Common use of General Audit Clause in Contracts

General Audit. Upon no less than [*] days prior written notice to Hospira, Cempra shall have the right to have representatives or designees (which may include representatives of Cempra’s Affiliates, or Cempra’s or its Affiliates’ licensees or sublicensees) visit the Facility during normal business hours to review Hospira’s manufacturing and development operations, documents, and records relating to the Product and assess its compliance with cGMP, Applicable Laws, the Product Specifications, and quality assurance standards and to discuss any related issues with Hospira’s manufacturing and management personnel. Hospira shall provide Cempra and any such designees with copies of Hospira’s manufacturing records (including the Master Batch Record) and any other relevant documentation relating to the Products or the development or manufacture thereof under this Agreement for the purposes of assuring Product quality and compliance with this Agreement and/or agreed-upon manufacturing procedures. Such general audits shall (i) be limited to [*], (ii) last for no more than [*] days, and (iii) may be conducted not more than [*].

Appears in 2 contracts

Sources: Development and Supply Agreement (Cempra, Inc.), Development and Supply Agreement (Cempra, Inc.)