Collaboration And License Agreement

COLLABORATION AND LICENSE AGREEMENT by and Between VOYAGER THERAPEUTICS, INC. AND NEUROCRINE BIOSCIENCES, INC.

Exhibit 10.5

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(c) and Rule 24b-2

COLLABORATION AND LICENSE

AGREEMENT

 

By and between

VOYAGER THERAPEUTICS, INC.


AND

NEUROCRINE BIOSCIENCES, INC.

 


 

TABLE OF CONTENTS

ARTICLE 1

DEFINITIONS1

ARTICLE 2

COLLABORATION; PRE-TRANSITION DEVELOPMENT19

 

2.1

Collaboration and Programs19

 

2.2

Development Costs22

 

2.3

Records of Activities23

 

2.4

No Representation23

 

2.5

Subcontracting23

 

2.6

Academic Collaborators23

ARTICLE 3

MANAGEMENT OF THE COLLABORATION24

 

3.1

Joint Steering Committee and Subcommittees24

 

3.2

Formation and Dissolution of Subcommittee(s)26

 

3.3

Working Groups26

 

3.4

Membership27

 

3.5

Meetings28

 

3.6

Decision-Making28

 

3.7

Alliance Managers30

 

3.8

Authority30

ARTICLE 4

POST-TRANSITION ACTIVITIES30

 

4.1

Co-Development and Co-Commercialization30

 

4.2

Neurocrine Development and Commercialization34

 

4.3

Program Transition35

 

4.4

Transition Activities36

ARTICLE 5

GRANT OF LICENSES37

 

5.1

License Grant37

 

5.2

In-License Agreements37

 

5.3

Obligations Under In-Licenses39

 

5.4

Genzyme Agreement41

 

5.5

Neurocrine’s Sublicensing Rights41

 

5.6

Licenses to Voyager41

 

5.7

No Other Rights42

 

5.8

Section 365(n) of the Bankruptcy Code42

ARTICLE 6

MANUFACTURING43

 

6.1

Manufacturing Responsibilities Prior to Transition Date43

 

6.2

Manufacturing After Transition Date43

ARTICLE 7

GENERAL PROVISIONS RELATING TO ACTIVITIES43

 

7.1

Compliance43

 

7.2

Regulatory Activities43

 

7.3

Sale of Priority Review Voucher44

 

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7.4

Records and Audits45

ARTICLE 8

INITIAL FEE; MILESTONES AND ROYALTIES; PAYMENTS45

 

8.1

Initial Consideration45

 

8.2

Milestone Payments45

 

8.3

Royalties50

 

8.4

Royalty Period53

 

8.5

Royalty Adjustments53

 

8.6

Reports; Payment of Royalty54

 

8.7

Accounting; Audit55

 

8.8

Currency Conversion56

 

8.9

Books and Records56

 

8.10

Methods of Payments56

 

8.11

Taxes56

 

8.12

Late Payments57

ARTICLE 9

EXCLUSIVITY57

 

9.1

Exclusivity57

 

9.2

Exception for Basic Research58

 

9.3

Acquisitions58

ARTICLE 10

INTELLECTUAL PROPERTY RIGHTS59

 

10.1

Ownership of Inventions; Disclosure59

 

10.2

Patent Prosecution and Maintenance60

 

10.3

Enforcement and Defense64

 

10.4

Infringement Claimed by Third Parties66

 

10.5

Marking66

 

10.6

Trademarks67

ARTICLE 11

CONFIDENTIALITY67

 

11.1

Confidentiality; Exceptions67

 

11.2

Authorized Disclosure68

 

11.3

Press Release; Disclosure of Agreement69

 

11.4

Publications70

 

11.5

Remedies70

 

11.6

[*...***...] Agreement70

ARTICLE 12

REPRESENTATIONS AND WARRANTIES71

 

12.1

Representations and Warranties of Both Parties71

 

12.2

Representations, Warranties and Covenants, as applicable, of Voyager71

 

12.3

Mutual Covenants75

 

12.4

Disclaimer76

ARTICLE 13

INDEMNIFICATION; INSURANCE76

 

13.1

Indemnification by Neurocrine76

 

13.2

Indemnification by Voyager77

 

13.3

Procedure77

 

13.4

Insurance78

 

 

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13.5

Limitation of Liability78

ARTICLE 14

TERM AND TERMINATION79

 

14.1

Term79

 

14.2

Termination by Neurocrine79

 

14.3

Termination for Breach79

 

14.4

Termination for Failure to Make Equity Purchase80

 

14.5

Termination for Patent Challenge80

 

14.6

Effects of Termination Other than by Neurocrine for Voyager Breach80

 

14.7

Effects of Termination by Neurocrine for Voyager Breach83

 

14.8

HSR Filing; Termination Upon HSR Denial83

 

14.9

Accrued Rights; Surviving Provisions of the Agreement84

ARTICLE 15

MISCELLANEOUS84

 

15.1

Governing Law84

 

15.2

Dispute Resolution84

 

15.3

Arbitration Request84

 

15.4

Assignment86

 

15.5

Change of Control86

 

15.6

Performance by Affiliates and Sublicensees86

 

15.7

Force Majeure86

 

15.8

Notices87

 

15.9

Export Clause88

 

15.10

Waiver88

 

15.11

Severability88

 

15.12

Entire Agreement88

 

15.13

Independent Contractors89

 

15.14

CREATE Act89

 

15.15

Headings; Construction; Interpretation89

 

15.16

Further Actions90

 

15.17

Parties in Interest90

 

15.18

Counterparts90

SCHEDULES

Schedule 1.37Existing In-License Agreements
Schedule 1.68Knowledge Individuals
Schedule 5.2.1Specific Obligations under the [...***...] Agreement
Schedule 5.2.4(a)Certain Intellectual Property
Schedule 8.1Allocation of Initial Fee

EXHIBITS

Exhibit AStock Purchase Agreement
Exhibit BVoyager Licensed Patent Rights
Exhibit CSchedule of Exceptions

 

 

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This COLLABORATION AND LICENSE AGREEMENT (the “Agreement”) is entered into as of January 28, 2019 (the “Execution Date”), by and between Voyager Therapeutics, Inc., a Delaware corporation, having its principal place of business at 75 Sidney Street, Cambridge, MA 02139 (“Voyager”), and Neurocrine Biosciences, Inc., a Delaware corporation, having its principal place of business at 12780 El Camino Real, San Diego, CA 92130 (“Neurocrine”).  Voyager and Neurocrine shall be referred to herein individually as a “Party” and collectively as the “Parties”.

RECITALS

WHEREAS, Voyager is a gene therapy company focused on the research and development of products for the treatment of diseases of the central nervous system and other neurodegenerative diseases;

WHEREAS, Neurocrine is a biopharmaceutical company focused on developing and commercializing treatments for neurological and endocrine-related disorders, and possesses expertise in the research, development, manufacturing and commercialization of human therapeutics;

WHEREAS, Voyager and Neurocrine desire to engage in a collaborative effort in which Voyager will carry out certain preclinical research activities and clinical development activities relating to the identification and development of Development Candidates (as defined herein), and pursuant to which Neurocrine will have certain rights to further develop and commercialize Collaboration Products (as defined herein); and

WHEREAS, Voyager and Neurocrine believe that combining their respective expertise will allow them to identify and develop more Development Candidates and bring Collaboration Products to market more quickly than they could without this Agreement, as well as to take advantage of other efficiencies stemming from their complementary expertise.

NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1
DEFINITIONS

As used in this Agreement, the following terms will have the meanings set forth in this Article 1 unless context dictates otherwise:

1.1AADC” means the enzyme aromatic L-amino acid decarboxylase, which is defined by the ENSEMBL Gene ID ENSG00000132437, or any naturally occurring variant thereof.

1.2AADC Program” means all activities under this Agreement directed to the Development, Manufacture and Commercialization of Gene Therapy Products intended to treat Parkinson’s disease by delivery of a gene encoding AADC, which gene is the Target of the AADC Program (it being understood that the foregoing does not limit the rights granted to Neurocrine with respect to the Field).

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1.3AADC Program Development Plan” means the plan and budget for the Development of VY-AADC through completion of Voyager’s ongoing Pivotal Clinical Trial (1105) therefor (the “Existing Pivotal Trial”), as such plan and budget may be updated by the JSC from time to time in accordance with Section 2.1.3(a). The initial AADC Program Development Plan will be mutually agreed to by the Parties within [...***...] of the Effective Date.

1.4AAV” means a recombinant adeno-associated Virus Vector.

1.5Accounting Standards” means (a) GAAP (United States Generally Accepted Accounting Principles) or (b) IFRS (International Financial Reporting Standards), in either case, consistently applied, as reported in the applicable financial statements.

1.6Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with a Party to this Agreement, regardless of whether such Affiliate is or becomes an Affiliate on or after the Effective Date, but only for so long as such control exists.  A Person shall be deemed to “control” another Person if it (a) owns, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the outstanding voting securities or capital stock of such other Person, or has other comparable ownership interest with respect to any Person other than a corporation; or (b) has the power, whether pursuant to contract, ownership of securities or otherwise, to direct the management and policies of such other Person.

1.7Annual Net Sales” means, on a Collaboration Product-by-Collaboration Product basis, the total Net Sales of such Collaboration Product in the U.S. or in the Territory outside the U.S., as applicable, in a particular Calendar Year.

1.8Antitrust Laws” means any law relating to competition that is enforced by the U.S. Federal Trade Commission or the Antitrust Division of the U.S. Department of Justice.

1.9Biosimilar Product” means, with respect to a particular Collaboration Product in a particular country in the Territory, any Gene Therapy Product sold by a Third Party not authorized by or on behalf of Neurocrine, its Affiliates, or Sublicensees, that targets the same Target as the Collaboration Product and, on the basis of a prior Regulatory Approval granted to a Collaboration Product, (a) is approved by the FDA pursuant to Section 351(k) of the PHSA or successor thereto, (b) is approved by the EMA pursuant to EU Directive 2001/83/EC or successor thereto in the European Union or any member state thereof citing such Collaboration Product as the reference product, or (c) has received abbreviated Regulatory Approval from the applicable Regulatory Authority in another foreign jurisdiction.

1.10BLA” means a Biologics License Application submitted to the FDA pursuant to 21 U.S.C. §601.2 (or successor regulation thereto), for purposes of obtaining Regulatory Approval for a new biologic in the United States, or any equivalent filing in a country or regulatory jurisdiction other than the United States.

1.11Business Day” means a day on which banking institutions in Boston, Massachusetts or San Diego, California are open for business, excluding any Saturday or Sunday.

 

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1.12Calendar Quarter” means a period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively; provided that, the first Calendar Quarter starts on the Effective Date and ends on March 31, 2019.

1.13Calendar Year” means a period of twelve (12) consecutive months beginning on January 1 and ending on December 31; provided that the first Calendar Year starts on the Effective Date and ends on December 31, 2019.

1.14[...***...] License Agreement” means that certain license agreement by and between Voyager and [...***...], dated [...***...] as of the Execution Date.

1.15cGMP” means the current Good Manufacturing Practices as provided for (and as amended from time to time) in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7 (ICH Q7), and the United States Code of Federal Regulations 21 CFR Parts 210 and 211, or any similar regulation in other applicable jurisdictions.

1.16Change of Control” means, with respect to a Party, (a) the acquisition of beneficial ownership, directly or indirectly, by any Third Party of securities or other voting interest of such Party representing a majority or more of the combined voting power of such Party’s then outstanding securities or other voting interests, (b) any merger, consolidation or business combination involving such Party with a Third Party that results in the holders of beneficial ownership (other than by virtue of obtaining irrevocable proxies) of the voting securities or other voting interests of such Party (or, if applicable, the ultimate parent of such Party) immediately prior to such merger, consolidation or business combination ceasing to hold beneficial ownership of more than fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, consolidation or business combination, or (c) any sale, lease, exchange, contribution or other transfer to a Third Party (in one transaction or a series of related transactions) of all or substantially all of the assets of such Party to which this Agreement relates.  The acquiring or combining Third Party in any of clause (a), (b) or (c), is referred to herein as the “Acquirer”.

1.17Clinical Trial” means a Phase 1 Clinical Trial, Phase 2 Clinical Trial, Phase 3 Clinical Trial or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational.

1.18Collaboration Candidate” means (a) with respect to the AADC Program, VY-AADC and all other Gene Therapy Products Developed in the AADC Program and (b) with respect to each other Program, any form, formulation, or dosage of a Gene Therapy Product that is Developed by or on behalf of Voyager under such Program, or in the case of the FA Program, was Developed by Voyager prior to the Effective Date and is directed to the Target for the FA Program.

1.19Collaboration Product” means, with respect to each Program, a product containing a Collaboration Candidate in such Program, alone or in combination with other active or inactive components or ingredients, in any formulation, dosage or form.  Except where the context otherwise requires, the term “Collaboration Product” includes any Co-Co Product.

 

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1.20Commercialization” and “Commercialize” means any and all activities undertaken relating to the marketing, obtaining pricing and reimbursement approvals, promotion (including advertising, detailing or continuing medical education), any other offering for sale or any sale of a product, including any distribution, importation, exportation or transport of a product for sales purposes.  “Commercialization” shall not include Development, but may include Manufacturing to the extent applicable.

1.21Commercial Milestones” means the Milestone Events described in Section 8.2.4.

1.22Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to an agreed objective, such reasonable, diligent, and good faith efforts that a biopharmaceutical company of similar size would normally use taking into account the reasonable allocation of such company’s resources under the circumstances to accomplish a similar objective for its own internally developed product that is of similar market potential at a similar stage in its Development, Commercialization or product life, taking into account all relevant factors, including (a) the potential profitability of the product, (b) the costs and risks of Developing, Manufacturing, having Manufactured, using and Commercializing the product, (c) scientific, safety and regulatory concerns, (d) product profile, (e) the competitiveness of the marketplace and (f) the proprietary position of the product.  In addition, “Commercially Reasonable Efforts” shall be determined on a country-by-country or market-by-market basis (as most applicable) for a particular Collaboration Product, and it is anticipated that the level of effort will change over time, including to reflect changes in the status of the Collaboration Product and the countries (or markets) involved.  For the avoidance of doubt, where a Party has an obligation to use Commercially Reasonable Efforts, the efforts of such Party and its Affiliates, subcontractors and Sublicensees shall be considered in determining whether such Party has satisfied such obligation.

1.23Competitive Product” means, with respect to a Program, a Gene Therapy Product (other than a Collaboration Product under the Collaboration) that is directed to the Target to which Collaboration Products in such Program are directed, provided, however, that to the extent such Target is a derivative or fragment of a gene that is (i) the same derivative or fragment of a different gene and (ii) is a potential Target for a Gene Therapy Product in a different indication, a Gene Therapy Product that is directed to such Target for use in such different indication shall not be a Competitive Product.

1.24Control” means, subject to Section 5.2.3, with respect to a Person and any Know-How or Patent Right, the possession by such Person of the right (whether through ownership or license (other than by a license under this Agreement) or control (as defined in Section 1.6) over an Affiliate with such right) to grant the licenses or sublicenses as provided herein without violating the terms of any agreement or other arrangement with any Third Party.

1.25Cover” means, in the absence of ownership of or a license granted under a Valid Claim, (a) with respect to a Collaboration Product, that the manufacture, use or sale of such Collaboration Product and (b) with respect to any other invention, that the practice of such invention, in each case (a) and (b) would infringe such Valid Claim (or, in the case of a Valid Claim that has not yet issued, would infringe such Valid Claim if it were to issue).

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1.26Develop” or “Development” means non-clinical, pre-clinical and clinical research and development activities, including discovery, identification, research, engineering, characterization, development, modification, optimization, drug metabolism and pharmacokinetics, translational research, toxicology, pharmacology toxicology studies, statistical analysis and report writing, formulation development and optimization, Clinical Trials, regulatory affairs (including preparation for a Regulatory Approval Application submission and other submission-related activities), product approval and registration activities, and all other activities necessary to conduct IND-enabling studies, conduct Clinical Trials, or seek, obtain and maintain Regulatory Approval.  “Development” shall not include Commercialization, but may include Manufacturing to the extent applicable.

1.27Development Candidate” means (a) with respect to the AADC Program, VY-AADC, (b) with respect to the FA Program, initially, VY-FXN01, and (c) on a Program-by-Program basis, other than with respect to the AADC Program, a Gene Therapy Product that (i) is Developed by or on behalf of Voyager in the course of such Program, (ii) has been nominated as a development candidate by either Voyager or Neurocrine in accordance with Section 2.1.9(a) and (iii) either (A) has been determined to meet the development candidate criteria developed by the JSC (the “Development Candidate Criteria”) or (B) has otherwise been selected by the JSC as a Development Candidate notwithstanding its failure to meet the Development Candidate Criteria, in each case (A) and (B) pursuant to Section 2.1.9(b).

1.28Development Costs” means the FTE Costs (at the then-current FTE Rate) and the Out-of-Pocket Costs (without markup) incurred by or on behalf of a Party or any of its Affiliates in the conduct of the Development of a Collaboration Product.

1.29Development Milestones” means the Milestone Events described in Sections 8.2.1, 8.2.2 and 8.2.3.

1.30Development Plan” means an Existing Program Development Plan or a Discovery Program Development Plan, as applicable.

1.31Discovery Program” means, with respect to each Discovery Target, all activities under this Agreement directed to the Development, Manufacture and Commercialization of Gene Therapy Products directed to such Discovery Target.

1.32Discovery Target” means each of two Targets approved for the Discovery Programs by the JSC pursuant to Section 2.1.2.

1.33Dollars” or “$” means the legal tender of the U.S.

1.34Effective Date” means the HSR Clearance Date.

1.35EMA” means the European Medicines Agency, and any successor entity thereto.

1.36Executive Officers” means the Chief Executive Officer, or his or her designee, in the case of Voyager, and the Chief Executive Officer, or his or her designee, in the case of Neurocrine.

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1.37Existing In-License Agreement” means those in-licenses of Voyager or any of its Affiliates set forth on Schedule 1.37 attached hereto.

1.38Existing Program” means each of (a) the AADC Program and (b) the FA Program.

1.39Existing Program Development Plan” means each of (a) the AADC Program Development Plan and (b) the FA Program Development Plan.

1.40Exploit” or “Exploitation” means to make, have made, import, use, sell, or offer for sale, Develop, Manufacture or Commercialize.

1.41FA” means Friedreich’s Ataxia.

1.42FA Program” means all activities under this Agreement directed to the Development, Manufacture and Commercialization of Gene Therapy Products intended to treat FA.  The Target of the FA Program is the gene encoding Frataxin.

1.43FA Program Development Plan” means the plan and budget for the Development of VY-FXN01 (or any successor Development Candidate in the FA Program) through completion of the Phase 1 Clinical Trial therefor, the initial version of which will be mutually agreed to by the Parties within [...***...] of the Effective Date, as such plan and budget may be updated by the JSC from time to time in accordance with Section 2.1.3(a).

1.44FDA” means the U.S. Food and Drug Administration, and any successor entity thereto.

1.45Field” means all human and veterinary diagnostic, prophylactic, and therapeutic uses.

1.46First Commercial Sale” means, with respect to a Collaboration Product and a country in the Territory, the first sale for end use or consumption of such Collaboration Product in such country after all Regulatory Approvals and pricing and reimbursement approvals legally required for such sale have been granted by the applicable Regulatory Authority of such country or, if Regulatory Approval is not required, after the date on which sales are permitted by applicable Law.

1.47Frataxin” means the protein encoded by the FXN gene which is defined by ENSEMBL Gene ID ENSG00000165060, or any naturally occurring variant thereof.

1.48FTE” means one (1) person (or the equivalent of one (1) person) working full time for one (1) twelve (12) month period in a Development, regulatory or other relevant capacity (excluding persons employed in general and administrative, non-technical management or other non-technical capacities) employed by Voyager or Neurocrine or any of their respective Affiliates and assigned to perform specified work, with such commitment of time and effort to constitute one (1) employee performing such work on a full-time basis, which for purposes hereof shall be [...***...] hours per year.  No additional payment shall be made with respect to any person who works more than [...***...] hours per year (which person shall be deemed one (1) FTE) and any person who devotes less than [...***...]

 

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[...***...] hours per year shall be treated as an FTE on a pro rata basis based upon the actual number of hours worked divided by [...***...].

1.49FTE Costs” means the FTE Rate multiplied by the applicable number of FTEs who perform a specified activity pursuant to this Agreement.

1.50FTE Rate” means $[...***...] per FTE for the period commencing on the Effective Date and ending December 31, 2019.  On January 1, 2020 and on January 1st of each subsequent Calendar Year, the foregoing rate shall be increased for the Calendar Year then commencing by the percentage increase, if any, in the Consumer Price Index (“CPI”) as of December 31 of the then most recently completed Calendar Year with respect to the level of the CPI on December 31, 2019.  Consumer Price Index or CPI means the Consumer Price Index – Urban Wage Earners and Clerical Workers, US City Average, All Items, 1982-84 = 100, published by the United States Department of Labor, Bureau of Labor Statistics (or its successor equivalent index).

1.51Future In-License Agreement” means any agreement between Voyager (or any of its Affiliates), on the one hand, and a Third Party, on the other hand, entered into after the Effective Date, pursuant to which Voyager or any of its Affiliates acquires Control of any Know-How or Patent Right that, subject to Section 5.2, would be Voyager IP.

1.52GCP” means the then-current good clinical practice standards for clinical trials for pharmaceuticals, as set forth in the United States Food, Drug and Cosmetic Act, as amended from time to time (the “Act”), or other applicable law, and such standards of good clinical practice as are required by the Regulatory Authorities of the EU and other organizations and Governmental Authorities in countries for which the applicable Collaboration Candidate or Collaboration Product is intended to be developed, to the extent such standards are not less stringent than United States GCP.

1.53Gene Therapy Product” means a Virus Vector, including without limitation AAV, that delivers a polynucleotide to certain cells of a patient for a purpose in the Field. Gene Therapy Products include, but are not limited to, Development Candidates, other Collaboration Candidates and Collaboration Products.

1.54Genzyme Agreement” means that certain Collaboration Agreement by and between Voyager and Genzyme Corporation (“Genzyme”) dated February 11, 2015, as amended March 28, 2017, including the Post-Termination Under Collaboration Agreement dated December 8, 2017.

1.55GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or comparable regulatory standards in jurisdictions outside the United States.

1.56Governmental Authority” means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, regulatory, administrative or taxing authority or functions of any nature pertaining to government.

 

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1.57HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended from time to time.

1.58HSR Clearance Date” means the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act in the U.S.

1.59HSR Filing” means filings by Neurocrine and Voyager with the U.S. Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in this Agreement, together with all required documentary attachments thereto.

1.60In-License Agreement” means (a) any Existing In-License Agreement and (b) any Future In-License Agreement.

1.61IND” means an investigational new drug application submitted to the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto.  References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries.

1.62Initiation” means, with respect to a Clinical Trial, the first dosing of the first subject enrolled in such Clinical Trial with a Collaboration Product.

1.63Invention” means any new invention, discovery, process, method, machine, manufacture, design, composition of matter, material or improvement thereof (whether patentable or not).

1.64Joint IP” means the Joint Know-How and Joint Patent Rights.

1.65Joint Know-How” means Joint Inventions and other Know-How that is jointly invented, discovered, conceived or generated by one or more employees, agents or consultants of Voyager, on the one hand, and one or more employees, agents or consultants of Neurocrine, on the other hand, in the conduct of activities under this Agreement, including in the conduct of the Development, Manufacture or Commercialization of Collaboration Products.

1.66Joint Patent Right” means any Patent Right that Covers Joint Know-How.

1.67Know‑How” means all information, know-how and data, including trade secrets, inventions (whether patentable or not), discoveries, methods, specifications, processes, expertise, technology, other non-clinical, pre-clinical and clinical data, documentation and results (including pharmacological, toxicological, biological, chemical, physical, safety and manufacturing data and results), analytical and quality control data and results, Regulatory Filings and other technical information.  “Know-How” excludes in any event any Patent Rights.

1.68Knowledge” means (a) with respect to Voyager, the knowledge after reasonable investigation of the individuals set forth on Schedule 1.68, and (b) with respect to Neurocrine, the knowledge after reasonable investigation of the individuals set forth on Schedule 1.68.

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1.69Law” means any law, statute, rule, regulation, order, judgment or ordinance having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision.

1.70“[...***...]” means any of the following:  [...***...].

1.71Manufacture” or “Manufacturing” means all activities related to the manufacturing of a Collaboration Candidate and/or Collaboration Product, including test method development and stability testing, formulation, process development, manufacturing scale-up, manufacturing for use in non-clinical and clinical studies, manufacturing for commercial sale, packaging, release of product, quality assurance/quality control development, quality control testing (including in-process, in-process release and stability testing) and release of product or any component or ingredient thereof, and regulatory activities related to all of the foregoing.  “Manufacturing” may be included as part of Development or Commercialization, to the extent applicable.

1.72Net Sales” means, with respect to any Collaboration Product, the gross amount invoiced by Neurocrine, any of its Affiliates and or any Sublicensee (each, a “Selling Party”) to a Third Party (including a customer, distributor, wholesaler or end user) for sales of such Collaboration Product, less the following deductions as calculated in accordance with the applicable Accounting Standard as consistently applied:

1.72.1normal trade, cash, quantity and other customary discounts actually given to customers in the ordinary course of business;

1.72.2rebates, credits and allowances given by reason of rejections, returns, damaged or defective product or recalls;

1.72.3government-mandated rebates and any other compulsory payments, credits, adjustments and rebates actually paid or deducted;

1.72.4price adjustments, allowances, credits, chargeback payments, discounts, rebates, fees and reimbursements or similar payments granted or made to managed care organizations, group purchasing organizations or other buying groups, pharmacy benefit management companies, health maintenance organizations and any other providers of health insurance coverage, health care organizations or other health care institutions (including hospitals), health care administrators, patient assistance or other similar programs, or to federal state/provincial, local and other governments, including their agencies, or to wholesalers, distributors or other trade customers;

1.72.5reasonable and customary freight, shipping, insurance and other transportation expenses, if actually borne by the applicable Selling Party without reimbursement from any Third Party;

1.72.6reasonable distributors’ and inventory management fees, including fees for services provided by wholesalers and warehousing chains, in connection with the sale and distribution of such Collaboration Product;

 

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1.72.7that portion of administrative fees paid to group purchasing organizations, pharmacy benefit managers, Medicare prescription drug plans or any other facilitator of drug access for patients relating specifically to such Collaboration Product;

1.72.8uncollectible amounts or reasonable reserves accrued therefor (it being understood that any subsequent reductions in such accrual amounts due to collections in subsequent periods shall be included in Net Sales when such reductions occur);

1.72.9that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales of such Collaboration Product;

1.72.10sales, value-added, excise taxes, tariffs and duties, and other taxes and government charges directly related to the sale, delivery or use of such Collaboration Product (but not including taxes assessed against the net income derived from such sale); and

1.72.11any other similar and customary deductions that are consistent with Accounting Standards, as agreed by the Parties in writing or, if the Parties fail to agree on any such deductions proposed by Neurocrine, as determined by a mutually agreed independent accounting expert, whose decision will be final and binding on the Parties.

If non-monetary consideration is received for any Collaboration Product, Net Sales will be calculated based on the average price charged for such Collaboration Product during the preceding Calendar Quarter in the relevant country, or in the absence of such sales, the fair market value of the Collaboration Product, as determined by the Parties in good faith.

Resales or sales of a Collaboration Product made in good faith between or among Neurocrine, any of its Affiliates or any Sublicensee shall not be included in the calculation of Net Sales as long as, with respect to such resales or sales, the first sale thereafter to a non-Sublicensee Third Party is included in the calculation of Net Sales.

Net Sales shall not include any amounts received for Collaboration Products supplied for use in clinical trials, or supplied at or below the fully-burdened cost of good thereof under early access, compassionate use, named patient, indigent access, patient assistance or other reduced pricing programs.

In the event that a Collaboration Product under this Agreement is sold by a Selling Party in combination (a “Combination Product”) with one or more therapeutically active compound(s) that are not Collaboration Products (“Supplemental Ingredient(s)”), then “Net Sales” of the Combination Product shall be calculated using one of the following methods:

(x)By multiplying the Net Sales of the Combination Product (calculated prior to the application of this formula) by the fraction A/(A+B), where A is the average gross selling price, during the applicable Calendar Quarter in the country concerned, of the Collaboration Product when sold separately, and B is the average gross selling price, during the applicable Calendar Quarter in the country concerned, of the Supplemental Ingredient(s) when sold separately; or

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(y)In the event that no such separate sales are made of the Collaboration Product or any of the Supplemental Ingredients in such Combination Product during the applicable Calendar Quarter in the country concerned, Net Sales shall be calculated using the above formula where A is the reasonably estimated commercial value of the Collaboration Product sold separately and B is the reasonably estimated commercial value of the Supplemental Ingredient(s) sold separately.  Any such estimates shall be determined using criteria to be mutually agreed upon by the Parties.  If the Parties are unable to agree on the criteria for determining such estimates, the Parties will submit such dispute for resolution to a mutually agreed independent accounting expert, whose decision will be final and binding on the Parties.

1.73Neurocrine IP” means the Neurocrine Know-How and the Neurocrine Patent Rights.

1.74Neurocrine Know-How” means (a) all Know-How that (i) is Controlled by Neurocrine or any of its Affiliates on the Effective Date or during the Term, (ii) prior to any disclosure to Voyager hereunder or under the Existing Confidentiality Agreement was not generally known to the public and (iii) is necessary or reasonably useful to Exploit in the Field in the Territory any Collaboration Product; and (b) Neurocrine’s interest in the Joint Know-How. Notwithstanding anything in this Agreement to the contrary, Neurocrine Know-How shall not include any Know-How to the extent Controlled by any Person that acquires all or any part of Neurocrine or an Affiliate of Neurocrine, or any affiliates of such Person, in each case (x) which is Controlled by such Person immediately prior to the effective date of the acquisition (and such Control was not acquired through acquisition or license from Neurocrine or any Affiliate of Neurocrine in existence prior to the effective date of such acquisition) or (y) which is Controlled by such Person on or after the effective date of acquisition but is not Controlled by Neurocrine or an Affiliate of Neurocrine (excluding for purposes of this provision, such Person and Affiliates of Neurocrine that are such Affiliates by virtue of controlling, being controlled by or under common control with such Person and were not Affiliates of Neurocrine prior to the acquisition) and was developed, invented or obtained without the direct or indirect use of any non-public Neurocrine Know-How.

1.75Neurocrine Patent Rights” means (a) all Patent Rights Controlled by Neurocrine or any of its Affiliates as of the Effective Date or during the Term, that Cover any Collaboration Product; and (b) Neurocrine’s interest in the Joint Patent Rights.  Notwithstanding anything in this Agreement to the contrary, Neurocrine Patent Rights shall not include any Patents to the extent owned or Controlled by any Person that acquires all or any part of Neurocrine or an Affiliate of Neurocrine, or any affiliates of such Person, in each case (x) which is Controlled by such Person immediately prior to the effective date of the acquisition (and such Control was not acquired through acquisition or license from Neurocrine or any Affiliate of Neurocrine in existence prior to the effective date of such acquisition) or (y) which is Controlled by such Person on or after the effective date of acquisition but is not Controlled by Neurocrine or an Affiliate of Neurocrine (excluding for purposes of this provision, such Person and Affiliates of Neurocrine that are such Affiliates by virtue of controlling, being controlled by or under common control with such Person and were not Affiliates of Neurocrine prior to the acquisition) and was developed, invented, or obtained without the direct or indirect use of any non-public Neurocrine Know-How.

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1.76[...***...] Agreement” means that certain [...***...] Agreement by and between [...***...] and Voyager, dated [...***...].

1.77Out-of-Pocket Costs” means actual out-of-pocket costs and expenses paid by a Party or any of its Affiliates to Third Parties, including to a consultant or contractor of such Party.

1.78Patent Right” means (a) any patent or patent application (including any provisional application) in any country or multinational jurisdiction in the Territory (including any converted application, continuation, continuation-in-part, continued prosecution application or divisional of any such application, any reissue, renewal, extension, substitution, reexamination, supplementary protection certificate, pediatric exclusivity period or the like of any such patent); (b) any foreign equivalent of any patent or patent application described in clause (a); and (c) all rights of priority in any of the foregoing.

1.79PHSA” means the Public Health Service Act as set forth in 42 U.S.C. Chapter 6A, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).

1.80PMDA” means the Pharmaceuticals and Medical Devices Agency in Japan, and any successor entity thereto.

1.81Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, Governmental Authority, or any other entity not specifically listed in this Section 1.81.

1.82Phase 1 Clinical Trial” means a human clinical trial (or a portion of a human clinical trial) of a product in any country, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, that would satisfy the requirements of 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

1.83Phase 2 Clinical Trial” means a human clinical trial (or a portion of a human clinical trial) of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and whose design is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

1.84Phase 3 Clinical Trial” means a human clinical trial (or a portion of a human clinical trial) of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(c) and whose design is intended to (a) establish that the product is safe and efficacious for its intended use, (b) define warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product.

1.85Pivotal Clinical Trial” means a Clinical Trial that is designed to be sufficient to support the filing of a BLA for such product.

 

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1.86Program” means, with respect to a Target, all activities under this Agreement directed to the Development, Manufacture and Commercialization of Collaboration Products directed to such Target.  The Term “Program” includes any Existing Program or Discovery Program or Co-Co Program, but specifically excludes any Terminated Program.

1.87Proof of Mechanism” means, with respect to the FA Program and each Discovery Program, achievement of the milestones or metrics determined by the JSC and identified as such in the applicable Development Plan.

1.88Prosecution and Maintenance” or “Prosecute and Maintain”  means, with regard to a Patent Right, the preparation, filing, prosecution and maintenance of such Patent Right, as well as re-examinations, reissues, appeals, and requests for patent term adjustments and patent term extensions with respect to such Patent Right. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any enforcement actions taken with respect to a Patent Right.

1.89Public Official or Entity” means (a) any officer, employee (including physicians, hospital administrators, or other healthcare professionals), agent, representative, department, agency, de facto official, representative, corporate entity, instrumentality or subdivision of any government, military or international governmental organization, including any ministry or department of health or any state-owned or affiliated company or hospital, or (b) any candidate for political office, any political party or any official of a political party.

1.90Regulatory Approval” means all approvals of the applicable Regulatory Authority necessary for the commercial marketing and sale of a product in a country(ies), excluding any pricing and reimbursement approvals that may be required.

1.91Regulatory Approval Application” means (a) a BLA, or (b) any other application to seek Regulatory Approval of a product in any country or multinational jurisdiction, as defined in applicable Laws and filed with the relevant Regulatory Authorities of such country or jurisdiction.

1.92Regulatory Authority” means the FDA in the United States or any Governmental Authority in another country or regulatory jurisdiction in the Territory that is a counterpart to the FDA and holds responsibility for granting Regulatory Approval for a product in such country or regulatory jurisdiction, including the EMA and PMDA, and any successor(s) thereto.

1.93Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to any Collaboration Product, excluding Patent Rights, that precludes the use of any clinical data collected and filed for such Collaboration Product for the benefit of any Regulatory Approval for a generic or biosimilar product (for any use), including orphan or pediatric exclusivity where applicable.

1.94Regulatory Filing” means, with respect to a product, any documentation comprising any filing or application with any Regulatory Authority with respect to such product, or its use or potential use in the Field, any document submitted to any Regulatory Authority, including any IND and any Regulatory Approval Application, and any correspondence to, from or

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with any Regulatory Authority with respect to such product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

1.95Target” means a gene as defined by a specific gene ID, all mutants of such gene, derivatives or fragments with similar functional properties to such gene, or allelic variants of such gene, (a) whose DNA is delivered, replaced, substituted for, or altered upon administration of a Gene Therapy Product; (b) whose level of expressed RNA (including mRNA) or protein is modulated, silenced, augmented or eliminated upon administration of a Gene Therapy Product; or (c) whose protein expression product serves in whole or in part as an antigen and whereby, upon binding by an immunoglobulin encoded by a Gene Therapy Product such protein is neutralized or destroyed. All of the Gene Therapy Products described in the preceding clauses (a), (b) and (c) are considered “directed to” such Target.

1.96Terminated Program” shall mean a Program that is terminated by the JSC pursuant to Section 3.1.2(q), by the mutual agreement of the Parties or pursuant to Article 14.

1.97Territory” means (a) with respect to the AADC Program and each Discovery Program, all countries in the world (excluding any countries for which this Agreement has been terminated with respect to such Program) and (b) with respect to the FA Program, the United States and, upon expiration of Genzyme’s option to the FA Program without exercise thereof, all countries in the world (excluding any countries for which this Agreement has been terminated with respect to such Program).

1.98Third Party” means any Person that is neither a Party nor an Affiliate of a Party.

1.99Transition Date” means the date upon which the applicable Transition Event occurs.

1.100Transition Event” means (a) with respect to the AADC Program, Voyager’s receipt of topline data with respect to the Existing Pivotal Trial, (b) with respect to the FA Program, Voyager’s receipt of topline data with respect to the first Phase 1 Clinical Trial for a Product in the FA Program, and (c) with respect to the Discovery Programs, preparation by Voyager and approval by Neurocrine of the IND to be filed by Neurocrine for the first Development Candidate in each such Discovery Program.

1.101United States” or “U.S.”  means the United States of America and all of its territories and possessions.

1.102Valid Claim” means (a) a claim of an issued and unexpired patent, which claim has not been revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction and that has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise, or (b) a claim of a patent application that has been pending less than [...***...] from the date of filing of the earliest patent application from which such patent application claims priority, which claim has not been cancelled, withdrawn or abandoned or finally rejected by an administrative agency action from which no appeal can be taken.

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1.103Vectorization IP” means all Vectorization Know-How and Vectorization Patent Rights.

1.104Vectorization Know-How” means all Know-How, including Inventions, that is conceived, discovered, developed or otherwise made or acquired under any Program during the Term (a) by or on behalf of either Party (or its Affiliates or its or their (sub)licensees/Sublicensees) or (b) jointly by or on behalf of Neurocrine (or its Affiliates or its or their Sublicensees), on the one hand, and Voyager (or its Affiliates or its or their licensees), on the other hand, in each case ((a) and (b)), that is directed to Vectorization Technology. Vectorization Know-How shall be considered the Confidential Information of Voyager.

1.105Vectorization Patent Rights” means any Patent Rights that Cover Vectorization Know-How.

1.106Vectorization Technology” means Voyager’s proprietary Virus Vector platform, including any of the following aspects of such platform: (a) Virus Capsids or (b) Know-How regarding the design, Manufacture or optimization of Virus Capsids for the creation of vectorized payloads, including (i) Voyager’s system of manufacturing recombinant adeno-associated virus (“rAAV”), comprising molecular materials and methods of generating baculovirus expression vectors (BEVs) that express AAV structural and non-structural proteins essential for replication; (ii) processes for purifying rAAV from the cell culture; (iii) genetic modifications to the Spodoptera frugiperda (Sf9) cell line and baculovirus and (d) Know-How regarding the administration or delivery of any Virus Vectors as therapeutics. For clarity, Vectorization Technology shall not include Know-How related to specific Collaboration Products or Targets or the manufacture of specific Collaboration Products.

1.107Vector Genome” means a polynucleotide, whether single stranded (ss) or self-complementary (sc), having a configuration capable of selectively encoding one (1) or more payloads or including one or more transgenes when encapsulated by a Virus Capsid.

1.108Virus Capsid” means an engineered or naturally occurring capsid protein or proteins (or the encoding nucleic acid sequence thereof), including, but not limited to, from an AAV, that is capable of encapsulating a Vector Genome.

1.109Virus Vector” means a virus comprising a Virus Capsid and Vector Genome encapsulated therein.

1.110Voyager IP” means the Voyager Know-How, Voyager Licensed Patent Rights and all Vectorization IP.

1.111Voyager Know-How” means (a) all Know-How that (i) is Controlled by Voyager or any of its Affiliates on the Effective Date or during the Term, (ii) prior to any disclosure to Neurocrine hereunder or under the Existing Confidentiality Agreement was not generally known to the public and (iii) is necessary or reasonably useful to Exploit in the Field in the Territory any Collaboration Product; (b) Vectorization Know-How; and (c) Voyager’s interest in the Joint Know-How. Notwithstanding anything in this Agreement to the contrary, Voyager Know-How shall not include any Know-How to the extent Controlled by any Person that acquires all or any part of Voyager or an Affiliate of Voyager, or any affiliates of such Person, in each case (x) which

 

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is Controlled by such Person immediately prior to the effective date of the acquisition (and such Control was not acquired through acquisition or license from Voyager or any Affiliate of Voyager in existence prior to the effective date of such acquisition) or (y) which is Controlled by such Person on or after the effective date of acquisition but is not Controlled by Voyager or an Affiliate of Voyager (excluding for purposes of this provision, such Person and Affiliates of Voyager that are such Affiliates by virtue of controlling, being controlled by or under common control with such Person and were not Affiliates of Voyager prior to the acquisition) and was developed, invented or obtained without the direct or indirect use of any non-public Voyager Know-How.

1.112Voyager Licensed Patent Rights” means (a) all Patent Rights Controlled by Voyager or any of its Affiliates as of the Effective Date or during the Term, that claim or Cover any Collaboration Product; and (b) Voyager’s interest in the Joint Patent Rights. Notwithstanding anything in this Agreement to the contrary, Voyager Licensed Patent Rights shall not include any Patents to the extent owned or Controlled by any Person that acquires all or any part of Voyager or an Affiliate of Voyager, or any affiliates of such Person, in each case (x) which is Controlled by such Person immediately prior to the effective date of the acquisition (and such Control was not acquired through acquisition or license from Voyager or any Affiliate of Voyager in existence prior to the effective date of such acquisition) or (y) which is Controlled by such Person on or after the effective date of acquisition but is not Controlled by Voyager or an Affiliate of Voyager (excluding for purposes of this provision, such Person and Affiliates of Voyager that are such Affiliates by virtue of controlling, being controlled by or under common control with such Person and were not Affiliates of Voyager prior to the acquisition) and was developed, invented, or obtained without the direct or indirect use of any non-public Voyager Know-How.  Notwithstanding the foregoing, the Voyager Licensed Patent Rights exclude any Patent Rights licensed to Voyager under that certain License Agreement between Voyager and ReGenX Biosciences, LLC, dated May 28, 2014 (the “ReGenX Agreement”), which will not be considered an Existing In-License Agreement unless and until Neurocrine requests in writing that the ReGenX Agreement becomes an Existing In-License Agreement.  Notwithstanding the foregoing, the Voyager Licensed Patent Rights exclude any Patent Rights licensed to Voyager under the [...***...] License Agreement, which Patent Rights will not be considered sublicensed hereunder unless and until Neurocrine requests in writing that such Patent Rights be so sublicensed following the naming of a Development Candidate with respect to the FA Program or either Discovery Program.  Notwithstanding the foregoing, the Voyager Licensed Patent Rights exclude any Patent Rights licensed to Voyager under the [...***...] Agreement, which Patent Rights will not be considered sublicensed hereunder unless and until [...***...] consents to the sublicense of such Patent Rights, at which time such Patent Rights shall be considered sublicensed hereunder without any further action by either Party.

1.113Voyager Licensed Platform Patent Rights” means all Voyager Licensed Patent Rights that are not Voyager Target-Specific Patent Rights.

1.114Voyager Target-Specific Patent Rights” means those Voyager Licensed Patent Rights that contain claims (a) directed specifically toward a particular Collaboration Candidate, Collaboration Product, or its formulation, manufacture or use, (b) directed toward a method of treatment or use relating to any Program or (c) that relate to modulation of a Target in a Program, its expression or activity of its gene products.

 

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1.115VY-AADC” means the Gene Therapy Product under Development by Voyager for the treatment of Parkinson’s disease prior to the execution of this Agreement that will be utilized initially in the AADC Program as a Development Candidate, as described in IND Nos. [...***...], the Development of which is afforded a right of reference to the Avigen/Genzyme IND, [...***...].

1.116VY-FXN01” means the Gene Therapy Product under Development by Voyager for the treatment of FA prior to the execution of this Agreement that will be utilized initially in the FA Program as a Development Candidate.

1.117Additional Definitions.  Each of the following definitions is set forth in the section of this Agreement indicated below:

Definition:

Section:

Acquired Affiliate

9.3.1

Acquired Competing Product

9.3.1

Acquired Competing Program

9.3.1

Acquirer

1.16

Acquisition Party

9.3.1

Act

1.52

Agreement

Preamble

Alliance Manager

3.7

Allocation Schedule

8.1.1

Alternative Method

5.2.4

[...***...]

7.3

[...***...]

1.14

[...***...] Indemnitees

13.1.2

Co-Co Agreement

4.1.1

Co-Co Option

4.1.1

Co-Co Product

4.1.1

Co-Co Program

4.1.1

Co-Co Rate

4.1.3

Co-Co Territory

4.1.1

Co-Co Trigger Date

4.1.1

Collaboration

2.1.1

Collaboration IP Working Group

3.3.1(b)

Combination Product

1.72

Committee

3.3.1

Competitive Infringement

10.3.1

Confidential Information

11.1

CPI

1.50

Defense Proceeding

10.2.1(a)(ii)

Delivery Event

5.8

Development Candidate Criteria

1.27

Discovery Program Development Plan

2.1.3(b)

Disclosing Party

11.1

Dispute

15.2

 

 

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Execution Date

Preamble

Existing Confidentiality Agreement

11.1

Existing Pivotal Trial

1.3

ICC

15.3.2

Genzyme

1.54

Inbound Licensor

5.2.1

Indemnified Party

13.3

Indemnifying Party

13.3

Initial Fee

8.1.1

Joint CMC Working Group

3.3.1(c)

Joint Invention

10.1.1

Joint R&D Working Group

3.3.1(a)

JRA Exception

15.14

JSC

3.1.1

Losses

13.1

Major Market Countries

4.2.2

Milestone Event

8.2(a)

Milestone Payment

8.2(a)

Neurocrine

Preamble

Neurocrine Plan

4.2.3

Neurocrine Product Marks

10.6

Neurocrine PRV Use

7.3

Parties

Preamble

Party

Preamble

Patent Challenge

14.5

Payee

8.7.1

Payor

8.7.1

Potential Target List

2.1.2

PRV

7.3

PRV Sale

7.3

rAAV

1.106

Rate-Shifting Fee

4.1.3

Receiving Party

11.1

Redacted Version

11.3.2

ReGenX Agreement

1.112

Royalty Term

8.4

Secondary Market Countries

4.2.2(b)

Selling Party

1.72

Stock Purchase Agreement

8.1.2

Subcommittee

3.1.1

Sublicense

5.5

Sublicensee

5.5

Supplemental Ingredient(s)

1.72

Target Nomination Period

2.1.2

Term

14.1

Title 11

5.8

 

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Third Party Claims

13.1

Transition Plan

4.3

Voyager

Preamble

Withholding Tax Action

8.11.3

Working Group

3.3.1

 

ARTICLE 2
COLLABORATION; PRE-TRANSITION DEVELOPMENT

2.1Collaboration and Programs.

2.1.1Collaboration.  The Parties agree to collaborate on the conduct of four (4) Programs under this Agreement: the AADC Program, the FA Program and two (2) Discovery Programs.  The Development, Manufacturing and Commercialization activities for Collaboration Candidates and Collaboration Products conducted pursuant to this Agreement under all four Programs, as well as any such activities conducted pursuant to any Co-Co Agreement, together, shall constitute the “Collaboration”.

2.1.2Selection of Targets for Discovery Programs. Within [...***...] after the Effective Date, the Parties shall agree to a list of up to eight (8) Targets (the “Potential Target List”) from which Neurocrine will have the right, after consultation with Voyager, to nominate Targets for the two (2) Discovery Programs by written notice to the JSC, which nomination shall occur within [...***...] after the Parties’ designation of the Potential Target List (the “Target Nomination Period”).  Promptly following each such nomination by Neurocrine, Voyager shall provide Neurocrine with an analysis of such proposed Target, including technological feasibility, intellectual property protection, whether any In-License Agreement would be applicable to such Discovery Program, preliminary development timelines and a preliminary budget.  Promptly thereafter, the JSC shall hold a meeting to discuss each proposed Target and determine whether to approve such proposed Target as a Discovery Target.  Each Discovery Target must be approved by consensus of the JSC (or, if applicable, consensus of the Executive Officers), and upon approval by the JSC or Executive Officers of a Target nominated by Neurocrine, such Target will become a Discovery Target.  Promptly thereafter, Voyager shall update Schedule 1.37 to include any Existing In-License Agreements applicable to such Discovery Program.  Voyager may not withhold approval of any proposed Discovery Target selected from the Potential Target List unless Voyager has a bona fide technical reason or other substantial concern that the proposed Discovery Target is not suitable for conducting a Discovery Program.  If Voyager withholds its approval of any Target from the Potential Target List proposed by Neurocrine as a Discovery Target, then (a) Voyager shall concurrently provide a written description of its technical reason or other substantial concern to Neurocrine and (b) Voyager shall not, during the [...***...] period after the end of the Target Nomination Period, conduct any activities, itself or with or through a Third Party, or grant a Third Party a license or otherwise enable a Third Party to conduct any activities, related to the development or commercialization of a Gene Therapy Product directed to such Target.  If following the JSC’s approval of any Discovery Target, the JSC fails to approve an initial Development Plan therefor, such Discovery Target will no longer be a Discovery Target, the restriction in the preceding clause (b) will apply thereto, and Neurocrine shall within [...***...] nominate an additional Target from the Potential Target List as a Discovery Target pursuant

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to this Section 2.1.2.  Until the JSC’s approval of two (2) Discovery Targets and Development Plans therefor, Voyager shall not conduct any activities, itself or with or through a Third Party, or grant a Third Party a license or otherwise enable a Third Party to conduct any activities, related to the development or commercialization of a Gene Therapy Product directed to a Target on the Potential Target List.  The foregoing restriction shall terminate upon the JSC’s approval of the second Discovery Target and Development Plan therefor.

2.1.3Conduct of Programs.

(a)Existing Programs.  Voyager shall conduct each Existing Program pursuant to the applicable Existing Program Development Plan.  The JSC shall, prior to the end of each Calendar Year prior to the applicable Transition Date, review the Existing Program Development Plans and determine whether to update such plans, including to prepare a detailed budget for the subsequent Calendar Year.  A Party may also develop and submit to the JSC from time to time proposed substantive amendments to the AADC Program Development Plan or the FA Program Development Plan.  The JSC shall review such proposed amendments and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time in its discretion and, upon any such approval by the JSC, the AADC Program Development Plan or FA Program Development Plan, as applicable, shall be amended accordingly.

(b)Discovery Programs.  Each Discovery Program shall be conducted pursuant to a research plan and associated budget (each such research plan, including the associated budget, a “Discovery Program Development Plan”).  Each Discovery Program Development Plan shall set forth the activities to be conducted with respect to the applicable Discovery Program prior to the applicable Transition Date, and, subject to any mutually agreed contributions from Neurocrine pursuant to Section 2.1.7, shall assign to Voyager responsibility for all Development and associated Manufacturing activities with respect to such Discovery Program until filing by Neurocrine of the IND with respect to such Discovery Program.  Following the JSC’s approval of a Target as a Discovery Target, Voyager shall prepare the initial draft of the applicable Discovery Program Development Plan and submit it to the JSC for review and approval.  The JSC shall approve each initial Discovery Program Development Plan with respect to each Discovery Program in accordance with Section 3.1.2(d).  The JSC shall, prior to the end of each Calendar Year prior to the applicable Transition Date, review and update, as appropriate, each Discovery Program Development Plan, including preparing a detailed budget for the subsequent Calendar Year.  A Party may also develop and submit to the JSC from time to time proposed substantive amendments to any Discovery Program Development Plan.  The JSC shall review such proposed amendments and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time in its discretion and, upon any such approval by the JSC, the applicable Discovery Program Development Plan shall be amended accordingly.

2.1.4Voyager Program Responsibilities. Except as otherwise provided in this Agreement or the applicable Development Plan, Voyager shall have sole responsibility for the conduct of each Program (including any Clinical Trials and Manufacture of Collaboration Candidates and Collaboration Products) until the Transition Date with respect to such Program (and responsibility for any post-Transition Date activities that the Parties mutually agree in accordance with this Agreement).  Subject to the terms and conditions of this Agreement, until the

 

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earlier of (i) the Transition Date or (ii) termination of the applicable Program by the JSC or by a Party pursuant to Article 14, Voyager shall use Commercially Reasonable Efforts to Develop VY-AADC, VY-FXN01 and each other Development Candidate and to identify Development Candidates in the Discovery Programs and FA Program, and shall conduct all Development of Collaboration Candidates, including Development Candidates, in accordance with the applicable Development Plan.  There shall be no more than two (2) Development Candidates per Program in each of the FA Program and each Discovery Program, unless otherwise mutually agreed by the Parties. Voyager shall conduct all activities allocated to it under the Development Plans and shall use Commercially Reasonable Efforts to comply with the timelines and budgets therein.

2.1.5Voyager Development Breach.  If Voyager materially breaches its obligations with respect to the conduct of activities under the Development Plan for a Discovery Program and fails to cure such breach within [...***...] after written notice of such breach from Neurocrine, then Neurocrine shall have the right, but not the obligation, to assume the conduct of the applicable Program, itself or through an Affiliate or Third Party contractor (other than a competitor of Voyager), by written notice to Voyager.  If Neurocrine elects to assume the conduct of any Program, then Voyager shall conduct all activities and provide all assistance reasonably necessary to transition the Program to Neurocrine or its permitted designee, including the transfer of Voyager Know-How and the provision of materials.  Notwithstanding anything the contrary herein, in such event, Neurocrine shall not be responsible to reimburse any Development Costs incurred by Voyager to conduct any activities that were not properly conducted by Voyager or whose conduct Neurocrine has assumed.

2.1.6Voyager Reporting Obligations.  On a Calendar Quarterly basis until all four Transition Events have occurred, in advance of each regularly-scheduled JSC meeting, Voyager shall provide Neurocrine with a reasonably detailed report describing the activities undertaken and accomplishments achieved under each Development Plan, setting forth the Development Costs incurred to conduct such activities and including a copy of all results generated by Voyager in the performance of such Development Plan, in each case since the last such report.  Voyager shall promptly respond to Neurocrine’s reasonable requests for more information with respect to each such Calendar Quarterly report with respect to any Program.  In addition, at Neurocrine’s request in between such quarterly reports, Voyager shall provide all information reasonably requested by Neurocrine, including results and Development Costs incurred.

2.1.7Neurocrine Program Responsibilities.  On a Program-by-Program basis with regard to each Program, prior to the Transition Date with respect to such Program, Neurocrine shall, at Neurocrine’s cost and expense, (a) contribute Development expertise to such Program as determined by the JSC and (b) provide reasonable Development assistance to Voyager during the conduct of such Program, where such assistance is reasonably requested by Voyager and approved by the JSC based on particular Neurocrine expertise.

2.1.8Neurocrine Reporting Obligations.  On a Calendar Quarterly basis for the AADC Program and the FA Program and on an annual basis for the Discovery Programs, following the Transition Event on a Program-by-Program basis, in advance of the regularly-scheduled JSC meeting, Neurocrine shall provide Voyager with a reasonably detailed report describing the activities undertaken and accomplishments achieved under each Program, including a summary of all results generated by Neurocrine under each Program, in each case since the last such report.  In

 

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addition, prior to the Transition Event on a Program-by-Program basis, to the extent Neurocrine has conducted any activities under a Development Plan since the preceding JSC meeting, Neurocrine shall provide Voyager with a reasonably detailed report describing all activities undertaken and accomplishments achieved under each Development Plan, including a copy of all results generated by Neurocrine in the performance of such Development Plan, in each case since the last such report. Neurocrine shall promptly respond to Voyager’s reasonable requests for more information with respect to each such Calendar Quarterly or annual report with respect to any Program.

2.1.9Development Candidates.

(a)On a Program-by-Program basis with respect to the FA Program and each Discovery Program, prior to the applicable Transition Date, Voyager shall notify Neurocrine of potential Development Candidates that are Developed by or on behalf of Voyager under such Program. Based upon the Development Candidate Criteria and the results of Development activities with respect to the FA Program or any Discovery Program, either Party may nominate a development candidate for such Program by providing written notification thereof to the JSC.

(b)Following nomination of a development candidate by either Party, the JSC shall determine whether such nominated development candidate meets the Development Candidate Criteria.  Voyager shall respond to reasonable requests from the JSC for additional information regarding each nominated development candidate.  If the JSC agrees that a nominated development candidate meets the Development Candidate Criteria, or if the JSC otherwise decides to designate a Collaboration Candidate as a Development Candidate notwithstanding its failure to achieve the Development Candidate Criteria, then such nominated development candidate shall thereafter be deemed to be a Development Candidate hereunder.

2.2Development Costs.

2.2.1In General.  Neurocrine shall be responsible for all Development Costs incurred by Voyager in connection with Voyager’s performance under each applicable Development Plan in accordance with the terms of this Agreement, provided that such Development Costs are in accordance with the budget set forth in such Development Plan, subject to Section 2.2.2.

2.2.2Payment.  Within [...***...] following the end of each Calendar Quarter in which Voyager conducts activities under a Development Plan, Voyager shall provide Neurocrine with a preliminary report detailing, on a Program-by-Program basis, all Development Costs actually incurred by Voyager in such Calendar Quarter to conduct its activities under each Development Plan in accordance with the budget in such Development Plan. Within [...***...] following the end of each Calendar Quarter in which Voyager conducts activities under a Development Plan, Voyager shall provide Neurocrine with an invoice detailing, on a Program-by-Program basis, all Development Costs actually incurred by Voyager in such Calendar Quarter to conduct its activities under each Development Plan in accordance with the budget in such Development Plan. Voyager shall include with each invoice documentation for any individual Out-of-Pocket Costs in excess of [...***...] Dollars ($[...***...]).  To the extent that the invoiced amounts for each activity are less than or equal to [...***...] percent ([...***...]%) of the corresponding amounts set forth in the budget in the applicable Development Plan, Neurocrine

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shall pay each such invoice, unless subject to a bona fide dispute, within [...***...] after receipt thereof. Neurocrine shall have the right to conduct an audit of Voyager’s books and records to verify the amount of Development Costs pursuant to Section 8.7. Such audit shall not be performed more frequently than [...***...] period. If Voyager anticipates that the FTE Costs or Out-of-Pocket Costs it incurs to conduct any activity under a Development Plan will exceed, or if any such costs do exceed, the amount set forth in the applicable budget for such activity by more than [...***...] percent ([...***...]%), Voyager shall promptly notify the JSC, and the JSC shall discuss in good faith and decide whether to increase such budget.

2.3Records of Activities.  Each Party shall maintain complete, current and accurate records of all Development activities conducted by it under the Collaboration, and all data and other information resulting from such activities.  Such records shall fully and properly reflect all work done and results achieved in the performance of such Development activities in good scientific manner appropriate for regulatory and patent purposes.  Each Party shall document all non-clinical studies and clinical trials for Programs in formal written study records according to applicable Laws, including national and international guidelines such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, GCP, GLP and cGMP.  Neurocrine shall have the right to review and copy such records maintained by Voyager at reasonable times, as reasonably requested by Neurocrine.

2.4No Representation.  No Party makes any representation, warranty or guarantee that the Collaboration will be successful, or that any other particular results will be achieved with respect to the Collaboration, any Program or any Collaboration Product.

2.5Subcontracting.  Subject to the terms of this Agreement, each Party shall have the right to engage Affiliates or Third-Party subcontractors (including contract manufacturing organizations)  to perform its Development or Manufacturing obligations under this Agreement.  Any such Affiliate or subcontractor shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity and perform such work consistent with the terms of this Agreement; provided, however, that a Party engaging an Affiliate or subcontractor hereunder shall remain fully responsible and obligated for all activities performed by such Affiliate or subcontractor.  Unless otherwise agreed by the Parties, each Party will obligate each of its Third-Party subcontractors hereunder to agree in writing to assign to such Party ownership of, or, solely after using reasonable efforts to obtain such an assignment and being unable to obtain such an assignment, grant to such Party an exclusive, royalty-free, worldwide, perpetual and irrevocable license (with the right to freely grant sublicenses through multiple tiers) to, any inventions arising under its agreement with such Third Party to the extent related to or resulting from the Development, Manufacture or Commercialization of Collaboration Products; and such Party shall structure such assignment or exclusive license so as to enable such Party to license or sublicense such Third Party inventions to the other Party pursuant to the applicable provisions of this Agreement (including permitting such other Party to grant further sublicenses in accordance with this Agreement).

2.6Academic Collaborators.  If any Party collaborates with an academic institution or one or more individuals at an academic institution to Develop Collaboration Products, such Party shall be required to obligate such academic collaborator to agree in writing to grant the same rights specified in Section 2.5 with respect to ownership or licenses to inventions; it being understood

 

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and agreed that, solely in the case of academic collaborations to Develop Collaboration Products which are not reasonably expected by the applicable Party to result in inventions related to composition of matter or methods of use, in lieu of the rights specified in Section 2.5, it shall be sufficient for such Party to obtain a non-exclusive, worldwide, royalty-free, perpetual license (with the right to freely grant sublicenses through multiple tiers) to, and a right to negotiate for an exclusive license, with the right to grant sublicenses to, any such inventions, which sublicensing rights must permit sublicensing to the other Party pursuant to the applicable provisions of this Agreement (including permitting such other Party to grant further sublicenses in accordance with this Agreement).

ARTICLE 3
MANAGEMENT OF THE COLLABORATION

3.1Joint Steering Committee and Subcommittees.

3.1.1The Parties hereby establish the Joint Steering Committee (the “JSC”) to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement, as more fully described in this Article 3.  The Parties anticipate that the JSC will not be involved in day-to-day implementation of the activities under this Agreement but shall have the responsibilities and decision-making authority set forth herein or as mutually agreed by the Parties in writing from time to time.  The JSC may establish subcommittees as set forth in Section 3.2 (each a “Subcommittee”).

3.1.2Responsibilities.  The JSC shall perform the following functions with respect to the Collaboration, subject to the final decision-making authority of the respective Parties as set forth in Section 3.6:

(a)serve as an information transfer vehicle, from time to time, to facilitate discussions regarding the Development of Collaboration Products;

(b)review and determine whether to update the Existing Program Development Plans or Discovery Program Development Plans (including related budgets) at the end of each Calendar Year in accordance with Sections 2.1.3(a);

(c)discuss and approve as a Discovery Target any Target proposed by Neurocrine under Section 2.1.2;

(d)within [...***...] after submission by Voyager pursuant to Section 2.1.3(b), review, provide comments on and approve each Discovery Program Development Plan;

(e)review and approve any substantive amendments to a Development Plan proposed by a Party, including any amendments to the budget therein;

(f)establish the Development Candidate Criteria for the FA Program promptly after the Effective Date and for each Discovery Program promptly after approval of the Development Plan therefor;

 

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(g)review and approve the designation of each Development Candidate in accordance with Section 2.1.9(b);

(h)discuss and determine what CMC and Development expertise, if any, Neurocrine shall contribute to each Program in accordance with Section 2.1.7;

(i)review and discuss progress reports on the Development activities submitted by each Party, including the reports submitted by Voyager under Section 2.1.6 and by Neurocrine under Section 2.1.8;

(j)address any issues or disputes arising from the conduct of the Development activities hereunder;

(k)determine whether Proof of Mechanism has been established for the FA Program and for each Discovery Program;

(l)on a Program-by-Program basis for those Programs for which Voyager has exercised the Co-Co Option, review and approve plans for co-Development and co-Commercialization in accordance with the Co-Co Agreements to be entered into by the Parties;

(m)on a Program-by-Program basis for the Discovery Programs and those Programs for which Voyager has a Co-Co Option but has not exercised such Co-Co Option (i) review and, to the extent related to Development of Collaboration Products, approve the Neurocrine Plan, (ii) review and approve any amendments to the Neurocrine Plan to the extent related to the Development of Collaboration Products, and (iii) review (but not approve) any amendments to the Neurocrine Plan related to the Commercialization of Collaboration Products;

(n)if Voyager exercises its Co-Co Option with respect to the AADC Program, review and approve branding decisions with respect to the Co-Co Products thereunder;

(o)resolve disputes between the Parties with respect to the Co-Co Programs;

(p)review the progress reports on the Development and Commercialization activities submitted by Neurocrine in accordance with Section 4.2.4;

(q)determine that successful Development under a Development Plan is not commercially or scientifically viable, and terminate such Program, thereby deeming such program a Terminated Program;

(r)review and discuss Collaboration Product formulation and formulation optimization;

(s)periodically review and provide comments on the Development and post-approval status of each Collaboration Product;

(t)review and discuss manufacturing scale-up, validation and Collaboration Product supply;

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(u)review and discuss any potential Future In-License Agreements and reports or recommendations of the JSC;

(v)discuss patent term extensions in accordance with Section 10.2.7;

(w)review and discuss any reports or recommendations of the Joint R&D Working Group;

(x)review and discuss any reports or recommendations of the Collaboration IP Working Group;

(y)review and discuss any reports or recommendations of the Joint CMC Working Group;

(z)review and resolve any disputes of the Joint R&D Working Group, the Collaboration IP Working Group, the Joint CMC Working Group or any other Subcommittee or Working Group;

(aa)form such Subcommittees and additional Working Groups as it deems necessary to achieve the objectives and intent of this Agreement;

(bb)assign responsibilities that may fall within the purview of more than one Subcommittee to a particular Subcommittee or more than one Working Group to a particular Working Group; and

(cc)perform such other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing from time to time.

Except with respect to Co-Co Products in the Co-Co Territory as set forth in Section 4.1.2(a), the JSC will not have any decision-making authority with respect to Commercialization of Collaboration Products, including the content of the Neurocrine Plans to the extent related to Commercialization. For clarity, the JSC shall not have any authority beyond the specific matters set forth in this Section 3.1.2, and in particular shall not have any power to amend or modify the terms of this Agreement or waive a Party’s compliance with this Agreement.

3.2Formation and Dissolution of Subcommittee(s).  The JSC may, in its discretion, establish Subcommittees from time to time to handle specific matters within the scope of the JSC’s area of authority and responsibility, and no Subcommittee’s authority and responsibility may be greater than that of the JSC itself.  Each Subcommittee shall have such authority and responsibility as determined by the JSC from time to time, and decisions and recommendations of any Subcommittee shall be made in accordance with Section 3.6.  The JSC shall determine when each Subcommittee it forms shall be dissolved.

3.3Working Groups.

3.3.1Formation of Working Groups.  From time to time, the Parties, the JSC or any Subcommittee (each, a “Committee”) may establish a working group (each, a “Working

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Group”) to oversee particular projects or activities.  Each Working Group shall undertake the activities allocated to it herein or delegated to it by the Committee to which it reports.  During the process of establishing a Working Group, such Working Group and the Committee to which it reports shall agree regarding which matters such Working Group will resolve on its own and which matters such Working Group will advise the Committee regarding (and with respect to which such advice-specific matters the Committee will resolve); provided that the Parties acknowledge and agree that each Working Group is intended to function primarily in a supporting role providing advice to the Committee to which it reports, but that each Working Group will be best positioned to provide expedited guidance and decisions regarding certain operational matters as determined by the Committee to which such Working Group reports.

(a)Joint R&D Working Group.  The Parties shall establish a joint research and development working group (the “Joint R&D Working Group”) within [...***...] following the Effective Date.  The Joint R&D Working Group will be responsible for the oversight of the day-to-day implementation of (i) the Development activities conducted prior to the applicable Transition Event under this Agreement and (ii) providing the JSC with all relevant information and any recommendations necessary for the JSC to exercise its decision-making authority set forth in Section 3.6 with respect to such Development activities.  The Joint R&D Working Group will report to the JSC.

(b)Collaboration IP Working Group.  The Parties shall establish an intellectual property working group (the “Collaboration IP Working Group”) within [...***...] following the Effective Date.  The Collaboration IP Working Group will be responsible for providing the JSC and the Parties with guidance with respect to matters relating to (i) the preparation, filing, prosecution and maintenance of Voyager Licensed Patent Rights and Joint Patent Rights, (ii) freedom-to-operate matters, (iii) discussing any challenges to any Third Party’s Patent Rights that may Cover any Collaboration Products, and (iv) advising the JSC regarding which of the Existing In-License Agreements are relevant to any Collaboration Products. The Collaboration IP Working Group will report to the JSC.

(c)Joint CMC Working Group.  The Parties shall establish a joint Manufacturing working group (the “Joint CMC Working Group”) within [...***...] following the Effective Date.  The Joint CMC Working Group will be responsible for providing the JSC and the Parties with guidance with respect to matters relating to the generation and maintenance of chemistry, manufacturing and controls (CMC) data required by applicable Law to be included or referenced in, or otherwise support, an IND or Regulatory Approval Application and coordinating the sharing and exchange of such data between Voyager and Neurocrine.  The Joint CMC Working Group will report to the JSC.

3.4Membership.  Each Committee shall be composed of an equal number of representatives appointed by each of Voyager and Neurocrine.  The JSC shall be comprised of [...***...] representatives of each Party, and each other Committee shall be comprised of such number of representatives of each Party as is agreed upon by the Parties.  Each Party shall appoint at least one (1) representative to each Working Group and shall have the right, but not the obligation, to appoint the same number of representatives to any Working Group as are appointed by the other Party to such Working Group.  Each individual appointed by a Party as a representative to the JSC shall be an employee of such Party.  Each individual appointed by a Party as a

 

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representative to any Subcommittee or Working Group shall be an employee of such Party, an employee of such Party’s Affiliate or, upon the other Party’s approval, a contractor to such Party or its Affiliate; provided that, with respect to the Collaboration IP Working Group, either Party may appoint outside intellectual property counsel as a representative. Each Party may replace any of its Committee or Working Group representatives at any time upon written notice to the other Party, which notice may be given by e-mail sent to the other Party’s co-chairperson of such Committee and, with respect to a change of representatives to any Working Group, to the other Party’s co-chairperson of the Committee to which such Working Group reports.  Each Committee and Working Group shall be co-chaired by one designated representative of each Party.  Any member of a Committee or Working Group may designate a substitute who is an employee of the applicable Party to attend and perform the functions of that member at any meeting of such Committee, as applicable.  Notwithstanding the foregoing, each Party shall ensure at all times during the existence of a Committee or Working Group that its representatives (including any replacements or substitutes therefor) on such Committee or Working Group are appropriate in terms of seniority, experience, expertise and decision-making authority and are subject to obligations of confidentiality and non-use with respect to the other Party’s Confidential Information that are no less stringent than those set forth in Article 11.

3.5Meetings.

3.5.1The co-chairpersons shall be responsible, with respect to their Committee or Working Group, as applicable, for (a) calling meetings; (b) preparing and circulating an agenda in advance of each meeting; provided that the co-chairpersons shall include any agenda items proposed by either Party on such agenda; (c) ensuring that all decision-making is carried out in accordance with the voting and dispute resolution mechanisms set forth in this Agreement; and (d) preparing and issuing minutes of each meeting within [...***...] (or such shorter time as is agreed by the relevant Committee or Working Group) thereafter.  The location of regularly scheduled meetings shall alternate between Voyager’s offices located in Cambridge, Massachusetts and Neurocrine’s offices located in San Diego, California, unless otherwise agreed by such Committee or Working Group.  Such Committee or Working Group may also determine that a meeting will instead be held telephonically, by video conference or by any other media; provided, however, that the JSC shall hold at least one (1) meeting in person each Calendar Year.  For the avoidance of doubt, each Party may designate the same individual as a representative on more than one Committee or Working Group.  Each Party will bear all expenses it incurs in regard to participating in all meetings of each Subcommittee and Working Group, including all travel and living expenses.

3.5.2The JSC shall meet at least once each Calendar Quarter prior to the time of First Commercial Sale of a Collaboration Product from all Programs, and annually thereafter, or more or less frequently as the Parties mutually deem appropriate, on such dates and at such places and times as provided herein or as the Parties shall agree.

3.6Decision-Making.

3.6.1Escalation to JSC.  Except as otherwise provided herein, all decisions of each Committee and each Working Group shall be made by consensus, with all of a Party’s voting members collectively having one (1) vote.  If a Committee or Working Group other than the JSC

 

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is incapable of reaching unanimous agreement on a matter before it within [...***...] after first attempting to decide such matter, the matter shall be referred to the JSC for resolution.  If the JSC is incapable of reaching unanimous agreement on a matter before it within [...***...] after first attempting to decide such matter and after having at least [...***...], unless agreed otherwise in writing by the Parties, such agreement not to be unreasonably withheld, conditioned or delayed, the matter shall be resolved in accordance with Section 3.6.2.

3.6.2Escalation to the Executive Officers.  If the JSC cannot agree on a matter within [...***...] after it has first attempted to reach such decision and, unless agreed otherwise pursuant to Section 3.6.1, after having at least [...***...], then either Party may, by written notice to the other, have such issue referred to the Executive Officers for resolution.  The Parties’ respective Executive Officers shall meet within [...***...] after such matter is referred to them, after having at least [...***...], unless agreed otherwise in writing by the Parties, and shall negotiate in good faith to resolve the matter.

3.6.3Escalation to the Parties.  If the Executive Officers are unable to resolve the matter within [...***...] after the matter is referred to them, then:

(a)Existing Programs. With respect to each Existing Program:

(i)Prior to the exercise by Voyager of its Co-Co Option for such Program, Neurocrine shall have the right to decide such unresolved matter;

(ii)From and after the timely exercise by Voyager of its Co-Co Option for such Program, (A) to the extent the unresolved matter relates to the Development or Manufacturing prior to commercial launch in the Co-Co Territory of Collaboration Products in such Program, neither Party shall have the right to decide such unresolved matter and such unresolved matter shall be deadlocked until resolved by mutual agreement of the Parties or the JSC, (B) to the extent the unresolved matter relates to the Manufacturing or Commercialization in the Co-Co Territory of the Collaboration Products in such Program, Neurocrine shall have the right to decide such unresolved matter; and (C) to the extent the unresolved matter relates to the Development, Manufacturing following commercial launch or Commercialization outside of the Co-Co Territory of Collaboration Products in such Program, Neurocrine shall have the right to decide such unresolved matter; and

(iii)If Voyager does not timely exercise its Co-Co Option with respect to such Program, then Neurocrine shall have the right to decide such unresolved matter.

Notwithstanding the foregoing, in no event shall any Committee or Working Group, without Voyager’s explicit agreement, or Neurocrine alone have the power or authority to (1) cause Voyager to deviate from its hiring plan for the AADC Program through completion of the Existing Pivotal Trial as it pertains to work through the Transition Date for the AADC Program, (2) cause Voyager to deviate from its hiring plan for the FA Program through completion of the first Phase 1 Clinical Trial for the FA Program as it pertains to work through the Transition Date for the FA Program, or (3) cause Voyager to reallocate or realign its existing personnel as of the Effective Date in relation to any Existing Program.

 

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(b)Discovery Programs. Neurocrine shall have the right to resolve all unresolved matters relating to the Discovery Programs, provided that Neurocrine shall not have the right to approve (i) any proposed Target as a Discovery Target, (ii) the initial Discovery Program Development Plan for each Discovery Program or (iii) any Development Plan or amendment thereto that would require Voyager to conduct any activities thereunder for which Voyager does not have, and is not able to obtain with the exercise of Commercially Reasonable Efforts, sufficient personnel or resources, or to conduct any activities that are not included in the budget in such Development Plan;

provided, however, that in no event shall any Committee, Working Group or any Party alone have the power or authority to (1) amend this Agreement, (2) determine whether a Party has fulfilled or breached its obligations under this Agreement, (3) impose any requirements on either Party to undertake obligations beyond those for which it is responsible, or to forgo any of its rights, under this Agreement, (4) make a decision that is expressly stated under this Section 3.6.3 to require the mutual agreement of the Parties or of the JSC, (5) make a decision that could reasonably be expected to cause Voyager to breach an In-License Agreement or give rise to the right of the applicable Inbound Licensor to take any action under such In-License Agreement, or (6) require any Party to perform any act that it reasonably believes to be inconsistent with any Law.  Any decision made by the Executive Officers in accordance with Section 3.6.2 or by a Party in accordance with this Section 3.6.3 shall be considered a decision made by the JSC.

3.7Alliance Managers.  Promptly after the Effective Date, each Party shall appoint an individual (who may not be a then-current member of the JSC) to act as alliance manager for such Party (each, an “Alliance Manager”).  Each Alliance Manager shall thereafter be permitted to attend meetings of the JSC as a nonvoting observer, subject to the confidentiality provisions of Article 11.  The Alliance Managers shall be the primary point of contact for the Parties regarding the activities contemplated by this Agreement.  The Alliance Managers shall also be responsible for assisting the JSC in performing its oversight responsibilities.  The name and contact information for each Party’s Alliance Manager, as well as any replacement chosen by such Party, in its sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 15.8.

3.8Authority.  Each Party will retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion will be delegated to or vested in the JSC or any other Subcommittee or any Working Group unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.

ARTICLE 4
POST-TRANSITION ACTIVITIES

4.1Co-Development and Co-Commercialization.

4.1.1Voyager’s Opt-In Right.  On an Existing Program-by-Existing Program basis, Voyager shall have the right to elect to co-develop and co-commercialize Collaboration Products that are the subject of such Existing Program in the United States (the “Co-Co Option”) by providing Neurocrine with written notice of such election within [...***...] following the applicable Co-Co Trigger Date.  Upon such exercise, the Parties shall negotiate in good faith and

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enter into an agreement, which shall be based on terms and conditions substantially the same as those set forth in this Section 4.1 and otherwise consistent with this Agreement (each such agreement, a “Co-Co Agreement”), pursuant to which the Parties will jointly Develop and Commercialize and share in the Development Costs, Commercialization costs and profit or loss resulting from the Development and Commercialization of such Collaboration Products in the United States (the “Co-Co Territory”).  Once Voyager exercises the Co-Co Option with respect to an Existing Program, each Collaboration Product in such Existing Program shall be designated a “Co-Co Product” hereunder and such Existing Program shall be designated a “Co-Co Program” hereunder, and the Parties will share Development Costs incurred thereafter. The “Co-Co Trigger Date” shall mean (a) with respect to the AADC Program, Voyager’s receipt of topline data with respect to the Existing Pivotal Trial, which data Voyager shall submit to Neurocrine promptly after availability thereof and (b) with respect to the FA Program, the date upon which the JSC determines that Proof of Mechanism has been achieved.

4.1.2Co-Co Agreement General Principles.  It is the intent of the Parties that Development and Commercialization of each Co-Co Product in the Co-Co Territory under the applicable Co-Co Agreement will be conducted in accordance with the following principles, except as otherwise mutually agreed by the Parties in writing.  The Parties shall take into account and attempt to implement the following principles in their decision-making, including preparation, review and approval of any updates to and amendments of the Development plan and Commercialization plan under such Co-Co Agreement:

(a)Development and Commercialization of each Co-Co Product in and for the Co-Co Territory shall be conducted according to a mutually agreed Development plan and Commercialization plan, respectively, prepared and updated periodically by Neurocrine, in consultation with Voyager, and submitted to the JSC for review and approval. Such plans shall (i) set forth the Development activities and Commercialization activities, respectively, to be undertaken by the Parties with respect to the applicable Co-Co Product in and for the Co-Co Territory in the subsequent [...***...], (ii) be updated at least [...***...] and (iii) include a related detailed budget.  Either Party may propose amendments to a Development plan or Commercialization plan to the JSC for review and approval.  No Development or Commercialization activities shall be delegated to a Party in the Development plan or Commercialization plan (or any amendment thereto) without such Party’s prior agreement.  Each Party will use Commercially Reasonable Efforts to perform the Development and Commercialization activities delegated to such Party in the Development plan and Commercialization plan, as applicable.  Each Party’s Development Costs for the Co-Co Program shall be calculated in a manner consistent with Development Costs calculation under this Agreement (including related definitions).  FTE Costs with respect to Commercialization costs for the Co-Co Program shall be calculated in a manner consistent with this Agreement. Notwithstanding the foregoing, the terms of the Co-Co Agreement (i) shall not require any realignment or decrease in the size of the then Neurocrine field  forces, and (ii) shall be reasonably directed to maximize sales of the Co-Co Product.

(b)The Development plan and the Commercialization plan under the Co-Co Agreement shall each include an allocation of responsibilities between the Parties reasonably and equitably determined after taking into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities. Notwithstanding the

 

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foregoing, but subject to the last sentence of Section 4.1.2(a), the Development plan and the Commercialization plan under the Co-Co Agreement shall include meaningful participation in Development activities, Commercialization activities (including participation in field sales and detailing), preparation for Commercialization, and medical affairs activities by Voyager (unless otherwise agreed by Voyager), provided that in all cases Neurocrine will be responsible for booking sales of Collaboration Products.

(c)The Parties shall share Development and Commercialization costs incurred by either Party or its Affiliates in accordance with the applicable budgets in conducting activities for the Co-Co Territory in accordance with the applicable Co-Co Rate pursuant to the Development plan and Commercialization plan under the Co-Co Agreement.  The Co-Co Agreement shall provide that (i) if either Party incurs Development Costs or Commercialization costs in excess of [...***...] percent ([...***...]%) of the Development Costs or Commercialization costs, as applicable, budgeted for activities assigned to such Party in the budget of the then-current version of the Development plan or Commercialization plan, as applicable, then such Party shall be solely responsible for such excess costs unless such Party has received the other Party’s written approval to share such excess costs and (ii) global Development Costs incurred for Development activities that support Regulatory Approval in the Co-Co Territory and in other countries of the Territory shall be reasonably and equitably allocated to the Co-Co Program in accordance with the reasonably expected proportion of Co-Co Product sales in the Co-Co Territory as compared with other countries in the Territory, as mutually agreed by the Parties.

(d)All profit or loss (which shall be defined in the Co-Co Agreement in a customary manner) and any amounts due to any Inbound Licensor under an In-License Agreement from and after the exercise of the Co-Co Option (including royalty, milestone, and sublicense income payments) with respect to the Co-Co Products shall be shared between the Parties at the Co-Co Rate, to the extent such amounts are allocable to the Co-Co Territory. Proceeds of the sale of any PRV granted to Neurocrine in connection with the approval of the BLA for a Co-Co Product shall be considered Net Sales for the Co-Co Program and costs and expenses associated with any Third Party engaged to facilitate such sale shall be considered a cost for the Co-Co Program, but only if Voyager approves of the engagement of such Third Party prior to such sale. Notwithstanding Sections 13.1.1(c) or 13.2.3, and regardless of the Parties’ respective insurance coverages, any losses incurred by either Party arising from Third Party Claims related to Exploitation of the Co-Co Products in or for the Co-Co Territory, including Third Party Claims based on intellectual property infringement, product liability or personal injury, shall be shared between the Parties at the Co-Co Rate, except to the extent resulting from the gross negligence, recklessness or intentional misconduct of a Party or any of its Affiliates or its or their respective directors, officers, employees, agents or representations or a Party’s breach of this Agreement.

(e)Neurocrine’s obligation to pay the royalty set forth in Sections 8.3.1(a) and 8.3.2(a) shall terminate, and Neurocrine’s obligation to make milestone payments with respect to such Co-Co Products shall be modified as set forth in Section 8.2(b).

(f)Regardless of the specific division of responsibility between the Parties for particular activities at any particular time, the JSC shall serve as a conduit for sharing information, knowledge and expertise relating to the Development and Commercialization of each Co-Co Product.

 

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(g)The Co-Co Agreement shall specify that the mutual consent of both Parties shall be required to Develop and Commercialize each Co-Co Product with any Third Party in the Co-Co Territory, including the sale, licensing or divestiture of marketing rights or product assets as to such Co-Co Product in the Co-Co Territory.

(h)The dispute resolution provisions in the Co-Co Agreement shall mirror Sections 15.2 and 15.3 of this Agreement and the Parties shall agree that any arbitration brought under a Co-Co Agreement may be consolidated with an arbitration brought under another Co-Co Agreement or this Agreement.

4.1.3Co-Co Rate.  Each Party shall receive (in the case of profits) or pay (in the case of losses), as applicable, its allocable share of profit and losses with respect to each Co-Co Product in the Co-Co Territory.  The rate at which the Parties shall share in such profit and losses is referred to herein as the “Co-Co Rate”.  The Co-Co Rate for the FA Program shall be 60% for Neurocrine and 40% for Voyager, and the Co-Co Rate for the AADC Program shall initially be 50% for each of Neurocrine and Voyager; provided that, Neurocrine may elect, by delivery of written notice and payment to Voyager of the Rate-Shifting Fee within [...***...] of BLA acceptance for filing by the FDA with respect to the Co-Co Product for the AADC Program, to change the Co-Co Rate for the AADC Program to 55% for Neurocrine and 45% for Voyager.  The “Rate-Shifting Fee” shall be Thirty-Five Million Dollars ($35,000,000). If Neurocrine so elects, the Co-Co Rate shall be adjusted effective as of the first day of the month following Neurocrine’s election, and there shall be no credit or accounting for profit and losses shared by the Parties prior to such date.  If Neurocrine does not notify Voyager of its election and pay the Rate-Shifting Fee within such [...***...] period, then the Co-Co Rate for Co-Co Products in the AADC Program shall remain 50% for each of Neurocrine and Voyager for the term of the applicable Co-Co Agreement.

4.1.4Termination of Co-Co Agreement.

(a)Voyager shall have the right to terminate any Co-Co Agreement for any or no reason on [...***...] prior written notice. For the avoidance of doubt, following termination of a Co-Co Agreement as set forth in this subsection (a), Voyager shall not be entitled to any refund or credit for amounts that it may have paid under such Co-Co Agreement prior to termination (other than amounts that may be payable or creditable to Voyager as a final reconciliation of its share of profits and losses through termination).

(b)Neurocrine shall have the right to terminate any Co-Co Agreement upon a Change of Control of Voyager if the Acquirer is Developing or Commercializing a branded product that directly competes with a product being Developed or Commercialized by Neurocrine.  In such event, the Parties will negotiate in good faith a reasonable royalty to Voyager (in excess of the applicable royalties in Section 8.3) that would approximate Voyager’s share (at the Co-Co Rate) of profit under the Co-Co Agreement, and if the Parties fail to agree on such share, the dispute will be submitted to an independent mutually agreed expert for determination, whose decision will be final and binding on the Parties.

(c)If a Co-Co Agreement is terminated, as set forth above in this Section 4.1.4 or in accordance with the terms of such Co-Co Agreement, then (i) the Co-Co

 

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Products from such Co-Co Program shall be deemed Collaboration Products (and not Co-Co Products) hereunder for the remainder of the Term, (ii) the Parties shall cease to share profit and loss with respect to such Collaboration Products and Neurocrine’s obligation to pay the royalties set forth in Sections 8.3.1(a) and 8.3.2(a), as applicable, shall be reinstated from and after the effective date of termination and (iii) Neurocrine’s obligations to make milestone payments with respect to such Collaboration Products shall thereafter be as set forth in Section 8.2(b) for Collaboration Products that are not Co-Co Products; provided, that Neurocrine shall not have any obligation to make milestone payments with respect to milestones that occurred prior to the effective date of termination of the Co-Co Agreement.

4.2Neurocrine Development and Commercialization.

4.2.1Neurocrine Responsibilities.  From and after the Transition Date with respect to a Program that is not a Co-Co Program, Neurocrine shall be solely responsible at Neurocrine’s cost and expense for all Development, Manufacturing and Commercialization activities in connection with the Collaboration Products that are the subject of such Program in the Field in the Territory, which activities shall be conducted in accordance with the Neurocrine Plan and this Agreement; provided that Voyager shall provide reasonable Development assistance to Neurocrine as reasonably requested by Neurocrine and reasonably agreed by Neurocrine in connection with activities for which Voyager has expertise. Neurocrine shall reimburse Voyager for all Development Costs incurred by Voyager under this Section 4.2.1 within [...***...] of Voyager’s submission of an invoice therefor.

4.2.2Neurocrine Diligence.

(a)Major Market Countries.  Neurocrine shall use Commercially Reasonable Efforts (i) to Develop, seek Regulatory Approval for and Commercialize at least one (1) Collaboration Product in each Program in each of [...***...] (collectively, the “Major Market Countries”) and (ii) to Commercialize at least one (1) Collaboration Product in each Program in each Major Market Country in which it receives Regulatory Approval and, if applicable, pricing and reimbursement approval for such Collaboration Product.

(b)Secondary Market Countries.  Neurocrine shall use Commercially Reasonable Efforts (i) to Develop, seek Regulatory Approval for and Commercialize Collaboration Products in [...***...] (collectively, the “Secondary Market Countries”) and (ii) to Commercialize such Collaboration Products in the Secondary Market Countries for which it receives Regulatory Approval and, if applicable, pricing and reimbursement approval for such Collaboration Products to the extent sufficient commercial opportunities exist in such countries and such activities do not impede Development or Commercialization of Collaboration Products in any Major Market Countries.

Notwithstanding the foregoing or any other provision under this Agreement, it will be consistent with the exercise of Commercially Reasonable Efforts for Neurocrine to prioritize one Program over all other Programs at any given time, and it will not be consistent with the exercise of Commercially Reasonable Efforts for Neurocrine to prioritize another Program over the AADC

 

 

 

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Program, and Neurocrine may not give priority to another Program over the AADC Program without Voyager’s written agreement.

4.2.3Neurocrine Plan.  Within [...***...] after the Transition Date with respect to a Program, Neurocrine shall submit a written plan, prepared in good faith, (such plan, as each may be amended from time to time in accordance with this Agreement, the “Neurocrine Plan”) to the JSC for review and approval (to the extent set forth in Section 3.1.2(m)), which Neurocrine Plan shall include a description and overall summary of the Development, Manufacturing and Commercialization activities that Neurocrine intends to conduct in order to obtain Regulatory Approval for each Collaboration Product that is the subject of such Program in the Territory, which shall specifically include such activities in each of the [...***...].  Neurocrine shall use Commercially Reasonable Efforts to execute the activities specified in the Neurocrine Plan.  Neurocrine may submit to the JSC proposed amendments to the Neurocrine Plan from time to time during the term of this Agreement.  All amendments to the Neurocrine Plan shall be reviewed and, to the extent provided in Section 3.1.2, approved by the JSC.

4.2.4Neurocrine Reports. Neurocrine shall, within [...***...] after the end of each of the first and second halves of each Calendar Year prior to First Commercial Sale of a Collaboration Product in all Programs, and annually thereafter, provide Voyager with written progress reports on the status of the Development and Commercialization activities under the applicable Neurocrine Plan with respect to each Collaboration Product in such Calendar Year. Notwithstanding the foregoing, Neurocrine agrees that to the extent that an In-License Agreement applicable to a given Program requires more thorough or more frequent reporting or requires that reports be provided on a different timeline than that set forth in this Section 4.2.4, Voyager shall notify Neurocrine of the deadline and content of such reports, and Neurocrine shall provide such reports to Voyager as requested by Voyager no less than [...***...] prior to the date that Voyager is required to submit such report pursuant to the applicable In-License Agreement.

4.3Program Transition.  On a Program-by-Program basis, no later than [...***...] before the reasonably anticipated Transition Date with respect to such Program, the Parties shall commence preparing in good faith and prior to such Transition Date shall agree to a plan to transfer to Neurocrine (or its designee (other than a competitor of Voyager who is developing or commercializing a gene therapy, gene editing or anti-sense oligonucleotide product)) all Development and Manufacturing activities relating to Collaboration Product(s) in such Program then being undertaken by Voyager (the “Transition Plan”).  Voyager shall transition all such activities to Neurocrine, at Neurocrine’s cost and expense, and shall conduct all transition activities in accordance with the Transition Plan as soon as reasonably practicable.  As part of each such Transition Plan, Voyager shall provide to Neurocrine all Voyager Know-How relevant to the applicable Program and not previously provided to Neurocrine.

4.3.1Reimbursement.  To the extent that Neurocrine is required to reimburse Voyager hereunder for any costs incurred by Voyager or pursuant to the activities under the Transition Plan, Voyager shall submit an invoice itemizing such costs and expenses Voyager has incurred, on a Calendar Quarter basis, together with any written evidence of such costs.  Neurocrine shall pay such invoice, unless subject to a bona fide dispute, within [...***...] of

 

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receipt.  For the avoidance of doubt, any such costs shall be calculated by Voyager as Development Costs.

4.4Transition Activities.  In connection with the transition of each Program to Neurocrine, and as further detailed in the Transition Plan, Voyager shall conduct the following activities for no additional consideration:

4.4.1Voyager shall provide all assistance reasonably necessary for Neurocrine or its designees to continue the Manufacture and Development of all Collaboration Products in such Program;

4.4.2Upon Neurocrine’s request, Voyager shall assign to Neurocrine any agreements (including any agreement with any Third Party manufacturer with respect to a Collaboration Candidate or Collaboration Product) solely relating to the Development or Manufacture of any Collaboration Candidate or Collaboration Product to which Voyager or any of its Affiliates is a party; provided that if any such agreement is not assignable to Neurocrine (because consent is required or because it relates to products that are not Collaboration Products), Voyager shall take all actions reasonably requested by Neurocrine so that Neurocrine may receive the benefits of such agreement applicable to Collaboration Candidates and Collaboration Products, which may include assigning a statement of work or work order to Neurocrine and facilitating a discussion of the terms of a services agreement between Neurocrine and the applicable counterparty;

4.4.3Voyager shall transfer to Neurocrine copies of all data, reports, records, materials and other information arising out of the applicable Program, including all non-clinical and clinical data relating to any Collaboration Candidate or Collaboration Product, and all adverse event or other safety data resulting from such Program, as well as any chemistry, manufacturing and controls (CMC) or other Manufacturing data generated in connection with such Program; and

4.4.4Voyager shall provide Neurocrine with a written summary of its inventory of Collaboration Candidates and Collaboration Products, and Voyager shall, at Neurocrine’s election, promptly destroy such inventory or deliver such inventory to Neurocrine.  Voyager represents and warrants that, at the time of delivery, all clinical supply of Collaboration Candidates and Collaboration Products (a) will have been Manufactured in accordance with applicable Law, including cGMP, (b) will not be adulterated or misbranded under the Act and may be introduced into interstate commerce pursuant to the Act, (c) will comply with the specifications therefor, and (d) will comply with the quality agreement to be entered into between the Parties. In the event that Voyager cannot make such representations with respect to any such inventory, Voyager shall destroy such inventory and certify such destruction to Neurocrine, unless requested otherwise by Neurocrine; provided that if any such non-compliance results from either (i) Voyager’s gross negligence or willful misconduct in the Manufacture of such inventory or (ii) Voyager’s negligence or willful misconduct in the oversight of any Third Party’s Manufacture of such inventory, Voyager shall reimburse the amounts paid by Neurocrine under the Development Plan for the Manufacture of such inventory.

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ARTICLE 5
GRANT OF LICENSES

5.1License Grant.  Subject to the terms and conditions of this Agreement, Voyager hereby grants to Neurocrine, and Neurocrine accepts, an exclusive, royalty-bearing, non-transferable (except in accordance with Section 15.4), sublicenseable (subject to Section 5.5) license under the Voyager IP to Develop, Commercialize, Manufacture, have Manufactured and use Collaboration Candidates and Collaboration Products in the Field in the Territory during the Term; provided, however, that, such license shall be subject to Voyager’s retained rights under the Voyager IP to conduct the activities allocated to Voyager under any Development Plan or Co-Co Agreement or otherwise under this Agreement.  The license granted under this Section 5.1 shall automatically convert to a fully paid-up, non-royalty bearing, perpetual, irrevocable, exclusive license on a country-by-country and Collaboration Product-by-Collaboration Product basis upon the expiration of the Royalty Term applicable to such Collaboration Product in such country (but not upon an earlier termination of this Agreement with respect thereto).

5.2In-License Agreements.

5.2.1Neurocrine acknowledges that the license granted by Voyager to Neurocrine in Section 5.1 includes sublicenses under certain Voyager IP that is licensed to Voyager pursuant to In-License Agreements, and that such sublicenses are subject to the applicable terms of the In-License Agreements, the scope of the licenses granted to Voyager or the applicable Affiliate thereunder and the rights granted to or retained by the Third Party counterparties and any other Third Parties (including Governmental Authorities) (each, an “Inbound Licensor”) set forth therein. To the extent Patent Rights under the In-License Agreements are sublicensed to Neurocrine hereunder, Neurocrine covenants to comply with, and to cause its sublicensed Affiliates and to require its Sublicensees to comply with, the In-License Agreements, pursuant to their terms, including Sections 5.1, 5.2, 8.1, 10.1, 10.2, 12.5, and 13.7-13.9 of the [...***...] Agreement the text of which Sections are set forth on Schedule 5.2.1 in compliance with Section 4.2 of the [...***...] Agreement and if the Patent Rights under the [...***...] Agreement are sublicensed to Neurocrine hereunder, Section 2.3 of the [...***...] Agreement.  To the extent there is a conflict between any of the terms of any In-License Agreement and the rights granted to Neurocrine hereunder (including with respect to any sublicensing rights, Prosecution and Maintenance, enforcement and defense rights) the terms of such In-License Agreement shall control with respect to the Know-How and Patent Rights licensed to Voyager under such In-License Agreement.

5.2.2If either Party becomes aware of any Third Party’s Know-How that would be necessary or reasonably useful for the Development, Manufacturing or Commercialization of a Collaboration Product or any Third Party’s Patent Right that Covers in the Territory any Collaboration Product, such Party shall promptly notify the other Party, and the Parties shall discuss whether to seek a license under such Know-How or Patent Rights.  Voyager shall have the first right to enter into Third Party licenses related to Know-How, Patent Rights, or other intellectual property rights related to any Vectorization Technology, in Voyager’s sole discretion.  If Voyager determines to enter into such a license, then prior to doing so Voyager shall provide written notice to Neurocrine and, if Neurocrine expresses a desire to obtain a sublicense to such license pursuant to Section 5.2.3, Voyager shall thereafter provide Neurocrine with a reasonable opportunity to review and comment on the proposed terms of such license that are applicable to

 

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Neurocrine as a sublicensee thereunder.  Voyager shall use reasonable efforts to negotiate the terms of such license accordingly.  Neurocrine shall have the first right to seek any other Third Party license related to Know-How, Patent Rights, or other intellectual property rights.  If Neurocrine elects not to seek any other such license, and if Voyager seeks such license, and if Neurocrine expresses a desire to obtain a sublicense to such license pursuant to Section 5.2.3, Voyager shall thereafter provide Neurocrine with a reasonable opportunity to review and comment on the proposed terms of such license that are applicable to Neurocrine as a sublicensee thereunder.  Voyager shall use reasonable efforts to negotiate the terms of such license accordingly.  For the avoidance of doubt, nothing contained in this Section 5.2.2 creates an obligation for Voyager to obtain any Third Party license.

5.2.3If, after the Effective Date, subject to Section 5.2.2, Voyager or any of its Affiliates enters into a Future In-License Agreement with a Third Party pursuant to which Voyager (or, subject to the last sentence of this Section 5.2.3, any of its Affiliates) obtains Control over a Third Party’s Know-How that is necessary or reasonably useful for the Development, Manufacturing or Commercialization of a Collaboration Product or any Patent Right that Covers in the Territory any Collaboration Product, Voyager shall promptly provide such Future In-License Agreement to Neurocrine and provide any information reasonably requested by Neurocrine with respect thereto, and such Third Party’s Know-How and Patent Rights shall be included in the license granted to Neurocrine under Section 5.1 and considered Voyager IP hereunder, only if Neurocrine agrees in writing to pay the share of the payments due to Inbound Licensors applicable to the Collaboration Product(s), as well as a reasonably allocable share of any other payments due to Inbound Licensors not specific to a compound or product, as set forth in Section 5.2.4.

5.2.4As between the Parties, the amounts payable under all In-License Agreements shall be allocated as follows:

(a)With respect to an Existing Program (unless and until such Existing Program becomes a Co-Co Program), (i) Voyager shall be responsible for any payment required under applicable Existing In-License Agreements and (ii) each of Voyager and Neurocrine shall be responsible for fifty percent (50%) of all payments under any applicable Future In-License Agreement that are specifically related to a Collaboration Product, it being agreed that if Voyager’s fifty percent (50%) share of royalties payable under the Future In-License Agreement exceed the royalties payable by Neurocrine to Voyager with respect to the applicable Collaboration Product in the applicable country in the applicable Calendar Quarter, then Neurocrine shall bear such excess. Notwithstanding the foregoing, Voyager shall be solely responsible for all payments under any potential In-License Agreements for intellectual property referenced on Schedule 5.2.4(a) for Existing Programs.

(b)With respect to the Discovery Programs, (i) each of Voyager and Neurocrine shall be responsible for fifty percent (50%) of all payments under any Existing In-License Agreement and Future In-License Agreement that are specifically related to Vectorization Technology, it being agreed that if Voyager’s fifty percent (50%) share of royalties payable under the Existing In-License Agreement or Future In-License Agreement exceed the royalties payable by Neurocrine to Voyager with respect to the applicable Collaboration Product in the applicable country in the applicable Calendar Quarter, then Neurocrine shall bear such excess and (ii)

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Neurocrine shall be responsible for 100% of all payments under any Future In-License Agreement that are not specifically related to Vectorization Technology.

(c)With respect to any Co-Co Program, from and after the exercise of the Co-Co Option, pursuant to Section 4.1.2(d), any amounts due to any Inbound Licensor under an In-License Agreement (including royalty, milestone and sublicense income payments) with respect to the Co-Co Products shall be shared between the Parties at the Co-Co Rate, to the extent such amounts are allocable to the Co-Co Product in the Co-Co Territory.

Notwithstanding the fact that Voyager has obtained a license related to Know-How, Patent Rights or other intellectual property rights Covering Vectorization Technology and that such intellectual property rights may be included within Neurocrine’s license to Existing In-License Agreements or that Neurocrine may elect, under Section 5.2.3 to take a sublicense to Know-How, Patent Rights or other intellectual property rights Covering Vectorization Technology under a Future In-License Agreement, to the extent that Voyager demonstrates that an alternative methodology or approach that is not Covered by such licensed intellectual property rights (an “Alternative Method”) yields results that are of materially equivalent or superior quality, and Voyager proposes to Neurocrine that such Alternative Method be deployed in a Collaboration Program on a timeline that is practicable and does not introduce unreasonable risk to the success of a Program, then Neurocrine shall reasonably consider deploying such Alternative Method for the relevant Collaboration Program; provided that if, notwithstanding Voyager’s proposal for the use of the Alternative Method, Neurocrine exercises its final-decision making authority pursuant to Section 3.6 to decline the use of the Alternative Method, then any payments under the Existing Licensed Agreement or Future In-License Agreement implicated by Neurocrine’s refusal to adopt the Alternative Method shall be allocated between the Parties as set forth in Section 5.2.4(a) (without giving effect to the last sentence thereof).

5.2.5Neurocrine shall prepare and deliver to Voyager any additional reports required under the applicable In-License Agreements of Voyager, in each case to the extent requested by Voyager, and, provided that Voyager has notified Neurocrine reasonably sufficiently in advance of the applicable deadline, to enable Voyager to comply with its obligations under the applicable In-License Agreements.

5.3Obligations Under In-Licenses.

5.3.1Voyager shall not take (or fail to take) any action, including failure to pay any amounts when due (except that any such failure to pay that was caused by Neurocrine’s failure to make a payment required to be made by Neurocrine under Section 5.2.4 will not be considered an action or failure to take action by Voyager for purposes of this Section 5.3.1), that constitutes a material breach under any In-License Agreement.  Voyager will not, without the consent of Neurocrine (a) take any action with respect to any In-License Agreement (including amending, terminating or otherwise modifying) that diminishes the rights granted to Neurocrine under this Agreement; or (b) fail to take any action with respect to an In-License Agreement that is reasonably necessary to avoid diminishing the rights granted to Neurocrine under this Agreement.

5.3.2Voyager shall reasonably enforce, or otherwise take all actions necessary to enable Neurocrine to enforce, at Voyager’s expense, Voyager’s rights and benefits and the

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obligations of the counterparty under each In-License Agreement that may affect the rights, benefits and obligations of Neurocrine hereunder, including taking such actions as Neurocrine may request, and will inform Neurocrine of any action it takes under any In-License Agreement to the extent such action may affect Neurocrine’s rights under this Agreement.

5.3.3Voyager shall not (and shall cause its Affiliates not to) assign (except an assignment to a party to which this Agreement has been assigned as permitted under Section 15.4) any In-License Agreement without the prior written consent of Neurocrine.

5.3.4Voyager shall (and shall cause its Affiliates to) provide Neurocrine with prompt notice of any claim of a breach under any In-License Agreement or notice of termination of any In-License Agreement, made by any of Voyager, its Affiliate or the Inbound Licensor, and shall promptly send to Neurocrine (or cause its Affiliates promptly to send to Neurocrine) copies of all material correspondence regarding each In-License Agreement, to the extent relevant to the rights or obligations of Neurocrine under this Agreement.

5.3.5In the event that Voyager or its Affiliate receives written notice of an alleged breach by Voyager or its Affiliate under any In-License Agreement, where termination of such In-License Agreement or any diminishment of the licenses granted to Neurocrine under the Voyager IP is being or could be sought by the Inbound Licensor, then Voyager will promptly, but in no event less than [...***...] thereafter, provide written notice thereof to Neurocrine and grant Neurocrine the right (but not the obligation) to cure such alleged breach, and if Neurocrine elects to and does cure such breach, then Neurocrine may offset any Out-of-Pocket Costs and expenses incurred by or on behalf of Neurocrine or any of its Affiliates in connection with curing such breach against Neurocrine’s future payment obligations to Voyager under this Agreement. Each Party shall notify the other Party if it intends to cure such breach and again promptly after curing such breach.

5.3.6Neurocrine acknowledges and agrees that, if any license granted to Voyager under an In-License Agreement is terminated then Neurocrine’s sublicense under such terminated license shall automatically terminate, subject to Neurocrine’s right to receive a direct license from any Inbound Licensor of such In-License Agreement to the extent specified in the applicable In-License Agreement.  In the event that any In-License Agreement is terminated by the applicable Inbound Licensor, and such In-License Agreement does not permit the sublicense to survive (or Neurocrine to receive a direct license), then Voyager will take all reasonable actions requested by Neurocrine to facilitate Neurocrine’s entry into a direct license agreement with the applicable Inbound Licensor.  In the event that any In-License Agreement is terminated by the applicable Inbound Licensor, and such In-License Agreement permits the sublicense to survive (or Neurocrine to receive a direct license), Neurocrine will have the right, at Neurocrine’s election, to convert the applicable sublicenses granted under this Agreement by Voyager to a direct license from the applicable Inbound Licensor to Neurocrine on the terms and conditions contained in such In-License Agreement, or such other terms and conditions as may be negotiated by Neurocrine and the applicable Inbound Licensor, and Voyager will reasonably cooperate with Neurocrine and its Affiliates to effectuate such direct license and assist Neurocrine in discussions with Inbound Licensors to accomplish such direct license. In the event Neurocrine enters into any such direct license with an Inbound Licensor, Neurocrine may offset any Out-of-Pocket Costs and expenses incurred by or on behalf of Neurocrine or any of its Affiliates or Sublicensees in connection with

 

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entering into and exercising its rights or performing under such direct license, against Neurocrine’s future payment obligations to Voyager under this Agreement.

5.4Genzyme Agreement.  Voyager shall notify Neurocrine within [...***...] after Genzyme’s rights to the FA Program outside the United States expire and shall provide written confirmation thereof from Genzyme.  Upon such expiration, the Territory with respect to the FA Program will automatically expand to include all countries in the world.  If instead Genzyme exercises its option with respect to the FA Program, then promptly thereafter Voyager will use Commercially Reasonable Efforts to facilitate negotiation of a cooperation agreement among Genzyme, Neurocrine and Voyager including provisions related to data sharing, license grants and coordination of development activities for Collaboration Candidates and Collaboration Products in the FA Program.

5.5Neurocrine’s Sublicensing Rights.  Neurocrine shall have the right to grant and authorize sublicenses under the rights granted to it under Section 5.1 to any of its Affiliates and Third Parties through multiple tiers (each such Third Party, a “Sublicensee”).  Neurocrine shall provide Voyager with a fully-executed copy of any agreement (redacted as necessary to protect confidential or commercially sensitive information that is not necessary for Voyager to determine Neurocrine’s compliance with this Agreement or for Voyager to comply with any applicable In-License Agreement) reflecting any such sublicense to a Third Party promptly after the execution thereof (a “Sublicense”).  If Neurocrine or any Affiliate or Sublicensee grants a sublicense, the terms and conditions of this Agreement that are applicable to Sublicensees shall apply to such Sublicensee to the same extent as they apply to Neurocrine.  Neurocrine will itself pay and account to Voyager for all payments due under this Agreement by reason of operation of any such sublicense.  Each Sublicense must be consistent with, and require the Sublicensee to meet, all applicable obligations and requirements of the In-License Agreements.  Notwithstanding the foregoing, unless and until the receipt of written agreement by the applicable Inbound Licensor to permit further sublicensing to a Third Party, Neurocrine shall not have the right to grant any sublicenses to the extent not permitted under the applicable In-License Agreement; provided that upon Neurocrine’s request, Voyager will use Commercially Reasonable Efforts to obtain the right for Neurocrine to grant sublicenses to the extent not already permitted by an In-License Agreement.

5.6Licenses to Voyager.

5.6.1Development License.  Subject to the terms and conditions of this Agreement, Neurocrine hereby grants to Voyager, and Voyager accepts, a non-exclusive, royalty-free, non-transferable (except in accordance with Section 15.4), sublicenseable (only to its permitted subcontractors under Section 2.5) license under the Neurocrine IP to conduct the Development and Manufacturing activities allocated to Voyager under the Development Plans in the Field in the Territory in accordance with this Agreement.

5.6.2Co-Co License.  Subject to the terms and conditions of this Agreement and each applicable Co-Co Agreement, on a Program-by-Program basis, upon Voyager’s exercise of the Co-Co Option with respect to such Program in accordance with Section 4.1.1, Neurocrine grants to Voyager, and Voyager accepts, a non-exclusive, non-transferable (except in accordance with Section 15.4), sublicenseable (solely as set forth in the applicable Co-Co Agreement) license

 

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under the Neurocrine IP to conduct those Development, Commercialization and Manufacturing activities that are allocated to Voyager under such Co-Co Agreement with respect to Co-Co Products in such Program in the Field in and for the Co-Co Territory during the term of such Co-Co Agreement.

5.7No Other Rights.  Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any ownership interest, license right or other right in any Know-How, Patent Rights or other intellectual property rights of the other Party or any of its Affiliates, including items owned, controlled, developed or acquired by the other Party or any of its Affiliates, or provided by the other Party to the first Party at any time pursuant to this Agreement.

5.8Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by a Party to the other, including those set forth in Sections 5.1 and 5.6, are and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the U.S. Bankruptcy Code (“Title 11”), licenses of rights to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code.  The Parties agree that the Parties shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code and any foreign counterpart thereto.  Without limiting the Parties’ rights under Section 365(n) of Title 11, if a case under Title 11 is commenced by or against either Party, the other Party shall be entitled to a copy of any and all such intellectual property and all embodiments of such intellectual property, and the same, if not in the possession of such other Party, shall be promptly delivered to it (a) before this Agreement is rejected by or on behalf of such Party, within [...***...] after such other Party’s written request, unless such Party, or its trustee or receiver, elects within [...***...] to continue to perform all of its obligations under this Agreement, or (b) after any rejection of this Agreement by or on behalf of such Party, if not previously delivered as provided under clause (a) above (any such event described in clause (a) or (b) above, and occurring while such Title 11 case is pending, being a “Delivery Event”).  All rights of the Parties under this Section 5.8 and under Section 365(n) of Title 11 are in addition to and not in substitution of any and all other rights, powers, and remedies that each Party may have under this Agreement, Title 11, and any other applicable Laws. The Parties agree that they intend the foregoing rights to extend to the maximum extent permitted by Law and any provisions of applicable contracts with Third Parties, including for purposes of Title 11, (i) the right of access to any intellectual property (including all embodiments thereof) of Voyager or Neurocrine, as applicable, or any Third Party with whom Voyager or Neurocrine contracts to perform an obligation of Voyager or Neurocrine under this Agreement, and, in the case of the Third Party, that is necessary for the Development and Manufacture of Collaboration Products and (ii) the right to contract directly with any Third Party described in clause (i) in this sentence to complete the contracted work, provided however, that in each case such rights shall be subject to the confidentiality obligations contemplated by this Agreement.  If a bankruptcy proceeding is commenced by or against Voyager, notwithstanding anything to the contrary in Article 10, Neurocrine may, to the maximum extent permitted by Law, take appropriate actions in connection with the filing, prosecution, maintenance and enforcement of any Voyager Licensed Patent Rights licensed to Neurocrine under this Agreement to the extent that Voyager is required or has the right to take such actions under this Agreement and to the extent that Voyager fails to take such actions following at least [...***...] prior written notice from Neurocrine.

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ARTICLE 6
MANUFACTURING

6.1Manufacturing Responsibilities Prior to Transition Date.  Prior to the Transition Date for a Program, Voyager shall be responsible for the Manufacture of Collaboration Products from such Program, subject to Section 2.1.7 or unless otherwise agreed by the Parties in writing.

6.2Manufacturing After Transition Date.  No later than [...***...] prior to the anticipated Transition Date for a Program, the Parties shall discuss in good faith the allocation of Manufacturing and supply responsibilities between the Parties with regard to the Collaboration Product(s) from such Program in connection with Neurocrine’s and, to the extent applicable, Voyager’s Development and Commercialization activities hereunder.  The Parties may negotiate in good faith either or both a clinical supply agreement and/or a commercial supply agreement for Voyager to supply Neurocrine with any Collaboration Product.

ARTICLE 7
GENERAL PROVISIONS RELATING TO ACTIVITIES

7.1Compliance.  All Development, Manufacturing and Commercialization activities to be conducted by a Party under this Agreement shall be conducted in compliance with applicable Laws, including all applicable cGMP, GLP and GCP requirements.

7.2Regulatory Activities.

7.2.1INDs and Related Communications.

(a)Subject to the terms of any applicable Co-Co Agreement, from and after the applicable Transition Date, Neurocrine shall, as between the Parties, have the sole right to prepare, obtain and maintain all INDs, Regulatory Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, pricing and reimbursement approvals and other submissions and to conduct communications with the Regulatory Authorities and Governmental Authorities in the Territory for the applicable Collaboration Products. Neurocrine will be the regulatory sponsor for all Clinical Trials commenced on Collaboration Products from and after the Effective Date.  Upon Neurocrine’s request, Voyager shall provide reasonable assistance to Neurocrine in connection with the regulatory activities for Collaboration Products, including the preparation of the IND for the FA Program and other relevant Regulatory Filings.

(b)With regard to the Existing Programs, subject to the terms of any applicable Co-Co Agreement, Neurocrine shall provide drafts of each such IND, Regulatory Approval Application or other material submission or communication described in Section 7.2.1(a) to Voyager for Voyager’s review and comment a reasonable period of time prior to such submission of such IND, Regulatory Approval Applications or other material submission or communications to the applicable Regulatory Authority.  Neurocrine shall, and shall cause its Affiliates to, reasonably incorporate any comments of Voyager into such IND, Regulatory Approval Applications and other material submissions and communications if received by Neurocrine within [...***...] after Neurocrine has provided access to Voyager.

 

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(c)With regard to the Existing Programs, subject to the terms of any applicable Co-Co Agreement, Neurocrine shall provide Voyager with prior written notice, to the extent Neurocrine has advance knowledge, of any scheduled meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the Territory relating to any substantive matter with respect to any Collaboration Product in such Existing Program, within [...***...] after Neurocrine or its Affiliate first receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give Voyager a reasonable opportunity to attend such meeting, conference, or discussion).  Voyager shall have the right to have one (1) or, to the extent reasonable, more of its employees or agents attend and participate in all such meetings, conferences, and discussions.

(d)For clarity, this Section 7.2.1 shall not in any way prohibit Neurocrine from complying with its reporting requirements pursuant to applicable Law, including with respect to adverse event reporting.

7.2.2Ownership and Assignment of Regulatory Filings.  All Regulatory Filings (including all Regulatory Approvals) and pricing and reimbursement approvals in the Territory with respect to the applicable Collaboration Products shall be owned by, and shall be the sole property and held in the name of, Neurocrine or its designated Affiliate, Sublicensee or designee.Voyager shall and hereby does assign to Neurocrine all of its right, title and interest in and to all Regulatory Filings (including INDs) relating to each Collaboration Product, and Voyager shall deliver such Regulatory Filings (and any documentation or correspondence, including conversation logs, relating to or supporting such Regulatory Filings) to Neurocrine within [...***...] after the Effective Date.  No later than [...***...] after the Effective Date, Voyager shall submit to the FDA a letter transferring sponsorship of IND Nos. [...***...] to Neurocrine, and Neurocrine shall submit to the FDA a letter accepting transfer of sponsorship of IND Nos. [...***...] from Voyager.  Each Party shall notify the other Party concurrently with its submission of its respective letter to the FDA, such notification to include a copy of such letter.

7.3Sale of Priority Review Voucher. If the FDA grants to Neurocrine a priority review voucher in connection with the approval of the BLA for a Collaboration Product (a “PRV”), Neurocrine may (a) sell the PRV to a Third Party in an arm’s-length transaction (a “PRV Sale”), (b) keep the PRV for its own use or use by any of its Affiliates for any product other than a Collaboration Product (a “Neurocrine PRV Use”) or (c) use the PRV for a Collaboration Product (in which event (c) no payments will be due to Voyager under this Section 7.3).  In the event of a PRV Sale: (1) if the PRV was for a Collaboration Product in an Existing Program and the Co-Co Option for such Existing Program was either previously exercised or had not expired or been waived by Voyager, Neurocrine shall pay Voyager an amount equal to the [...***...]; and (2) with respect to the PRV for any other Collaboration Product from an Existing Program or a Discovery Program, Neurocrine shall pay Voyager an amount equal to the [...***...]. In the Event of a Neurocrine PRV Use: (1) if the PRV was for a Collaboration Product in an Existing Program and the Co-Co-Option for such Existing Program was either previously exercised or had not expired or been waived by Voyager, Neurocrine shall pay Voyager an amount equal to [...***...]

 

 

 

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[...***...]; and (2) with respect to the PRV for any other Collaboration Product from an Existing Program or a Discovery Program, Neurocrine shall pay Voyager an amount equal to the [...***...]. All payments under this Section 7.3 shall be made within [...***...] after the closing of the PRV Sale or the effective date of Neurocrine PRV Use, as applicable.

7.4Records and Audits.  Each Party shall, and shall require its Affiliates and permitted subcontractors to, maintain materially complete, current and accurate hard and electronic (as applicable) copies of records of all work conducted pursuant to its Development, Manufacturing and Commercialization activities under this Agreement, and all results, data, developments and Know-How made in conducting such activities.  Such records shall accurately reflect all such work done and results achieved in sufficient detail and in good scientific manner appropriate for applicable patent and regulatory purposes.  Neurocrine shall have the right to receive and retain a copy of all such records of Voyager at reasonable times, upon reasonable prior written notice to Voyager, after the applicable Transition Date with regard to all such records relating to the Development or Manufacturing activities conducted by Voyager with respect to the applicable Collaboration Product(s).  Neurocrine agrees that to the extent that an In-License Agreement applicable to a given Program requires records to be retained for a period longer than the period set forth in this Section 7.4, Neurocrine shall retain applicable records for such time period as required by the applicable In-License Agreement.

ARTICLE 8
INITIAL FEE; MILESTONES AND ROYALTIES; PAYMENTS

8.1Initial Consideration.

8.1.1Upfront Fee.  In partial consideration for the rights granted to Neurocrine hereunder, Neurocrine shall pay Voyager a one-time, non-refundable, non-creditable upfront payment of One Hundred Fifteen Million Dollars ($115,000,000) (the “Initial Fee”) within five (5) Business Days after the Effective Date.  The Initial Fee shall be allocated as set forth on Schedule 8.1 (the “Allocation Schedule”).

8.1.2Equity Purchase.  In partial consideration of the rights granted hereunder, Voyager shall issue and sell to Neurocrine, and Neurocrine shall purchase from Voyager, shares of Voyager common stock, par value $0.001 per share, pursuant to the terms of the stock purchase agreement attached as Exhibit A (the “Stock Purchase Agreement”) and executed by the Parties concurrently with this Agreement.

8.2Milestone Payments.

(a)Each event described in Sections 8.2.1, 8.2.2, 8.2.3 and 8.2.4 is referred to as a “Milestone Event.” In partial consideration for the rights and licenses granted to Neurocrine hereunder, (i) within [...***...] after (A) in the case of Milestone Events (a), (b) and (c) (but only if [...***...]) under Section 8.2.2 and Milestone Event (a) under Section 8.2.3, Neurocrine’s receipt of written

 

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notice from Voyager following Voyager’s achievement of the applicable Milestone Event or the JSC’s determination that such Milestone Event was achieved and (B) in all other cases under Sections 8.2.1, 8.2.2 and 8.2.3, the first achievement of a Milestone Event set forth below by or on behalf of Neurocrine, any of its Affiliates or any Sublicensee, and (ii) in the case of Section 8.2.4, within [...***...] after the end of the Calendar Quarter in which achievement of the applicable Commercial Milestone first occurs, Neurocrine shall make a one-time (except as provided below), non-refundable, non-creditable milestone payment to Voyager in the amount below corresponding to such Milestone Event (each, a “Milestone Payment”).

(b)If Voyager does not timely exercise its Co-Co Option with respect to an Existing Program, then the tables in Section 8.2.1 (for Development Milestones), Section 8.2.2 (for Development Milestones), and Section 8.2.4 (for Commercial Milestones) shall apply in their entirety with respect to such Existing Program.  If Voyager exercises its Co-Co Option with respect to an Existing Program, then Voyager shall be entitled to receive Milestone Payments only with respect to any Milestone Event that relates to the Territory outside the Co-Co Territory for so long as such Existing Program remains a Co-Co Program, as further provided below. If a Co-Co Agreement is terminated and the applicable Program is no longer a Co-Co Program, then the tables in Section 8.2.1 (for Development Milestones), Section 8.2.2 (for Development Milestones), and Section 8.2.4 (for Commercial Milestones) shall thereafter apply with respect to such Existing Program in the United States, but only with respect to Milestone Events achieved after termination of the Co-Co Program.

(c)Except as expressly set forth below, each Milestone Payment shall be deemed earned as of the achievement of the corresponding Milestone Event.

8.2.1Development Milestone Payments for Collaboration Products under AADC Program.

 

Milestone Event

Milestone Payment

($)

(a)

[...***...]

[...***...] ($[...***...])*

(b)

[...***...]

[...***...] ($[...***...])*

(c)

[...***...]

[...***...] ($[...***...])*

(d)

[...***...]

[...***...] ($[...***...])

(e)

[...***...]

[...***...] ($[...***...])

*subject to adjustment as set forth below

All Milestone Payments above may be paid only one (1) time. The Milestone Payment for Milestone Event (a), if achieved, will not be payable unless and until Voyager’s Co-Co Option for the AADC Program expires unexercised or at such time as Voyager provides a signed written notice of its decision not to exercise such Co-Co Option.  If the Development Milestone described

 

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in Section 8.2.1(a) is not achieved with respect to the [...***...], then the Milestone Payment associated with Section 8.2.1(a) shall become due and payable upon commencement of a [...***...].  In the event that Voyager exercises its Co-Co Option with respect to the AADC Program, the Milestone Payments for the Milestone Events described in Sections 8.2.1(a) through (c) will not be due. In the event that a Development Milestone described in either Sections 8.2.1(b) or (c) occurs as a result of the [...***...], the payment of the amount of the Milestone Payment with respect to Section 8.2.1(b) shall be increased to [...***...] Dollars ($[...***...]) and the payment of the amount of the Milestone Payment with respect to Section 8.2.1(c) shall be increased to [...***...] Dollars ($[...***...]).

8.2.2Development Milestone Payments for Collaboration Products under FA Program.

 

Milestone Event

Milestone Payment

($)

(a)

[...***...]

[...***...] ($[...***...])

(b)

[...***...]

[...***...] ($[...***...])

(c)

[...***...]

[...***...] ($[...***...])*

(d)

[...***...]

[...***...] ($[...***...])*

(e)

[...***...]

[...***...] ($[...***...])

(f)

[...***...]

[...***...] ($[...***...])

(g)

[...***...]

[...***...] ($[...***...])

(h)

[...***...]

[...***...] ($[...***...])

*subject to adjustment as set forth below

The Milestone Payment described in Section 8.2.2(a) may be paid for up to two (2) Development Candidates under the FA Program. All other Milestone Payments above may be paid only one (1) time for the FA Program.  In the event the Development Milestone described in Section 8.2.2(f) occurs with respect to a Collaboration Product but the Milestone Event described in Section 8.2.2(e) has not occurred and the corresponding Milestone Payment has not been paid, then the Milestone Payment associated with the Milestone Event described in Section 8.2.2(e) shall be due and payable with the payment associated with the Development Milestone described in Section 8.2.2(f). In the event that Voyager exercises its Co-Co Option with respect to the FA Program, the Milestone Payments for the Milestone Events described in Sections 8.2.2(c) through (g) shall not be due. If  Voyager does not timely exercise its Co-Co Option with respect to the FA

 

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Program and the Development Milestones described in Sections 8.2.2(c) and (d) occur as a result of the same study, the Milestone Payment associated with Section 8.2.2(c) shall not be payable upon achievement of the Milestone Event in Section 8.2.2(c) and instead will become due and payable (if applicable) upon occurrence of the Development Milestone described in Section 8.2.2(e), provided that if the Milestone Event described in Section 8.2.2(e) has not occurred when the Milestone Event described Section 8.2.2(f) occurs, then the Milestone Payment associated with Section 8.2.2(c) shall become due and payable upon occurrence of the Development Milestone described in Section 8.2.2(f).  If the Development Milestone described in Section 8.2.2(d) has not occurred when the Milestone Event described in Section 8.2.2(e) occurs, then the Milestone Payment associated with Section 8.2.2(d) shall become due and payable upon occurrence of the Development Milestone described in Section 8.2.2(e). In the event the Development Milestone described in Section 8.2.2(g) occurs with respect to a Collaboration Product, all prior such Development Milestones that have not occurred shall be deemed to have occurred, and any Milestone Payment(s) associated with such prior Development Milestones that have not previously been paid shall be due and payable with the Milestone Payment associated with the Milestone Event described in Section 8.2.2(g). The Milestone Payment described in Section 8.2.2(h) shall only become payable if, as of the relevant time, the Territory has expanded to include countries outside the United States with respect to the FA Program in accordance with Section 5.4.

8.2.3Development Milestone Payments for Collaboration Products under Discovery Programs.

 

Milestone Event

Milestone Payment

($)

(a)

[...***...]

[...***...] ($[...***...])

(b)

[...***...]

[...***...] ($[...***...])

(c)

[...***...]

[...***...] ($[...***...])

(d)

[...***...]

[...***...] ($[...***...])

(e)

[...***...]

[...***...] ($[...***...])

(f)

[...***...]

[...***...] ($[...***...])

(g)

[...***...]

[...***...] ($[...***...])

(h)

[...***...]

[...***...] ($[...***...])

(i)

[...***...]

[...***...] ($[...***...])

 


 

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The Milestone Payment described in Section 8.2.3(a) may be paid for up to two (2) Development Candidates in each Discovery Program.  All other Milestone Payments above may be paid only one (1) time per Discovery Program.  In the event the Development Milestone described in Section 8.2.3(f) occurs with respect to a Collaboration Product but the Milestone Event described in Section 8.2.3(e) has not occurred and the corresponding Milestone Payment has not been paid, then the Milestone Payment associated with the Milestone Event described in Section 8.2.3(e) shall be due and payable with the payment associated with the Development Milestone described in Section 8.2.3(f). If the Development Milestones described in Sections 8.2.3(c) and (d) occur as a result of the same study, the Milestone Payment associated with Section 8.2.3(c) shall not be payable upon achievement of the Milestone Event in Section 8.2.3(c) and instead will become due and payable upon occurrence of the Development Milestone described in Section 8.2.3(e), provided that if the Milestone Event described in Section 8.2.3(e) has not occurred when the Milestone Event described in Section 8.2.3(f) occurs, then the Milestone Payment associated with Section 8.2.3(c) shall become due and payable upon occurrence of the Development Milestone described in Section 8.2.3(f).  If the Development Milestone described in Section 8.2.3(d) has not occurred when the Milestone Event described in Section 8.2.3(e) occurs, then the Milestone Payment associated with Section 8.2.3(d) shall become due and payable upon occurrence of the Development Milestone described in Section 8.2.3(e). In the event the Development Milestone described in Section 8.2.3(g) occurs with respect to a Collaboration Product, all prior such Development Milestones that have not occurred shall be deemed to have occurred, and any Milestone Payment(s) associated with such prior Development Milestones that have not previously been paid shall be due and payable with the Milestone Payment associated with the Milestone Event described in Section 8.2.3(g).

8.2.4Commercial Milestones for Collaboration Products.

 

Milestone Event

$ in Millions

(a)

Aggregate Territory-wide (except as provided below) Net Sales of such Collaboration Product greater than or equal to $[...***...]

[...***...] ($[...***...])

(b)

Aggregate Territory-wide (except as provided below) Net Sales of such Collaboration Product greater than or equal to $[...***...]

[...***...] ($[...***...])

(c)

Aggregate Territory-wide (except as provided below) Net Sales of such Collaboration Product greater than or equal to $[...***...]

[...***...] ($[...***...])

(d)

Aggregate Territory-wide (except as provided below) Net Sales of such Collaboration Product greater than or equal to $[...***...]

[...***...] ($[...***...])

 

Total per Collaboration Product

Two Hundred and Seventy-Five Million ($275,000,000)

 

The Milestone Payments above will be payable one time for each Collaboration Product to achieve the corresponding Milestone Event (subject to the aggregate cap below).  With respect to Co-Co Products, Net Sales in the Co-Co Territory will not be included in aggregate Net Sales for purposes of determining whether the Commercial Milestones above have been achieved.

 

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The aggregate amount payable under this Section 8.2.4 will not exceed one billion one hundred million dollars ($1,100,000,000).

8.3Royalties.  Subject to the adjustments under Section 8.5, Neurocrine will make royalty payments, during the applicable Royalty Terms, as set forth in this Section 8.3.

8.3.1Royalties on Collaboration Products under AADC Program.

(a)Annual Net Sales in the United States.  In further consideration for the licenses and other rights granted to Neurocrine with respect to the AADC Program, Neurocrine shall make tiered royalty payments to Voyager in respect of Annual Net Sales in the United States, on a Collaboration Product-by-Collaboration Product basis, of Collaboration Products under the AADC Program that are not Co-Co Products.

 

Annual Net Sales in the United States of the Collaboration Product

Tiered Royalty Rate

(a)

Annual Net Sales in the United States less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(b)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(c)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(d)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...])

[...***...] Percent
([...***...]%)

 

(b)Annual Net Sales outside of the United States.  In further consideration for the licenses and other rights granted to Neurocrine with respect to the AADC Program, Neurocrine shall make tiered royalty payments to Voyager in respect of Annual Net Sales in the Territory outside the United States, on a Collaboration Product-by-Collaboration Product basis, of Collaboration Products under the AADC Program.

 

Annual Net Sales outside the United States of the Collaboration Product

Tiered Royalty Rate

(a)

Annual Net Sales outside the United States less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(b)

Annual Net Sales outside the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(c)

Annual Net Sales outside the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

 

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Annual Net Sales outside the United States of the Collaboration Product

Tiered Royalty Rate

(d)

Annual Net Sales outside the United States greater than or equal to [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

 

8.3.2Royalties on Collaboration Products under FA Program.

(a)Annual Net Sales in the United States.  In further consideration of the licenses and other rights granted to Neurocrine with respect to the FA Program, Neurocrine shall make tiered royalty payments to Voyager in respect of Annual Net Sales in the United States, on a Collaboration Product-by-Collaboration Product basis, of Collaboration Products under the FA Program that are not Co-Co Products.

 

Annual Net Sales in the United States of the Collaboration Product

Tiered Royalty Rate

(a)

Annual Net Sales in the United States less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(b)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(c)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(d)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

 

(b)Annual Net Sales outside of the United States.  In further consideration of the licenses and other rights granted to Neurocrine with respect to the FA Program, Neurocrine shall make tiered royalty payments to Voyager in respect of Annual Net Sales in the Territory outside the United States, on a Collaboration Product-by-Collaboration Product basis, of Collaboration Products under the FA Program.  Such royalty payments shall become payable only if the Territory expands to include countries outside the United States with respect to the FA Program.

 

Annual Net Sales outside the United States of the Collaboration Product

Tiered Royalty Rate

(a)

Annual Net Sales outside the United States less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(b)

Annual Net Sales outside the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

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Annual Net Sales outside the United States of the Collaboration Product

Tiered Royalty Rate

(c)

Annual Net Sales outside the United States greater than or equal to [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

8.3.3Royalties on Collaboration Products under Discovery Programs

(a)Annual Net Sales in the United States.  In further consideration of the licenses and other rights granted to Neurocrine with respect to each Discovery Program, Neurocrine shall make tiered royalty payments to Voyager in respect of Annual Net Sales in the United States, on a Collaboration Product-by-Collaboration Product basis, of Collaboration Products under each Discovery Program.

 

Annual Net Sales in the United States of the Collaboration Product

Tiered Royalty Rate

(a)

Annual Net Sales in the United States less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(b)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(c)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(d)

Annual Net Sales in the United States greater than or equal to [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

 

(b)Annual Net Sales outside of the United States.  In further consideration of the licenses and other rights granted to Neurocrine with respect to each Discovery Program, Neurocrine shall make tiered royalty payments to Voyager in respect of Annual Net Sales in the Territory outside the United States, on a Collaboration Product-by-Collaboration Product basis, of Collaboration Products under each Discovery Program.

 

Annual Net Sales outside the United States of the Collaboration Product

Tiered Royalty Rate

(a)

Annual Net Sales outside the United States less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(b)

Annual Net Sales outside the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

(c)

Annual Net Sales outside the United States greater than or equal to [...***...] Dollars ($[...***...]) but less than [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

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Annual Net Sales outside the United States of the Collaboration Product

Tiered Royalty Rate

(d)

Annual Net Sales outside the United States greater than or equal to [...***...] Dollars ($[...***...])

[...***...] Percent ([...***...]%)

 

8.3.4Calculation of Royalties.  Royalties on aggregate Net Sales of Collaboration Products in a Calendar Year shall be paid at the rate applicable to the portion of Net Sales within each of the Annual Net Sales tiers during such Calendar Year.  For example, if, during a Calendar Year, Annual Net Sales of Collaboration Products under the AADC Program in the United States are equal to $[...***...], then the royalties payable by Neurocrine would be calculated by adding [...***...], to equal total royalties of $[...***...].

8.4Royalty Period.  On a country-by-country and Collaboration Product-by-Collaboration Product basis, royalty payments in the Territory shall commence on the First Commercial Sale of such Collaboration Product in such country and terminate upon the latest of:  (a) the expiration, invalidation or abandonment date of the last Valid Claim of the Voyager Licensed Patent Rights or Joint Patent Rights that claims the composition of matter or method of use (for an indication for which such Collaboration Product received Regulatory Approval in such country) of such Collaboration Product in such country; (b) ten (10) years from First Commercial Sale of such Collaboration Product in such country; and (c) expiration of Regulatory Exclusivity for such Collaboration Product in such country (the applicable “Royalty Term”).

8.5Royalty Adjustments.

8.5.1Valid Claim Expiration.  If, with respect to a Collaboration Product in any country in the Territory, at any time in the Royalty Term for such Collaboration Product and country there is no Valid Claim within the Voyager Licensed Patent Rights or the Joint Patent Rights that claims the composition of matter or method of use (for an indication for which such Collaboration Product received Regulatory Approval in such country) of such Collaboration Product in such country, then the royalties payable for such Collaboration Product in such country shall be reduced by fifty percent (50%) from the royalties otherwise due for such Collaboration Product in such country under Section 8.3.  If such royalty reduction applies to any country other than the United States, it will be calculated by determining the portion of total Net Sales in the Territory outside the United States of the relevant Collaboration Product in a Calendar Quarter that is attributable to the country in which such reduction applies, and by determining the total royalties for the Territory outside the United States without reduction, and then reducing by fifty percent

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(50%) the applicable portion (based on Net Sales) of the total royalties attributable to the country in which such reduction applies.

8.5.2Biosimilar Reduction.  If, in any country in the Territory during the Royalty Term in such country for a Collaboration Product, a Biosimilar Product with respect to such Collaboration Product is launched in such country, then, for any Calendar Quarter in which such Biosimilar Product(s) comprise greater than or equal to [...***...] percent ([...***...]%) of the total units of such Collaboration Product and Biosimilar Product(s) sold in such country (based on sales of units of such Collaboration Product and Biosimilar Product(s) as reported by IQVIA, or, if such data are not available, such other reliable data source as reasonably determined by Voyager and Neurocrine) the royalties payable for such Collaboration Product with respect to such country for such Calendar Quarter shall be reduced by fifty percent (50%) from the royalties otherwise due for such Collaboration Product in such country under Section 8.3. Such reduction shall be calculated as described in the last sentence of Section 8.5.1.

8.5.3Stacking.  If Neurocrine or any of its Affiliates determines in good faith that it is reasonably necessary to (a) obtain a license from a Third Party under one or more Valid Claims licensable by such Third Party Covering a Collaboration Product or under Know-How licensable by such Third Party in order for Neurocrine, its Affiliates and Sublicensees to Exploit such Collaboration Product in the Field in a country in the Territory and (b) make payments under such license, and Neurocrine or any of its Affiliates actually enters into any such license, then the amount of Neurocrine’s royalty payments under Section 8.3 for such Collaboration Product in such country in a Calendar Quarter may be reduced by fifty percent (50%) of the royalties and other amounts actually paid by Neurocrine or any of its Affiliates to such Third Party to the extent applicable to such Collaboration Product in such country during such Calendar Quarter; provided, however, that neither Neurocrine nor any of its Affiliates shall be entitled to make reductions hereunder for any amounts payable by Neurocrine or any of its Affiliates relating to any Neurocrine IP existing as of the Effective Date.

8.5.4Limits on Deductions.  On a Collaboration Product-by-Collaboration Product basis, in no event shall the cumulative effect of the adjustments in Sections 8.5.1, 8.5.2 or 8.5.3  reduce the royalties payable to Voyager pursuant to Section 8.3 below fifty percent (50%) of the amounts that would otherwise have been payable with respect to the applicable Collaboration Product in the applicable country in the applicable Calendar Quarter, as determined pursuant to Section 8.3.4. Neurocrine may carry forward to subsequent Calendar Quarters any amounts it could not deduct as a result of the application of the preceding sentence.

8.6Reports; Payment of Royalty.

8.6.1Reports.  During the Term, following the First Commercial Sale of any Collaboration Product in any country in the Territory (excluding the First Commercial Sale in the United States of a Co-Co Product for which reporting shall be addressed in the applicable Co-Co Agreement), Neurocrine shall furnish to Voyager a written report within [...***...] after the end of each Calendar Quarter showing, on a Collaboration Product-by-Collaboration Product and country-by-country basis, the Net Sales of each Collaboration Product in each country of the Territory and the royalties payable under this Agreement.  Royalties with respect to Net Sales of Collaboration Products shall be due and payable on the date such royalty report is due.

 

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8.6.2Compliance with In-License Agreements.  Neurocrine and its Affiliates and Sublicensees shall provide any information reasonably requested by Voyager to enable Voyager to comply with any applicable reporting requirements under the In-License Agreements.  Provided that Voyager timely notifies Neurocrine of such reporting requirement, Neurocrine shall ensure that all applicable and necessary information is received by Voyager from Neurocrine, whether generated by Neurocrine, any of its Affiliates or any Sublicensee, sufficiently in advance (no fewer than [...***...] in advance) of the date(s) on which such information is due to the relevant Inbound Licensor under an In-License Agreement to avoid a breach of such In-License Agreement. All payments owed by Voyager under the In-License Agreements, including license fees, royalties and milestones, shall be allocated between the Parties as set forth in Section 5.2.4 and such payment shall be remitted to the applicable Inbound Licensor by Voyager. Notwithstanding anything to the contrary in this Agreement, unless otherwise agreed by the applicable counterparty, the provisions regarding currency conversion, international payments and late payments, and other relevant definitions and provisions, of the relevant In-License Agreements shall apply to calculate the payments due under the relevant In-License Agreements (but not the payments due under this Agreement).

8.7Accounting; Audit.

8.7.1Each Party (the “Payor”) agrees to keep, and to require its Affiliates and Sublicensees to keep, full, clear and accurate records for a minimum period of [...***...] after the relevant payment is owed pursuant to this Agreement, setting forth as applicable the sales and other disposition of Collaboration Products sold or otherwise disposed of, the Development and Commercialization activities with respect to Collaboration Products, and the Development Costs incurred therewith, in sufficient detail to enable royalties and compensation payable to, or the Development Costs payable by, the other Party (the “Payee”) hereunder to be determined.

8.7.2Neurocrine agrees, upon not less than [...***...] prior written notice, to permit, and to require its Affiliates to permit, such books and records relating to such Collaboration Products to be examined by an independent accounting firm selected by Voyager and reasonably acceptable to Neurocrine for the purpose of verifying reports provided (or required to be provided) by Neurocrine under this Article 8 or under the Co-Co Agreements.  Voyager agrees, upon not less than [...***...] prior written notice, to permit, and to require its Affiliates to permit, such books and records relating to Development Costs and other costs under the Co-Co Agreements to be examined by an independent accounting firm selected by Voyager and reasonably acceptable to Neurocrine for the purpose of verifying reports provided (or required to be provided) by Voyager under Section 2.2.2 or under the Co-Co Agreements.  Any such audit shall not be performed more frequently than [...***...] period, shall not audit any previously audited records, and shall be conducted under appropriate confidentiality provisions, for the sole purpose of verifying the accuracy and completeness of all financial, accounting and numerical information and calculations provided under this Agreement or under the Co-Co Agreements.  The independent accounting firm shall only share the results of the audit, not the underlying records, with the auditing party.

8.7.3Any audit conducted by Voyager is to be made at the expense of Voyager, except if the results of the audit reveal an underpayment of royalties, milestones or other payments to Voyager under this Agreement or under the Co-Co Agreements of [...***...] percent ([...***...]%) or more in

 

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the audited period, in which case (a) Neurocrine shall promptly remit to Voyager the amount of such underpayment and (b) the reasonable fees and expenses for such audit shall be paid by Neurocrine.  Any audit conducted by Neurocrine is to be made at the expense of Neurocrine, except if the results of the audit reveal an overpayment of Development Costs or other payments to Voyager under this Agreement or under the Co-Co Agreements of [...***...] percent ([...***...]%) or more in the audited period, in which case (x) Voyager shall promptly remit to Neurocrine the amount of such overpayment and (y) the reasonable fees and expenses for such audit shall be paid by Voyager.  For clarity, any audit that reveals an underpayment or overpayment, as the case may be, of less than [...***...] percent ([...***...]%) in the audited period, shall be made at the expense of the Party conducting the audit.

8.8Currency Conversion.  When calculating Net Sales, the amount of such sales or costs in foreign currencies shall be converted into Dollars using the standard methodologies employed by Neurocrine generally for consolidation purposes.  Neurocrine shall provide reasonable documentation of the calculation and reconciliation of the conversion figures on a Collaboration Product-by-Collaboration Product and country-by-country basis as part of its report of Net Sales for the period covered under the report.

8.9Books and Records.  Any books and records to be maintained under this Agreement by a Party or its Affiliates or Sublicensees shall be maintained in accordance with Accounting Standards.

8.10Methods of Payments.  All payments due from one Party to the other Party under this Agreement shall be paid in Dollars by wire transfer to a bank in the United States designated in writing by the Payee.

8.11Taxes.

8.11.1Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the activities of the Parties under this Agreement.

8.11.2In the event that Neurocrine is required to withhold any tax to be paid to, or held for the benefit of, the tax or revenue authorities in any country in the Territory regarding any payment to Voyager, such amount shall be deducted from the payment to be made by Neurocrine; provided that Neurocrine shall take reasonable and lawful actions to avoid and minimize such withholding and promptly notify Voyager so that Voyager may take lawful actions to avoid and minimize such withholding.  Neurocrine shall promptly furnish Voyager with copies of any tax certificate or other documentation evidencing such withholding, as necessary, to enable Voyager to support a claim, if permissible, for income tax credit in respect of any amount so withheld.  Each Party shall cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty in effect from time to time.  The Parties shall use commercially reasonable efforts to reduce or eliminate such withholding, including providing any reasonable documentation to reduce or eliminate such withholding.

8.11.3If a withholding or deduction obligation arises as a result of any action by Neurocrine (including any assignment, sublicense, change of place of incorporation, or failure to

 

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comply with applicable Laws or filing or record retention requirements) (a “Withholding Tax Action”), then the sum payable by Neurocrine (in respect of which such deduction or withholding is required to be made) shall be increased to the extent necessary to ensure that Voyager receives a sum equal to the sum which it would have received had no such Withholding Tax Action occurred.

8.12Late Payments.  Any undisputed amount owed by Neurocrine to Voyager under this Agreement that is not paid on or before the date such payment is due shall bear simple interest at a rate per annum equal to the lesser of (a) the greater of (i) the prime or equivalent rate per annum quoted by The Wall Street Journal on the first Business Day after such payment is due, plus [...***...], or (ii) [...***...] percent ([...***...]%) per month, or (b) the highest rate permitted by applicable Law, calculated on the number of days such payments are paid after such payments are due.

ARTICLE 9
EXCLUSIVITY

9.1Exclusivity.

9.1.1Voyager.

(a)During the Term of this Agreement, neither Voyager nor any of its Affiliates shall, except as otherwise permitted in this Article 9, either alone or with or for any Third Party, Develop, Manufacture or Commercialize any Competitive Product or grant any Affiliate or Third Party a license or sublicense to enable any Third Party to do so.

(b)Notwithstanding the foregoing, (i) Voyager shall have no restriction under this Section 9.1.1 with respect to the Development, Manufacture or Commercialization of Gene Therapy Products directed to any Target that was the subject of a Terminated Program and is not the subject of any other Program, provided, however, that, Voyager may not utilize any Neurocrine IP or Confidential Information of Neurocrine in such Development, Manufacture or Commercialization, and (ii) nothing in this Section 9.1.1 shall preclude Voyager from complying with its obligations to grant rights to Genzyme under and in accordance with the Genzyme Agreement (as such agreement exists as of the Effective Date) if Genzyme exercises the option granted to it thereunder.

9.1.2Neurocrine.

(a)During the Term of this Agreement, neither Neurocrine nor any of its Affiliates shall, except as otherwise permitted in this Article 9, either alone or with or for any Third Party, Develop, Manufacture or Commercialize any Competitive Product or grant any Affiliate or Third Party a license or sublicense to do so.

(b)Notwithstanding the foregoing, Neurocrine shall have no restriction under this Section 9.1.2 with respect to the Development, Manufacture or Commercialization of Gene Therapy Products directed to any Target that was the subject of a Terminated Program and is not the subject of any other Program; provided, however, that Neurocrine may not utilize any

 

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Voyager IP or Confidential Information of Voyager in such Development, Manufacture or Commercialization.

9.2Exception for Basic Research.  Notwithstanding Section 9.1, Neurocrine and Voyager shall be free during the Term, either alone or with or for an Affiliate or a Third Party, to conduct basic scientific, non-clinical and pre-clinical Development with respect to the biological mechanism of action, pharmacology, structure-activity relationship (SAR) or the like for any Gene Therapy Product; provided, however, that neither Party shall conduct any basic scientific, non-clinical and pre-clinical Development with respect to a Collaboration Product, other than under a Development Plan, Neurocrine Plan or Co-Co Agreement, without the prior written approval of the Joint R&D Working Group, and the conduct of such non-clinical and pre-clinical Development shall be subject to the supervision and oversight of the Joint R&D Working Group.

9.3Acquisitions.

9.3.1If, during the term of the exclusivity covenant in Section 9.1, a Party or any of its Affiliates (such Party, the “Acquisition Party”) acquires or is acquired by a Third Party (an “Acquired Affiliate”) (whether such acquisition occurs by way of a purchase of assets, merger, consolidation, change of control or otherwise) that is, at the time of such acquisition, engaging in any activities that would violate Section 9.1.1 or 9.1.2, as applicable, if conducted by such Acquisition Party (such activities, an “Acquired Competing Program” and any product Developed, Commercialized or otherwise Exploited thereunder, an “Acquired Competing Product”), then the Acquisition Party or its Acquired Affiliate shall, no later than [...***...] following the date of consummation of the relevant acquisition, notify the other Party in writing that the Acquisition Party or such Acquired Affiliate shall:

(a)divest, whether by license or otherwise, its interest in the Acquired Competing Program to a Third Party, to the extent necessary to be in compliance with Section 9.1, with no rights in such Acquired Competing Program retained by the Acquisition Party or any of its Affiliates; or

(b)terminate Research, Development, Manufacture and Commercialization under the Acquired Competing Program, to the extent necessary to be in compliance with Section 9.1.

9.3.2If the Acquisition Party or its Acquired Affiliate notifies the other Party in writing that it intends to divest such Acquired Competing Program or terminate Development, Manufacture and Commercialization under the Acquired Competing Program as provided in Section 9.3.1(a) or 9.3.1(b), then the Acquisition Party or Acquired Affiliate, as applicable, shall effect the consummation of such divestiture within [...***...] or effect such termination within [...***...] after the consummation of the relevant acquisition, subject to compliance with applicable Law, and shall confirm to the other Party in writing when such divestiture or termination has been completed.  The Acquisition Party shall keep the other Party reasonably informed of its and its Affiliates’ efforts and progress in effecting such divestiture or termination until it is completed.  Until such divestiture or termination occurs, the Acquisition Party shall keep its and its Affiliates’ activities with respect to such Acquired Competing Program separate from their activities under this Agreement or any Co-Co Agreement.

 

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9.3.3Subject to the Acquisition Party’s compliance with this Section 9.3, the activities of such Acquisition Party or its Acquired Affiliate with respect to any Competing Acquirer Program shall not be a breach of this Agreement.

ARTICLE 10
INTELLECTUAL PROPERTY RIGHTS

10.1Ownership of Inventions; Disclosure.

10.1.1Ownership.  Subject to Section 10.1.2, (a) title to all Inventions made solely by employees or agents of Voyager in the course of activities conducted pursuant to this Agreement shall be owned by Voyager; (b) title to all Inventions made solely by employees or agents of Neurocrine in the course of activities conducted pursuant to this Agreement shall be owned by Neurocrine; and (c) title to all Inventions made jointly by employees or agents of Neurocrine and employees or agents of Voyager in the course of activities conducted pursuant to this Agreement (each, a “Joint Invention”) shall be owned jointly by Neurocrine and Voyager.  For purposes of determining ownership hereunder, inventorship of Inventions made pursuant to this Agreement shall be determined in accordance with the patent laws of the United States.  Except as expressly provided in this Agreement, each Party may (subject to the licenses and exclusivity provisions of this Agreement) practice the Joint IP, but neither Party may grant licenses or otherwise encumber its ownership interest in any Joint IP without the prior written consent of the other Party.

10.1.2Exceptions.  Notwithstanding Section 10.1.1 and anything to the contrary set forth in this Agreement, Voyager shall exclusively own all Vectorization IP made in the course of the Collaboration, regardless of which Party or its employees or agents conceived or reduced to practice such Invention or whether such Invention was jointly developed by the Parties. Neurocrine, on behalf of itself and its Affiliates, hereby assigns, and to the extent such present assignment is not possible, agrees to assign, to Voyager all of Neurocrine’s right, title and interest in and to such Vectorization IP, and all intellectual property rights therein, and, thereafter, such Vectorization IP and any intellectual property rights therein shall not be considered Neurocrine IP or Joint IP, but shall be considered Voyager IP, to the extent applicable.

10.1.3Disclosure of Inventions.

(a)During the Term, the Parties shall promptly disclose to each other any Inventions relating to any Collaboration Candidate, Development Candidate or Collaboration Product.

(b)During the Term, Neurocrine shall promptly disclose to Voyager any Vectorization Know-How made solely by Neurocrine or jointly by the Parties.

10.1.4Background IP.  Each Party shall retain ownership of intellectual property rights, including Patent Rights and Know-How, existing as of the Effective Date, and nothing in this Agreement shall assign any ownership to the other Party with respect to such intellectual property rights.

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10.2Patent Prosecution and Maintenance.

10.2.1Voyager Licensed Platform Patent Rights.

(a)Subject to the terms of any applicable In-License Agreement and Co-Co Agreement:

(i)Subject to the remainder of this Section 10.2.1(a), Voyager shall have the sole right, at its sole cost and cost and expense, for Prosecuting and Maintaining the Vectorization Patent Rights and for conducting and defending any Defense Proceeding relating thereto.

(ii)Subject to Section 10.2.2, Voyager shall have the first right, at its sole cost and expense, for Prosecuting and Maintaining the Voyager Licensed Platform Patent Rights and for conducting and defending any opposition, reexamination request, nullity action, interference, or other post-grant proceeding involving an attack upon the validity, title or enforceability thereof relating thereto, and for initiating any interference, including in each case any appeals therefrom (each, a “Defense Proceeding”) (except that in connection with any actions subject to Section 10.3, the Party with responsibility for such action pursuant to Section 10.3 shall have responsibility for any related Defense Proceedings).  Upon request by Neurocrine, the Parties shall coordinate and use reasonable efforts, in connection with Voyager’s Prosecution and Maintenance of the Voyager Licensed Platform Patent Rights, to enable Neurocrine to file patent applications, including divisionals, continuations or other patent applications for Voyager Target-Specific Patent Rights.

(iii)Voyager shall keep Neurocrine fully informed with respect to (A) the issuance of a Voyager Licensed Platform Patent Right being Prosecuted and Maintained by Voyager pursuant to this Section 10.2.1(a), and (B) the abandonment of any Voyager Licensed Platform Patent Right.

(iv)Without limiting the foregoing, Voyager shall (A) provide Neurocrine with copies of the text of the applications for any Voyager Licensed Platform Patent Right as soon as practicable but at least [...***...] before filing, except for urgent filings, in which case Voyager shall provide copies as soon as practicable before, simultaneously with or immediately after filing; (B) provide Neurocrine with a copy of each submission made to and material or substantive document received from a patent authority, court or other tribunal regarding any Voyager Licensed Platform Patent Right reasonably promptly after making such filing or receiving such document, including a copy of each application as filed together with notice of its filing date and application number; (C) keep Neurocrine advised of the status of all substantive communications, actual and prospective filings or submissions regarding any Voyager Licensed Platform Patent Right, and give Neurocrine copies of any such communications, filings and submissions proposed to be sent to any patent authority or judicial body; and (D) consider in good faith and reasonably incorporate Neurocrine’s comments on such communications, filings and submissions for any Voyager Licensed Platform Patent Right (including particular countries in which Neurocrine desires Voyager to file a particular Voyager Licensed Platform Patent Right, provided, however, that Neurocrine shall reimburse Voyager for all expenses incurred in Prosecuting and Maintaining Patent Rights in countries requested by Neurocrine in which a

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company similarly situated to Voyager may not file patent applications in accordance with commercially reasonable business practices), unless incorporating such comments would reasonably be expected to have a material adverse effect on the scope of any Voyager Licensed Platform Patent Right that covers products being developed or commercialized by Voyager that are not Collaboration Products. Neurocrine’s rights pursuant to this Section 10.2.1(a)(iv) shall terminate with respect to Voyager Licensed Platform Patent Rights that are relevant to one Program only at such time as such Program is terminated pursuant to the terms of this Agreement.

(b)Voyager shall notify Neurocrine as to any decision to abandon, to cease Prosecution and Maintenance of, or not to continue to pay the expenses of Prosecution and Maintenance of, any Voyager Licensed Platform Patent Right in any country in which it was filed.  Voyager will provide such notices at least [...***...] prior to any filing or payment due date, or any other due date that requires action, in connection with such Voyager Licensed Platform Patent Right.  Thereafter, Neurocrine may, upon written notice to Voyager, in Voyager’s name and at Neurocrine’s sole cost and expense, control the Prosecution and Maintenance of such Voyager Licensed Platform Patent Right, and Neurocrine shall keep Voyager informed of the status of such Voyager Licensed Platform Patent Right in accordance with Sections 10.2.1(a)(iii) and (iv), mutatis mutandis.

10.2.2Voyager Target-Specific Patent Rights.

(a)Subject to the terms of any applicable In-License Agreement and Co-Co Agreement:

(i)Neurocrine shall have the first right, at its sole cost and expense, for Prosecuting and Maintaining the Voyager Target-Specific Patent Rights and for conducting any Defense Proceeding relating thereto (except that in connection with any counterclaims brought in actions subject to Section 10.3, the Party with responsibility for such action pursuant to Section 10.3 shall have responsibility for such Defense Proceedings); provided, however, that with regard to patent applications within Voyager Target-Specific Patent Rights that were filed prior to the Effective Date and patent applications claiming priority thereto, Voyager shall continue to Prosecute and Maintain, at Neurocrine’s expense, such patent applications until [...***...], or earlier as the Parties agree in writing;  and provided further that the provisions of Section 10.2.1(a)(iv) shall apply to Voyager’s Prosecution and Maintenance of such patent applications within the Voyager Target-Specific Rights.

(ii)Neurocrine shall keep Voyager fully informed with respect to (A) the issuance of a Voyager Target-Specific Patent Right being Prosecuted and Maintained by Neurocrine pursuant to this Section 10.2.2(a), and (B) the abandonment of any Voyager Target-Specific Patent Right Prosecuted and Maintained by Neurocrine pursuant to this Section 10.2.2(a); provided, however, that if Voyager continues to Prosecute and Maintain Voyager Target-Specific Patent Rights pursuant to Section 10.2.2(a)(i), Voyager shall not be permitted to abandon such Patent Rights without Neurocrine’s written consent.

(iii)Without limiting the foregoing, Neurocrine shall (A) provide Voyager with copies of the text of the applications for any Voyager Target-Specific Patent Right it Prosecutes or Maintains as soon as practicable but at least [...***...] before filing, except

 

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for urgent filings, in which case Neurocrine shall provide copies as soon as practicable before, simultaneously with or immediately after filing; (B) provide Voyager with a copy of each submission made to and material or substantive document received from a patent authority, court or other tribunal regarding any Voyager Target-Specific Patent Right reasonably promptly after making such filing or receiving such document, including a copy of each application as filed together with notice of its filing date and application number; (C) keep Voyager advised of the status of all substantive communications, actual and prospective filings or submissions regarding any Voyager Target-Specific Patent Right, and give Voyager copies of any such communications, filings and submissions proposed to be sent to any patent authority or judicial body; and (D) consider in good faith Voyager’s comments on such communications, filings and submissions for any such Voyager Target-Specific Patent Right and shall reasonably incorporate such comments unless their incorporation would reasonably be expected to have a material adverse effect on the scope of any Voyager Target-Specific Patent Right.

(b)Neurocrine shall notify Voyager as to any decision to abandon, to cease Prosecution and Maintenance of, or not to continue to pay the expenses of Prosecution and Maintenance of, any Voyager Target-Specific Patent Right in any country in which it was filed.  Neurocrine will provide such notices at least [...***...] prior to any filing or payment due date, or any other due date that requires action, in connection with such Voyager Target-Specific Patent Right.  Thereafter, Voyager may, upon written notice to Neurocrine, in Voyager’s name and at Voyager’s sole cost and expense, control the Prosecution and Maintenance of such Voyager Target-Specific Patent Right, and Neurocrine will have the rights thereto as set forth in Sections 10.2.1(a)(i) and (ii) with respect to such Voyager Target-Specific Patent Right.

10.2.3Neurocrine Patent Rights.  Neurocrine shall be responsible, at its sole cost and expense, and shall have the exclusive right, but not the obligation, for Prosecuting and Maintaining the Neurocrine Patent Rights and for conducting Defense Proceedings relating thereto.

10.2.4Joint Patent Rights.

(a)Subject to the terms of any applicable Co-Co Agreement:

(i)Subject to Section 10.2.4(b), Neurocrine shall have the first right, at its sole cost and expense, for Prosecuting and Maintaining in both Parties’ names the Joint Patent Rights specifically excluding any Vectorization Patent Rights Covering Vectorization Know-How that was jointly developed by the Parties and assigned to Voyager pursuant to Section 10.1.2). Voyager shall execute any powers of attorney necessary for Neurocrine’s counsel to conduct such activities.

(ii)Neurocrine shall keep Voyager fully informed with respect to (A) the issuance of any Joint Patent Right being Prosecuted and Maintained by Neurocrine pursuant to this Section 10.2.4(a), and (B) the abandonment of any Joint Patent Right being Prosecuted and Maintained by Neurocrine pursuant to this Section 10.2.4(a).

(iii)Without limiting the foregoing, Neurocrine shall (A) provide Voyager with copies of the text of the applications for any such Joint Patent Right as soon as

 

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practicable but at least [...***...] before filing, except for urgent filings, in which case Neurocrine shall provide copies as soon as practicable before, simultaneously with or immediately after filing; (B) provide Voyager with a copy of each submission made to and material or substantive document received from a patent authority, court or other tribunal regarding any such Joint Patent Right reasonably promptly after making such filing or receiving such material document, including a copy of each application as filed together with notice of its filing date and application number; (C) keep Voyager advised of the status of all substantive communications, actual and prospective filings or submissions regarding any such Joint Patent Right, and shall give Voyager copies of any such communications, filings and submissions proposed to be sent to any patent authority or judicial body; and (D) consider in good faith Voyager’s comments on such communications, filings and submissions for any such Joint Patent Right.

(b)Neurocrine shall notify Voyager as to any decision to abandon, to cease Prosecution and Maintenance of, or not to continue to pay the expenses of Prosecution and Maintenance of, any such Joint Patent Right in any country in which it was filed.  Neurocrine shall provide such notices at least [...***...] prior to any filing or payment due date, or any other due date that requires action, in connection with such Joint Patent Right.  Thereafter, Voyager may, upon written notice to Neurocrine, in both Parties’ names and at Voyager’s sole cost and expense, control the Prosecution and Maintenance of such Joint Patent Right, and Voyager shall keep Neurocrine reasonably informed of the status of such Joint Patent Right in accordance with Sections 10.2.4(a)(ii) and (iii), mutatis mutandis.

10.2.5The Parties shall undertake reasonable efforts and cooperate to ensure to the fullest extent practicable and not prejudicial that Joint Patent Rights are Prosecuted and Maintained in a manner that separates the claims pertaining to one Program and the Collaboration Products arising therefrom, on the one hand, from other Programs and the Collaboration Products arising therefrom, on the other hand, into distinct patent applications and ultimately separate issued patents.

10.2.6Cooperation.  Each Party shall reasonably cooperate with and assist the other Party in connection with the activities of such Party under Section 10.2 upon the reasonable request of the other Party, including by making scientists and scientific records reasonably available and the execution of all such documents and instruments and the performance of such acts as may be reasonably necessary in order to permit the other Party to continue any Prosecution or Maintenance of the applicable Patent Rights.

10.2.7Patent Term Extension.  Notwithstanding anything to the contrary in Section 10.2.1, 10.2.2 or 10.2.4, the JSC shall discuss all decisions regarding patent term extensions in the Territory, including in the United States with respect to extensions pursuant to 35 U.S.C. § 156 et. seq. and in other jurisdictions pursuant to supplementary protection certificates, and in all jurisdictions with respect to any other extensions that are now or become available in the future, wherever applicable, for Voyager Licensed Patent Rights and the Joint Patent Rights, in each case including whether or not to so apply and which Party shall so apply; provided that Neurocrine shall have the right to make all decisions with respect to any such extension of a Voyager Patent Right or Joint Patent Right Covering any Collaboration Product; provided that Neurocrine shall not have the right to extent any Voyager Licensed Platform Patent Right that Voyager intends to extend with respect to a different product for which there is no other Patent

 

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Right reasonably available to extend. Each Party shall provide prompt and reasonable assistance, as requested by the other Party, including by taking such action as is required under any applicable Law to obtain such extension or supplementary protection certificate.

10.3Enforcement and Defense.  Subject to the terms of any applicable In-License Agreement and any applicable Co-Co Agreement:

10.3.1Notice.  Each Party shall promptly notify the other of any knowledge it acquires of any (a) actual or potential infringement by a Third Party of any Voyager Patent Right, Neurocrine Patent Right or Joint Patent Right that is or would be competitive with a Collaboration Product or (b) submission to a Party or a Regulatory Authority of an application for a product (including an application under Section 351(k) of the PHSA) that references a Product (“Competitive Infringement”).

10.3.2Actions.

(a)If any Neurocrine Patent Right is infringed by a Third Party in any country in the Territory, then Neurocrine shall have the sole right, but not the obligation, to institute and control any action or proceeding with respect to such infringement of such Patent Right, by counsel of its own choice.

(b)If any Vectorization Patent Right that is not a Voyager Patent Right is infringed by a Third Party in any country in the Territory, then Voyager shall have the sole right, but not the obligation, to institute and control any action or proceeding with respect to such infringement of such Patent Right, by counsel of its own choice.  If, in any such proceeding brought by Voyager, Neurocrine is required to join for standing purposes or in order for Voyager to commence or continue such proceeding, then Neurocrine shall join such proceeding, at Voyager’s expense, and shall be represented in such proceeding by counsel of Voyager’s choice at Voyager’s expense, unless Neurocrine elects to be represented by counsel of its own chose at Neurocrine’s expense.

(c)Voyager shall have the primary right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to Competitive Infringement of any Voyager Licensed Platform Patent Right, by counsel of its own choice, provided that Voyager shall not unreasonably refuse to accept input from Neurocrine with respect to such proceeding.  If in any such proceeding brought by Voyager, Neurocrine is required to join for standing purposes or in order for Voyager to commence or continue any such proceeding, then Neurocrine shall join such proceeding, at Voyager’s expense, and shall be represented in such proceeding by counsel of Neurocrine’s choice at Neurocrine’s expense.  If Voyager does not bring an infringement action pursuant to this Section 10.3.2(c) within [...***...] after receipt of notice of the existence of an infringement (or in cases where there is a relevant statutory period during which an infringement action must be commenced or in which any material rights may be lost that would expire prior to the expiration of such [...***...] period and of which Neurocrine has notified Voyager promptly after it becomes aware, [...***...] prior to the expiration of such relevant statutory period), Voyager and Neurocrine shall meet and discuss Voyager’s reasons for not initiating a lawsuit or otherwise making or prosecuting a claim.  If following such discussions Neurocrine desires to initiate a lawsuit or otherwise make or prosecute a claim with

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respect to the Competitive Infringement and so notifies Voyager in writing, then upon receiving Voyager’s prior written consent, which consent shall not be unreasonably withheld, Neurocrine may institute, prosecute, and control such action; provided that, if, under the terms of an applicable In-License Agreement, Voyager has an applicable enforcement right that it cannot delegate to Neurocrine then, at Neurocrine’s request and expense, Voyager shall exercise such rights in such infringement action as directed by Neurocrine.  If in any such proceeding Voyager is required to join for standing purposes or in order for Neurocrine (or an Inbound Licensor) to commence or continue any such proceeding, then Voyager shall join such proceeding, at Neurocrine’s expense, and shall be represented in such proceeding by counsel of Voyager’s choice at Voyager’s expense.

(d)Neurocrine shall have the primary right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to Competitive Infringement of any Voyager Target-Specific Patent Right or Joint Patent Right, by counsel of its own choice, provided that Neurocrine shall not unreasonably refuse to accept input from Voyager with respect to such proceeding.  If in any such proceeding brought by Neurocrine, Voyager is required to join for standing purposes or in order for Neurocrine to commence or continue any such proceeding, then Voyager shall join such proceeding, at Neurocrine’s expense, and shall be represented in such proceeding by counsel of Voyager’s choice at Voyager’s expense.  The exercise by Neurocrine of the right to bring an infringement action shall be subject to and consistent with the terms of all applicable In-License Agreements; provided that, if, under the terms of an applicable In-License Agreement, Voyager has an applicable enforcement right that it cannot delegate to Neurocrine then, at Neurocrine’s request and expense, Voyager shall exercise such rights in such infringement action as directed by Neurocrine.  If Neurocrine does not bring an infringement action pursuant to this Section 10.3.2(d) within [...***...] after receipt of notice of the existence of an infringement (or in cases where there is a relevant statutory period during which an infringement action must be commenced or in which any material rights may be lost that would expire prior to the expiration of such [...***...] period and of which Voyager has notified Neurocrine promptly after it becomes aware, [...***...] prior to the expiration of such relevant statutory period), Voyager and Neurocrine shall meet and discuss Neurocrine’s reasons for not initiating a lawsuit or otherwise making or prosecuting a claim.  If following such discussions Voyager desires to initiate a lawsuit or otherwise make or prosecute a claim with respect to the Competitive Infringement and so notifies Neurocrine in writing, then upon receiving Neurocrine’s prior written consent, which consent shall not be unreasonably withheld, Voyager may institute, prosecute, and control such action.  If in any such proceeding Neurocrine is required to join for standing purposes or in order for Voyager (or an Inbound Licensor) to commence or continue any such proceeding, then Neurocrine shall join such proceeding, at Voyager’s expense, and shall be represented in such proceeding by counsel of Neurocrine’s choice at Neurocrine’s expense.  The Party initiating the suit shall have the sole and exclusive right to elect counsel for any suit initiated by it pursuant to Section 10.3.2(a), (c) or (d); provided that, with respect to a Voyager Target-Specific Patent Right or Joint Patent Right, such counsel is reasonably acceptable to the other Party.

(e)Each Party agrees to cooperate fully in any action under this Section 10.3.2 that is controlled by the other Party, including executing legal papers and cooperating in the prosecution as may be reasonably requested by the controlling Party, all at the controlling Party’s expense.

 

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(f)Unless otherwise agreed by the Parties in writing, and subject to the terms of the Co-Co Agreements, the amount of any recovery from a proceeding brought under this Section 10.3.2 shall first be applied to the Out-of-Pocket Cost of such action incurred by the Party prosecuting the applicable action, and any remaining recovery amount shall be applied to the Out-of-Pocket Cost of such action incurred by the other Party (if any), and then, of the remaining amount, (i) any recovery for a proceeding brought by Neurocrine with respect to a Voyager Target-Specific Patent Right, Voyager Licensed Platform Patent Right or Joint Patent Right or a proceeding brought by Voyager with respect to a Voyager Licensed Platform Patent Right shall be retained by Neurocrine, but shall be deemed Net Sales of the applicable Collaboration Product in the applicable country and subject to royalty payments under Section 8.3 or, with respect to Co-Co Products, shared between the Parties at the Co-Co Rate, (ii) any recovery for a proceeding brought by Voyager with respect to a Voyager Target-Specific Patent Right shall be allocated [...***...] percent ([...***...]%) to Voyager and [...***...] percent ([...***...]%) to Neurocrine and (iii) any recovery for a proceeding brought with respect to a Neurocrine Patent Right shall be retained by Neurocrine.  If, in connection with a proceeding brought under this Section 10.3.2 with respect to a Voyager Target-Specific Patent Right, an Inbound Licensor is entitled to a portion of any recovery that is greater than the portion of the recovery payable, after costs, to Voyager, the Parties will meet and agree in good faith on an alternative sharing of such recovery to that set forth in the immediately preceding sentence that takes into account the amounts payable to the applicable Inbound Licensor and results in an equitable allocation of the remaining amounts to Neurocrine and Voyager after payment of such amounts to the applicable Inbound Licensor.

10.3.3Defense.  With respect to any defense or declaratory judgment actions relating to, or other attack upon, validity or enforceability of a Voyager Patent Right, Neurocrine Patent Right or Joint Patent Right that is not a Defense Proceeding, the Party with responsibility for the Prosecution and Maintenance of such Patent Right shall have the first right, but not the obligation, to assume the defense thereof at its sole cost and expense, except that if such action is in connection with a Competitive Infringement, Section 10.3.2 will apply to such action (as if it were enforcement against a Competitive Infringement).

10.4Infringement Claimed by Third Parties.

10.4.1If a Third Party commences, or threatens to commence, any proceeding against a Party alleging infringement of such Third Party’s intellectual property by the Exploitation by a Party, its Affiliates, subcontractors or Sublicensees of any Collaboration Candidate or any Collaboration Product, the Party against whom such proceeding is threatened or commenced shall give prompt notice to the other Party.

10.4.2Unless the Party against whom such proceeding is filed seeks indemnification for a claim covered pursuant to Article 13, such Party shall, as between the Parties, have the sole right to control the defense and settlement of any such proceeding under Section 10.4.1 at its own cost.

10.5Marking.  Neurocrine and its Affiliates and Sublicensees shall mark each Collaboration Product in such a manner to conform with the patent laws and practice of any country in which such Collaboration Product is Manufactured or sold or to which such

 

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Collaboration Product is shipped to ensure maximum enforceability of Patent Rights in such country.

10.6Trademarks.  Except for Collaboration Products arising from the AADC Program if Voyager exercises its Co-Co Option for such Program, Neurocrine shall have the right to brand Collaboration Products in the Territory using Neurocrine-related trademarks and any other trademarks and trade names it determines appropriate, which may vary by country or within a country (“Neurocrine Product Marks”). Neurocrine shall own all rights in the Neurocrine Product Marks and, as between the Parties, shall have the sole right to register, maintain, enforce and defend the Neurocrine Product Marks, at its sole expense, provided that Neurocrine will provide Voyager appropriate licenses to the Neurocrine Product Marks under any applicable Co-Co Agreement to undertake activities assigned to Voyager thereunder so requiring such licenses.  If Voyager exercises its Co-Co Option for the AADC Program, branding of Co-Co Products arising from the AADC Program shall be governed by the applicable provisions of the applicable Co-Co Agreement and subject to final review and approval of the JSC.

ARTICLE 11
CONFIDENTIALITY

11.1Confidentiality; Exceptions.  Except to the extent expressly authorized by this Agreement, or as otherwise agreed in writing, the Parties agree that the receiving Party (the “Receiving Party”) (a) shall keep confidential and shall not publish or otherwise disclose and (b) shall not use for any purpose other than as provided for in this Agreement (which purpose includes exercising its rights and performing its obligations under this Agreement), in each case (a) and (b) any Know-How or other confidential and proprietary information and materials, patentable or otherwise, in any form (written, oral, photographic, electronic, magnetic, or otherwise) that is disclosed to it by the other Party (the “Disclosing Party”), including trade secrets, Know-How, inventions or discoveries, proprietary information, formulae, processes, techniques and information relating to the Disclosing Party’s past, present or future marketing, financial, or Exploitation activities of any product or potential product or useful technology of the Disclosing Party or the pricing thereof (collectively, “Confidential Information” of the Disclosing Party), except that “Confidential Information” shall exclude information to the extent that it can be established by the Receiving Party that such information:

11.1.1was in the lawful knowledge and possession of the Receiving Party prior to the time it was first disclosed to the Receiving Party by the Disclosing Party, or was otherwise developed independently by the Receiving Party without reference to any of the Disclosing Party’s Confidential Information, as evidenced by written records kept in the ordinary course of business, or other documentary proof of actual use by the Receiving Party;

11.1.2was generally available to the public or otherwise part of the public domain at the time of its first disclosure to the Receiving Party by the Disclosing Party;

11.1.3became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party by the Disclosing Party and other than through any act or omission of the Receiving Party in breach of this Agreement or the Existing Confidentiality Agreement; or

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11.1.4was lawfully disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others.

For the avoidance of doubt, any information disclosed by a Party to the other Party prior to the Execution Date pursuant to the Confidential Disclosure Agreement between Voyager and Neurocrine dated August 28, 2018 (as amended from time to time, the “Existing Confidentiality Agreement”), that was considered Confidential Information (as defined in the Existing Confidentiality Agreement) of a Party shall be Confidential Information of such Party hereunder, subject to the provisions of Sections 11.1.1, 11.1.2, 11.1.3 and 11.1.4.  Notwithstanding the foregoing, any Inventions within the Vectorization Know-How shall be considered the Confidential Information of Voyager, with Voyager considered the Disclosing Party and Neurocrine considered the Receiving Party, and Neurocrine may not rely on Section 11.1.1 with respect to any such Inventions developed by Neurocrine under this Agreement and assigned to Voyager.

11.2Authorized Disclosure.  Except as expressly provided otherwise in this Agreement, a Receiving Party may disclose Confidential Information of the Disclosing Party as follows:  (a) to the extent required to those of its employees, agents and representatives who reasonably need to know such Confidential Information in order to advise or assist the Receiving Party in connection with the performance of its obligations or exercise of its rights granted or reserved in this Agreement and under appropriate written (or legal or ethical such as in the case of attorneys) confidentiality and non-use obligations no less protective of the Disclosing Party than those set forth in this Agreement; (b) as required by applicable Law; provided, however, that if a Receiving Party is required by Law to make any such disclosure of a Disclosing Party’s Confidential Information it will, except where impracticable, give reasonable advance notice to the Disclosing Party of such disclosure requirement, limit disclosure to only the Confidential Information requested to be disclosed and, if requested by the Disclosing Party, cooperate with the Disclosing Party to secure confidential treatment of such Confidential Information required to be disclosed; (c) in communication with existing or bona fide prospective investors, lenders, professional advisors, acquirers, merger partners, subcontractors, licensees or Inbound Licensors on a need to know basis, in each case under appropriate written (or legal or ethical such as in the case of attorneys) confidentiality and non-use obligations substantially equivalent to those of this Agreement, except that the term of such obligations may be shorter, and with respect to any disclosure to an Inbound Licensor under an Existing In-License Agreement, Neurocrine acknowledges that the relevant Inbound Licensor is obligated to retain any information provided to it in confidence only as required pursuant to the terms of the applicable Existing In-License Agreement; (d) to the extent mutually agreed to in writing by the Parties; (e) to a patent authority in connection with Prosecution and Maintenance, Defense Proceedings and enforcement of Patent Rights in accordance with Article 10; and (f) in the case of Neurocrine as Receiving Party, in Regulatory Filings for Collaboration Products and, in each case under appropriate written confidentiality and non-use obligations substantially equivalent to those of this Agreement, to Third Party contractors in connection with its Development, Manufacture and Commercialization of Collaboration Products.  The confidentiality and non-use obligations set forth under this Agreement shall survive the termination or expiration of this Agreement for a period of [...***...].

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11.3Press Release; Disclosure of Agreement.

11.3.1On or promptly after the Effective Date, the Parties shall jointly issue a public announcement of the execution of this Agreement.  Subject to Sections 11.3.2, 11.3.3 and 11.4, neither Party may issue any subsequent press release or other public disclosure regarding this Agreement or its terms or the Parties’ activities hereunder, or any results or data arising hereunder, except (a) with the other Party’s prior written consent, (b) for any disclosure that is reasonably necessary to comply with applicable securities exchange listing requirements or other applicable Laws, provided that the Party making such disclosure provides the other Party a copy of the proposed disclosure as soon as reasonably practicable and reasonably considers any comments thereto provided by the other Party within [...***...] after the receipt of such proposed disclosure or such shorter period required to comply with applicable Laws, (c) in the case of Voyager, to announce the exercise of the Co-Co Option, provided that Voyager first provides Neurocrine a copy of the proposed disclosure and reasonably considers any timely comments thereto provided by Neurocrine, or (d) in the case of Neurocrine, disclosure of any information relating to the Development, Manufacture or Commercialization of any Collaboration Product that does not include Confidential Information of Voyager, provided that Neurocrine first provides Voyager a copy of the proposed disclosure and reasonably considers any timely comments thereto provided by Voyager. Notwithstanding the foregoing, to the extent information regarding this Agreement has already been publicly disclosed, each Party (other than a Party that had caused such information to become publicly disclosed in breach of this Article 11, if applicable) may subsequently disclose the same information to the public without the consent of the other Party, as long as it remains accurate at the time of subsequent disclosure.

11.3.2Notwithstanding Section 11.3.1, each Party shall be permitted to disclose the existence and terms of this Agreement to the extent required to comply with applicable Laws or legal process, including the rules or regulations of the U.S. Securities and Exchange Commission, or similar agency in any country other than the United States, or of any stock exchange, including Nasdaq.  Notwithstanding the foregoing, before disclosing this Agreement or any of the terms hereof, the Parties will coordinate in advance with each other in connection with the redaction of certain provisions of this Agreement with respect to any filings with the U.S. Securities and Exchange Commission or similar agency in any country other than the United States, or of any stock exchange, including Nasdaq, on which securities issued by a Party or a Party’s Affiliate are traded (the “Redacted Version”), and each Party will use commercially reasonable efforts to seek confidential treatment for such terms as may be reasonably requested by the other Party; provided that the Parties will use commercially reasonable efforts to file redacted versions with any governing bodies that are consistent with the Redacted Version.

11.3.3Each Party shall be permitted to disclose the terms of this Agreement, in each case under appropriate confidentiality obligations substantially equivalent to those of this Agreement (except that the term of the obligations may be shorter as consistent with the applicable Party’s ordinary business practices with regard to the protection of its confidential information), to any existing or bona fide prospective investors, lenders, professional advisors, acquirers, merger partners, licensees or Inbound Licensors, except that, with respect to any disclosure to an Inbound Licensor under an Existing In-License Agreement, Neurocrine acknowledges that the relevant Inbound Licensor is obligated to retain any information provided to it in confidence only as required pursuant to the terms of the applicable Existing In-License Agreement.

 

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11.4Publications.  The Parties recognize that it may be useful or required to publish or publicly disclose the results of Exploitation activities conducted hereunder, and each Party (and its Affiliates and Sublicensees) shall be free to publish or publicly disclose such results, including on its clinical trials registry or on a government-sponsored database such as www.clinicaltrials.gov, subject to the prior review by the other Party for patentability and protection of its Confidential Information as described in this Section 11.4; provided that any publication by Voyager of any data or results obtained under activities conducted under the subject matter of this Agreement shall be subject to approval by the JSC.  The Party that desires to publish such results shall provide the other Party with a copy of such proposed abstract, manuscript, or presentation no less than [...***...] in the case of abstracts) prior to its intended submission for publication.  The reviewing Party shall respond in writing promptly and in no event later than [...***...] in the case of abstracts) after receipt of the proposed material, with one or more of the following:  (a) comments on the proposed material, which the publishing Party shall consider in good faith, (b) a specific statement of concern, based upon the need to seek patent protection or to block publication if the reviewing Party determines that the proposed disclosure contains or describes intellectual property that should be maintained as a trade secret to protect a Collaboration Product or any Exploitation activities conducted under this Agreement, and/or (c) an identification of the reviewing Party’s Confidential Information that is contained in the material reviewed.  In the event of concern over patent protection or whether maintaining a trade secret would be a priority, the publishing Party agrees not to submit such publication or to make such presentation that contains such information until the reviewing Party is given a reasonable period of time, and in no event more than [...***...], unless otherwise agreed by the Parties, to seek patent protection for any material in such publication or presentation which it believes is patentable or to resolve any other issues; provided, however, that the publishing Party shall abandon such proposed publication or presentation if the reviewing Party reasonably determines in good faith that maintaining such information as a trade secret is a commercially reasonable priority.  Any Confidential Information of the reviewing Party shall, if requested by the reviewing Party, be removed.  Furthermore, with respect to any proposed abstracts, manuscripts or summaries of presentations by Clinical Trial investigators, such materials shall be subject to review under this Section 11.4 to the extent that Neurocrine or Voyager (as the case may be) has the right to do so. Voyager shall not grant any other Third Party any rights to publish results generated under this Agreement without approval by an appropriate Committee.

11.5Remedies.  Each Party shall be entitled to seek, in addition to any other right or remedy it may have, at Law or in equity, a temporary injunction, without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Article 11.

11.6[...***...] Agreement.  Pursuant to Section 14.8 of the [...***...] Agreement, Neurocrine agrees that it shall not make any form of representation or statement which would constitute an express or implied endorsement by [...***...] of any Licensed Products (as defined in the [...***...] Agreement), and that it shall not authorize others to do so, without first having obtained written approval from [...***...], except as may be required by governmental law, rule or regulation.

 

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ARTICLE 12
REPRESENTATIONS AND WARRANTIES

12.1Representations and Warranties of Both Parties.  Each Party hereby represents and warrants to the other Party, as of the Execution Date and as of the Effective Date, that:

12.1.1such Party is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

12.1.2such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;

12.1.3this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;

12.1.4the execution, delivery and performance of this Agreement by such Party do not conflict with or result in a breach of any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a party or by which it is bound, or any provision of the organization documents of such Party, nor violate any Laws of any court, governmental body or administrative or other agency having jurisdiction over such Party; and

12.1.5no 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 Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements, except as may be required to obtain clearance of this Agreement under the HSR Act, to conduct Clinical Trials, to Manufacture Collaboration Products, or to seek or obtain Regulatory Approvals.

12.2Representations, Warranties and Covenants, as applicable, of Voyager.  Voyager hereby represents, warrants, and covenants to Neurocrine, as of the Execution Date and, except as set forth below, with respect to each Discovery Program, as of the date the JSC approves the applicable Discovery Target (subject to any disclosures in the Schedule of Exceptions attached hereto as Exhibit C, which disclosures shall be deemed to be exceptions to such representations and warranties) that:

12.2.1Voyager has the right to grant all rights and licenses it purports to grant to Neurocrine under this Agreement;

12.2.2Voyager has not granted, and will not during the Term grant, any right or license to any Third Party that would conflict with the rights or licenses granted to Neurocrine hereunder;

12.2.3Exhibit B sets forth a true and complete list, as of the Execution Date, of all Voyager Licensed Patent Rights, indicating the assignee(s) of each such Patent Right; and Voyager

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is the sole and exclusive owner of, or otherwise Controls via an exclusive license, the Voyager Licensed Patent Rights, free and clear of any claims, liens, charges or encumbrances other than licenses granted by Voyager that do not conflict with the licenses granted to Neurocrine under this Agreement;

12.2.4The inventions claimed by the Voyager Licensed Patent Rights (a) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof and (b) are not a “subject invention” as that term is described in 35 U.S.C. Section 201(e) and (c) are not otherwise subject to 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated thereunder;

12.2.5No claim or litigation has been brought or threatened in writing against Voyager or, to its Knowledge, any Third Party by any Person alleging that the Voyager IP or Vectorization Technology is infringing or, if practiced or commercialized, will infringe the rights of any Third Party, or that the development of the Voyager IP or Vectorization Technology infringed or misappropriated the intellectual property rights of any Third Party, and to Voyager’s Knowledge there is no basis for any such claim;

12.2.6To Voyager’s Knowledge, the conduct of the Development Plans have not, do not and will not infringe any Patent Rights or misappropriate any materials, Know-How or other intellectual property of any Third Party;

12.2.7There are no judgments, orders, decrees or settlements against or owed by Voyager or any of its Affiliates, and, there is no written claim, written demand, suit, proceeding, arbitration, and to Voyager’s Knowledge, other claim, demand, inquiry, investigation or other legal action of any nature, civil, criminal, regulatory or otherwise, pending or, to the Knowledge of Voyager, threatened against Voyager or any of its Affiliates, in each case relating to the Voyager IP, the Programs and Collaboration Products or the transactions contemplated by this Agreement;

12.2.8To Voyager’s Knowledge, no Person is infringing or threatening to infringe, or misappropriating or threatening to misappropriate, the Voyager IP, and no Person has challenged or threatened to challenge the inventorship, ownership, Voyager’s right to use, scope, validity or enforceability of, or Voyager’s or any Inbound Licensor’s rights in or to, any Voyager Licensed Patent Rights (including through the institution or threat of institution of interference, derivation, post-grant review, opposition, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous Governmental Authority);

12.2.9To Voyager’s Knowledge, the Voyager Licensed Patent Rights are valid and enforceable, or in the case of pending patent applications, will be valid and enforceable upon issuance, the inventorship of each Voyager Patent Right is properly identified on each patent and patent application, and Voyager has complied (and, to its Knowledge, its Inbound Licensors have complied) with, all applicable Laws and duties of candor with respect to the filing, prosecution and maintenance of the Voyager Licensed Patent Rights.  Voyager has paid, with respect to all Voyager Licensed Patent Rights to which Voyager has prosecution and maintenance rights, and, to Voyager’s Knowledge, its Inbound Licensors have paid all maintenance and annuity fees with respect to the Voyager Licensed Patent Rights due as of the Execution Date;

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12.2.10All of its employees, officers, and consultants have executed agreements or have existing obligations under applicable Laws requiring assignment to Voyager of all inventions made during the course of and as the result of their association with Voyager and obligating the individual to maintain as confidential Voyager’s Confidential Information as well as confidential information of other Persons (including Neurocrine and its Affiliates) which such individual may receive, in each case to the extent required to support Voyager’s obligations under this Agreement;

12.2.11(i) Neither Voyager nor, to Voyager’s Knowledge, any Third Party, is in breach of any In-License Agreement in any material respect and, to Voyager’s Knowledge, each In-License Voyager Agreement is in full force and effect, and neither Voyager nor any of its Affiliates has received any written notice of breach of any In-License Agreements; (ii) there are no agreements between Voyager (or any of its Affiliates), on the one hand, and a Third Party, on the other hand, pursuant to which Voyager or any of its Affiliates has Control of any Voyager IP as of the Execution Date other than those listed on Schedule 1.37, (iii) none of the Existing In-License Agreements includes any obligations that restrict or conflict with the practice of the licenses granted by Neurocrine hereunder; and (iv) true, correct and complete copies of each Existing In-License Agreement have been provided to Neurocrine.

12.2.12Except for any contract granting only a non-exclusive license to (a) a Third Party to provide services or products to Voyager in a fee-for-service arrangement that does not convey to any Third Party or allow any Third Party to retain any rights in any Voyager Licensed Patent Rights or Voyager Know-How or (b) Inbound Licensors for non-commercial research and educational purposes, there are no agreements pursuant to which Voyager or any of its Affiliates has granted any right or license to practice any Voyager Licensed Patent Rights or Voyager Know-How that would be inconsistent or in conflict with the rights granted pursuant to this Agreement;

12.2.13Voyager has taken reasonable precautions to preserve the confidentiality of the Voyager Know-How, including requiring each Person having access to the Voyager Know-How to be subject to confidentiality, non-use and non-disclosure obligations protecting the Voyager Know-How as the confidential, proprietary materials and information of Voyager;

12.2.14Voyager has made available to Neurocrine (a) all Regulatory Filings relating to Collaboration Candidates, (b) all information in Voyager’s or its Affiliates’ Control related to the safety or efficacy of any Collaboration Candidate or Collaboration Product and (c) all other information in Voyager’s Control requested by Neurocrine.

12.2.15Voyager and its Affiliates have generated, prepared, maintained and retained all Regulatory Filings for Collaboration Candidates and Collaboration Products in accordance with GLP, GCP and all other applicable Laws, and all such information is complete and accurate;

12.2.16Voyager and its Affiliates have conducted, and its and their respective contractors and consultants have conducted, all Development of Collaboration Candidates and Collaboration Products in accordance with GLP, GCP and all other applicable Laws;

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12.2.17Neither Voyager nor any of its Affiliates, nor, to Voyager’s Knowledge, any of its or their respective officers, employees or agents, has (a) committed an act, (b) made a statement or (c) failed to act or make a statement that, in each case (a), (b) and (c), (A) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Authority with respect to the Exploitation of Collaboration Candidates and Collaboration Products or (B) could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “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 any analogous laws or policies in the Territory;

12.2.18Since November 10, 2015, Voyager and its Affiliates have conducted and will conduct their business in compliance with the Foreign Corrupt Practices Act of 1977 and any other applicable anti-corruption Laws. Voyager covenants as follows:

(a)Voyager and its and its Affiliates’ employees and contractors shall not, in connection with the performance of their respective obligations under this Agreement, directly or indirectly through Third Parties, unlawfully pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a Public Official or Entity or other person for the purpose of corruptly obtaining or retaining business for or with, or directing business to, any person, including, without limitation, either Party, and Voyager represents and warrants that as of the Execution Date, Voyager, and to its Knowledge, its and its Affiliates’ employees and contractors, have not directly or indirectly promised, offered or provided any unlawful corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a Public Official or Entity or any other person in connection with the performance of Voyager’s obligations under this Agreement, and Voyager covenants that it and its Affiliates’ employees and contractors shall not, directly or indirectly, engage in any of the foregoing.

(b)Voyager and its Affiliates, and their respective employees and contractors, in connection with the performance of their respective obligations under this Agreement, shall not cause Neurocrine or its respective Affiliates, employees or agents to be in violation of the FCPA or any other applicable Law.

(c)Voyager shall without unreasonable delay notify Neurocrine if Voyager has any credible information or reasonable suspicion that there may be a violation of the FCPA or any other applicable Law in connection with the performance of this Agreement or the Development, Manufacture or Commercialization of any Collaboration Candidate or Collaboration Product.

(d)In connection with the performance of its obligations under this Agreement, Voyager shall comply and shall cause its and its Affiliates’ employees and contractors to comply with Voyager’s own anti-corruption and anti-bribery policy, a copy of which will be provided to Neurocrine within [...***...] of the Effective Date.

(e)Neurocrine will have the right, upon reasonable prior written notice and during Voyager’s regular business hours, to engage an independent Third Party to audit

 

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Voyager’s books and records in the event that a suspected violation of any of the representations, warranties or covenants in this Section 12.2.18 needs to be investigated.

(f)In the event that Voyager has violated or been reasonably suspected of violating any of the representations, warranties or covenants in this Section 12.2.18, Voyager will cause its or its Affiliates’ personnel or others working under its direction or control to submit to periodic training that Voyager will provide on anti-corruption law compliance.

(g)Voyager will, at Neurocrine’s request, annually certify to Neurocrine in writing Voyager’s compliance, in connection with the performance of Voyager’s obligations under this Agreement, with the representations, warranties or covenants in this Section 12.2.18.

(h)Neurocrine shall have the right to suspend or terminate this Agreement in its entirety where there is a credible finding, after a reasonable investigation, that Voyager, in connection with performance of its obligations under this Agreement, has violated the FCPA; and

12.2.19Voyager (a) will promptly notify Neurocrine of any lawsuits, claims, administrative actions, regulatory inquiries or investigations, or other proceedings asserted or commenced against Voyager or its Affiliates or their respective employees or agents involving in any material way the ability of Voyager to deliver the rights, licenses and sublicenses granted herein; and (b) will promptly notify Neurocrine in writing of any facts or circumstances that come to Voyager’s attention and that cause, or are reasonably expected to cause, any of the representations and warranties contained in Section 12.1 or 12.2 to be untrue in any material respect at any time during the Term.

12.3Mutual Covenants.  Each Party hereby covenants to the other Party that:

12.3.1All individuals who are employees or independent contractors of such Party or any of its Affiliates working under this Agreement are and will be under written obligation to assign or, in the case of independent contractors, assign or exclusively license, all right, title and interest in and to all Inventions and other Know-How, and all intellectual property rights therein, developed under this Agreement to such Party or its Affiliate as the sole owner or exclusive licensee thereof;

12.3.2Such Party will not employ, or use any contractor or consultant that employs or uses, any Person (a) that is debarred by the FDA (or subject to a similar sanction of EMA or any other Governmental Authority) or (b) to such Party’s Knowledge, that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA or any other Governmental Authority), in each of clauses (a) and (b) in the conduct of its activities under this Agreement;

12.3.3In performing its obligations or exercising its rights under this Agreement, such Party, its Affiliates, and, with respect to Neurocrine, its Sublicensees, shall comply with all applicable Law, including all anti-corruption Laws; and

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12.3.4Such Party will not grant any license relating to the Voyager IP (if such Party is Voyager) or the Neurocrine IP (if such Party is Neurocrine) that would conflict with the rights or licenses granted or to be granted to the other Party hereunder.

12.4Disclaimer.  Except as otherwise expressly set forth in this Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.

ARTICLE 13
INDEMNIFICATION; INSURANCE

13.1Indemnification by Neurocrine.  Subject to Section 13.3 and the terms of the Co-Co Agreement, Neurocrine shall indemnify, hold harmless and defend:

13.1.1Voyager and its Affiliates, and its or their respective directors, officers, employees, agents and representatives, from and against any and all liabilities, damages, losses, costs and expenses, including the reasonable fees of attorneys and other professional advisors (collectively, “Losses”), to the extent arising out of or resulting from any Third Party suits, claims, actions, proceedings or demands (“Third Party Claims”) to the extent resulting from:

(a)The gross negligence, recklessness or intentional misconduct of Neurocrine or any of its Affiliates, or its or their respective directors, officers, employees, agents or representatives, in connection with performance by or on behalf of Neurocrine of Neurocrine’s obligations or exercise of Neurocrine’s rights under this Agreement;

(b)any breach of this Agreement, including any representation or warranty or covenant, by Neurocrine; or

(c)the Exploitation of Collaboration Candidates and Collaboration Products conducted by or on behalf of Neurocrine, any of its Affiliates or any Sublicensee hereunder (excluding Development or Manufacturing carried out by Voyager hereunder), including (a) any product liability, personal injury, property damage or other damage, and (b) infringement of any Patent Rights or other intellectual property rights of any Third Party, except to the extent related to any Vectorization Technology licensed to Neurocrine hereunder; provided, however, that, Losses arising from Exploitation of any Collaboration Product under any Co-Co Agreement shall be shared as Development Costs or profit or loss, as applicable, in accordance with the term of such Co-Co Agreement;

except, in each case ((a)-(c)), to the extent arising from the gross negligence, recklessness or intentional misconduct of Voyager or any of its Affiliates or its or their respective directors, officers, employees, agents or representatives or Voyager’s breach of this Agreement, including any representation, warranty or covenant.

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13.1.2[...***...], its trustees, officers, agents and employees (the “[...***...] Indemnitees”), as set forth in Section 9.3 of the [...***...] Agreement, if the Patent Rights under the [...***...] Agreement become sublicensed to Neurocrine hereunder.

13.2Indemnification by Voyager.  Subject to Section 13.3 and the terms of the Co-Co Agreements, Voyager shall indemnify, hold harmless and defend, Neurocrine and its Affiliates, and its or their respective directors, officers, employees and agents, from and against any and all Losses, to the extent arising out of or resulting from any Third Party Claims to the extent resulting from:

13.2.1the gross negligence, recklessness or intentional misconduct of Voyager or any of its Affiliates or subcontractors, or its or their respective directors, officers, employees, agents or representatives, in connection with performance by or on behalf of Voyager of Voyager’s obligations or exercise of Voyager’s rights under this Agreement;

13.2.2any breach of this Agreement, including any representation or warranty or covenant, by Voyager;

13.2.3the Exploitation of Collaboration Candidates and Collaboration Products conducted by or on behalf of Voyager or any of its Affiliates, or any of their respective licensees (excluding Development, Manufacturing or Commercialization carried out by Neurocrine hereunder), outside of the Territory or before the Effective Date or after termination of this Agreement, and including (a) any product liability, personal injury, property damage or other damage and (b) infringement of any Patent Rights or other intellectual property rights of any Third Party; provided, however, that, Losses arising from Exploitation of any Collaboration Product under any Co-Co Agreement shall be shared as Development Costs or profit or loss, as applicable, in accordance with the term of such Co-Co Agreement; or

13.2.4the infringement of any Patent Rights or other intellectual property rights of any Third Party by the Exploitation of any Collaboration Product conducted by or on behalf of Neurocrine or its Affiliates or any Sublicensees, to the extent related to any Vectorization Technology licensed to Neurocrine by Voyager hereunder;

except, in each case (13.2.1 – 13.2.4), to the extent arising from the gross negligence, recklessness or intentional misconduct of Neurocrine or any of its Affiliates or its or their respective directors, officers, employees, agents or representatives or Neurocrine’s breach of this Agreement, including any representation, warranty or covenant.

13.3Procedure.  A Person entitled to indemnification under this Article 13 (an “Indemnified Party”) shall give prompt written notification to the Person from whom indemnification is sought (the “Indemnifying Party”) of the commencement of any Third Party Claim for which indemnification may be sought or, if earlier, upon the assertion of any such Third Party Claim (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Third Party Claim as provided in this Section 13.3 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually damaged as a result of such failure to give notice).  Within [...***...] after delivery of such notification, the Indemnifying Party may, upon

 

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written notice thereof to the Indemnified Party, assume control of the defense of such Third Party Claim with counsel reasonably satisfactory to the Indemnified Party.  If the Indemnifying Party does not assume control of such defense, the Indemnified Party shall control such defense and, without limiting the Indemnifying Party’s indemnification obligations, the Indemnifying Party shall reimburse the Indemnified Party for all reasonable costs and expenses, including attorney fees, incurred by the Indemnified Party in defending itself within [...***...] after receipt of any reasonably detailed invoice and supporting documentation therefor from the Indemnified Party.  The Party not controlling such defense may participate therein at its own expense; provided that, if the Indemnifying Party assumes control of such defense and the Indemnified Party in good faith concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such Third Party Claim, the Indemnifying Party shall be responsible for the reasonable fees and expenses of counsel to the Indemnified Party in connection therewith.  The Party controlling such defense shall keep the other Party advised of the status of such Third Party Claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto.  The Indemnified Party shall not agree to any settlement of such Third Party Claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, delayed or conditioned.  The Indemnifying Party shall not, without the prior written consent of the Indemnified Party, which shall not be unreasonably withheld, delayed or conditioned, agree to any settlement of such Third Party Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party.

13.4Insurance.  Subject to the terms of any applicable Co-Co Agreement:

13.4.1Voyager’s Insurance Obligations.  Voyager shall maintain, at its cost, insurance against liability and other risks associated with its activities and obligations under this Agreement, including its Clinical Trials and its indemnification obligations hereunder, in such amounts, subject to such deductibles and on such terms as are reasonable for a company such as Voyager for the activities to be conducted by it under this Agreement.  Voyager shall furnish to Neurocrine evidence of such insurance upon request.  If the Patent Rights under the [...***...] Agreement become sublicensed to Neurocrine hereunder, Neurocrine shall name the [...***...] Indemnitees as additional insureds, pursuant to Section 13.1 of the [...***...] Agreement.

13.4.2Neurocrine’s Insurance Obligations.  Neurocrine shall maintain, at its cost, insurance against liability and other risks associated with its and its Affiliates’ and any Sublicensees’ activities and obligations under this Agreement, including Clinical Trials, the Exploitation of Collaboration Products and Neurocrine’s indemnification obligations hereunder, in such amounts and on such terms as are reasonable and customary for a company such as Neurocrine for the activities to be conducted by it under this Agreement.  Neurocrine shall furnish to Voyager evidence of such insurance upon request.

13.5Limitation of Liability.  EXCEPT FOR A BREACH OF ARTICLE 9 OR ARTICLE 11 OR FOR CLAIMS OF A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 13, NEITHER VOYAGER NOR NEUROCRINE, NOR ANY OF THEIR RESPECTIVE AFFILIATES, LICENSORS, LICENSEES OR SUBLICENSEES, WILL BE LIABLE TO THE OTHER PARTY, ITS

 

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AFFILIATES OR SUBLICENSEES FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES, OR LOST PROFITS, ROYALTIES, DATA OR PROCUREMENT OF SUBSTITUTE GOODS, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.

ARTICLE 14
TERM AND TERMINATION

14.1Term.  This Agreement shall commence as of the Effective Date and, unless terminated earlier, this Agreement shall continue in full force and effect until the later of (a) the expiration of the last to expire Royalty Term with respect to all Collaboration Products in all countries in the Territory or (b) the last expiration or termination of all Co-Co Agreements (the “Term”).

14.2Termination by Neurocrine.  Neurocrine may terminate this Agreement in its entirety or on a Program-by-Program and/or country-by-country basis by providing written notice of termination to Voyager, which notice specifies the scope of the termination and includes an effective date of termination at least (a) one hundred eighty (180) days after the date of the notice if such notice is provided prior to First Commercial Sale of any Collaboration Product to which the termination applies or (b) one (1) year after the date of the notice if such notice is provided after First Commercial Sale of any Collaboration Product to which the termination applies.

14.3Termination for Breach.

14.3.1This Agreement may be terminated (a) on a Program-by-Program basis, at any time upon written notice by either Party if the other Party is in material breach of this Agreement with respect to such Program or (b) in its entirety, at any time upon written notice by either Party if the other Party is in material breach of this Agreement with respect to all Programs, or if such material breach does not relate specifically to any Program, in either case ((a) or (b)) except if the breaching Party has cured such breach within [...***...] in the case of a payment breach ([...***...] in the case of the Initial Fee), or within [...***...] in the case of all other breaches, after the non-breaching Party has provided written notice to the breaching Party of such breach; provided that if the breach is curable but is not capable of cure within such [...***...] period, then the cure period will be extended for so long as the breaching Party is diligently implementing a cure plan reasonably designed to cure such breach, provided that, such cure period does not exceed [...***...] in total.

14.3.2Without limiting Section 14.3.1, if the applicable material breach is a material breach by Neurocrine of its obligations under Section 4.2.2 to use Commercially Reasonable Efforts with respect to a Program in one or more, but not all, of the Major Market Countries, then Voyager will not have the right to terminate this Agreement with respect to such Program in all countries but instead may terminate this Agreement with respect to such Program

 

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only in the Major Market Country(ies) in which there was an uncured material breach by Neurocrine with respect to its obligation to use Commercially Reasonable Efforts.

14.3.3If the Parties reasonably and in good faith disagree as to whether there has been a material breach, the Party that seeks to dispute that there has been a material breach shall contest the allegation in accordance with Section 15.2 during the applicable cure period.  The cure period for any allegation made in good faith as to a material breach under this Agreement will, subject to Sections 14.3.1 and 15.3, including the suspension of such cure period set forth therein, run from the date that written notice of breach was first provided to the breaching Party by the non-breaching Party.

14.4Termination for Failure to Make Equity Purchase.  If Neurocrine fails to purchase from Voyager shares of Voyager common stock pursuant to the terms and within the timeframe specified in the Stock Purchase Agreement (subject to any cure provisions therein), then Voyager shall have the right to terminate this Agreement in its entirety upon written notice to Neurocrine.

14.5Termination for Patent Challenge.  If, during the Term, Neurocrine (a) commences or participates in any action or proceeding (including any patent opposition or re-examination proceeding), or otherwise asserts any claim, challenging or denying the validity or enforceability of any claim of Voyager Licensed Patent Rights, except in the normal course of patent prosecution, or (b) actively assists any other Person in bringing or prosecuting any action or proceeding (including any patent opposition or reexamination proceeding) challenging or denying the validity or enforceability of any claim of Voyager Licensed Patent Rights (each of (a) and (b), a “Patent Challenge”), then, to the extent permitted by applicable Laws, Voyager shall have the right, exercisable within sixty (60) days following receipt of notice regarding such Patent Challenge, in its sole discretion, to terminate this Agreement with respect to such Voyager Patent Right(s), such termination to be effective ninety (90) days following such notice (or such longer period as Voyager may designate in such notice) unless Neurocrine withdraws or causes to be withdrawn all such challenge(s) (or in the case of ex-parte proceedings, multi-party proceedings, or other Patent Challenges that Neurocrine does not have the power to unilaterally withdraw or cause to be withdrawn, Neurocrine ceases actively assisting any other party to such Patent Challenge and, to the extent Neurocrine is a party to such Patent Challenge, it withdraws from such Patent Challenge) within such ninety (90)-day period.  The foregoing sentence shall not apply (i) with respect to any Voyager Licensed Patent Rights that Voyager first asserts against Neurocrine or any of its Affiliates where the Patent Challenge is made in defense of such assertion, or (ii) with respect to any Patent Challenge commenced by a Third Party that after the Effective Date acquires or is acquired by Neurocrine or its Affiliates or its or their business or assets, whether by stock purchase, merger, asset purchase or otherwise, but only with respect to Patent Challenges commenced prior to the closing of such acquisition. The following will not be considered a Patent Challenge: (A) responding to compulsory discovery, subpoenas or other requests for information in a judicial or arbitration proceeding or (B) complying with any applicable Law or court order.

14.6Effects of Termination Other than by Neurocrine for Voyager Breach.  Without limiting any other legal or equitable remedies that either Party may have, if this Agreement is terminated (in whole or in part) for any reason except by Neurocrine pursuant to Section 14.3 above, then the following shall apply, provided that if termination of this Agreement is limited to

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a particular country(ies) or Program(s) then the following shall apply only with respect to such country(ies) or Program(s):

14.6.1the license grants to Neurocrine in Section 5.1 shall terminate immediately;

14.6.2Neurocrine shall, and hereby does, effective upon such termination, grant to Voyager a royalty-bearing, sublicenseable (through multiple tiers) license under the Neurocrine IP that has been used with or incorporated into Collaboration Products in such Program as of the effective date of termination to Exploit Collaboration Products in such Program in the terminated country(ies), which license will be non-exclusive or exclusive as requested by Voyager; the Parties shall negotiate in good faith commercially reasonable royalties payable by Voyager to Neurocrine on sales of such Collaboration Products, which shall reflect the value of, and Neurocrine’s investment in the development of, such Collaboration Products and the exclusivity of the license, and the terms related to such royalty payments.

14.6.3if Voyager so requests, and to the extent permitted under the relevant agreement at the time of termination, Neurocrine shall transfer to Voyager any agreements between Neurocrine or any of its Affiliates, on the one hand, and any Affiliate or Third Party, on the other hand, to the extent relating to the Exploitation of any Collaboration Product in the terminated Program(s) and country(ies) to which Neurocrine or any of its Affiliates or any Sublicensees is a party, subject to any required consents of such Third Party, which Neurocrine shall use commercially reasonable efforts to obtain promptly (but shall not be obligated to pay any additional consideration to such Third Party);

14.6.4if the date of expiration or termination of the Agreement is after any Transition Event, then, with respect to any Collaboration Product that is the subject of a terminated Program:

(a)Neurocrine shall provide to Voyager a fair and accurate description of the status of the Exploitation of any Collaboration Product in such Program in the Field in the terminated country(ies) through the effective date of termination or expiration;

(b)Neurocrine shall as promptly as practicable transfer to Voyager or Voyager’s designee (i) possession and ownership of all Regulatory Filings (including any supporting documentation or data therefor), Regulatory Approvals and pricing and reimbursement approvals relating to the Exploitation of such Collaboration Products in the terminated Program(s) and country(ies), (ii) copies of all non-clinical and clinical data relating to any of such Collaboration Products, and all adverse event or other safety data in the possession or Control of Neurocrine, any of its Affiliates or any Sublicensee related to such Collaboration Products; (ii) if this Agreement is terminated in its entirety, all records and materials containing Confidential Information of Voyager. To the extent required to effect the transfer of any Regulatory Filing or Regulatory Approvals in any terminated country(ies), Neurocrine shall appoint, and cause its Affiliates and use Commercially Reasonable Efforts to cause its Sublicensees to appoint, Voyager as the agent for Neurocrine, its Affiliates and, as applicable, the Sublicensees for all matters relating to such Collaboration Products involving Regulatory Authorities in such terminated country(ies) until all Regulatory Approvals and other Regulatory Filings have been transferred to Voyager or its designee;

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(c)if the effective date of termination or expiration is after the First Commercial Sale of a Collaboration Product in any country in the Territory, then Neurocrine shall appoint Voyager or its designee as the exclusive distributor of the Collaboration Product in the Territory and grant Voyager the right to appoint sub-distributors, until such time as all Regulatory Approvals and pricing and reimbursement approvals in the Territory have been transferred to Voyager or its designee;

(d)if Neurocrine or any of its Affiliates is Manufacturing such Collaboration Product, then, at Voyager’s option, Neurocrine shall supply such Collaboration Product to Voyager in the Territory at Neurocrine’s fully burdened manufacturing cost plus [...***...] percent ([...***...]%) thereof (except that such percentage above cost shall not apply if Voyager terminated this Agreement pursuant to Section 14.3 above), until the earlier of (A) such time as all Regulatory Approvals and pricing and reimbursement approvals in the Territory have been transferred to Voyager or its designee, Voyager has obtained all necessary Manufacturing approvals and Voyager has procured or developed its own source of the Collaboration Product supply for the Territory or (B) [...***...] following the effective date of such termination or expiration;

(e)Neurocrine shall promptly transfer and assign to Voyager all of Neurocrine’s and its Affiliates’ and shall use Commercially Reasonable Efforts to cause its Sublicensees to transfer and assign any Sublicensee’s rights, title and interests in and to all Neurocrine Product Marks used in the Commercialization of such Collaboration Products (but not any house marks of such Person or any trademark containing the word “Neurocrine” owned by Neurocrine or any of its Affiliates or, as applicable, any Sublicensee); and

(f)Neurocrine shall, upon Voyager’s written request, transfer to Voyager any inventory of such Collaboration Products owned or controlled by Neurocrine or any of its Affiliates and shall use Commercially Reasonable Efforts to cause any Sublicensee to transfer any such inventory of such Collaboration Products owned or controlled by such Sublicensee as of the termination date at the actual price paid by Neurocrine, such Affiliate or, as applicable, such Sublicensee for such supply.

14.6.5Neurocrine shall provide any other assistance reasonably requested by Voyager for the purpose of allowing Voyager or its designee to proceed expeditiously with the Exploitation of Collaboration Products in the Field in the Territory over a [...***...] period following termination, and Voyager shall pay Neurocrine’s FTE Costs and Out-of-Pocket Costs to conduct such assistance (except in the event Voyager terminated this Agreement pursuant to Section 14.3 above);

14.6.6Neurocrine shall, and shall cause its Affiliates and use Commercially Reasonable Efforts to cause its Sublicensees to, execute all documents as may be reasonably requested by Voyager in order to give effect to the foregoing clauses; and

14.6.7If this Agreement is terminated in its entirety, Voyager shall return to Neurocrine or destroy, and certify such destruction in writing any Confidential Information of Neurocrine, except for any such Confidential Information that Voyager has the right to use pursuant to the terms of this Agreement.

 

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14.7Effects of Termination by Neurocrine for Voyager Breach.  If Neurocrine terminates this Agreement with respect to one or more Programs pursuant to Section 14.3, then all rights and obligations under this Agreement with respect to such terminated Programs will terminate, except as expressly provided in Section 14.9, and if such termination is of this Agreement in its entirety, Voyager shall return to Neurocrine or destroy, and certify such destruction in writing, any Confidential Information of Neurocrine.  If Neurocrine has the right to terminate this Agreement with respect to one or more Programs for Voyager’s material breach pursuant to Section 14.3, then in lieu of termination, and in addition to the remedies provided in Section 2.1.5, Neurocrine shall have the right to keep this Agreement in effect and to elect the following upon written notice to Voyager:

14.7.1If a Co-Co Agreement is then in effect with respect to the terminated Program(s), then such Co-Co Agreement(s) will terminate, and Voyager will no longer have the right to co-develop and co-commercialize the applicable Collaboration Products with Neurocrine; and

14.7.2Subject to the applicable terms of any In-License Agreement, Neurocrine shall no longer have any obligations with respect to diligence or to use Commercially Reasonable Efforts with respect to any Collaboration Products resulting from the applicable Programs.

14.8HSR Filing; Termination Upon HSR Denial.

14.8.1Except for the Parties’ obligations under Article 11, Article 12 and this Section 14.8, which shall be effective as of the Execution Date, this Agreement shall not become effective until the Effective Date.

14.8.2Each Party will use reasonable efforts to do, or cause to be done, all things necessary, proper and advisable to, as promptly as practicable, take all actions necessary to obtain expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act, including filing with the U.S. Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice, any HSR Filing required of it under the HSR Act with respect to the transactions contemplated hereby within ten (10) Business Days after the Execution Date (or such later time as may be agreed to in writing by the Parties). The Parties shall cooperate with one another to the extent necessary in the preparation of any such HSR Filing and during the review by the U.S. Federal Trade Commission and/or the Antitrust Division of the U.S. Department of Justice.  Each Party shall be responsible for its own costs, expenses, and filing fees associated with any HSR Filing; provided, however, that Neurocrine shall be solely responsible for any fees (other than penalties that may be incurred as a result of actions or omissions on the part of Voyager) required to be paid in connection with making any such HSR Filing. If the Parties make an HSR Filing hereunder, then this Agreement shall terminate (a) at the election of either Party, immediately upon notice to the other Party, if the U.S. Federal Trade Commission or the U.S. Department of Justice seeks a preliminary injunction under the Antitrust Laws against Neurocrine and Voyager to enjoin the transactions contemplated by this Agreement; or (b) at the election of either Party, immediately upon notice to the other Party, in the event that the HSR Clearance Date shall not have occurred on or prior to one hundred eighty (180) days after the effective date of the HSR Filing. In the event of such termination, this Agreement shall be of no further force and effect.

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14.9Accrued Rights; Surviving Provisions of the Agreement.

14.9.1Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination or expiration, including any payment obligations hereunder , and any and all damages or remedies arising from any breach hereunder.  Such termination or expiration shall not relieve any Party from obligations which are expressly indicated to survive expiration or termination of this Agreement.

14.9.2The provisions of Articles 10, 11, 13, and 15 and Sections 2.2.2, 2.3, 2.4, the last sentence of 5.1 (only for those licenses that have become irrevocable prior to termination), 8.7, 8.8, 8.9, 8.10, 8.11, 8.12, 12.4, 14.6, 14.7, 14.9, shall survive the termination of this Agreement in its entirety or expiration of this Agreement for any reason, in accordance with their respective terms and conditions, and for the duration stated, and where no duration is stated, shall survive indefinitely.

ARTICLE 15
MISCELLANEOUS

15.1Governing Law.  This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed in accordance with the Laws of the State of New York without reference to conflicts of laws principles; provided that with respect to matters involving the enforcement of intellectual property rights, the Laws of the applicable country shall apply.  The provisions of the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement or any subject matter hereof.

15.2Dispute Resolution.  Except for the disputes at the JSC, which matters shall be resolved as provided in Section 3.6, in the event of any dispute arising out of or in connection with this Agreement (“Dispute”), either Party shall refer such Dispute in writing to the Parties’ respective Executive Officers, and such Executive Officers shall attempt in good faith to resolve such Dispute.  If the Dispute is not resolved within [...***...] after it has been referred to the Executive Officers, the Dispute shall be finally settled through binding arbitration pursuant to Section 15.3.  Any disputes concerning the propriety of the commencement of arbitration shall be finally settled by the arbitral tribunal.

15.3Arbitration Request.

15.3.1No Arbitration of Patent Issues.  Any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Patents Covering the Manufacture, use, importation, offer for sale or sale of Collaboration Products shall be submitted to a court of competent jurisdiction in the country in which such Patents were granted or arose.

15.3.2Arbitration Procedure.  Any Disputes that have not been amicably resolved pursuant to Section 15.2 within the [...***...] time period specified therein shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (the “ICC”) before a tribunal comprised of three arbitrators.  Each Party shall nominate one arbitrator and within [...***...] of the second arbitrator’s appointment, the two party-nominated arbitrators shall nominate the third arbitrator, who shall serve as president of the tribunal.  The arbitrators shall have experience in pharmaceutical licensing disputes.  An arbitrator shall be deemed to meet

 

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this qualification unless a Party objects within [...***...] after the arbitrator is nominated.  The seat, or legal place, or will be New York City, New York, United States.  The language of the arbitration shall be English.  The Parties shall mutually agree on the rules to govern discovery and the rules of evidence for the arbitration within [...***...] after the commencement of the arbitration.  If the Parties fail to timely agree to such rules, the United States Federal Rules of Civil Procedure will govern discovery and the United States Federal Rules of Evidence will govern evidence for the arbitration.  Subject to Section 13.5, the arbitrators shall be authorized to award compensatory damages, but shall not be authorized to award punitive, special, consequential, or any other similar form of damages, or to reform, modify, or materially change this Agreement.  The arbitrators shall also be authorized to grant temporary, preliminary or permanent equitable remedies or relief, including an injunction or order for specific performance.  The award of the arbitrators shall be the sole and exclusive remedy of the Parties, except for those remedies that are set forth in this Agreement or which apply to a Party by operation of the applicable provisions of this Agreement, and the Parties hereby expressly agree to waive the right to appeal from the decisions of the arbitrator, and there shall be no appeal to any court or other authority (government or private) from the decision of the arbitrator.  Judgment on the award rendered by the arbitrators may be entered in any court of competent jurisdiction.

15.3.3Costs.  During the pendency of the arbitration each Party shall bear its own attorneys’ fees, costs, and expenses of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators and the ICC administrative expenses; provided, however, that the arbitrators, in their final award, shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party its costs and expenses of arbitration, including its reasonable attorneys’ fees, the fees and costs of the arbitrators and ICC, and other costs and expenses (including, for example, expert witness fees and expenses, transcripts, photocopy charges and travel expenses), as determined by the arbitrators.

15.3.4Preliminary Injunctions.  Notwithstanding anything in this Agreement to the contrary, a Party may seek a temporary restraining order, preliminary injunction or other interim relief from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the award of the arbitrators on the ultimate merits of any dispute.

15.3.5Confidentiality.  The Parties agree that the arbitration shall be kept confidential.  The existence and contents of the arbitration, any non-public information provided in the arbitration, and any submissions, orders or awards made in the arbitration shall be deemed Confidential Information of each of the Parties and subject to Article 11, except that a Party may disclose such information to the arbitrators, the ICC, its counsel, experts, witnesses and any other person to the extent required for the conduct of the arbitration, or as required by applicable Law, to protect or pursue a legal right, or to enforce or challenge an awards in bona fide legal

15.3.6Suspension of Cure Period.  From the date the Secretariat of the International Court of Arbitration receives the request for arbitration and until such time as the Dispute has been finally settled, the running of the time periods as to which Party must cure a breach of this Agreement shall be suspended as to any breach that has been referred to arbitration.