Audits; Observation of Product Manufacture Sample Clauses

Audits; Observation of Product Manufacture. Notwithstanding anything to the contrary herein or in any Binding Forecast or Stockpile Order, STA agrees that it shall not commence any manufacture of Product until: (a) FibroGen has completed an audit (and if required, STA has instituted appropriate corrective actions to FibroGen’s satisfaction) of the STA Facility and quality systems in place at the STA Facility; and (b) FibroGen has approved the applicable Master Batch Record. On an ongoing basis, FibroGen, other Recipients, and other authorized agents designated by FibroGen shall have the right to perform, directly or through its representatives or agents, certain audits of records and documentation, and to have representatives of FibroGen (or its designee) visit the STA Facility at agreed-upon times, at FibroGen’s expense, to review STA’s manufacturing operations, to assess its compliance with Quality Control Procedures and regulatory standards, and to discuss any related issues with manufacturing and management personnel as set forth in the Quality Agreement or as otherwise agreed in writing by STA and FibroGen. STA shall cooperate fully in all such reviews, audits, and inspections. STA shall provide at no further cost all personnel time and resources that are commercially reasonable to complete such audits. FibroGen shall provide reasonable advance notice to STA of visits to the STA Facility. FibroGen, its representatives or agents shall comply with all reasonable rules promulgated by STA regarding the STA Facility they are visiting and may, at the reasonable discretion of STA, be prohibited from entering or only given limited access to certain areas within the STA Facility. STA may require that FibroGen or the representatives execute an agreement that regulates the representatives’ conduct during their visit.
Sample 1
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