:
(a) have the API for the Product manufactured by a manufacturer licensed under Isis’ proprietary manufacturing and analytical technology; or
(b) have the API for the Product manufactured using a process not covered by Isis’ proprietary manufacturing and analytical technology.
Manufacturing of Product a. Sensar shall, and has full rights to, manufacture the Product for sale by SAES under this agreement. Sensar shall use its best efforts to manufacture the Product in a timely manner to meet the sales efforts of SAES. SAES shall allow ninety (90) days delivery time for Products from date of order, although Sensar shall deliver Products fully tested and in compliance to mutually agreed specifications as rapidly as possible.
b. SAES may require Sensar to identify the Product with SAES' name by adding a label of appropriate size, stating "Manufactured for SAES Getters S.p.A. by Sensar Corporation, a subsidiary of Xxxxxx Xxxxx Inc.," or such other language as may be agreed to from time to time.
c. Sensar agrees that it shall indemnify, defend and hold SAES harmless from and against any claims, damages, costs and expenses (including attorney's fees) caused by the negligence of Sensar and attributable to the Product including, without limitation, claims for product liability or claims based on patent, copyright or trademark infringement and caused by reason of any defective design or manufacture of the Product and without the fault or negligence of SAES. SAES agrees that it shall indemnify, defend and hold Sensar harmless from and against any claims, damages, costs and expenses (including attorney's fees) attributable to or arising out of the fault or negligence of SAES.
Manufacturing of Product. All Product supplied by Celltrion hereunder shall have been manufactured in compliance with the Product Specifications. Celltrion shall maintain the Facility in which the Product is manufactured in compliance with requirements of all applicable Regulatory Authorities including, without limitation, then-current Good Manufacturing Practices ("cGMP") established by the FDA. Product Specifications, manufacturing and testing procedures and equipment may not be modified by Celltrion without VaxGen's written approval; provided, however, that if such modification is mandated by a Regulatory Authority, Celltrion shall inform VaxGen as soon as possible and the parties shall work in good faith to affect such change in a manner that least disrupts production or distribution of the Product. Unless and until otherwise expressly agreed by the Parties, compliance with the Product Specifications, Storage Specifications and all applicable cGMP requirements as certified in a "Certificate of Compliance" shall be deemed to constitute the "Acceptance Criteria" for the Product.
Manufacturing of Product. 5.1 Epro shall use its best efforts to manufacture the Product in the quantities and at the times specified in Schedule 2, attached hereto. The Product shall be manufactured in accordance with the Specifications and for clinical uses under cGMP.
5.2 All manufacturing activities related to the Project will be conducted in accordance with the terms of this Agreement and a Quality Agreement to be negotiated by the Parties (the “Quality Agreement”). The Quality Agreement will include the detailed requirements related to the manufacture and Release of the Product, including, without limitation, the procedures and requirements related to the Documents, Manufacturing Instructions, Batch Records and Certificate of Analysis. The Parties will use their best efforts to finalize the Quality Agreement within sixty (60) days after the date of this Agreement. If the Parties are unable to finalize the Quality Agreement, senior management of each Party will discuss all open issues and, if still unable to finalize the Quality Agreement, will participate, in good faith, in commercial mediation to resolve any open issues. The cost of such mediation shall be split equally between the Parties. Portions of this document have been redacted pursuant to a Request for Confidential Treatment. Redacted portions are indicated with the notation “[*****]”
5.3 In anticipation of the possibility that, in BioMarin’s discretion, BioMarin determines that the clinical trials related to the Product in one or more indications in the BioMarin Field of Use are successful and that BioMarin wishes to proceed with commercialization of the Product, or in the event that Epro develops the Product for an indication in the Epro Field of Use, or the Parties develop an alternate commercial application for the Product or the Project Intellectual Property Rights, the Parties will execute a Commercial Supply and License Agreement (the “Commercial Supply and License Agreement”) that the Parties expect will supersede this Agreement, include the development terms contained herein and the additional terms set forth in the Term Sheet related to commercialization, the manufacturing protocols contained in the Quality Agreement and such other terms and conditions as the Parties may agree. The Commercial Supply and License Agreement shall also include the terms of the license from, and royalty payable to, BioMarin related to Epro’s use of the Project Intellectual Property Rights in Epro’s Field of Use and the terms rel...
Manufacturing of Product. 2.4.1 Isis will have the first right to manufacture the Product, on mutually agreeable, commercially reasonable terms and conditions, and pursuant to a supply agreement to be agreed to by the Parties containing standard terms. If Isis is unable or unwilling to manufacture the Product, or if the Parties cannot reach agreement on the terms and conditions within [***] days of a request for transfer pricing quote by Sarissa, Sarissa may (i) have the Product manufactured by a manufacturer already licensed under Isis' proprietary manufacturing and analytical technology; or (ii) have the Product manufactured using a process not covered by Isis' proprietary manufacturing and analytical technology. ARTICLE 3—
Manufacturing of Product. 1.1. Manufacturing Procedures
1.2. Deviations
1.3. Rejection of Product
