Extract to table

Under the second draft, Penterra agrees to name Veridian and each participating site as additional insureds under the Briarcliff policy

Any protocol-deviation reporting obligation must be integrated with the existing safety reporting framework set forth in Exhibit J of the MCTA

Under the current framework, SAEs must be reported within 24 hours from site awareness, and IND safety reports follow 7-day and 15-day reporting timelines pursuant to 21 C

• Source Document Retention: Sites must retain source documents for a minimum of 15 years following study completion

I recommend proposing alternative language that: (a) Acknowledges that Penterra will not unreasonably withhold, condition, or delay its consent to the publication of study results, including negative or inconclusive results; (b) Confirms that Penterra's review right does not constitute a right to suppress scientific findings or data; (c) Preserves Penterra's right to request, and require, the removal of trade secrets, proprietary manufacturing information, and Sponsor Confidential Information from any manuscript or presentation prior to publication or dissemination; and (d) Provides that any dispute over whether particular information constitutes Sponsor Confidential Information shall be resolved through the MCTA's dispute resolution procedures, with the manuscript held pending resolution

During this period, subjects in active treatment must be transitioned to alternative care or permitted to complete their current treatment cycle