Responsibilities of ARC. 1.1 ARC will use reasonable efforts to provide source leukocytes and plasma products (“Services”) in connection with Customer’s clinical trial (the “Clinical Trial”), the protocol for which is entitled “A Phase Ill, Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell™ as an Adjunct to Good Wound Care Measures in Treating Lower Extremity Chronic Ulcers in Adults with Diabetes Mellitus” (the “Clinical Protocol”). The Clinical Protocol is attached to this Agreement as Attachment A. In providing the Services, ARC will use reasonable efforts to collect source leukocytes and plasma (“Blood Related Material” or “BRM”) from eligible volunteer donors according to the Clinical Protocol). IRBs at other institutions participating in the Clinical Trial (including without limitation Customer’s IRB) will be responsible for conducting independent reviews of the Clinical Trial. The Parties agree, therefore, that the ARC IRB is not the IRB of record for these other institutions, each of which is responsible for compliance with regulations for the protection of human subjects of research at their respective sites. ARC will not be obligated to provide any Services to Customer until the Clinical Trial has met applicable regulatory and other legal requirements, including without limitation, review and approval by all required IRBs (including third party IRBs), receipt of confirmation that each such subject participating in the Clinical Trial has given all necessary informed consent and execution of required investigator agreements. Customer will provide a copy of their institutional IRB approval memo to ARC prior to the start of Services.
Responsibilities of ARC. ARC shall undertake the responsibilities set forth in this Section 1.
Responsibilities of ARC
