QUALITY AUDITING Sample Clauses

QUALITY AUDITING. ‌ 7.1.1 Not later than 90 days after the Effective Date, or at an alternate time accepted by the City in the Submittal Schedule and Register, Design-Builder shall submit to the City the Quality Audit Plans. Design-Builder shall submit to the City updated Quality Audit Plans at 12 month intervals thereafter. 7.1.2 Each Quality Audit Plan shall: (a) contain an auditing process that is capable of identifying Nonconformities, necessary Corrective Actions and Preventive Actions and facilitate continuous improvement; and (b) detail the Quality Audits that Design-Builder shall conduct on its own processes and those of the Subcontractors, the planned dates of such Quality Audits, and the conditions or circumstances which could give rise to an unscheduled Quality Audit. 7.1.3 Design-Builder shall provide the following advance notice to the City’s Representative prior to the start of any Quality Audit, or any change to the planned date for a Quality Audit: (a) at least 5 Business Days for Quality Audits performed in Alberta; (b) at least 14 days for Quality Audits performed outside of Alberta but within North America; and (c) at least 30 days for Quality Audits performed outside of North America. The notice shall describe the scope and objectives of the applicable Quality Audit. Quality Audits must be scheduled or rescheduled to meet the notice requirements outlined in this Section 7.13.

QUALITY AUDITING. 9.1 Thera, or any other Person designated by Thera subject to the confidentiality provisions of this Agreement or similar provisions of a confidentiality agreement executed with Bachem, shall be allowed to conduct Audits of Bachem facilities. Thera shall send a request to schedule an Audit with Bachem at least [Redacted: Term] prior to the proposed Audit date. Thera, or any Person designated by Thera, shall be permitted to conduct [Redacted: Amount] Audit per Calendar Year, unless an Audit discovers a problem or unsatisfactory conditions. In the event an Audit discovers a problem or unsatisfactory conditions, Thera, or any Person designated by Thera, shall be entitled to proceed with as many Audits as it deems necessary upon reasonable prior written notice to Bachem until such problem or unsatisfactory conditions are solved. For the purposes of this Section, “Audit” shall mean a Bachem audit involving the audit and inspection of all elements and systems of the manufacturing process of the Active Ingredient and of Bachem’s records of the elements and systems of the manufacturing process.

QUALITY AUDITING. 7.1.1 Not later than 90 days after the Effective Date, or at an alternate time accepted by the City in the Submittal Schedule and Register, Project Co shall submit to the City the Quality Audit Plans. Project Co shall submit to the City updated Quality Audit Plans at 12 month intervals thereafter. 7.1.2 Each Quality Audit Plan shall: (a) contain an auditing process that is capable of identifying Nonconformities, necessary Corrective Actions and Preventive Actions and facilitate continuous improvement; and (b) detail the Quality Audits that Project Co shall conduct on its own processes and those of the Subcontractors, the planned dates of such Quality Audits, and the conditions or circumstances which could give rise to an unscheduled Quality Audit. 7.1.3 Project Co shall provide the following advance notice to the City’s Representative prior to the start of any Quality Audit, or any change to the planned date for a Quality Audit: (a) at least 5 Business Days for Quality Audits performed in Alberta; (b) at least 14 days for Quality Audits performed in the rest of North America; and (c) at least 30 days for Quality Audits performed outside of North America. The notice shall describe the scope and objectives of the applicable Quality Audit.

QUALITY AUDITING. 6.1.1 Not later than 90 days after the Effective Date, Project Co shall submit the Quality Audit Plans to the City’s Representative in accordance with the Review Procedure. Project Co shall submit updated Quality Audit Plans to the City’s Representative, in accordance with the Review Procedure, at 12 month intervals thereafter. 6.1.2 Project Co shall provide the following advance notice to the City’s Representative prior to the start of any Quality Audit, or any change to the planned date for a Quality Audit: (a) at least 7 Business Days for Quality Audits performed in Alberta; (b) at least 14 days for Quality Audits performed in the rest of North America; and (c) at least 30 days for Quality Audits performed outside of North America. The notice shall describe the scope and objectives of the applicable Quality Audit.

QUALITY AUDITING. 6.1 Thera, or any other Person designated by Thera subject to the confidentiality provisions of this Agreement or similar provisions of a confidentiality agreement executed with Bachem, shall be allowed to conduct audits of Bachem facilities in accordance with the terms of the Quality Agreement. 6.2 Any dispute of the audit responses relating to the quality systems of Bachem that cannot be resolved by the Parties in accordance with the Quality Agreement will be submitted to arbitration pursuant to the terms of Section 14. Until settlement of a dispute, Thera shall be entitled to have Lots of Active Ingredient manufactured by another supplier without being in breach of any provision of this Agreement. In the event the arbitration ruling is entirely in favour of the Bachem position, the entire quantity of Active Ingredient ordered and delivered by another supplier shall be added to the Minimum Purchase Obligation of Thera hereunder during the Calendar Year in which the ruling was issued if the ruling is issued on or before June 30 and during the following Calendar Year if the ruling is issued after June 30.