Common use of General Audit Clause in Contracts

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

Appears in 1 contract

Sources: Master Supply Agreement (Genzyme Corp)

General Audit. Upon [**] days prior written notice to Hospira, Genzyme shall have the right to visit the Facility during normal business hours to review Hospira’s Manufacturing manufacturing operations related to the Products, Products and 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 Genzyme with copies of Hospira’s Manufacturing manufacturing records relating to the Products for the purposes of assuring the quality of the Products and compliance with agreed-upon Manufacturing manufacturing procedures. Such general audits shall: (ia) be limited to not more than [**] auditors designated by or representing Genzyme; (iib) last for not more than [**] days; and (iiic) may be conducted not more than [**] per calendar year.

Appears in 1 contract

Sources: Technology Transfer and Supply Agreement (Genzyme Corp)