Document:

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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A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

 

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.
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Stability 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
	 	 	[†]	 

 

			
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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	 	 
	 

	 	 
	 	 	 	 	 	 	 	 

 

			
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Exhibit 10.41

AGREEMENT FOR ANTIBODY DISCOVERY AND DEVELOPMENT

This is an Agreement between Omeros Corporation (“Omeros”), a Washington corporation having an
address at 1420 Fifth Avenue, Suite 2600, Seattle, Washington 98101, and Affitech AS (“Affitech”),
having an address at Oslo Research Park, Gaustadalléen 21, N-0349 Oslo, Norway, and is effective as
of July 25, 2008 (the “Effective Date”). Omeros and Affitech may be referred to herein each as a
“Party” or together as the “Parties”.

Omeros’ business includes the research and development of pharmaceuticals and biological
therapeutic products. Affitech is in the business of the discovery of human recombinant antibodies.
Omeros wishes to access Affitech’s expertise to isolate and optimize antibodies to human MASP-2
that block its ability to mediate lectin pathway activation, which Omeros will further develop and
commercialize, as further described below, and Affitech wishes to provide such expertise to Omeros.

Therefore, for the above and other consideration, Omeros and Affitech hereby agree as follows:

	1	 	Key Definitions
	 
	1.1	 	“Active Agent” shall mean a biological or pharmaceutical agent that provides a desired
therapeutic effect when administered in a biological or pharmaceutical drug product, and does
not include carriers, binders, fillers, solubilizers, stabilizers, buffers, acidifying agents
or other excipients that do not exert therapeutic effect.
	 
	1.2	 	“Affitech-Originated MASP-2 Antibody” shall mean any MASP-2 antibody or antibody fragment
that specifically binds to MASP-2 polypeptides or portions thereof, including, without
limitation, any single chain variable fragment (“scFv”), that was isolated and/or developed
for and delivered to Omeros by Affitech under this Agreement or that is derived from an MASP-2
antibody or antibody fragment that was isolated and/or developed for and delivered to Omeros
by Affitech under this Agreement.
	 
	1.3	 	“Best Efforts” shall mean the application of continuing reasonable and material efforts,
activities and measures that a diligent third party company active in a similar field as the
respective Party would consider to be commercially reasonable, feasible and viable to be
performed, undertaken or made in or under the specific circumstances.

	 
	1.4	 	“Combination Product” shall mean any MASP-2 Therapeutic containing both an
Affitech-Originated MASP-2 Antibody and one or more additional Active Agent(s) that do not
constitute an Affitech-Originated MASP-2 Antibody.
	 
	1.5	 	“FDA” shall mean the US Food and Drug Administration.
	 
	1.6	 	“ICD Category Indications” shall mean therapeutic indications that are classified differently
at the second digit level in the tabular index of the International Classification of Diseases
and Related Health Problems, ninth edition, e.g., indications falling within ICD 340 and ICD
350, respectively, would be considered different ICD Category Indications while indications
falling within ICD 340 and ICD 349, respectively, would be considered the same ICD Category
Indications.

 

			
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	1.7	 	“IND” shall mean an Investigational New Drug Application, if submitted to FDA, or
corresponding application to permit the commencement of clinical trials for the evaluation of
a pharmaceutical or biological therapeutic if submitted to another Regulatory Agency.
	 
	1.8	 	“Intellectual Property Rights” shall mean all inventions, ideas, discoveries, issued,
reissued or reexamined patents, pending and future patent applications, continuation and
continuation-in-part patent applications, divisional patent applications, utility models,
inventor’s certificates, trade secrets and know-how.
	 
	1.9	 	“MASP-2” shall refer to human mannan binding lectin-associated serine protease 2.
	 
	1.10	 	“MASP-2 Antibody Patents” shall mean all patent applications and patents owned by Omeros that
claim Affitech-Originated MASP-2 Antibodies, MASP-2 Therapeutic compositions, or methods of
manufacturing, formulating or packaging Affitech-Originated MASP-2 Antibodies or MASP-2
Therapeutic compositions. For the avoidance of doubt, the term “manufacturing” or “method of
manufacturing” in this Agreement does not include screening of libraries or affinity
maturation of antibodies.
	 
	1.11	 	“MASP-2 Therapeutic” shall mean a biological therapeutic that contains an Affitech-Originated
MASP-2 Antibody that is manufactured, offered for sale, sold or used by Omeros or by a
licensee of Omeros.
	 
	1.12	 	“Net Sales” shall refer to (a) the gross total of the monetary amounts invoiced and collected
by Omeros or, if Omeros has licensed manufacturing and distribution rights to a licensee, by
Omeros’ licensee, for the initial sale or distribution of MASP-2 Therapeutics, but excluding
any amounts invoiced or collected by parties other than Omeros or Omeros’ licensee for
subsequent sales or distribution provided no part of such amounts invoiced or collected by
such parties is directly or indirectly paid to Omeros or Omeros’ licensee, less (b) the sum of
the following actual and customary deductions where applicable: cash, trade, or quantity
discounts; sales, use, tariff, import/export duties or other excise taxes, and any other
governmental taxes imposed on particular sales; transportation charges and allowances; sales
commissions to third parties (but excluding sales commissions to Omeros’ employees); wholesale
charge backs; distributor fees; Medicare/Medicaid rebates; customer rebates; refunds for
recalls; and allowances or credits to customers because of rejections or returns, provided
such deductions are documented. [†]. For purposes of this paragraph, the acquisition of MASP-2
Therapeutics from Omeros as part of an acquisition or other transfer or conveyance of all or a
substantial part of the assets of Omeros’ business to which this Agreement pertains, or as
part of a merger, acquisition, reorganization or other change of control of Omeros, shall not
be considered a sale or distribution of MASP-2 Therapeutics.
	 
	1.13	 	“Overall Objective” shall mean the isolation and optimization of an Affitech-Originated
MASP-2 Antibody that is suitable for advancement by Omeros through preclinical and clinical
development and ultimate manufacture, commercialization, distribution and sale in the form of
one or more MASP-2 Therapeutics.

 

			
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	1.14	 	[†].
	 
	1.15	 	“Patented MASP-2 Therapeutics” shall mean MASP-2 Therapeutics manufactured, sold, offered for
sale or used in (a) a country or territory in which such MASP-2 Therapeutics would read upon a
claim of an issued patent, that has not been declared invalid or unenforceable by a patent
office or court of common jurisdiction after appeal to a court or tribunal of appeal (e.g.,
the Federal Circuit in the U.S.) or a claim of a pending patent application included within
the MASP-2 Antibody Patents in such country or territory [†].
	 
	1.16	 	“Regulatory Agency” shall mean FDA or corresponding foreign national or international agency
that regulates and approves the clinical testing, marketing and sale of pharmaceuticals and
biological therapeutics.
	 
	1.17	 	[†].
	 
	2	 	Services and Deliverables
	 
	2.1	 	[†]. Affitech shall provide Omeros the following services (“Services”) and deliverables
(“Deliverables”), as more fully specified and described in the initial research plan (the
“Initial Research Plan”) attached to this agreement as Exhibit A:
	 
	 	 	a) Affitech shall conduct the initial testing of [†] that meet all of the requirements
therefore specified in the Initial Research Plan (“First-Generation Candidates”), [†], as
further described in Exhibit A. [†].
	 
	 	 	b) Upon written request by Omeros in writing, Affitech shall initiate [†], as further
described in Exhibit A. [†]. If requested by Omeros in writing, Affitech will supply [†].
	 
	2.2	 	[†]. If requested by Omeros in writing, Affitech shall [†] that may be mutually agreed in
writing between the parties, and produce and deliver to Omeros [†].
	 
	2.3	 	Additional Services and Deliverables. In addition to the Services and Deliverables described
in the Initial Research Plan, Affitech and Omeros may mutually agree that additional Services
not envisioned by the Initial Research Plan will be provided under this Agreement, which shall
be specified, including additional Deliverables and fee compensation payable, in one or more
additional research plan(s) (each an “Additional Research Plan”).
	 
	2.4	 	Joint Advisory Committee. Affitech and Omeros shall each designate a scientific point of
contact, who shall communicate with each other regularly by e-mail, phone and/or in person, at
least as frequently as requested by either Party, regarding the progress of the Services and
Deliverables during any periods of time in which there are any uncompleted Services or
undelivered Deliverables under the Initial Research Plan and any Additional Research Plan(s).
For Omeros, the initial scientific point of contact shall be [†]. For Affitech, the initial
scientific point of contact shall be [†]. Each Party
shall also designate two additional scientific and/or business
representatives who shall participate, together with the scientific
points of contact, in a joint advisory committee
(“JAC”) that shall meet, by phone or in person, at
least once every month or on another mutually agreed schedule during any
periods of time in which there are any uncompleted Services or undelivered Deliverables under
the Initial Research Plan and any Additional Research

 

			
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	 	 	Plan(s), to discuss the progress of the Services and Deliverables and to determine the
optimal technical approach and steps to be taken to meet Milestones I and II and to achieve
the Overall Objective. The JAC shall be formed within [†] from the Effective Date and remain
active until (i) completion of the Initial Research Plan and any Additional Research
Plan(s)or (ii) termination of the Agreement, whatever event occurs first.
	 
	2.5	 	Best Efforts. Affitech shall use Best Efforts to complete all Services, to deliver all Deliverables and meet
all Milestones set forth in the Initial Research Plan and any Additional Research Plan(s) [†],
and to achieve the Overall Objective, and [†] that all Services are carried out and
Deliverables generated and developed [†]; provided, however, that any delays or interruptions
in Affitech’s’ activities or efforts due to availability of compounds, materials or necessary
processes shall not be deemed to be a failure of Affitech to exert Best Efforts under this
Section 2.5.
	 
	2.6	 	[†].
	 
	2.7	 	Compliance with Laws. Affitech shall comply with all applicable international, national,
county and local laws, rules and regulations in providing the Services. Affitech shall
promptly notify Omeros if any regulatory agency takes action against Affitech for any defect
or deficiency, during the Research Term (as defined in Section 8.1 herein below) of this
Agreement, [†].
	 
	2.8	 	Transfer of Antibodies. During the Research Term or upon completion of the Research Term or
any termination of this Agreement by Omeros for breach by Affitech,
Affitech shall assist Omeros and cooperate with transfer of the
scFv-format or IgG-format Final Candidate(s) to third party(ies)
designated by Omeros for further development and/or manufacture of
preclinical, clinical and commercial supplies of Affitech-Originated
MASP-2 Antibodies.
	 
	2.9	 	Development and Commercialization of Antibodies. Following receipt of one or more Final
Candidate(s) from Affitech, Omeros shall use Best Efforts to develop a Final Candidate for use in preclinical
and clinical investigation and subsequent commercialization of an Affitech-Originated MASP-2
Antibody; provided, however, that: (a) any delays or interruptions in Omeros’ activities or
efforts due to any regulatory processes, availability of compounds, materials or necessary
processes, the procurement of or disputes related to Intellectual Property Rights or licenses,
or funding and resource constraints; or (b) any delays or interruptions of less than [†],
shall not be deemed to be a failure of Omeros to exert Best Efforts under this Section 2.9.
	 
	3	 	Payments and Royalties
	 
	3.1	 	Payment Terms. As full and complete consideration for the Services and Deliverables under
the Initial Research Plan, all licenses, intellectual property and other rights conveyed, and
all obligations undertaken in accordance with this Agreement for the Initial Research Plan,
Omeros shall pay Affitech the amounts set forth in this Section 3 [†]. Affitech shall invoice
Omeros for each of the payments as it becomes due and payable, and Omeros shall make payments
for fees due and payable on a [†] from receipt of invoice basis.

 

			
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	 	 	a) Technology Access Fee. Omeros shall pay Affitech a fee of [†] (the “Technology Access
Fee”) upon execution of this Agreement for access rights during the Agreement Term, solely
for the purpose of making, using (including, without limitation, research, development and
commercialization) and selling [†] (as such terms are defined in Subsections 7.1 and 7.2(a)
below, respectively) and the license provided in Subsection 7.3 below to permit Omeros to
use, develop, commercialize, sell and distribute the Deliverables provided to Omeros under
the Initial Research Plan and any Additional Research Plan(s). The Technology Access Fee
shall be payable by Omeros [†] under the Initial Research Plan.
	 
	 	 	b) [†]. (i) Following completion of [†] Milestone I under the Initial Research Plan, [†],
Omeros shall pay Affitech a Milestone I fee of [†] (the “Milestone I Fee”). [†].
	 
	 	 	(ii) After payment of the Milestone I Fee, [†]. Following completion of the [†] Milestone I
criteria set forth in the Initial Research Plan, Omeros shall pay Affitech a fee of [†].
	 
		 	(iii) The Milestone I Fee, if the Milestone I Fee becomes due as provided for above in this
Section 3.1, shall be payable by Omeros [†] under the Initial Research Plan. The [†], shall
be payable by Omeros [†] under the Initial Research Plan.
	 
		 	c) [†]. Omeros shall pay Affitech a fee of [†] (the “Milestone II Fee”) upon [†] Affitech
has completed Milestone II under the Initial Research Plan, [†].
	 
	 	 	If one or more of the Milestone II criteria under the Initial Research Plan are [†].
	 
	 	 	The Milestone II Fee, if the Milestone II Fee becomes due as provided for above in this
Section 3.1, shall be payable by Omeros [†] under the Initial Research Plan.
	 
		 	d) [†]. If Omeros elects in writing, [†], to have Affitech [†], Omeros shall pay Affitech on
invoice upon receipt [†] of the [†] in conformity with Exhibit A, as set forth in the
following price schedule. [†], Omeros shall complete reasonable third party Intellectual
Property Rights diligence related to such [†] and shall secure for Affitech, or for Omeros
with a right to sublicense to Affitech, any third party license(s) that may be required for
Affitech to complete the Services and produce the Deliverables that are specific to such [†].

 

			
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	[†]

	 	Price
	 

	 	 
	[†]

	 	[†]
	[†]

	 	[†]
	[†]

	 	[†]
	[†]

	 	[†]
	[†]

	 	[†]
	[†]

	 	[†]

Upon Omeros’ written request to Affitech to provide [†].

e) Additional Services and Deliverables. Fees for any additional Services and Deliverables
not envisioned by the Initial Research Plan shall be as set forth in any Additional Research
Plan(s) and shall be determined on a per project basis.

f) Development Milestone Payments. Omeros shall pay Affitech the following [†] development
milestone payments (each a “Development Milestone Payment”) on invoice upon completion of the
associated development activity (each a “Development Milestone”) by Omeros or by a licensee
of Omeros. Omeros shall provide Affitech written notice of the completion of each Development
Milestone by Omeros or Omeros’ licensee within [†] of such Development Milestone completion.

	 	 	 
	Development Milestone	 	Development Milestone Payment
	[†]

	 	[†]
	[†]

	 	[†]
	[†]

	 	[†]
	[†]

	 	[†]
	[†]

	 	[†]
	[†]

	 	[†]

g) Royalties. Omeros shall pay Affitech a royalty as a percentage of Net Sales (the “Sales
Royalty”). [†], the Sales Royalty shall be [†] on Net Sales of [†] on Net Sales of [†]. [†]
shall be [†] on Net Sales of [†] on Net Sales of [†]. Sales Royalties shall be paid on a [†]
within [†] following the end of each [†] for Net Sales realized during such [†].

	3.2	 	Invoices. Affitech shall submit invoices to Omeros for payments, other than Sales Royalties
that have become due. The terms of payment are [†] after Omeros’ receipt of

 

			
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	 	 	Affitech’s invoice, or in the event that any invoice is disputed in good faith, [†] after
mutual agreement or other resolution is reached on the disputed invoice or receipt of a
corrected invoice. Invoices shall reference this Agreement and the relevant the Initial
Research Plan or Additional Research Plan (as applicable) and specify the milestone payment
or other fee that is being invoiced. Payment for Sales Royalties shall be made by Omeros
concurrent with delivery of the Net Sales reports specified in Subsection 4.1(a) herein
below.
	 
	 	 	Invoices shall be sent to Omeros by mail addressed to the following or subsequently updated
address:

Accounts Payable

Omeros Corporation

1420 Fifth Avenue, Suite 2600

Seattle, WA 98101

	 	 	Affitech shall provide and keep Omeros updated on invoice payment instructions, including
wire transfer information or the payee and address for checks.
	 
	3.3	 	Obligation to Pay Taxes. Payments under this Agreement shall be made in full in the agreed
amounts without deduction for taxes of any kind whatsoever. [†].
	 
	4	 	Reports; Records; Audits; Inspections
	 
	4.1	 	Reports and Record Maintenance.
	 
		 	a) By Omeros. Following the initial approval by a Regulatory Agency for the sale by Omeros
or a licensee of Omeros of a MASP-2 Therapeutic, Omeros shall provide Affitech with a Net
Sales report on a [†] setting forth the quantity of sales of MASP-2 Therapeutics, the gross
monetary amounts invoiced and collected by either Omeros or by a licensee of Omeros for the
initial distribution or sale of MASP-2 Therapeutics, and the total of all deductions provided
for in Subsection 1.9 herein above during such [†], within [†] following the end of each [†]
for Net Sales realized during such [†].
	 
		 	b) By Affitech. Within [†] of completion of each milestone, Affitech will provide [†],
relating to the achievement of the particular milestone. Within [†] of delivery to Omeros of
any Final Candidate(s), [†], Affitech shall provide to Omeros [†]. [†] after completion of
the Initial Research Plan and any Additional Research Plan(s) and thereafter, it will be the
responsibility of Omeros to maintain such Records and Materials. [†]. At any time during
which Affitech is [†] maintain such Records and Materials, if Omeros requests receipt of all
or any portion of Affitech’s copy of the Records and Materials, including upon termination of
the Agreement [†], Affitech shall send such Records and Materials to Omeros at Omeros’
reasonable expense.
	 
	4.2	 	Audit of Omeros Books. Affitech shall have the right to employ a certified public accountant
to review and reconcile the directly relevant accounting records and procedures of Omeros
solely as they relate to the determination of Sales Royalties, during reasonable business
hours and no more than [†] a year, and Omeros agrees to make available at

 

			
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	 	 	Omeros’ place of business all such directly relevant accounting records for that purpose
within [†] of written request by Affitech. The cost of such review shall be borne by
Affitech, unless it is found that Omeros under-paid [†] Sales Royalty for any [†] by an
amount of [†] or greater [†] during the term of this Agreement, in which case the cost of
such review shall be borne by Omeros.
	 
	4.3	 	Visits, Audits and Inspections. Omeros’ representatives may visit Affitech’s facilities at
reasonable times and with reasonable frequency during normal business hours to observe the
progress of the Services and Deliverables, within [†] of written request. Affitech shall
assist Omeros in scheduling and implementing such visits. During the visits, Omeros
representatives may examine all Records and Materials, facilities and equipment that pertain
to the Services and Deliverables, and any other relevant resources pertaining to the Initial
Research Plan and any Additional Research Plan(s), as well as any other audit reports prepared
by or on behalf of Affitech with respect to quality audits of such relevant resources. Omeros’
costs of such visit shall be borne by Omeros. If Affitech receives a request from any
Regulatory Agency to inspect any portion of Affitech’s facilities related to the performance
of the Services and Deliverables, Affitech shall notify Omeros in advance and provide Omeros
an opportunity, at Omeros’ effort and expense, to participate in such inspection, [†].
	 
	5	 	Samples
	 
	5.1	 	Use of Samples. Omeros shall transfer to Affitech the sufficient or requested quantities of
proteins, reagents and/or other materials involved in the Services as specified in the Initial
Research Plan and any Additional Research Plan(s) (“Omeros Samples”). Omeros shall provide all
pertinent information known to Omeros regarding the Omeros Samples to the extent necessary for
carrying out the Initial Research Plan and any Additional Research Plan(s). Affitech shall be
responsible for [†]. Affitech shall not use or analyze any Omeros Samples provided by Omeros
under this Agreement except as necessary to carry out the Initial Research Plan or any
Additional Research Plan(s) and shall not administer [†]. After completion of the Services,
Affitech shall either return the Omeros Samples to Omeros or dispose of the Omeros Samples,
upon written request by Omeros and at Omeros’ risk and expense. Affitech [†] of all Omeros
Samples or other compounds or materials used in the performance of the Services and shall [†]
of the Omeros Samples after delivery to Affitech.
	 
	5.2	 	Ownership of Samples. The Omeros Samples are and shall remain the sole property of Omeros
and nothing in this Agreement shall be construed as granting to Affitech, by implication or
otherwise, any right or license with respect to the Omeros Samples, or any patent or other
intellectual property rights with respect to the Omeros Samples, except as required to
complete the Services and generate the Deliverables, and Affitech shall not file applications
or otherwise seek any proprietary rights in respect of the Omeros Samples or any Confidential
Information (as that term is defined below in Subsection 6.1) that Omeros provides under this
Agreement.

 

			
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	6	 	Confidentiality and Non-use
	 
	6.1	 	As used in this Agreement, “Confidential Information” shall mean any Omeros Samples, other
materials, data, research, development, manufacturing, marketing, financial, personnel, sales,
business, and other non-public, proprietary or technical information provided by a disclosing
Party (the “Disclosing Party”) to a receiving Party (the “Recipient”), including, without
limitation, all Deliverables, Records and Materials (which shall be considered Omeros’
Confidential Information even if generated or provided by Affitech), except any portion of
such information that the Recipient establishes:
	 
		 	a) is or becomes generally available to the public or within the industry to which such
information relates, other than as a result of a breach of this Agreement; or
	 
		 	b) is known by Recipient at the time of receipt of the Disclosing Party’s information, as
evidenced by Recipient’s contemporaneous written records; or
	 
		 	c) is provided to Recipient on a non-confidential basis by a third party who has the legal
right to make such disclosure; or
	 
		 	d) was or is independently developed by or for Recipient without access to or use of the
information of the Disclosing Party, as evidenced by Recipient’s contemporaneous written
records.
	 
	6.2	 	Obligations of Confidentiality and Non-use. Each Party agrees that the Disclosing Party has
and shall retain sole and exclusive rights of ownership of all Confidential Information
disclosed or owned by such Party. Each Recipient agrees that during the Agreement Term and for
[†] thereafter it will not use any Confidential Information of the Disclosing Party except for
the purposes of performing under this Agreement, unless otherwise agreed by the Parties in
writing. Each Recipient agrees not to disclose any Confidential Information of the Disclosing
Party to others (except to Recipient’s employees, consultants, professional advisors, agents
and Affiliates who reasonably require disclosure of such Confidential Information to achieve
the purposes of this Agreement and who are bound to the Recipient by like obligations as to
confidentiality and non-use no less stringent than those set forth herein) during the
Agreement Term and for [†] thereafter without the prior written consent of the Disclosing
Party. Affitech agrees that with respect to the Records and Materials, which are included in
Omeros’ Confidential Information, these obligations of non-use and confidentiality shall
subsist beyond [†] after the termination of this Agreement. Each Party agrees to maintain and
follow reasonable procedures to prevent unauthorized disclosure or use of the other Party’s
Confidential Information and to prevent it from becoming disclosed or being accessed by
unauthorized persons. Each Party agrees that it may disclose to authorized persons only such
Confidential Information of the Disclosing Party as is necessary for each such authorized
person to perform his/her responsibilities under this Agreement. Recipient shall advise the
Disclosing Party of any disclosure, loss, or use of Confidential Information of the Disclosing
Party in violation of this Agreement as soon as practicable. Each Party agrees to return or
destroy the Confidential Information of the other Party, whether in written, graphic,
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	 	 	tangible form, upon written request, provided, however, that legal counsel for each Party may
retain an archival copy of Confidential Information solely for purposes of ensuring
compliance with this Agreement.
	 
	6.3	 	Disclosure of this Agreement. The terms of this Agreement shall be considered each Party’s
Confidential Information, and accordingly except for disclosures expressly permitted under
this Agreement, neither Party may release any information to any third party regarding the
terms of this Agreement without the prior written consent of the other Party. Notwithstanding
the foregoing, the terms of this Agreement may be disclosed by Omeros or by Affitech to their
respective existing or potential investors, acquirers, merger partners, commercial partners,
shareholders, directors, officers and professional advisors as long as such individuals or
entities are subject to similar conditions of confidentiality.
	 
	6.4	 	Permitted Disclosures. Notwithstanding anything to the contrary, a Party may disclose
Confidential Information of the other Party, including, without limitation, the terms of this
Agreement, to the extent such disclosure is reasonably necessary: (a) to secure patent
protection for an Intellectual Property Right developed pursuant to this Agreement consistent
with the ownership provisions set forth in Section 7; (b) to comply with applicable laws or
regulations, the requirements of any Regulatory Agency or other regulatory or governmental
authority, including, without limitation, FDA, the US Securities and Exchange Commission, the
Federal Trade Commission and/or the Department of Justice, or judicial order from a court of
competent jurisdiction; or (c) as necessary for Omeros to conduct pre-clinical studies,
clinical trials, achieve the Overall Objective or to seek regulatory approval to market MASP-2
Therapeutics. Prior to making any such permitted disclosures, however, the Recipient shall
give reasonable advance notice to the Disclosing Party with as much detail as possible in
relation to the disclosure. Each Party agrees that it shall cooperate fully and in a timely
manner with the other Party with respect to all such permitted disclosures, including
determining what information should be released and requests for confidential treatment of
Confidential Information of either Party included in any such disclosure where possible;
provided that in no event shall a Party be required to delay any filing or release
unreasonably hereunder.
	 
	6.5	 	Remedies. Because of the unique nature of the Confidential Information, each Recipient
acknowledges and agrees that the Disclosing Party may suffer irreparable injury if the
Recipient fails to comply with the obligations set forth in this Section 6, and that monetary
damages may be inadequate to compensate the Disclosing Party for such breach. Accordingly,
each Recipient agrees that the Disclosing Party will, in addition to any other remedies
available to it at law, in equity or otherwise, without the requirement to post a bond, be
entitled to seek injunctive relief and/or specific performance to enforce the terms, or
prevent or remedy the violation, of this Section 6. This provision shall not constitute a
waiver by either Party of any rights to damages or other remedies which it may have pursuant
to this Agreement or otherwise.

 

			
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	7	 	Intellectual Property; Licenses and Protection
	 
	7.1	 	Pre-existing Intellectual Property. Except as expressly provided in this Section 7, neither
Party shall, as a result of this Agreement, acquire any right, title, or interest in any
Intellectual Property Rights that the other Party owned, licensed or controlled as of the
Effective Date of, or that the other Party obtains ownership, license or control of separate
and apart from the performance of, this Agreement (each Party’s “Pre-existing Intellectual
Property”).
	 
	7.2	 	New Intellectual Property
	 
		 	a) Affitech shall own all right, title and interest in “New Affitech Intellectual Property”,
which shall mean Intellectual Property Rights that Affitech develops, conceives, invents,
reduces to practice or makes in the course of performance under this Agreement that is
directed to subject matter of general applicability to the current business of Affitech or
[†].
	 
		 	b) Omeros shall own all right, title, and interest in (a) the MASP-2 Antibody Patents, (b)
all Intellectual Property Rights that either Party, solely or jointly with others, develops,
conceives, invents, reduces to practice, improves, or makes in the course of performance
under this Agreement that is specific to: MASP-2; any inhibitor of MASP-2; any MASP-2
antibody or antibody fragment that binds to MASP-2 polypeptides or portions thereof,
including, without limitation, Affitech-Originated MASP-2 Antibodies; any pharmaceutical or
biological therapeutic for the inhibition of MASP-2, including, without limitation, any
MASP-2 Therapeutic; any methods or processes for manufacturing, formulating or packaging any
MASP-2 antibody or antibody fragment that binds to MASP-2 polypeptides or portions thereof,
including, without limitation, Affitech-Originated MASP-2 Antibodies; any methods or
processes for manufacturing, formulating or packaging MASP-2 Therapeutics; and any method of
treatment by inhibiting MASP-2, and (c) any and all other Intellectual Property Rights,
excluding the New Affitech Intellectual Property (collectively, the “New Omeros Intellectual
Property”). [†] of the New Omeros Intellectual Property, and any documents required to apply
for, maintain and enforce any patents or other rights in the New Omeros Intellectual
Property. Upon Omeros’ request and at Omeros’ reasonable expense, and [†] in the New Omeros
Intellectual Property. Omeros shall use [†] to file and prosecute patent applications and
maintain patents, where issued, which patent applications and patents include claim(s) that
read on the Affitech-Originated MASP-2 Antibodies and/or MASP-2 Therapeutics in: a)
countries or territories that are [†], and in b) other countries or territories that Omeros
may, in the exercise of its reasonable judgment and discretion, consider to represent [†] for
such [†], taking into additional consideration [†] prior to filing of such applications or to
prosecuted such patent applications or maintain such patents, if issued, in a country or
territory in which there is a [†].
	 
		 	c) Upon termination of this Agreement, Affitech shall not use or have used the Omeros Samples
in the production of such MASP-2 antibodies and such MASP-2 antibodies shall not include [†]
delivered to Omeros under this Agreement. [†].

 

			
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	7.3	 	[†].
	 
	7.4	 	Field Exclusivity. [†]
	 
	7.5	 	Limitation for Breach of Best Efforts to Develop. If during the term of this Agreement
(a) Omeros advises Affitech in writing, in response to a query from Affitech, that Omeros has decided to permanently abandon all development of Affitech-Originated MASP-2
Antibodies, (b) Omeros provides Affitech written notice that Omeros has expressly abandoned all development of Affitech-Originated MASP-2 Antibodies or (c) Omeros materially
breaches its obligation to use Best Efforts for development under Subsection 2.9 above, Affitech shall have the right to provide Omeros notice that Affitech intends to produce
and/or develop MASP-2 therapeutics for Affitech’s benefit or for third parties. Upon receipt by Omeros of such notice, the restrictions on Affitech concerning field exclusivity
of Subsection 7.4 above shall terminate.

	 
	8	 	Term and Termination
	 
	8.1	 	Research Term. The research term of this Agreement during which Affitech is obligated to
provide Services begins on the Effective Date and, unless this Agreement is earlier terminated
as provided for below in this Section 8, will continue until Affitech’s completion of all
Services and delivery of all Deliverables described in the Initial Research Plan and any
Additional Research Plan(s) (the “Research Term”).
	 
	8.2	 	Royalty Term. The royalty term of this Agreement during which Omeros is obligated to pay
Sales Royalties to the extent provided herein, unless this Agreement is earlier terminated as
provided for below in this Section 8, begins on the date of the first commercial sale of a
MASP Therapeutic and will continue until the point in time at which there are no patent
application(s) in the process of being prepared for filing, no pending patent applications and
no valid and enforceable claim included within any patent, utility model or inventor’s
certificate within (i) the MASP-2 Antibody Patents, (ii) Affitech’s Pre-existing Intellectual
Property that reads on any Affitech-Originated MASP-2 Antibody or any MASP-2 Therapeutic or
(iii) the New Affitech Intellectual Property that reads on any Affitech-Originated MASP-2
Antibody or any MASP-2 Therapeutic (the “Royalty
Term”). In the event Omeros decides not to file any patent
applications in one or more countries, the Royalty Term shall be 15
years from the first commercial sale of a MASP-2 Therapeutics.
	 
	8.3	 	Agreement Term. This Agreement, unless terminated earlier as provided for below in this
Section 8, begins on the Effective Date and continues in full force and effect until the end
of both the Research Term and the Royalty Term (the “Agreement Term”).
	 
	8.4	 	Survival. The provisions of Subsections and Sections 2.8, and Sections 5, 6, 7.1, 7.2, 8.6
and 9-14, and any payments and royalties due prior to termination to Affitech from Omeros
under Section 3, shall survive the Agreement Term.
	 
	8.5	 	Termination for Cause or Futility. Either Party may terminate this Agreement at any time in
the event that the other Party breaches any material obligation of this Agreement by first
submitting written notice of breach to the breaching Party, which breach is not substantially
cured within ninety (90) days of the receipt of such notice, followed by written notice of termination then
being sent to the breaching Party. Additionally, Omeros may terminate
this Agreement for cause if the Final Candidate(s) delivered to
Omeros are not patentable. Additionally, if despite Affitech’s
Best Efforts including, without limitation, the completion of the [†], Affitech is unable to identify even one suitable
scFv format First Generation Candidate, Affitech shall have the right to terminate this
agreement for futility due to exhaustion of its library.
	 
	8.6	 	Termination By Omeros Without Cause; Intellectual Property Reversion. Prior to Omeros’
payment of the Technology Access Fee, Omeros may terminate this Agreement without cause by
providing Affitech thirty (30) days advance written notice to Affitech but shall remain

 

			
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	 	 	obligated to pay the Technology Access Fee. Following
payment of the Technology Access Fee but before
Affitech’s delivery of the First-Generation Candidates, Omeros may terminate this
Agreement without cause by providing Affitech thirty (30) days
advance written notice to Affitech but shall remain
obligated to pay the Milestone I Fee. Following payment
of the Milestone I fee, upon request by Omeros for
Affitech to undertake an [†], but before delivery of
any First-Generation Candidates identified by such [†], Omeros may terminate this
Agreement but shall remain obligated to pay the [†]. After
payment of the Milestone I Fee but prior to Omeros’
requesting Affitech to proceed with affinity maturation, Omeros may,
without the payment of any additional fees other than
for any completed IgG conversion and production and/or the
[†], if applicable, terminate this
Agreement without cause by providing Affitech thirty (30) days
advance written notice to Affitech. Following Omeros’
request for Affitech to commence affinity maturation of First
Generation Candidates under the Initial
Research Plan but before Affitech’s delivery of the Final
Candidates,
Omeros may terminate this Agreement without cause by
providing Affitech thirty (30) days advance written notice to
Affitech but shall remain obligated to pay the
Milestone II Fee. After Omeros has requested Affitech
to generate IgG Candidate, Omeros may terminate this agreement,
but shall remain obligated to pay IgG Candidate price for the
particular amount requested as detailed in the table in
Section 3.1(d). In addition, if Omeros terminates this
Agreement under this Subsection 8.6 or under Subsection
8.5 other than due to breach by Affitech, but not if
Omeros terminates this Agreement for cause under
Subsection 8.5 due to breach by Affitech, neither
Omeros nor Affitech shall use any of the
Affitech-Originated MASP-2 Antibodies or Records and
Materials generated under this Agreement to file or
cause to be filed any patent applications claiming the
Affitech-Originated MASP-2 Antibodies, MASP-2
Therapeutic compositions, or methods or processes for
manufacturing, formulating or packaging
Affitech-Originated MASP-2 Antibodies or MASP-2
Therapeutic compositions, and each party shall destroy
all Omeros Samples (if held by Affitech), antibodies,
antibody fragments, clones, expression constructs or
other materials in its possession that were provided or
generated under this Agreement.

	 
	9	 	Representations and Warranties
	 
	9.1	 	Authority. Each Party represents and warrants that it has full power and authority to
execute, deliver and perform this Agreement, and that the terms of this Agreement do not
conflict with any other contractual agreement or obligation to which it is a Party.
	 
	9.2	 	Intellectual Property. Affitech represents and warrants that:

	 	a)	 	[†]
	 
	 	b)	 	[†]
	 
	 	c)	 	[†]

	9.3	 	No Other Warranties. EXCEPT AS EXPRESSLY SET FORTH HEREIN, NEITHER PARTY MAKES ANY
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY OF THE
IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SAFETY, EFFICACY AND
NONINFRINGEMENT REGARDING THE OMEROS SAMPLES, THE DELIVERABLES, THE AFFITECH-ORIGNATED MASP-2

 

			
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	 	 	ANTIBODIES, THE MASP-2 THERAPEUTICS, METHODS OF DISCOVERING OR
MANUFACTURING SAID ANTIBODIES OR THERAPEUTICS OR ANY OTHER
SUBJECT MATTER OF THIS AGREEMENT.
	 
	10	 	Indemnification; Limitation of Liability
	 
	10.1	 	Indemnification. Each Party (the “Indemnifying Party”) shall indemnify, defend and hold
harmless the other Party, its affiliates, subsidiaries, officers, directors, employees,
consultants, and agents (collectively the “Indemnitees”) from any and all liability, loss
(including reasonable attorneys’ fees) or damage any of them may suffer as the result of
claims, demands, costs or judgments against them by unaffiliated third parties (collectively
“Claims”) that arise from the Indemnifying Party’s breach of any of its obligations,
representations, covenants and warranties under this Agreement, or the Indemnifying Party’s
negligent act or omission, willful misconduct or unlawful act, except and to the extent that
such Claims result from the breach by any Indemnitee of any of the Indemnitees’ obligations,
representations, covenants and warranties under this Agreement or any of the Indemnitees’
gross negligence, willful misconduct or unlawful act.
	 
	 	 	Omeros shall indemnify, defend and hold harmless Affitech, its affiliates, subsidiaries,
officers, directors, employees, consultants, and agents from any and all Claims arising
directly from infringement by Affitech of third party Intellectual Property Rights due solely
to Affitech’s [†], which third party Intellectual Property Rights are specific to such [†]
and excluding any Claims that would have arisen if Affitech had [†].
	 
	10.2	 	Procedure. In the event that any third party claim, action or suit is instituted against an
Indemnitee in respect of which indemnity may be sought pursuant to Subsection 10.1, the
Indemnitee will promptly notify the Indemnifying Party in writing (provided that the failure
to give such notice promptly will not prejudice the rights of an Indemnitee, except to the
extent that the failure to give such prompt notice materially adversely affects the ability of
the Indemnifying Party to defend the claim, action or suit). Promptly after the Indemnitee
gives such written notice, the Indemnifying Party and the Indemnitee shall meet to discuss how
to respond to such claim, action or suit. The Indemnifying Party shall control the defense of
such claim, action or suit. The Indemnitee shall cooperate with the Indemnifying Party in the
defense of such claim, action or suit, at the expense of the Indemnifying Party. In any such
proceeding, the Indemnitee shall also have the right to retain its own counsel at its own
expense. The Indemnifying Party shall not be liable for damages with respect to a claim,
action or suit settled or compromised by the Indemnitee without the Indemnifying Party’s prior
written consent. No offer of settlement, settlement or compromise by the Indemnifying Party
shall be binding on an Indemnitee without the Indemnitee’s prior written consent (which
consent shall not be unreasonably withheld, conditioned or delayed), unless such settlement
fully releases the Indemnitee without any liability, loss, cost or obligation to such
Indemnitee, provided, however, that the Indemnifying Party shall have no authority to take any
action as part of any such defense or settlement that invalidates or otherwise compromises or
renders unenforceable any of

 

			
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	 	 	the Indemnitees’ Intellectual Property Rights without the Indemnitees’ express prior written
consent.
	 
	10.3	 	Limitation of Liability. Without limitation of any Party’s obligations to indemnify third
party Claims under Subsection 10.1, neither Party shall be liable for any indirect,
consequential, exemplary or incidental damages arising under or in association with this
Agreement, except for any such liability arising from fraud by the Party or from any breach of
the Party’s obligations regarding Confidential Information or Intellectual Property Rights
under this Agreement.
	 
	11	 	Insurance
	 
	 	 	Omeros shall procure and maintain during the Agreement Term and for a minimum period of [†]
thereafter, product liability insurance in an amount not less than [†] in the annual
aggregate and each of Affitech and Omeros shall procure and maintain during the Research Term
and for a minimum period of [†] thereafter commercial general Liability including premises
operations, blanket contractual liability, personal injury and advertising injury including
fire legal liability for bodily injury and property damage in an amount not less than [†] (or
monetary equivalent of each above sum based on prevailing currency exchange rates). Each
Party shall include the other Party and its subsidiaries, affiliates, directors, officers,
employees and agents as additional insureds with respect to the respective insurance
coverages set forth above. Each Party shall make available to the other Party, at such other
Party’s request, evidence of its maintenance of insurance in satisfaction of its obligations
under this Section 11.
	 
	12	 	Use of Names
	 
	 	 	Except as may be required by law or regulation after first providing reasonable advance notice
to the other Party, neither Party may use the other Party’s name in any promotional,
advertising or other materials without the prior written consent of the other Party. Affitech
hereby consents to Omeros’ disclosure of Affitech’s name in connection with the provision of
the Services and the Deliverables under this Agreement to Omeros’ current and potential
employees, consultants, directors, shareholders, investors and partners, and to any Regulatory
Agency or other regulatory authority including, without limitation, FDA and the US Securities
and Exchange Commission.
	 
	13	 	Notices
	 
	 	 	Any notice required or permitted to be given hereunder by either Party shall be in writing
and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested,
postage prepaid, (c) sent by an internationally recognized courier service guaranteeing
next-day delivery, charges prepaid, or (d) delivered by facsimile (with the original promptly
sent by any of the foregoing manners) to the address or facsimile number of the other Party
set forth below, or at such other address as may from time to time be furnished by notice by
either Party. The effective date of any notice hereunder shall be the date of receipt by the
receiving Party.

 

			
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	 	If to Omeros:
	 	If to Affitech:
	 
	 	 	 	 
	 

	 	Omeros Corporation
	 	Affitech AS
	 

	 	1420 Fifth Avenue
	 	Oslo Research Park
	 

	 	Suite 2600
	 	Gaustadalléen 21
	 

	 	Seattle, WA 98101
	 	N-0349 Oslo
	 

	 	U.S.A.
	 	Norway
	 
	 	 	 	 
	 

	 	Attention: CEO
	 	Attention: CEO
	 

	 	And copy to: General Counsel	 	 
	 
	 

	 	Fax: 206.676.5005
	 	Fax: +47 22 95 83 58
	 

	 	Phone: 206.676.5000
	 	Phone: +47 22 95 87 58
	 
	 	 	 	 
	 

	 	 	 	And a copy to:
	 

	 	 	 	Affitech USA, Inc.
	 

	 	 	 	2855 Mitchell Drive, Suite 106
	 

	 	 	 	Walnut Creek, CA 94598
	 

	 	 	 	USA
	 

	 	 	 	Attention: President
	 
	 	 	 	 
	 

	 	 	 	Fax: 925.465.7059
	 

	 	 	 	Phone: 925.465.7058

	14	 	Miscellaneous
	 
	14.1	 	Integration. This Agreement including the Initial Research Plan and any Additional Research
Plan(s), appendices and exhibits attached thereto or incorporated by reference therein
constitutes the entire understanding of the Parties hereto regarding the subject matter of
this Agreement, and no other representation, agreement, promise or undertaking altering,
modifying, taking from or adding to the terms of this Agreement shall have any effect unless
the same is reduced to writing and duly executed by the Parties hereto. In the event of any
conflict between the main body of this Agreement and any attachments thereto or documents
incorporated by reference therein, the provisions of the main body of this Agreement shall
control.
	 
	14.2	 	No Waiver. Either Party’s failure to enforce any provision of this Agreement will not be
considered a waiver of future enforcement of that or any other provision.
	 
	14.3	 	Governing Law. The laws of the state of California, United States, without regard to its
conflict-of-laws provisions, shall govern this Agreement, its interpretation and its
enforcement, and any disputes arising out of or related to this Agreement.
	 
	14.4	 	Arbitration. The Parties agree that, except as provided herein below, any claim or
controversy arising out of or relating to this Agreement or breach thereof shall be settled by
arbitration in the state of California, United States, in accordance with the commercial rules of

 

			
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	 	 	the American Arbitration Association by a panel of three arbitrators, one selected by each
Party and the third selected by the other two arbitrators. In any such arbitration
proceeding, judgment upon the award rendered by the arbitrator shall be final and binding
upon the Parties and may be entered by either Party in any court or forum of competent
jurisdiction as provided herein below. Notwithstanding the foregoing, both Parties agree that
any claims or controversies concerning the infringement, validity or enforceability of any
Intellectual Property Rights, or the actual or threatened disclosure or misuse of any
Confidential Information, may alternately be resolved by a civil action in the court of
competent jurisdiction specified in Subsection 14.5 herein below, and both Parties further
agree that each shall retain the right to seek injunctive relief in the court of competent
jurisdiction specified in Subsection 14.5 herein below to prevent a breach, threatened breach
or continuing breach of this Agreement that would cause irreparable injury, including,
without limitation, breaches of confidentiality, infringement of Intellectual Property Rights
or breach of Subsection 7.4 herein above [†].
	 
	14.5	 	Jurisdiction and Venue. Any civil action prosecuted or instituted by either Party as
permitted herein above with respect to any matters arising out of or related to this Agreement
shall be brought in either the United States District Court located in the state of California,
United States (if federal subject matter jurisdiction therein lies) or the Superior Courts in
the state of California, United States (only if there is no subject matter jurisdiction in federal
court), and each Party hereby consents to the exclusive jurisdiction and venue of such courts
for such purposes.
	 
	14.6	 	Attorney’s Fees. In the event that it is
necessary for either Party to take legal action to enforce any of the terms, conditions or rights contained herein, or to defend any such action,
then the prevailing Party in such action shall be entitled to recover from the other Party all
reasonable attorneys fees, costs and expenses related to such legal action.
	 
	14.7	 	Severability. In the event that any portion of this Agreement is held invalid or
unenforceable by a court of law, that provision will be construed and reformed to permit
enforcement of the provision to the maximum extent permissible consistent with the Parties’
original intent, and if such construction is not possible, such provision shall be struck from
this Agreement, and the remainder of the Agreement shall remain in full force and effect as if
such provision had never been part of this Agreement.
	 
	14.8	 	Independent Contractors. For the purposes of this Agreement, the Parties hereto are
independent contractors, and nothing in this Agreement shall be construed to place them in the
relationship of partners, principal and agent, employer/employee or joint venturers. Except as
provided expressly herein, each Party agrees that it shall have no authority to bind or
obligate the other Party, nor shall any Party hold itself out as having such authority.
	 
	14.9	 	Force Majeure. Neither Party will be liable for failure or delay in performing any
obligation under this Agreement, or will be considered in breach of this Agreement, if such
failure or delay is due to a natural disaster or any cause reasonably beyond such Party’s
control, provided that such Party resumes performance as soon as possible following the

 

			
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	 	 	end of the event that caused such delay or failure of performance.
	 
	14.10	 	Assignment. Neither Party may assign this Agreement, or any obligation or right under this
Agreement, in whole or in part, without the other Party’s prior written consent, which consent
will not be unreasonably withheld. This Section shall not be construed in any way to limit
Omeros’ rights to grant, at Omeros’ sole discretion, sublicenses hereunder. Affitech hereby
consents to Omeros’ assignment of this Agreement in whole or in part to any successor in
interest to Omeros as part of a merger, acquisition, other change of control or together with
a sale, transfer or other conveyance of all or substantially all of that part of Omeros’
assets that pertain to this Agreement. Each Party’s obligations and rights under this
Agreement will be binding upon and will inure to the benefit of the Parties’ permitted
successors and assignees.
	 
	14.11	 	Counterparts. This Agreement may be executed in one or more counterparts, each of which
will be considered an original, and all of which will constitute the same instrument.

This Agreement is accepted and acknowledged by each Party through the signature of its authorized
representative below:

	 	 	 	 	 	 	 	 	 
	AFFITECH AS	 	 	 	OMEROS CORPORATION
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Martin Welschof
 

	 	 
	 	By:
	 	/s/ Gregory A. Demopulos
 
 
	Name:

	 	Martin Welschof, Ph.D.
	 	 	 	Name:
	 	Gregory A. Demopulos, M.D.
	 
	 	 	 	 	 	 	 	 
	Title:

	 	Chief Executive Officer
	 	 	 	Title:
	 	Chairman & CEO
	 
	 	 	 	 	 	 	 	 
	Facsimile:

	 	 +47 22 95 83 58
	 	 	 	Facsimile:
	 	 206 676 5005

 

			
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Exhibit A to

Omeros Corporation

AGREEMENT FOR ANTIBODY DEVELOPMENT SERVICES

Initial Research Plan

July 25, 2008

 

			
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Exhibit A (attached to Agreement for Antibody Discovery and Development)

July 25, 2008

Omeros-Affitech — Initial Research Plan

to Isolate Human Antibodies against MASP-2

	 	 	 
	1. Goal:

	 	To generate high-affinity human antibodies specific for human MASP-2 with functional
blocking activity, as evidenced by their ability to inhibit activation of the complement
system through the lectin pathway.
	 
	 	 
	2. Required functionality:

	 	[†].
	 
	 	 
	 

	 	[†].
	 
	 	 
	 

	 	[†].
	 
	 	 
	3. Required specificity profile:

	 	[†].
	 
	 	 
	 

	 	[†].
	 
	 	 
	4. Required cross-reactivity profiles:
	 
	 	 
	 

	 	[†].
	 
	 	 
	 

	 	[†].
	 
	 	 
	5. Technical Considerations
	 	 
	 
	 	 
	5.1 [†].
	 	 

 

			
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5.2 Reagents to be delivered to Affitech by Omeros:

     [†].

     [†].

     [†].

     [†].

     [†].

     [†].

5.3 Assays:

     Assays to be run at Affitech:

     [†].

     [†].

     [†].

     [†].

     [†].

     Assays to be run at Omeros:

     [†].

     [†].

     [†].

5.4 [†]:

     [†].

     [†].

     [†].

     [†].

5.5 [†]:

 

			
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     [†].

5.6 [†]:

     [†].

5.7 [†]:

     Affitech shall exert [†] to generate one or more of the [†].

     If Omeros elects to have Affitech complete optional [†].

5.8 [†]:

     [†].

     [†].

6. Deliverables:

     Milestone-I:     Following completion of [†].

     Milestone-II:    [†].

     If Omeros elects and directs Affitech in writing to have Affitech complete [†].

     Deliverable data and reagents: [†].

7. Timelines for Arriving at Specific Milestones at Affitech:

     Milestone I: [†].

     [†].

     Milestone II: [†].

     [†].

Summary Research Plan

	 	 	 	 	 	 	 	 	 
	Items	 	Main task	 	Sub tasks	 	Deliverables	 	Timeline
	1

	 	Protocol development.
	 	 	 	 	 	[†]

 

			
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The above research plan is accepted and acknowledged by each Party through the signature of its
authorized representative below, and is effective as of this 25th day of July, 2008.

	 	 	 	 	 	 	 	 	 	 	 
	AFFITECH AS	 	 	 	OMEROS CORPORATION	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Martin Welschof
 

	 	 	 	By:
	 	/s/ Gregory A. Demopulos
 

	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name: Martin Welschof, Ph.D.	 	 	 	Name: Gregory A. Demopulos, M.D.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title: Chief Executive Officer	 	 	 	Title: Chairman & CEO	 	 

 

			
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Exhibit B to

Omeros Corporation

AGREEMENT FOR ANTIBODY DEVELOPMENT SERVICES

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Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00163-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00163-of-00352.parquet"}]]