Common use of General Audit Clause in Contracts

General Audit. Upon [***] days prior written notice to Hospira, Theravance shall have the right to have representatives visit the Facility during normal business hours to review Hospira’s manufacturing operations relating to the Product and assess its compliance with cGMP and quality assurance standards and to discuss any related issues with Hospira’s manufacturing and management personnel. Hospira shall provide Theravance with copies of Hospira’s manufacturing records (including the Master Batch Record) and other relevant documentation relating to the Products for the purposes of assuring Product quality and compliance with agreed-upon manufacturing procedures. Such general audits shall: (i) be limited to not more than [***] auditors designated by or representing Theravance; (ii) last for not more than [***]; and (iii) may be conducted not more than [***] per calendar year.

General Audit. Upon [***] days prior written notice to Hospira, Theravance Genzyme shall have the right to have representatives visit the Facility during normal business hours to review Hospira’s manufacturing Manufacturing operations relating related to the Product and Products, assess its compliance with cGMP and quality assurance standards and to discuss any related issues with Hospira’s manufacturing Manufacturing and management personnel. Hospira shall provide Theravance Genzyme with copies of Hospira’s manufacturing Manufacturing records (including the Master Batch Record) and other relevant documentation relating to the Products for the purposes of assuring Product the quality of the Products and compliance with agreed-upon manufacturing Manufacturing procedures. Such general audits shall: (i) be limited to not more than [***] auditors designated by or representing TheravanceGenzyme; (ii) last for not more than [***]] days; and (iii) may be conducted not more than [***] per calendar year.

General Audit. Upon [***] days prior written notice to Hospira, Theravance shall have the right to have representatives visit the Facility during normal business hours to review Hospira’s manufacturing operations relating to the Product and assess its compliance with cGMP and quality assurance standards and to discuss any related issues with Hospira’s manufacturing and management personnel. Hospira shall provide Theravance with copies of Hospira’s manufacturing records (including the Master Batch Record) and other relevant documentation relating to the Products for the purposes of assuring Product quality and compliance with agreed-upon manufacturing procedures. Such general audits shall: (i) be limited to not more than [***] auditors designated by or representing Theravance; (ii) last for not more than [***]] days; and (iii) may be conducted not more than [***] per calendar year.

General Audit. Upon [***] days prior written notice to Hospira, Theravance Genzyme shall have the right to have representatives visit the Facility during normal business hours to review Hospira’s manufacturing operations relating related to the Product Products and assess its compliance with cGMP and quality assurance standards and to discuss any related issues with Hospira’s manufacturing and management personnel. Hospira shall provide Theravance Genzyme with copies of Hospira’s manufacturing records (including the Master Batch Record) and other relevant documentation relating to the Products for the purposes of assuring Product the quality of the Products and compliance with agreed-upon manufacturing procedures. Such general audits shall: (ia) be limited to not more than [***] auditors designated by or representing TheravanceGenzyme; (iib) last for not more than [***]] days; and (iiic) may be conducted not more than [***] per calendar year.