Quality Procedures. 4.1.1 The Supplier shall perform the Contract with the degree of skill, care, diligence and prudence which would reasonably and ordinarily be expected from a skilled, experienced and competent supplier (the “Good Industry Practices”), and in accordance with all the terms and conditions stated in the Contract, regulations and standards in force where the Supply is to be performed. The Supplier’s Quality Manual, available thought the following url: xxxxx://xxx.xxxxx.xxxxxxxxx.xxxxxx.xxx/, defines the Purchaser’s quality expectations so as to enable the Supplier to determine appropriate actions that it may require to be carried out. The Supplier shall ensure that its sub-suppliers and/or subcontractor’ comply with this contractual requirements, applicable regulations and Good Industry Practices.
Quality Procedures. Part 3 The Quality Procedures set out the consequences of failing to comply with the control limits set out in the Quality Standards Table, including when we may reject or suspend your Milk collection in accordance with section 6 of this Agreement for breach of the Specifications or other Quality Standards. Part 2: Quality Standards Table A TARGET B CONTROL LIMITS C TEST METHOD D MINIMUM TEST FREQUENCY MICROBIOLOGICAL Aerobic Plate Count (APC) or Total Plate Count (TPC) <10,000 cfu/mL <50,000 cfu/mL AS 1766.2.1 or Petrifilm SM, or Bactoscan As per Bega specified period Somatic Cell Count (SCC) <200,000 cells/mL <400,000 cells/mL Fosomatic FC 5000 or appropriate IR method calibrated by AS method Every delivery Thermoduric bacteria <2,000 cfu/mL <5,000 cfu/mL Pour Plate Method Testing may occur every Quality Assessment Period CHEMICAL Protein (True) 3.25% m/v min 3.0% m/v Milkoscan 4000 or appropriate IR method as calibrated by AS method Every delivery Milk fat 3.8% m/v min 3.2% m/v Milkoscan 4000 or appropriate IR method as calibrated by AS method Every delivery Antibiotics and Inhibitory Substances zero zero Any approved testing method in Australia Every delivery PHYSICAL Temperature 1–4°C 1–5°C Tanker digital thermometer – calibrated by AS method Every delivery/Every vat Acidity <0.12% < 0.15% Titratable Acidity test method and or approved internal method (ref AS 2300) Every delivery Sensory and Appearance White to cream in appearance, free from foreign matter, taints and coagulation White to cream in appearance, free from foreign matter, taints and coagulation Smell and visual test prior to pumping from tanker Every delivery pH >6.65 >6.65 and < 6.75 Approved internal pH test method As required Foreign Matter (Sediment) Disc 1 Disc 2 minimum Sediment Lintine disc test or approved internal method (AS 2300, 1.7-1990) Every delivery Freezing point -0.512 °C <-0.517 °C Freezing point depression test – AS 2300.2.5 Randomly / As required
Quality Procedures. Part 3 The Quality Procedures set out the consequences of failing to comply with the control limits set out in the Quality Standards Table, including when we may reject or suspend your Milk collection in accordance with section 6 of this Agreement for breach of the Specification or other Quality Standards. Part 2: Quality Standards Table A TARGET B CONTROL LIMITS C TEST METHOD D MINIMUM TEST FREQUENCY MICROBIOLOGICAL Aerobic Plate Count (APC) or Total Plate Count (TPC) <10,000 cfu/mL <50,000 cfu/mL AS 1766.2.1 or Petrifilm SM, or Bactoscan Once every Quality Assessment Period Somatic Cell Count (SCC) or BMCC <200,000 cells/mL <400,000 cells/mL IR method (Combifoss) Every delivery Thermoduric bacteria <2,000 cfu/mL <5,000 cfu/mL AS 5013.28 Testing may occur every month CHEMICAL Protein (True) 3.25% m/v min 3.0% m/v IR method (Combifoss) Every delivery Milk fat 3.8% m/v min 3.2% m/v IR method (Combifoss) Every delivery Antibiotics and Inhibitory Substances Not detected Not detected Australian regulator approved testing methods for maximum residue limits by substance set out in the FSANZ Code Every delivery PHYSICAL Temperature 1–4°C 1-5°C Tanker digital thermometer – calibrated by AS method Every delivery/Every vat Acidity <0.12% < 0.15% Titratable Acidity test method and or approved internal method (equivalent to AS 2300) Every delivery Sensory and Appearance White to cream in appearance, free from foreign matter, taints and coagulation White to cream in appearance, free from foreign matter, taints and coagulation Smell and visual test prior to pumping tanker Every delivery/ Every vat pH >6.6 >6.6 and < 6.8 AS 2300.1.6-2010 As required Foreign Matter (Sediment) Disc 1 Disc 2 minimum Sediment Lintine disc test or approved internal method (AS 2300, 1.7-1990) As required Freezing point -0.512 °C <-0.517 °C Freezing point depression test – AS 2300.2.5 As required Milk supplied must also meet the following control limits:
Quality Procedures. The Parties acknowledge the importance of ensuring that the Specialty Allografts and Bone Paste are of the highest quality and are safe and effective for their intended or expected uses. Accordingly, within ten (10) days after signing this Agreement, RTI shall provide MSD with a full and complete copy of its policies and procedures for ensuring the quality and safety of Specialty Allografts and Bone Paste (the “Quality Procedures”). The Quality Procedures shall be consistent with the terms of this Agreement and provide greater detail for the arrangement and responsibilities of the parties in the procurement, processing, testing and delivery of Specialty Allografts and Bone Paste hereunder as well as regulatory reporting functions and the exchange of information relevant to any of the foregoing. The Quality Procedures shall also set forth material specifications and acceptability criteria for the Specialty Allografts and Bone Paste, which specifications and criteria shall be no less stringent than industry standards and shall include, at a minimum, standards and procedures for donor screening, intake evaluation, tissue processing, tissue storage, tissue record keeping, retained samples, maintenance and access to documentation. Within ten (10) days after signing this Agreement, the parties shall each designate in writing an appropriate contact person for communications regarding the Quality Procedures, and the parties will promptly notify each other in writing of any changes in such personnel. The designated contacts for each party, and other reasonably appropriate safety and quality assurance personnel as the parties may designate from time to time, shall meet in person or via other appropriate means no less often than quarterly to review the Quality Procedures and consider modifications thereto. Quality Procedures will be amended from time to time by RTI with the advice and comment from MSD to reflect changes in technology, laws, regulations and industry standards, provided that no party will be required to agree to any change to the Quality Procedures that, in the reasonable discretion of such party, would adversely impact the quality, safety or efficacy of any Specialty Allograft or Bone Paste. RTI will not modify or amend the Quality Procedures without providing prompt written notice to MSD
Quality Procedures. Quoin and Licensee shall comply with the terms of the quality requirements set forth in a quality agreement to be negotiated in good faith by the Parties and entered into by the Parties as soon as practicable after the date hereof (the “Quality Agreement”) with respect to the manufacture of the Product. To the extent that any inconsistencies or conflicts exist between the Quality Agreement and this Agreement with regard to quality requirements and compliance with applicable Law, the provisions in this Agreement shall prevail.
Quality Procedures. Each Manufacturer and Buyer shall comply with the terms of the quality requirements set forth in a quality agreement to be negotiated in good faith by the Parties and entered into by the Parties as soon as practicable after the date hereof, but on or prior to the Closing Date (the “Quality Agreement”) with respect to the manufacture of the Supply Products. To the extent that any inconsistencies or conflicts exist between the Quality Agreement and this Supply Agreement with regard to quality requirements and compliance with Governmental Rules, the provisions in the Quality Agreement shall prevail.
Quality Procedures. Manufacturer and Buyer shall comply with the terms of the quality requirements set forth in a quality agreement to be negotiated in good faith by the Parties and entered into by the Parties as soon as practicable after the date hereof, but on or prior to the Closing Date (the [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. “Quality Agreement”) with respect to the manufacture of the Supply Products. To the extent that any inconsistencies or conflicts exist between the Quality Agreement and this Supply Agreement with regard to quality requirements and compliance with Governmental Rules, the provisions in the Quality Agreement shall prevail.
Quality Procedures. Licensor and Licensee shall comply with the terms of the quality requirements set forth in a quality agreement to be negotiated in good faith by the Parties and entered into by the Parties as soon as practicable after the date hereof, but on or prior to the earlier of the receipt of the Licensee Regulatory Approvals or sixty (60) days after the Effective Date (the "Quality Agreement"). To the extent that any inconsistencies or conflicts exist between the Quality Agreement and this Agreement, the provisions in the Quality Agreement shall prevail solely with respect to quality requirements and compliance with Governmental Rules.
Quality Procedures. 5.1. The Supplier undertakes to comply with the Purchaser’s quality requirements expressed on the face of the Order or/and expressed in the Homologation Program launched by the Purchaser at the beginning of the relationship.
Quality Procedures. If any Quality Management Systems refer to, rely on or incorporate any quality procedure, such quality procedure or the relevant parts thereof shall be submitted to the Authority Contract Manager at the time that the relevant Quality Management Systems or change to the Quality Management Systems is submitted in accordance with Clauses 22.1.4, 22.1.6 or
