Extract to table

Importantly, and as specifically agreed at the June 9 session, the MCTA provides that indemnification for claims arising from product defects shall be uncapped, reflecting the parties' mutual understanding that defect-based claims properly rest with the sponsor

Certificates of insurance shall be exchanged within 15 business days of execution of the MCTA and annually thereafter for the duration of the study

Each party shall provide at least 30 days' prior written notice of any material change in, cancellation of, or non-renewal of any required insurance coverage

Where an investigator deviates from the Protocol as necessary to protect the immediate safety or well-being of a study subject, no liability shall be allocated to the investigator or site, and such deviations shall not constitute a basis for any carve-out from Penterra's indemnification obligations

Where a deviation from the Protocol has been authorized by Penterra in writing prior to its occurrence, such deviation shall be treated as an amendment to the Protocol for purposes of indemnification, and liability shall not be allocated to the investigator or site

Where a site or investigator deviates from the Protocol without prior written authorization from Penterra and outside the scope of immediate subject safety, such deviation shall be allocated to the site and investigator under the reciprocal indemnification provisions of Exhibit D