MANUFACTURE AND QUALITY CONTROL. (a) The Licensee, and riot Jennicor, shall - be solely responsible for the manufacture, production, marketing, sale and delivery of the Products. Jennicor shall not be liable or otherwise responsible for any problems encountered by the Licensee in manufacturing, producing, marketing or selling the Products.
(b) The Licensee shall manufacture the Products for sale under the Xxxxxxxx Gucci Name and the Jennicor Marks in strict accordance with designs, patterns, specifications, directions and high quality standards selected or approved by Jennicor Marks and any products not so manufactured.
MANUFACTURE AND QUALITY CONTROL. 12.1. PHARMA shall manufacture or have manufactured all the Products and Lamps supplied to INC hereunder in accordance with all of the following:
a. all product specifications and requirements within the Regulatory Approval;
b. all applicable Good Manufacturing Practices (GMP); and
c. all other applicable laws and regulations in connection with the manufacture, shipment, handling and distribution of the Products including, but not limited to, the Regulatory Approvals.
12.2. PHARMA shall perform QC testing and thereafter provide INC with the Certificate of GMP Compliance and the Certificate of Analysis confirming that the Products have met all current and applicable Product specifications and requirements set forth in this Agreement or as modified according to future amendments of the regulatory approval.
12.3. PHARMA will quality check all Lamps according to the Specifications prior to shipment. INC will check the Lamps promptly after arrival for any obvious damages. The lamp will be covered by the standard 2-year warranty for manufacturing defects.
12.4. INC may reject, within [***] working days of actual receipt, any or all of a shipment of Product and, within [***] working days of actual receipt, any or all of a shipment of Lamps that INC reasonably determines does not conform to the Product specifications and PHARMA shall replace any non-conforming Products at PHARMA’s expense.
12.5. Upon justified request by INC, PHARMA shall send a new shipment of the Products or Lamps to INC (of similar quantity as the batch of the Products and at the selling price and on such other terms and conditions as set forth herein) so as to enable INC to continue to supply the Products and Lamps to its customers. In the event that the Parties agree, or in the event that any of the Products or Lamps is verified as defective or not in conformity with the Products specifications, replacement shall be made by PHARMA as expeditiously as reasonably possible.
12.6. INC shall not be obligated to pay for any shipment (or partial shipment) of the Products or Lamps which does not conform to the Product specifications as in place and amended at the time of shipment. If INC notifies PHARMA that any or all of a shipment of the Products or Lamps do not conform to the specifications, then payment for such shipment shall be delayed until resolution of the discrepancy by consultation between the Parties. Any units of the Products or Lamps that are determined by agreement between the Parties ...
MANUFACTURE AND QUALITY CONTROL. (a) For each shipment of Product, AccuLase shall conform to the requirements set forth in Xxxxxx'x Supplier Quality Standard attached hereto as Exhibit B and any other incoming quality standards which are agreed to by the parties.
(b) All Product shall meet the Specifications. All product shall be manufactured in accordance with Good Manufacturing Practices for Medical Devices established by the United States Food and Drug Administration ("FDA") as provided in 21 U.S.C. 360j (f) and as promulgated by regulations in 21 CFR 820. Product shall be subjected to quality control inspection by AccuLase in accordance with Xxxxxx'x quality control standards and the quality control system to be developed by AccuLase prior to production of any Product. AccuLase shall permit Baxter to review periodically AccuLase's production and quality control procedures and records and to visit AccuLase's facilities at reasonable times with a representative of AccuLase present in order to assure satisfaction of the requirements of this Agreement.
MANUFACTURE AND QUALITY CONTROL. 5.1 The Supplier is responsible for the purchase, receipt, testing, storage, release and overall quality of all Raw Materials in accordance with the terms and conditions of this QA Agreement.
5.2 The Supplier shall perform its obligations in this QA Agreement with reasonable skill and care in accordance with best practice and standards in the Supplier's industry or trade and in accordance with all applicable laws and regulations.
5.3 The Supplier is responsible for and shall undertake a quality assessment of key vendors of Critical and Raw Materials. Critical and Raw Materials shall only be sourced from third parties who have been evaluated and approved by the Supplier in accordance with its written internal requirements.
5.4 The Supplier shall control and release the Raw Materials according to written test procedures and specifications which the Supplier shall maintain and keep current.
5.5 The Supplier shall ensure that the Material is manufactured, controlled and supplied in accordance with applicable regulations, standards and guidelines as defined in Annex 3.
5.6 During the manufacture of the Material, Supplier shall perform in-process and release control testing in accordance with written and internally approved methods and specifications.
5.7 The Supplier shall ensure that no materials from animal origin shall be used in the manufacture of Material unless certified as TSE (Transmissible Spongiform Encephalopathies) risk free by the appropriate agency or authority.
5.8 The Supplier shall ensure that all equipment used in or in connection with the manufacture and testing of the Material is qualified, calibrated and maintained as appropriate in accordance with applicable regulations, standards and guidelines as defined in Annex 3.
5.9 The Supplier shall ensure that at all times there will be a sufficient number of personnel engaged in the manufacture of the Material with a suitable level of skill, qualification and experience.
MANUFACTURE AND QUALITY CONTROL. (a) Vendor shall and shall cause its supplier to maintain an effective quality assurance system for manufacture, testing, packaging and shipping of the Materials, and routines for quality verification and corrective actions in accordance with the standards of ISO 9001 or an equivalent quality assurance system.
(b) All Materials shall be subject to quality assurance control prior to release by Vendor.
MANUFACTURE AND QUALITY CONTROL. 7.1 All Products shall meet the Specifications, shall be manufactured in accordance with Good Manufacturing Practice ("GMP") for Medical Devices established by the United States Food and Drug Administration as provided under 21 U.S.C. 3600)(f), and shall be subjected to quality control inspection by Rochester in accordance with quality control standards including without limitation process controls, as established by Rochester and approved by EI.
7.2 EI shall have the right to review and approve Rochester's production and quality control procedures, including without limitation Rochester's internal assembly procedures and procedures for testing subassemblies at different stages of assembly, and Rochester's engineering, assembly and testing documentation for the Products, and to visit Rochester's facilities at reasonable times with a representative of Rochester present in order to assure satisfaction of the requirements of this Restated Agreement. EI shall be deemed to approve Rochester's production and quality control procedures complying with ISO 9001 and CM 4601.
7.3 Rochester will notify EI immediately of any inspection of its facilities by a federal, state or local regulatory agency that results in advice of noncompliance with GMP, CE Xxxx, or similar regulatory requirements; will furnish EI with the results of such inspection; and will furnish EI with advice of corrective actions, and the results thereof, taken by Rochester to achieve such compliance.
MANUFACTURE AND QUALITY CONTROL. The nature and quality of the Products shall be subject to the approval of the Licensor, which approval shall not be unreasonably withheld and in connection therewith:
(a) The Products shall be of quality and shall manufactured according to the prevailing standards of the health and beauty aids industry.
(b) The Products sold by Licensee here under shall be manufactured only by quality manufacturers selected by Licensee. Licensee, and not Licensor, shall be solely responsible for the manufacture and production of Licensee's requirements thereof and for the marketing, sale and delivery of the Products.
(c) Prior to commercial production of any Product, Licensee shall deliver to Licensor for its inspection and approval, free of charge, one prototype sample of each such Product proposed to be manufactured and sold by Licensee and thereafter, upon Licensor's request, Licensee shall submit to Licensor, free of charge, a reasonable quantity of production samples of the Products. Licensor may disapprove of any samples submitted by Licensee which in the Licensor's reasonable opinion, do not conform to the quality standards and specifications established by Licensor or which are reasonably deemed by Licensor not to be consistent with the quality and reputation associated with Porcelana. Licensor shall not unreasonably disapprove of any samples. In the event Licensor disapproves of any samples, Licensee shall not manufacture market, advertise, promote, sell or distribute any of the Products that were rejected until Licensee makes such modifications in the manufacturing process, methods of manufacture and material and components used, as Licensor shall reasonably and specifically request. Licensor may disapprove of any samples required to be delivered to it hereunder upon notice received by Licensee within ten (10) days after such delivery to Licensor and if Licensee does not receive notice of approval or disapproval within such period, such samples shall be deemed approved.
(d) Licensee shall furnish to Licensor proposed product packaging for each Product that Licensee proposes to manufacture, sell and distribute. Licensor shall not disapprove of any such proposed product packaging unreasonably, and if Licensee does not receive notice of such approval or disapproval within ten (10) days after receipt of such product packaging by Licensor, such product and packaging shall be deemed approved. Licensee may not use any product or packaging unless Licensor has approved s...
MANUFACTURE AND QUALITY CONTROL. 4.1 Unless otherwise agreed by Advancis, Clonmel shall manufacture the Product(s) only at its production facility at Waterford Road, Clonmel, Co. Tipperary, Clonmel, Ireland (the “Facility”).
4.2 Clonmel shall manufacture, package, handle, and provide quality assurance for Product manufactured under this Agreement, as set forth in the Master Production Record and in accordance with GMP Rules and Marketing Authorization and in all material respects in accordance with Applicable Laws, and to deliver to Advancis the quantities of Product ordered by Advancis in accordance with this Agreement.
4.3 Clonmel shall package and label Product for shipment in accordance with the Master Production Record. Clonmel shall deliver Product FCA (having the meaning and importing the rights and obligations provided in Incoterms 2000) delivered at the Facility to a common carrier for shipment designated by Advancis to Clonmel in writing and risk shall pass accordingly. Advancis shall pay for all shipping costs in connection with each shipment of Product. Each shipment shall be accompanied by the Shipping Documentation. Should Clonmel at any time during the term of this Agreement have reason to believe that it shall be unable to meet a delivery date, Clonmel shall promptly notify Advancis. Upon passing of title to Product to Advancis, Advancis shall be responsible for all storage, shipping, handling and distribution of Product by Advancis and/or any Third Party on behalf of Advancis, including without limitation any agents and sub-contractors of Advancis.
4.4 Clonmel shall maintain accurate records for the production of Product as required by Applicable Laws, including GMP Rules. Clonmel shall retain ownership of Clonmel Operating Documents, and shall make copies thereof available to Advancis upon Advancis’ request. Clonmel Operating Documents shall remain Clonmel Confidential Information. Advancis shall have the right to use, read, audit and reference any of the foregoing in connection with a filing for or maintaining Marketing Authorizations of Product; in connection with the review of manufacturing activities related to preventive maintenance, calibrations, equipment validations, testing, housekeeping, or personnel training, or as otherwise authorized by this Agreement. Advancis shall own the Master Production Record and all Batch Records. Clonmel shall be entitled to retain possession of the originals thereof in the files of Clonmel, as Confidential Information of Advancis.
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MANUFACTURE AND QUALITY CONTROL. Product shall be manufactured in compliance with cGMP, as defined by Regulatory Authorities within the Licensed Territory, and the Regulatory Approval.
MANUFACTURE AND QUALITY CONTROL. 6.1 CHEM shall with reasonable assistance from E/ICC:
(a) obtain all necessary manufacturing and product licenses as well as any other governmental permissions and registrations necessary for the design, manufacture, packaging, sale and distribution of Systems;
(b) manufacture the Systems strictly in accordance with E/ICC's specifications and directions;
(c) follow such quality control procedures as E/ICC shall from time to time specify to assure that the Systems sold by CHEM under E/ICC's trademarks and trade names meet E/ICC's quality standards and customer specifications;
(d) ship to E/ICC at E/ICC's expense, if available if requested by E/ICC a representative System produced by CHEM for test and approval of quality by E/ICC; and
(e) permit the duly authorized representatives of E/ICC to inspect during normal working hours each of CHEM's plants, the process of manufacture and packaging of the Systems by CHEM, and
