Avecia Deliverables. 6.1.3.1 [* *] report, including Avecia analysis of previous work: • Master and executed batch records • [* *] reports ([* *], etc.) • [* *] • [* *] report • [* *] report • [* *] reports [*] = CONFIDENTIAL TREATMENT REQUEST(ED). • Draft [* *]
Avecia Deliverables. 6.3.3.1 [* *] transfer report, including Avecia review of previous work: • API Container closure system suitability • API Stability data and stability program design • [* *] API formulation process
Avecia Deliverables. 6.4.3.1 [* *] transfer report; including analysis of: • [* *] assays • Assays requiring [* *] • [* *] developed • Avecia’s [* *] development
Avecia Deliverables. Meeting minutes, action items, and completed transfer summary report [*] = CONFIDENTIAL TREATMENT REQUEST(ED).
Avecia Deliverables. 7.2.2.1 Experiments to: • Characterize [* *] • Determine [* *] — Cell Paste storage data • Evaluate [* *] vs. [* *] phase • Characterize [* *] scales and steps • Determine [* *] strategy
Avecia Deliverables. 7.3.2.1 Experiments to investigate: • Initial [* *] • [* *] • [* *] • [* *] HspE7 • [* *] • Final overall HspE7 [* *] • [* *] [*] = CONFIDENTIAL TREATMENT REQUEST(ED).
Avecia Deliverables. 7.4.2.1 Experiments to: • [* *] • [* *] • [* *] of HspE7 • [* *] of the formulated API
Avecia Deliverables. 7.5.2.1 Experiments to: • [* *] methods [* *] • [* *] assays as required, e.g., • [* *] need • [* *] • Review [* *] for entire process • [* *] batch release and stability assays
Avecia Deliverables. 7.6.3.1 Summary [* *] Report, including [* *] plans and goals for [* *] stage. 8 [* *] STAGE Upon Stressgen’s approval to proceed with [* *], Avecia will execute the [* *] from the [* *] stage in order to develop [* *]. Avecia will parallel track its work to the extent possible, and will resource the work adequately to allow [* *], particularly on [* *]. This stage will [* *] the final [* *] for the pivotal clinical trial supply and commercial manufacture, and produce pilot batches at scale.
Avecia Deliverables. 8.3.2.1 Updated Technical Summary Report
