Project Plan for Process Development/Transfer, and cGMP Manufacturing of Recombinant Single
Cardinal Health’s Services-Phase B: Process Development and [**see footnote] L Scale-down runs
Project Plan and Quotation Page 1 of 3
**Note: Confidential Information has been omitted pursuant to a request for confidential treatment and has been
filed separately with the Securities and Exchange Commission.
Aspen Bio, Inc. (AB)
Cardinal Health-Middleton (CH-M)
CH-M will qualify the concentration assay already transferred to CH-M.
Phase A of the project has been completed under a separate agreement.
At initiation, this project will fall under the MTA executed to support Phase A of the project, but a Scope of Work
(SOW) document and Developing and Manufacturing Agreement will be executed to support this project.
Objective of Phase B is to develop scaleable, robust processes to support cGMP manufacturing activities.
Objective of Phase C is to carry out cGMP manufacturing at the [**see footnote] L scale in preparation for eventual
production at the [**see footnote] L scale.
Consumables and testing are not included in phases B and C. The price of these items will be based on the final
processes and protocols developed but estimates are provided.
Shipping and handling is not included and will be billed on a monthly basis.
All prices are in US dollars and are non-binding until a contract is executed.
Phase B: Step
Qualification of concentration assay
Upstream non-cGMP production
Master Cell Bank (MCB) Manufacture
$ [**see footnote] if perfo