Common use of FACILITIES ACCESS AND REGULATORY INSPECTIONS Clause in Contracts

FACILITIES ACCESS AND REGULATORY INSPECTIONS. PathoGenesis shall have reasonable access to the manufacturing activities conducted in AeroGen facilities. PathoGenesis' representatives shall be permitted, from time to time and upon reasonable notice, to visit the AeroGen facilities during normal or usual hours of operation to monitor the manufacturing activities. In addition, PathoGenesis shall have the right, upon reasonable notice to AeroGen, and provided such subcontractor agrees to such visit, to visit the facilities of any of the subcontractors AeroGen utilizes pursuant to Section 2.4 or 7.3; provided that the PathoGenesis representatives are accompanied by AeroGen representatives. AeroGen shall promptly notify PathoGenesis of any regulatory inspection of AeroGen facilities used in the manufacturing, processing or packaging of the Inhaler Product. At the reasonable written request of PathoGenesis, AeroGen shall promptly provide to PathoGenesis copies of the documents relating to or arising out of the inspection such as FDA Form 483 list of observations, establishment inspection reports, and warning letters.