exv10w37



 





Exhibit 10.37




 






Project Plan for

Non-GMP and cGMP

Fill and Finish of OMS302




 






Prepared for:




Wayne Gombotz, Ph.D.

Vice President, Pharmaceutical Operations

Omeros Corporation

1420 Fifth Avenue, Suite 2600

Seattle, WA 98101

206-623-4688 (phone)

206-264-7856 (fax)




Prepared by:




Althea Technologies 

11040 Roselle Street 

San Diego, CA 92121 

858-882-0123 
858-882-0133 (fax)











 




			
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TABLE OF CONTENTS





	1.	 	Outline of Deliverables
	 
	2.	 	Detailed Description of Deliverables and Pricing Summary
	 
	3.	 	Specifications and Stability Testing Outlines
	 
	4.	 	Quality Agreement
	 
	5.	 	Project Total
	 
	6.	 	Authorizations







 




			
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1. Outline of Deliverables




A. Timing of Deliverables




1. Contract Approval (May 31, 2007)

2. Initial HPLC Assay Transfer (May-July 2007)

3. Non-GMP API Delivered to Althea (July 2007)

4. Non-GMP OMS302 Product, [†] and Placebo Fills (July 16-20, 2007)

5. Non-GMP Product Released (6 weeks after completion of the fill)

6. GMP Documentation Preparation (Product Batch Records) (September 2007)

7. GMP API Delivered to Althea (September 2007)

8. GMP OMS302 Product Fill (October 8-9, 2007)

9. GMP [†] Product Fill (October 10-11, 2007)

10. Released GMP Product Lot, C of A and Audited Batch Records (6 weeks after completion of the
fill)




B. Summary of Deliverables to Omeros Corporation




This is a Project Plan dated May 31, 2007 under the Drug Product Development and Supply Agreement
dated January 20, 2006 between Althea Technologies, Inc. and Omeros Corporation



Project: Non-GMP and cGMP Production of OMS302 (“Product”) per cGMP Master Batch Record to be
developed by Althea and approved by Omeros.




	 	 	 
	Non-GMP OMS302 Product Vials
	 	1 x 400
	Non-GMP [†]Product Vials
	 	1 x 400
	Non-GMP Placebo Vials
	 	1 x 400
	cGMP OMS302 Product Vials
	 	1 x 3,000
	cGMP [†] Product Vials
	 	1 x 3,000
	Audited Batch Records
	 	2
	Audited Test Results
	 	2
	Cs of A
	 	5
	DMF Reference Letter
	 	1






	 	 	 
	Miscellaneous
 


	 	 
	
2 Site Visits for Inspection/Audit, 2 auditors at a time.










 




			
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2. Detailed Description of Deliverables and Pricing Summary



A. Detailed Description of Fill and Finish Deliverables and Pricing Summary




	 	 	 	 	 	 	 	 	 
	Service Description	 	Units	 	Unit Price	 	Total Price
	Media Fill Validation	 	3 x 3000	 	[†]	 	[†]
	 
	 	 	 	 	 	 	 	 
	-

	 	Media fill validation performed in accordance
with ICH guidelines of 3 x 3000 2 mL glass
vials.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Non-GMP Aseptic Fill and Finish (Product and Placebo)	 	 ~400 vials/fill
(OMS302
Product)	 	[†]

Per Fill	 	[†]
	 
	 	 	 	 	 	 	 	 
	-

	 	Omeros to supply all released API- [†]
	 	 	 	Discounted Unit Price:	 	 
	-

	 	Althea to purchase and release citric acid
	 	~400 vials/fill
	 	 	 	 
	 

	 	monohydrate, sodium citrate and WFI.
	 	[†]	 	 	 	 
	-

	 	Althea to purchase and release vials, stoppers
and seals as specified in completed product
survey
	 	~400 vials

per fill
	 	[†]

Per Fill	 	 
	-

	 	Non-GMP batch record preparation for product
and placebo fills
	 	(Placebo)	 	 	 	 
	-

	 	Non-GMP filling of formulated bulk and placebo
into 5 mL glass vials	 	 	 	 	 	 
	-

	 	Standard label preparation- additional charges
may apply for non-standard labels.	 	 	 	 	 	 
	-

	 	Release testing to include sterility, Endotoxin,
pH, appearance, osmolality, potency, purity,
identity and USP particulate. Samples of
the product will be sent to Omeros for potency
testing.	 	 	 	 	 	 
	-

	 	Fill may be performed in either Althea’s clean
room filling suites or in a hood in a Class 10,000
room	 	 	 	 	 	 
	-

	 	Two domestic shipments	 	 	 	 	 	 








 




			
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A. Detailed Description of Fill and Finish Deliverables and Pricing Summary continued




	 	 	 	 	 	 	 	 	 
	Service Description	 	Units	 	Unit Price	 	Total Price
	GMP Aseptic Fill and Finish (OMS302 Product)	 	3000 Vials	 	[†]	 	[†]
	 
	 	 	 	 	 	 	 	 
	-

	 	Omeros to supply all released APIs	 	 	 	 	 	 
	-

	 	Althea to purchase and release citric acid
monohydrate and sodium
citrate dihydrate buffer.	 	 	 	 	 	 
	-

	 	Althea to purchase and release vials, stoppers
and seals as specified in completed product
survey	 	 	 	 	 	 
	-

	 	GMP batch record preparation	 	 	 	 	 	 
	-

	 	GMP aseptic filling of formulated bulk into 2 mL
clear glass vials	 	 	 	 	 	 
	-

	 	Standard label preparation- additional charges
may apply for non-standard labels.	 	 	 	 	 	 
	-

	 	Release testing to include sterility (Nelson or
Northview Labs), Endotoxin, pH, appearance,
osmolality, potency, purity, identity
and USP particulate (Quadrants). Samples will
be sent to Omeros for potency testing.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	GMP Aseptic Fill and Finish ([†] Product)	 	3000 Vials	 	[†]	 	[†]
	 
	 	 	 	 	 	 	 	 
	-

	 	Omeros to supply all released API	 	 	 	 	 	 
	-

	 	Althea to purchase and release citric acid
monohydrate and sodium Citrate dihydrate buffer.	 	 	 	 	 	 
	-

	 	Althea to purchase and release vials, stoppers
and seals as specified in completed product
survey	 	 	 	 	 	 
	-

	 	GMP batch record preparation	 	 	 	 	 	 
	-

	 	GMP aseptic filling of formulated bulk into 2 mL
clear glass vials	 	 	 	 	 	 
	-

	 	Standard label preparation- additional charges
may apply for non-standard labels.	 	 	 	 	 	 
	-

	 	Release testing to include sterility (Nelson or
Northview Labs), Endotoxin, pH, appearance,
        ,osmolality, potency, purity, identity
and USP particulate (Quadrants). Samples will
be sent to Omeros for potency testing.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Fill and Finish Total	 	 	 	 	 	[†]








 




			
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B. Detailed Description of Stability Testing and Analytical Transfer Deliverables and
Pricing Summary



	 	 	 	 	 	 	 	 	 
	Service Description	 	Units	 	Unit Price	 	Total Price
	HPLC Transfer and Qualification
-      Transfer of HPLC method, including all SOPs
and protocols. Assay qualification. 


	 	 	1	 	 	[†]
	 	[†]
	 
	 	 	 	 	 	 	 	 
	Final Product (Non-GMP OMS302 Product Only- No
Placebo) Stability Program Setup and Maintenance

	 	2 Storage
Conditions
	 	[†]
	 	[†]
	 
	 	 	 	 	 	 	 	 
	Includes storage, execution and management of a 18
month stability program described below at two
temperatures with the option of extending the
program to 24 months. Also includes the issuance
of a C of A at
each time interval and stability condition.
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Final Product (Non-GMP [†] Only- No Placebo)
Stability Program Setup and Maintenance

	 	2 Storage
Conditions
	 	[†]
	 	[†]
	 
	 	 	 	 	 	 	 	 
	Includes storage, execution and management of an 18
month stability program described below at two
temperatures with the option of extending the
program to 24 months. Also includes the issuance
of a C of A at
each time interval and stability condition.
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Final Product (GMP Product OMS302) Stability
Program Setup and Maintenance

	 	2 Storage
Conditions
	 	[†]
	 	[†]
	 
	 	 	 	 	 	 	 	 
	Includes storage, execution and management of an 18
month stability program described below at two
temperatures with the option of extending the
program to 24 months. Also includes the issuance
of a C of A at
each time interval and stability condition.
	 	 	 	 	 	 	 	 








 




			
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B. Detailed Description of Stability Testing and Analytical Transfer Deliverables and
Pricing Summary Continued




	 	 	 	 	 	 	 
	Service Description	 	Units	 	Unit Price	 	Total Price
	Final Product (GMP Product [†] Only- No Placebo)
Stability Program Setup and Maintenance

	 	2 Storage
Conditions
	 	[†]
	 	[†]
	 
	 	 	 	 	 	 
	Includes storage, execution and management of an 18
month stability program described below at two
temperatures with the option of extending the
program to 24 months. Also includes the issuance
of a C of A at
each time interval and stability condition.
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Stabiity and Analytical Transfer Total

	 	 	 	 	 	[†]








 




			
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C.  Payment Schedule



The above Fill and Finish and Stability and Analytical Transfer pricing will be [†]. The
total budgeted [†] shall be payable in accordance with the following schedule in response to
invoices to be submitted by Althea monthly for milestones completed during the month. Invoices
will be paid by Omeros in accordance with Section 2.11 of the Development and Supply Agreement.




	 	 	 
	Milestone	 	Invoice Amount
	Execution of Project Plan (advance payment — [†] of Fill and Finish)*

	 	[†]
	 
	 	 
	Completion of HPLC Transfer and Qualification

	 	[†]
	 
	 	 
	Completion of Non-GMP OMS302 Product Fill and Finish

	 	[†]
	 
	 	 
	Completion of Non-GMP Placebo Product Fill and Finish

	 	[†]
	 
	 	 
	Completion of Non-GMP [†] Product Fill and Finish

	 	[†]
	 
	 	 
	Setup of Non-GMP Product Stability Program ([†] of Stability Program
Price for OMS302)

	 	[†]
	 
	 	 
	Delivery of Stability Data for Each Time Point (1, 3, 6, 9, 12 and
18 Month) for the Non-GMP OMS203 a Product Stability Program (each
at [†] of Program Price)

	 	[†]/timepoint
	 
	 	 
	Setup of Non-GMP Product Stability Program ([†] of Stability Program
Price for [†])

	 	[†]
	 
	 	 
	Delivery of Stability Data for Each Time Point (1, 3, 6, 9, 12 and
18 Month) for the Non-GMP [†]Product Stability Program (each at [†]
of Program Price)

	 	[†]/timepoint
	 
	 	 
	Completion of GMP OMS302 Product Fill ([†] of batch price)

	 	[†]
	 
	 	 
	Approval of Released cGMP OMS302 Product by Omeros within the
timeframe described in section 5.1, Non-Conforming Drug Product in
the Development and Supply Agreement ([†] of batch price)

	 	[†]
	 
	 	 
	Completion of GMP [†] Product Fill ([†] of batch price)

	 	[†]
	 
	 	 
	Approval of Released cGMP [†] Product by Omeros within the timeframe
described in section 5.1, Non-Conforming Drug Product in the
Development and Supply Agreement ([†] of batch price)

	 	[†]
	 
	 	 
	Setup of cGMP OMS302 Product Stability Program ([†] of Stability
Program Price)

	 	[†]
	 
	 	 
	Setup of cGMP [†] Product Stability Program ([†] of Stability
Program Price)

	 	[†]
	 
	 	 
	Delivery of Stability Data for Each Time Point (1, 3, 6, 9, 12 and
18 Month) for the GMP OMS302 Product Stability Program (each at [†]
of Program Price)

	 	[†]/timepoint
	 
	 	 
	Delivery of Stability Data for Each Time Point (1, 3, 6, 9, 12 and
18 Month) for the GMP [†] Product Stability Program (each at [†] of
Program Price)

	 	[†]/timepoint








 




			
	*	 	In the event that the Project Plan is terminated early, any portion of the advance payment
remaining (less any penalties that may be due in accordance with Section 3.3(b) of the Development
and Supply Agreement) shall be promptly refunded to Omeros.
	 
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3. Specifications and Components




	 	 	 	 	 
	Assay	 	Test	 	Specification
	Purity

	 	HPLC
	 	Report Result; % area of each individual Related
Substances peak and total % Related Substances
	 
	 	 	 	 
	Potency

	 	HPLC
	 	Report Result; % Label claim [†] HCL and % Label
claim [†]
	 
	 	 	 	 
	Identity

	 	HPLC
	 	Retention time of parent compound matches retention
time of drug substance reference standards
	 
	 	 	 	 
	Appearance

	 	Visual per Althea SOP
	 	Clear colorless solution free of visible particulates
	 
	 	 	 	 
	pH

	 	USP [†]
	 	[†]
	 
	 	 	 	 
	Osmolality

	 	USP [†]
	 	Report Result
	 
	 	 	 	 
	Sterility

	 	USP [†]
	 	Sterile
	 
	 	 	 	 
	Particulate Count

	 	USP [†]
	 	Particulates >/= [†]/Unit

Particulates >/= [†]/Unit
	 
	 	 	 	 
	Endotoxin

	 	LAL USP [†]
	 	[†]/mL






Component Specifications




	 	 	 	 	 
	Component	 	Description	 	Althea Part Number
	Vial

	 	West 5 mL, 20 mm opening-68000318,
	 	RM-551
	Stopper

	 	West 20 mm Daikyo Fluortec D777-1 Gray-19500120
	 	RM-512
	Seal

	 	20 mm Purple Flip-Off Truedge West-542027
	 	RM-711
	Filter
	 	 	 	 






Excipients




	 	 	 
	Excipients	 	Catalog Number
	Citric acid Monohydrate USP

	 	EM Science —
EM-0002425B
	Sodium Citrate (Dihydrate USP)

	 	EM Science —
EM-SX0442-1








 




			
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Stability Testing Outlines



Proposed Stability Program (Non-GMP Product Only- No Placebo)- Two Storage Conditions




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Assay
	 	 	1	 	 	 	3	 	 	 	6	 	 	 	9	 	 	 	12	 	 	 	18	 
	HPLC
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	Appearance
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	pH
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	USP Particulates
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 
	Sterility
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 
	Endotoxin
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 






Proposed Stability Program (Product)- Two Storage Conditions




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Assay
	 	 	1	 	 	 	3	 	 	 	6	 	 	 	9	 	 	 	12	 	 	 	18	 
	HPLC
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	Appearance
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	pH
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 
	USP Particulates
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 
	Sterility
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 
	Endotoxin
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 








 




			
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4. Quality Agreement





Purpose




The Quality Management Agreement has been developed to define the regulatory compliance roles
and responsibilities of Omeros Corporation (Omeros) and Althea Technologies (Althea). The
Quality Management Agreement shall constitute part of the agreement between Omeros and Althea
and may be revised from time to time on the basis of mutual agreement of the parties. In the
event of a conflict between the provisions of the Drug Product Development and Clinical Supply
Agreement and Quality Management Agreement, the provisions of the Drug Product Development and
Clinical Supply Agreement shall prevail.




Definitions




“Agreement” shall mean the Drug Product Development and Clinical Supply Agreement executed
between Omeros and Althea on January 20, 2006.




“cGMP” shall mean Current Good Manufacturing Practices as promulgated under the US Federal Food
Drug and Cosmetic Act and 21 CFR sections 210, 211, 600 and 610




“Party” means either Omeros or Althea




“Parties” means both Omeros and Althea




“Products” shall mean Omeros drug products and all intermediate precursors




Regulatory Activities




Roles of the parties




Omeros will be the holder the IND or equivalent and the holder of the registration submission
and subsequent license. Althea will support these submissions as a contract manufacturer under
the direction of Omeros.




Regulatory submissions




Omeros will be responsible for the submission of documentation to regulatory authorities in
support of the Products. Althea will provide Omeros with the information necessary to complete
regulatory submissions in a timely and effective manner.




Althea and Omeros will mutually agree upon responses, which Omeros will make, to FDA questions
and requests regarding production processes and product testing relevant to Althea.


Inspections



Omeros will inform Althea in a timely fashion when regulatory agencies are seeking to schedule






 




			
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inspections concerning the Products at Althea’s facilities.



Omeros will be permitted two representatives during the opening, closing and daily wrap up portions
of the inspection at Althea’s facilities.



Althea’s communication and commitments with regulatory inspectors will be limited to matters
outside of Omeros’ regulatory submissions, and Omeros will be informed of all such communication
and commitments that could impact Omeros’ regulatory submissions. Althea and Omeros will mutually
agree upon responses, which Omeros will make, to FDA questions and requests regarding production
processes and product testing. Omeros will determine and make all other responses to regulatory
authorities.



Compliance



Roles of the parties



Althea, in its activities under the Agreement, is responsible for cGMP, other applicable guidelines
and Althea SOPs.



Omeros, in its activities under the Agreement, is responsible for cGMP and applicable guidelines
and with confirming Althea’s cGMP, other applicable guidelines and Althea SOPs.



Audits



In addition to other audit rights provided for in Section 4.7 of the Agreement, Omeros has the
right to perform one audit of Althea facilities, laboratories and warehouses each year for the
purposes of confirming Althea’s compliance with cGMP, applicable guidelines and Althea SOPs in the
manufacture, testing and validation of the Product. The audit will be limited to 2 business days to
occur on mutually agreed upon dates.



Omeros may also perform an annual audit of each Althea subcontractor involved in the manufacture,
testing and validation of the Product, providing that Omeros provides Althea with prior written
notification of its intent to audit. Althea will provide commercially reasonable efforts to
facilitate the scheduling and execution of Omeros’ audits of subcontractors.



In addition to the annual compliance audit, Omeros may also audit Althea and its subcontractors in
the event of failure or recall of a product lot.



At the conclusion of each audit, Omeros will hold a wrap up meeting with Althea and/or its
subcontractors to review all significant audit observations.



Within 60 days of each audit it performs at Althea and its subcontractors, Omeros will provide
Althea with a written report of its observations and recommendations. Within 60 days of receipt of
Omeros’ audit report, Althea and/or its subcontractors will provide a written response to Omeros
including a response to all Omeros observations and details regarding corrective actions.



Documentation






 




			
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Althea is responsible for generating and maintaining records of equipment usage, cleaning and
maintenance.



Althea is responsible for developing documentation to support the manufacturing, testing and
validation of the Product. All documents and procedures which are specific to the product must be
approved by Omeros prior to implementation. Althea will provide Omeros with copies of all documents
used in the production, testing and validation of the Product.



Changes to documentation will be implemented according to the Change Control section of this
document.



Althea is responsible for maintaining Product batch production and testing records for the period
of product expiry plus one year. Written authorization from Omeros QA is required prior to the
movement or destruction of Product records. When Althea is no longer willing or able to store
Product records, Omeros may have the records destroyed, or transferred to an alternate storage
location at Omeros’ expense.



Product Release



Althea and Omeros will each identify a Quality Assurance representative who will function as the
points of contact between the companies for the purposes of communication regarding product release
and regulatory compliance activities.



Althea will propose sources and specifications for raw materials and components to be used in the
manufacture of the Product. Omeros will be responsible for approving all sources for raw materials
and components used in the manufacture of the Product.



Althea and Omeros will mutually agree upon testing specifications for the Product. The parties will
mutually agree in writing to all changes to specification prior to implementation.



Althea may subcontract some or all of the Product testing subject to prior written approval by
Omeros.



Althea is responsible for control and monitoring of the Product manufacturing process and
production facility.



Althea is responsible for reviewing product lot records, test results and specifications and
determining whether to reject the lot or issue Althea’s release to Omeros QA. Omeros QA is
responsible for the formal release of each Product lot.



Althea will issue a Certificate of Analysis and Certification of Compliance to Omeros for each lot
that receives Althea’s release. The Certificate of Analysis will contain a summary of the product
test results, specifications and test methods. The Certificate of Compliance will contain a
statement signed by Althea’s QA representative stating that the lot has been manufactured and
tested in compliance with cGMP, Althea procedures and applicable guidelines.



Omeros may request additional documentation to support its review and release of Product lots,






 




			
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including but not limited to copies of Batch Production Records, testing results, raw data from
Product testing and in-process test results.



Omeros will make reasonable efforts to release each lot within 90 days of receipt of the
Certificate of Analysis, Certificate of Compliance and requested documents.



Althea will store and ship the Product according to written Omeros instructions and in compliance
with cGMP.



Product Recall



Omeros is responsible for instituting and facilitating a Product recall.



Omeros will notify Althea in a timely fashion when a Product recall may be due to issues related to
the manufacturing of the Products.



In the event that a Product recall may be due to manufacture of the Products, Althea will provide
Omeros complete information regarding the relevant Product lots including, but not limited to trace
trees, equipment and facility data, etc. Althea will provide this information to Omeros within 10
business days of receipt of the request from Omeros.



At Omeros’ request and under Omeros’ direction, Althea will support communication with regulatory
authorities.



Change Control



All changes to procedures, documents and equipment used in the manufacture, testing and validation
of the Product must be mutually approved by Althea and Omeros in writing prior to implementation.



Validation



All validation specific to the Product must be executed according to protocols approved prior to
execution by Omeros.



Althea will provide Omeros with copies of all validation reports used to support manufacture and
testing of the Product, upon request.



Investigations



Althea will notify Omeros of all excursions, deviations, observations and investigations which
could impact past, current or future lots of the Product.



Althea will notify Omeros of all Product testing failures within 2 business days, and prior to
initiating retesting.






 




			
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All investigations concerning the Product and conducted at Althea will be reviewed and approved by
Althea and Omeros.



Product
Supply Roles of the parties




Althea will perform manufacture, testing and validation of the Products in its facilities.



Omeros is authorized to have 2 representatives present at Althea’s manufacturing facilities during
Product manufacture, testing and/or validation. Additional Omeros representatives may be permitted
when mutually agreed with Althea.



Authorization of production



Manufacture of the Product at Althea will be authorized in accordance with the Agreement



Lot numbers



Althea is responsible for assigning and tracking unique identifier numbers to each lot of raw
material, component, product intermediate and Product.



Dates of production and expiration



The dates of manufacture will be determined by, and documented in, the Batch Production Records.
The expiration date of the Product will be determined by Omeros.



Dispute Resolution



Disputes concerning the acceptability of Product lots or general compliance issues will be resolved
by the Quality Assurance representatives of the Parties. If the dispute is not resolved after 30
days, either Party may upon written notification to the other request that the dispute be resolved
according to the provisions of the Agreement.






 




			
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5. Summary Pricing




	 	 	 	 	 
	Fill and Finish Total
	 	 	[†]	 
	 
	 	 	 	 
	Stability and Analytical Transfer Total
	 	 	[†]	 
	 
	 	 	 	 
	Project Total
	 	 	[†]	 
	 
	 	 	 	 
	Discounted Project Total
	 	 	[†]	 








 




			
	†	 	DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION





 









 





6. Authorizations



IN WITNESS WHEREOF, the parties hereto have each caused this Project Plan to be executed by
their duly-authorized representatives as of June 4, 2007.




	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	OMEROS CORPORATION	 	 	 	 	 	ALTHEA TECHNOLOGIES, INC	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Gregory A. Demopulos
	 	 	 	By:
	 	/s/ Melissa Rosness	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name:

	 	Gregory A. Demopulos, M.D.
	 	 	 	Name:
	 	Melissa Rosness	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	Chairman & CEO
	 	 	 	Title:
	 	Director, Contract Management	 	 
	 

	 	 
	 	 	 	 	 	 	 	 







 




			
	†	 	DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION