Right to Inspect Manufacturing. LILLY shall have the right to audit and approve all subcontractors selected by RPI to manufacture Ribozyme Product or bulk products as provided and in addition to Section 7.3. LILLY quality assurance shall have the right to audit all manufacturing facilities for Ribozyme Product for clinical studies and commercial sale. Such reviews shall occur as soon as reasonably practical. RPI will assure compliance with regulatory commitments and will correct any deficiencies prior to manufacturing of any Ribozyme Product. RPI will promptly notify LILLY of any regulatory inspections and inquiry/communications which involve Ribozyme Product and give LILLY an opportunity to assist RPI in responding to any such inquires.
Appears in 3 contracts
Samples: Collaboration and License Agreement (Ribozyme Pharmaceuticals Inc), License Agreement (Ribozyme Pharmaceuticals Inc), License Agreement (Ribozyme Pharmaceuticals Inc)
Right to Inspect Manufacturing. LILLY shall have the right to audit and approve all subcontractors selected by RPI to manufacture Ribozyme Product or bulk products as provided and in addition to Section 7.3. LILLY quality assurance shall have the right to audit all manufacturing facilities for Ribozyme Product for clinical studies and commercial sale. Such reviews shall occur as soon as reasonably practical. RPI will assure compliance with regulatory commitments and will correct any deficiencies prior to manufacturing of any Ribozyme Product. RPI will promptly notify LILLY of any regulatory inspections and inquiry/communications which involve Ribozyme Product and give LILLY an opportunity to assist RPI in responding to any such inquires.. 10.3
Appears in 1 contract
Samples: Research Collaboration and License Agreement (Ribozyme Pharmaceuticals Inc)