Common use of General Audit Clause in Contracts

General Audit. [*], ▇▇▇▇▇▇▇ shall have the right to have representatives visit the Facility during normal business hours to review Pfizer’s manufacturing operations relating to the Product and assess its compliance with cGMP and quality assurance standards and to discuss any related issues with Pfizer’s manufacturing and management personnel. Pfizer shall provide ▇▇▇▇▇▇▇ with copies of Pfizer’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 ▇▇▇▇▇▇▇, (ii) last for not more than [*] days, and (iii) may be conducted not more than [*] per calendar year.

Appears in 2 contracts

Sources: Development and Supply Agreement (Trevena Inc), Development and Supply Agreement (Trevena Inc)