MANUFACTURING AND QUALITY CONTROL Clause Samples

The MANUFACTURING AND QUALITY CONTROL clause sets out the standards and procedures that must be followed during the production of goods to ensure they meet agreed-upon specifications. It typically outlines requirements for manufacturing processes, quality assurance testing, and compliance with regulatory standards, and may require regular inspections or audits. This clause is essential for ensuring that products delivered under the contract are consistent, safe, and of the expected quality, thereby reducing the risk of defects and disputes between the parties.
MANUFACTURING AND QUALITY CONTROL. 5.1 The Peretti Trademarks will not be applied to, or used in connection with the sale of, any products which have not been manufactured in strict conformance with the Peretti Designs and with standards of quality in materials and workmanship established by Pere▇▇▇. 5.2 Only manufacturing techniques approved by Pere▇▇▇ ▇▇▇l be used in the production of Peretti Products. 5.3 Peretti shall have the right at any time during regular business hours to conduct examinations of Peretti Products manufactured or being manufactured by or for Tiffany to determine compliance with her designs and standards. If at any time any Peretti Products fail to conform to such designs or standards, Pere▇▇▇ ▇▇▇ll notify Tiffany. Upon such notification, Tiffany shall not sell such nonconforming products until Pere▇▇▇'▇ ▇tandards of quality have been met. 5.4 Tiffany agrees to furnish to Pere▇▇▇ ▇▇ her representatives samples of Peretti Products as she or her authorized representatives may request from time to time in quantities sufficient for inspections and tests to assure conformance with her standards and designs. Upon completion of such inspections and tests, Pere▇▇▇ ▇▇▇ll return such inspected and tested samples, if requested by Tiffany. Tiffany shall bear the cost of transportation of such samples to Pere▇▇▇ ▇▇ her representative and for return of such samples to Tiffany, as well as the risk of loss or damage to such samples. 5.5 On a regular basis Tiffany will discuss with Peretti its plans for the manufacture of Peretti Products. 5.6 Tiffany will continue to place orders for manufacture of certain Peretti Products with manufacturers in Spain who have been designated by Pere▇▇▇ and who have, for many years, provided Peretti Products meeting the quality standards of Peretti and Tiff▇▇▇. ▇▇ is understood that such manufacturers must continue to meet existing quality, price and delivery standards. 5.7 Tiffany agrees to compensate Pere▇▇▇ ▇▇▇ all quality control services performed by her or her representatives outside the United States. 5.8 Tiffany will provide to Pere▇▇▇ ▇ ▇ample of each Peretti Object that is not presently included in the collection of Peretti Products now maintained by Pere▇▇▇ ▇▇ San Mart▇-▇▇▇▇, ▇▇ain and a sample of each item of Peretti Jewelry rendered in silver, other than items of Peretti Jewelry that are manufactured in Spain.
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MANUFACTURING AND QUALITY CONTROL. 12.1 RTI shall establish and maintain a quality system for all stages of manufacture of the Implants, including donor eligibility and procurement of tissue, in compliance with Applicable Laws and Applicable Industry Standards, such as 21 CFR 1271, parts 820 and ISO 13485. 12.2 RTI shall establish and maintain an effective product and process validation system relative to all aspects of quality, e.g., design, sterilization and packaging. 12.3 RTI shall manage an effective document change control system relative to all aspects of the design, manufacture, storage, and distribution of the Implants. 12.3.1 Prior to making a Major Change to an Implant, RTI will submit written notice of the Major Change to ▇▇▇▇▇▇’▇ Director of RA/QA, via fax or email. This notice shall include a full description of the Major Change with adequate information to determine its impact on the finished Implant Specifications and regulatory status. 12.3.2 Zimmer will review and respond to RTI within fifteen (15) Business Days of receipt of Major Change notice. If the Major Change is being implemented to improve the safety of the Implant, RTI will implement the change as soon as reasonably possible without prior approval by Zimmer. 12.4 RTI shall ensure that its tissue procurement organization and contract suppliers maintain a quality program/system, in compliance with Applicable Laws and Applicable Industry Standards e.g., 21 CFR 1271, United States Department of Agriculture (“USDA”) , EN 12442, as appropriate for the materials and components e.g., bovine bone, bovine tissue, human bone, human tissue. 12.5 Zimmer shall establish and maintain a quality system in compliance with applicable sections of Applicable Laws, e.g., 21 CFR 1271, 820 and ISO 13485.
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MANUFACTURING AND QUALITY CONTROL. 5.1 SCHERING shall supply all raw materials and packaging components for the product of pilot batches according to specifications provided by BUYER. The pilot batches shall be manufactured in accordance with Good Manufacturing Procedures (GMP's). All pilot production is on a best efforts basis. As SCHERING has no experience with the manufacture of Product, there can be no guarantees as to the success of pilot production. SCHERING and BUYER agree that BUYER's manufacturing representative be present to review manufacturing procedures and witness the manufacture of all pilot batches. 5.2 For manufacture of Products, SCHERING shall supply all raw materials and packaging components according to specifications provided by BUYER. 5.3 SCHERING shall utilize the quality control and manufacturing process provided SCHERING by the BUYER employing the same methodology or equivalent techniques agreed to by SCHERING and the BUYER. 5.4 SCHERING shall provide validation services at the price set forth in Exhibit A. 5.5 SCHERING shall provide accelerated stability testing for pilot batches at the prices and according to the conditions set forth in Exhibit A.
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MANUFACTURING AND QUALITY CONTROL. 5.1 For manufacture of Products, IFP shall supply all raw material and packaging components according to specifications provided by BUYER. 5.2 IFP shall utilize the quality control and manufacturing process provided IFP by the BUYER employing the same methodology or equivalent techniques agreed to by IFP and the BUYER. 5.3 IFP shall provide validation services at the price set forth in Exhibit A. 5.4 IFP shall send to an outside facility for accelerated stability testing for pilot batches at the prices and according to the conditions set forth in Exhibit A.
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MANUFACTURING AND QUALITY CONTROL. 4.1 Lifecore shall Manufacture the Product in accordance with the Master Services Agreement or any other subsequent written agreement executed between Lifecore and Semnur. Without limiting the scope of the foregoing in any way, Lifecore shall, among other things: • Manufacture the Product in accordance with written Batch records, the Product Specifications, Lifecore SOPs, and Applicable Law. • Validate in accordance with Applicable Law all analytical methods, equipment, Facilities, processes, computerized systems, software, and cleaning used in connection with the Manufacture of the Product. • Retain Batch documentation and maintain such other original manufacturing records as required by the Master Production Record, Lifecore SOPs, Semnur requirements and Applicable Law. • Provide adequate personnel with appropriate education, training, and experience, or any combination thereof, to Manufacture, test, and release Product and to fulfill Lifecore☐s obligations under this Agreement. • Obtain and maintain during the term hereof, as relating to the Facility, all government and regulatory authority licenses, permits, registrations, and approvals required by Applicable Law in order to Manufacture the Product pursuant to the terms hereof. 4.2 In the event that prior to entering into this Quality Agreement, or at any time during the term of this Quality Agreement, LIFECORE has Manufactured, handled or stored (or intends to do so, as the case may be) any Critical Compounds in the same area where the Products are to be Manufactured, handled or stored, LIFECORE will maintain on file a risk assessment demonstrating appropriate separation and segregation of the operations. Where new Product risks become evident or there is adverse impact to existing Product risks, the change must be communicated and approved by SEMNUR, as described in section Change Control. 4.3 Lifecore is responsible for quality assurance of (a) Raw Materials, (b) Components (c) Primary and secondary packaging (d) Formulation and in process steps, (f) filtration, filling and packaging and (g) the Product, including testing and documentation thereof, and retention of Product archive samples and documentation in accordance with Lifecore SOPs, the Master Production Record, and Applicable Law. Changes to any of the above will be addressed per Article 6, Changes. 4.4 Lifecore is responsible for any outside contracted services associated with the Manufacture or testing of the Product and Raw Materials. Cha...
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MANUFACTURING AND QUALITY CONTROL. (1) Seller will conduct incoming quality control inspections on all Components and materials or to have such controls adequate to ensure the conformance of purchased materials and services to Seller's specifications. (2) Seller will perform manufacturing, testing, and quality control according to the processes and specifications in Exhibit B, if applicable. (3) Seller will maintain facilities, workflow and material handling in such a mannert hat materials, Components, Product, and reference material are protected from damage, loss, contamination or mix- up during production or storage. Returned, damaged, quarantine or non-conforming Product will be physically segregated and clearly identified as to status. (4) Seller will be responsible for the validation and ongoing monitoring of processes whose output cannot be fully tested and verified in order to ensure compliance to Specifications for all of the material produced. (5) Seller will have suitable line clearance procedures for products manufactured immediately before Intuitive Products. Equipment used for the manufacture or service of Intuitive Products will not be used for the manufacture of inherently hazardous, toxic or poisonous materials. (6) All Products provided by Seller will conform to the 2002/95/EC directive on Restriction on use of Hazardous Substances (RoHS), the 2002/96/EC directive on Waste Electrical and Electronic Equipment (WEEE) and will be so certified to comply. Seller will maintain documentation of compliance of raw materials purchased to these standards in accordance with Section 10(f) (Records). (7) All Products provided to Intuitive under this Agreement will be manufactured, tested, packaged and transported in accordance with the Specifications and procedures established by Intuitive and Seller.
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MANUFACTURING AND QUALITY CONTROL. 5.1 API and Clinical Supplies delivered by Servier to XOMA shall be released by Servier’s quality control unit and shall be accompanied by a certificate of analysis and compliance signed by an authorized representative of Servier certifying that each lot of API and Clinical Supplies has been manufactured in accordance with Servier’s batch record documentation and in compliance with US cGMPs (in the case of API), EU cGMPs (in the case of Clinical Supplies), the Specifications, the Quality Agreement and the representations and warranties contained herein that relate to API or Clinical Supplies, as the case may be. 5.2 Clinical Supplies shall be delivered by Servier in bulk tablet form. The Clinical Supplies shall be packaged and released by XOMA’s quality control unit or XOMA’s designee before any consumption by humans in clinical trials. 5.3 Servier shall maintain a completed manufacturing record, packaging record and analytical record, and shall retain samples, for each lot of API or Clinical Supplies manufactured for XOMA and such other records as specified in the Quality Agreement for a period of time specified in the Quality Agreement. Such records and retained samples shall be made available to XOMA upon appropriate advance written request and to the FDA immediately upon request. 5.4 Servier and its Affiliates shall carry out, and shall cause each permitted Third Party toll or contract manufacturer acting on Servier’s behalf to carry out, all of their responsibilities hereunder in conformity with US cGMPs (in the case of API), EU cGMPs (in the case of Clinical Supplies) and all other applicable Laws and guidelines. Servier and its Affiliates shall maintain, and shall use Diligent Efforts to cause each permitted toll or contract manufacturer acting on Servier’s behalf to maintain, all licenses, permits and registrations required under applicable Laws to perform their obligations under the Agreement. 5.5 XOMA shall have the right, alone or with consultants or designees reasonably acceptable to Servier and subject to obligations of confidentiality no less stringent than those set forth in the Agreement, and Servier shall permit or cause to be permitted, on reasonable prior written notice from XOMA to Servier, XOMA and such consultants or designees, to inspect the Servier or Third Party contractor facility and the equipment used or to be used in the manufacturing, filling, packaging, storage, testing, shipping or receiving of API or Clinical Supplies once ...
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MANUFACTURING AND QUALITY CONTROL. 4. 1Lifecore shall Manufacture the Product in accordance with the Master Services Agreement or any other subsequent written agreement executed between Lifecore and Semnur. Without limiting the scope of the foregoing in any way, Lifecore shall, among other things: · Manufacture the Product in accordance with written Batch records, the Product Specifications, Lifecore SOPs, and Applicable Law. · Validate in accordance with Applicable Law all analytical methods, equipment, Facilities, processes, computerized systems, software, and cleaning used in connection with the Manufacture of the Product. · Retain Batch documentation and maintain such other original manufacturing records as required by the Master Production Record, Lifecore SOPs, Semnur requirements and Applicable Law. · Provide adequate personnel with appropriate education, training, and experience, or any combination thereof, to Manufacture, test, and release Product and to fulfill Lifecore’s obligations under this Agreement. · Obtain and maintain during the term hereof, as relating to the Facility, all government and regulatory authority licenses, permits, registrations, and approvals required by Applicable Law in order to Manufacture the Product pursuant to the terms hereof.
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MANUFACTURING AND QUALITY CONTROL. 4.1. The Parties hereby agree to enter into a Supplier Quality Agreement that will dictate the obligations of the Parties regarding manufacturing and quality control. In the event that the terms of this Agreement contradict the terms of the Supplier Quality Agreement, the Supplier Quality Agreement shall govern.
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Related to MANUFACTURING AND QUALITY CONTROL

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Participates in an annual performance development review. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures. 4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Actively participates in the Peak Performance program. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.

  • NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment. 2.2 Participates in an annual performance development review. 2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 2.4 Completes mandatory training (including safety and quality training) as relevant to role. 2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures. 2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • STANDARDS AND QUALITY The Supplier shall at all times during the Contract Period ensure that the Services are delivered in accordance with: the Digital Service Design Manual (and the Supplier shall comply with the processes and procedures set out therein); the Standards; the KPIs; the Methodology; the applicable SOW; and all other applicable provisions of this Contract.

  • 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);