DEFINITIONS.

1

ASSET ACQUISITION; ASSUMPTION OF LIABILITIES

26

2.1

Acquired Assets

26

2.2

Excluded Assets

29

2.3

Assumed Liabilities

30

2.4

Excluded Liabilities

30

2.5

Assignment of Certain Transferred Assets; Shared Contracts

31

CLOSING

33

3.1

Closing

33

3.2

Payment of Consideration

34

3.3

Closing Deliveries by Omeros

34

3.4

Closing Deliveries by Novo Nordisk

35

EFFORTS; ANTITRUST APPROVAL

35

LICENSE GRANT; EXCLUSIVITY

36

5.1

Licenses to Novo Nordisk

36

5.2

Licenses to Omeros

36

5.3

Sublicenses

37

5.4

Exclusivity

37

5.5

No Implied Right

38

5.6

Technology Transfer

39

5.7

Know-How Disclosure

39

5.8

Manufacturing Technology Transfer Obligations

39

DEVELOPMENT, MEDICAL AFFAIRS, AND COMMERCIALIZATION

40

6.1

Development and Medical Affairs

40

6.2

Clinical Records and Regulatory Assistance

40

6.3

Right of Reference

40

6.4

Commercialization

40

6.5

Diligence Obligations

40

6.6

Omeros Support

41

6.7

Acknowledgment

41

6.8

Rare Pediatric Priority Review Voucher

41

FINANCIAL TERMS

41

7.1

Upfront Fee

41

7.2

Development Milestones

42

7.3

Sales Milestones

42

7.4

Net Sales Payments

43

7.5

Expiration of the Net Sales Term

43

7.6

Payment Reductions

43

7.7

Payment Terms

44

7.8

Currency and Exchange Rate

44

7.9

Mode of Payment

45

7.10

Royalty Reports

45

7.11

Audit Right

45

7.12

Taxes

46

INTELLECTUAL PROPERTY.

48

8.1

Ownership of Background Technology

48

8.2

Ownership of Arising Technology

48

8.3

Prosecution and Maintenance

48

8.4

Third Party Infringement

49

8.5

Third Party Rights

50

8.6

Patent Right Term Extension

51

8.7

Regulatory Patent Right Listings

51

CONFIDENTIALITY; PUBLICITY; PRIVILEGE.

51

9.1

Confidential Information; Non-Disclosure and Non-Use Obligations

51

9.2

Exemptions

52

9.3

Permitted Disclosures

52

9.4

Breaches of Confidentiality

53

9.5

Publication

54

9.6

Publicity

54

9.7

Attorney-Client Privilege

55

REPRESENTATIONS AND WARRANTIES; COVENANTS.

55

10.1

Mutual Representations

55

10.2

Representations of Omeros

58

10.3

DISCLAIMER OF WARRANTIES

74

10.4

Additional Covenants by Omeros

75

10.5

Compliance

79

10.6

Prohibited Conduct

80

10.7

Further Assurances

80

10.8

PIIA Rights

80

10.9

Access to Information

81

10.10

Transfer of Acquired Assets

82

10.11

Wrong Pockets

82

Conditions to Close

83

11.1

Conditions to Each Party’s Obligations

83

11.2

Conditions to Obligations of Novo Nordisk

83

11.3

Conditions to Obligations of Omeros.

11.4

Frustration of Closing Conditions

INDEMNIFICATION

85

12.1

Survival

85

12.2

Indemnification by Omeros

86

12.3

Indemnification by Novo Nordisk

87

12.4

Indemnification Procedures

87

12.5

Third Party Claim Procedures

89

12.6

Limitation of Liability

89

12.7

Set-Off

89

12.8

Insurance

90

12.9

No Double Recovery

90

12.10

Scrape

90

12.11

Mitigation

90

12.12

Exclusive Remedy

90

TERM; TERMINATION

91

13.1

Term

91

13.2

Termination Prior to Closing

91

13.3

Termination for Bankruptcy; Rights in Bankruptcy

92

13.4

Effects of Termination

93

13.5

Remedies

94

13.6

Novo Nordisk Termination Fee.

95

13.7

Survival

95

DISPUTE RESOLUTION

95

14.1

Governing Law; Venue

95

14.2

Disputes

95

14.3

Equitable Relief

96

14.4

Excluded Claims

96

MISCELLANEOUS

96

15.1

Assignment

96

15.2

Omeros Change of Control.

97

15.3

Relationship of the Parties

98

15.4

Entire Agreement

98

15.5

Amendments

98

15.6

Severability

98

15.7

Force Majeure

98

15.8

Notices

99

15.9

Construction

100

15.10

Interpretation

100

15.11

Headings

100

15.12

Waiver and Non-Exclusion of Remedies

100

15.13

Performance by Affiliates

101

15.14

Further Assurances

101

15.15

No Third Party Beneficiary Rights

101

15.16

Counterparts

101

Schedule1.52

Compound Sequences

Schedule1.86

Excluded Contracts

Schedule1.120

Grandfathered MASP-3 Antibody

Schedule1.123

Grandfathered SMOL MASP-3 Molecule

Schedule1.151

Licensed Background Know-How

Schedule1.152

Licensed Background Patent Rights

Schedule1.171

Multi-Target Patent Rights

Schedule1.188

Novo Nordisk Licensed Technology

Schedule1.191

Omeros Account

Schedule1.251(b)

Shared Contracts

Schedule1.278

Unrestricted Field

Schedule2.1.1(a)

Physical Acquired Assets

Schedule2.1.1(b)(i)

Transferred Patent Rights

Schedule2.1.1(b)(ii)

Transferred Know-How

Schedule2.1.1(c)

Closing Transferred Contracts

Schedule2.1.2(a)

Delayed Transferred Contracts

Schedule2.1.2(b)

Delayed Transferred Regulatory Submissions

Schedule2.5.1

Non-Transferrable Assets

Schedule2.5.2

Non-Transferrable Licenses

Schedule2.5.6

Shared Contract Sublicenses

Schedule3.3.2

Assignment and Assumption Agreement

Schedule3.3.3

Bill of Sale

Schedule3.3.6

Lien Release Consent

Schedule3.3.7

Transition Services Agreement

Schedule3.3.8

Intellectual Property Assignment Agreement

Schedule5.1.2

Certain Licensed Patent Rights

Schedule7.7

Invoice Instructions

Schedule9.6.1

Press Release

Schedule11.1.1

Governmental Consents

1.1.

[***].

1.2.

“Accounting Standards” means, with respect to a Party or its Affiliate (or, in the case of Novo Nordisk, its or its Affiliates’ Sublicensee), GAAP or IFRS, as such Party, Affiliate, or Sublicensee uses for its financial reporting obligations, in each case consistently applied, which in the case of Novo Nordisk, will be IFRS.

1.4.

“Acquiring Entity” means (a) a Third Party that acquires all or at least a majority of the outstanding voting equity securities of Omeros (whether in one transaction or a series of related transactions) or to which Omeros transfers all or substantially all of its (i) clinical or commercial business and assets or (ii) business and assets related to compounds and products Directed To targets within the alternative pathway or complement factors, (b) a Third Party that acquires greater than 50% of the outstanding voting equity securities of Omeros and otherwise has the power, directly or indirectly, to exercise managerial authority over the business and affairs of Omeros, or (c) any Affiliate of the Third Party described in clause (a) and (b), other than Omeros or any Affiliates of Omeros prior to the date of the transaction pursuant to which such Third Party became an Acquiring Entity.

1.5.

“Additional Permitted Product” has the meaning set forth in Section 2.5.8 (Assignment of Certain Transferred Assets; Shared Contracts).

1.7.

“Adverse Law or Order” means (a) any Applicable Law enacted, promulgated, or enforced by any Governmental Authority of competent jurisdiction that prohibits or makes illegal the consummation of the transactions contemplated by this Agreement or (b) any Order preventing the consummation of the transactions contemplated by this Agreement, whether preliminary or final.

1.8.

“Affiliate” means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person, in each case, for so long as such control exists. For purposes of this Agreement, a Person will be deemed to control another Person if it owns, directly or indirectly, more than 50% of the equity securities or capital stock of such other Person entitled to vote in the election of directors (or, in the case that such other Person is not a corporation, for the election of the corresponding managing authority), or otherwise has the power, directly or indirectly, to appoint at least a majority of the members of the board of directors (or similar governing body) of such Person. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than 50%, and that in such case, such lower percentage will be substituted in the preceding sentence; provided that such foreign investor has the power, directly or indirectly, to direct or cause the direction of the management and policies of such entity. For purposes of this definition, notwithstanding the foregoing, Novo Holdings A/S, the Novo Nordisk Foundation, and their respective affiliates (other than Novo Nordisk A/S, Novo Nordisk and its or their subsidiaries and any Person that controls the foregoing other than Novo Holdings A/S or the Novo Nordisk Foundation) will not be considered Affiliates of Novo Nordisk hereunder and each will be considered a Third Party hereunder.

1.9.

“Agreement” has the meaning set forth in the preamble. 

1.10.

“aHUS” means atypical hemolytic uremic syndrome.

1.11.

“[***]” means [***] Corporation.

1.12.

“[***] MSA” means that certain Master Services Agreement, dated as of [***] [***] by and between [***] and Omeros, as amended by that certain Amendment #1, dated as of [***], and as further amended by that certain Amendment #2, dated as of [***].

1.13.

“Alternative Pathway Target” means [***], or any precursors, catalytic forms, or intermediates of the foregoing [***].

1.14.

“Ancillary Agreements” means the Intellectual Property Assignment Agreement, the Bill of Sale, the Assignment and Assumption Agreement, the Transition Services Agreement, and any certificate delivered by a Party hereto or any of the Parties’ respective Affiliates at the Closing or otherwise pursuant to this Agreement.

1.15.

“Anti-Corruption Laws” means all U.S. and non-U.S. Applicable Laws relating to the prevention of corruption or bribery, including the U.S. Foreign Corrupt Practices Act of 1977, as amended.

1.16.

“Anticipated Product” means a Product that (a) comprises, consists of, incorporates, or contains the CDR sequences of ‘906 or [***], but (b) expressly excluding any Product for which, [***].

1.15.

“Antitrust Approval” means (a) the HSR Conditions and (b) any other consent of a Governmental Authority of competent jurisdiction under Antitrust Laws, in each case (a) and (b), as required to consummate the transactions contemplated by this Agreement.

1.16.

“Antitrust Laws” means any Applicable Law designed or intended to prohibit, restrict, or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening competition through merger or acquisition, including the HSR Act, the Sherman Act, the Clayton Act and the Federal Trade Commission Act, in each case, as amended along with the rules and regulations promulgated under each, and other similar antitrust, competition, or trade regulation laws of any jurisdiction other than the United States, including any requirement relating to competition and foreign direct investment laws.

1.17.

“Applicable Law” means any applicable international, national, federal, state, regional, provincial, municipal or local government law, rule, treaty (including Tax treaty), regulation or stock exchange listing requirement, as such may be amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto), including the FD&C Act and any other laws, rules, regulations, guidelines, or requirements of Regulatory Authorities, each as may be then in effect, as applicable and amended from time to time.

1.18.

“Applicable Privacy Laws” has the meaning set forth in Section 1.64 (Data Protection and Security Requirements).

1.19.

“Arising Know-How” means any and all Know-How conceived, invented, developed, or otherwise made during the Term by or on behalf of either Party or any of its Affiliates, licensees, sublicensees, or subcontractors, either alone or jointly with the other Party or any such other Party’s Affiliates, licensees, sublicensees, or subcontractors, in each case, in the performance of activities or exercise of rights under this Agreement, the Transition Services Agreement, or any Ancillary Agreement. Arising Know-How includes Arising Sideground Know-How and Know-How within Assigned Arising Technology.

1.20.

“Arising Sideground Know-How” has the meaning set forth in Section 8.2.1 (Arising Sideground Technology).

1.23.

“Asset Sale” has the meaning set forth in the Recitals.

1.32.

“Business Day” means a day other than Saturday, Sunday, or any other day on which commercial banking institutions located in Seattle, Washington or Copenhagen, Denmark, are authorized or obligated by Applicable Law to close.

1.34.

“Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31, except that (a) the first Calendar Quarter of the Term will commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1, or October 1 after the Effective Date, and (b) the last Calendar Quarter will end upon the expiration or termination of this Agreement.

1.44.

“Closing” has the meaning set forth in Section 3.1 (Closing).

1.61.

“Creditor Lien Release Amount” means the payoff amount set forth in the Lien Release Consent calculated through the Effective Date.

1.66.

“Delayed Acquired Assets” has the meaning set forth in Section 2.1.2 (Delayed Acquired Assets).

1.85.

“Excluded Assets” has the meaning set forth in Section 2.2 (Excluded Assets).

1.89.

“Excluded Regulatory Submissions and Approvals” means any Regulatory Submission, Regulatory Approval, or Pricing and Reimbursement Approval Controlled by Omeros that does not reference a Compound or a Product.

1.90.

“Execution Date” has the meaning set forth in the preamble.

1.91.

“Executive Officers” means (a) with respect to Omeros, its Chief Executive Officer and (b) with respect to Novo Nordisk, its Chief Scientific Officer, or, in each case ((a) and (b)), any other person that such officer designates from time to time.

1.92.

“Existing Credit Facility” means the credit facilities and other arrangements provided pursuant to that certain Credit and Guaranty Agreement, dated as of June 3, 2024, among Omeros, as borrower, certain of its Subsidiaries, as guarantors, the lenders party thereto from time to time, Wilmington Savings Fund Society, FSB, as administrative agent for the lenders and as collateral agent for the secured parties therein and any other documents entered into in connection therewith, in each case, as have been or may be amended, restated, supplemented, or otherwise modified from time to time in a manner not otherwise prohibited hereunder.

1.93.

“Exploitation” means to Develop, Manufacture, perform Medical Affairs activities, Commercialize, or otherwise exploit. When used as a verb, to “Exploit” means to engage in any of the foregoing activities.

1.94.

“Family 1” means [***] and all Patent Rights that share a common priority therewith.

1.96.

“Family 3” means [***] and all Patent Rights that share a common priority therewith.

1.97.

“Family 4” means [***] and all Patent Rights that share a common priority therewith.

1.98.

“Family 5” means [***] and all Patent Rights that share a common priority therewith.

1.99.

“Family 6” means U.S. Patent Application No. [***], U.S. Patent Application No. [***], and all Patent Rights that share a common priority with either of the foregoing.

1.100.

“Family 7” means [***] and all Patent Rights that share a common priority therewith.

1.101.

“Family 8” means that certain provisional patent application claiming [***], and all Patent Rights that share a common priority therewith.

1.102.

“FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder.

1.103.

“FDA” means the United States Food and Drug Administration and any successor Regulatory Authority having substantially the same function.

1.104.

“Firewall Indications” means (a) any Indication in the following [***], (b) [***], and (c) [***].

1.105.

“Firewalls” means reasonable walls and screens established between Omeros, on the one hand, and on the other hand an Acquiring Entity, that are consistent with the industry standard to ensure that no Confidential Information of Novo Nordisk, or any non-public information or materials (such as lab notebooks, document management systems, or other documented or memorialized Know-How) or resources (personnel or otherwise) relating to any Acquired Assets, Licensed Technology, or Program In-Licenses are accessible by personnel of such Acquiring Entity of Omeros participating in the Exploitation of a Competing Product or an Alternative Pathway Product, as applicable, during the Term of this Agreement and, other than with respect to any Licensed Technology or Program In-Licenses, thereafter.

1.106.

“First Commercial Sale” means, with respect to a Product in any country, on a Product-by-Product and country-by-country basis, the first commercial transfer or disposition for value of such Product for end use in such country to a Third Party (not being a Sublicensee for the relevant Product) by Novo Nordisk or any of its Affiliates or Sublicensees after such Product has been granted Regulatory Approval in such country and where the sale results in recordable Net Sales. The following sales will not constitute a “First Commercial Sale”: (a) any distribution or other sale solely for so-called investigational new drug sales, clinical studies, compassionate or emergency use, named patient programs, promotional samples, testing samples, donations, or any similar instances; and (b) sales between Novo Nordisk or its Affiliates or Sublicensees for resale.

1.107.

“First Reimbursed Sale” means, with respect to a Product in a country, the First Commercial Sale by Novo Nordisk or any of its Affiliates or Sublicensees after receipt of any applicable Pricing and Reimbursement Approvals for such Product in such country.

1.108.

“Force Majeure” means conditions beyond a Party’s control, including acts of God; war, terrorism, or civil commotion; labor strike or lock-out; any new regulation, law, or order of any Governmental Authority; epidemics or pandemics; failure or default of public utilities or common carriers; and destruction of facilities or materials by fire, earthquake, storm, or like catastrophe.

1.109.

“Fraud” means, with respect to a Party, fraud in respect of the making of any representation or warranty set forth in this Agreement, as applicable, or in any certificate delivered pursuant to this Agreement and requires (a) a false representation (b) knowledge or belief that such representation is false or with reckless indifference to its falsity, (c) an intention to induce the Party to whom such representation is made to act or refrain from acting, (d) that Party’s action or inaction resulted from reasonable reliance upon such false representation, and (e) such Party suffered damage.

1.110.

“FTC” means the United States Federal Trade Commission or any successor agency thereto.

1.111.

“FTE” means the equivalent of a full-time employee or consultant based on annual working hours of [***] hours per year (with no further reductions for vacations and holidays). Overtime, and work on weekends, holidays and the like will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. Additionally, any individual contributing fewer than [***] hours per Calendar Year (or equivalent pro-rata portion thereof for any partial Calendar Year during the Term) will be deemed a fraction of an FTE on a pro-rata basis. The portion of an FTE year devoted by an employee or consultant to activities contemplated by this Agreement will be determined by dividing the number of hours during any [***] period devoted by such employee or consultant to such activities by [***]; provided that no matter how many hours an individual employee or consultant works in such [***] period, such employee or consultant will in no event count for more than [***] FTE.

1.112.

“FTE Costs” means, for any period, the FTE Rate multiplied by the number of FTEs in such period. FTEs will be pro-rated on a daily basis if necessary. The FTE Rate for each Calendar Year after [***] shall be subject to an annual adjustment equal to the change in the consumer price index for the immediately preceding Calendar Year as reported by the United States Bureau of Labor Statistics.

1.113.

“FTE Rate” means a rate of $[***], per FTE per Calendar Year (pro-rated for any partial Calendar Year and for any partial Calendar Year during the Term). The FTE Rate shall be deemed to encompass compensation for expenses of salaries, benefits, supplies, other employee expenses and supporting overhead and general and administration allocations.

1.114.

“GAAP” means the United States generally accepted accounting principles.

1.115.

“Good Laboratory Practices” or “GLPs” means (a) the then-current requirements, standards, practices, and procedures promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58; and (b) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time.

1.116.

“Good Manufacturing Practices” or “GMPs” means (a) the then-current good manufacturing practices and standards promulgated or endorsed by the FDA, as set forth in 21 C.F.R. Parts 210 and 211 and (b) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time.

1.117.

“Government Official” means: (a) any officer, employee (including physicians, hospital administrators, or other healthcare professionals), agent, representative, department, agency, official, or subdivision of any government, military, or international organization, including any ministry or department of health or any state-owned or affiliated company or hospital; (b) any candidate for political office, any political party, or any official of a political party; or (c) any Person acting in an official capacity on behalf of any of the foregoing.

1.118.

“Governmental Authority” means any United States or foreign federal, state, or local government authority of any nature or political subdivision thereof, any multinational organization or authority, or any authority, agency, or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory, or Taxing Authority of any governmental authority or other governmental instrumentality, including, for clarity, a Regulatory Authority, or any governmental court or tribunal (or any department, bureau, or division thereof), or any arbitrator or arbitral body.

1.119.

“Governmental Authorizations” means, other than Regulatory Approvals, all licenses, consents, permits, certificates, filings, registrations, notifications, record-filings, franchises, concessions, authorizations, approvals, ratifications, permissions, clearances, confirmations, exemptions, endorsements, waivers, designations or qualifications issued, granted, given or otherwise made available by or under the authority of any Governmental Authority or pursuant to any requirement under the Applicable Law, including INDs.

1.120.

“Grandfathered MASP-3 Antibody” means any antibody Directed To MASP-3 that contains the CDR sequences set forth on Schedule 1.120.

1.121.

“Grandfathered MASP-3 Antibody Products” means any and all products containing or comprising a Grandfathered MASP-3 Antibody, or any modifications, improvements, or derivatives thereof, in each case, that are Directed To MASP-3.

1.122.

“Grandfathered MASP-3 Products” means any and all Grandfathered MASP-3 Antibody Products and Grandfathered SMOL MASP-3 Products.

1.123.

“Grandfathered SMOL MASP-3 Molecule” means any small molecule Directed To MASP-3 that contains any scaffold that is set forth on Schedule 1.123.

1.124.

“Grandfathered SMOL MASP-3 Products” means any and all small molecule products containing or comprising a Grandfathered SMOL MASP-3 Molecule, or any modifications, improvements or derivatives thereof, in each case, that are Directed To MASP-3.

1.125.

“Health Care Laws” has the meaning set forth in Section 10.2.7(b) (Compliance with Law).

1.126.

“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act and the regulations promulgated thereunder governing privacy, security, and breach notification obligations with respect to individually identifiable health information.

1.127.

“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder.

1.128.

“HSR Conditions” means the following collective conditions, to the extent applicable: (a) any applicable mandatory waiting period under the HSR Act will have expired or earlier been terminated; (b) no injunction (whether temporary, preliminary, or permanent) under any Antitrust Law prohibiting consummation of the transactions contemplated by this Agreement or any material portion thereof will be in effect; and (c) no judicial or administrative proceeding under any Antitrust Law opposing consummation of all or any part of the transactions contemplated by this Agreement will be pending.

1.129.

“HSR Filing” has the meaning set forth in Section 4.1 (Efforts; Antitrust Approval).

1.130.

“IFRS” means the International Financial Reporting Standards.

1.131.

“[***]” has the meaning set forth in Section 7.2.1 (Development Milestone Events and Payments).

1.132.

“In-Licensed Intellectual Property” means the Intellectual Property licensed to Omeros or any of its Affiliates by a Third Party pursuant to an Intellectual Property license or other agreement and that is used or held for use in connection with (a) the Program or (b) the Development, Manufacture, Commercialization, or other Exploitation of a Product or Compound.

1.133.

“IND” means an investigational new drug application filed with the FDA pursuant to 21 C.F.R. Part 312 or any similar application filed with a Regulatory Authority in a country other than the U.S. required to commence Clinical Trials of a pharmaceutical or biologic product, and all supplements or amendments that may be filed with respect to the foregoing.

1.134.

“Indemnification Objection Notice” has the meaning set forth in Section 12.4.1(c) (Direct Claim Procedures).

1.135.

“Indemnification Objection Period” has the meaning set forth in Section 12.4.1(c) (Direct Claim Procedures).

1.136.

“Indemnified Party” has the meaning set forth in Section 12.4.1(a) (Direct Claim Procedures).

1.137.

“Indemnify” has the meaning set forth in Section 12.2.1 (Indemnification by Omeros).

1.138.

“Indemnifying Party” has the meaning set forth in Section 12.4.1(a) (Direct Claim Procedures).

1.139.

“Indication” means a separate and distinct disease, syndrome, disorder, or medical condition in humans that a Product (a) that is in a Clinical Trial is intended to treat in such Clinical Trial, or (b) has received a separate and distinct Regulatory Approval (provided that [***].

1.140.

“Indirect Tax” has the meaning set forth in Section 7.12.5 (Indirect Tax).

1.141.

“Inflation Reduction Act” or “IRA” means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), as it may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

1.142.

“Infringement” has the meaning set forth in Section 8.4.1 (Notification).

1.143.

“Initiate” means with respect to a Clinical Trial, the first dosing of a human subject pursuant to the protocol for such Clinical Trial. “Initiated” will have corresponding meaning.

1.144.

“Intellectual Property” means intellectual property or other proprietary rights anywhere in the world, including registered, unregistered, applied for and pending: (a) Patent Rights; (b) Know-How; (c) trademarks, service marks, trade names, trade dress, corporate names, logos, in each case whether or not registered, together with derivations and combinations thereof, and common law rights thereto, and the goodwill associated with the foregoing, and applications (including intent to use applications), registration and renewals of the foregoing; and (d) published and unpublished works of authorship including computer software programs, applications, source code and object code, and technical databases, copyrights in and to the foregoing, together with common law rights and moral rights therein, and any applications and registrations therefor, including extensions, renewals, restorations, reversions, derivatives, translations, localizations, adaptations and combinations of the above; and all rights to collect royalties and proceeds in connection with any of the foregoing, and to sue and bring other claims for past, present and future infringement, misappropriation or other violation of any of the foregoing, and to recover damages in connection therewith.

1.145.

“Intellectual Property Assignment Agreement” has the meaning set forth in Section 3.3.8 (Closing Deliveries by Omeros).

1.146.

“Invention Assignment Agreement” has the meaning set forth in Section 10.2.11(g) (Employee Invention Assignment and Confidentiality).

1.147.

“Inventory” means, as of the Closing, (a) all inventory of finished Product (including those manufactured for clinical studies) owned by Omeros or any of its Affiliates, whether or not Labeled, (b) all Product work-in-progress (including drug substances and those manufactured for clinical studies) owned by Omeros or any of its Affiliates, and (c) all other inventory (including any non-GMP materials, reference materials, any associated drug products, drug substances, and any active pharmaceutical ingredient related impurities) owned by Omeros or any of its Affiliates, in each case, used or held for use in connection with the Exploitation of any Compound or any Product, whether located at a facility of Omeros or any of its Affiliates or its suppliers and manufacturers.

1.148.

“Know-How” means all commercial, technical, scientific, and other know-how and information, in each case, that is not in the public domain or otherwise publicly known, including concepts, strategies, models, instructions, materials, protocols, inventions, discoveries, trade secrets, knowledge, technology, methods, processes, practices, formulae, amino acid sequences, nucleotide sequences, instructions, skills, techniques, procedures, ideas, technical assistance, designs, drawings, assembly procedures, specifications, and data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety, manufacturing, and quality control data and know-how, including regulatory data, study designs, and protocols), in all cases, whether or not patentable and in written, electronic, or any other form now known or hereafter developed, but expressly excluding all published Patent Rights. For clarity, Know-How includes any such information comprised or embodied in any applicable physical materials, but excludes published Patent Rights.

1.149.

“Labeling” (and the correlative terms “Label” and “Labeled”) has the meanings as defined in Sections 201(k) and 201(m) of the FDCA (21 U.S.C. § 321(k), (m)) and other comparable non-U.S. Applicable Law relating to the subject matter thereof, including the applicable Product’s label, packaging and package inserts accompanying such Product, and any other written, printed, or graphic materials accompanying such Product, including patient instructions or patient medication guides.

1.150.

“Liability” means, with respect to any Person, any debt, liability, duty, or obligation of such Person, whether known or unknown, absolute or contingent, accrued or unaccrued, matured or unmatured, disputed or undisputed, liquidated or unliquidated, secured or unsecured, joint or several, due or to become due, vested or unvested, executory, determined, determinable, or otherwise.

1.151.

“Licensed Background Know-How” means, other than Transferred Know-How, any other Know-How Controlled by Omeros or any of its Affiliates as of the Effective Date, that is necessary or reasonably useful to Exploit one or more Compounds or Products or otherwise conduct the Program, including the Know-How set forth on Schedule 1.151.

1.152.

“Licensed Background Patent Right” means, other than Transferred Patent Rights, (a) any other Patent Rights Controlled by Omeros or any of its Affiliates as of the Effective Date, that Cover any Licensed Background Know-How or are otherwise necessary or reasonably useful to Exploit one or more Compounds or Products or otherwise conduct the Program, including those Patent Rights set forth on Schedule 1.152, (b) any other Patent Rights that come into the Control of, or are Controlled by, Omeros or any of its Affiliates during the period commencing on the Effective Date and expiring on the expiration of the applicable Net Sales Term that Cover any Licensed Background Know-How or are otherwise are necessary or reasonably useful to Exploit one or more Products, (c) Multi-Target Patent Rights unless and until divisionals or continuations thereof are filed in accordance with Section 2.5.7 (Assigned and Retained Target Patent Rights) to create Novo Nordisk Assigned Target Patent Rights and Omeros Retained Target Patent Rights, and (d) all Patent Rights in Family 7.

1.153.

“Licensed Background Technology” means the Licensed Background Know-How and the Licensed Background Patent Rights.

1.154.

“Licensed Know-How” means (a) the Licensed Background Know-How, (b) the Arising Sideground Know-How that is necessary or reasonably useful to Exploit one or more Compounds or Products, and (c) any Know-How licensed to Omeros pursuant to a Non-Transferrable License unless and until such Consent is obtained to sell, convey, assign, transfer, or deliver the applicable Non-Transferrable License, but in all cases, expressly excluding all Know-How included in the Transferred Intellectual Property.

1.155.

“Licensed Patent Right” means (a) the Licensed Background Patent Rights, (b) the Arising Sideground Patent Rights that Cover any Licensed Know-How or are otherwise necessary or reasonably useful to Exploit one or more Compounds or Products, (c) any Patent Right licensed to Omeros pursuant to a Non-Transferrable License unless and until such Consent is obtained to sell, convey, assign, transfer, or deliver the applicable Non-Transferrable License, and (d) the Omeros Retained Target Patent Rights that Cover any Licensed Know-How or are otherwise necessary or reasonably useful to Exploit one or more Compounds or Products, but in all cases, expressly excluding all Transferred Patent Rights and any Patent Right that Novo Nordisk elects to exclude from the Licensed Patent Rights in accordance with Section 7.4 (Net Sales Payments).

1.156.

“Licensed Technology” means all Licensed Know-How and all Licensed Patent Rights.

1.157.

“Lien” means any lien, encumbrance, mortgage, security interest, pledge, license, conditional sale agreement, or other title retention agreement.

1.158.

“Lien Release Consent” has the meaning set forth in Section 3.3.6 (Closing Deliveries by Omeros).

1.159.

“Losses” has the meaning set forth in Section 12.2.1 (Indemnification by Omeros).

1.160.

“MAA” or “Marketing Authorization Application” means a biologics license application submitted to the FDA as defined in the Public Health Service Act and 21 C.F.R. 601.2 (including all additions, supplements, extensions, and modifications thereto) or other marketing authorization application, in each case, filed with the applicable Regulatory Authority in a country or other regulatory jurisdiction, which application is required to commercially market or sell a pharmaceutical or biologic product in such country or jurisdiction (and any amendments thereto).

1.161.

“Major European Market” means any of France, Germany, Italy, Spain, or the United Kingdom.

1.162.

“Manufacture” or “Manufacturing” means, with respect to any product (including active pharmaceutical ingredient and other material contained therein), any and all activities related to the manufacture of such product, including qualification, validation and scale-up, pre-clinical, clinical, and commercial manufacture, packaging, labeling, filling, finishing, assembly, processing, in-process and finished product testing, release of such product or any component or ingredient thereof, quality assurance, quality control and audit activities related to manufacturing, testing and release of such product, ongoing stability tests, record-keeping, storage, shipping, supply or storage of such product (or any components or process steps involving such product or any companion diagnostic), placebo or comparator agent, as the case may be, product characterization, technical support activities, and regulatory activities related to any of the foregoing, but excluding any activities directed to Development, Commercialization, or Medical Affairs.

1.163.

“MASP-1” means mannan-binding lectin-associated serine protease-1.

1.164.

“MASP-2” means mannan-binding lectin-associated serine protease-2.

1.165.

“Material Adverse Effect” means any event, fact, condition, occurrence, change, or effect (each, an “Effect”) that individually or in the aggregate, (a) has had or would reasonably be expected to have a material adverse effect on the Acquired Assets, the Assumed Liabilities, the Exploitation of any Compound or Product by Omeros, or the condition of the Program, taken as a whole, or (b) prevents or materially impairs or delays beyond the Outside Date, or would reasonably be expected to prevent or materially impair or delay beyond the Outside Date, the consummation by Omeros of the transactions contemplated by this Agreement; provided, however, that no Effect arising or resulting from the following will be deemed to constitute a Material Adverse Effect or will be taken into account for the purposes of the foregoing clause (a) when determining whether a Material Adverse Effect has occurred or would reasonably be expected to occur: [***].

1.166.

“Maximum Fair Price” means, with respect to a year during a Price Applicability Period for a Selected IRA Drug, the price negotiated pursuant to Section 1194 (and updated pursuant to Section 1195(b), as applicable) under the Inflation Reduction Act for such drug and year.

1.167.

“Medical Affairs” means, with respect to a Product, any and all activities performed by or on behalf of a Party’s or its Affiliates’ medical affairs departments interacting with physicians or other healthcare professionals who may utilize or conduct research related to a pharmaceutical or biological product, including: supporting continuing medical education and other medical programs and communications; patient advocacy programs; development, publication, and dissemination of publications; development and fulfillment of medical information responses; development and execution of disease awareness education including symposia and digital education initiatives; sponsorship and booth exhibition at key congresses; conducting health economic, burden of illness/disease, natural history (to support endpoint validation) and real world evidence studies; seroprevalence studies and registry studies; supporting educational fellowships and research grants, supporting external research efforts such as scientific research agreements and investigator initiated trials (following Regulatory Approval); medical resourcing, training and allocation; medical and scientific platform and content development; conducting appropriate activities involving opinion leaders, including communications and engagement; conducting medical science liaison activities; advisory boards or other consulting programs (to the extent related to medical affairs or clinical guidance); establishing patient registries and expanded access programs; post-approval investigator initiated trials or scientific research agreements; post-approval life cycle management activities and clinical research (other than required by Regulatory Authorities as part of any conditional approval). “Medical Affairs” does not include Development, Manufacturing, or Commercialization.

1.168.

“Medicare Price” means, in respect of a Product, the average negotiated price (as defined in Section 1860D-2(d) of the Social Security Act) under prescription drug plans or MA-PD plans for such Product during the plan year immediately prior to the Initial Price Applicability Year (as defined in Section 1191(b)(1) of the Social Security Act).

1.169.

“Milestone Events” has the meaning set forth in Section 7.3 (Sales Milestones).

1.170.

“Milestone Payments” has the meaning set forth in Section 7.3 (Sales Milestones).

1.171.

“Multi-Target Patent Rights” means the Patent Rights in each of Family 1 and Family 4, which are set forth on Schedule 1.171 (Multi-Target Patent Rights), and the Patent Rights in Family 2 that are set forth on Schedule 1.171 (Multi-Target Patent Rights).

1.172.

“Mutual Confidentiality Agreement” means the Mutual Confidential Disclosure Agreement dated [***], between the Parties (as amended from time to time).

1.173.

“Net Sales” means, as calculated with respect to a Product in the same manner as Novo Nordisk calculates net sales reported to its shareholders, all revenues recognized in accordance with IFRS applied on a consistent basis from the sale of such Product by Novo Nordisk or its Affiliates, licensees, assignees, and Sublicensees to Third Party(ies) (including distributors), less the following deductions, in each case, that are not duplicative and that are actually incurred, allowed, paid, accrued, or otherwise allocated to or for such Product:

(a)

[***]

1.174.

“Net Sales Payments” has the meaning set forth in Section 7.4 (Net Sales Payments).

1.175.

“Net Sales Term” means, on a Product-by-Product and country-by-country basis, the time period beginning on the First Reimbursed Sale of a Product in a country and expiring on the latest of: [***].

1.176.

“Net Sales Term Extending Patent Right” means, with respect to a Product, [***].

1.177.

“Non-Transferrable Asset” has the meaning set forth in Section 2.5.1 (Assignment of Certain Transferred Assets; Shared Contracts).

1.178.

“Non-Transferrable License” has the meaning set forth in Section 2.5.2 (Assignment of Certain Transferred Assets; Shared Contracts).

1.179.

“Novo Nordisk” has the meaning set forth in the preamble.

1.180.

“Novo Nordisk Assigned Target Patent Rights” has the meaning set forth in Section 2.5.7(a) (Assigned and Retained Target Patent Rights).

1.181.

“Novo Nordisk Back Up Omeros Retained Target Patent Rights” means the Omeros Retained Target Patent Rights described in Section 2.5.7(b)(i)(B) (Assigned and Retained Target Patent Rights) and Section 2.5.7(b)(ii)(B) (Assigned and Retained Target Patent Rights). 

1.182.

“Novo Nordisk Closing Certificate” has the meaning set forth in Section 11.3.1(c) (Conditions to Obligations of Omeros).

1.183.

“Novo Nordisk Disclosure Schedule” has the meaning set forth in Section 10.1 (Mutual Representations).

1.184.

“Novo Nordisk First Right Licensed Patent Rights” has the meaning set forth in Section 8.3.4 (Novo Nordisk First Right).

1.185.

“Novo Nordisk First Right Net Sales Patent Rights” has the meaning set forth in Section 8.3.4 (Novo Nordisk First Right).

1.186.

“Novo Nordisk Fundamental Representations” means the representations and warranties of Novo Nordisk as set forth in Section 10.1.1 (Organization), Section 10.1.2 (Binding Agreement), Section 10.1.3 (Authorization) and Section 10.1.4(b) (No Conflicts).

1.187.

“Novo Nordisk Indemnitees” has the meaning set forth in Section 12.2.1 (Indemnification by Omeros).

1.188.

“Novo Nordisk Licensed Technology” means [***] in each case ((a)-(c)), that is necessary [***] in accordance with this Agreement.

1.189.

“OFAC” has the meaning set forth in Section 1.247 (Sanctioned Person).

1.190.

“Omeros” has the meaning set forth in the preamble.

1.191.

“Omeros Account” means the account (or accounts) set forth on Schedule 1.191 hereto or such other account (or accounts) as may be designated by Omeros in writing from time to time.

1.192.

“Omeros Closing Certificate” has the meaning set forth in Section 11.2.1(d) (Conditions to Obligations of Novo Nordisk).

1.193.

“Omeros Disclosure Schedule” has the meaning set forth in Section 10.1 (Mutual Representations).

1.194.

“Omeros Fundamental Representations” means the representations and warranties [***].

1.195.

“Omeros Indemnitees” has the meaning set forth in Section 12.3.1 (Indemnification by Novo Nordisk).

1.196.

“Omeros’ Knowledge”, as used in Omeros’ representations and warranties in Article 10 (Representations and Warranties; Covenants), means the actual knowledge of [***] and [***].

1.197.

“Omeros Reimbursement Amount” means an amount [***].

1.198.

“Omeros Retained Target Patent Rights” has the meaning set forth in Section 2.5.7(b) (Assigned and Retained Target Patent Rights).

1.199.

“Omeros Systems” has the meaning set forth in Section 1.249 (Definition of “Security Incident”).

1.200.

“Order” means any writ, judgment, edict, decree, injunction, ruling, order, determination, or other binding obligation issued by any Governmental Authority (whether preliminary or final).

1.201.

“Organizational Documents” means, with respect to any Person, collectively, its certificate of incorporation, certificate of formation, articles of organization, articles of association, bylaws, operating agreement, certificate of limited partnership, partnership agreement, or equivalent organizational document, as applicable.

1.202.

“Other Components” has the meaning set forth in Section 1.47 (Combination Product).

1.203.

“Out-of-Pocket Costs” means costs and expenses paid by a Party or any of its Affiliates to Third Parties for goods or services, but not including any FTE Costs or such Party’s, or any of its Affiliates’, other internal or general overhead costs or expenses, and expressly excluding any travel costs (unless such travel was expressly requested by Novo Nordisk in writing) and other expenses incurred by a Party’s or any of its Affiliates’ personnel (even if paid to a Third Party).

1.204.

“Outside Date” has the meaning set forth in Section 13.2.2(a) (Termination Prior to Closing).

1.205.

“Party” or “Parties” has the meaning set forth in the preamble.

1.206.

“Patent Right” means all issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region where filed, including all provisional applications, non-provisional applications, substitutions, continuations, supplementary protection certificates, continuations-in-part, continued prosecution applications including requests for continued examination, divisional applications and renewals, and all letters patent or certificates of invention granted thereon, and all reissues, reexaminations, extensions (including pediatric exclusivity patent extensions), term restorations, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions of or to any of the foregoing, and all foreign counterparts of any of the foregoing.

1.207.

“Patent Term Extension” has the meaning set forth in Section 8.6 (Patent Right Term Extension).

1.208.

“Paying Party” has the meaning set forth in Section 7.12.2 (Withholding Tax).

1.209.

“Permitted Financing” means (a) the Existing Credit Facilities and (b) any other arrangements or agreements for the incurrence of indebtedness by Omeros or its Subsidiaries that the creditor requires must be secured by all assets Controlled by Omeros or such Subsidiary (subject to customary or de minimis exceptions).

1.210.

“Permitted Financing Liens” means, subject to Section 10.4.5 (No Encumbrances), any Liens securing a Permitted Financing.

1.211.

“Permitted Lien” means the following Liens: (a) Liens for Taxes, assessments or other governmental charges or levies that are not yet due and payable or that are being contested in good faith by appropriate proceedings and for which adequate reserves have been established in accordance with GAAP; and (b) with respect to any Transferred Contract, any Lien reflected in the terms and conditions of such Transferred Contract.

1.212.

“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture, or other similar entity or organization, including a government or political subdivision, department, or agency of a government.

1.213.

“Personal Information” means any information relating to an identified or identifiable individual or household, including any such information that constitutes “personal data,” “personal information,” “personally identifiable information,” “protected health information,” or an analogous term under applicable Data Protection and Security Requirements.

1.214.

“Phase 2 Trial” means a Clinical Trial of a Product that is designed to evaluate initial efficacy and safety for a particular Indication in patients with the disease or condition under study and that satisfies the requirements of a Phase 2 study in 21 C.F.R. § 312.21(b), or any successor regulation thereto or foreign equivalents.

1.215.

“Phase 3 Trial” means a Clinical Trial of a Product that is designed to demonstrate that such product is safe and effective for an Indication and that satisfies the requirements of a Phase 3 study in 21 C.F.R. § 312.21(c), or any successor regulation thereto or foreign equivalents. Notwithstanding any provision to the contrary set forth in this Agreement, treatment of patients as part of an expanded access program, compassionate sales or use program (including named patient program or single patient program), or an indigent program, in each case, will not be included in determining whether or not a Clinical Trial is a Phase 3 Trial or whether a patient has been dosed thereunder. [***].

1.216.

“PHS Act” means the Public Health Services Act (Title 42, U.S.C., Chapter 6A).

1.217.

“PIIAs” has the meaning set forth in Section 10.8 (PIIA Rights).

1.218.

“PNH” has the meaning set forth in Section 7.2.1 (Development Milestone Events and Payments).

1.219.

“Pre-Closing Period” has the meaning set forth in Section 10.4.1(a) (Conduct of the Business).

1.220.

“Price Applicability Period” means, with respect to a qualifying single source drug, the period beginning on or after 2026 with respect to which such drug becomes a Selected IRA Drug and ending at the end of the last year during which such drug is a Selected IRA Drug.

1.221.

“Pricing and Reimbursement Approval” means [***].

1.222.

“Priority Review Voucher” has the meaning set forth in Section 6.8 (Rare Pediatric Priority Review Voucher).

1.223.

“Proceeding” or “Proceedings” means any claim, action, arbitration, audit, hearing, inquiry, prosecution, contest, examination, proceeding, investigation, litigation, suit (whether civil, criminal, administrative, or investigative or appellate proceeding) commenced, brought, conducted, or heard by or before, or otherwise involving any Governmental Authority, arbitrator, or arbitration panel.

1.224.

“Process” or “Processing” means any operation or set of operations whether or not by automatic means, including collection, recording, organization, storage, retention, access, adaptation, alteration, retrieval, consultation, use, disclosure, dissemination, making available, alignment, combination, blocking, deleting, erasure, or destruction.

1.225.

“Product” means a product that comprises, consists of, incorporates, or contains one or more Compounds, in any presentation, format, formulation or dosage form, but excluding the Grandfathered MASP-3 Products. [***].

1.226.

“Program” means the business of Omeros and its Affiliates relating to the Exploitation of the Compounds and Products, or any candidate, precursor, or intermediate thereof, in each case, as it exists as of the Execution Date or the Effective Date.

1.227.

“Program In-License” means (a) that certain [***] Agreement, dated as of [***], by and between Omeros Corporation and [***] as such agreement may be amended, restated, modified or supplemented from time to time (the “[***] License”); (b) that certain [***] Agreement, dated [***], by and between Omeros Corporation and the [***]; (c) [***]Agreement, dated [***], by and among [***] and Omeros Corporation; and (d) [***]Agreement, dated [***], by and between Omeros Corporation and [***] (“[***]”) as such agreement may be amended, restated, modified, or supplemented from time to time (the “[***] Agreement”).

1.228.

“Proposed Summary” has the meaning set forth in Section 6.1 (Development and Medical Affairs).

1.229.

“Prosecution and Maintenance” or “Prosecute and Maintain” means, with regard to a particular Patent Right in a jurisdiction in the Territory, the preparation, drafting, filing, prosecution, maintenance, correspondences with the applicable Governmental Authorities therefor, and extension of such Patent Right (including any patent office proceedings such as any oppositions, interferences, reissue proceedings, ex-parte reexaminations, and post-grant proceedings for such Patent Right).

1.230.

“Receiving Party” has the meaning set forth in Section 9.1 (Confidential Information; Non-Disclosure and Non-Use Obligations).

1.231.

“Recipient” has the meaning set forth in Section 7.12.2 (Withholding Tax).

1.232.

“Redacted Agreement” has the meaning set forth in Section 9.6.2 (Confidential Treatment).

1.233.

“Registered Intellectual Property” has the meaning set forth in Section 10.2.11(a) (Registered Intellectual Property).

1.234.

“Regulatory Approval” means, individually or collectively, any and all approvals (including MAAs), licenses, registrations, or authorizations of any Regulatory Authority that are necessary to Commercialize a pharmaceutical or biologic product (including a Product) in a given jurisdiction, including any supplements and amendments thereto, but expressly excluding all Pricing and Reimbursement Approvals.

1.235.

“Regulatory Authority” means any Governmental Authorities with authority over the Development, Manufacture, Commercialization, or other Exploitation of a pharmaceutical or biologic product (including a Product), including the right to grant Regulatory Approvals or Pricing and Reimbursement Approvals, which includes the FDA in the U.S., and any other applicable Governmental Authorities having jurisdiction.

1.236.

“Regulatory Exclusivity” means, with respect to an Anticipated Product in a country, any period of market exclusivity [***] granted or afforded by Applicable Law or by a Regulatory Authority in such country that (a) confers exclusive marketing rights [***], and (c) [***]

1.237.

“Regulatory Submissions” means all (a) applications, filings, dossiers, and other documents submitted to a Regulatory Authority in support of the Development, Manufacture, Commercialization, or Exploitation of, or to obtain Regulatory Approval or Pricing and Reimbursement Approvals for, a pharmaceutical or biologic product, including all INDs and MAAs; (b) correspondence and reports submitted to or received from Regulatory Authorities or Review Boards (including all email correspondence and any minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and data with respect thereto, including complete adverse event files, complaint files, and related documents; (c) supplements, amendments, or changes to any of the foregoing following receipt of Regulatory Approval; (d) supporting documentation, filings, notifications, and other items for any of the foregoing, including informed consents or quality-, Manufacturing-, or patient-related documents; and (e) clinical, non-clinical, chemical, biological, analytical, manufacturing, and other data (including from in vitro, ex vivo, or in vivo studies, and indication development data) contained in, referenced in, or relied upon in any of the foregoing; in each case ((a), (b), (c), (d), and (e)) relating to a Compound or Product.

1.238.

“Representatives” has the meaning set forth on Section 10.1.7 (Non-Use and Non-Disclosure by Representatives).

1.239.

“Restricted Field” means the treatment, prevention, diagnosis, or cure of any Indication that is not in the Unrestricted Field.

1.240.

“Restricted Field Period” means the period starting on the Effective Date and ending on the [***] anniversary of the First Commercial Sale of a first Product under the Agreement.

1.241.

“Restricted Indication” means any of the following Indications: [***] provided that if Novo Nordisk or its Affiliates, licensees, assignees, or Sublicensees has not [***] within [***] years after the Effective Date (the “Restricted Indication Period”), then, on an Indication-by-Indication basis, such unpursued Indication(s) will no longer be included as a Restricted Indication; [***].

1.242.

“Restricted Indication Period” has the meaning set forth in Section 1.241 (Restricted Indication).

1.243.

“Review Board” means all institutional review boards, data safety monitoring boards, or ethics committees responsible for review, oversight, or approval of any study (preclinical or clinical) involving any Product in any jurisdiction.

1.244.

“Sales Milestone Event” has the meaning set forth in Section 7.3 (Sales Milestones).

1.245.

“Sales Milestone Payment” has the meaning set forth in Section 7.3 (Sales Milestones).

1.246.

“Sanctioned Country” means any country or region that is the subject or target of a comprehensive embargo under Trade Control Laws (including Cuba, Iran, North Korea, Syria and the Crimea, the so-called Donetsk People’s Republic, and the so-called Luhansk People’s Republic regions of Ukraine).

1.247.

“Sanctioned Person” means any individual or entity that is the subject or target of sanctions or restrictions under applicable Sanctions Laws, including: (a) any individual or entity listed on any applicable U.S. or non-U.S. sanctions- or export-related restricted party list, including the List of Specially Designated Nationals and Blocked Persons administered by the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”); (b) any entity that is, in the aggregate, 50% or greater owned by, directly or indirectly, one or more individuals or entities described in clause (a); or (c) any entity or individual located in, organized under the laws of, a blocked national of, or ordinarily resident in, any Sanctioned Country.

1.248.

“Sanctions Laws” means all Applicable Laws relating to economic or trade sanctions administered or enforced by the United States (including by OFAC or the U.S. Department of State) or any other applicable Governmental Authority.

1.249.

“Security Incident” means (a) any unauthorized access, acquisition, interruption, alteration or modification, loss, theft, corruption or other unauthorized Processing of Personal Information or other confidential information in the possession or control of Omeros or any of its Affiliates, (b) inadvertent, unauthorized, or unlawful sale, or rental of Personal Information or confidential information by Omeros or any of its Affiliates, or (c) any breach of the security of or other unauthorized access to or use of or other compromise to the integrity or availability of the information systems used by Omeros to Process Confidential Information or Personal Information, in each case, in the course of performing activities related to the Program, Acquired Assets, Assumed Liabilities, or any Compound or Product (“Omeros Systems”).

1.250.

“Selected IRA Drug” means a Product that was selected for Medicare Price negotiation and published by the Secretary of the U.S. Department of Health and Human Services, in each case, under the Inflation Reduction Act.

1.251.

“Sharable Summary” has the meaning set forth in Section 6.1 (Development and Medical Affairs).

1.252.

“Shared Contracts” means any Contract that is used in or necessary for both (a) the Program and (b) the operation of any of the businesses or programs of Omeros or its Subsidiaries, other than the Program, including the Contracts set forth on Schedule 1.251(b).

1.253.

“Sublicensee” means any Person, other than a Party or an Affiliate of a Party, to whom Novo Nordisk (or a downstream Sublicensee of Novo Nordisk or owner of the Acquired Assets) grants a sublicense under the licenses or rights granted to Novo Nordisk (or such downstream Sublicensee) under this Agreement.

1.254.

“Subsidiary” means, with respect to any Person, any company, corporation or other organization or Person, whether incorporated or unincorporated, of which (a) such party or any other subsidiary of such party is a general partner (excluding such partnerships where such party or any subsidiary of such party does not have a majority of the voting interest in such partnership) or (b) at least a majority of the securities or other interests having by their terms ordinary voting power to elect a majority of the board of directors or others performing similar functions with respect to such corporation or other organization is directly or indirectly owned or controlled by such party or by any one or more of its subsidiaries or Affiliates.

1.255.

“Target” means mannan-binding lectin-associated serine protease-3 (also commonly referred to as MASP-3).

1.256.

“Tax” means (whether disputed or not) any (a) wherever arising federal, state, local, regional, municipal, or other tax or taxation, levy duty, charge, withholding, capital gains taxes, tariffs, or other assessment of any kind (including any related fine, penalty, addition to tax surcharge, or interest) imposed by, or payable to, a Governmental Authority, including sales, use, excise, stamp, transfer, property, employment, social security, ad valorem, alternative minimum tax, value added, goods and services, withholding, and franchise taxes, and (b) liability for the payment of any amounts of the type described in clause (a) as a result of being party to any tax sharing agreement or as a result of any express or implied obligation to indemnify any other Person with respect to the payment of such amounts.

1.257.

“Taxing Authority” means any federal, state, local or foreign government, any subdivision, agency, commission, or authority thereof, or any quasi-governmental body, exercising tax regulatory authority.

1.258.

“Term” has the meaning set forth in Section 13.1 (Term).

1.259.

“Territory” means worldwide.

1.260.

“Third Party” means any Person other than a Party or a Party’s Affiliates.

1.261.

“Third Party Claim” has the meaning set forth in Section 12.5 (Third Party Claim Procedures).

1.262.

“Third Party Claim Notice” has the meaning set forth in Section 12.5 (Third Party Claim Procedures).

1.263.

“Third Party Expert” has the meaning set forth in Section 2.5.8 (Assignment of Certain Transferred Assets; Shared Contracts).

1.264.

“Third Party IP Payments” has the meaning set forth in Section 7.6.3 (Third Party Payments).

1.265.

“Top Suppliers” has the meaning set forth in Section 10.2.15 (Suppliers).

1.266.

“Trade Control Laws” means (a) any applicable Sanctions Laws, (b) any Applicable Law concerning the importation, exportation, re-exportation, or transfer of goods, software, or technology, including the Export Administration Regulations administered by the U.S. Department of Commerce’s Bureau of Industry and Security, the International Traffic in Arms Regulations administered by the U.S. Department of State’s Directorate of Defense Trade Controls, and customs and import Applicable Laws administered by U.S. Customs and Border Protection, and (c) the antiboycott Applicable Laws administered by the U.S. Department of Commerce’s Office of Antiboycott Compliance and the IRS.

1.267.

“Transfer Plan” has the meaning set forth in Section 5.6 (Technology Transfer).

1.268.

“Transferred Books and Records” has the meaning set forth in Section 2.1.1(e) (Acquired Assets).

1.269.

“Transferred Clinical and Technical Data” has the meaning set forth in Section 2.1.1(f) (Acquired Assets).

1.270.

“Transferred Contracts” means the Closing Transferred Contracts and the Delayed Transferred Contracts.

1.271.

“Transferred Intellectual Property” has the meaning set forth in Section 2.1.1(b) (Acquired Assets).

1.272.

“Transferred Know-How” has the meaning set forth in Section 2.1.1(b) (Acquired Assets).

1.273.

“Transferred Patent Rights” has the meaning set forth in Section 2.1.1(b) (Acquired Assets).

1.274.

“Transferred Regulatory Submissions” has the meaning set forth in Section 2.1.1(d) (Acquired Assets).

1.275.

“Transition Services Agreement” has the meaning set forth in Section 3.3.7 (Closing Deliveries by Omeros).

1.276.

“[***]” has the meaning set forth in Section 1.227 (Program In-License).

1.277.

“[***] Agreement” has the meaning set forth in Section 1.227 (Program In-License).

1.278.

“Unrestricted Field” means the treatment, prevention, diagnosis, or cure of (a) any Indication in the following disease areas: ophthalmology, dermatology, or oncology, (b) any Indication in the following disease areas that is included on Schedule 1.278: musculoskeletal, gastrointestinal, and neurology, or (c) any other Indication in which Omeros is permitted to Exploit a Grandfathered SMOL MASP-3 Product in accordance with Section 5.2 (Licenses to Omeros) or as otherwise agreed in writing by the Parties.

1.279.

“Upfront Fee” has the meaning set forth in Section 7.1 (Upfront Fee).

1.280.

“U.S.” or “United States” means the United States of America and its possessions and territories, including Puerto Rico.

1.281.

“Valid Claim” means, with respect to a Patent Right and a particular country, (a) a claim of any issued and unexpired patent in such country whose validity, enforceability, or patentability has not been terminated by any of the following: (i) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (ii) a holding, finding, or decision of invalidity, unenforceability, or non-patentability, from which decision no appeal can be further taken, or (b) a claim within a patent application in such country that has not been pending for more than [***] from the earliest date to which such claim or the applicable patent application is entitled to claim priority and which claim has not been revoked, cancelled, withdrawn, held invalid, abandoned, or finally rejected by a Governmental Authority from which no appeal can be or has been taken.

1.282.

“Willful Breach” means a deliberate act or omission by a Party, with knowledge of, or reckless disregard for, the reasonably likely consequences of such act or omission, that constitutes a breach of this Agreement.

1.283.

“[***] License” has the meaning set forth in Section 1.227 (Program In-License).

1.284.

“906” has the meaning set forth in Section 1.52 (Compound).

2.1

Acquired Assets.

2.1.1

At the Closing, in accordance with and pursuant to the terms and subject to the conditions of this Agreement, for consideration consisting of the Upfront Fee and any applicable Milestone Payments, Omeros will and will cause its applicable Affiliates to, grant, sell, transfer, convey, assign, and deliver to Novo Nordisk, or any of its Affiliates, as designated by Novo Nordisk, and Novo Nordisk will purchase and accept from Omeros or its Affiliates, all rights, title, and interests of Omeros and its Affiliates, as applicable, as of the Closing, in and to all of the following assets, properties, rights, and interests (collectively, the “Acquired Assets”), free and clear of all Liens, other than Permitted Liens:

(a)

the physical materials under the direct or indirect control of Omeros or its applicable Affiliates, that are [***] to the Compounds or Products or the Development, Manufacture, Commercialization, or other Exploitation thereof, research controls, retained materials from Clinical Trials, and other biological materials, in each case as listed on Schedule 2.1.1(a), except all Inventories (which will be Delayed Acquired Assets to be delivered to Novo Nordisk A/S or its designated Affiliate). Novo Nordisk A/S (or its designated Affiliate) shall pay for, and take possession of certain of, such Inventories in accordance with Section 2.1.2 (Delayed Acquired Assets) below and the Transition Services Agreement;

(b)

(i) the Patent Rights that are owned (whether solely or jointly) or purported to be owned by Omeros or any of its Affiliates [***] any Compound or Product, or any candidate, precursor, or intermediate thereof, or the Manufacture or use thereof (including all composition of matter, method of use, or method of manufacturing Patent Rights) and are, [***] (collectively, the “Transferred Patent Rights”), subject to any limitations, obligations, and rights further set forth in Schedule 2.1.1(b)(i) and Section 2.5.7 (Assigned and Retained Target Patent Rights); (ii) all Know-How owned (solely or jointly) or purported to be owned by Omeros or any of its applicable Affiliates that is [***] and discloses, describes, teaches, or otherwise increases the benefits or reduces the burdens of Exploiting such Compound or Product, or any candidate, precursor, or intermediate thereof or conducting the Program, including the Know-How that is described on Schedule 2.1.1(b)(ii) (collectively, the “Transferred Know-How”); and (iii) all Intellectual Property (other than Patent Rights and Know-How) owned (solely or jointly) or purported to be owned by Omeros or its Affiliates that is [***], including any trademarks, domain names, copyrights, and other brand-associated Intellectual Property relating primarily or specifically to any Product (including “zaltenibart”, domain names containing or comprising “zaltenibart” and variations thereof) (and, together with the Transferred Patent Rights and Transferred Know-How, the “Transferred Intellectual Property”); and in each case ((i)-(iii)), including the right to sue and recover for infringement, misappropriation, unauthorized use, or disclosure with respect to the Transferred Intellectual Property;

(c)

all Contracts identified on Schedule 2.1.1(c), including all rights, benefits, and interests thereunder (the “Closing Transferred Contracts”);

(d)

all Regulatory Submissions held by or on behalf of Omeros or its Affiliates, other than Delayed Transferred Regulatory Submissions, for the Compounds or Products, [***] (the “Closing Transferred Regulatory Submissions”, and together with Delayed Transferred Regulatory Submissions, collectively, “Transferred Regulatory Submissions”);  

(e)

copies of all books and records, including supplier and consultant lists, data, reports, specifications, account lists, distribution lists, batch records, development and commercialization plans and life cycle management data, plans or documents including market research, documents and records of advisory boards, documents and records of Medical Affairs, scientific publications, and any other documents or materials discussed with or distributed to payors or formulary committees, supplier correspondence (in all cases, in any form or medium) and scientific records and files (including laboratory notebooks and invention disclosures), in each case, [***] the Program or the Compounds or Products, or the Development, Manufacture, Commercialization, or other Exploitation thereof [***] (the “Transferred Books and Records”);

(f)

all Clinical and Technical Data [***] the Compounds or Products (the “Transferred Clinical and Technical Data”);

(g)

(i) any and all rights to causes of action, lawsuits, judgments, claims, counterclaims, rights of recovery, and demands and (ii) amounts due to Omeros or any of its applicable Affiliates in respect of a Proceeding or Order, in each case, [***] to or arising from the Transferred Contracts, Compounds or Products, or the Development, Manufacture, Commercialization, or other Exploitation thereof and arising in respect of, or otherwise attributable to, the period on or after the Effective Date;

(h)

all rights under any guaranties, warranties, indemnities, rights of contribution, rights to refunds, rights of reimbursement, and other rights of recovery and similar rights [***] to the Compounds or Products, or the Development, Manufacture, Commercialization, or other Exploitation thereof or the Assumed Liabilities, in each case, to the extent arising on or after the Closing; and

(i)

any other asset, property, or right owned by or belonging to Omeros or its Affiliates, that are not physical materials (including Inventory), Patent Rights or other Intellectual Property, or Contracts, that [***] to the Compounds or Products, or any candidate, precursor, or intermediate thereof, or the Development, Manufacture, Commercialization, or other Exploitation thereof, in each case, [***].

2.1.2

Notwithstanding any provision to the contrary set forth in this Agreement, including in Section 2.1.1 (Acquired Assets), all Contracts identified on Schedule 2.1.2(a) (the “Delayed Transferred Contracts”) and all Regulatory Submissions identified on Schedule 2.1.2(b), as well as all (a) applications, filings, supplements, amendments, and other documents submitted to a Regulatory Authority; (b) correspondence and reports submitted to or received from Regulatory Authorities or Review Boards (including all email correspondence, meeting minutes, and contact reports), including complete adverse event files, complaint files, and related documents; and (c) all supporting documents, reports, and clinical, non-clinical, chemical, analytical, manufacturing, and other data contained in, referenced in, or relied upon in any of the foregoing; in each case ((a), (b), and (c), relating to the Regulatory Submissions identified in Schedule 2.1.2(b) (the “Delayed Transferred Regulatory Submissions”), and all Inventories, and all rights, benefits, and interests thereunder, after the Closing, including any rights to (i) Inventory and any manufacturing capacity, reservations, or allocations under any Delayed Transferred Contracts or (ii) being the direct, named party with respect to any Governmental Authorities under any Delayed Transferred Regulatory Submissions; in each case, will not be granted, transferred, conveyed, assigned, or delivered at Closing by Omeros to Novo Nordisk (or in the case of Inventories, Novo Nordisk A/S or its designated Affiliate), and instead, (A) will be utilized as further provided in the Transition Services Agreement, and (B) except as otherwise provided in the Transition Services Agreement or directed by Novo Nordisk, upon termination or expiration of the Transition Services Agreement, Omeros will grant, transfer, convey, assign, and deliver to Novo Nordisk (and in the case of Inventories, Novo Nordisk A/S or its designated Affiliate), and Novo Nordisk (and in the case of Inventories, Novo Nordisk A/S or its designated Affiliate) will accept from Omeros, all rights, title, and interests of Omeros and its Affiliates, as applicable, at the time of such transfer, conveyance, assignment or delivery, in and to such Delayed Transferred Contracts, Delayed Transferred Regulatory Submissions, and Inventories (collectively, the “Delayed Acquired Assets”), free and clear of all Liens, other than Permitted Liens, in accordance with and pursuant to the terms and subject to the conditions of this Agreement and the Transition Services Agreement. For the avoidance of doubt (x) all Inventory included in the Delayed Acquired Assets will remain owned by Omeros until the transfer, conveyance, assignment, or delivery to Novo Nordisk or its Affiliate pursuant to Section 4.11 of the Transition Services Agreement, and (y) all Delayed Acquired Assets constitute a part of Acquired Assets.

2.2

Excluded Assets. Notwithstanding any provision to the contrary set forth in this Agreement, other than pursuant to Section 2.1.2 (Delayed Acquired Assets) above or the licenses granted under Section 5.1 (Licenses to Novo Nordisk) or as expressly provided in any Ancillary Agreement, Omeros and its applicable Affiliates will retain and will not grant, sell, transfer, convey, assign, or deliver to Novo Nordisk, and Novo Nordisk will not purchase, accept, or otherwise acquire any rights, title, or interests in any assets of Omeros that are not Acquired Assets, including the following assets, which are expressly excluded from the Acquired Assets and are not to be acquired by Novo Nordisk pursuant to this Agreement (the “Excluded Assets”):

2.2.1

all cash, cash equivalents, deposits, bank accounts, other pre-Closing balance sheet assets, and securities and similar cash items of Omeros;

2.2.2

the Licensed Background Technology;

2.2.3

the (a) Omeros Retained Target Patent Rights, and (b) Family 7 Patent Rights;

2.2.4

the Grandfathered MASP-3 Products;

2.2.5

narsoplimab or any other compound or molecule of Omeros or its Affiliates that is not a Compound or Product, including any compound or molecule that is not Directed To the Target;

2.2.6

rights of Omeros or its Affiliates arising under this Agreement or the Ancillary Agreements, as applicable, and all books, documents, records, files, or other items relating to the negotiation and consummation of this Agreement and the other transactions contemplated by this Agreement or the Ancillary Agreements or otherwise prepared in connection with the transactions contemplated hereby and thereby, including all confidential communications with legal counsel representing Omeros and the right to assert attorney-client privilege with respect thereto;

2.2.7

all Tax refunds, credits, offsets, rebates, recoveries, credits of Taxes, Tax losses, loss and credit carry-forwards, and similar benefits related to the Acquired Assets for any taxable period (or portion thereof) ending on or before the Closing or to the extent relating to the other Excluded Assets or any Excluded Liability for all periods;

2.2.8

any rights, claims, causes of action, privileges, counterclaims, or defenses of Omeros or its Affiliates against Third Parties to the extent not related to, or arising from the Program, Acquired Assets, or Assumed Liabilities;

2.2.9

all Excluded Contracts;

2.2.10

any and all personnel, employment compensation, medical and benefits and labor relations records relating to the current and former employees, independent contractors, officers, and directors of Omeros or its Affiliates, or any assets thereof; and

2.2.11

all real property owned by Omeros, and all leasehold interests in real property, that are held by Omeros or any of its Affiliates.

2.3

Assumed Liabilities.

2.3.1

At the Closing, in accordance with and pursuant to the terms and conditions of this Agreement, Novo Nordisk will assume and agree to satisfy and discharge the following Liabilities of Omeros and its applicable Affiliates relating to the Acquired Assets, whether arising on or after the Closing (collectively, the “Assumed Liabilities”):

(a)

all Liabilities arising out of Novo Nordisk’s or any of its Affiliates’, assignees’, licensees’ or Sublicensees’ ownership or use of, or performance under, the Program, any Acquired Asset, any Compounds or Products, or the Exploitation thereof, solely to the extent (i) first arising on or after the Closing and (ii) not arising out of or accruing as a result of any facts or occurrences existing prior to the Closing, including not arising out of or accruing as a result of any failure to perform or other breach, default, or violation by Omeros or any of its Affiliates prior to the Closing;

(b)

all Liabilities arising out of or relating to, or requiring performance under, any Transferred Contracts, solely to the extent (i) arising on or after the Closing and (ii) not arising out of or accruing as a result of any facts or occurrences existing prior to the Closing, including not arising out of or accruing as a result of any failure to perform or other breach, default, or violation by Omeros or any of its Affiliates of any such Transferred Contracts prior to the Closing; and

(c)

all Liabilities arising under any Non-Transferrable Asset arising after the Closing, to the extent not arising from any breach, default or violation of such Non-Transferrable Asset by Omeros prior to the Closing, including not arising out of or accruing as a result of any failure to perform or other breach, default, or violation by Omeros or any of its Affiliates prior to the Closing.

2.3.2

Notwithstanding any provision to the contrary set forth in this Agreement, without duplication of any amounts owed to Omeros under the Transition Services Agreement, Novo Nordisk will assume and agree to satisfy and discharge Assumed Liabilities relating to the Delayed Acquired Assets pursuant to this Agreement on the Effective Date, and the Liabilities of Omeros or its Affiliates relating to such Delayed Acquired Assets shall constitute Assumed Liabilities, to the extent that such Liabilities do not arise from any breach, default, or violation of any Delayed Acquired Assets by Omeros on or prior to the date on which such Delayed Acquired Assets are assigned or transferred to Novo Nordisk.

2.4

Excluded Liabilities. Notwithstanding any provision to the contrary set forth in this Agreement, neither Novo Nordisk nor any of its Affiliates will assume, nor will they be or become responsible for, any Liabilities of the Program or of Omeros or any of its Affiliates other than the Assumed Liabilities, including the following (collectively, the “Excluded Liabilities”):

2.4.1

all Liabilities related to the Grandfathered MASP-3 Products; and

2.4.2

all Liabilities related to or arising out of the activities performed by or on behalf of Omeros or any of its Affiliates in the performance of any activities under Section 5.2 (Licenses to Omeros) or otherwise permitted by Section 5.4 (Exclusivity), including in the Exploitation of any Grandfathered MASP-3 Antibody Products, Grandfathered SMOL MASP-3 Products, or products Directed To an Alternative Pathway Target.

2.5

Assignment of Certain Transferred Assets; Shared Contracts.

2.5.1

Notwithstanding any provision to the contrary set forth in this Agreement or in the Transition Service Agreement, this Agreement will not constitute an agreement for Omeros to sell, convey, assign, transfer, or deliver to Novo Nordisk any Acquired Asset or any claim or right or any benefit arising thereunder or resulting therefrom or for Novo Nordisk to purchase, acquire, or receive any Acquired Asset or assume any liability, in each case, if an attempted sale, conveyance, assignment, transfer, or delivery thereof, without the consent, authorization, or approval of a Third Party (including any Governmental Authority) (a “Consent”), would constitute a breach thereof or a violation of Applicable Law (each, a “Non-Transferrable Asset”). For clarity, any Non-Transferrable Asset that would otherwise constitute an Acquired Asset will not be deemed an Acquired Asset unless and until such Consent is obtained; provided that following Omeros’ receipt of the relevant Consent, Omeros will promptly assign or transfer to Novo Nordisk the Non-Transferrable Asset and such asset will thereafter be deemed an “Acquired Asset” for purposes of this Agreement. Schedule 2.5.1 sets forth a list of the Non-Transferrable Assets identified by the Parties as of the date hereof.

2.5.2

Solely with respect to the [***] MSA, if such Consent is not obtained prior to the Closing , then during the period commencing on the expiration or termination of the TSA or Novo Nordisk’s earlier request after Closing and ending on the earliest of [***], the “[***] Obligation End Date”), Omeros will promptly use its reasonable best efforts to obtain such Consent to transfer the [***] MSA to Novo Nordisk or assist Novo to obtain an equivalent alternative of the [***] MSA from such applicable Third Party. In addition, until the [***] Obligation End Date, Omeros will use reasonable best efforts to provide to Novo Nordisk substantially comparable benefits that are provided to Omeros under the [***] MSA and will cooperate with any reasonable arrangement proposed by Novo Nordisk under which Novo Nordisk will obtain, to the extent permitted under Applicable Law, operational equivalent of the transfer of the [***] MSA to Novo Nordisk as of the Closing, under substantially similar economics. Omeros will, until the [***] Obligation End Date, grant a sublicense to Novo Nordisk under all intellectual property rights that are granted to Omeros pursuant to the [***] MSA (if any).

2.5.3

If any such Consent for any Non-Transferrable Asset, other than the [***] MSA, is not obtained prior to the Closing such that the attempted sale, conveyance, assignment, transfer, or delivery of such Non-Transferrable Asset would constitute a breach thereof or a violation of Applicable Law, then, for a period of [***] years following the Closing, Omeros will promptly use its reasonable best efforts to obtain such Consent to transfer such Non-Transferrable Asset to Novo Nordisk, and during such period in which Omeros attempts to obtain such Consent, Omeros will use reasonable best efforts to provide to Novo Nordisk substantially comparable benefits thereof and will cooperate with any reasonable arrangement proposed by Novo Nordisk under which Novo Nordisk will obtain substantially similar economics and, to the extent permitted under Applicable Law, operational equivalent of the transfer of such Acquired Asset to Novo Nordisk as of the Closing. Notwithstanding the foregoing, and other than with respect to any Program In-License or other Transferred Contract identified on Schedule 2.5.2 (a “Non-Transferrable License”) or the [***] MSA, Omeros may terminate any Non-Transferrable Assets effective as of the date that is [***] years following the Effective Date. Omeros will, at its sole cost and expense, (a) license to Novo Nordisk as Licensed Technology (pursuant to the license grant in Section 5.1 (Licenses to Novo Nordisk)) all intellectual property rights that are the subject of any Non-Transferrable License and (b) during the [***] year period following the Effective Date until Consent is obtained to assign and transfer any Non-Transferrable License, cooperate and provide reasonable assistance to Novo Nordisk upon Novo Nordisk’s request to (i) obtain such Consent (including, for example, by Novo Nordisk seeking such Consent in Omeros’ name) or (ii) obtain a duplicate alternative of such Non-Transferrable Asset from such applicable Third Party.

2.5.4

If, at any time after Closing, Omeros receives the Consents required to transfer any Non-Transferrable Asset to Novo Nordisk (including the [***] MSA), then Omeros will transfer and convey such Non-Transferrable Asset to Novo Nordisk without payment of any additional consideration by Novo Nordisk.

2.5.5

Without limiting Omeros’ obligations in the final sentence of Section 2.5.3 (Assignment of Certain Transferred Assets; Shared Contracts), with respect to the [***] MSA, upon Novo Nordisk's request, Omeros will, during the term of the Transition Services Agreement and until all activities under the relevant statements of work under the [***] MSA specific to the Compound or Product have been fully performed or, if earlier, until all such statements of work expire or otherwise terminates (provided that in the event such activities under the relevant statements of work under the [***] MSA specific to the Compound or Product are not fully performed or such statements of work have not expired or otherwise terminated immediately following expiration or termination of the Transition Services Agreement, the Parties will agree upon a plan and budget pursuant to which such activities will be performed, and Omeros may invoice Novo Nordisk for the FTE Costs and documented Out-of-Pocket Costs incurred to perform such activities in accordance with the plan and budget, and Novo Nordisk will pay the undisputed invoiced amounts within [***] days after the date of such invoice):

2.5.6

[***] With respect to Program In-Licenses identified on Schedule 2.5.6, Novo Nordisk and Omeros will execute a written sublicense under such Shared Contracts, at or promptly after the Effective Date, in accordance with requirements thereunder to the extent necessary to pass-through any obligations or rights that are specific to such Program In-License, and, subject to the execution of any such separate sublicenses, any such rights to be so sublicensed will be deemed Licensed Technology pursuant to Section 5.1 (Licenses to Novo Nordisk) hereunder.

2.5.7

Assigned and Retained Target Patent Rights.

(a)

“Novo Nordisk Assigned Target Patent Rights” means: (i) with respect to Family 1, any pending or granted Patent Right [***], regardless of whether such Patent Rights may contain [***], (ii) with respect to Family 2, any pending or granted Patent Right [***] regardless of whether such Patent Rights may contain [***] and (iii) with respect to Family 4, any pending or granted Patent Right [***].

(b)

“Omeros Retained Target Patent Rights” means: (i) with respect to Family 1, (A) any pending or granted Patent Right [***] and (B) any other Patent Rights within Family 1 that are not Novo Nordisk Assigned Target Patent Rights or encompassed under the foregoing (A), (ii) with respect to Family 2, (A) any pending or granted Patent Right [***] and (B) [***].

(c)

To further effectuate the division of the Patent Rights set forth in Section 2.5.7(a) and Section 2.5.7(b) above, (i) prior to the Closing, Omeros will, in jurisdictions that allow for such divisional or continuation filings to be filed during such time (which, in any case, will include (A) with respect to Family 1, [***](B) with respect to Family 2, [***], and (C) with respect to Family 4, [***] and (ii) [***], Omeros will use its reasonable efforts to, in either case ((i) or (ii)), create divisionals or continuations of the designated patent applications on Schedule 2.1.1(b)(i) (x) with respect to such patent applications that are in Family 1 and Family 2 and are also within the Multi-Target Patent Rights, to segregate the subject matter of such patent applications therein into applications containing (1) [***], which applications and any resulting Patent Rights will each be Novo Nordisk Assigned Target Patent Rights, and Novo Nordisk will not expand Prosecution and Maintenance thereof to Cover subject matter that is [***], and (2) any other independent claims, which applications and any resulting Patent Rights will each be Omeros Retained Target Patent Rights, and Omeros will not expand Prosecution and Maintenance thereof to include [***]; and (y) with respect to such patent applications that are in Family 4 and are also within the Multi-Target Patent Rights, to segregate the subject matter of such patent applications therein into (1) applications containing [***], which applications and any resulting Patent Rights will each be Novo Nordisk Assigned Target Patent Rights, and [***], and (2) any other Patent Rights within Family 4 (including the parent application) that is not encompassed under the foregoing (1), which Patent Rights shall be deemed Omeros Retained Target Patent Rights, [***]. Any of the foregoing Novo Nordisk Assigned Target Patent Rights filed in accordance with this Section 2.5.7(c) (Assigned and Retained Target Patent Rights) will be included in the Transferred Patent Rights and will be assigned, and are hereby assigned, to Novo Nordisk, effective promptly following the completion of any of the above applicable filing process for the Novo Nordisk Assigned Target Patent Rights (irrespective of whether such filing occurs prior to or after the Closing). Any of the foregoing Omeros Retained Target Patent Rights filed in accordance with this Section 2.5.7(c) (Assigned and Retained Target Patent Rights) will be included as Licensed Background Patent Rights to the extent they are necessary or reasonably useful to Exploit one or more Compounds or Products. As set forth in Section 1.152 (Licensed Background Patent Right), the Multi-Target Patent Rights will be included in the Licensed Background Patent Rights [***].

2.5.8

[***].

3.1

Closing. The closing of the Asset Sale (the “Closing”) will take place virtually in accordance with and pursuant to the terms and conditions of this Agreement as promptly as practicable and no later than [***] Business Days following the satisfaction or waiver (to the extent permitted by Applicable Law) of all of the conditions set forth in Article 11 (Conditions to Close) (other than satisfaction of those conditions that by their nature are to be satisfied at the Closing itself) or at such other time, date or place, including electronically, as Omeros and Novo Nordisk may mutually agree. The date on which the Closing actually occurs is herein referred to as the “Effective Date.”

3.2

Payment of Consideration. Novo Nordisk will (in addition to the assumption of the Assumed Liabilities), and solely with respect to the Inventory, Novo Nordisk shall cause Novo Nordisk A/S to:

3.2.1

at the Closing, pay to (a) Omeros in the Omeros Account an amount equal to the Upfront Fee and (b) its Creditor in the Creditor Account an amount equal to the Creditor Lien Release Amount. Omeros shall provide such Creditor Account to Novo Nordisk at least [***] Business Days prior to Closing;

3.2.2

pay to Omeros the costs for the Inventory as set forth in Section 4.11 (Inventory) of the Transition Services Agreement;

3.2.3

upon the achievement, if any, of the Development Milestone Events, pay to Omeros the corresponding Development Milestone Payment in accordance with Section 7.2 (Development Milestones); and

3.2.4

upon the achievement, if any, of the Sales Milestone Events, pay to Omeros the corresponding Sales Milestone Payment in accordance with Section 7.3 (Sales Milestones).

3.3

Closing Deliveries by Omeros. At the Closing, Omeros will deliver or cause to be delivered to Novo Nordisk:

3.3.1

the Acquired Assets;

3.3.2

a counterpart of the Assignment and Assumption Agreement, substantially in the form attached hereto as Schedule 3.3.2 (the “Assignment and Assumption Agreement”), duly executed by Omeros;

3.3.3

a counterpart of the Bill of Sale, substantially in the form attached hereto as Schedule 3.3.3 (the “Bill of Sale”), duly executed by Omeros;

3.3.4

a duly executed IRS Form W-9 of Omeros;

3.3.5

a duly executed IRS Form 6166 of Omeros or validly filed Form 8802 request for Form 6166;

3.3.6

a duly executed copy of the Lien Release Consent, substantially in the form attached hereto as Schedule 3.3.6 (the “Lien Release Consent”);

3.3.7

a counterpart of the Transition Services Agreement, substantially in the form attached hereto as Schedule 3.3.7 (the “Transition Services Agreement”), duly executed by Omeros;

3.3.8

a counterpart of the Intellectual Property Assignment Agreement, substantially in the form attached hereto as Schedule 3.3.8 (the “Intellectual Property Assignment Agreement”), duly executed by Omeros;

3.3.9

the Omeros Closing Certificate; and

3.3.10

a certificate of Omeros, dated as of the Effective Date, executed by an authorized officer of Omeros, (a) certifying as to (i) Omeros’ Organizational Documents, (ii) the resolutions of the board of directors of Omeros authorizing the execution, delivery, and performance by Omeros of this Agreement and any Ancillary Agreements to which it is a party, and (iii) the incumbency and signatures of the individuals signing this Agreement or any Ancillary Agreements delivered in connection herewith on behalf of Omeros, and (b) attaching a good standing certificate of the jurisdiction of organization of Omeros and each of its Affiliates that hold Acquired Assets or Assumed Liabilities (if applicable), to the extent available under the Applicable Laws of such jurisdiction, dated as of a date not more than [***] Business Days prior to the Effective Date, certifying as to the good standing of Omeros or such Affiliate.

3.4

Closing Deliveries by Novo Nordisk. At the Closing, Novo Nordisk will deliver to Omeros:

3.4.1

a counterpart of the Assignment and Assumption Agreement, duly executed by Novo Nordisk;

3.4.2

a counterpart of the Bill of Sale, duly executed by Novo Nordisk;

3.4.3

a counterpart of the Transition Services Agreement, duly executed by Novo Nordisk;

3.4.4

a counterpart of the Intellectual Property Assignment Agreement, duly executed by Novo Nordisk;

3.4.5

the Novo Nordisk Closing Certificate; and

3.4.6

a certificate of Novo Nordisk, dated as of the Effective Date, executed by an authorized officer of Novo Nordisk, certifying as to (a) Novo Nordisk’s Organizational Documents, (b) the resolutions of the governing body of Novo Nordisk authorizing the execution, delivery, and performance by Novo Nordisk of this Agreement and any Ancillary Agreements to which it is a party, and (c) the incumbency and signatures of the individuals signing this Agreement or any Ancillary Agreements delivered in connection herewith on behalf of Novo Nordisk.

4.1

Each of Omeros and Novo Nordisk will, and will cause their respective Affiliates to, use their reasonable best efforts to (a) make an appropriate filing of a Notification and Report Form pursuant to the HSR Act (“HSR Filing”) with respect to the transactions contemplated hereby as promptly as practicable, and in any event within [***] Business Days after the Execution Date, and submit a copy of such HSR Filing to the Attorney General of the State of Washington promptly thereafter, (b) make appropriate filings with any other Governmental Authorities that may be necessary, proper, or advisable under any other Antitrust Law with respect to the transactions contemplated hereby as promptly as practicable after the date hereof, (c) cooperate and coordinate with the other Party in the making of such filings, (d) supply the other Party with any information that may be required in order to effectuate such filings, and (e) cause the expiration or termination of the applicable waiting periods under any applicable Antitrust Laws, and obtain all required Consents of Governmental Authorities that are necessary for the consummation of the transactions contemplated hereby. Each of Omeros and Novo Nordisk will promptly inform the other Party of any material communication (and, if in writing, furnish them copies of (or, in the case of oral communications, advise them of the contents of) such material communication) from any Governmental Authorities regarding any of the transactions contemplated hereby. [***].

4.2

In furtherance and not in limitation of the foregoing, [***].

4.3

Each Party will bear its own expenses in connection with activities under this Article 4 (Efforts; Antitrust Approval) [***].

5.1

Licenses to Novo Nordisk.

5.1.1

Subject to Section 2.5.8 (Assignment of Certain Transferred Assets; Shared Contracts), Omeros, on behalf of itself and its Affiliates, hereby grants to Novo Nordisk an exclusive (even as to Omeros and its Affiliates), perpetual, irrevocable, royalty-bearing, transferrable (solely in connection with an assignment of this Agreement permitted under Section 15.1 (Assignment), including to any Affiliate), sublicensable (in accordance with Section 5.3 (Sublicenses)) license under the Licensed Technology (including any Clinical and Technical Data or other data contained in Regulatory Submissions) to (a) Develop, Manufacture, Commercialize, and otherwise Exploit the Compounds and Products and (b) exercise its rights to settle a Competing Infringement in accordance with Section 8.4.5 (Competing Infringement; Novo Nordisk First Right to Enforce; Omeros Second Right); provided that the foregoing license does not provide Novo Nordisk a license to Exploit compounds other than Compounds and Products, including any compounds or products Directed To MASP-2 or any other target that is not the Target.

5.1.2

Omeros, on behalf of itself and its Affiliates, hereby grants to Novo Nordisk an exclusive (even as to Omeros and its Affiliates), perpetual, irrevocable, royalty-bearing, transferrable (solely in connection with an assignment of this Agreement permitted under Section 15.1 (Assignment) including to any Affiliate), sublicensable (in accordance with Section 5.3 (Sublicenses)) sublicense under Omeros’ interest in all Intellectual Property Controlled by Omeros that is set forth in Schedule 5.1.2, to manufacture, use, sell, offer for sale, distribute, export and import any and all products and to practice all methods covered by or included in such Intellectual Property.

5.2

Licenses to Omeros.

5.2.1

Novo Nordisk, on behalf of itself and its Affiliates, hereby grants to Omeros an exclusive, worldwide, royalty-free, transferrable (solely in connection with an assignment of this Agreement permitted under Section 15.1 (Assignment)), sublicensable (in accordance with Section 5.3 (Sublicenses)), [***] license under the Novo Nordisk Licensed Technology to Exploit the Grandfathered MASP-3 Products, solely in accordance with, and as permitted under, Section 5.4 (Exclusivity), including with respect to (a) fields, (b) uses, and (c) time durations set forth thereunder.

5.2.2

Novo Nordisk, on behalf of itself and its Affiliates, hereby grants to Omeros a non-exclusive, worldwide, royalty-free, transferrable (solely in connection with an assignment of this Agreement permitted under Section 15.1 (Assignment)), sublicensable (in accordance with Section 5.3 (Sublicenses)), [***] license under the Novo Nordisk Assigned Target Patent Rights to Exploit compounds Directed To (a) targets other than the Target and (b) the Target, solely in accordance with, and as permitted under, Section 5.4 (Exclusivity), including with respect to (i) fields, (ii) uses, and (iii) time durations set forth thereunder.

5.2.3

Novo Nordisk, on behalf of itself and its Affiliates, hereby grants to Omeros a non-exclusive, worldwide, royalty-free, transferrable (solely in connection with an assignment of this Agreement permitted under Section 15.1 (Assignment)), sublicensable (in accordance with Section 5.3 (Sublicenses)) license under the Novo Nordisk Licensed Technology to use [***].

5.2.4

Notwithstanding any provision herein to the contrary, Omeros shall be permitted to retain copies of the Novo Nordisk Licensed Technology, including all Transferred Know-How and Assigned Arising Technology, solely to the extent necessary to enable the exercise of the foregoing licenses for the duration during which such licenses are granted, subject to Article 9 and Section 13.4.1(a) (Effect of Termination).

5.3

Sublicenses.

5.3.1

Novo Nordisk will have the right to grant sublicenses of the rights granted to it under Section 5.1 (Licenses to Novo Nordisk) through multiple tiers to one or more Affiliates or Third Parties, including to any contractor engaged by or on behalf of Novo Nordisk or any of its Affiliates. Any such sublicense must be consistent with the applicable terms of this Agreement. [***].

5.3.2

Omeros will have the right to grant sublicenses of the rights granted to it under Section 5.2 (Licenses to Omeros) or Section 2.5.8 (Assignment of Certain Transferred Assets; Shared Contracts) through multiple tiers to one or more Affiliates or Third Parties. Any such sublicense must be consistent with the applicable terms of this Agreement, including the requirements of Section 5.4 (Exclusivity) below.

5.4

Exclusivity

5.4.1

Target Exclusivity Covenant. Subject to the allowances, licenses, and exceptions set forth in Section 5.4.2 (Grandfathered MASP-3 Antibody Restrictions), Section 5.4.3 (Grandfathered SMOL MASP-3 Product Restrictions ), and Section 5.4.4 (Alternative Pathway Restrictions), Section 5.4.5 (Exceptions), and Section 5.4.6 (Termination of Exclusivity), during the Term of the Agreement, Omeros will not, and will cause its Affiliates to not, either directly or indirectly, whether for itself or with, for, or on behalf of any Third Party (including through subcontractors or the grant of any license or option to any Third Party or otherwise permitting a Third Party to) conduct, undertake, provide to any Third Party, enable, or engage in any Development, Manufacturing, Commercialization, or other Exploitation activities in the Territory with respect to, or in support of, any Competing Product; provided that nothing in this Agreement will limit Omeros’ rights to Exploit, directly or indirectly, any of Omeros’ compounds or products Directed To MASP-2, including narsoplimab and OMS1029, or any compounds or products that are the subject of Omeros’ complement-targeting programs that are not Directed To MASP-3, including its T-CAT program, including, in each case, in multi-specific products so long as any such multi-specific product does not incorporate a compound that is Directed To MASP-3 [***].

5.4.2

Grandfathered MASP-3 Antibody Restrictions. Omeros will have the right, directly or indirectly, to Develop, Manufacture, Commercialize, and otherwise Exploit Grandfathered MASP-3 Antibody Products in the Territory; provided that, during the period commencing on the Effective Date and expiring, on a country-by-country basis, upon the expiration of the final Net Sales Term in such country, Omeros and its Affiliates will not, directly or indirectly, whether for itself or with, for, or on behalf of any Third Party (including through the grant of any license or option to any Third Party or otherwise permitting a Third Party to) submit an MAA for, or otherwise Commercialize, any Grandfathered MASP-3 Antibody Products.

5.4.3

Grandfathered SMOL MASP-3 Product Restrictions. Omeros will have the right, directly or indirectly, to Develop, Manufacture, Commercialize, and otherwise Exploit Grandfathered SMOL MASP-3 Products in the Territory; provided that Omeros and its Affiliates will not, directly or indirectly, whether for itself or with, for, or on behalf of any Third Party (including through the grant of any license or option to any Third Party or otherwise permitting a Third Party to), Initiate any Phase 2 Clinical Trial or Phase 3 Clinical Trial or perform any Commercialization activities, in each case, [***] (A) if Omeros or its Affiliate or licensee has held a customary pre-Clinical Trial meeting with the FDA or EMA for, or Initiated, a Phase 2 Clinical Trial or a Phase 3 Clinical Trial or performed any Commercialization activities after Initiation of such a Phase 2 Clinical Trial or Phase 3 Clinical Trial, in each case, with respect to a Grandfathered SMOL MASP-3 Product for such Indication or (B) if otherwise agreed by the Parties in writing, then, in each case ((A) or (B)), such Indication will be included in the Unrestricted Field.

5.4.4

[***].

5.4.5

Exceptions. Section 5.4.1 (Target Exclusivity Covenant), Section 5.4.2 (Grandfathered MASP-3 Antibody Restrictions), Section 5.4.3 (Grandfathered SMOL MASP-3 Product Restrictions), and Section [***] will not apply to products owned or controlled by an acquirer of Omeros [***]; provided that no such product uses, incorporates, or otherwise relies on any Licensed Technology and the terms of Section 15.2.2 (Firewall) will apply at all times with respect to any such products that are Competing Products or [***]. In addition[***]

5.4.6

Termination of Exclusivity. [***].

5.4.7

Acknowledgement. Omeros acknowledges and agrees that (a) the provisions of Section 5.4 (Exclusivity) have been negotiated by the Parties, (b) any geographical and time limitations on activities set forth in Section 5.4 (Exclusivity) are reasonable, valid, and necessary in light of the Parties’ circumstances and necessary for the adequate protection of the Exploitation of the Compounds and Products, and (c) Novo Nordisk would not have entered into this Agreement without the protection afforded it by Section 5.4 (Exclusivity). If, notwithstanding the foregoing, a court of competent jurisdiction determines that the restrictions set forth in Section 5.4 (Exclusivity) are too broad or otherwise unreasonable (for example, due to a change in circumstance) under Applicable Law, including with respect to duration, geographic scope, or space, then the court is hereby requested and authorized by the Parties to, and if the court cannot do so, then the Parties will, revise Section 5.4 (Exclusivity) to include the maximum restrictions allowable under such Applicable Law.

5.5

No Implied Right. Except for the licenses and rights expressly granted under this Agreement, no rights, title, or interests of any nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by a Party to the other Party. All rights with respect to Know-How, Patent Rights, or other Intellectual Property rights that are not specifically granted herein are reserved to the owner thereof.

5.6

Technology Transfer. During the Pre-Closing Period, Omeros will make available to Novo Nordisk and maintain the current virtual dataroom (to be hosted on Box.com and to include download privileges and permissions for all documents) that will include all documents contained therein as of the Execution Date and any other documents agreed by the Parties that are reasonably necessary for Novo Nordisk’s integration planning purposes or that are otherwise agreed by the Parties. Promptly, and in no event later than [***] days after the Execution Date, [***] a technology and data transfer plan setting forth the responsibilities, timeline, and format of the transfer (the “Transfer Plan” which shall be the same plan attached as Schedule B to the Transition Services Agreement), and which Transfer Plan may be amended from time to time by written agreement of the Parties (including via email), pursuant to which Omeros will, and if applicable, will cause its Affiliates to and will direct its Representatives to, following the Effective Date, in accordance with the Transfer Plan (including the formats and timelines set forth therein), (a) transfer to Novo Nordisk: (i) all Transferred Know-How, (ii) all Transferred Clinical and Technical Data, (iii) complete and accurate copies of all Transferred Regulatory Submissions, and (iv) Transferred Books and Records, and (b) disclose to Novo Nordisk copies of all Licensed Know-How (other than that which is related to Manufacturing, the disclosure of which is addressed in Section 5.8 (Manufacturing Technology Transfer Obligations) below), in each case ((a) and (b)), whether in the possession or control of Omeros, any of its Affiliates, or any Third Parties. Following the Effective Date, Omeros will take all actions as outlined in, and comply with, the Transfer Plan (as may be amended from time to time upon written agreement of the Parties), including any such actions that may also be required under the Transition Services Agreement. For the avoidance of doubt, [***] will not relieve Omeros’ obligation to transfer all such technology and data to Novo Nordisk in accordance with this Section 5.6 (Technology Transfer).

5.7

Know-How Disclosure. Thereafter, during the Term with respect to Arising Sideground Technology within the Licensed Technology, [***], Omeros will provide to Novo Nordisk copies of all such Arising Know-How (including any such data related to all Compounds or Products) that is made, conceived, discovered, or otherwise generated by or on behalf of Omeros or any of its Affiliates, or that otherwise comes into the possession and Control of Omeros or any of its Affiliates, after the initial disclosure of technologies in accordance with Section 5.6 (Technology Transfer). During the term of the Transition Services Agreement and for [***] thereafter, with respect to Assigned Arising Technology, Omeros will provide to Novo Nordisk copies of all such Arising Know-How that Omeros or any of its Affiliates makes, conceives, discovers, generates, or otherwise comes into possession of, but at least [***], in accordance with the Transition Services Agreement. In addition to providing copies of the relevant Know-How in accordance with this Section 5.7 (Know-How Disclosure), and without limiting its obligations with respect to Know-How for the Manufacture of any Compound or Product, during the term of the Transition Services Agreement, Omeros will make its personnel reasonably available to perform the activities assigned to Omeros pursuant to the Transition Services Agreement, so as to enable Novo Nordisk to practice under the Licensed Technology and Assigned Arising Technology in connection with the Exploitation of the Compounds or Products.

5.8

Manufacturing Technology Transfer Obligations. The Parties agree that certain Transferred Intellectual Property and Licensed Know-How for the Manufacture of the Compounds and Products will be disclosed to Novo Nordisk pursuant to the Transition Services Agreement. For the avoidance of doubt, except as otherwise expressly set forth under the Transition Services Agreement and Omeros’ technology transfer obligations hereunder, Novo Nordisk will be solely responsible for, have sole control over, and decision-making authority with respect to, the Manufacturing of the Compounds and Products, including in connection with Third Party contractors, at Novo Nordisk’s sole cost and expense.

6.1

Development and Medical Affairs. As of the Effective Date, Novo Nordisk will have sole control over, and decision-making authority with respect to, the Development of, and the performance of all Medical Affairs with respect to, all Compounds and Products, at its cost and expense[***]. Novo Nordisk will provide Omeros with [***] progress reports with respect to its Development of Products, setting forth a high level summary of the material Development activities conducted during such [***], including the Products being Developed and the Indications for which they are being Developed, within 60 days after the end of each [***] until [***]. After receipt of each such progress report, Omeros shall have the right to propose to Novo Nordisk a summary of such report to be shared with Third Parties [***] (each such agreed summary, a “Sharable Summary”).

6.2

Clinical Records and Regulatory Assistance. Omeros will assist Novo Nordisk in its efforts to prepare and submit any Regulatory Submissions and to obtain, support, or maintain any INDs, MAAs, and Regulatory Approvals for all Products [***].

6.3

Right of Reference. Following the Effective Date, subject to the rules of the relevant Regulatory Authority and the terms of this Agreement, Omeros hereby grants to Novo Nordisk a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Applicable Law recognized outside of the United States) to all information, data, and other Know-How relating to the Compounds or Products that are included or referenced in any Regulatory Submission, Regulatory Approval, Pricing and Reimbursement Approval, in each case Controlled by Omeros, but excluding the Excluded Regulatory Submissions and Approvals, for Novo Nordisk’s or its Affiliates’, licensees’, assignees’, or Sublicensees’ use in the Development and Commercialization of the Compounds or Products and to otherwise enable Novo Nordisk to fulfill its obligations or exercise its rights with respect to [***] or more Compounds or Products, in each case, in accordance with this Agreement. All such information and data contained in any such Regulatory Submissions or Regulatory Approvals will be considered Confidential Information of Omeros and subject to the terms of Article 9 (Confidentiality; Publicity; Privilege). If requested by Novo Nordisk, Omeros will provide a signed statement to this effect to the FDA or applicable Regulatory Authority in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor rule or analogous Applicable Law outside of the United States) to give effect to the intent of this Section 6.3 (Right of Reference).

6.4

Commercialization. As of the Effective Date, Novo Nordisk will have sole control over, and decision-making authority with respect to, the Commercialization of all Products and applications for obtaining, supporting, and maintaining Pricing and Reimbursement Approvals for all Products, at its cost and expense.

6.5

Diligence Obligations. Novo Nordisk, itself or through its Affiliates, licensees, Sublicensees, or one or more Third Parties, will use Commercially Reasonable Efforts [***]. Novo Nordisk will have no other diligence obligations under this Agreement with respect to the Development, Regulatory Approval, or Commercialization of any Compound or Products. Notwithstanding any provision to the contrary set forth in this Agreement, [***] will not constitute a breach of Novo Nordisk’s obligations set forth in this Section 6.5 (Diligence Obligations).

6.6

Omeros Support. The Parties understand and agree that, in addition to the cooperation and assistance to be expressly provided under Section 5.6 (Technology Transfer), Section 5.7 (Know-How Disclosure), Section 5.8 (Manufacturing Technology Transfer Obligations), and the Transition Services Agreement or other Ancillary Agreements, from time to time it may be necessary for Novo Nordisk to seek other assistance and cooperation from Omeros in connection with the Exploitation of the Compounds and Products and the preparation and submission of all Regulatory Submissions for all Products. Omeros hereby agrees to use reasonable efforts to provide any such assistance and cooperation reasonably requested by Novo Nordisk, as a consultant [***].

6.7

Acknowledgment. None of Novo Nordisk, its Affiliates, or any of their respective Representatives owes any fiduciary duty to Omeros with respect to any Milestone Payments or any Net Sales Payments. Omeros further acknowledges and agrees that, subject to Section 6.1 (Development and Medical Affairs) and Section 6.5 (Diligence Obligations), (a) Novo Nordisk and its Affiliates will have complete control and sole discretion with respect to the Exploitation of the Compounds or Products after the Closing and such control and discretion by Novo Nordisk and its Affiliates could result in the Milestone Payments and Net Sales Payments not being made; and (b) neither Novo Nordisk nor any of its Affiliates or Representatives has furnished or provided, whether written or oral, any assurances or commitments regarding the achievability of the condition to the payment of the Milestone Payments or the Net Sales Payments or the likelihood thereof and Omeros has not relied on, and expressly disclaims any rights with respect to, any such statements in electing to proceed with the execution and delivery of this Agreement.

6.8

Rare Pediatric Priority Review Voucher. [***].

7.1

Upfront Fee. As a one-time payment for the acquisition of the Acquired Assets and the rights licensed to Novo Nordisk under Section 5.1 (Licenses to Novo Nordisk), Novo Nordisk will pay Omeros a one-time up-front fee of $240,000,000 less the Creditor Lien Release Amount (the “Upfront Fee”) in accordance with Section 3.2 (Payment of Consideration).

7.2

Development Milestones.

7.2.1

Development Milestone Events and Payments. Novo Nordisk will make one-time milestone payments (each, a “Development Milestone Payment”) to Omeros upon the first achievement by Novo Nordisk or its Affiliates, licensees, assignees, or Sublicensees of each of the development milestone events (each, a “Development Milestone Event”) set forth in Table 7.2.1 below, for the first Covered Product to achieve the applicable Development Milestone Event. For the avoidance of doubt, each Development Milestone Payment hereunder will be payable only once upon the first achievement of the applicable Development Milestone Event. No additional Development Milestone Payments will be made for any subsequent achievement of such Development Milestone Event. Novo Nordisk will notify Omeros in writing of the achievement of a Development Milestone Event by Novo Nordisk or its Affiliates, licensees, assignees, or Sublicensees no later than [***] days after the achievement thereof. Thereafter, Omeros will provide Novo Nordisk with an invoice for the corresponding Development Milestone Payment, and Novo Nordisk will pay to Omeros such Development Milestone Payment no later than [***] days after its receipt of an invoice for such Development Milestone Payment. If Novo Nordisk or its Affiliates, licensees, assignees, or Sublicensees achieve all Development Milestone Events (regardless of the number of times such events occur or the number of Covered Products that trigger such event), then the Development Milestone Payments payable by Novo Nordisk under this Section 7.2.1 (Development Milestone Events and Payments) will not exceed $510,000,000.

Table 7.2.1 – Development Milestones

Development Milestone

Event

Development Milestone Payment for the specified Indication

[***]

[***]

[***]

[***]

1

[***]

[***]

[***]

[***]

[***]

2

[***]

[***]

[***]

[***]

[***]

3

[***]

[***]

[***]

[***]

[***]

4

[***]

[***]

[***]

[***]

[***]

5

[***]

[***]

[***]

[***]

[***]

[***]

7.2.2

[***]

7.3

Sales Milestones. Subject to Section 7.5 (Expiration of the Net Sales Term) and Section 7.6 (Payment Reductions), Novo Nordisk will make one-time payments (each, a “Sales Milestone Payment” and together with the Development Milestone Payments, the “Milestone Payments”) to Omeros upon the first achievement by Novo Nordisk or its Affiliates, licensees, assignees, or Sublicensees of each of the sales-based milestones events (each, a “Sales Milestone Event” and together with the Development Milestone Events, the “Milestone Events”) set forth in Table 7.3 (Sales Milestones) below with respect to aggregate annual Net Sales of Anticipated Products by Novo Nordisk and its Affiliates, licensees, assignees, and Sublicensees, subject to the paragraph below Table 7.3. Each of the Sales Milestone Payments set forth below will be payable [***]. Novo Nordisk will notify Omeros in writing of the achievement of a Sales Milestone Event by Novo Nordisk or its Affiliates, licensee, assignee, or Sublicensees no later than [***] days after the end of the Calendar Quarter in which such Sales Milestone Event is achieved. Thereafter, Omeros will provide Novo Nordisk with an invoice for the corresponding Sales Milestone Payment(s), and Novo Nordisk will pay to Omeros such Sales Milestone Payment(s) no later than [***] days after its receipt of an invoice for such Sales Milestone Payment. If Novo Nordisk or its Affiliates, licensees, assignees, or Sublicensees achieve all Sales Milestone Events, then the Sales Milestone Payments payable by Novo Nordisk under this Section 7.3 (Sales Milestones) will not exceed $1,300,000,000.

Table 7.3: Sales Milestones

Sales Milestone Event

Sales Milestone Payment

1

First Calendar Year in which aggregate annual Net Sales of Anticipated Products are greater than or equal to $[***]

$[***]

2

First Calendar Year in which aggregate annual Net Sales of Anticipated Products are greater than or equal to $[***]

$[***]

3

First Calendar Year in which aggregate annual Net Sales of Anticipated Products are greater than or equal to $[***]

$[***]

7.4

Net Sales Payments. Subject to Section 7.5 (Expiration of the Net Sales Term) and Section 7.6 (Payment Reductions), on an Anticipated Product-by-Anticipated Product and country-by-country basis, Novo Nordisk will pay to Omeros tiered payments at the rates set forth in Table 7.4 based on annual aggregate worldwide Net Sales of Anticipated Products in a given Calendar Year during the applicable Net Sales Term for each such Anticipated Product (such payments, “Net Sales Payments”). The Net Sales for all Anticipated Products will be aggregated, for purposes of determining the rates below. [***].

Table 7.4: Net Sales Payments

Portion of Annual Net Sales of Anticipated Products

Net Sales Payment Rate

For that portion of annual Net Sales of Anticipated Products less than or equal to $[***]

[***]%

For that portion of annual Net Sales of Anticipated Products greater than $[***] but less than or equal to $[***]

[***]%

For that portion of annual Net Sales of Anticipated Products greater than $[***] but less than or equal to $[***]

[***]%

For that portion of annual Net Sales of Anticipated Products greater than $[***]

[***]%

7.5

Expiration of the Net Sales Term. Upon expiration of the Net Sales Term for a given Anticipated Product in a given country (a) no further payments under this Article 7 (Financial Terms) will be payable in respect of sales of such Anticipated Product in such country, and (b) the licenses granted to Novo Nordisk under Section 5.1 (Licenses to Novo Nordisk) for such Anticipated Product in such country will automatically become fully paid-up and royalty free and, for the avoidance of doubt, will remain exclusive. For clarity, only a single Net Sales Payment will be payable as a result of one or more Valid Claims claiming an Anticipated Product during its Net Sales Term.

7.6

Payment Reductions.

7.6.1

Lack of Valid Claims. If an Anticipated Product is not Covered by a Net Sales Term Extending Patent Right in a country, then commencing in the first Calendar Quarter following the Calendar Quarter in which such Anticipated Product is not so Covered by a Net Sales Term Extending Patent Right, the Net Sales of such Anticipated Product used for purposes of calculating the Net Sales Payments on such Anticipated Product in such country hereunder, in each case, will be reduced by [***]% for the remainder of its Net Sales Term for such Anticipated Product in such country.

7.6.2

Biosimilar Products. [***]

7.6.3

Third Party Payments. Novo Nordisk may deduct from any payments due and payable by Novo Nordisk to Omeros hereunder an amount equal to [***]% (or, if any such amounts are paid to a Third Party as a result of Omeros’ breach of any of its representations and warranties under Section 10.2 (Representations of Omeros), then [***]% of all such amounts) of the total payments actually paid by Novo Nordisk or its Affiliates, licensees, assignees, or Sublicensees to any Third Party pursuant to an agreement with such Third Party in consideration for rights under any Patent Right or Patent Rights together with Know-How, in each case, owned or controlled by such Third Party (whether by acquisition or license) (including pursuant to Section 8.5.2 (Product Related Third Party Patent Rights) or Section 8.5.4 (Settlement) or as a part of any damages or settlement amounts paid in connection with an action pursuant to Section 8.5.3 (Defense)) that are necessary or reasonably useful for the Exploitation of any Compound or Product (collectively, “Third Party IP Payments”).

7.6.4

Program In-License Deductions. Novo Nordisk may deduct from (a) Net Sales Payments due and payable by Novo Nordisk to Omeros hereunder on an Anticipated Product an amount equal to [***],

7.6.5

Inflation Reduction Act Deductions. If, during the Net Sales Term for an Anticipated Product in the United States, such Anticipated Product is designated as a Selected IRA Drug by the Secretary of the U.S. Department of Health and Human Services, and Novo Nordisk or its Affiliate or its or their licensee or Sublicensee is required to negotiate and is ultimately subject to a Maximum Fair Price that will apply to sales of such Anticipated Product during the Price Applicability Period (the Calendar Quarter during which such event occurred, the “Event Quarter”), then the Net Sales of such Anticipated Product in the United States[***] will be reduced by [***].

7.6.6

Reduction Floor. Notwithstanding the foregoing, in no event will the Net Sales Payments payable to Omeros under Section 7.4 (Net Sales Payments) with respect to an Anticipated Product in a country be reduced in each Calendar Quarter as a result of the cumulative applicable deductions in Section 7.6.1 (Lack of Valid Claims), Section 7.6.2 (Biosimilar Products), Section 7.6.3 (Third Party Payments), to less than [***]% [***]; provided that, no such floor will apply [***].

7.7

Payment Terms. All payments under this Article 7 (Financial Terms) will be paid in accordance with the timing set forth herein and will be non-refundable (other than subject to Section 7.12 (Taxes) below). With respect to any amounts owed under this Agreement by one Party to the other for which no other invoicing and payment procedure is specified in this Agreement (except for the payment due under Section 7.1 (Upfront Fee)), the incurring Party will provide an invoice to the other Party, together with reasonable supporting documentation, for such amounts owed. The owing Party will pay any undisputed amounts within [***] days after receipt of the invoice and will pay any disputed amounts owed by such Party within [***] days after resolution of the Dispute. Omeros will invoice Novo Nordisk according to Novo Nordisk’s invoice instructions attached to this Agreement as Schedule 7.7 (Invoice Instructions).

7.8

Currency and Exchange Rate. Net Sales in the Territory will be calculated and reported in USD. With respect to Net Sales invoiced in a currency other than USD, (a) the rate of exchange to be used in computing the currency equivalent in USD of Net Sales used to determine Net Sales Payments payable will be the Calendar Quarter average exchange rate between each currency of origin and USD and (b) the rate of exchange to be used in computing the currency equivalent in USD of Net Sales used to determine the achievement of any Sales Milestone Events will be the Calendar Year average exchange rate between each currency of origin and USD, and in either ((a) and (b)), will be based on the exchange rate source normally used by Novo Nordisk for consolidation of external financial reporting.

7.9

Mode of Payment. All payments to be made by Novo Nordisk to Omeros under this Agreement will be made in USD in immediately available funds. Payments to Omeros will be made by electronic wire transfer to the Omeros Account in accordance with the requirements set forth in Schedule 7.7 (Invoice Instructions).

7.10

Royalty Reports. During the Net Sales Term, on a Calendar Quarter-by-Calendar Quarter basis, Novo Nordisk will, within [***] days after the end of such Calendar Quarter (or within [***] days after Novo Nordisk’s receipt of the relevant Net Sales information from a licensee, assignee, or Sublicensee, if later), provide to Omeros a written report containing the Net Sales on an [***] country-by-country basis, including [***].

7.11

Audit Right. Each Party will keep complete and accurate records relating to the calculations of Net Sales generated in the then current Calendar Year and payments required under this Agreement, for a period of [***] after the end of the Calendar Year in which such payment was due. Each Party will require its Affiliates and its and their respective licensees, assignees, and Sublicensees to retain and provide to the applicable Party all records of payments that such Party would be required to keep as if incurred by such Party, to enable the other Party to audit such records pursuant to this Section 7.11 (Audit Right). Each Party will have the right during the Term and for a period of [***] thereafter, no more than once annually at its own expense, to have an internationally recognized, independent, certified public accounting firm reasonably acceptable to the other Party, currently one of the following: PWC, E&Y, KPMG, or Deloitte (the “Auditor”), selected by it, review any such records of the other Party and its Affiliates, licensees, assignees, and Sublicensees (the “Audited Party”) in the location(s) where such records are maintained by the Audited Party subject to the following terms.

7.11.1

Notice. The non-Audited Party will provide the Audited Party at least [***] days’ prior written notice of when its Auditor will visit the Audited Party.

7.11.2

Confidentiality. At least [***] days prior to inspecting any records, the Auditor must enter into a confidentiality agreement with the Audited Party that is reasonably satisfactory to the Audited Party. All books and records made available for inspection or audit will be deemed to be Confidential Information of the Audited Party.

7.11.3

Conduct of Audit. The Audited Party will make their books and records available for review by the Auditor solely to verify that the payments made by the Audited Party under this Agreement were correct. The Audited Party will give access to the Auditor during regular business hours at the place or places where the books and records are usually kept. While inspecting such accounts and records, the Auditor must abide by all of the Audited Party’s standard rules and regulations.

7.11.4

Audit Report. The Auditor will prepare and deliver to each Party a report solely setting out whether the payments made by the Audited Party under this Agreement were correct and the specific details concerning any discrepancies no later than [***] days after the audit has been completed. No other information will be provided to the auditing Party without the prior written consent of the Audited Party. The Auditor will share its findings with the Audited Party prior to delivering the report in order for the parties to in good faith discuss any discrepancies. Any report by the Auditor under this Section 7.11 (Audit Right) will be deemed Confidential Information of the Audited Party and auditing Party will keep such report and any other information received or learned in connection with the audit confidential.

7.11.5

Frequency of Audits. No Calendar Year will be subject to audit under this Section 7.11 (Audit Right) more than once and the audit may cover a period ending not more than [***] months prior to the date of such request; and

7.11.6

Discrepancies. Should such inspection lead to the discovery of a discrepancy to a Party’s detriment, the other Party will, within [***] days after receipt of such report from the Auditor, pay any undisputed amount of the discrepancy. The non-audited Party will pay the full cost of the review unless the underpayment of amounts due to the non-Audited Party is greater than [***]% of the amount due for any consecutive [***]-month period during the entire period being examined, in which case the Audited Party will pay the cost charged by the Auditor for such review. If the audit leads to the discovery of a discrepancy to Novo Nordisk’s detriment, then Novo Nordisk may at its option, in lieu of receiving a payment from Omeros, credit the amount of the discrepancy against future payments payable to Omeros under this Agreement.

7.12

Taxes.

7.12.1

Income Tax. Each Party will be responsible for the payment of any and all income (including capital gains) Taxes levied on the payments it receives under this Agreement, except as provided under Section 7.12.3 (Withholding Tax Actions).

7.12.2

Withholding Tax. The Parties agree that all payments under this Agreement will be made without any deduction or withholding for or on account of any Taxes or other amounts unless required by Applicable Law; provided that the Parties agree to use reasonable best efforts to avoid, in accordance with Applicable Law, double taxation or similar obligations. The Parties agree no Taxes are required to be withheld from the payments made to Omeros pursuant to this Agreement under the current Applicable Law; provided that Omeros delivers a duly completed and validly executed Internal Revenue Service Form W-9 to Novo Nordisk. To the extent either Party that makes a payment (the “Paying Party”) to the other Party (the “Recipient”) under this Agreement is required under Applicable Law to deduct and withhold Taxes on any such payment, the Paying Party will (a) deduct those withholding Taxes from the payment or from any other payment owed by the Paying Party; (b) pay the amount of such withholding Taxes to the proper Governmental Authority in a timely manner; and (c) send to the Recipient evidence of such payment and any related governmental receipt or certificate provided. The Paying Party will use commercially reasonable best efforts to provide the Recipient with advance notice prior to withholding any Taxes from payments payable to the Recipient and provide a reasonable opportunity to furnish any forms, certificates, or other items necessary in order to reduce or eliminate such deduction or withholding, including as may be necessary in order for the Paying Party to withhold Tax at a reduced rate under an applicable bilateral income Tax treaty, in accordance with Applicable Law. Each Party will [***] to provide the other Party with assistance to enable the recovery, as permitted by Applicable Law, of withholding Taxes or similar obligations resulting from payments made under this Agreement. In the event that a Governmental Authority retroactively determines that a payment made by a Paying Party to the Recipient pursuant to this Agreement should have been subject to withholding (or to additional withholding) Taxes, and the Paying Party remits such withholding Taxes to the Governmental Authority, the Paying Party will have the right (i) to offset such amount, including any interest and penalties that may be imposed thereon (except to the extent any such interest or penalties result from the negligence or misconduct of the Paying Party), against future payment obligations of the Paying Party under this Agreement, or (ii) to invoice the Recipient for such amount (which will be payable by the Recipient within [***] days of its receipt of such invoice).

7.12.3

Withholding Tax Actions. Notwithstanding any provision to the contrary set forth in this Section 7.12 (Taxes), but subject to Recipient’s obligation to provide the Paying Party with information or documentation necessary to reduce or eliminate deduction or withholding pursuant the third sentence of Section 7.12.2 (Withholding Tax), the Parties acknowledge and agree that if the Paying Party (or its assignee pursuant to Section 15.1 (Assignment)) is required by Applicable Law to withhold Taxes in respect of any amount payable under this Agreement, and if such withholding obligation arises or (is increased) solely as a result of any assignment of this Agreement by the Paying Party, a Change of Control of the Paying Party, a change in Tax residency of the Paying Party, or a change in the entity making payment under this Agreement, then [***].

7.12.4

VAT. For the avoidance of doubt, any consideration payable under this Agreement is exclusive of VAT. If VAT is payable in respect of any payments under this Agreement, then the Paying Party will pay such VAT at the applicable rate in respect of such payment to the Recipient or to the relevant Taxing Authority, as appropriate. Where VAT reverse charge is applicable, the Paying Party will declare and pay the VAT to the relevant Taxing Authority. VAT (if any) will become due and payable to the Recipient (if appropriate) upon presentation of a valid VAT invoice (or, where there is no provision in the legislation for the jurisdiction concerned that a VAT invoice is required to be issued, a written demand containing such information as is customary in that jurisdiction) and which complies with the requirements in Schedule 7.7 (Invoice Instructions).

7.12.5

Indirect Tax. It is understood and agreed between the Parties that all payments made under this Agreement are exclusive of indirect Taxes (including VAT, transfer, documentary, sales, use, stamp, registration, tariffs, goods and services Tax, consumption Tax, and other similar Taxes (each an “Indirect Tax”)). If any Indirect Taxes are chargeable in respect of any payments under Applicable Law, the Paying Party will pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an invoice in the appropriate form issued by the Recipient in respect of those payments and indicating applicable Indirect Taxes. The Parties will, in accordance with Applicable Laws, use commercially reasonable best efforts to reduce non-deductible VAT in connection with this Agreement. If the Indirect Taxes originally paid or otherwise borne by the Paying Party are in whole or in part subsequently determined not to have been chargeable, commercially reasonable steps will be taken by the Recipient to receive a refund of these undue Indirect Taxes from the applicable Governmental Authority or other fiscal authority and any amount of such undue Indirect Taxes repaid by such authority to the Recipient, net of any reasonable out-of-pocket costs incurred by the Recipient in obtaining such refund, and net of any income Taxes incurred by the Recipient in respect of such amount of refund received, will be transferred to the Paying Party within [***] days of receipt. The Parties will reasonably cooperate with each other in seeking any tax exemption or credits that may be available, including with respect to any tariffs, Development, or Products, including reasonable provision of invoices and other documentation, that could provide a material Tax benefit to either Party. The Parties will use reasonable efforts to provide, and to cause their respective Affiliates, subcontractors, sublicenses, customers, and applicable Third Parties to provide, any information and documentation reasonably requested by the other Party to obtain the benefits of (a) any current Tax Applicable Law (e.g., Section 250 of the Internal Revenue Code of 1986, as amended and the applicable Treasury Regulations) or (b) any Tax Applicable Law enacted during the term of this Agreement that could provide a material Tax benefit to either Party.

8.1

Ownership of Background Technology. Subject to the license granted to Novo Nordisk under Section 5.1 (Licenses to Novo Nordisk), the assignment to Novo Nordisk of the Acquired Assets, the terms of this Article 8 (Intellectual Property), and the terms and conditions of the Transition Services Agreement, each Party will retain ownership of all rights, title, and interests in and to any Patent Rights and Know-How that it Controls prior to the Effective Date or that such Party develops or acquires outside the scope of performance of activities under this Agreement, the Transition Services Agreement, or any Ancillary Agreement.

8.2

Ownership of Arising Technology.

8.2.1

Arising Sideground Technology. Subject to the license granted to Novo Nordisk under Section 5.1 (Licenses to Novo Nordisk) and Section 8.1 (Ownership of Background Technology), as between the Parties, Omeros will own all rights, title, and interests in and to any (a) [***], the “Arising Sideground Know-How”) and (b) any Patent Rights Covering any such Arising Know-How (“the Arising Sideground Patent Rights”, and together with the Arising Sideground Know-How, the “Arising Sideground Technology”).

8.2.2

Other Arising Technology. Other than [***] (such Arising Know-How and such Patent Rights, collectively, the “Assigned Arising Technology”). Omeros hereby does, and will cause its Affiliates to, assign to Novo Nordisk, all rights, title, and interests held by Omeros or its Affiliates in any Assigned Arising Technology, and Novo Nordisk hereby accepts such assignment. Upon Novo Nordisk’s written request, Omeros will provide Novo Nordisk with all reasonably requested assistance to effect such assignment and will execute any and all documents necessary to perfect such assignment. To the extent that Omeros is not able to assign to Novo Nordisk any such [***], Omeros hereby grants to Novo Nordisk an exclusive, perpetual, irrevocable, transferrable, and sublicensable (through multiple tiers) license to use, practice, and otherwise Exploit such Arising Know-How or any Patent Rights that Cover any such Arising Know-How, in each case, for any and all purposes.

8.3

Prosecution and Maintenance.

8.3.1

Omeros Sole Right. Subject to Section 8.3.5 (Cooperation), Omeros will have the sole right, but not the obligation, to Prosecute and Maintain in all jurisdictions in the Territory all (a) [***] and (b) [***] in each case ((a) and (b)), at its cost and expense and will keep Novo Nordisk reasonably informed with respect thereto.

8.3.2

Novo Nordisk Sole Right. Subject to Section 8.3.5 (Cooperation), Novo Nordisk will have the sole right, but not the obligation, to Prosecute and Maintain in all jurisdictions in the Territory all (a) [***] (b) [***], and (c) [***], in each case ((a)-(c)), that are not [***], at its cost and expense.

8.3.3

Omeros First Right. Subject to Section 8.3.1 (Omeros Sole Right) and Section 8.3.5 (Cooperation), Omeros will have the first right, but not the obligation, to Prosecute and Maintain in all jurisdictions in the Territory all Licensed Patent Rights other than those within the [***] (the “Omeros First Right Licensed Patent Rights”). If Omeros elects to cease to Prosecute and Maintain in any country any such Omeros First Right Licensed Patent Rights [***], then Omeros will provide Novo Nordisk with written notice of such election not less than [***] days prior to the next filing or payment date for such Patent Right, and Novo Nordisk will have the right to assume responsibility using patent counsel of its choice, for the Prosecution and Maintenance of [***] at its cost and expense [***].

8.3.4

Novo Nordisk First Right. Subject to Section 8.3.5 (Cooperation), Novo Nordisk will have the first right, but not the obligation, to Prosecute and Maintain in all jurisdictions in the Territory (a) [***] (such Licensed Patent Rights that Novo Nordisk has such first rights to Prosecute and Maintain, in each case ((a) and (b)), the “Novo Nordisk First Right Licensed Patent Rights”), and (c) any [***] (such Net Sales Term Extending Patent Rights that are issued patents and that Novo Nordisk has such first rights to Prosecute and Maintain, in each case ((i) through (iii)), the “Novo Nordisk First Right Net Sales Patent Rights”) at its cost and expense and will keep Omeros reasonably informed with respect thereto. In Prosecuting and Maintaining the Novo Nordisk First Right Licensed Patent Rights or Novo Nordisk First Right Net Sales Patent Rights, Novo Nordisk [***]. If Novo Nordisk elects not to Prosecute and Maintain in any country any Novo Nordisk First Right Licensed Patent Rights or Novo Nordisk First Right Net Sales Patent Rights, then Novo Nordisk shall provide Omeros with written notice of such election not less than [***] days prior to the next filing or payment date for such Patent Right, and Omeros will have the right to assume responsibility using patent counsel of its choice, for the Prosecution and Maintenance of such Novo Nordisk First Right Licensed Patent Right or Novo Nordisk First Right Net Sales Patent Rights, at its cost and expense [***].

8.3.5

Cooperation. Each Party will provide the other Party all reasonable assistance and cooperation in the Prosecution and Maintenance of the Transferred Patent Rights Licensed Patent Rights pursuant to this Section 8.3 (Prosecution and Maintenance), including providing any necessary powers of attorney and executing any other required documents or instruments for such Prosecution and Maintenance, and providing patent authority correspondence and related documents.

8.4

Third Party Infringement.

8.4.1

Notification. During the Term, (a) Novo Nordisk will promptly inform Omeros in writing if either Party becomes aware of any suspected, threatened, or actual infringement by any Third Party of any Transferred Patent Right, and (b) Omeros will promptly inform Novo Nordisk in writing if either Party becomes aware of any suspected, threatened, or actual infringement by any Third Party of any Licensed Patent Right (each, an “Infringement”), including any Infringement that [***] (a “Competing Infringement”). [***].

8.4.2

Other Infringement; Omeros First Right to Enforce; Novo Nordisk Second Right. [***].

8.4.3

Infringement; Novo Nordisk Sole Right to Enforce. [***].

8.4.4

Infringement; Omeros Sole Right to Enforce. [***].

8.4.5

Competing Infringement; Novo Nordisk First Right to Enforce; Omeros Second Right. [***].

8.4.6

Settlement. [***].

8.4.7

Expenses and Recoveries. A Party bringing an enforcement action under this Section 8.4 (Third Party Infringement) against any Third Party will be solely responsible for any costs and expenses incurred by such Party or the other Party (upon such enforcing Party’s request) as a result of such action. If such Party recovers monetary damages from such Third Party in such action, then such recovery will first be applied to all Out-of-Pocket Costs incurred by the Parties in connection therewith, including attorneys’ fees, but excluding [***]. If such recovery is insufficient to cover all such costs and expenses of both Parties, then [***]. If after such reimbursement any funds remain from such damages recovered, then such funds will be shared as follows: [***]. 

8.4.8

Assistance. Each Party will have the right to request assistance from the other Party in connection with an enforcement action undertaken pursuant to this Section 8.4 (Third Party Infringement). If a Party requests such assistance from the other Party, then the requesting Party will pay all of the costs and expenses incurred by the other Party for providing such requested assistance, which assistance will not be unreasonably withheld, conditioned, or delayed.

8.5

Third Party Rights.

8.5.1

Notification. With respect to (a) the practice of a [***] each Party will promptly notify the other Party of any written allegation that such Party receives that any activity pursuant to this Agreement infringes or misappropriates any Patent Right or other Intellectual Property rights of any Third Party, and (b) the practice of any [***].

8.5.2

Product Related Third Party Patent Rights. Subject to Section 8.5.3 (Defense) and Section 8.5.4 (Settlement), with respect to any Third Party Patent Right or other Intellectual Property right notified under Section 8.5.1 (Notification), as between the Parties, Novo Nordisk will have the sole right to seek a license [***].

8.5.3

Defense. Without altering a Party’s financial responsibilities for any such matter as set forth in Article 12 (Indemnification), if applicable, Novo Nordisk will have the first right, but not the obligation, to defend any Third Party claim or assertion that [***], at Novo Nordisk’s cost and expense. Omeros will reasonably cooperate with Novo Nordisk, including if required to conduct such defense, furnishing a power of attorney, at Novo Nordisk’s reasonable request and expense.

8.5.4

Settlement. Without the prior written consent of the other Party (not to be unreasonably withheld, conditioned, or delayed), neither Party will settle any claim notified under Section 8.5.1 (Notification) in any manner that would impose any material obligations, restriction, or limitation on the other Party; [***].

8.5.5

Cooperation. Each Party will have the right to request reasonable assistance from the other Party in connection with a defense action undertaken pursuant to this Section 8.5 (Third Party Rights), including where necessary, furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access to relevant documents and other evidence, and making its employees available at reasonable business hours. If a Party requests such assistance from the other Party, then the requesting Party will pay all of the costs and expenses incurred by the other Party for providing such requested assistance, which assistance will not be unreasonably withheld, conditioned, or delayed. The Parties will otherwise reasonably cooperate with one another in defending any action undertaken pursuant to this Section 8.5 (Third Party Rights), at the cost and expense of the Party controlling such defense.

8.6

Patent Right Term Extension. Novo Nordisk will have the full and exclusive right and discretion to determine and control all filings of requests for patent term extension under the Drug Price Competition and Patent Right Restoration Act of 1984 in the U.S., supplementary protection certificates in the member states of the EU and their equivalents throughout the Territory, or equivalents thereto in any country in the Territory, in each case, arising from the Regulatory Approval of or otherwise applicable to a Product (hereinafter “Patent Term Extensions”). Novo Nordisk will have the exclusive right to file for Patent Term Extensions in any Licensed Patent Right with respect to the Products. All such costs and expenses relating to a Product’s Patent Term Extensions will be borne solely by Novo Nordisk. Upon the reasonable request of, and at the cost and expense of, Novo Nordisk, Omeros will provide support, assistance, and all necessary documents, in full executed form if needed, to Novo Nordisk for the purpose of supporting, filing, obtaining, and maintaining such Patent Term Extensions.

8.7

Regulatory Patent Right Listings. Novo Nordisk will have the full and exclusive right, in its sole discretion, to determine and control the listing of any Licensed Patent Right in the then-current edition of the FDA’s Purple Book in connection with the Regulatory Approval of any Product, or in equivalent patent listings in any other country within the Territory with respect to the Product.

9.1

Confidential Information; Non-Disclosure and Non-Use Obligations. Notwithstanding any provision to the contrary set forth in this Agreement: (a) the existence and terms of this Agreement and the Ancillary Agreements will be Confidential Information of both Parties (and both Parties will be deemed to be the Disclosing Party and the Receiving Party with respect thereto), (b) all confidential or proprietary information included in the Excluded Assets and the Excluded Liabilities will be the Confidential Information of Omeros; and (c) following the Closing, all confidential or proprietary information, to the extent included in the Acquired Assets, Assumed Liabilities, or the Program will be Confidential Information of Novo Nordisk. Omeros acknowledges and stipulates that the Licensed Know-How may include valuable trade secrets, and Omeros will not and will not permit any of its Affiliates, sublicensees, or subcontractors to, access, use, or otherwise exploit such Licensed Know-How, other than on confidentiality terms at least as protective as the confidentiality provisions of this Agreement, and Omeros will use reasonable efforts to protect the confidentiality of such trade secrets; [***]. Prior to the Closing, Omeros and Novo Nordisk acknowledge that they each are and remain bound by the terms of the Mutual Confidentiality Agreement. Each of Omeros and Novo Nordisk will abide by the terms of the Mutual Confidentiality Agreement, the terms of which are incorporated herein by reference. The Mutual Confidentiality Agreement will remain in full force and effect until the Closing, and will automatically terminate upon the Closing. During the period commencing on the Closing and ending on the expiration of the Term, and for a period of [***] thereafter, each Party agrees that a Party (the “Receiving Party”) that receives the Confidential Information of the other Party (the “Disclosing Party”) pursuant to this Agreement will: (i) maintain in confidence such Confidential Information using not less than the efforts that such Receiving Party uses to maintain in confidence its own proprietary information of similar kind and value, but in no event less than a reasonable degree of efforts; (ii) not disclose such Confidential Information to any Third Party without first obtaining the prior written consent of the Disclosing Party, except for disclosures expressly permitted pursuant to this Article 9 (Confidentiality; Publicity; Privilege); and (iii) not use such Confidential Information for any purpose except those permitted under this Agreement or any Ancillary Agreement, including the exercise of each Party’s rights and performance of its obligations hereunder and thereunder and, the exercise of the licenses granted to such Party hereunder and, in the case of Novo Nordisk, the Exploitation or practice of the Acquired Assets and Assigned Arising Technology conveyed to Novo Nordisk hereunder.

9.2

Exemptions. The following information will not be deemed Confidential Information for purposes of, or subject to the confidentiality obligations set forth in, this Agreement:

9.2.1

information that is known by the Receiving Party at the time of its receipt from the Disclosing Party without any obligation to keep it confidential or restriction on its use, and not through a prior disclosure by the Disclosing Party, as documented by the Receiving Party’s contemporaneous written records;

9.2.2

information that is or becomes publicly available or part of the public domain through no breach of this Agreement or any Ancillary Agreement by the Receiving Party;

9.2.3

information that, after disclosure by the Disclosing Party, is subsequently disclosed to the Receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality or any restriction on use with respect to such information; and

9.2.4

information that is developed by the Receiving Party independently of Confidential Information received from the Disclosing Party, as documented by the Receiving Party’s contemporaneous written records.

9.3

Permitted Disclosures. In addition to the exceptions contained in Section 9.1 (Confidential Information; Non-Disclosure and Non-Use Obligations) and Section 9.2 (Exemptions), the Receiving Party may disclose Confidential Information of the Disclosing Party (including the existence and terms of this Agreement):

9.3.1

if such disclosure is required by Applicable Law, including as may be required in connection with any filings made with, or by the rules and regulations of a major stock exchange (in which case the terms of such disclosures will be subject to Section 9.6.2 (Confidential Treatment));

9.3.2

if prosecuting or defending litigation in accordance with the terms of this Agreement, including responding to a subpoena in a Third Party litigation;

9.3.3

with respect to the Licensed Technology, where Omeros is the Receiving Party, to Exploit compounds and products owned or controlled by Omeros that are not Compounds and Products; provided that such Exploitation is permitted under, and consistent with, the terms and conditions of this Agreement;

9.3.4

if such disclosure is deemed necessary by the Receiving Party to be disclosed to such Party’s attorneys, independent accountants, or financial advisors for the sole purpose of enabling such attorneys, independent accountants, or financial advisors to provide advice to the Receiving Party, provided that such attorneys, independent accountants, and financial advisors are bound by confidentiality and non-use obligations substantially as protective as the provisions of this Agreement as they apply to the Receiving Party;

9.3.5

[***]

9.3.6

to any bona fide potential or actual investor, lenders, financing sources, or acquirors (and their applicable advisors and representatives) for the sole purpose of diligence for a potential investment, acquisition, merger, or public offering; provided that, with respect to both Parties, such disclosure will be limited to the terms of this Agreement, the Ancillary Agreements (unless otherwise agreed in writing by the other Party), reports provided under Section 7.10 (Royalty Reports) and any Sharable Summaries, and in all such instances, any such parties are bound by confidentiality and non-use obligations no less protective than the provisions of this Agreement as they apply to the Receiving Party; and

9.3.7

to its Affiliates; and each of its and its Affiliates’ employees, licensees, Sublicensees, or prospective licensee, Sublicensees, subcontractors, or prospective subcontractors, in each case, on a strict “need-to-know” basis in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement and the Ancillary Agreements; provided that, such parties are bound by confidentiality and non-use obligations no less protective than, the provisions of this Agreement as they apply to the Receiving Party; provided further that (a) the financial terms of this Agreement will be redacted from any such disclosure of the terms of this Agreement, and (b) the Receiving Party will remain responsible for any failure by any Person who receives Confidential Information pursuant to this Section 9.3.7 (Permitted Disclosures) to treat such Confidential Information as required under this Article 9 (Confidentiality; Publicity; Privilege).

9.4

Breaches of Confidentiality. The Receiving Party will remain responsible for any non-compliance of this Article 9 (Confidentiality; Publicity; Privilege) by its Representatives who receives Confidential Information. The Receiving Party will promptly notify the Disclosing Party when the Receiving Party becomes aware of any breach of this Article 9 (Confidentiality; Publicity; Privilege) by any Person to whom the Receiving Party has disclosed any Confidential Information. The Receiving Party will provide all reasonable assistance to the Disclosing Party in connection with any action, demand, claim, or proceeding that the Disclosing Party may institute against any such Person in respect of such disclosure.

9.5

Publication. Notwithstanding any provision to the contrary set forth in this Agreement, following the Closing, Novo Nordisk will have the sole right to publish the results related to any Compound or Product and any information related to the Compounds and Products in academic, scientific, and medical publications or public presentations, and Omeros may not publish the results related to any Compound or Product or any Assigned Arising Technology, in each case, without Novo Nordisk’s prior written approval.

9.6

Publicity.

9.6.1

Press Releases. The Parties have agreed that the contents of an initial press release to be issued jointly by the Parties promptly after the Effective Date will be substantially in the form attached hereto as Schedule 9.6.1 (Press Release). Except as may be expressly permitted under Section 9.3 (Permitted Disclosures) or Section 9.5 (Publication), neither Party will make any public announcement regarding this Agreement without the prior written approval of the other Party, except for either Party’s references to the other as licensor (or seller) or licensee (or buyer) (as applicable) under this Agreement. After the issuance of any such press release or any other permitted public disclosure by a Party, the publishing Party may make subsequent public disclosures reiterating such same information without having to obtain the other Party’s prior consent and approval so long as such same information in such press release or other public announcement remains true, correct, and the most current information with respect to the subject matters set forth therein. Notwithstanding the foregoing, neither Party will be required to obtain the consent of the other Party prior to making any public disclosure that is (i) required by Applicable Law (subject to such Party’s obligations to consult with counsel to limit such disclosures only to information such Party is legally required to disclose in accordance with Section 9.3 (Permitted Disclosures)); and (ii) consistent with, and still up-to-date in view of, other public disclosure made by the Parties in accordance with the terms of this Section 9.6.1 (Press Releases). Notwithstanding the foregoing, Omeros shall be permitted to make public announcements regarding its Exploitation of the Grandfathered MASP-3 Products, its exploitation of products pursuant the licenses and rights granted under Section 5.2 (Licenses to Omeros), or its conduct of the activities permitted under Section 5.4 (Exclusivity), in each case, without the prior written approval of Novo Nordisk; and Novo Nordisk shall be permitted to make public announcements regarding the Compounds and the Products, and its Exploitation thereof, without the prior written approval of Omeros.

9.6.2

Confidential Treatment. The Parties acknowledge that either or both Parties may be obligated to file a copy of this Agreement (or portions of this Agreement or an abstract of the terms of this Agreement) with the SEC or other Governmental Authorities. Each Party will be entitled to make such a required filing, provided that it initially files a redacted copy of this Agreement (or portions of this Agreement or an abstract of the terms of this Agreement) (“Redacted Agreement”) and requests confidential treatment of certain terms of this Agreement for a reasonable period of time. In the event of any such filing, each Party will (a) permit the other Party to review and comment upon such request for confidential treatment (including the Redacted Agreement) and any subsequent correspondence with respect thereto at least [***] Business Days in advance of its submission to the SEC or such other Governmental Authorities (to the extent practicable), (b) reasonably consider and incorporate the other Party’s comments thereon to the extent consistent with Applicable Law governing redaction of information from material agreements that must be publicly filed in the applicable country, (c) promptly deliver to the other Party any written correspondence received by it or its representatives from such Governmental Authority, if any, with respect to such confidential treatment request and promptly advise the other Party of any other communications between it or its representatives with such Governmental Authority with respect to such confidential treatment request, (d) upon the written request of the other Party, request an appropriate extension of the term of the confidential treatment period, where available, and (e) if such Governmental Authority requests any changes to the redactions set forth in the Redacted Agreement, use reasonable efforts to support the redactions in the Redacted Agreement as originally filed (to the extent consistent with the then-current legal requirements governing redaction of information from material agreements that must be publicly filed) and, to the extent reasonably practicable, not agree to any changes to the redactions proposed by such Governmental Authority in the Redacted Agreement without first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes. Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration, or notification.

9.6.3

No Other Use of Company Names. Except as otherwise expressly set forth herein, neither Party will use the name, trademark, trade name, or logo of the other Party, its Affiliates or its or their employees in any publicity or news release relating to this Agreement or its subject matter without the prior express written permission of the other Party; provided that each Party may reference the other Party in partnering, investor, and corporate presentations and discussions to the extent such referenced information is in the public domain and already connected to such other Party.

9.7

Attorney-Client Privilege. The Parties acknowledge and agree that both Omeros and Novo Nordisk may have a common interest in a potential Proceeding arising from the transactions contemplated hereby, and that neither Party is waiving, nor will be deemed to have waived or diminished, any of its attorney work product protections, attorney-client privileges or similar protections and privileges recognized under the Applicable Laws of any jurisdiction as a result of disclosing information pursuant to this Agreement or any Ancillary Agreement, or any of its Confidential Information (including Confidential Information related to pending or threatened litigation) to the Receiving Party, regardless of whether the Disclosing Party has asserted, or is or may be entitled to assert, such privileges and protections. The Parties may become joint defendants in proceedings to which the information covered by such protections and privileges relates and may determine that they share a common legal interest in disclosure between them that is subject to such privileges and protections, and in such event, may enter into a joint defense agreement setting forth, among other things, the foregoing principles but are not obligated to do so.

10.1

Mutual Representations. Except as disclosed in the disclosure schedule delivered by Omeros or Novo Nordisk, as applicable, on the date hereof, which disclosure schedule will be organized into sections corresponding to the Sections (or, if applicable, subsections) of this Section 10.1 (Mutual Representations) or, in the case of Omeros, Section 10.2 (Representations of Omeros) (provided, that any disclosure in a Section or subsection of the disclosure schedule shall apply to the corresponding Section or subsection of this Section 10.1 (Mutual Representations), or, in the case of Omeros, Section 10.2 (Representations of Omeros), as well as to the matters represented or warranted in such other Sections or subsections of this Section 10.1 (Mutual Representations), or, in the case of Omeros, Section 10.2 (Representations of Omeros) with respect to which it is reasonably apparent on the face of such disclosure that such disclosure would apply or qualify) (the “Omeros Disclosure Schedule,” and the “Novo Nordisk Disclosure Schedule,” as applicable), each of Omeros and Novo Nordisk hereby represents and warrants, as of the Execution Date and the Closing as follows:

10.1.1

Organization. Such Party is a legal entity duly organized, validly existing and, where relevant, in good standing under the Applicable Laws of its respective jurisdiction of organization and has all requisite corporate or similar power and authority to own, lease, and operate its properties and assets and to carry on its business as presently conducted. Each Party is qualified to do business and is in good standing as a foreign corporation or other entity in each jurisdiction where the ownership, leasing, or operation of its assets or properties or conduct of its business requires such qualification, with respect to Omeros, as would not have a Material Adverse Effect, and, with respect to Novo Nordisk, as would not reasonably be expected to materially delay, prevent or impair the consummation of the transactions contemplated by this Agreement.

10.1.2

Binding Agreement. This Agreement has been duly and validly executed and delivered by such Party and constitutes a legal, valid, and binding obligation of such Party, and each Ancillary Agreement will be, prior to the Closing, duly and validly executed and delivered by such Party (or its applicable Affiliate) and will, upon the Closing, constitute a legal, valid and binding obligation of such Party, in each case enforceable against such Party in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium, or similar Applicable Laws affecting creditors’ rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or at law).

10.1.3

Authorization. Such Party has all requisite corporate power and authority to execute and deliver this Agreement and each Ancillary Agreement to which it will be a party, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated pursuant to this Agreement. The execution and delivery by such Party of this Agreement and each such Ancillary Agreement, the performance by such Party of its obligations hereunder and thereunder and the consummation of the transactions contemplated hereby have been duly authorized by all requisite corporate action on the part of such Party and its applicable Affiliates, and no further approval or authorization of any equity holder, shareholder, or other holder of securities of Omeros is necessary in connection therewith.

10.1.4

No Conflicts. The execution, delivery, and performance by such Party of this Agreement and each Ancillary Agreement to which it is party, the consummation of the transactions contemplated herby and thereby, and its compliance with the terms and conditions hereof and thereof do not and will not (a) with respect to Omeros, conflict with, result in a breach of, constitute a default under, give rise to any right of or result in the termination, cancellation, modification, or acceleration (whether after the giving of notice or the lapse of time or both) of any right or obligation of such Party under, or to a loss of any benefit to which such Party is entitled under, any Transferred Contract, (b) violate any provisions of its Organizational Documents, (c) violate or result in any violation of any Applicable Law to which such Party is subject or may be bound, (d) violate or result in any violation of any Order of any Governmental Authority entered against it or by which any of its property is bound, (e) result in the creation of any Lien (other than a Permitted Lien) on any Acquired Asset, or (f) result in a fraudulent conveyance under the Applicable Laws of any jurisdiction applicable to such Party, whether on or after the Closing.

10.1.5

No Further Governmental Approval. Except for compliance with and filings under the HSR Act and any other Antitrust Laws and the expiration or early termination of any waiting period with respect thereto or the receipt of any consent thereunder, and the consents required for the transfer of the Governmental Authorization included in the Acquired Assets to Novo Nordisk, no government authorization, consent, approval, license, exemption of or filing, or registration with any court or governmental department, commission, board, bureau, agency, or instrumentality, domestic or foreign, under any Applicable Law currently in effect, is or will be necessary for, or in connection with, the transactions contemplated by this Agreement and each Ancillary Agreement, for the performance by such Party of its obligations under this Agreement and each Ancillary Agreement, or to consummate the transaction contemplated by this Agreement and each Ancillary Agreement, except, with respect to Omeros, as would not reasonably be expected to be material to any Acquired Asset, any Assumed Liability or the Program, or, with respect to Novo Nordisk, as would not reasonably be expected to materially delay, prevent or impair the consummation of the transactions contemplated by this Agreement.

10.1.6

No Further Third Party Approval. Except for compliance with and any filings under the HSR Act and any other Antitrust Laws and the expiration or early termination of any waiting period with respect thereto or the receipt of any consent thereunder, and the consents required for the transfer of the Governmental Authorization included in the Acquired Assets to Novo Nordisk, such Party has obtained all necessary authorizations, consents, and approvals of any Third Party that is required to be obtained by it for, or in connection with, the transactions contemplated by this Agreement and each Ancillary Agreement, for the performance by it of its obligations under this Agreement and each Ancillary Agreement, or to consummate the transaction contemplated by this Agreement and each Ancillary Agreement.

10.1.7

Non-Use and Non-Disclosure by Representatives. It has obtained from each of its existing employees, independent contractors, subcontractors, consultants, Sublicensees, agents, and others who perform activities for such Party under this Agreement (collectively, “Representatives”), written agreements containing obligations of confidentiality and non-use and an assignment to the applicable Party of all inventions and intellectual property rights (and all of such Person’s rights thereto) for which Omeros or Novo Nordisk is intended to have ownership or license rights under this Agreement such that no such Representative will retain any rights to such inventions or intellectual property rights that would prevent or conflict with Omeros’ or Novo Nordisk’s (as applicable) rights of ownership or use of such inventions or intellectual property rights as contemplated under this Agreement.

10.1.8

Orders. There are no Orders issued by any Governmental Authority binding on Novo Nordisk or any of its Affiliates, and there are no, and since [***], there have been no, to Novo Nordisk’s knowledge, Proceedings pending or threatened in writing by or against Novo Nordisk or any of its Affiliates as would reasonably be expected to materially delay, prevent or impair the consummation of the transactions contemplated by this Agreement.

10.1.9

Novo Nordisk Sufficiency of Funds. Novo Nordisk has as of the date of this Agreement and will have at the Closing (a) sufficient funds to make all payments contemplated by this Agreement in connection with the transactions contemplated by this Agreement at the time such payments become due and payable; and (b) the resources and capabilities (financial and otherwise) to perform its obligations under this Agreement.

10.2

Representations of Omeros. Except as disclosed in the Omeros Disclosure Schedule (it being understood that any disclosure in a Section or subsection of the Omeros Disclosure Schedule shall apply to the corresponding Section or subsection of Section 10.1 (Mutual Representations) or this Section 10.2 (Representations of Omeros) as well as to the matters represented or warranted in such other Sections or subsections of Section 10.1 (Mutual Representations) or this Section 10.2 (Representations of Omeros) with respect to which it is reasonably apparent on the face of such disclosure that such disclosure would apply or qualify), Omeros hereby further represents and warrants to Novo Nordisk as of the Execution Date and the Closing that:

10.2.1

Authority to Grant Rights. Omeros has the full right, power, and authority to grant all of the licenses and rights granted to Novo Nordisk under this Agreement.

10.2.2

Sole Ownership. No Affiliate of Omeros owns, Controls, or otherwise holds rights to any assets, property, rights, or interests (including any Intellectual Property) in or to any Compound, Product, or Acquired Asset. Except as otherwise set forth on Schedule 10.2.2 (Sole Ownership), all Acquired Assets and Licensed Technology, are owned or Controlled by Omeros. Except as set forth on Section 10.2.2 of the Omeros Disclosure Schedule, to Omeros’ Knowledge, no Third Party owns or otherwise holds rights or interests under the Transferred Intellectual Property or the Licensed Technology to Exploit any Compound or Product.  

10.2.3

Title.

(a)

Omeros has, and as of the Closing, Omeros will have good, marketable, and valid title to, or a valid leasehold interest in or a valid license to use all of the Acquired Assets and Licensed Technology, free and clear of all Liens (including claims by any Governmental Authority or academic or non-profit institution) other than Permitted Liens, and the Acquired Assets and Licensed Technology are not subject to any other Third Party agreement or existing royalty or other payment obligations to any Third Party, other than as set forth in the Program In-Licenses.

(b)

Omeros has the right to grant to Novo Nordisk the licenses and rights granted herein with respect to the Licensed Technology.

(c)

At the Closing, except with respect to the Delayed Acquired Assets, Novo Nordisk will acquire from Omeros good and marketable title to, or valid contract rights to, as applicable, all of the Acquired Assets, free and clear of all Liens (other than Permitted Liens).

(d)

To Omeros’ Knowledge, any finished clinical samples of any Product that are included in the Inventory were Manufactured on behalf of Omeros or its Affiliates in all material respects in compliance with GMPs, and comparable state and foreign Applicable Laws, and other Applicable Law. All other materials comprising the Inventory are of a quality and quantity usable in the ordinary course of business consistent with past practices.

10.2.4

Absence of Changes.

(a)

From [***] through the Execution Date, there has not occurred any Effect that has had, or would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

(b)

From [***] through the Execution Date, other than with respect to the transactions contemplated by this Agreement, the Program has been conducted, in all material respects, in the ordinary course of business consistent with past practices.

(c)

Except as set forth in Section 10.2.4(c) of the Omeros Disclosure Schedule, from [***] through the Execution Date, none of Omeros or any of its Subsidiaries has taken any of the actions described in Section 10.4.1(b) (Conduct of the Business) (other than Sections 10.4.1(b)(ix), 10.4.1(b)(xi), 10.4.1(b)(xii) 10.4.1(b)(xiv) and 10.4.1(b)(xv)).

(d)

The transactions contemplated by the Contract set forth on Section 10.2.4(d) of the Omeros Disclosure Schedule will not materially impair or materially delay the consummation of the transactions contemplated by this Agreement.

10.2.5

Transferred Contracts; Shared Contracts.

(a)

Set forth on Section 10.2.5(a) of the Omeros Disclosure Schedule is a true, complete, and accurate list, as of the Execution Date, of each Transferred Contract and each Shared Contract that:

(i)

contains any non-compete, exclusivity, most-favored nations, or similar provisions that restricts the Program, the Exploitation of any Compound or Product, or the Acquired Assets;

(ii)

grants any option, right of first refusal or right of first offer or similar right to, contingent or otherwise, that limits or purports to limit the ability of Omeros or its Affiliates (or following the Closing, Novo Nordisk or any of its Affiliates), or that grants any Third Party the right to own, operate, sell, transfer, pledge, or otherwise dispose of, any Acquired Assets or any portion of the Program;

(iii)

creates a partnership, joint venture, or similar arrangement;

(iv)

is a Contract related to the Program (other than any employment or consulting Contract) that involved the payment of more than $[***] (or equivalent local currency) in the year ending on [***] or which Omeros reasonably anticipates will involve the payment of more than such amount in the year ending on [***] under such Contract;

(v)

is a Contract for the purchase of services, materials, supplies, or equipment by Omeros or its Affiliates related to the Program that involved the payment of more than $[***] (or equivalent local currency) in the year ending on [***] or that Omeros reasonably anticipates will involve the payment of more than such amount in the year ending on [***];

(vi)

is a Contract with a Top Supplier;

(vii)

is a Contract for capital expenditures or the acquisition or construction of fixed assets which requires aggregate future payments in excess of $[***] (or equivalent local currency);

(viii)

under which Omeros or any Affiliate thereof has granted or received a license to any Intellectual Property used, useful, or held for use in the operation of the Program (but excluding any licenses for generally available off-the-shelf software);

(ix)

relates to the conduct of Clinical Trials of any Compound or Product, including any such Contract with investigators, contract research organizations, Clinical Trial sites, and Clinical Trial support services;

(x)

is a Contract in which Omeros or any of its Affiliates has granted Manufacturing, marketing, or distribution rights relating to any Compound or Product;

(xi)

is a Contract with any academic institution, research center, or Governmental Authority (or any Person working for or on behalf of any of the foregoing) that relates to any Compound or Product, including the Development or other creation of any Intellectual Property related to any Compound or Product; or

(xii)

is a Contract used, useful, or held for use in the operation of the Program under which Omeros or any Affiliate thereof provides for or receives any royalty, milestone, profit sharing, contingent, or deferred payments or similar obligations of any kind with respect to any Compound or Product.

(b)

Each Transferred Contract and each Shared Contract is in full force and effect and constitutes a legal, valid and binding agreement of Omeros or its applicable Affiliates and, to Omeros’ Knowledge, each other party thereto, and is enforceable in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium, or similar Applicable Laws affecting creditors’ rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or at law).

(c)

None of Omeros or its applicable Affiliates are in, or, to Omeros’ Knowledge, are alleged to be in, material breach of or material default under any of the Transferred Contracts or Shared Contracts, and to Omeros’ Knowledge, no other party to any of the Transferred Contracts has materially breached or defaulted thereunder or otherwise taken any action that would give rise to any right of or result in the termination, cancellation, modification, or acceleration (whether after the giving of notice or the lapse of time or both) of any right or obligation thereunder, or to a loss of any benefit thereunder.

(d)

Since [***] through the Execution Date, neither Omeros nor any of its applicable Affiliates has received from or delivered to any counterparty to a Transferred Contract or Shared Contract any written notice (i) alleging actual or alleged violation or breach of, or default under, such Transferred Contract or Shared Contract or (ii) stating intent to cancel or terminate such Transferred Contract or Shared Contract.

(e)

Omeros has, prior to the Execution Date, delivered to, or made available to, Novo Nordisk or its Representatives, true, complete, and accurate copies of each Transferred Contract and Shared Contract, including all amendments, modifications, and waivers relating thereto.

(f)

Except for the Excluded Contracts, the Transferred Contracts constitute all of the material Contracts that are necessary or useful to enable Novo Nordisk, immediately following the Closing, to conduct the Program as currently conducted by Omeros and its Affiliates as of the Closing.

10.2.6

Orders. There are no Orders issued by any Governmental Authority binding on the Program or the Acquired Assets, and there are no, and since [***], there have been no, Proceedings pending (or, to Omeros’ Knowledge, threatened in writing) by or against Omeros or any of its Affiliates with respect to the Acquired Assets, Assumed Liabilities or the Program. “Proceedings” as used in this Section 10.2.6 (Orders) will not include any patent office proceedings, such as any oppositions, interferences, reissue proceedings, ex-parte reexaminations, or post-grant proceedings for a Patent Right. To Omeros’ Knowledge, there are no facts or circumstances that would reasonably be expected to give rise to any Proceeding or Order described in the preceding sentence.

10.2.7

Compliance with Law.

(a)

Omeros and its Affiliates hold all Governmental Authorizations included in the Acquired Assets. Omeros and its Affiliates are operating in material compliance with all such Governmental Authorizations included in the Acquired Assets. There are no Proceedings pending or, to Omeros’ Knowledge, threatened in writing which would reasonably be expected to result in the limitation, adverse modification, revocation, cancellation, or suspension of any such Governmental Authorizations included in the Acquired Assets. Section 10.2.7(a) of the Omeros Disclosure Schedule sets forth a true, complete, and accurate list of all Regulatory Approvals included within the Governmental Authorizations included in the Acquired Assets.

(b)

Omeros and its Affiliates have, since [***], conducted the Program in compliance with all Applicable Laws, including all Applicable Laws with respect to the research, nonclinical and clinical testing, development, manufacturing, ownership, operation, storage, import, export, distribution, marketing, pricing, sale, promotion, document retention, warehousing, packaging, Labeling, and handling of any Compound or Product, including the FDCA and its implementing regulations, and any comparable state and foreign Applicable Laws (all such Applicable Laws, collectively, the “Health Care Laws”), as applicable, except, in each case, as would not be material to the Acquired Assets, Assumed Liabilities or the Program, taken as a whole. Since [***], none of Omeros or its Affiliates, or, to Omeros’ Knowledge, any Third Party manufacturer of any Compound or Product has received any written notice relating to such Compound or Product, including any FDA Form 483, clinical hold, warning letter, “dear doctor” letter, notice of adverse finding, notice of violation, untitled letter, safety notice, notice of deficiency, or similar communication from FDA or any other Governmental Authority, (i) alleging that any Compound, Product or the ownership, manufacturing, operation, storage, import, export, distribution, development, Clinical Trials, marketing, pricing, sale, promotion, warehousing, packaging, Labeling, handling, or testing thereof is in violation of any Applicable Law including any Health Care Law or Governmental Authorizations included in the Acquired Assets, or (ii) otherwise alleging any material violation of any Applicable Law including any Health Care Laws by Omeros or any of its Affiliates with respect to the Program or any Compound or Product. Omeros and its Affiliates are conducting and have conducted the Program since [***], in material compliance with all published or formal guidance applicable to the Program.

(c)

All Clinical Trials relating to any Compound or Product conducted by Omeros and its Affiliates have been and are being conducted in compliance in all material respects with valid study protocols and all other Applicable Laws, including Health Care Laws applicable to informed consents and the collection of Personal Information in Clinical Trials. Neither Omeros nor its Affiliates have received any written notice that FDA or any other Governmental Authority, or any Review Board or ethics committee has recommended, warned, initiated, or threatened to initiate any action to suspend or terminate any Clinical Trial or any IND or other approval necessary to conduct the Clinical Trial with respect to any Compound or Product sponsored by Omeros or any of its Affiliates, or to otherwise materially restrict the preclinical research or Clinical Trial of any Compound or Product. All Clinical Trials relating to any Compound or Product conducted by or on behalf of Omeros or any of its Affiliates, and the results of all such Clinical Trials, have been registered and disclosed in accordance with Section 801 of the Food and Drug Administration Amendments Act of 2007 (Section 402(j) of the Public Health Service (PHS) Act), 42 C.F.R. Part 11, to the extent required, and all other Applicable Laws, including applicable drug Clinical Trial registration requirements in other jurisdictions.

(d)

All material documents, reports, and notices required to be filed with any Governmental Authority by or on behalf of Omeros or any of its Affiliates with respect to the Program or the Compound or Products, including any such Regulatory Submissions therefor, have been so filed on a timely basis, were prepared and have been maintained in accordance with Applicable Law relating to good industry practice, and were complete and accurate in all material respects as of the date of filing, or were subsequently updated, changed, corrected, or modified to be so. No such filing with any Governmental Authority contains any materially false, misleading, or otherwise materially inaccurate statements or information, whether express or due to omission of material information, as of the date of filing.

(e)

Section 10.2.7(e) of the Omeros Disclosure Schedule sets forth a true, complete, and accurate list, as of the Execution Date, of all material preclinical studies (including in vitro, ex vivo, or in vivo studies, and indication development data) and Clinical Trials previously or currently undertaken or sponsored by or on behalf of Omeros or any of its Affiliates or any Third Party investigator for whom Omeros and its Affiliates directly provided material financial support for any such Clinical Trial, in each case, with respect to any Compound or Product. True, complete, and accurate copies of all interim and final study data and clinical study reports with respect to such material preclinical studies and Clinical Trials, and of any material conclusions or findings thereof, have been made available to Novo Nordisk. None of Omeros or any of its Affiliates have any outstanding applications for any local or global Clinical Trial amendments. Omeros has made available to Novo Nordisk a true, complete, and accurate copy of all submissions, formal correspondence, formal meeting minutes, and any formal records or any other material communications (whether formal or informal) relating to any Compound or Product between Omeros or its Affiliates, or any Third Party investigator for whom Omeros or its Affiliates provides material or financial support on the one hand and FDA, other Governmental Authorities, or any Review Board regarding such Clinical Trials on the other hand.

(f)

Neither Omeros nor any of its Affiliates have (i) opened any clinical site for the conduct of any Phase 3 Clinical Trial or (ii) enrolled or dosed any patients in any such Phase 3 Clinical Trial, in each case ((i) and (ii)), for any Compound or Product.

(g)

All animal studies or other preclinical tests performed by Omeros or its Affiliates, or, to Omeros’ Knowledge, by a Third Party acting on behalf of Omeros or its Affiliates, submitted to Governmental Authorities in support of any Governmental Authorizations or Regulatory Approvals for a clinical investigation or marketing of a Compound or Product (i) have been conducted in accordance with applicable Good Laboratory Practice regulations as described in 21 C.F.R. Part 58 or comparable state or foreign Applicable Laws or (ii) involved experimental research techniques that were not performed by a registered Good Laboratory Practice testing laboratory (with appropriate notice being given to FDA or other applicable Regulatory Authorities) but have employed procedures and controls as required by Applicable Laws relating to animal or preclinical study of products comparable to the Compounds or Products.

(h)

To Omeros’ Knowledge, all Manufacturing operations conducted by, or for the benefit of, Omeros or its Affiliates with respect to a Compound or Product being used in human Clinical Trials, since [***] have been and are being conducted in accordance in all material respects with current Good Manufacturing Practices, as set forth in 21 C.F.R. Parts 210 and 211, or otherwise under 21 U.S.C. § 351, and comparable state and foreign Applicable Laws, to the extent applicable. All such Manufacturing operations are in material compliance with all applicable registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207 and all similar Applicable Laws in those jurisdictions in which Clinical Trials or Manufacturing activities have been or are being conducted by Omeros and its Affiliates involving a Compound or Product, to the extent applicable. No Manufacturing site used for the manufacture of any Compound or Product is subject to a Regulatory Authority shutdown or import or export prohibitions. Neither Omeros nor any of its Affiliates has received any written notice that FDA or any other Governmental Authorities or Review Board has initiated, or threatened to initiate, any action to recall or suspend the manufacture of any Compound or Product.

(i)

Omeros has made available to Novo Nordisk true, complete, and accurate copies of (i) all INDs related to any Compound or Product held by Omeros or any of its Affiliates, (ii) all substantive correspondence in Omeros’ or any of its Affiliates’ possession or control to or from FDA and any other applicable Regulatory Authorities, in each case concerning (A) any Compound, (B) any Product, (C) Omeros’ or any of its Affiliates’ compliance with Applicable Laws regarding any Compound or Product, and (D) the likelihood or timing of, or requirements for, Regulatory Approval of any Compound or Product; and (iii) all substantive information in Omeros’ or any of its Affiliates’ possession or control concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of any Compound or Product.

(j)

None of Omeros or any of its Affiliates has received any: (i) written notice, complaint, or Order alleging non-compliance with any Applicable Laws relating to the sampling, collecting, using, trading, transferring, or exporting of human genetic resources; (ii) written claim for compensation for loss or unauthorized sampling, collecting, using, trading, transferring or exporting of human genetic resources; or (iii) written Order for rectification, confiscation, erasure, or destruction of human genetic resources, imposition of fines, or any other penalty.

(k)

None of Omeros or any of its Affiliates or any of their respective directors, officers or employees, or, to Omeros’ Knowledge, any other Representatives acting for Omeros or its Affiliates, or any Third Party investigators for whom Omeros and its Affiliates provides material or financial support has committed any prohibited act, made any or failed to make any statement, relating to any Compound or Product or the Development or Manufacturing thereof that would reasonably be expected to provide a basis for FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or for any Governmental Authority to invoke a similar policy under equivalent foreign Applicable Laws. Additionally, none of Omeros, any of its Affiliates or any of their respective directors, officers or employees, or, to Omeros’ Knowledge, any other Representative acting for Omeros or its Affiliates or any Third Party investigator for whom Omeros or its Affiliates provides financial support in connection with the Program, is or ever has been debarred, excluded, or suspended from participation, or otherwise been deemed ineligible to participate, in any health care programs of any Governmental Authority or under PRC’s human genetic resource regulations, or convicted of any crime regarding health care products or services, or engaged in any conduct that would reasonably be expected to result in any such debarment, exclusion, suspension, or ineligibility, including (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign Applicable Law and (ii) exclusion under 42 U.S.C. Section 1320a- 7 or any similar state or foreign Applicable Law.

(l)

Neither Omeros nor any of its Affiliates is a party to any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or similar agreement imposed by any Governmental Authority that relates any Compound, Product, or any of the Acquired Assets.

10.2.8

Program Not a TID U.S. Business. The Program is not a “U.S. business” engaged in (a) the design, fabrication, development, testing, production, or manufacture of one or more “critical technologies” within the meaning of the Defense Production Act of 1950, as amended, including all implementing regulations thereof (the “DPA”); (b) the ownership, operation, maintenance, supply, manufacture, or servicing of “covered investment critical infrastructure” within the meaning of the DPA (where such activities are covered by column 2 of Appendix A to 31 C.F.R. Part 800); or (c) the maintenance or collection, directly or indirectly, of “sensitive personal data” of U.S. citizens within the meaning of the DPA.

10.2.9

Taxes.

(a)

All income and other material Tax Returns that are required to be filed with respect to the Acquired Assets and the Program, if any, have been timely filed (taking into account any extension of time within which to file), and all such Tax Returns are true, complete, and accurate in all material respects.

(b)

All income and other material Taxes due and owing with respect to the Acquired Assets and the Program have been, or will be, timely (considering any valid extensions available under Applicable Law) and properly paid to the applicable Taxing Authority and all related Tax reporting requirements, if any, have been, and will be properly satisfied in all material respects.

(c)

There are no Liens for Taxes (other than Liens for Taxes not yet due and payable) on any of the Acquired Assets or any portion of the Program.

(d)

No Tax Proceedings are pending, in progress or have been threatened in writing with respect to any Taxes relating to the Acquired Assets or the Program and there are no matters under audit or appeal with any Taxing Authority relating to the Acquired Assets or the Program.

(e)

There are no Tax sharing, Tax allocation, Tax indemnity or similar agreements with respect to the Acquired Assets or the Program to which Novo Nordisk would or might become liable for the Taxes of another Person in relation to Acquired Assets or the Program, other than any agreement entered into in the ordinary course of business the primary purpose of which is not related to Taxes.

(f)

Omeros has provided or made available to Novo Nordisk proof of tax residency.

10.2.10

Patent Rights.

(a)

All of the issued Licensed Background Patent Rights and Transferred Patent Rights that are identifiable and existing as of the Closing are subsisting and, to Omeros’ Knowledge, valid, and enforceable. To Omeros’ Knowledge, Omeros and its Affiliates either own and Control or otherwise Control all Patent Rights that are necessary or reasonably useful to Develop, Manufacture, Commercialize, or otherwise Exploit the Compounds or Products as the same exists as of the Effective Date. Neither Omeros nor any of its Affiliates have taken any action that would render any Licensed Background Patent Rights or Transferred Patent Rights unpatentable.

(b)

Omeros has timely paid all application, registration, maintenance, and renewal fees due with respect to all Licensed Background Patent Rights and Transferred Patent Rights and has filed all necessary documents with the relevant patent registries for the purpose of maintaining such Licensed Background Patent Rights and Transferred Patent Rights.

(c)

Omeros has not given any written notice to any Third Party asserting infringement by such Third Party of any Licensed Background Patent Rights or Transferred Patent Rights and, to Omeros’ Knowledge, there is no unauthorized use, infringement, or misappropriation of any Licensed Background Patent Rights or Transferred Patent Rights.

10.2.11

Intellectual Property.

(a)

Registered Intellectual Property. Section 10.2.11(a) of the Omeros Disclosure Schedule sets forth a true, complete, and accurate list of all registered Intellectual Property, as of the Execution Date (i) included within (A) the Transferred Intellectual Property, (B) the Licensed Background Technology, or (C) otherwise used or held for use by Omeros or its Affiliates in connection with the Program or the Development, Manufacture, Commercialization, or other Exploitation of any Compound or Product, and all such Transferred Intellectual Property, Licensed Background Technology, or Intellectual Property that are subject to a current application for registration (collectively, the “Registered Intellectual Property”), which list includes information regarding, for all such Registered Intellectual Property: (1) all current owners thereof, (2) all jurisdictions in which Registered Intellectual Property has been or is registered, granted, issued or in which registrations, grants or issuances have been applied for or, in the case of a domain name, the registrar for that domain name, (3) all registration numbers, issuance numbers, grant numbers, serial numbers or application numbers, as applicable, (4) all filing, maintenance, and other deadlines with respect to the Transferred Intellectual Property that are due within [***] days after the Effective Date, and (5) all expiration dates of such registrations, grants, issuances or applications, where applicable. Omeros has provided to Novo Nordisk a copy of all applications related to each such item of Registered Intellectual Property. All Registered Intellectual Property is subsisting and in full force and effect and, to Omeros’ Knowledge, all Registered Intellectual Property (other than pending applications) is valid and enforceable. All necessary registration, maintenance, and renewal fees for each item of Registered Intellectual Property have been timely and appropriately made and all necessary documents, recordations, and certificates in connection with such Registered Intellectual Property have been filed with the relevant Governmental Authority for the purposes of prosecuting, maintaining or perfecting such Registered Intellectual Property, including recordation of all assignment documents vesting ownership of the Registered Intellectual Property. None of the Registered Intellectual Property has been abandoned, disclaimed, rendered unenforceable, or has expired, lapsed, or been declared revoked, unpatentable, invalid or unenforceable (in each case, in whole or in part) by any Governmental Authority. The entity identified as the applicant upon initial filing of each Patent Right within the Registered Intellectual Property that contains a priority claim to an earlier patent application held the right to claim such priority to such earlier patent application at the time of such initial filing. To Omeros’ Knowledge, there are no facts or circumstances that would reasonably be likely to provide a basis for abandonment, invalidity, or unenforceability of any Registered Intellectual Property.

(b)

Sufficiency of Intellectual Property. Except pursuant to a Shared Contract, the Transferred Intellectual Property and the Licensed Background Technology constitute all of the Patent Rights and Know-How that are owned, Controlled, or licensed by Omeros or its Affiliates that are necessary or useful for the conduct of the Program as currently conducted or the Development, Manufacture, Commercialization, or other Exploitation of any Compound or Product as the same exists as of the Effective Date. No provision of this Section 10.2.11(b) (Sufficiency of Intellectual Property) will be deemed a representation or warranty of Omeros, and Omeros make no representation or warranty pursuant to this Section 10.2.11(b) (Sufficiency of Intellectual Property) with respect to, non-infringement of any Intellectual Property of any Third Party.

(c)

Intellectual Property Licenses. Section 10.2.11(c)(i) of the Omeros Disclosure Schedule contains a true, complete, and accurate list of each Contract relating to any In-Licensed Intellectual Property (other than Excluded Licenses). Section 10.2.11(c)(ii) of the Omeros Disclosure Schedule contains a true, complete, and accurate list of each Contract under which any Third Party has been granted any license, or ownership right, under or in, or otherwise benefits from any right (whether actual or contingent) or interest in, any Transferred Intellectual Property or Licensed Background Technology.

(d)

Proper Ownership and Rights. Omeros is the (i) proper and rightful owner of or licensee to the Patent Rights and Know-How licensed to Novo Nordisk under Section 5.1 (Licenses to Novo Nordisk), and Omeros has the rights necessary to grant the license set forth in Section 5.1 (Licenses to Novo Nordisk) to Novo Nordisk (including under any Third Party in-license agreements) and (ii) sole and exclusive owner of all rights, title, and interests in and to the Transferred Intellectual Property, free and clear of any Liens (other than Permitted Liens and Liens under the Existing Credit Facility). To Omeros’ Knowledge, as of the Effective Date, other than the Transferred Intellectual Property, Omeros or its Affiliates own and Control all intellectual property or other rights necessary for Exploiting all Compounds and Products containing ‘906 as the same exists as of the Effective Date, and all such intellectual property or other rights may be exercised without additional payment or other consideration to be paid by Novo Nordisk for such intellectual property or other rights. To Omeros’ Knowledge, Omeros and its Affiliates have sufficient rights to use the In-Licensed Intellectual Property for all purposes related to the Exploitation of the Compounds and Products for which they have used and use such In-Licensed Intellectual Property, in each case, pursuant to valid and enforceable written Contracts. Neither Omeros nor any of its Affiliates, nor any Transferred Intellectual Property, Licensed Background Technology, or In-Licensed Intellectual Property, is subject to any Contract containing any obligation, restriction or other provision that limits or restricts the ability of Omeros and its Affiliates (or Novo Nordisk or its Affiliates following the Closing) to use, exploit, or enforce any of the Transferred Intellectual Property, Licensed Background Technology, or In-Licensed Intellectual Property.