Exhibit 10.1

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MASTER

SERVICES

AGREEMENT

between

LONZA BIOLOGICS TUAS PTE LTD

and

OMEROS CORPORATION

 

 

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DISCLOSED

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THIS AGREEMENT is made on the 28th day of July 2019 (the “Effective Date”)

BETWEEN

1. LONZA BIOLOGICS TUAS PTE LTD, of 35 Tuas South Ave 6, SG Singapore 637377
(“Lonza”) and

2. OMEROS CORPORATION, of 201 Elliott Avenue West, Seattle, WA 98119, USA
(“Omeros”).

Omeros and Lonza are hereinafter also collectively referred to as the “Parties”
and each individually also as a “Party”.

WHEREAS

A. Omeros is the proprietor of the human IgG known as narsoplimab (OMS721), an
antibody that binds to and inhibits MASP-2; and

B. Lonza and its Affiliates have the expertise in the production of monoclonal
antibodies for therapeutic use;

C. Omeros wishes to contract Lonza for the Launch and commercial supply of
narsoplimab and for related support Services, as described in this Agreement;
and

D. Lonza is prepared to perform such Services for Omeros on the terms and
conditions set out herein.

NOW IT IS AGREED AS FOLLOWS:

1. Definitions and Interpretation

The following terms shall have the following meanings unless the context
requires otherwise:

 

 

“Affiliate”

means any Company, partnership or other entity which directly or indirectly
Controls, is Controlled by or is under common Control with the relevant Party to
this Agreement.

“Agreement”

means this agreement incorporating all Appendices and Schedules as amended or
varied from time to time by written agreement of the Parties.

“Applicable Laws”

means all applicable laws, including relevant federal, state and local laws,
statutes, rules, and regulations which are applicable to a Party’s activities in
the Territory hereunder, including, without limitation, the applicable
regulations and guidelines of any Governmental Authority, Food and Drug
Administration (FDA) and EMA (European Medicines Agency) and all applicable cGMP
together with amendments thereto, all of the clauses required to be inserted
into this Agreement as set forth in U.S. Federal Acquisition Regulations (FAR)
52.244-6 that are applicable to Lonza for Manufacturing Services at the
Facility, which shall be deemed to be inserted herein,  and the United States
Foreign Corrupt Practices Act and the UK Bribery Act 2010.

 

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“Approval”

means marketing approval by the FDA or the EMA, of Product manufactured at the
Facility for commercial supply and the date of first Approval shall be the date
on which the earliest of these approvals occurs (hereinafter “First Approval"),
but excludes any authorizations for limited distribution, use or sale of Product
on an early access, expanded access or compassionate use basis in advance of
authorization to broadly market the Product.

“Batch”

means the total Product obtained from one (1) fermentation and associated
purification using the Process, which fermentation and purification will be
carried out in accordance with cGMP unless otherwise agreed and specified in a
SOW.

“Binding Order”

has the meaning given to it in Clause 6 3.2.

“Biosimilar”

means [***].

“Campaign”

means a series of cGMP Batches at the Facility.

"Cell Line"

means the Omeros Cell Line used by Lonza to express Product specified in
Specifications Document, and any clones or derivatives thereof.

 

For the purposes of this Agreement, "Omeros Cell Line" means a cell line
provided by Omeros and any clones or derivatives thereof, used by Lonza to
express Product specified in the Specifications Document.

“Certificate of Analysis”

means a document prepared by Lonza listing and certifying the tests performed by
Lonza or approved external laboratories, the Specifications and test results.

“Certificate of Compliance”

means a document prepared by Lonza: (i) listing the manufacturing date, unique
Batch number, and concentration of Product in such Batch, (ii) certifying that
such Batch was manufactured in accordance with the Master Batch Record and,
unless otherwise specified in a SOW for development work, cGMP.

“cGMP”

means those laws and regulations applicable in the U.S. and Europe, relating to
the manufacture of medicinal products for human use, including, without
limitation, current good manufacturing practices as specified in the ICH
guidelines, including without limitation, ICH Q7A “ICH Good Manufacturing
Practice Guide for Active Pharmaceutical Ingredients”, US Federal Food Drug and
Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the Guide to Good
Manufacturing Practices for Medicinal Products as promulgated under European
Directive 91/356/EEC, 2003/94/EC, as amended, and 2001/83/EC, as amended.  For
the avoidance of doubt, Lonza’s operational quality standards are defined in
internal cGMP policy documents as will be further detailed in the Quality
Agreement (as such term is defined in Clause 2.14 herein).

 

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“cGMP Product”

means Product that is required under this Agreement or a SOW to be manufactured
in accordance with cGMP; for purposes of clarity, all Product manufactured under
this Agreement or a SOW shall be manufactured under cGMP unless expressly agreed
otherwise in a SOW for development work.

“Commencement Date”

means the date of removal of the vial of cells from frozen storage for the
production of a Batch.

“Competing Contract Manufacturer”

shall mean any Third Party who, together with its Affiliates, undertakes or
performs more than fifty per cent (50%) of their business as a Third Party
manufacturer of monoclonal antibodies and/or therapeutic proteins or any product
of a similar nature to which this Agreement relates.

“Control”

means the ownership of more than fifty percent (50%) of the issued share capital
or the legal power to direct or cause the direction of the general management
and policies of the Party in question.

“Development Agreement”

means the Master Services Agreement between the Parties dated 1 October 2015 and
as subsequently amended, inclusive of the Reservation Letter dated 11 August
2017.

“Deliver”, “Delivered” or “Delivery”

has the meaning given to it in Clause 5.

“Extension Term”

has the meaning given to it in Clause 12.1.1.

"External Laboratories"

means any Third Party instructed by Lonza, only with Omeros’ advance written
consent, to conduct activities required to complete the Services, including but
not limited to, third parties that synthesise DNA or perform tests on the Cell
Line, Product or materials derived therefrom.

“Facility”

means Lonza’s manufacturing facilities in [***], or such other Lonza facility as
may be mutually agreed upon in writing.

“Failure Notice”

has the meaning given to it in Clause 5.9.

“Forecast”

has the meaning given in to it in Clause 6.2.1.

“Latent Defect”

means a defect which may be present at Delivery but which cannot be detected at
the time of inspection as specified in Clause 5.9 despite diligent inspection by
Omeros and which is directly attributable to a breach of Lonza’s obligations
under this Agreement. Latent Defect shall exclude any failures due to
mishandling, improper storage or contamination of the Product by Omeros or Third
Parties after Delivery by Lonza.

“Launch”

means and shall be deemed to occur at such time that (i) the First Approval has
been obtained and (ii) the Product has been shipped for commercial sale by or on
behalf of Omeros to a wholesaler or hospital. Omeros shall provide notice of
such shipment to a wholesaler or hospital in writing to Lonza (such notice not
to be unreasonably delayed).  For the avoidance of doubt, Launch excludes any
shipment or sale of Product pursuant to authorizations

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for use, distribution or sale of Product on an early access, expanded access or
compassionate use basis.

“Intellectual Property”

means all patents, copyright, rights in designs, know-how, trade secrets, and
all other intellectual or industrial property rights, in each case whether
registered or unregistered and including applications or rights to apply for
them and together with all extensions and renewals of them, and in each and
every case all rights or forms of protection having equivalent or similar effect
anywhere in the world.

“Initial Term”

has the meaning given to it in Clause 12.1.

“IP-Respecting Entity”

means[***].

"Lonza Know-How"

means all technical and other information relating directly or indirectly, to
the Process and/or the performance of the Services known to Lonza from time to
time other than Omeros Information and information in the public domain.

"Lonza Patent Rights"

means all inventions, patents and patent applications of any kind throughout the
world relating to the Process which from time to time Lonza is the owner of or
is entitled to use, which for purposes of clarity shall not include inventions,
patents and patent applications related to the Process to the extent specific to
the Product and not generally applicable to other products.

“Master Batch Record”

means the document, proposed by Lonza and approved by Omeros, which defines the
manufacturing methods, test methods and other procedures, directions and
controls associated with the manufacture and testing of Product.

“Minimum Campaign”

has the meaning given to it in Clause 6 1.1.

“Minimum Exclusivity”

has the meaning given to it in Clause 4.5.

“Minimum Order”

has the meaning given to it in Clause 6 1.2.

“New General Intellectual Property”

has the meaning given to it in Clause 8.2.

“New Omeros Intellectual Property”

has the meaning given to it in Clause 8.3.

"Omeros Information"

means all technical and other information that was not known to Lonza
independently of Omeros and this Agreement, or that is generated by Lonza for
Omeros during the performance of Services under this Agreement, relating to the
Product, the Omeros Cell Line, to the extent specific to the Product, from time
to time supplied by Omeros to Lonza or generated by Lonza during the term of
this Agreement and excluding any  Lonza Know-How, Lonza Patent Rights and New
General Application Intellectual Property.

"Omeros Materials"

means the materials supplied by Omeros to Lonza (if any) and identified as such
in a Specifications Document hereto or any SOW or otherwise demonstrated by
substantial written evidence to have been provided by Omeros.

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“Omeros Patent Rights”

means all inventions, patents and patent applications of any kind throughout the
world relating to the Product and improvements or modifications thereof, the
Omeros Cell Line and improvements or modifications thereof, the Process to the
extent specific to the Product, excluding the Lonza Patent Rights, or Lonza
Know-How and New General Application Intellectual Property.

"Price"

means the price specified in (i) a SOW for the Services other than Batch
manufacture or (ii) a Binding Order in accordance with Schedule 1 for
manufacture of Batches.

"Process"

means the production process for the manufacture of the Product from the Cell
Line, including any improvements or modifications thereto from time to time.

 

For the purposes of this Agreement, "Omeros Process" means a Process provided by
Omeros for the production of the Product from the Omeros Cell Line, inclusive of
adaptations of such process by Lonza to substitute animal components (e.g.,
amino acids) with non-animal components, and shall, to the extent applicable, be
subject to Clause 8.4 below, and "Lonza Process" means a Process provided by or
developed by Lonza for the production of Product from the Omeros Cell Line using
inter alia Lonza-proprietary media and feeds.

"Product"

means Omeros’ proprietary narsoplimab (OMS721) antibody to MASP-2 product
manufactured using the Process (including any test sample thereof), particulars
of which are set out in the Specifications Document and includes all derivatives
thereof.

“Proprietary Feed License”

has the meaning given to it in Clause 2.8.

“Purchase Order”

means a purchase order placed by Omeros for the production and delivery of
Batches or other Services.

“Quality Agreement”

has the meaning given to it in Clause 2.12.

“Raw Materials”

means those materials procured by Lonza and including those filters and other
consumables as required and used by Lonza in the production of the Product at
the Facility.

“Raw Materials Fee”

means the procurement and handling fee of [***] of the acquisition cost of Raw
Materials by Lonza that is charged to Omeros in addition to the cost of such Raw
Materials (excluding Resins, which are not subject to a handling fee).

“Recall”

has the meaning given to it in Clause 5.13.

“Regulatory Authority(ies)”

means the FDA, EMA, European national regulatory authorities, and any other
similar regulatory authorities as may be agreed upon in writing by the Parties.

“Release”

has the meaning given to it in Clause 5.1.

"Resins"

means the purification Resins, UF membranes and any other materials that are
used across multiple Batches as part of the provision of Services.

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"Services"

means all or any part of the services performed by Lonza (including, without
limitation, cell culture evaluation, purification evaluation, master, working
and extended cell bank creation, Processing and sample and bulk production of
the Product), particulars of which are set out in one or more SOWs.

"Specifications"

means all written requirements, standards, quality control testing and other
data for Product, particulars of which are set out in Specifications Document.

“Specifications Document”

means the mutually agreed document setting out the requirements, standards,
quality control testing and other parameters for the Product, as may be amended
from time to time by written agreement of the Parties.

“Statement of Work” and SOW”

means a document setting out particular Services to be performed, including a
description of the Services to be performed, any agreed Price and terms of
payment for the Services to be performed, and any changes or additions to
previously agreed Specifications, which shall be incorporated into this
Agreement upon execution by authorized representatives of each Party. In the
event of any conflict between the provisions of this Agreement and the
provisions of any SOW, the provisions of this Agreement shall control except to
the extent that specific terms are expressly indicated in a SOW as superseding
terms of this Agreement.

“Supply Failure”

has the meaning given to it in Clause 6 6.1.

“Term”

has the meaning given to it in Clause 12.1.

“Termination Fee”

means the fees payable on termination in accordance with Clause 12.6.

"Terms of Payment"

means the terms of payment specified in this Agreement with respect to Purchase
Orders for Batches and the terms of payment specified in a SOW for other
Services. In the event of a conflict between the provisions of this Agreement
and the provisions of any Purchase Order or SOW, the provisions of this
Agreement shall control.

“Territory”

means [***] and any other additional territory(ies) for which Omeros provides
Lonza with reasonable prior written notice and subject to Lonza’s agreement that
it can support such additional territory(ies) (such agreement not to be
unreasonably withheld).

“Third Party”

means any party other than Omeros, Lonza and their respective Affiliates.

References to the singular number include the plural and vice versa, references
to Clauses and Schedules are references to clauses and schedules to this
Agreement.

2. Provision of the Services

2.1 (a)    Lonza shall itself and through its Affiliates, diligently carry out
the Services as provided in this Agreement and each SOW, and shall use
reasonable endeavours to perform the Services without defect and according to
the estimated timelines as set forth in this Agreement and each applicable SOW
or Binding Order. Lonza will, in accordance with the terms of this Agreement and
the Quality Agreement, manufacture at the Facility and Release to Customer, cGMP
Batches that comply with the Master Batch Record, cGMP and the Specifications,
and provide a corresponding Certificate of Analysis and Certificate of
Compliance for each such cGMP Batch.

2.1 (b)   Lonza shall retain appropriately qualified and trained personnel with
the requisite knowledge and experience to perform the Services in accordance
with this Agreement. Lonza may subcontract or delegate any portion of the
Services under this Agreement to a Third Party analytical laboratory or other
Third Party only with Omeros’ advance written approval, not to be unreasonably
withheld; provided, that any such subcontracted Third Party shall be subject to
the same obligations and other provisions contained in this Agreement and any
applicable SOW or Binding Order and Lonza shall be responsible for such

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subcontracted services, unless such subcontracted Third Party has been selected
by Omeros, in which case Lonza shall not be responsible for such subcontracted
services.

2.2         Lonza shall manufacture cGMP Product in accordance with the Master
Batch Record to meet the Specifications using the Omeros Cell Line, provided
that there shall be no such obligation to meet the Specifications in respect of
the [***] cGMP Batch manufactured following any material change in the Process
agreed to or requested by Omeros in writing, provided, however, that in such
cases Lonza shall still be required to use commercially reasonable efforts to
meet the Specifications and shall still comply with all Applicable Laws and
Lonza’s standard operating procedures.

2.3         The quantities of Product for Delivery set out in Purchase Orders
are estimates only, which quantities Lonza shall use commercially reasonable
efforts to meet. Promptly following First  Approval and the manufacture of  the
[***] cGMP Batch manufactured on or after [***] by Lonza for Omeros at each
facility at which Lonza manufactures Batches for Omeros, (not including batches
manufactured under the Development Agreement or other development batches), and
taking into account sampling from Batches, the Parties shall mutually determine
and agree in writing on target yield quantities and an acceptable range of yield
for future cGMP Batches along with associated pricing adjustments.

2.4         Without prejudice to Lonza’s obligations under Clauses 2.1 and 2.2,
Omeros shall be entitled to cancel any unfulfilled part of the Services or to
refuse to accept the Services on grounds of late performance or late delivery to
the extent specified within this Agreement.

2.5         Lonza shall perform the Services in compliance with this Agreement,
the applicable SOW, all Applicable Laws and Lonza’s standard operating
procedures applicable to the Services.

2.6         Lonza shall not use the Cell Line, the Omeros Process, Omeros Patent
Rights, Omeros Materials or Omeros Information (or any part thereof) [***] for
any purpose other than the performance of the Services for Omeros under this
Agreement. [***].

2.7          Lonza shall:

(a) at all times use commercially reasonable efforts to keep the Cell Line, the
Omeros Information and/or Omeros Materials secure and safe from loss and damage
in a commercially reasonable manner that is as rigorous as such manner as Lonza
stores its own material of similar nature;

(b) not part with possession of the Cell Line and/or Omeros Materials or the
Product or the Omeros Information, save for the purpose of activities at the
authorized External Laboratories or as otherwise authorised in writing by
Omeros; and

(c) ensure that all External Laboratories are subject to obligations of
confidence substantially in the form of those obligations of confidence imposed
on Lonza under this Agreement.

2.8         Omeros acknowledges and agrees that this Agreement is entered into
so that Lonza can provide the Services based on the options provided below:

(a)  Omeros Cell Line and Lonza Process.

Lonza shall provide notice to Omeros, and obtain Omeros’ consent, prior to the
incorporation into the Product or the Process of a material or process that
would require a license from Lonza or a Third Party, which notice shall include
the proposed license terms for such new material or process applicable to
technology transfer in accordance with Clause 12.8  but which, in the case of
any new material or process that requires a license from Lonza rather than a
Third Party, such license shall be royalty free for the Process during the Term
of this Agreement, but Omeros acknowledges that the terms of any license with
any such Third Party shall be subject to terms and price to be agreed between
Omeros and such Third Party..  If Omeros consents to such terms, the material or
process may be incorporated into the Product or the Process; if Omeros does not
consent to such terms, Lonza shall continue to manufacture the Product using the
Process without such incorporation. Omeros shall have the option to purchase
Lonza’s proprietary media and feeds from Lonza or a Third Party supplier. Lonza
agrees that it shall make available to Omeros a license for purchase of Lonza’s
proprietary feeds from Third Party suppliers or Lonza and to use the Lonza
Process in connection with nonclinical and in vivo human clinical research and
development, manufacture, marketing and sales and commercialization purposes (a
“Proprietary Feed License”).  For current and any future media and feeds, the
Proprietary Feed License shall be fully paid up and subject always to Clause
12.8, no royalties or other compensation owed other than as may be charged by
Third Party media and feed suppliers for supply of such current media and
feeds.  The Proprietary Feed License for any future media and feeds incorporated
into the Process after approval by Omeros will be provided on these same terms
to the extent that Lonza is able to so provide such terms.  The option to
purchase proprietary feeds and the Proprietary Feed License shall be assignable
by Omeros to a Third Party which is an IP-Respecting Entity.

(b)  Omeros Cell Line and Omeros Process.

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Where the Cell Line is the Omeros Cell Line and Product is produced using the
Omeros Process, Lonza acknowledges that, other than as conveyed to Omeros under
Clause 8.4 herein, no license shall be required from Lonza for Omeros to exploit
the Omeros Cell Line, the Omeros Process or the Product provided that no New
General Application Intellectual Property has been applied by Lonza in the
Omeros Process other than as provided under Clause 8.4 herein. Subject to the
foregoing provision, Omeros shall also have the option to purchase Lonza’s
proprietary media and feeds from Lonza or a Third Party supplier and use such
media and feeds to modify the Omeros Process. Omeros shall have the right to
require a technology transfer in accordance with Clause 12.8. The option to
purchase proprietary feeds and the Proprietary Feed License shall be assignable
by Omeros to a Third Party which is an IP-Respecting Entity.

2.9         Unless otherwise agreed by the parties in writing or specified in
the applicable SOW, Lonza shall provide all supplies (other than the materials
as provided for in any SOW) and standard processing and manufacturing equipment
needed for completion of the Services, at its sole cost and expense unless
otherwise provided for in a SOW (including, without limitation, shipping costs
in connection with such supplies and equipment). All Omeros-specific supplies
and Omeros-dedicated equipment shall be specified in the SOW and shall be
purchased at Omeros’ reasonable cost and expense.

2.10       At Lonza’s expense, Lonza shall be responsible for destruction of any
and all waste, including hazardous waste, including, without limitation,
rejected Product, in accordance with the Applicable Laws.  Provided, however,
the destruction by Lonza of any Resins owned by Omeros shall be at Omeros’
request and expense.

2.11       Lonza shall, at its own cost and expense, with a reputable and
solvent insurance provider, obtain and maintain in full force and effect the
following insurance during the Term: (a) commercial general liability insurance
with a per-claim limit of not less than [***] USD; and (b) products and
completed operations liability insurance with a per-occurrence limit of not less
than [***] USD and an annual aggregate limit of not less than (i)  [***] USD
prior to Launch and (ii)  not less than [***] USD after Launch. Lonza shall
supply Omeros with a copy of the certificate of insurance upon reasonable
request and shall not terminate or materially decrease the level of coverage of
such policies during the Term of this Agreement.

2.12       The Parties shall enter into a separate quality agreement (the
“Quality Agreement”) to define their responsibilities in relation to the
disposition of the Product.  In the event of any conflict between the terms of
this Agreement and the terms of the Quality Agreement, the terms of the Quality
Agreement shall control in relation to the disposition of the Product and this
Agreement shall control all other aspects.

2.13       Omeros shall be permitted to have, at no additional cost, one (1)
employee or contracted representative at the Facility as reasonably requested by
Omeros, at any time during the Process for the purpose of observing, reporting
on, and consulting as to the performance of the Services. Such employee or
contracted representative shall be subject to abide by confidentiality
obligations as set forth herein and Lonza’s customary practices and operating
procedures regarding persons in plant, and such employee agrees to comply with
all instructions of Lonza’s employees at the Facility.

2.14       Lonza reserves the right to initiate any and all required
investigational work, such as that related to out of Specification (“OOS”)
investigations as set out further under a separate Quality Agreement.  Lonza
will inform Omeros of such investigational work as soon as reasonably
practicable.  Lonza will seek Omeros’ approval prior to beginning such
investigational work if any costs would be incurred in connection with such work
would be chargeable to Omeros at Lonza’s standard rates.

2.15       Raw Materials. Lonza shall procure all required Raw Materials other
than those raw materials that are Omeros Materials.  Omeros shall be responsible
for payment of Raw Materials irrevocably committed to be procured by Lonza under
a Binding Order hereunder that are not (as reasonably determined by Lonza)
returnable or useable for other customers.

2.16       For any regulatory support services for Approval of the Product in
each Territory that Omeros requests, the cost of any such regulatory support
will be paid for by Omeros in accordance with Schedule 1 to this Agreement.

3.  Scale Up Within Lonza Network

In the event that the Parties agree to transfer the manufacture of Product to a
larger scale at the same Facility or such alternate Lonza facility as may be
mutually agreed to meet the supply requirements, then the cost of transferring
the manufacture of the Product to the larger scale or from the Facility to such
other Lonza facility will be agreed in good faith between the Parties by way of
an amendment to this Agreement, with manufacturing at such larger scale or at
such other Lonza facility to be undertaken under the terms of this Agreement,
amended solely as may be necessary to address such transfer and incorporate
applicable adjustments to Batch pricing.

4. Omeros Obligations

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4.1         Omeros has supplied to Lonza the Omeros Information, together with
full details of any known hazards relating to the Omeros Cell Line, if
applicable, and/or Omeros Materials, their storage and use. Title to the Omeros
Cell Line and/or Omeros Materials and/or Omeros Information supplied to Lonza is
and shall remain vested in Omeros.

4.2         Omeros shall pay the Price set out in each SOW for provision of the
Services other than Batch manufacture performed in accordance with this
Agreement or in accordance with Schedule 1  for Batches manufactured under this
Agreement, as set out in each Binding Order, together with any additional costs
and expenses that fall due under this Agreement in accordance with the Terms of
Payment.

4.3         Omeros hereby grants Lonza the non-exclusive right to use the Omeros
Cell Line, the Omeros Materials and the Omeros Information for the sole purpose
of performing the Services in accordance with this Agreement.

4.4         Omeros shall, at its own cost and expense, obtain and maintain in
full force and effect products liability insurance with a reputable and solvent
insurance provider with a per occurrence limit of not less than [***] USD and an
annual aggregate limit of not less than (i)  [***] USD prior to Launch and (ii)
 not less than [***] USD following Launch. Omeros shall supply Lonza with a copy
of the certificate of insurance upon reasonable request and shall not terminate
or materially decrease the level of cover of such policy during the Term of this
Agreement.

4.5         During the Term of the Agreement, Omeros and Lonza intend Lonza to
be the supplier of a minimum of [***]% of Omeros’ requirements for Product sold
by Omeros or its Affiliates, to customers, to distributors, or commercial
partners  (“Minimum Exclusivity”),  as measured on [***] sales (i.e., [***]),
 over any [***] calendar year period following Launch. [***].

5. Delivery, Transportation of Product and Omeros Tests

5.1         Product shall be Delivered EXW (ex-works) (as defined by Incoterms
2010) Lonza’s Facility which means (a) Delivery shall occur when Lonza places
Product, packaged for transport in accordance with the Specifications, at the
disposal of Omeros at Lonza’s premises (not cleared for export and not loaded
onto a carrier’s vehicle) and (b) risk and title to Product shall pass to Omeros
upon Delivery (“Deliver,” “Delivery,” or “Delivered,” as appropriate); provided,
however, that Lonza shall remain responsible for storage of Product in
accordance with the Specifications until Product is loaded into a carrier’s
vehicle and shall remain liable for any damage or loss of Product due to
improper storage during this time period. Subject to Clause 5.2, Lonza shall
deliver to Omeros the signed Certificate of Analysis and a completed Certificate
of Compliance not later than the date of Delivery (“Release”). Transportation of
Product packaged in accordance with the Specifications, whether or not under any
arrangements made by Lonza on behalf of Omeros, shall be made at the sole risk
and expense of Omeros. Lonza shall provide such deliverables in accordance with
the shipping and packaging instructions set forth in the Specifications or
applicable SOW or as otherwise provided in advance by Omeros and agreed to by
Lonza and shall provide all necessary supporting shipping information.

5.2         At Omeros’ request and subject to the agreement of both parties,
Lonza will Deliver Product in quarantine prior to delivery of the Certificate of
Analysis. Such request shall be accompanied by Omeros’ written acknowledgement
that the Product has been Delivered without the transmittal to Omeros of a
Certificate of Analysis, that accordingly the Product cannot be administered to
humans until transmittal of the Certificate of Analysis, and that Omeros
nevertheless accepts full risk of loss, title and ownership of the Product. The
Delivery of Product in quarantine shall be subject to such testing requirements
as Lonza may reasonably require, and the forty-five (45) day period referred to
in Clause 5.9 shall run from the Release of Product Delivered to Omeros.

5.3         Lonza or any subcontracted Third Party that performs testing on
behalf of Lonza shall perform quality control tests in accordance with the
Quality Agreement and as necessary to ensure that each Batch of Product is
produced in accordance with and conforms to the Specifications and all
Applicable Laws, including cGMP when applicable. All quality control test
results, raw data associated with these test results and copies thereof,
including notebook entries, generated by or at Lonza or by or at any
subcontracted Third Party analytical laboratory,  shall be made available to
Omeros upon written request of Omeros at Lonza’s Facility to the extent that
such information is specific to Lonza’s Facility or such subcontracted Third
Party’s facility. Lonza shall provide Omeros with timely access to properly
completed copies of batch records for such Batch, prepared in accordance with
the Master Batch Record, Specifications and Applicable Laws, which shall
accurately reflect in all material respects the processes and procedures
followed by Lonza in Processing Product.

5.4         Unless otherwise agreed, Lonza shall package and label Product for
Delivery in accordance with its standard operating procedures, the Master Batch
Record and the Specifications. It shall be the responsibility of Omeros to
inform Lonza in writing in advance of any special packaging and labelling
requirements for Product. All reasonable additional costs and expenses of
whatever nature to be incurred by Lonza in complying with such special
requirements shall be agreed to in advance with Omeros and then charged to
Omeros in addition to the Price.

[***] CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE
IT BOTH (A) IS NOT MATERIAL AND (B) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED

Picture 1 [ex-10d1g001.jpg]

5.5         If requested in writing by Omeros, Lonza will (acting as agent for
Omeros for such purpose) arrange for insurance of Product whilst held by Lonza
after Delivery (awaiting transportation) for a maximum of fourteen (14) days on
terms equivalent to those under which Lonza insures product prior to Delivery.
All additional costs and expenses of whatever nature incurred by Lonza in
arranging such insurance shall be charged to Omeros in addition to the Price.

5.6         If requested in writing by Omeros, Lonza will (acting as agent of
Omeros for such purpose) arrange the transportation of Product from Lonza’s
premises to the destination indicated by Omeros together with insurance coverage
for Product in transit at its invoiced value. All additional costs and expenses
of whatever nature incurred by Lonza in arranging such transportation and
insurance shall be charged to Omeros in addition to the Price.

5.7         Where Lonza has made arrangements for the transportation of Product,
Omeros or its Third Party designee shall diligently examine the Product for
transportation damage as soon as practicable after receipt. Notice of all claims
(time being of the essence) arising out of:

(a) visible damage to or total or partial loss of Product in transit shall be
given in writing to Lonza and the carrier within three (3) working days of
receipt by Omeros; or

(b) non-delivery shall be given in writing to Lonza within ten (10) days after
the date of Lonza’s despatch notice, which despatch notice shall be e-mailed
contemporaneously with shipment to an Omeros project manager designated by
Omeros.

5.8         Omeros shall make damaged Product and associated packaging materials
available for inspection and shall comply with the requirements of any insurance
policy covering the Product notified by Lonza to Omeros. Lonza shall offer
Omeros all reasonable assistance (at the cost and expense of Omeros) in pursuing
any claims arising out of the transportation of Product.

5.9         Promptly following receipt of Product or any sample thereof, Omeros
may carry out any of the tests outlined or referred to in the Specifications or
any SOW. Subject to Clause 2.2, if such tests show that the Product fails to
meet Specifications, then Omeros shall provide Lonza written notice thereof
(“Failure Notice”) within forty-five (45) days from the date of Release and
shall, upon Lonza’s request and with Omeros’ agreement, return such Product to
Lonza’s premises for further testing (at Lonza’s cost and expense if the Product
is shown to fail to meet Specifications and such failure is due (in whole or in
part) to the acts of omissions of Lonza). In the absence of such Failure Notice,
Product shall be deemed to have been accepted by Omeros as meeting
Specifications.

Subject to Clause 2.2, if a  Batch fails to meet the Specification prior to
Delivery, or if Omeros has reasonably demonstrated to Lonza that Product that
has been Delivered fails to meet Specification and that such failure is not due
(in whole or in part) to acts or omissions of Omeros or any Third Party after
Delivery, Lonza shall propose to Omeros a schedule for manufacture and Delivery
of a  replacement for the failed Batch. Omeros may accept or reject the proposed
replacement schedule of any failed Batch.  If Omeros accepts the proposed
replacement schedule of any failed Batch, then Lonza shall Process and Deliver
the replacement Batch in accordance with the agreed replacement schedule, and
following Delivery, Omeros shall pay Lonza the remaining [***] of the Batch
Price (taking into account the [***] payment already made by Omeros in respect
of the failed Batch), provided, however, that if the agreed scheduled thaw date
for the replacement Batch is later than [***] months after the scheduled
Commencement Date of the original failed Batch, Lonza shall if requested by
Omeros refund the initial [***] payment already made by Omeros and reinvoice
Omeros for such payment to be made upon the rescheduled Commencement Date. If
Omeros rejects the proposed replacement of any failed Batch, then Lonza shall
issue a credit or, if requested by Omeros, pay a refund to Omeros for the amount
of the Price previously paid that relates to the production of such failed
Batch. In the event that Lonza is required to replace such Product, Lonza shall
use all reasonable endeavours to do so with the minimum delay having regard to
its commitments to third parties in the timing of such replacement. Omeros shall
notify Lonza of any Latent Defect immediately upon discovery. Lonza shall be
responsible for Latent Defects which are directly attributable to Lonza’s breach
of obligations under this Agreement and Omeros shall have the same remedies
available to it hereunder.

5.10       Subject to Clause 2.2, if there is any dispute concerning (i) whether
Product fails to comply with Specifications or cGMP or (ii) whether such failure
is due (in whole or in part) to acts or omissions of Omeros or any Third Party
after Delivery, such dispute shall be referred for decision to an independent
expert (acting as an expert and not as an arbitrator) to be appointed by
agreement between Lonza and Omeros. The costs of such independent expert shall
be borne equally between Lonza and Omeros. The decision of such independent
expert shall be in writing and, save for manifest error on the face of the
decision, shall be binding on both Lonza and Omeros.

5.11       Except as otherwise expressly set forth in this Agreement, the
provisions of Clauses 2.4, 5.9 and 5.10 shall be the sole remedy available to
Omeros in respect of Product that fails to meet Specification.

[***] CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE
IT BOTH (A) IS NOT MATERIAL AND (B) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED

Picture 1 [ex-10d1g001.jpg]

5.12       Following completion of each Batch of Product retained samples will
be stored at Lonza’s Facility in accordance with the Applicable Laws, the Master
Batch Record and any instructions set forth in a SOW, including for the time
period of any stability study to be performed in accordance with any SOW.  After
the expiration of any minimum hold periods required by the Applicable Laws
and/or any SOW, Lonza will notify Omeros in writing if it intends to dispose of
specified samples, at Omeros’ reasonable cost, unless written instructions have
been provided by Omeros to Lonza within thirty (30) days of Omeros’ receipt of
such disposal notice to return samples to Omeros or a Third Party designee at
Omeros’ reasonable cost.  Lonza will return unused Omeros Materials to Omeros
within ninety (90) days of the termination of the relevant SOW, at Omeros’
reasonable cost, unless prior written instructions have been provided by Omeros
to dispose of such materials at Omeros’ reasonable cost.  Lonza will store
Omeros Materials free of charge during the term of the applicable SOW and for
thirty (30) days thereafter.

5.13       If a Regulatory Authority orders or requires the recall of any
Product supplied hereunder or if Omeros or Lonza believes a recall, field alert,
biological product deviation, Product withdrawal or field correction (“Recall”)
may be necessary with respect to any Product supplied under this Agreement, the
Party receiving the notice from the Regulatory Authority or that holds such
belief shall promptly notify the other Party in writing.  With respect to any
Recall, Lonza shall provide all necessary cooperation and assistance to Omeros.
The cost of any Recall shall be borne by Omeros, and Omeros shall reimburse
Lonza for reasonable expenses incurred in connection with any Recall, except to
the extent such Recall is caused by (A) Lonza’s negligence in which case Lonza’s
liability for such Recall costs and reasonable expenses is the Price charged for
the recalled Product or (B) Lonza’s gross negligence or willful misconduct, in
which case Lonza’s liability for such Recall costs and expenses shall not be
limited. For purposes of clarification, Recall costs and reasonable expenses
shall include, without limitation, notification to customers, Product retrieval,
Product destruction, recall-related regulatory submissions, shipping and
taxes.  In the event that a Product is Recalled or Omeros is required to
disseminate information relating to Product covered by this Agreement, Omeros
shall so notify Lonza within a reasonable time so as to enable Lonza to provide
Omeros with such assistance in connection with such Recall as may reasonably be
requested by Omeros.  Lonza will comply with all such reasonable requests from
Omeros.  Omeros shall handle exclusively the organization and implementation of
all Recalls of Products. Any such Recall shall be implemented and administered
in a manner that is appropriate and reasonable under the circumstances and in
conformity with any requests or orders of the applicable Regulatory Authority
and, to the extent consistent, accepted trade practices.

6.  Minimum Order, Forecasting, Ordering, Rescheduling,  Cancellation,  and
Supply Failure

6.1         Minimum Order

6.1.1      Minimum Campaign Size.  The minimum Campaign size shall be [***]
Batches (“Minimum Campaign”).

6.1.2      Minimum Order.  Commencing from the [***] of the [***] following
Launch, Omeros commits to order and Lonza commits to supply not less than [***]
Batches per calendar year (“Minimum Order”).  For purposes of illustration only,
 the following is an example of the calculation for commencement of the Minimum
Order: If Launch occurs on [***], then Omeros’ commitment to the Minimum Order
begins for the calendar year commencing [***].

6.2         Forecasting for Batches

6.2.1      Forecast.  Omeros shall provide to Lonza, in writing, a rolling [***]
forecast, based on desired Delivery date,  of the number of Batches to be
ordered in each calendar year.  The forecast shall be updated [***] by Omeros
 (e.g., each [***])  and is non-binding (the “Forecast”).

6.2.2      Forecast Response.  No later than [***]  following Lonza’s receipt of
a Forecast, Lonza shall respond to each Forecast (“Forecast Response”) with a
written schedule to Omeros of whether it has (as of the date of receipt of the
Forecast) capacity available to manufacture the number of Batches  Forecasted
therein, and shall provide Omeros with an estimated production schedule showing
the estimated Commencement Date and Delivery date of such Batches.  Lonza shall
schedule all Batches for manufacture in each calendar year as [***], unless
otherwise requested by Omeros in the Forecast; provided, however, that, at its
option, Omeros shall have the right to split annual aggregate orders of [***] or
more Batches into [***] Campaigns, each at least as large as the Minimum
Campaign size. If [***] Batches during a calendar year are split into [***]
Campaigns at Omeros’ request, the Batch Price shall be determined based on the
size of the [***] Campaigns.  If [***] Batches during a calendar year are split
into [***] Campaigns by Lonza and not in response to a request by Omeros, the
Batch Price shall be determined based on the aggregate number of Batches ordered
in the Binding Order.

6.2.3      [***].

6.3          Purchase Orders

6.3.1      Omeros shall issue a Purchase Order for any Batches it wishes to
order in accordance with the Lonza Forecast Response no later than [***] prior
to the Commencement Date of each Campaign.

[***] CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE
IT BOTH (A) IS NOT MATERIAL AND (B) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED

Picture 1 [ex-10d1g001.jpg]

6.3.2      Lonza shall confirm the Commencement Date(s),  Delivery date(s) and
number of Batches to be Delivered to Omeros as set out in each Purchase Order
within [***] of receipt from Omeros of the relevant Purchase Order. Upon
acceptance of each Purchase Order from Lonza, it will then be regarded by the
Parties as a binding order (“Binding Order”).  Any Commencement Date or Delivery
date set forth in Lonza’s written confirmation of a Purchase Order shall be an
estimated date only,  provided that the estimated Commencement Date or Delivery
date for a Batch by Lonza is no earlier or no later than [***] from Lonza’s most
recent Forecast Response.

6.3.3      Omeros may request to add additional Batches into an existing
Campaign under a Purchase Order with less than [***] prior notice and Lonza
shall determine and notify Omeros within [***] of such request whether such
additional Batches can be accommodated into that Campaign,  creating a Binding
Order if accepted by Lonza.  For clarity, Lonza shall have no obligation to
accept Purchase Orders for any requested additional Batches, or to reserve
capacity prior to accepting such requested Purchase Orders.

6.3.4      Unless otherwise permitted by Lonza in its discretion, Omeros shall
issue Purchase Orders for any Services other than Batch manufacture no later
than [***] prior to the commencement of each of the Services or such earlier
time as reasonably requested by Lonza.

6.3.4      Any additional or inconsistent terms or conditions of any
Omeros-issued Purchase Orders, acknowledgement or similar standardized form
given or received pursuant to this Agreement shall have no effect and such terms
and conditions are hereby rejected, unless specifically acknowledged and
accepted by Lonza.

6.4         Rescheduling

6.4.1      Lonza shall have the right to reschedule the Commencement Date and
Delivery Date of any Batch or Campaign under Binding Order upon reasonable prior
written notice to Omeros, delivered as soon as reasonably practicable following
Lonza’s determination that it wishes to reschedule a Batch or Campaign;
provided, that the rescheduled Commencement Date and Delivery Date is no earlier
or no later than ninety (90) days from the Commencement Date and Release Date
originally estimated at the time of Lonza’s confirmation of the Binding Order,
and that any such Batches that are delayed by Lonza into a subsequent calendar
year, shall count towards Omeros’ annual total for the originally scheduled
calendar year for purposes of the Minimum Campaign or Minimum Order, as
applicable.

6.4.2      Omeros shall have the right to request to reschedule any Batch or
Campaign upon prior written notice to Lonza.  Lonza shall use commercially
reasonable efforts to accommodate such reschedule request from Omeros wherever
possible, but whilst observing its contractual commitments of other customers.
 [***] Omeros acknowledges that any such rescheduling request may not be
fulfilled by Lonza.

6.5         Cancellation of a Batch under Binding Order

6.5.1      Omeros shall notify Lonza of any Batches (the Binding Order for which
has been confirmed) that it wishes to cancel. Lonza shall use commercially
reasonable efforts to try and secure a replacement batch for a new project,
whilst observing its contractual commitments of other customers.

6.5.2      If Lonza is unable to resell the cancelled Batch(es), Omeros shall
pay [***] of the Batch Price for each Batch cancelled in accordance with the
previously agreed Batch Price payment schedule of [***] at scheduled
Commencement Date and [***] at scheduled Release date.

6.5.3      If Lonza is able to resell any cancelled capacity to any Third Party
then the cancellation fee provided for under Clause 6.5.2 for that Batch shall
be waivered.

6.5.4      In addition, any Raw Materials that are irrevocably committed and
shall expire before use in any other production Campaign shall be invoiced by
Lonza and paid for by Omeros in accordance with the previously agreed scheduled
Release date and the handling fee shall be paid for by Omeros.  Such Raw
Materials may be either shipped to Omeros, stored for future use for Omeros, or
disposed of as requested by Omeros.  All such Raw Materials paid for by Omeros
shall be owned by Omeros.

6.6         Supply Failure

6.6.1      Following Launch of the Product, If Lonza fails (where failure,  for
example, includes but is not limited to, failure to comply with the Master Batch
Record during Processing of a Batch, failure of  a Batch to meet Specifications,
 failure to Deliver a Batch, or failure due to reasons within Lonza’s control to
Release a Batch)  to produce [***] or more Batches within a [***] (“Supply
Failure”), Lonza 's remediation plan for the Supply Failure shall be to Deliver
replacement Batches within [***] (or any such timeframe as agreed between the
Parties) of such Supply Failure. In the event that Lonza is unable to Deliver
replacement Batches within the above timeframe, Omeros may terminate this
Agreement by providing [***] advance written notice.

[***] CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE
IT BOTH (A) IS NOT MATERIAL AND (B) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED

Picture 1 [ex-10d1g001.jpg]

7. Price and Terms of Payment

7.1         Unless otherwise indicated in writing by Lonza, all prices and
charges are exclusive of Value Added Tax or of any other applicable taxes,
levies, imposts, duties and fees of whatever nature imposed by or under the
authority of any government or public authority, which shall be paid by Omeros
(other than taxes on Lonza’s income). All invoices are strictly net and payment
must be made within thirty (30) days of receipt of invoice unless disputed.
Payment shall be made without deduction, deferment, set-off, lien or
counterclaim of any nature.

7.2         Any invoices that are disputed by Omeros must be notified to Lonza
in writing and within thirty (30) days of issue of the invoice by Lonza.  The
Parties shall meet (in person or by telephone) within ten (10) days to resolve
such dispute.  Payment shall be made promptly after resolution of the dispute.

7.3         In case of any default of payment on the due date:

(a) interest shall accrue on any amount overdue of an undisputed invoice at the
rate of [***] percent per month, interest to accrue on a day to day basis both
before and after judgment and not exceeding more than [***] percent per annum;
and

(b) Lonza shall, at its sole discretion, and without prejudice to any other of
its accrued rights, be entitled to suspend the provision of the Services or to
treat this Agreement as repudiated on not less than thirty (30) days’ prior
notice in writing to Omeros given at any time thereafter unless such payment
default is cured during or after such notice period and prior to repudiation.

7.4         Price Adjustments

7.4.1      Not more than once per calendar year, to be effective after March 31
of that year, Lonza may increase the Price for Batches in accordance with the US
Department of Labor’s Bureau of Labor Statistics Pharmaceutical Preparations
Index, [***] (or any successor index) increase for the previous calendar year. 
Any new Price reflecting a  Batch Price adjustment shall be effective only for
Purchase Orders submitted in [***] and subsequent years and any Price increase
shall not exceed [***% per annum].  Purchase Orders placed in a calendar year by
Omeros for Delivery of Batch(es) in that same calendar year, and accepted by
Lonza, shall not be subject to any Price increase.

7.4.2      In addition to the above, the Price may be changed by Lonza, upon
reasonable prior written notice to Omeros (providing reasonable detail in
support thereof), to reflect (i) any change in Process conditions that
materially impact Lonza cost of manufacture and (ii)  any material change in an
environmental, safety or regulatory standard to the extent such change
materially impacts manufacturing costs exclusive of capital expenditures.

7.4.3      In the event Omeros awards a second product to Lonza the parties
shall enter into good faith discussions to review the annual Price adjustments
of Clause 7.

7.5         Invoicing

7.5.1      Invoices will not be provided to Omeros until the related activity is
initiated or completed.

7.5.2      Lonza shall issue invoices to Omeros for [***] percent of the Price
for Batches upon the Commencement Date of each Batch and [***] percent upon
Release of each Batch, unless otherwise stated in the SOW or under a Binding
Order, provided, however, that if a Batch is rejected the final [***] payment
shall not become due until an investigation is completed and then payment
responsibility will depend on the outcome of the investigation.  Lonza shall (a)
issue invoices for Services (other than the manufacture of Batches) in
accordance with the schedule set forth in the applicable SOW. Omeros shall pay
all undisputed invoices within 30 days of receipt or as otherwise set forth in
the SOW.

7.5.3      Charges for Raw Materials and the Raw Materials Fee for each Batch
shall be invoiced upon the Release of each Batch.

7.5.4      The cost of Resins will be invoiced by Lonza to Omeros upon purchase
of the Resins by Lonza.

7.5.5      Any External Laboratory testing costs associated with testing will be
invoiced upon Delivery of Batch.

8. Intellectual Property

8.1         Neither Party will, as a result of this Agreement, acquire any
right, title, or interest in any Intellectual Property that the other Party owns
or controls as of the Effective Date of this Agreement, or that the other Party
obtains ownership or control of separate and apart from the performance of the
Services under this Agreement.

8.2         Lonza shall own all right, title and interest in “New General
Application Intellectual Property,” which as used in this Agreement means
Intellectual Property that Lonza and/or its Affiliates, contractors or agents
develops, conceives, invents, reduces to practice or makes in the course of
performance of the Services and that [***].

[***] CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE
IT BOTH (A) IS NOT MATERIAL AND (B) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED

Picture 1 [ex-10d1g001.jpg]

8.3         Except for and not including the New General Application
Intellectual Property, Omeros shall own all right, title, and interest in (a)
any and all Intellectual Property that Lonza and/or its Affiliates conceives,
invents, reduces to practice, develops or makes, solely or jointly with Omeros
or others, [***] and (b)[***] (collectively, the “New Omeros Intellectual
Property”).  Omeros grants to Lonza a non-exclusive, non-transferable,
royalty-free license to use the New Omeros Intellectual Property solely to the
extent necessary for Lonza to perform its obligations under this Agreement.  No
other license to the New Omeros Intellectual Property is hereby granted.  Lonza
hereby assigns to Omeros and shall continue to assign to Omeros all of its
right, title and interest in any New Omeros Intellectual Property. Lonza shall
promptly disclose to Omeros in writing all New Omeros Intellectual Property.
Lonza shall execute, and shall require Lonza’s personnel involved in the
performance of the Services to execute, any documents required to confirm
Omeros’ ownership of the New Omeros Intellectual Property, and any documents
required to apply for, maintain and enforce any patent or other right in the New
Omeros Intellectual Property. Upon Omeros’ request and at Omeros’ reasonable
expense, and at no cost to Lonza, Lonza shall assist Omeros as may be necessary
to apply for, maintain and enforce any patent or other right in the New Omeros
Intellectual Property. For the avoidance of doubt, the parties agree that the
term “New Omeros Intellectual Property” shall not under any circumstances be
interpreted or defined to include any “New General Application Intellectual
Property”.

8.4         [***]

9. Warranties and Indemnification

9.1         Lonza Warranty. Lonza warrants that:

(a) the Services shall be performed in accordance with Clauses 2.1, 2.2 and 2.5;

(b) unencumbered title (save for any Intellectual Property rights which may
exist) to Product will be conveyed to Omeros upon Delivery;

(c) as of the date of this Agreement the Lonza Know How and Lonza Patent Rights
are owned by Lonza or Lonza is otherwise entitled to use them for the purposes
of providing Services under this Agreement and during the term of this Agreement
Lonza shall not do or cause anything to be done that would adversely affect
their ownership or entitlement to use the same for those purposes;

(d) Lonza has the necessary corporate authorisations to enter into this
Agreement;

(e) as of the date of this Agreement to the best of Lonza’s knowledge and
belief, the use by Lonza of the Process (excluding any modifications or steps
made or developed by Omeros, Omeros Materials, Omeros Information and Omeros
Patent Rights), and Lonza Patent Rights and Lonza Know How for the performance
of the Services as provided herein will not infringe any rights (including
without limitation any intellectual or industrial property rights) vested in any
Third Party;

(f) Lonza will notify Omeros in writing immediately if it receives or is
notified of a claim from a Third Party that the use by Lonza of the Process
and/or the Lonza Know How or the Lonza Patent Rights for Services infringes any
Intellectual Property rights vested in such Third Party;

(g) subject to Clause 2.2 and at the time of Delivery by Lonza, Product shall
have been Processed in accordance with Applicable Laws and in conformance with
the Specifications, and shall not be adulterated, misbranded or mislabelled
within the meaning of Applicable Laws or misused, contaminated, tampered with or
otherwise altered or mishandled while in the custody and control of Lonza,
provided, that Lonza shall not be liable for defects attributable to Omeros
Materials or a breach of representations and warranties made by Omeros under
this Agreement;

(h) none of Lonza’s officers, directors, employees or, to Lonza’s knowledge,
direct subcontractors, providing Services under this Agreement, or Affiliates
has been debarred or, to Lonza’s knowledge, threatened with debarment under the
United States Generic Drug Enforcement Act or convicted of a crime which could
lead to debarment, and it has not utilized, and will not utilize, the services
of any individual or entity in the performance of any SOW that has been debarred
or threatened with debarment under the United States Generic Drug Enforcement
Act, convicted of a crime that could lead to debarment by the FDA, and in the
event that Lonza receives notice of the debarment or threatened debarment of any
individual or entity utilized by Lonza in connection with the Services, Lonza
shall notify Omeros in writing immediately, and Omeros shall have the right to
terminate this Agreement upon written notice in accordance with Clause 12.2 of
this Agreement, and make payments to Lonza of all accrued and unpaid obligations
up to the date of termination without any further financial penalties;

(i) each Certificate of Analysis and Certificate of Compliance will be true and
correct and accurately reflect the results of the tests conducted on the Batch
of Product to which it relates, and the records Delivered to Omeros will
accurately reflect in all

[***] CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE
IT BOTH (A) IS NOT MATERIAL AND (B) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED

Picture 1 [ex-10d1g001.jpg]

material respects the processes and procedures followed by Lonza in Processing
Product as set forth in the SOW, Master Batch Record and Specifications; and

(j) Lonza has obtained (or will obtain prior to Processing Product or
performance of other Services), and will remain in compliance with during the
term of this Agreement, all permits, licenses and other authorizations which are
required under Applicable Laws for the provision of the Services under this
Agreement.

9.2         Omeros Warranty. Omeros warrants that:

(a) Omeros has and shall at all times throughout the term of this Agreement have
the right to supply the Omeros Cell Line, the other Omeros Materials and the
Omeros Information to Lonza and the necessary rights to license or permit Lonza
to use the same for the purpose of the Services;

(b) Omeros has the necessary corporate authorisations to enter into this
Agreement;

(c) any of the Omeros Cell Line, the other Omeros Materials, Omeros Information
and Omeros Patent Rights not owned by Omeros are licensed to Omeros under a
license which will permit their use by Lonza to perform the Services;

(d) to the best of Omeros' knowledge and belief, the use by Lonza of the Omeros
Cell Line, other Omeros Materials, Omeros Information and Omeros Patent Rights
for the Services (including without limitation the Processing of the Product)
will not infringe any Intellectual Property rights of any Third Party (provided,
however, that Lonza shall waive any breach of this warranty that arises if a
court of competent jurisdiction determines that the use by Lonza of the Omeros
Cell Line, other Omeros Materials, Omeros Information or Omeros Patent Rights
for the Services infringes the Intellectual Property rights of a Third Party,
provided that and for so long as Omeros actually indemnifies Lonza pursuant to
Clause 9.5 below); and

(e) Omeros will promptly notify Lonza in writing if it receives or is notified
of a claim from a Third Party that the Omeros Cell Line, other Omeros Materials,
Omeros Information or the Omeros Patent Rights or that the use by Lonza thereof
for the provision of the Services infringes any Intellectual Property rights of
such Third Party.

9.3         Disclaimer. THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE
IN LIEU OF ALL OTHER WARRANTIES, AND, EXCEPT FOR THE WARRANTIES EXPRESSLY SET
FORTH IN THIS AGREEMENT, ALL OTHER WARRANTIES, BOTH EXPRESS AND IMPLIED, ARE
EXPRESSLY DISCLAIMED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

9.4         Indemnification by Lonza. Subject to Clauses 9.6, 9.7 and 9.8 below,
Lonza shall defend, indemnify and hold harmless each of Omeros (including
Affiliates) and its directors, officers, and employees and the successors and
assigns of any of the foregoing (each an “Omeros Indemnitee”) from and against
(i) any Third Party claim, loss, damage, costs and expenses (including court
costs and legal fees on a full indemnity basis) arising directly out of any
breach of the warranties given by Lonza in Clause 9.1 above or (ii) any Third
Party claims alleging that Lonza’s use of Lonza Know-How (excluding use of Lonza
Know-How with Omeros Materials or Omeros Information if such use of the Lonza
Know-How would not be infringing unless used specifically with Omeros Materials
or Omeros Information) infringes any rights (including without limitation any
intellectual property rights) vested in a Third Party (whether or not Lonza
knows or ought to have known the same) provided that there shall be excluded
from this indemnity all Omeros revenue, in each case, to the extent that such
claims resulted from the negligence, intentional misconduct or breach of this
Agreement by the Omeros Indemnitee.  Lonza shall further indemnify and maintain
Omeros promptly indemnified against all Third Party claims, actions, costs,
expenses (including court costs and legal fees on a full indemnity basis) or
other liabilities whatsoever caused by the negligent act or omission of Lonza in
the Processing and/or supply of Product.

9.5         Indemnification by Omeros. Subject to Clauses 9.6 and 9.7 below,
Omeros shall defend, indemnify and hold harmless each of Lonza (including
Affiliates) and its directors, officers, and employees and the successors and
assigns of any of the foregoing (each a “Lonza Indemnitee”) from and against (i)
any Third Party claim, loss, damage, costs and expenses of any nature (including
court costs and legal fees on a full indemnity basis), arising directly out of
any breach of the warranties given by Omeros in Clause 9.2 above or (ii) any
Third Party claims alleging Lonza’s use of the Omeros Cell Line, the Omeros
Materials or the Omeros Information infringes any rights (including, without
limitation, any intellectual property rights) vested in any Third Party (whether
or not Omeros knows or ought to have known about the same) provided that for
purposes of clarity there shall be excluded from this indemnity all Lonza actual
or potential revenues other than those which are an integral part of any Price
or fees that Omeros is obliged to pay to Lonza under this Agreement, in each
case, to the extent that such claims resulted from the negligence, intentional
misconduct or breach of this Agreement by the Lonza Indemnitee. Omeros shall
further indemnify and maintain Lonza promptly indemnified against all Third
Party claims, actions, costs, expenses (including court costs and legal fees on
a full indemnity basis) or other liabilities whatsoever in respect of:

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(a) any product liability in respect of Product, unless such liability is caused
by the negligent act or omission of Lonza in the Processing and/or supply of
Product; and

(b) any negligent or wilful act or omission of Omeros in relation to the use,
Processing, storage or sale of the Product.

9.6         Indemnification Procedure. If a Lonza Indemnitee or Omeros
Indemnitee (the “Indemnitee”) intends to claim indemnification under this Clause
9, it shall promptly notify the other Party (the “Indemnitor”) in writing of
such alleged liability. The Indemnitor shall have the right to control the
defence thereof with counsel of its choice as long as such counsel is reasonably
acceptable to Indemnitee; provided, however, that any Indemnitee shall have the
right to retain its own counsel at its own expense, for any reason, including if
representation of any Indemnitee by the counsel retained by the Indemnitor would
be inappropriate due to actual or potential differing interests between such
Indemnitee and any other party reasonably represented by such counsel in such
proceeding and provided further that the Indemnitor may not admit to any
unlawful act or infringement of a Third Party’s Intellectual Property by the
Indemnitee or agree to any invalidity or unenforceability of an Indemnitee’s
patent rights without the indemnitee’s written consent. The Indemnitee, its
employees and agents, shall reasonably cooperate with the Indemnitor and its
legal representatives in the investigation of any liability covered by this
Clause 9. The obligations of this Clause 9.6 shall not apply to amounts paid in
settlement of any claim, demand, action or other proceeding if such settlement
is effected without the consent of the Indemnitor, which consent shall not be
withheld or delayed unreasonably. The failure to deliver written notice to the
Indemnitor within a reasonable time after the commencement of any such action,
if prejudicial to its ability to defend such action, shall relieve the
Indemnitor of any obligation to the Indemnitee under this Clause 9. It is
understood that only Lonza or Omeros may claim indemnity under this Clause 9
 (on its own behalf or on behalf of its Indemnitees), and other Indemnitees may
not directly claim indemnity hereunder.

9.7         Disclaimer of Consequential Damages. Subject to the second sentence
of this Clause 9.7, in no event shall either Party be liable to the other Party
for incidental, indirect, special, punitive or consequential damages arising
from or related to breach of this Agreement. The foregoing disclaimer of damages
shall not apply in the case of (a) breach of Clause 10 (Confidentiality), (b)
personal injury or death, or (c) grossly negligent or intentionally wrongful
acts or omissions.

9.8         Limitation of Liability.  Except for Lonza’s indemnification
obligations under Clause 9.4 and the exceptions set forth in the second sentence
of Clause 9.7 and the second sentence of this Clause 9.8, in no event shall
Lonza’s liability to Omeros for direct damages arising from or related to breach
of this Agreement exceed [  ***] payable under this Agreement for Services,
including under any Binding Orders not yet completed, by Omeros. The foregoing
limitation of liability shall not apply in the case of (a) breach of Clause 10
(Confidentiality), (b) personal injury or death, or (c) grossly negligent or
intentionally wrongful acts or omissions.

10. Confidentiality

10.1       Omeros acknowledges that Lonza Know-How and Lonza acknowledges that
Omeros Information with which it is supplied by the other pursuant to the
Agreement, and Omeros Information that Lonza generates for Omeros during the
course of performing Services under this Agreement, is supplied or generated,
subject to Clause 10.5, in circumstances imparting an obligation of confidence
and each agrees to keep such Lonza Know-How or such Omeros Information secret
and confidential and to respect the other's proprietary rights therein and not
at any time for any reason whatsoever to disclose or permit such Lonza Know-How
or such Omeros Information to be disclosed to any Third Party save as expressly
provided herein.

10.2       Omeros and Lonza shall each ensure that all their respective
employees, consultants, contractors and persons for whom it is responsible
having access to Lonza Know-How or Omeros Information shall be subject to the
same obligations of confidence and non-use as the principals pursuant to Clauses
10.1 and 10.3 and shall be bound by secrecy and non-use agreements in support of
such obligations, and Omeros and Lonza may share information with such
employees, consultants, contractors and persons, in accordance with the
foregoing obligations, on a need-to-know basis and solely for purposes of
performance under this Agreement and to permit Omeros’ development and full use
of the Product in conformance with the terms of this Agreement.

10.3       Lonza and Omeros each undertake not to disclose or permit to be
disclosed to any Third Party (including, except as provided in Clause 10.2
above, any contractors or consultants not previously approved in writing by the
Parties, such approval not to be unreasonably withheld or delayed), or otherwise
make use of or permit to be made use of other than for purposes of performance
under this Agreement (a) any trade secrets or confidential information relating
to the technology, business affairs or finances of the other, any subsidiary,
holding company or subsidiary or any such holding company of the other, or of
any suppliers, agents, distributors, licensees or other customers of the other
which comes into its possession under this Agreement or (b) the commercial terms
of this Agreement except as required to be disclosed by applicable laws or
regulations; provided, however, that, except for filings required under the
United States Securities Exchange Act of 1934 and applicable rules promulgated

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thereunder, in each case to any extent that such information is required to be
disclosed pursuant to subpoena, court order, judicial process or otherwise by
law, provided the receiving Party provides prompt notice to the disclosing Party
of such requirement in order to give the disclosing Party an opportunity to
timely seek a protective order or other appropriate judicial relief. In the
event the disclosing Party is unable to obtain a protective order or other
appropriate judicial relief, the receiving Party shall disclose only that
portion of the disclosing Party’s confidential information which is legally
required to be disclosed, and ensure that all such confidential information of
the disclosing Party shall be redacted to the fullest extent permitted by law
prior to such disclosure and that the disclosing Party shall be given an
opportunity to review the confidential information prior to its disclosure.

10.4       The obligations of confidence and non-use referred to in this Clause
10 shall not extend to any information which the Party seeking to disclose such
information:

(a) is or becomes generally available to the public otherwise than by reason of
a breach by the receiving Party of the provisions of this Clause 10;

(b) is known to the receiving Party and is at its free disposal prior to its
receipt from the disclosing Party;

(c) is subsequently disclosed to the receiving Party without being made subject
to an obligation of confidence by a third Party;

(d) Lonza or Omeros may be required to disclose under any statutory, regulatory
or similar legislative requirement, subject to the imposition of obligations of
secrecy wherever possible in that relation; or

(e) is developed by any servant or agent of the receiving Party without access
to or use or knowledge of the information by the disclosing Party.

10.5       The Parties acknowledge that:

(a) without prejudice to any other rights and remedies that the Parties may
have, the Parties agree that the Lonza Know-How and Omeros Information is
valuable and that damages may not be an adequate remedy for any breach of the
provisions of this Clause 10. The Parties agree that the relevant Party will be
entitled without proof of special damage to seek the remedies of an injunction
and other equitable relief for any actual or threatened breach by the other
Party;

(b) save as provided herein Lonza shall not at any time have any right, title,
license or interest in or to Omeros Information, Omeros Patent Rights or any
other intellectual property rights vested in Omeros or to which Omeros is
entitled; and

(c) Omeros shall not at any time have any right, title, license or interest in
or to Lonza Know-How, the Lonza Patent Rights or any other intellectual property
rights relating to the Process which are vested in Lonza or to which Lonza is
otherwise entitled.

10.6       Following ten (10) years after the expiration or termination of this
Agreement, the Parties shall have no affirmative obligations under Clauses 10.1,
10.2 and 10.3 except with respect to trade secrets and/or know-how, for which
all affirmative obligations of this Clause 10 will continue for so long as such
information remains a trade secret and/or know-how under applicable law.
Notwithstanding any provision to the contrary, this Clause 10.6 shall not be
construed as the grant of any license or any other right to either Party to use
at any time the Intellectual Property, know-how, or confidential Information of
the other Party except as set forth expressly in this Agreement or in connection
with the ordinary course of performance under this Agreement.

11.  Audits, Inspections and Records

11.1       Once annually during the term of this Agreement, and subject to
Lonza’s obligations of confidentiality to Third Parties, Lonza will permit
Omeros to conduct one quality assurance audit of those portions of the
Facilities and Quality Systems where Services are being conducted upon
reasonable advance notice and at reasonable times during regular business hours,
provided, however, that Omeros may conduct additional “for cause” audits
following issuance of Form FDA-483s, GMP inspection reports or similar reports
delivered by Regulatory Authorities to Lonza pertaining to the Processing of
Product, performance of other Services for Omeros, or the occurrence of other
events which are likely to adversely affect the Processing of Product or other
Services for Omeros as frequently as requested by Omeros, at reasonable times
and for reasonable duration, until Lonza has corrected such deficiencies and as
set out further in a separate Quality Agreement. Additionally, Lonza will permit
Omeros to conduct a  mock pre-approval inspection audit, not to exceed three (3)
days in duration or as otherwise reasonably required, in support of Regulatory
Applications or cGMP Qualified Person audit to support Qualified Person batch
certification.

11.2       Each Party shall notify the other Party promptly of any inspection or
inquiry by any Regulatory Authority concerning the Lonza Facilities to the
extent pertaining to processing of cell banks, drug substance or drug product,
any SOW or Processing of Product and as set out further in a separate Quality
Agreement.  Each Party shall cooperate with Regulatory Authorities in connection
with any such inspection or inquiry and shall cooperate with the other Party in
providing the information needed for any

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response.  Each Party acknowledges that it may not direct the manner in which
the other Party fulfils its obligations to permit inspection by a Regulatory
Authority.

11.3       Unless the Parties otherwise agree in writing, Lonza shall maintain
materially complete and accurate batch, laboratory and other technical records
related to Product for the minimum period required by Applicable Laws, in
accordance with Lonza’s standard operating procedures and as set out further in
the Master Batch Record and the Quality Agreement.

11.4       Lonza and Omeros shall allocate responsibility for complying with
cGMP (if applicable) between themselves as set forth in the Quality Agreement.
Each Party shall provide the other with all reasonable assistance and take all
actions reasonably requested by the other to enable the requesting Party to
comply with any Applicable Laws relating to the performance by a Party of its
obligations hereunder.

11.6       Omeros shall be solely responsible for and will obtain all permits
and licenses required by any Regulatory Authority with respect to the Product
and any Services under this Agreement for which Omeros is responsible, including
any product licenses, applications and amendments in connection
therewith.  Lonza will be responsible to maintain all permits and licenses
required by any Regulatory Authorities in the United States, the EU and national
and local jurisdictions in which the Lonza Facility is located, with respect to
the Lonza Facility generally.  During the Term, Lonza will assist Omeros with
all regulatory matters relating to Services under this Agreement, at Omeros’
request and at Omeros’ expense.  Each Party intends and commits to cooperate to
satisfy all Applicable Laws relating to Services under this Agreement.

12.  Term and Termination

12.1       Term. This Agreement shall commence on the Effective Date and shall
expire five (5) years after Launch of Product in in either US or EU territory
unless terminated earlier as provided herein, or by mutual written agreement of
the Parties (the “Initial Term”).

12.1.1    Three (3) years prior to the end of the Initial Term, Omeros shall
provide written notice to Lonza if it wishes not to extend the Agreement for a
further four (4) years (an “Extension Term”) and absent such notice the
Agreement shall automatically extend for the further four (4) years  The Initial
Term and any Extension Term are together referred to herein as the “Term”.

12.2       If it becomes apparent to either Lonza or Omeros at any stage in the
provision of the Services that it will not be possible to obtain First Approval
of the Product from the Facility and written notice of such has been provided to
the other Party, following such written notice a[***] day period shall be
allowed for good faith discussion and attempts to resolve such problems. If such
problems are not resolved within such period, Lonza and Omeros shall each have
the right to terminate the Agreement forthwith by notice in writing. In the
event of such termination, Omeros shall pay to Lonza all amounts owed under
Purchase Orders for Batches ordered that have been cancelled by Omeros and
applicable SOWs for Services performed in accordance with the SOW and this
Agreement by Lonza prior to such termination (including a pro rata proportion of
the Price for any stage of the Services which is in process at the date of
termination) and all expenses reasonably incurred by Lonza in giving effect to
such termination, including the costs of terminating any commitments entered
into and in accordance the Agreement, [***].

12.3       The obligation to make payment under Clause 12.2 shall be reduced
(retrospectively, and hence Lonza shall make an appropriate refund to Omeros) to
the extent that Lonza mitigates its loss in this regard (and Lonza shall use
commercially reasonable efforts to mitigate its loss and shall promptly notify
Omeros of any such mitigation). This provision shall not entitle Omeros to be
refunded an amount greater than that paid by Omeros to Lonza pursuant to this
Clause 12 and Lonza shall be entitled to deduct from the amount due to be
refunded to Omeros its reasonable personnel and associated costs in attempting
to mitigate its loss.

12.4       For the avoidance of doubt activities relating to cGMP fermentation
shall be deemed to commence with the date of removal of the vial of cells from
frozen storage for the performance of the fermentation.

12.5       The Parties may each terminate the Agreement for cause forthwith by
notice in writing to the other Party upon the occurrence of any of the following
events:

(a) if the other commits a material breach of the Agreement (which shall include
a breach of the warranties set out in Clause 9 above) which in the case of a
breach capable of remedy is not remedied within [***] days of the receipt by the
other of notice identifying the breach and requiring its remedy  (reasonable
efforts to cure said breach shall be made within [***]  days of receipt of
notice); or

(b) if the other ceases for any reason to carry on business or compounds with or
convenes a meeting of its creditors or has a receiver or manager appointed in
respect of all or any part of its assets or is the subject of an application for
an administration order or of any proposal for a voluntary arrangement or enters
into liquidation (whether compulsorily or voluntarily) or undergoes any
analogous act or proceedings under foreign law; or

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(c) if the Product is withdrawn from US and EU markets following First Approval,
any Batches ordered at the time of termination may be cancelled by Omeros and
shall be subject to the termination provisions herein and any Raw Materials
received or irrevocably committed shall be paid to the extent specified in the
termination provisions herein.

12.6       Consequences of termination.

12.6.1    In the event of termination of this Agreement without cause by Omeros,
all Services and Batches ordered pursuant to a Purchase Order shall be deemed to
have been cancelled and Omeros shall pay Lonza for:

(a) all Services rendered up to the date of termination, including in respect of
any Product in-process;

(b) all costs incurred through the date of termination, including Raw Materials
costs and Raw Materials Fees for Raw Materials used or purchased or to which
Lonza is irrevocably committed for use in connection with the Services;

(c) all unused Raw Materials and Resins shall be paid for by Omeros within [***]
 days of invoice and at Omeros’ option will either be: (a) held by Lonza for
future use for the production of Product; (b) delivered to Omeros; or (c)
disposed of by Lonza.

12.6.2    Termination by Lonza under Clause 12.5(a) or 12.5(b). Upon termination
of this Agreement by Lonza under Clause 12.5(a) or 12.5(b), subject to Lonza’s
obligations under Clause 12.7,  Omeros  shall pay to Lonza: (a) Termination Fees
of any unpaid portions of [***]% of all Binding Orders in effect on the
notification date of such termination for which Services have commenced and/or
at least partial payment has been made by Omeros, less the amount of any such
slots that Lonza is able to resell, (b) Termination Fees of [***]% of all
Binding Orders placed but for which Services have not yet commenced and for
which Omeros has not yet made any payment, less the amount of any such slots
that Lonza is able to resell, and (c) for all Services provided but not paid as
of the effective date of termination (including a pro-rata proportion of the
Price for any stage of the Services which is in progress at the date of the
termination).

12.6.3    Termination by Omeros under Clause 12.5(a) or 12.5(b).  Upon
termination of this Agreement by Omeros under Clause 12.5(a) or 12.5(b) all
Binding Orders shall be deemed cancelled without any Termination Fees and Omeros
shall have no further obligation to Lonza under this Agreement, except that
Customer shall pay to Lonza: (a) for all Services not under dispute provided but
not paid as of the effective date of termination (including a pro-rata
proportion of the Price for any stage of the Services which is in progress at
the date of the termination); and (b) the costs of any non-cancellable
commitments of subcontractors and External Laboratories; and (c) all expenses
reasonably incurred by Lonza in giving effect to such termination, in each case
after reasonable efforts to mitigate all such expenses, including the costs of
terminating any non-cancellable commitments entered into under the Agreement
that cannot be cancelled despite reasonable efforts to do so or cannot be
re-purposed for other customers.

12.6.4.  Termination due to Market Withdrawal.  If Omeros withdraws the Product
from the U.S.  and European Union markets or is directed to do so by any
regulatory agency and as a result, Omeros or Lonza terminates the Agreement in
accordance with Clause 12.5(c), then Omeros shall pay a termination fee in the
amount of [***]% of the Batch Price for all  Batches under a Binding Order.
Lonza shall use commercially reasonable efforts to try and secure a replacement
reservation from a new project, whilst observing its contractual commitments of
other customers, and if it is able to secure such replacement reservation Omeros
shall be relieved proportionally of its obligation to pay a termination fee.

12.7       Upon the termination of the Agreement for whatever reason:

(a) Lonza shall promptly return to Omeros all Omeros Information and shall
dispose of or return to Omeros the Omeros Materials (and where supplied by
Omeros the Cell Line) and any materials therefrom, as directed by Omeros;

(b) Omeros shall promptly return to Lonza all Lonza Know-How it has received
from Lonza, except for that included as part of license provided for in Clauses
2.8(a), and 2.8 (b), as applicable, or as part of the license to the New General
Application Intellectual Property provided for in Clause 8.4;

(c) Omeros shall not thereafter use or exploit the Lonza Patent Rights or the
Lonza Know-How in any way whatsoever, except for that included as part of
license provided for in Clauses 2.8(a), and 2.8 (b), as applicable, or as part
of the license to the New General Application Intellectual Property provided for
in Clause 8.4;  and

(d) Lonza and Omeros shall do all such acts and things and shall sign and
execute all such deeds and documents as the other may reasonably require to
evidence compliance with this Clause 12.7.

12.8       Omeros will have the right upon its request, during the term of or
within [***] following expiration or termination of this Agreement, to transfer
the Cell Line and Process, to itself and any Third Party for the manufacture of
that Product (but no other product) that:

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(a) is an IP-Respecting Entity;

(b) is listed on Schedule 3 hereto, as the same may be updated from time-to-time
by written agreement of the Parties; or

(c) is consented to by Lonza in writing, such consent not to be unreasonably
withheld or delayed, and Lonza shall not be considered to be unreasonably
withholding its consent if (inter alia) Omeros wishes to transfer the Cell Line
and the Process to any legal person or entity which is not an IP-Respecting
Entity;

provided always, however, to the extent such technology transfer includes
Lonza‘s Confidential Information, Lonza’s Intellectual Property and/or New
General Application Intellectual Property such technology transfer shall be
subject to a royalty and licensing fee for the purchase of media and feeds as
provided for in Clauses 2.8(a) or 2.8(b), as applicable, and at all times shall
also be subject to the outline technology transfer terms set forth in Schedule 2
hereto.

Lonza shall diligently provide reasonably necessary documents to complete such
technology transfer and reasonable assistance to complete such technology
transfer, provided that Omeros shall reimburse Lonza for any costs based on
Lonza’s standard full-time employee rate for such support which is applicable at
the date of such technology transfer and the outline technology transfer terms
of Schedule 2.

For purposes of clarity, the outline technology transfer terms of Schedule 2
shall not apply if Omeros transfers the Cell Line to a Third Party without any
transfer of the Process.

12.9       Termination of this Agreement for whatever reason shall not affect
the accrued rights of either Lonza or Omeros arising under or out of this
Agreement and all provisions which are expressed to survive the Agreement shall
remain in full force and effect.

13. Force Majeure

13.1       If either Party is prevented or delayed in the performance of any of
its obligations under the Agreement by Force Majeure it shall give written
notice thereof to the other Party specifying the matters constituting Force
Majeure together with such evidence as it reasonably can give and specifying the
period for which it is estimated that such prevention or delay will continue,
and it shall be excused from the performance or the punctual performance of such
obligations as the case may be from the date of such notice for so long as such
cause of prevention or delay shall continue.  The Party that may invoke this
clause shall use commercially reasonable efforts to reinstate its ongoing
obligations to the other Party as soon as practicable.  If the cause(s) shall
continue unabated for 180 days, then both Parties shall meet to discuss and
negotiate in good faith what modifications to this Agreement should result from
such cause(s) and if not resolvable either Party shall have the right to
terminate this Agreement.

13.2       The expression "Force Majeure" shall be deemed to include any cause
affecting the performance by a Party of the Agreement arising from or
attributable to acts, events, acts of God, omissions or accidents beyond the
reasonable control of the Party.

14. Governing Law, Jurisdiction and Enforceability

14.1       The construction, validity and performance of the Agreement shall be
governed by the laws of the State of New York, USA, and Lonza and Omeros submit
to the non-exclusive jurisdiction of the US Federal Courts located in the State
of New York, USA.

14.2       No failure or delay on the part of either Lonza or Omeros to exercise
or enforce any rights conferred on it by the Agreement shall be construed or
operate as a waiver thereof nor shall any single or partial exercise of any
right, power or privilege or further exercise thereof operate so as to bar the
exercise or enforcement thereof at any time or times thereafter.

14.3       Any disputes relating to issues arising from this Agreement shall, in
the absence of resolution within thirty (30) days of the dispute arising, be
referred to the Chief Executive Officers of Omeros and Lonza, who shall discuss
the matter and attempt to resolve it by mutual consent. If the Chief Executive
Officers of Omeros and Lonza cannot resolve the dispute within thirty (30) days
of the matter being referred to them, either Party may, by written notice to the
other Party, invoke the mediation procedure set out in Clause 14.4 below.

14.4       If a dispute arises between the Parties that the Parties cannot
resolve pursuant to Clause 14.3 above, the Parties agree to attempt in good
faith to resolve such dispute by mediation administered by the CPR Institute for
Dispute Resolution, 366 Madison Avenue, New York, NY 10017, in New York, New
York, USA. The Parties agree that they shall share equally the cost of any
mediation fees, and the cost of the mediator. Each Party must bear its own
attorneys’ fees and associated costs and expenses. The place of any mediation
shall be New York, New York, USA. If efforts at mediation are unsuccessful
within sixty (60) days of either Party referring the dispute to mediation, then
either Party may require that the dispute shall be resolved by binding

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arbitration in accordance with the then existing commercial arbitration rules of
CPR Institute for Dispute Resolution, 366 Madison Avenue, New York, NY 10017.
Arbitration shall be conducted in New York, New York, USA.

14.5       Nothing in this Clause 14 shall prevent a Party from exercising any
right under this Agreement, including the right of termination under Clause 12
above.

15. Notices

15.1       Any notice or other communication to be given under this Agreement
shall be delivered personally or by international express courier with delivery
confirmation addressed as follows:

(a) If to Lonza to:

LONZA BIOLOGICS TUAS PTE LTD

35 Tuas South Ave 6,

SG Singapore, 637377

With a copy to:

Lonza Biologics plc

228 Bath Road

Slough

Berkshire SL1 4DX

England

For the attention of: The Head of Legal Services

(b) If to Omeros to:

Omeros Corporation

201 Elliott Avenue West

Seattle, WA 98119, USA

For the attention of: General Counsel

With a concurrent copy by e-mail (which shall not constitute notice) to
generalcounsel@omeros.com,

or to such other destination as either Party hereto may hereafter notify to the
other in accordance with the provisions of this Clause 15.

15.2       All such notices or other communications shall be deemed to have been
served as follows:

(a) if delivered personally, at the time of such delivery;

(b) if sent by first class pre-paid post, ten (10) business days (Saturdays,
Sundays and Bank or other public holidays excluded) after being placed in the
post.

16. Illegality

16.1       If any provision or term of this Agreement or any part thereof shall
become or be declared illegal, invalid or unenforceable for any reason
whatsoever:

(a) such provision shall, so far as it is illegal, invalid or unenforceable, be
given no effect by the Parties and shall be deemed not to be included in this
Agreement;

(b) the other provisions of this Agreement shall be binding on the Parties as if
such provision was not included therein; and

(c) the Parties agree to negotiate in good faith to amend such provision to the
extent possible for incorporation herein in such reasonable manner as most
closely achieves the intention of the Parties without rending such provision
invalid or unenforceable.

17. Miscellaneous

17.1       Lonza shall be entitled to instruct one of more of its Affiliates to
perform any of Lonza’s obligations contained in this Agreement within the same
Lonza Facility in which Product is Manufactured, subject to Omeros’ approval,
which shall not be unreasonably withheld or delayed, of the use of such
Affiliate at any other Facility or transfer of any aspect of Manufacturing to
any other of Lonza’s or its Affiliates’ Facility, with no increase in costs, but
Lonza shall remain fully responsible in respect of those

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obligations. Subject thereto, neither Party shall be entitled to assign,
transfer, charge or in any way assign, sub-contract, transfer or delegate the
benefit and/or the burden of this Agreement without the prior written consent of
the other which consent shall not be unreasonably withheld or delayed, save
that:

(a) Lonza shall be entitled without the prior written consent of the Omeros to
assign, transfer, charge, sub-contract, deal with or in any other manner make
over the benefit and/or burden of this Agreement (i) to an Affiliate or (ii) to
any joint venture company of which Lonza, is the beneficial owner of at least
fifty percent (50%) of the issued share capital thereof or (iii) to any company
with which Lonza may merge or (iv) to any company to which Lonza may transfer
its assets and undertaking; provided however in each case such assignee must be
an IP Respecting Entity; and

(b) Omeros shall be entitled to assign this Agreement, including all rights and
obligations arising thereunder, to any Third Party that:-

(i) is an IP-Respecting Entity and is not a Competing Contract Manufacturer,

(ii) is listed on Schedule 3 hereto, as the same may be updated from
time-to-time by written agreement of the Parties,

(iii) is consented to by Lonza, such consent not to be unreasonably withheld or
delayed, provided that Lonza shall not be considered to be unreasonably
withholding its consent if (inter alia) Omeros wishes to assign this Agreement
to any legal person or entity which is (i) a Competing Contract Manufacturer, or
(ii) not an IP-Respecting Entity; or

(iv) is in connection with the sale or transfer (by whatever method) of all or
substantially all of the business related to the subject matter of this
agreement; provided, further, that such Affiliate or Third Party, as applicable,
acknowledges and assumes in writing all of the assigning Party’s obligations
under the Agreement.  For purposes of this Clause 17.1, the terms “assign” and
“assignment” shall include, without limitation (i) the sale, exchange, transfer
or issuance of fifty percent (50%) or more of the outstanding stock of such
Party to an Affiliate of such Party or an unrelated entity or natural person,
(ii) the sale or transfer or other disposition of all or substantially all of
the assets of the Party or the line of business or Product to which this
Agreement relates, and (iii) a merger, consolidation, acquisition or other form
of business combination.  Any purported assignment in violation of the foregoing
shall be void.  No assignment shall relieve any Party of responsibility for the
performance of any obligation that accrued prior to the effective date of such
assignment. Subject to the foregoing, this Agreement shall bind and inure to the
benefit of the respective Parties and their successors and permitted assigns.

17.2       The obligations of the Parties under Clauses 2.8 (Omeros Cell Line
and Lonza Process and Omeros Cell Line and Omeros Process),  8  (Intellectual
Property), 9  (Warranties and Indemnification), 10 (Confidentiality), 12.6
(consequences of termination), 12.7 (Technology Transfer), 14 (Governing Law,
Jurisdiction and Enforceability) and 17 (Miscellaneous) shall survive the
termination of this Agreement for any reason.

17.3       The text of any press release or other communication to be published
by or in the media concerning the subject matter of the Agreement shall require
the prior written approval of Lonza and Omeros.

17.4       The Agreement embodies the entire understanding of Lonza and Omeros
and there are no promises, terms, conditions or obligations, oral or written,
expressed or implied, other than those contained in the Agreement. The terms of
the Agreement shall supersede all previous agreements (if any) which may exist
or have existed between Lonza and Omeros relating to the Services, except that
with respect to the process validation Batches ordered by Omeros under the
Development Agreement and the commercial Batches ordered by Omeros under the
Development Agreement,  all terms of this Agreement shall apply to such Batches
except for the price of such Batches, which shall be as set forth in the
Development Agreement rather than in this Agreement.

17.5       The Parties to this Agreement do not intend that any term hereof
should be enforceable by virtue of the Contracts (Rights of Third Parties) Act
1999 by any person who is not a Party to this Agreement.

17.6       The relationship of the Parties is that of independent contractors,
and neither Party will incur any debts or make any commitments for the other
Party except to the extent expressly provided in this Agreement.  Nothing in
this Agreement is intended to create or will be construed as creating between
the Parties the relationship of joint ventures, co-partners, employer/employee
or principal and agent.  Neither Party shall have any responsibility for the
hiring, termination or compensation of the other Party’s employees or
contractors or for any employee benefits of any such employee or contractor.

17.7       No variation of or addition to this Agreement or any part thereof
shall be effective unless in writing and signed on behalf of both Parties.
Notwithstanding the above the Parties hereby confirm that amendments to the
Specification shall be effective if reduced to writing and signed by the quality
and/or regulatory representative of both Parties, which quality and/or
regulatory representative shall be nominated from time to time by each Party.

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AS WITNESS the hands of the duly authorised representatives of the Parties
hereto the day and year first above written.

 

 

OMEROS CORPORATION 

LONZA BIOLOGICS TUAS PTE LTD

 

 

Signature: /s/ Gregory A. Demopulos

Signature: /s/ [***]

Printed Name: Gregory A. Demopulos, M.D.

Printed Name: [***]

Title: Chairman & CEO

Title: General Manager, [***]

 

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SCHEDULE 1

PRICING

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SCHEDULE 2

OUTLINE TERMS FOR TECHNOLOGY TRANSFER FROM LONZA TO CUSTOMERS

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SCHEDULE 3

APPROVED THIRD PARTIES

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