Investigational Product and Pharmacy. On behalf of Sponsor, Pharm-Olam shall provide at no cost to the Pharmacy and/or Institution, the Investigational Product and comparator, if applicable, as well as other Protocol directed ancillary drugs, in amounts reasonably determined by Sponsor to be sufficient for the conduct of the Study. The Institution, Investigator and Pharmacy shall maintain control of the Investigational Product, comparator, and ancillary drugs and ensure, that Investigational Product is stored and handled in accordance with Pharm-Olam’s and/or Sponsor’s written instructions, as set forth in the labelling of the Study materials, in accordance with applicable regulatory requirements, in accordance with ICH/GCP, and in the manner outlined in the Protocol. The Institution and Investigator shall use the Investigational Product, comparator and ancillary drugs for the sole purpose of conducting the Study in strict accordance with the Protocol and for no other purpose, and shall not transfer the Investigational Product, comparator or ancillary drugs to any third parties. The Institution and the Investigator shall ensure that the Investigational Product, comparator and ancillary drugs are stored and handled in a secure manner to prevent access or use by unauthorized persons and will otherwise observe reasonable safety measures customarily employed by the Institution and the Investigator with respect to similar materials in their possession. In the event that any quantity of the
