Collaborative Research,development And Licence Agreement

Exhibit 10.15


Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4),

200.83 and 230.406


COLLABORATIVE RESEARCH, DEVELOPMENT


AND LICENSE AGREEMENT


By and Among

ACADIA PHARMACEUTICALS INC.,

ALLERGAN, INC.

and


ALLERGAN SALES, LLC

TABLE OF CONTENTS PAGE 1. DEFINITIONS 1 1.1 "ACADIA Know-How" 1 1.2 "ACADIA Patents" 2 1.3 "ACADIA Product" 2 1.4 "ACADIA Reversion Product" 2 1.5 "ACADIA Royalty-Free Product" 2 1.6 "ACADIA Technology" 2 1.7 "Active Compound" 2 1.8 "Affiliate" 2 1.9 "Allergan Know-How" 2 1.10 "Allergan Patents" 3 1.11 "Allergan Product" 3 1.12 "Allergan Technology" 3 1.13 "Alpha Adrenergic Research Plan" 3 1.14 "Alpha Adrenergic Research Program" 3 1.15 "Amendment" 3 1.16 "Chemical-Genomics Asset List" 3 1.17 "Chemical-Genomics Project" 3 1.18 "Chemistry" 3 1.19 "Collaboration" 4 1.20 "Collaboration Know-How" 4 1.21 "Collaboration Patents" 4 1.22 "Collaboration Target/Chemistry" 4 1.23 "Collaboration Technology" 4 1.24 "Confidential Information" 4 1.25 "Control" 4 1.26 "Designated Target" 4 1.27 "Designated Target/Chemistry" 4 1.28 "Designated Target Project" 4 1.29 "Development Candidate" 5


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TABLE OF CONTENTS (CONTINUED)

PAGE 1.30 "Excluded Targets" 5 1.31 "Expanded Field" 5 1.32 "Field" 5 1.33 "First Commercial Sale" 5 1.34 "FDA" 5 1.35 "FTE" 5 1.36 "Good Laboratory Practices" or "GLP" 6 1.37 "Good Manufacturing Practices" or "GMP" 6 1.38 "IND" 6 1.39 "Joint Research Committee" or "JRC" 6 1.40 "Licensed Target/Chemistry" 6 1.41 "Major Market" 6 1.42 "NDA" 6 2. CONDUCT OF COLLABORATION; RESPONSIBILITIES; EXCLUSIVITY 8 2.1 Conduct of Collaboration 8 2.2 Research Program Responsibilities 8 2.3 [***] 9 3. GOVERNANCE 9 3.1 Joint Research Committee 9 3.2 Joint Research Committee Functions And Powers 9 3.3 Information and Reports 10 3.4 JRC Dispute Resolution 10 4. TECHNOLOGY TRANSFER 10 4.1 Transfer of ACADIA Technology 10 4.2 Transfer of Allergan Technology 11 5. DESIGNATION OF SELECTED TARGET/CHEMISTRIES, LICENSED TARGET/CHEMISTRIES,
AND DESIGNATED TARGET/CHEMISTRIES 11 5.1 Designation of Selected Target/Chemistries 11 5.2 [***] 12 5.3 Designation of Designated Targets 13


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TABLE OF CONTENTS (CONTINUED)

PAGE 5.4 [***] 13 5.5 [***] 13 6. PRODUCT DEVELOPMENT, MANUFACTURING AND SUPPLY 14 6.1 Research and Development Efforts 14 6.2 Development Candidates 14 6.3 [***] 14 7 LICENSE GRANTS; DILIGENCE OBLIGATIONS 14 7.1 License Grants for Research Program 14 7.2 License Grants to Allergan for Development and Commercialization 15 7.3 License Grant to ACADIA for Development and Commercialization 15 7.4 Sublicensing Rights 16 7.5 Diligence Obligations; License for ACADIA Reversion Products 16 8. FEES AND PAYMENTS 16 8.1 [***] 16 8.2 License Fees 17 8.3 Expanded Field Fee 17 8.4 Research Funding 17 8.5 Milestone Payments 18 8.6 Royalties 19 9. PAYMENTS; RECORDS; AUDITS 20 9.1 Payment; Reports 20 9.2 Exchange Rate; Manner and Place of Payment 20 9.3 Late Payments 21 9.4 Records and Audits 21 9.5 Withholding of Taxes 21 9.6 Exchange and Royalty Rate Controls 21 10. INTELLECTUAL PROPERTY 21 10.1 Ownership of Technology 21 10.2 Patent Prosecution 22 10.3 Cooperation of the Parties 23


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TABLE OF CONTENTS (CONTINUED)

PAGE 10.4 Infringement by Third Parties 23 10.5 Infringement of Third Party Rights 24 10.6 Trademarks 24 10.7 Patent Labeling 24 11. REPRESENTATIONS AND WARRANTIES 24 11.1 Representations and Warranties 24 11.2 ACADIA Representations and Warranties 25 11.3 Allergan Representations and Warranties 26 11.4 Disclaimer Concerning Technology 26 12. CONFIDENTIALITY; PUBLICATION 26 12.1 Confidentiality 26 12.2 Exceptions 26 12.3 Terms of Agreement 27 12.4 Authorized Disclosure 27 12.5 Publications 28 13. TERM AND TERMINATION 28 13.1 Term of the Agreement 28 13.2 Termination by Mutual Agreement 28 13.3 Termination by Allergan 28 13.4 Termination for Cause 29 13.5 Effect of Termination or Expiration; Surviving Obligations 29 14. INDEMNITY 30 14.1 Indemnification 30 14.2 Control of Defense 31 14.3 Insurance 31 15. GOVERNING LAW; DISPUTE RESOLUTION 31 15.1 Governing Law 31 15.2 Dispute Resolution 31 15.3 Jurisdiction and Venue 32


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TABLE OF CONTENTS (CONTINUED)

PAGE 16. GENERAL PROVISIONS 32 16.1 Notices 32 16.2 Force Majeure 33 16.3 Entirety of Agreement 33 16.4 Non-Waiver 33 16.5 Disclaimer of Agency or Partnership 33 16.6 Severability 33 16.7 Affiliates; Assignment 33 16.8 Headings 34 16.9 Limitation of Liability 34 16.10 Counterparts 34 16.11 Bankruptcy 34 16.12 Public Disclosure 34 16.13 Export 34 16.14 [***] 35


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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4),

200.83 and 230.406

COLLABORATIVE RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT

THIS COLLABORATIVE RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT (this "Agreement" ), entered into as of March 27, 2003 (the "Effective Date" ) by and among ACADIA PHARMACEUTICALS INC. , a Delaware corporation ("ACADIA" ), with offices at 3911 Sorrento Valley Blvd., San Diego, California 92121, and Allergan, Inc., a Delaware corporation, and Allergan Sales, LLC, a Delaware limited liability company (collectively "Allergan" ), both having offices at 2525 Dupont Drive, Irvine, California 92612.

W I T N E S S E T H:

WHEREAS, ACADIA possesses proprietary chemical-genomics technologies, including Targets (as defined below) and related chemistries, for use in research, discovery and development of pharmaceutical products;


WHEREAS, Allergan is engaged in the research, development, marketing, manufacture and sale of pharmaceutical products;


WHEREAS, ACADIA, Allergan and Vision Pharmaceuticals L.P. are parties to that certain Collaborative Research, Development and License Agreement, dated as of September 24, 1997, as amended by the Amendment (as defined below) (the "1997 Agreement" );


WHEREAS, Allergan desires to have broad access to ACADIA's chemical-genomics assets and discovery and development capabilities for purposes of discovering and developing compounds primarily for eye care applications; and

WHEREAS, ACADIA and Allergan desire to enter into a collaborative relationship for research, discovery and development activities using ACADIA's proprietary chemical-genomics technologies and development and commercialization of compounds resulting from such activities primarily for eye care applications.


NOW, THEREFORE, in consideration of the foregoing and the covenants and premises contained in this Agreement, the parties agree as follows:


1. DEFINITIONS. As used herein, the following terms shall have the following meanings:

1.1 "ACADIA Know-How" shall mean, to the extent useful for the purposes of the Collaboration or any subsequent commercialization of Allergan Products, all tangible or intangible know-how, trade secrets, inventions, (whether or not patentable), data, preclinical results, physical, chemical or biological material and other information and data pertaining to any of the Collaboration Target/Chemistries, including any assay developed by ACADIA for a Target within the Collaboration Target/Chemistries, or otherwise necessary or useful for the

1.

practice of the ACADIA Patents which are not generally publicly known and are Controlled by ACADIA as of the Effective Date or during the Term, including any replication or any part of such information or material, but excluding any ACADIA Patents or Collaboration Technology.

1.2 "ACADIA Patents" shall mean, to the extent useful for the purposes of the Collaboration and any subsequent commercialization of Allergan Products, all foreign and domestic: (a) patents existing as of the Effective Date or issued during the Term; and (b) patents issuing from patent applications that are pending as of the Effective Date or during the Term (including provisionals, divisionals, continuations and continuations-in-part of such applications); and (c) substitutions, extensions, reissues, renewals and inventors certificates relating to the foregoing patents, in each case, which pertain to any of the Collaboration Target/Chemistries and are Controlled by ACADIA. ACADIA Patents existing as of the Effective Date will be listed in Exhibit A within ten (10) days of the Effective Date.


1.3 "ACADIA Product" shall mean an ACADIA Reversion Product or ACADIA Royalty-Free Product, as applicable.

1.4 "ACADIA Reversion Product" shall mean any product containing, incorporating, discovered or identified, or the utility of which is discovered or identified, using any Licensed Target/Chemistry, which product receives Regulatory Approval for commercial marketing and sale for use in the Field and is commercialized by ACADIA, its Affiliates or its sublicensees, including all formulations, line extensions and modes of administration thereof.

1.5 "ACADIA Royalty-Free Product" shall mean: (a) any product containing, incorporating or discovered or identified, or the utility of which is discovered or identified, using any Licensed Target/Chemistry, which product receives Regulatory Approval for commercial marketing and sale for use outside the Field and is commercialized outside the Field by ACADIA or its Affiliates or sublicensees, including all formulations, line extensions and modes of administration thereof; and/or (b) any product containing, incorporating or discovered or identified or the utility of which is discovered or identified using any Target/Chemistry that was previously a Selected Target/Chemistry, which product receives Regulatory Approval for commercial marketing and sale for use in any field of use and is commercialized in any field of use by ACADIA or its Affiliates or sublicensees, including all formulations, line extensions and modes of administration thereof.

1.6 "ACADIA Technology" shall mean the ACADIA Patents and the ACADIA Know-How.


1.7 "Active Compound" shall mean a small molecule that specifically inhibits, stimulates or otherwise alters the production or activity of a Target.


1.8 "Affiliate" shall mean any company or entity controlled by, controlling, or under common control with a party hereto and shall include any company or entity of which greater than fifty percent (50%) of the voting stock or participating profit interest of which is owned or controlled, directly or indirectly, by a party, and any company or entity which owns or controls, directly or indirectly, greater than fifty percent (50%) of the voting stock of a party.


2.

1.9 "Allergan Know-How" shall mean, to the extent useful for the purposes of the Collaboration or any subsequent commercialization of ACADIA Products, all tangible or intangible know-how, trade secrets, inventions (whether or not patentable), data, preclinical results, physical, chemical or biological material and other information and data pertaining to any of the Collaboration Target/Chemistries or otherwise necessary or useful for the practice of the Allergan Patents, which are not generally publicly known and are Controlled by Allergan during the Term, including any replication or any part of such information or material, but excluding any Allergan Patents or Collaboration Technology.


1.10 "Allergan Patents" shall mean, to the extent useful for the purposes of the Collaboration and any subsequent commercialization of ACADIA Products, all foreign and domestic: (a) patents issued during the Term; and (b) patents issuing from patent applications that are pending during the Term (including provisionals, divisionals, continuations and continuations-in-part of such applications); and (c) substitutions, extensions, reissues, renewals and inventors certificates relating to the foregoing patents, in each case, which pertain to any of the Collaboration Target/Chemistries and are Controlled by Allergan.


1.11 "Allergan Product" shall mean any product containing or incorporating a Chemistry within a Licensed Target/Chemistry or a Designated Target/Chemistry or discovered or identified, or the utility of which is discovered or identified, using a Licensed Target/Chemistry or Designated Target/Chemistry, which product receives Regulatory Approval for commercial marketing and sale and is commercialized, including all formulations, line extensions and modes of administration thereof.

1.12 "Allergan Technology" shall mean the Allergan Patents and Allergan Know-How.


1.13 "Alpha Adrenergic Research Plan" shall mean the plan for conducting research with respect to alpha adrenergic receptors as currently in effect under the 1997 Agreement as may be updated from time to time by the Joint Research Committee pursuant to Section 3.2.

1.14 "Alpha Adrenergic Research Program" shall mean the collaborative research program between the parties with respect to alpha adrenergic receptors conducted under the 1997 Agreement during the Research Term pursuant to the Alpha Adrenergic Research Plan.


1.15 "Amendment" shall mean the amendment entered into among ACADIA, Allergan and Vision Pharmaceuticals L.P. regarding the Alpha Adrenergic Research Program.

1.16 "Chemical-Genomics Asset List" shall mean the list of ACADIA's chemical-genomics assets, identifying Targets that are not Excluded Targets, assays and Chemistries as provided to Allergan on a bi-monthly basis pursuant to Section 4.1.


1.17 "Chemical-Genomics Project" shall mean the program of collaborative research with respect to Selected Target/Chemistries and Licensed Target/Chemistries conducted during the Research Term pursuant to the Research Plan.


3.

1.18 "Chemistry" shall mean those Active Compounds identified by or on behalf of ACADIA or Allergan with respect to a specific Target pursuant to or as a result of the Collaboration.


1.19 "Collaboration" shall mean the programs of collaborative research and development with respect to Collaboration Target/Chemistries under this Agreement.


1.20 "Collaboration Know-How" shall mean any and all tangible or intangible know-how, trade secrets, inventions (whether or not patentable), data, preclinical results, physical, chemical or biological material, and other information and data that are (a) useful for purposes of the Collaboration and/or that relates to any Collaboration Target/Chemistry (including any Target/Chemistry that was formerly a Selected Target/Chemistry), Allergan Product or ACADIA Product and (b) derived from or developed pursuant to activities undertaken by either party, including their consultants or collaborators, in the conduct of the Collaboration, including, in each case, any replication or any part of such information or material.

1.21 "Collaboration Patents" shall mean all foreign and domestic patents (including substitutions, extensions, reissues, renewals and inventors certificates relating thereto) that issue from patent applications, including provisionals, divisionals, continuations and continuations-in-part of such applications, that claim inventions in the Collaboration Know-How and that are filed by one or both of the parties on behalf of one or both of the parties hereto.

1.22 "Collaboration Target/Chemistry" shall mean any Selected Target/Chemistry, Licensed Target/Chemistry and/or Designated Target/Chemistry, as applicable.


1.23 "Collaboration Technology" shall mean the Collaboration Patents and the Collaboration Know-How.

1.24 "Confidential Information" shall mean all information disclosed by a party to the other pursuant to this Agreement including, without limitation, manufacturing, marketing, financial, personnel, scientific and other business information and plans, and the material terms of this Agreement, whether in oral, written, graphic or electronic form.

1.25 "Control" shall mean possession of the ability to grant a license or sublicense without violating the terms of any agreement or other arrangement with any Third Party.

1.26 "Designated Target" shall mean any Target that is a specific G-protein coupled receptor or nuclear receptor, which is selected by Allergan by written notice to ACADIA pursuant to Section 5.3 and, as of the date of such notice is not listed on the Chemical-Genomics Asset List as having a Chemistry identified with respect to such Target.


1.27 "Designated Target/Chemistry" shall mean a Designated Target and/or the Chemistry identified with respect to such Designated Target.

4.

1.28 "Designated Target Project" shall mean the program of collaborative research with respect to Designated Targets conducted during the Research Term pursuant to the Research Plan.


1.29 "Development Candidate" shall mean any Active Compound within a Licensed Target/Chemistry for which GLP research or GMP production has been initiated.

1.30 "Excluded Targets" shall mean Targets which meet any one of the following criteria as of the applicable time of determination: [***].


1.31 "Expanded Field" shall mean all fields of use.

1.32 "Field" shall mean (a) with respect to a Selected Target/Chemistry or Licensed Target/Chemistry, all therapeutic, prophylactic and diagnostic uses related to eye care; [***].

1.33 "First Commercial Sale" of an Allergan Product or an ACADIA Product shall mean the first sale for use or consumption of such Allergan Product or ACADIA Reversion Product in a country after Regulatory Approval has been granted by the governing health regulatory authority of such country. Sale to an Affiliate or sublicensee shall not constitute a First Commercial Sale unless the Affiliate or sublicensee is the end user of the Allergan Product or ACADIA Reversion Product.


1.34 "FDA" shall mean the United States Food and Drug Administration or any successor agency thereto having the administrative authority to regulate the marketing of

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human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States of America.


1.35 "FTE" shall mean full-time equivalent scientific personnel.

1.36 "Good Laboratory Practices" or "GLP" shall mean current good laboratory practices under FDA rules and regulations.


1.37 "Good Manufacturing Practices" or "GMP" shall mean current good manufacturing practices under FDA rules and regulations.

1.38 "IND" shall mean an Investigational New Drug Application filed with the FDA, or the equivalent application or filing necessary to commence human clinical trials in another country, as applicable.

1.39 "Joint Research Committee" or "JRC" shall mean the committee formed pursuant to Section 3.1.

1.40 "Licensed Target/Chemistry" shall mean any Selected Target/Chemistry as to which Allergan has exercised its Option pursuant to Section 5.2.


1.41 "Major Market" shall mean [***].

1.42 "NDA" shall mean a New Drug Application, Product License Application or equivalent application filed with the FDA, or the equivalent community application filed in the European Union, or the equivalent application filed as a national application in Japan, the United Kingdom, France, Germany, Italy or Spain.


1.43 "Net Sales" with respect to any Allergan Product or ACADIA Reversion Product for which royalties are payable hereunder means, with respect to a given period of time, gross sales invoiced by Allergan or ACADIA, as applicable, and its Affiliates and sublicensees during such period, less the following deductions from such gross amounts which are actually incurred, allowed, accrued or specifically allocated:

(a) credits or allowances actually granted for damaged products, returns or rejections of product, price adjustments and billing errors;


(b) governmental and other rebates (or equivalents thereof) granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers or to trade customers;

(c) normal and customary trade, and quantity discounts, allowances and credits actually allowed or paid;


(d) commissions actually paid to Third Party distributors, brokers or agents (excluding sales personnel, sales representatives and sales agents that are employees or

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consultants of Allergan or ACADIA, as applicable, or its Affiliates or sublicensees) in countries outside the United States in which such commissions are paid by deducting such commissions from the gross sales invoiced for sales to such Third Parties;

(e) transportation costs, including insurance, for outbound freight related to delivery of the product;


(f) sales taxes, VAT taxes and other taxes directly linked to the sales of the product; and

(g) sales between or among Allergan and its Affiliates and sublicensees or ACADIA and its Affiliates and sublicensees shall be excluded from the computation of Net Sales, but the subsequent final sales to Third Parties by such Affiliates or sublicensees shall be included with Net Sales; provided however , that if such Affiliates or sublicensees are the end users of such Allergan Product or ACADIA Reversion Product, the amount billed therefore shall be deemed to be the amount that would be invoiced to a Third Party in an arm's length transaction for the sale of such products.

In the event an Allergan Product or ACADIA Reversion Product is sold in combination with one or more other active ingredients (a "Combination" ) then Net Sales shall be calculated by multiplying the Net Sales of that Combination by the fraction A/B, where A is the gross selling price of the Allergan Product or ACADIA Reversion Product sold separately and B is the gross selling price of the Combination. In the event that no such separate sales are made, Net Sales for royalty determination shall be calculated by multiplying Net Sales of the Combination by the fraction C/(C+D), where C is the fully allocated cost of the Allergan Product or ACADIA Reversion Product and D is the fully allocated cost of the other products in the Combination.

1.44 [***]


1.45 [***]


1.46 "Regulatory Approval" shall mean any and all approvals (including price and reimbursement approvals), licenses, registrations, or authorizations of the United States or European Union or any country, federal, state or local regulatory agency, department, bureau or other government entity that is necessary for the manufacture, use, storage, import, transport and/or sale of an Allergan Product or an ACADIA Product in such jurisdiction.

1.47 "Research Plan" shall mean the plan for conducting the Research Program, as amended from time to time by the JRC.

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1.48 "Research Program" shall mean, collectively, the Designated Target Project and the Chemical-Genomics Project.


1.49 "Research Term" shall mean the three (3) years following the Effective Date, as may be extended for additional, consecutive [***] periods by written agreement of the parties.


1.50 "Royalty Term" shall mean, in the case of each Allergan Product or ACADIA Reversion Product in any country, the period of time commencing on the First Commercial Sale and ending upon the later of (a) [***], or (b) [***].

1.51 "Selected Target/Chemistry" shall mean each of the up to three (3) Target/Chemistries selected from the Chemical-Genomics Asset List at any specific point in time during the Research Term pursuant to Section 5.1.


1.52 "Target" shall mean [***].


1.53 "Target/Chemistry" shall mean a Target and/or any Chemistry identified with respect to such Target.


1.54 "Term" shall have the meaning set forth in Section 13.1.


1.55 "Third Party" shall mean any entity other than Allergan or ACADIA or an Affiliate of Allergan or ACADIA.


1.56 "Valid Claim" shall mean a claim of an unexpired patent included within the patent rights licensed hereunder, which has not been held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction unappealable or unappealed within the time allowed for appeal or which has not been admitted to be invalid or unenforceable through reexamination, reissue, disclaimer, or otherwise.


2. CONDUCT OF COLLABORATION; RESPONSIBILITIES; EXCLUSIVITY.


2.1 Conduct of Collaboration. During the Research Term, the parties shall use commercially reasonable efforts to conduct the Research Program in accordance with the Research Plan and the terms of this Agreement. The initial Research Plan for conducting the Research Program will be completed and approved by the JRC within thirty (30) days of the Effective Date. Any amendments or revisions to the Research Plan shall be in writing and shall require unanimous approval of the JRC. Pursuant to the Research Program, the parties will collaborate in identifying and testing Collaboration Target/Chemistries for development and commercialization.

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2.2 Research Program Responsibilities.

(a) ACADIA and Allergan will be responsible for such activities under the Research Plan related to the Chemical-Genomics Project [***] as assigned to each such party by the JRC.

(b) ACADIA will be responsible for high-throughput screening of chemical libraries and determination of potency and selectivity of hits in the Designated Target Project pursuant to the Research Plan, and Allergan will be responsible for all other activities under the Research Plan related to the Designated Target Project.


(c) Each of ACADIA and Allergan will provide to the JRC quarterly reports setting forth such party's results and plans under the Research Program.


2.3 [***]


3. GOVERNANCE.

3.1 Joint Research Committee. Promptly after the Effective Date, the parties will form a Joint Research Committee ("JRC" ) comprised of three (3) representatives of each of ACADIA and Allergan. One (1) member of the JRC shall be selected to act as the chairperson of the JRC, with each chairperson acting for a term of twelve (12) months. The chairperson shall be selected alternately by Allergan and ACADIA, and ACADIA shall designate the first chairperson. The JRC shall determine the specific goals for the Collaboration and the Alpha Adrenergic Research Program, shall manage the ongoing research conducted under the Collaboration and the Alpha Adrenergic Research Program, and shall monitor the progress and ...