ACCESS AND INSPECTIONS. 4.13.1 *** shall (a) permit, and shall cause its Affiliates to permit, the FDA and other regulatory agencies to perform inspections of its factory which contains the manufacturing operations for Product; (b) as soon as reasonably practicable, but in no event later than forty-eight (48) hours after being notified of any proposed visit to, or inspection of, the factory, notify Eton of such inspections; and (c) permit Eton or its representatives to be present and participate in such visit or inspection. *** promptly shall notify Eton of all results of an inspection that affect the manufacturing processes of Product or that may affect *** ability to supply Products to Eton hereunder.
Appears in 4 contracts
Samples: Development, Supply and Commercialization Agreement (Eton Pharmaceuticals, Inc.), Development, Supply and Commercialization Agreement (Eton Pharmaceuticals, Inc.), Development, Supply and Commercialization Agreement (Eton Pharmaceuticals, Inc.)
