Exhibit 10.27





Exhibit 10.27 







    Cardinal Health 



Project Plan for Process
Development/Transfer, and cGMP Manufacturing of Recombinant Single Chain Gonadotropin  





		
	Prepared For:     

Prepared By:      

Estimate Number:
	Aspen Bio, Inc. (AB)

Cardinal Health-Middleton (CH-M)

AB.cgmp.04.21.05R.5










Assumptions: 



	 	o  	CH-M
will qualify the concentration assay already transferred to CH-M.  





	 	o  	Phase
A of the project has been completed under a separate agreement.  





	 	o 	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.  





	 	o  	Objective
of Phase B is to develop scaleable, robust processes to support cGMP manufacturing
activities.  





	 	o  	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. 





	 	o 	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.  





	 	o  	Shipping
and handling is not included and will be billed on a monthly basis.  






	 	o  	All
prices are in US dollars and are non-binding until a contract is executed.  






Cardinal Health’s
Services-Phase B:   Process Development and [**see footnote] L Scale-down runs  







		
	Phase B:   Step 



Qualification of concentration assay 

                                        



Upstream non-cGMP production 

                                        

                                        

                                        

                                        



Master Cell Bank (MCB) Manufacture 

$ [**see footnote] if performed at CH-M 

                                        

                                        



Downstream Process Transfer 

                                        

                                        



[**see footnote] L Scale-down run 

                                        

                                        

                                         
	$ [**see footnote] Description



Transferred concentration assay will be utilized for unpurified samples and

absorbance at 280nm will be used to determine purified protein concentration.



[**see footnote] liters of cell culture supernatant will be prepared in Wave

bioreactors in non-cGMP area. Approximately [**see footnote] liters of this

material will used to transfer AB's downstream process to CH-M and the remaining

material (about [**see footnote] liters) will be provided to AB for further

processing. This material will become available in [**see footnote] batches.



The chosen clone will be expanded to manufacture a [**see footnote] vial cell

bank. This bank will be suitable for cGMP manufacture after appropriate

testing. If banking is outsourced it will be billed at [**see footnote] plus

[**see footnote]



Transfer activities will involve the transfer of a one column process and [**see

footnote] hours are reserved for evaluating the addition of a second purification

step and viral clearance steps.



Upstream and Downstream activities will be run to produce non-cGMP low endotoxin

material suitable for formulation, stability studies, and use as a reference

standard. A copy of the batch record for the scale down run will be provided to

AB. Samples will be pulled for viral clearance study. 














Cardinal
Health-Middleton 
Project Plan and Quotation Page 1 of 3 
CONFIDENTIAL



**Note:
Confidential Information has been omitted pursuant to a request for confidential
treatment and has been 
filed separately with the Securities and Exchange Commission.


















Phase C: cGMP
Manufacturing  









			
	cGMP Manufacturing Services:   

Steps                          

                               



Upstream Production            

                               



Clarification and Downstream   

Processing                     

                               

                               



cGMP Documentation and         

Regulatory support             



cGMP Stability Study
	
$ [**see footnote] for three concurrent [**see footnote] L         Description: [**see footnote]  

Wave runs. Or $ [**see footnote] for [**see footnote] L

bioreactors.



[**see footnote] vials from the MCB will be thawed and scaled up to [**see footnote] L
bioreactors or Wave bags in one of Cardinal Health's cGMP suites.



Each [**see footnote] L batch will be processed separately. Pricing assumes a [**see footnote] step
purification, each with loading times of less than [**see footnote] hours per column and
minimal buffer exchanges. Includes viral clearance steps and bulk fill but NOT safety
testing, release testing, consumables or fill finish.




Copies of all batch records will be provided to client and CH-M will prepare support the
regulatory filings for the product including preparation of the CMC portion of the filing.



Adds approximately $ [**see footnote] - $ [**see footnote] per time point. 
	










Phase D1 Fill Finish
(performed at Cardinal Health Nexus Drive)  




Liquid or lyo, both are being considered, at scale TBD.
         TBD 



Price estimate for items
other than Cardinal Health’s services (estimates only)  



Table 1: Safety, in
Process and Release Testing Estimate. Some activities to be subcontracted and price willvary
depending testing plan and CTO chosen, and pricing includes [**see footnote] % markup
for managing samples(subcontracted testing) and auditing reports. Price TBD.  







		
	Pre-Bank testing                                               



Master Cell Bank Testing (IND level testing)                   



Phase I/II Viral Clearance Study (IND level testing)           



Testing of non-cGMP runs (IND level testing)                   

                                                               



Testing and release of cGMP material ([**see footnote] L) (IND level testing)



EPC testing (IND level testing)
	$ [**see footnote]



$TBD



$ [**see footnote], $ [**see footnote]



$ [**see footnote] per run or $ [**see footnote] per two

runs (one [**see footnote] L and one [**see footnote] L)



$ [**see footnote] - $ [**see footnote]



$TBD 










Testing of non-cGMP lots
and cGMP lots (beyond standard in process tests) will be subcontracted and billed to ABat

cost plus [**see footnote]%. AB will approve the final testing plan.  



Table 2: Estimate of
Project Consumables Approximately:$ [**see footnote] — $ [**see footnote] assuming
re-useof 
cGMP purification consumables add approximately  






		
	Cell Culture Media and consumables ($ [**see footnote] per Liter) 



Chromatography resins (assuming re-use) 



Project dedicated columns and filters 
	 $ [**see footnote]



 $ [**see footnote]



 $ [**see footnote] 












Cardinal
Health-Middleton 
Project Plan and Quotation Page 2 of 3 
CONFIDENTIAL



**Note:
Confidential Information has been omitted pursuant to a request for confidential
treatment and has been 
filed separately with the Securities and Exchange Commission.















Pricing summary: 







		
	Phase A: Cell line engineering: 

Phase B: Process development: 

Reference standard characterization (Optional): 

Phase D: cGMP Production: 

Fill/Finish: 

cGMP stability: 

Table 1: Testing (safety, in process and release): 

Table 2: Consumables:              

Total budget 
	Complete

$ [**see footnote]

$ [**see footnote] - $ [**see footnote]

$ [**see footnote] - $ [**see footnote]

$ TBD

$ [**see footnote] - $ [**see footnote]

$ TBD

$ [**see footnote] - $ [**see footnote]

$ TBD 











Invoicing [**see footnote] %
at the start of each phase and [**see footnote] % upon completion of final
report. 



Signature for
AB__________________________________________Date:___________________ 



Signature for CH-M:_______________________________________Date:____________________ 



Cardinal Health-Middleton
Contact information: 












		
	Michael E. Jenkins, PhD               

Director, Bus. Dev. & Commercial Ops. 

608-821-6223 (direct)                 

608-215-4881 (mobile)                 

michael.jenkins@cardinal.com
	8137 Forsythia St.

Middleton, WI 53562

608-824-9920

www.gala.com

www.cardinal.com

















Cardinal
Health-Middleton 
Project Plan and Quotation Page 3 of 3 
CONFIDENTIAL



**Note:
Confidential Information has been omitted pursuant to a request for confidential
treatment and has been 
filed separately with the Securities and Exchange Commission.