Common use of QA Audits Clause in Contracts

QA Audits. Upon written notice of no less than [***] ([***]) Business Days for routine audits to Manufacturer, Company and Collaboration Partner shall have the right to have representatives visit the Facilities during normal business hours to review Manufacturer’s manufacturing operations, assess its compliance with cGMPs and quality assurance standards, and discuss any related issues with Manufacturer’s manufacturing and management personnel. Manufacturer shall maintain the Facilities in accordance with cGMPs. Manufacturer’s failure to correct any cGMP deficiency regarding any aspect of Manufacturer’s manufacture within a reasonable time period after notice of such deficiency shall be a material breach of this Agreement. Upon reasonable notice, the Manufacturer will allow employees of the Company and its Collaboration Partner access to the Facility, documentation, and personnel to audit and for observation of the production process and quality control testing of the Exenatide Injection, disposal of waste and adherence to cGMP requirements and this Agreement. During such inspections, employees of the Company and its Collaboration Partner (number of persons should be restricted to not more than [***] ([***])) shall have the right to audit any aspect of the Manufacturers manufacture of Exenatide Injection, and such audit may include, without limitation, verification of Manufacturers maintenance of drug establishment registrations with the FDA and other applicable Regulatory Authorities, and review of conditions and documentation of any aspect of manufacture of Exenatide Injection.

QA Audits. Upon written notice of no less than [***] ([***]) Business Days for routine audits to Manufacturer, Company and Collaboration Partner shall have the right to have representatives visit the Facilities during normal business hours to review Manufacturer’s manufacturing operations, assess its compliance with cGMPs and quality assurance standards, and discuss any related issues with Manufacturer’s manufacturing and management personnel. Manufacturer shall maintain the Facilities in accordance with cGMPs. Manufacturer’s failure to correct any cGMP deficiency regarding any aspect of Manufacturer’s manufacture within a reasonable time period after notice of such deficiency shall be a material breach of this Agreement. Upon reasonable notice, the Manufacturer will allow employees of the Company and its Collaboration Partner access to the Facility, documentation, and personnel to audit and for observation of the production process and quality control testing of the Exenatide Injection, disposal of waste and adherence to cGMP requirements and this Agreement. During such inspections, employees of the Company and its Collaboration Partner (number no. of persons should be restricted to not more than [***] ([***])) shall have the right to audit any aspect of the Manufacturers manufacture of Exenatide Injection, and such audit may include, without limitation, verification of Manufacturers maintenance of drug establishment registrations with the FDA and other applicable Regulatory Authorities, and review of conditions and documentation of any aspect of manufacture of Exenatide Injection.