Common use of INTRODUCTION AND SCOPE Clause in Contracts

INTRODUCTION AND SCOPE. 2.1 The purpose of this Agreement is to define and establish the obligations and responsibilities of the PURCHASER and the SUPPLIER relating to Quality Assurance requirements of the manufacture, packing, analysis, release and / or distribution by SUPPLIER of PRODUCTS and the supply to PURCHASER of PRODUCTS in accordance with cGMPs. 2.2 The Quality Assurance Department of each of the parties are located at the addresses above and as specified in Appendix 1. Any Changes in such quality assurance contacts set forth in Appendix 1 shall be informed in writing and updated. 2.3 This Agreement is entered into pursuant to and is supplemental to the ‘Supply Agreement’. 2.4 This Agreement shall come into effect on the date of the last of the parties to sign on the front page of this agreement. The review date shall be 3 years from this date, unless changes are agreed in the interim period. 2.5 It is agreed between the parties that the following should apply: 2.5.1 SUPPLIER shall possess and maintain valid and appropriate licences under the relevant local public authority or authorities for the premises where PRODUCTS are produced.PURCHASER will possess and maintain valid and appropriate licences where PRODUCTS are received and distributed. 2.5.2 SUPPLIER shall implement and maintain a quality system based on Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) as enforced by Health Canada, ensuring all practices and procedures are performed according to written and approved procedures. 2.5.3 SUPPLIER shall ensure that technologies, facilities, processes and equipment used to produce the PRODUCTS are in compliance with GACP and GMP. 2.5.4 PURCHASER and SUPPLIER are responsible as defined in Appendix 2 for the steps involved in processing, analysis, packing, release and / or distribution of PRODUCTS. 2.5.5 PURCHASER and SUPPLIER must approve any changes that potentially impact on the product specification and manufacturing control prior to implementation. 2.5.6 SUPPLIER shall inform the PURCHASER of any incidents that may affect conformance of the PRODUCT to the Specifications. 2.5.7 This Agreement and appendices shall be accessible to Regulatory Agencies as required by law or as determined by the PURCHASER. 2.5.8 SUPPLIER is responsible for ensuring this document is updated. This document shall be revision controlled. SUPPLIER shall notify PURCHASER of any potential changes that may impact this agreement prior to implementation. 2.6 PURCHASER is to provide the SUPPLIER with all information and knowledge necessary to carry out the contracted operations correctly in accordance with Applicable Australian Laws and Regulations for the product concerned. 2.7 SUPPLIER shall ensure that all activities at the Facilities and locations, including activities of SUPPLIER’S approved Contract Manufacturers, associated with the Manufacture and supply of PRODUCT are carried out in compliance with Applicable Laws and Regulations and the PRODUCT Requirements.

INTRODUCTION AND SCOPE. 2.1 The purpose of this Agreement is to define and establish the obligations and responsibilities of the PURCHASER and the SUPPLIER relating to Quality Assurance requirements of the manufacture, packing, analysis, release and / or distribution by SUPPLIER of PRODUCTS and the supply to PURCHASER of PRODUCTS in accordance with cGMPsGMPs. 2.2 The Quality Assurance Department of each of the parties are located at the addresses above and as specified in Appendix 1. Any Changes in such quality assurance contacts set forth in Appendix 1 shall be informed in writing and updated. 2.3 This Agreement is entered into pursuant to and is supplemental to the ‘Supply Agreement’. 2.4 This Agreement shall come into effect on the date of the last of the parties to sign on the front page of this agreement. The review date agreement and it shall be 3 years from this date, unless changes are agreed remain in force and effect coterminously with the interim periodSupply Agreement. 2.5 It is agreed between the parties that the following should apply: 2.5.1 SUPPLIER shall possess and maintain valid and appropriate licences under the relevant local public authority or authorities for the premises where PRODUCTS are produced.. PURCHASER will possess and maintain valid and appropriate licences where PRODUCTS are received and distributed. 2.5.2 SUPPLIER shall implement and maintain a quality system based on Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) as enforced by Health Canada, ensuring all practices and procedures are performed according to written and approved procedures. 2.5.3 SUPPLIER shall ensure that technologies, facilities, processes and equipment used to produce the PRODUCTS are in compliance with GACP and GMP. 2.5.4 PURCHASER and SUPPLIER are responsible as defined in Appendix 2 for the steps involved in processing, analysis, packing, release and / or distribution of PRODUCTS. 2.5.5 PURCHASER and SUPPLIER must approve any changes that potentially impact on the product specification and manufacturing control prior to implementation. 2.5.6 SUPPLIER shall immediately inform the PURCHASER of any incidents that may affect conformance of the PRODUCT to the Specifications. 2.5.7 This Agreement and appendices shall be accessible to Regulatory Agencies as required by law or as determined by the PURCHASERlaw. 2.5.8 SUPPLIER is responsible for ensuring this document is updated. This document shall be revision controlled. SUPPLIER shall notify PURCHASER of any potential changes that may impact this agreement prior to implementation. 2.6 PURCHASER is to provide the SUPPLIER with all information and knowledge necessary to carry out the contracted operations correctly in accordance with Applicable Australian Laws and Regulations for the product concerned. 2.7 SUPPLIER shall ensure that all activities at the Facilities and locations, including activities of SUPPLIER’S 'S approved Contract Manufacturers, associated with the Manufacture and supply of PRODUCT are carried out in compliance with Applicable Laws and Regulations and the PRODUCT Requirements.