COLLABORATIVE RESEARCH, DEVELOPMENT
AND LICENSE AGREEMENT
AMONG
ACADIA PHARMACEUTICALS INC.,
AND
ALLERGAN, INC.
AND
ALLERGAN PHARMACEUTICALS (IRELAND) LIMITED, INC.
AND
ALLERGAN SALES, INC.
TABLE OF CONTENTS
PAGE
1. Definitions...................................................................................1
2. Scope of Collaboration; Development Responsibilities; Exclusivity and Governance..............6
2.1 Scope of Collaboration...............................................................6
2.2 Development Responsibilities.........................................................6
2.3 Exclusivity of the Collaboration.....................................................6
2.4 Research Management Committee........................................................7
2.5 Research Management Committee Functions And Powers...................................7
2.6 Information And Reports..............................................................8
2.7 RMC Dispute Resolution...............................................................8
3. Technology Transfer and Identification of Active Compounds....................................8
3.1 Transfer of ACADIA Technology........................................................8
3.2 Transfer of Allergan Technology......................................................8
3.3 Identification of Active Compounds...................................................9
4. Compound Testing And Selection................................................................9
4.1 Testing To Identify Active Compounds.................................................9
4.2 Selection of Designated Compounds....................................................9
4.3 Selection of Collaboration Lead Compounds...........................................11
5. Product Development Manufacturing and Supply.................................................12
5.1 Development of Collaboration Lead Compounds.........................................12
5.2 Disclosure of Study Data on Collaboration Lead Compounds............................12
5.3 Manufacture and Supply..............................................................12
6. License Grants; Failure to Pursue Development in Japan.......................................12
6.1 License Grants for Collaborative Research...........................................12
6.2 License Grant for Development and Commercial Purposes...............................13
6.3 Sublicensing Rights.................................................................13
6.4 Diligence Obligations...............................................................13
6.5 Failure to Pursue Development in Japan..............................................13
7. Fees and Payments............................................................................14
7.1 Up-front Fee........................................................................14
7.2 Research Funding....................................................................14
7.3 Milestone Payments..................................................................15
7.4 Royalties...........................................................................16
8. Payments; Records; Audits....................................................................18
8.1 Payment; Reports....................................................................18
8.2 Exchange Rate; Manner and Place of Payment..........................................18
8.3 Late Payments.......................................................................18
8.4 Records and Audits..................................................................18
-i-
8.5 Withholding of Taxes................................................................19
8.6 Exchange and Royalty Rate Controls..................................................19
9. Intellectual Property........................................................................19
9.1 Ownership of Technology.............................................................19
9.2 Patent Prosecution..................................................................19
9.3 Cooperation of the Parties..........................................................20
9.4 Infringement by Third Parties.......................................................20
9.5 Infringement of Third Party Rights..................................................21
9.6 Trademarks..........................................................................22
9.7 Patent Labeling.....................................................................22
10. Representations and Warranties...............................................................22
10.1 Representations and Warranties......................................................22
10.2 ACADIA Representations and Warranties...............................................22
10.3 Allergan Representations and Warranties.............................................23
10.4 Disclaimer Concerning Technology....................................................23
11. Confidentiality; Publication.................................................................24
11.1 Confidentiality.....................................................................24
11.2 Exceptions..........................................................................24
11.3 Terms of Agreement..................................................................24
11.4 Authorized Disclosure...............................................................24
11.5 Publications........................................................................25
12. Term and Termination.........................................................................26
12.1 Term of the Agreement...............................................................26
12.2 Termination by Mutual Agreement.....................................................26
12.3 Termination by Allergan.............................................................26
12.4 Termination for Cause...............................................................26
12.5 Accrued Rights, Surviving Obligations...............................................26
13. Indemnity....................................................................................28
13.1 Indemnification.....................................................................28
13.2 Control of Defense..................................................................28
13.3 Insurance...........................................................................28
14. Governing Law; Dispute Resolution............................................................29
14.1 Governing Law.......................................................................29
14.2 Dispute Resolution..................................................................29
14.3 Jurisdiction and Venue..............................................................29
15. General Provisions...........................................................................29
15.1 Notices.............................................................................29
15.2 Force Majeure.......................................................................30
15.3 Entirety of Agreement...............................................................30
15.4 Non-Waiver..........................................................................30
-ii-
15.5 Disclaimer of Agency................................................................30
15.6 Severability........................................................................30
15.7 Affiliates; Assignment..............................................................30
15.8 Headings............................................................................31
15.9 Limitation of Liability.............................................................31
15.10 Counterparts........................................................................31
15.11 Bankruptcy..........................................................................31
15.12 Public Disclosure...................................................................32
-iii-
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 July 26, 1999 (the "Effective Date") by and
among ACADIA PHARMACEUTICALS INC., a Delaware corporation ("ACADIA"), with
offices at 0000 Xxxxxxxx Xxxxxx Xxxx., Xxx Xxxxx, Xxxxxxxxxx 00000 and ALLERGAN
PHARMACEUTICALS (IRELAND) LIMITED, INC. a Panamanian corporation with offices at
Xxxxxxxxx xxxx Xxxxxxxx, Xxxxxx Xxxx, Xxxxxxx, ALLERGAN SALES, INC. a California
corporation with offices at 0000 Xxxxxx Xxxxx, Xxxxxx, Xxxxxxxxxx 00000 and
ALLERGAN, INC., a Delaware corporation, with offices at 0000 Xxxxxx Xxxxx,
Xxxxxx, Xxxxxxxxxx 00000 (hereinafter collectively "Allergan"),
W I T N E S S E T H:
WHEREAS, ACADIA has discovered compounds that are potent agonists
selective for the m1 muscarinic receptor which agonists may be useful in the
treatment of ocular disease such as glaucoma; and
WHEREAS Allergan is engaged in the research, development, marketing,
manufacture and sale of therapeutic products for the treatment of ocular
disease; and
WHEREAS, ACADIA and Allergan desire to enter into a collaborative
relationship to conduct research with the goal of designating two [***] specific
muscarinic receptor ligands as lead drug development compounds for development
and commercialization by Allergan for the treatment of ocular disease:
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 DESIGNATED COMPOUND" shall mean any one (1) of up to
[***] Active Compounds and their respective [***] (to the extent such [***]
are included in the mixture tested) and salts thereof, at any one time
selected as a drug candidate by ACADIA pursuant to Section 4.3(b).
1.2 "ACADIA KNOW-HOW" shall mean 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 on or relating to all [***] Muscarinics that (a) ACADIA
owns, controls or to which it has a license with the right to sublicense on
the Effective Date or (b) are independently developed by ACADIA or its
Affiliates during the Research Term and, in each case, any replication or any
part of such information or material.
1
*CONFIDENTIAL TREATMENT REQUESTED
1.3 "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 Research Term; and (b) patents issuing from patent
applications that are pending as of the Effective Date or during the Research
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,
which ACADIA owns or controls or to which ACADIA has a license (with the right
to sublicense). ACADIA Patents shall also mean any patents solely owned by
ACADIA pursuant to Section 9.1 hereof. ACADIA Patents existing as of the
Effective Date are the patents and applications listed in Exhibit C attached
hereto.
1.4 "ACADIA Pool Compounds" shall have the meaning set forth in Section
4.2.
1.5 "ACADIA PRODUCT" shall mean any product containing a Collaboration
Lead Compound which receives Regulatory Approval for commercial marketing and
sale for use in the Field and is commercialized in the Field by ACADIA, its
Affiliates or its 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 COMPOUNDS" shall mean any M1 Muscarinic that demonstrates
the requisite activity levels in the Assays pursuant to the Research Plan, as
such activity levels may be amended from time to time by the RMC.
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 of which greater than fifty percent (50%) of whose voting stock or
participating profit interest is owned or controlled, directly or indirectly, by
a party, and any company which owns or controls, directly or indirectly, greater
than fifty percent (50%) of the voting stock of a party.
1.9 "ALLERGAN DESIGNATED COMPOUND" shall mean any one (1) of up to
[***] Active Compounds, [***], at any one time selected as a drug candidate
by Allergan pursuant to Section 4.3(a) hereof for research and development in
the Field.
1.10 "ALLERGAN KNOW-HOW" shall mean all tangible or intangible
know-how, trade secrets, inventions (whether or not patentable), data,
preclinical and clinical results, physical, chemical or biological material, and
other information and data on or relating to all [***] Muscarinics that are
independently developed by Allergan or its Affiliates during the Research Term
and, in each case, any replication or any part of such information or material.
1.11 "ALLERGAN PATENTS" shall mean any patents solely owned by Allergan
pursuant to Section 9.1 hereof.
1.12 "Allergan Pool Compounds" shall have the meaning set forth in
Section 4.2.
2
*CONFIDENTIAL TREATMENT REQUESTED
1.13 "ALLERGAN PRODUCT" shall mean any product containing a
Collaboration Lead Compound which receives Regulatory Approval for commercial
marketing and sale for use in the Field and is commercialized in the Field by
Allergan, its Affiliates or its sublicensees; including all formulations, line
extensions and modes of administration thereof.
1.14 "ALLERGAN TECHNOLOGY" shall mean the Allergan Patents and Allergan
Know-How.
1.15 "ASSAYS" shall mean R-SAT-TM- assays used to measure activity at
all muscarinic receptors and other IN VITRO molecular assays as determined by
the RMC.
1.16 "COLLABORATION" shall mean the programs of collaborative
research and development under this Agreement for the discovery, selection,
synthesis, investigation, and preclinical and clinical development of [***]
Muscarinics for use in the Field.
1.17 "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 is (a) useful for purposes of the
Collaboration and/or that relates to [***] Muscarinics, Allergan Designated
Compounds, Allergan Pool Compounds or Collaboration Lead Compounds, but
excluding ACADIA Designated Compounds and ACADIA Pool Compounds and (b) that
is derived from or developed pursuant to activities undertaken by either
party, including their consultants or collaborators in the conduct of the
Collaboration, and, in each case, any replication or any part of such
information or material.
1.18 "COLLABORATION LEAD COMPOUND" shall mean [***]Compound selected
by Allergan pursuant to Section 4.5 hereof as [***] and commercialization for
use in the Field.
1.19 "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.
1.20 "COLLABORATION TECHNOLOGY" shall mean the Collaboration Patents
and the Collaboration Know-How.
1.21 "CONFIDENTIAL INFORMATION" shall mean all information, inventions,
know-how or data 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.
1.22 "FIELD" shall mean the prevention or treatment of ocular disease.
1.23 "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 such ACADIA Product in a country after Regulatory Approval has been
granted by the governing health regulatory
3
*CONFIDENTIAL TREATMENT REQUESTED
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 Product.
1.24 "FTE" shall mean full-time equivalent scientific personnel.
1.25 "IND" shall mean an Investigational New Drug Application filed
with the United States Food and Drug Administration, or the equivalent
application or filing necessary to commence human clinical trials in another
country, as applicable.
1.26 "[***] MUSCARINICS" shall mean all [***] muscarinic receptor
ligands (i) in ACADIA's possession as of the Effective Date, (ii) synthesized
during the Research Term pursuant to the Research Plan or in any other ACADIA
program which selectively targets activation of the [***] muscarinic
receptor, or (iii) acquired from Third Parties during the Research Term
pursuant to the Research Plan or in conjunction with any other ACADIA program
which selectively targets activation of the [***] muscarinic receptor.
1.27 "MAJOR MARKET" shall mean the [***].
1.28 "NDA" shall mean a New Drug Application, Product License
Application or equivalent application filed with the United States Food and
Drug Administration, or the equivalent community application filed in [***],
or the equivalent application filed as a national application in [***].
1.29 "NET SALES" shall mean, with respect to any Allergan Product or
ACADIA Product, the amount invoiced by Allergan or ACADIA, their Affiliates
or sublicensees to Third Parties which are not Affiliates or sublicensees of
the selling party, unless such Affiliates or sublicensees are the end users
of such Allergan Product or ACADIA Product in which case the amount billed
therefor 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 less (i)
cash discounts and/or quantity discounts allowed; (ii) credits and allowances
of returns, rejections and recalls; (iii) charges for freight, insurance and
transportation specifically included in the amount invoiced; (iv) sales and
use taxes, duties or other governmental tariffs and other similar taxes
incurred and government mandated rebates, (v) accruals for estimated
wholesaler chargebacks, contract rebates and bid rebates and Medicaid and
other similar government mandated rebates as Allergan or ACADIA may be
required to pay from time to time, all of which shall be determined in
accordance with such party's standard accounting methods. In the event an
Allergan Product or an ACADIA Product is sold in a combination product with
other biologically active components, Net Sales, for purposes of royalty
payments on the combination product, 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 Product sold separately and B
is the gross selling price of the combination product. 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 active ingredient
(Collaboration Lead Compound) in the Allergan Product or ACADIA Product and D
is the fully allocated cost of such other biologically active components. In
no event shall Net Sales of any
4
*CONFIDENTIAL TREATMENT REQUESTED
Allergan Product or ACADIA Product calculated under this provision with
respect to any combination product be less than [***] of the Net Sales of
such combination product. In the event an Allergan Product or an ACADIA
product is sold in a capitated arrangement or with other products (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 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 Product and D is
the fully allocated cost of the other products in the Combination. From time
to time, but not less often than annually, the party owing any royalty with
respect to Net Sales will determine the actual amount of rebates paid under
clauses (iv) and (v) above and any differences between the estimates accrued
under (v) above and the actual amounts paid will be treated as adjustments to
Net Sales subject to royalty in the period in which such differences are so
determined.
1.30 "PROOF OF CONCEPT IN GLAUCOMA PATIENTS" shall have the meaning
stated in Exhibit A hereto.
1.31 "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.
1.32 "RESEARCH MANAGEMENT COMMITTEE" or "RMC" shall mean the committee
formed pursuant to Section 2.4.
1.33 "RESEARCH PLAN" shall mean the plan for conducting the research
under the Collaboration, as amended from time to time by the RMC. The initial
Research Plan agreed upon by the parties hereto is attached to this Agreement as
Exhibit B. Any amendments or revisions to the Research Plan shall be in writing
and shall require unanimous approval of the RMC.
1.34 "RESEARCH PROGRAM" shall mean a collaborative research program in
the Field under this Agreement with the goal of designating two Collaboration
Lead Compounds for development and commercialization in the Field.
1.35 "RESEARCH TERM" shall mean [***] following the Effective Date
and one additional [***] renewal period upon written notice from Allergan no
less than [***] prior to the anniversary of the Effective Date, if Allergan
has not selected two Collaboration Lead Compounds during the [***] period
following the Effective Date. The Research Term may be further extended upon
terms to be agreed upon by the parties in good faith negotiations.
1.36 "ROYALTY TERM" shall mean, in the case of each Allergan Product or
ACADIA Product, in any country, the period of time commencing on the First
Commercial Sale and ending upon the later of (a) ten (10) years from the date of
First Commercial Sale in such
5
*CONFIDENTIAL TREATMENT REQUESTED
country, or (b) the expiration of the last to expire Valid Claim covering
such Allergan Product or ACADIA Product in such country.
1.37 "TERM OF THE AGREEMENT" shall have the meaning ascribed in Section
12.1.
1.38 "TERRITORY" shall mean all countries of the world.
1.39 "THIRD PARTY" shall mean any entity other than Allergan or ACADIA
or an Affiliate of Allergan or ACADIA.
1.40 "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 and which has not been admitted to be invalid or
unenforceable through reexamination, reissue or disclaimer.
2. SCOPE OF COLLABORATION; DEVELOPMENT RESPONSIBILITIES; EXCLUSIVITY
AND GOVERNANCE.
2.1 SCOPE OF COLLABORATION. The parties hereby agree to establish and
conduct, during the Research Term, a collaborative research program in
accordance with the Research Plan and the terms of this Agreement. The initial
Research Plan for conducting such research program is attached to this Agreement
as Exhibit B. Pursuant to the Collaboration, the parties will collaborate in
identifying Active Compounds with the goal of designating two Collaboration Lead
Compounds for development and commercialization.
2.2 DEVELOPMENT RESPONSIBILITIES. ACADIA will be primarily
responsible for providing all medicinal, computational and synthetic
chemistry and m1 muscarinic R-SAT-TM- analysis and other IN VITRO molecular
assays selected by the RMC. ACADIA will also be primarily responsible for
providing sufficient quantities [***] of non-GMP Allergan Designated
Compounds to Allergan for pre-IND animal proof of concept testing. Allergan
will be primarily responsible for the IN VIVO testing in relevant disease
models, the preclinical development of Allergan Designated Compounds in the
Field including, but not limited to; pharmaceutics, ADME, toxicology, process
chemistry and manufacturing scale up, and the further preclinical and
clinical development of Collaboration Lead Compounds.
2.3 EXCLUSIVITY OF THE COLLABORATION. During the Research Term, the
Research Program shall be the parties' exclusive means of collaborating
and/or conducting research and development on [***] muscarinics in the Field.
Other than pursuant to the terms of this Agreement, at the end of the
Research Term for as long as Allergan is developing, and until Allergan has
commercialized a Collaboration Lead Compound, Allergan shall not: (a)
collaborate with any Third Party for the purpose of discovering, developing
and/or commercializing any compounds for use in the Field that produce the
intended therapeutic effects principally by selective activation of the [***]
muscarinic receptor (b) license in or acquire from any Third Party any
compound and/or product for use in the Field that produces the intended
therapeutic effects principally by selective activation of the [***]
muscarinic receptor or (c) conduct any research and/or development for the
purpose of identifying compounds for use in the Field that produce the
intended therapeutic effects principally by selective activation of the [***]
muscarinic receptor.
6
*CONFIDENTIAL TREATMENT REQUESTED
For the purposes of the forgoing, ("selective") shall mean as set forth in
the initial Research Plan attached as Exhibit B activity at the [***]
muscarinic receptor at least [***] the activity at the [***] muscarinic
receptor. At the end of the Research Term: if Allergan is developing a
Collaboration Lead Compound in the Field, then (x) so long as Allergan is
actively developing a Collaboration Lead Compound or commercializing an
Allergan Product as permitted under this Agreement ACADIA shall not develop,
itself, or with a Third Party any Allergan Designated Compound or ACADIA
Designated Compound in the Field or any Collaboration Lead Compound in any
field, and (y) for [***] after the end of the Research Term, only if Allergan
continues to develop a Collaboration Lead Compound during such [***] period,
ACADIA shall not develop any Allergan Designated Compound, itself, or with a
Third Party, in any field, and (z) for [***] after the end of the Research
Term, only if Allergan continues to develop a Collaboration Lead Compound
during such [***] period, ACADIA shall not develop any [***] muscarinic,
itself, or with a Third Party, in the Field.
2.4 RESEARCH MANAGEMENT COMMITTEE. Promptly after the Effective
Date, the parties will form a Research Management Committee ("RMC") comprised
of three (3) representatives of each of ACADIA and Allergan. One member of
the RMC shall be selected to act as the chairperson of the RMC, with each
chairperson acting for a term of [***]. The chairperson shall be selected
alternately by Allergan and ACADIA, and ACADIA shall designate the first
chairperson. The RMC shall determine the specific goals for the
Collaboration, shall manage the ongoing research conducted under the
Collaboration, and shall monitor the progress and results of such work. All
decisions of the RMC shall be unanimous. The RMC shall meet on a quarterly
basis or at such other frequency as the RMC agrees. The parties shall agree
upon the time and place of meetings. Within [***] after each meeting, the RMC
chairperson will provide the parties with a written report describing, in
reasonable detail, the status of the Collaboration, a summary of the results
and progress to date, the issues requiring resolution, and the agreed
resolution of previously reported issues. A reasonable number of additional
representatives of a party may attend meetings of the RMC in a non-voting
capacity.
2.5 RESEARCH MANAGEMENT COMMITTEE FUNCTIONS AND POWERS. The RMC shall
encourage and facilitate ongoing cooperation between the parties, establish,
update, review and approve the Research Plan and other plans for accomplishing
the Collaboration goals, allocate tasks and coordinate activities required to
perform the Collaboration, monitor progress of the Collaboration and the
parties' diligence in carrying out their responsibilities thereunder, oversee
the conduct of all patent matters, determine the IN VITRO data and information
that must be provided to Allergan and to ACADIA on each Active Compound to
enable Allergan and ACADIA to determine their interest in selecting such Active
Compound as an Allergan Pool Compound or an ACADIA Pool Compound and carry out
the other duties and responsibilities described for it in this Agreement. The
RMC shall also be responsible for developing and approving an annual research
budget for activities to be performed by the parties pursuant to the Research
Plan for [***] of the Research Term (including any renewal or extension
thereof), subject to the minimum funding levels provided in Section 7.2. Such
budget shall set forth the research funding to be provided by Allergan to
ACADIA, which shall be determined based on the number of FTEs required for
ACADIA to perform its activities under the Research Plan.
7
*CONFIDENTIAL TREATMENT REQUESTED
In addition, the RMC shall maintain and, on a regular basis, update and
provide to the parties a list or lists of the following: Active Compounds,
ACADIA Designated Compounds, ACADIA Pool Compounds, Allergan Designated
Compounds, Allergan Pool Compounds, and Collaboration Lead Compounds.
2.6 INFORMATION AND REPORTS. Except as otherwise provided in this
Agreement, the parties will make available and disclose to one another all
results of the work conducted pursuant to the Collaboration prior to and in
preparation for RMC meetings, in the form and format to be designated by the
RMC.
2.7 RMC DISPUTE RESOLUTION. If the RMC is unable to decide or
resolve an issue unanimously, the issue shall be referred to the Chief
Scientific Officer of ACADIA and the President, Research and Development of
Allergan. Such officers of the parties will meet promptly thereafter and
shall negotiate in good faith to resolve such issue. If they cannot resolve
the issue within [***] of commencing such negotiations then the issue shall
be resolved as provided in Section 14.2.
3. TECHNOLOGY TRANSFER AND IDENTIFICATION OF ACTIVE COMPOUNDS.
3.1 TRANSFER OF ACADIA TECHNOLOGY. Commencing promptly after the
Effective Date and from time to time thereafter, ACADIA shall disclose to
Allergan such of the ACADIA Technology and relevant information with respect to
ACADIA Designated Compounds as is reasonably necessary to enable Allergan to
perform its Collaboration activities hereunder in accordance with the Research
Plan and otherwise to exercise fully the licenses granted to Allergan hereunder,
provided, however, that with respect to information relating to ACADIA
Designated Compounds, ACADIA shall only be required to disclose such information
to the extent that it is permitted to do so and Allergan shall only have the
right to use such information for research purposes. During the Term of the
Agreement, ACADIA will provide Allergan with reasonable technical assistance
relating to the use of such ACADIA Know-How and the practice of such ACADIA
Patents in the Field solely to the extent permitted under the licenses granted
to Allergan herein. In the event that ACADIA provides any materials to Allergan
pursuant to the Research Plan, the parties will enter into a Materials Transfer
Agreement in the form attached hereto as Exhibit D with respect to such
materials.
3.2 TRANSFER OF ALLERGAN TECHNOLOGY. Commencing promptly after the
Effective Date and from time to time thereafter, Allergan shall disclose to
ACADIA such of the Allergan Technology as is reasonably necessary to enable
ACADIA to perform its Collaboration activities hereunder in accordance with the
Research Plan and otherwise to exercise fully the licenses granted to ACADIA
hereunder. For the avoidance of doubt, Allergan shall have no obligation to
disclose to ACADIA clinical data related to Collaboration Lead Compounds other
than as required pursuant to Section 5.2, unless ACADIA exercises its right to
develop and commercialize collaboration Lead Compounds pursuant to Section 6.5,
12.5(b) or 12.5(c). In addition, Allergan shall make available all data and
information existing as of the Effective Date generated by Allergan, its
Affiliates or its collaborators under the Confidential Disclosure Agreement
dated March 1, 1998 between ACADIA and Allergan. During the Term of the
Agreement, Allergan will provide ACADIA with reasonable technical assistance
relating to the use of such Allergan Know-How and the practice of such Allergan
Patents solely to the extent
8
*CONFIDENTIAL TREATMENT REQUESTED
permitted under the license granted to ACADIA herein. In the event that
Allergan provides any materials to ACADIA pursuant to the Research Plan, the
parties will enter into a Materials Transfer Agreement in the form attached
hereto as Exhibit D with respect to such materials.
3.3 IDENTIFICATION OF ACTIVE COMPOUNDS. During the Research Term,
the parties shall collaborate in accordance with the Research Plan to perform
research to identify Active Compounds with the potential to become Allergan
Designated Compounds or ACADIA Designated Compounds. The parties shall report
the results of such research promptly to the RMC.
4. COMPOUND TESTING AND SELECTION.
4.1 TESTING TO IDENTIFY ACTIVE COMPOUNDS.
(a) COMPOUNDS FOR TESTING. During the Research Term, ACADIA will
make all [***] Muscarinics available for testing in the Assays pursuant to
the Research Plan. ACADIA will promptly provide to the RMC any information in
ACADIA's possession regarding the chemical structure and properties of such
compounds. In addition, the RMC may agree to have ACADIA synthesize
additional compounds and to obtain from Third Parties rights to screen
compounds owned or controlled by Third Parties; PROVIDED, HOWEVER, that if
there would be any amounts payable to such Third Party for testing such
compounds or making, using or selling products containing such compounds, no
such Third Party compounds will be procured and screened without the consent
of both parties.
(b) TESTING. ACADIA shall use commercially reasonable efforts to
conduct the testing in the Assays of [***] Muscarinics pursuant to the
Research Plan or selected for testing under Section 4.1(a). The primary goal
of the testing is to determine the activity of such selected compounds to
identify Active Compounds.
(c) IDENTIFICATION OF ACTIVE COMPOUNDS. Promptly after completing
the testing of a batch of compounds under this Section 4.1 in the Assays,
ACADIA will provide to the RMC the results of such testing. The RMC will
review such Assay results promptly after receipt and will determine which of
the screened compounds meet the requirements established in the Research Plan
for designation as Active Compounds, as such requirements may be modified by
the RMC. Upon designating Active Compounds, the RMC shall add such compounds
to the list of all Active Compounds, which shall be maintained by the RMC,
and shall forward the updated list to each party.
4.2 SELECTION OF POOL COMPOUNDS. The process for selection of
Active Compounds as Allergan Pool Compounds or as ACADIA Pool Compounds shall
be as set forth in this Section 4.2, and as such process may be amended by
the RMC from time to time.
The parties shall meet on a quarterly basis, or more frequently, as
agreed to by the RMC, to select Active Compounds which have the potential of
becoming Allergan Designated Compounds or ACADIA Designated Compounds,
hereinafter defined as a "Compound Selection Meeting". Such Compound
Selection Meetings shall be scheduled contemporaneously with RMC meetings, to
the extent practicable. At least [***] before each Compound Selection Meeting
ACADIA shall provide to the RMC the Assay results on all [***] Muscarinics
tested since the last report describing such Assay results was delivered to
the RMC. The Assay
9
*CONFIDENTIAL TREATMENT REQUESTED
results shall be provided in a form as agreed to by the RMC. Each Compound
Selection Meeting shall begin by reviewing the Assay results provided by
ACADIA prior to such Compound Selection Meeting and, pursuant to Section 4.1
(c), determining which of the screened compounds meet the requirements for
designation as Active Compounds.
The selection of Active Compounds by ACADIA and by Allergan shall
take place at each Compound Selection Meeting in [***] and each such Active
Compound selected [***] shall hereinafter be defined as an Allergan Pool
Compound or ACADIA Pool Compound, [***]. [***] shall make the [***] the
initial Compound Selection Meeting [***]. The RMC shall record [***]. From
the date upon which each [***] Pool Compound is designated hereunder until
the end of the Research Term, [***] shall not [***] Pool Compounds. At the
end of the Research Term all rights to [***] Pool Compounds but not [***]
Designated Compounds or Collaboration Lead Compounds shall [***].
4.3 SELECTION OF DESIGNATED COMPOUNDS.
(a) SELECTION BY ALLERGAN. Allergan shall have the right, in
consultation with the RMC, to select up to [***] Allergan Pool Compounds that
appear promising for preclinical evaluation by Allergan for use in the Field.
At the time of such selection, such selected Allergan Pool Compounds shall be
designated as Allergan Designated Compounds. From time to time thereafter,
Allergan may designate additional Allergan Pool Compounds as Allergan
Designated Compounds or remove the designation from previously designated
Allergan Designated Compounds so long as the total number of Allergan
Designated Compounds shall not exceed [***] at any time.
Allergan shall use reasonable efforts to conduct, at its own
expense, all preclinical testing and investigations necessary for Allergan to
select appropriate Allergan Designated Compounds to designate as
Collaboration Lead Compounds for further development. Such further
development may include, at Allergan's reasonable discretion, but not be
limited to, GLP toxicology studies, formulation and process development,
animal testing and other preclinical pharmaceutical development necessary to
prepare and file an IND and all additional animal testing and human clinical
testing necessary to file a NDA. Except as provided in Section 2.2, Allergan
will be responsible for providing, at its own expense, the supply of all
Allergan Designated Compounds and Collaboration Lead Compounds necessary for
preclinical and clinical development worldwide.
Allergan shall provide promptly to the RMC the results of all work
it performs pursuant to this Section 4.3(a) during the Research Term.
Allergan shall use reasonable efforts to conduct such work in order to select
a Collaboration Lead Compound as soon as possible. From the date upon which
each Allergan Designated Compound is designated hereunder until the date that
is [***] following the end of the Research Term, ACADIA will not grant any
license
10
*CONFIDENTIAL TREATMENT REQUESTED
to a Third Party under its interest in the Allergan Designated Compounds. On
the date that is [***] following the end of the Research Term all rights to
Allergan Designated Compounds (unless such Allergan Designated Compound has
been selected as a Collaboration Lead Compound and Allergan continues
development or commercialization of such Collaboration Lead Compound) shall
revert to ACADIA, subject to the provisions of Section 2.3 hereof.
(b) SELECTION BY ACADIA. ACADIA shall have the right, in
consultation with the RMC, to select up to [***] ACADIA Pool Compounds for
use in ACADIA's own research programs or the research programs of Third
Parties selected by ACADIA. At the time of such selection, such selected
ACADIA Pool Compounds shall be designated as ACADIA Designated Compounds.
From time to time thereafter, ACADIA may designate additional ACADIA Pool
Compounds as ACADIA Designated Compounds or remove the designation from
previously designated ACADIA Designated Compounds so long as the total number
of ACADIA Designated Compounds shall not exceed [***] at any time.
4.4 SUBSTITUTION OF DESIGNATED COMPOUNDS
In the event that Allergan elects to remove the designation from a
previously designated Allergan Designated Compound and replace such Allergan
Designated Compound with another Allergan Pool Compound, then Allergan shall
provide ACADIA notice of Allergan's intent to substitute such Allergan
Designated Compound and ACADIA shall have the right to select such previously
designated Allergan Designated Compound as an ACADIA Designated Compound. If
within [***] following such notice, ACADIA has not provided notice to
Allergan that it intends to select such previously designated compound as an
ACADIA Designated Compound then such previously designated Allergan
Designated Compound shall become an Allergan Pool Compound.
In the event that ACADIA elects to remove the designation from a
previously designated ACADIA Designated Compound and replace such ACADIA
Designated Compound with another ACADIA Pool Compound, then ACADIA shall
provide Allergan notice of ACADIA's intent to substitute such ACADIA
Designated Compound and Allergan shall have the right to select such
previously designated ACADIA Designated Compound as an Allergan Designated
Compound. If within [***] following such notice, Allergan has not provided
notice to ACADIA that Allergan intends to select such previously designated
compound as an Allergan Designated Compound then such previously designated
ACADIA Designated Compound shall become an ACADIA Pool Compound.
4.5 SELECTION OF COLLABORATION LEAD COMPOUNDS. Allergan shall have
the right to select and designate, by written notice to ACADIA and the RMC,
up to two (2) Collaboration Lead Compounds for clinical development. Allergan
shall use reasonable efforts to select a Collaboration Lead Compound prior to
the end of the Research Term. Upon selection of an Allergan Designated
Compound as a Collaboration Lead Compound, Allergan shall be entitled to
select another Allergan Pool Compound as an Allergan Designated Compound so
that it retains [***] Allergan Designated Compounds. Allergan may, at any
time, exchange a Collaboration Lead Compound for an Allergan Designated
Compound, which will then become a Collaboration Lead Compound.
11
*CONFIDENTIAL TREATMENT REQUESTED
5. PRODUCT DEVELOPMENT MANUFACTURING AND SUPPLY.
5.1 DEVELOPMENT OF COLLABORATION LEAD COMPOUNDS. After selection of
each Collaboration Lead Compound Allergan shall prepare and deliver to ACADIA
within a reasonable period, such period not to exceed [***] for a draft and
[***] for a final, thereafter, a written development plan for conducting
research and development on such Collaboration Lead Compound, describing the
activities and projected timing of the activities necessary to obtain
Regulatory Approval for such Collaboration Lead Compound. Each such
development plan shall be prepared by Allergan in a manner consistent with
commercially reasonable standards and practices in the industry. Allergan
shall have the sole responsibility for conducting preclinical and clinical
development of Collaboration Lead Compounds in accordance with the
development plan. Allergan agrees to use commercially reasonable efforts to
fund and perform such development in Major Markets.
5.2 DISCLOSURE OF STUDY DATA ON COLLABORATION LEAD COMPOUNDS. At
least once every [***] from the date upon which Allergan designates a
Collaboration Lead Compound(s), Allergan shall provide to ACADIA prior to an
IND filing for such Collaboration Lead Compound, a report summarizing the
scientific results of studies on such Collaboration Lead Compound and,
subsequent to an IND filing for such Collaboration Lead Compound, the IND
update or equivalent report required by the United States Food and Drug
Administration for such Collaboration Lead Compound. In each such report,
Allergan shall provide ACADIA a description of the progress made during the
[***] towards obtaining Regulatory Approval of such Collaboration Lead
Compound and the plans for the [***]. Allergan shall have the right to modify
the development plan in the event that commercial, scientific or competitive
conditions or regulatory requirements change during the course of the
development and/or there are unanticipated results obtained in preclinical or
clinical studies.
5.3 MANUFACTURE AND SUPPLY. Except as outlined in Section 2.2,
Allergan shall be responsible for providing, at its sole expense, the supply
of all Allergan Designated Compounds and Collaboration Lead Compounds
necessary for the preclinical and clinical development of such Allergan
Designated Compounds and Collaboration Lead Compounds and all Allergan
Products necessary for commercialization worldwide.
6. LICENSE GRANTS; FAILURE TO PURSUE DEVELOPMENT IN JAPAN.
6.1 LICENSE GRANTS FOR COLLABORATIVE RESEARCH.
(a) GRANT BY ACADIA. During the Research Term and for [***]
thereafter with respect to Allergan Designated Compounds, ACADIA grants to
Allergan an exclusive (except as to ACADIA's rights expressly set forth in
this Agreement), worldwide, non-transferable (except as to Japan),
royalty-free license, with the right to sublicense only as it relates to
Japan, under the ACADIA Technology and ACADIA's interest in the Collaboration
Technology to use such technology solely to the extent necessary or
appropriate to carry out Allergan's research responsibilities under the
Collaboration in the Field. Allergan has the right to subcontract with Third
Parties for the performance of research and development activities, PROVIDED,
HOWEVER, that (i) the contracted Third Party shall enter into a
confidentiality agreement with Allergan; and (ii) Allergan shall supervise
such subcontract work.
12
*CONFIDENTIAL TREATMENT REQUESTED
(b) GRANT BY ALLERGAN. During the Research Term, Allergan grants to
ACADIA a nonexclusive, worldwide, royalty-free license, under the Allergan
Technology and Allergan's interest in the Collaboration Technology, to use
such technology solely to the extent necessary or appropriate to carry out
ACADIA's research responsibilities under the Collaboration.
6.2 LICENSE GRANT FOR DEVELOPMENT AND COMMERCIAL PURPOSES. Subject
to other provisions of this Agreement, ACADIA grants to Allergan the
following rights and licenses:
(a) an exclusive, royalty-free license under the ACADIA Technology
and ACADIA's interest in the Collaboration Technology to make, have made, and
use Collaboration Lead Compounds in order to conduct necessary preclinical,
clinical and other development activities on such Collaboration Lead
Compounds to obtain Regulatory Approval for use in the Field as Allergan
Products;
(b) an exclusive, royalty-bearing license under the ACADIA
Technology and ACADIA's interest in the Collaboration Technology to make,
have made, use and sell Allergan Products in the Field in the Territory.
6.3 SUBLICENSING RIGHTS. Allergan shall have the right to sublicense
the rights granted by ACADIA in Section 6.2.
6.4 DILIGENCE OBLIGATIONS. Allergan's development and
commercialization rights will be subject to development, manufacturing, and
commercial diligence obligations consistent with Allergan's practice for
products with similar commercial potential. Such diligence obligations shall
include, but not be limited to, diligent execution of a development plan
pursuant to Section 5.1 and diligently beginning the development of each
Collaboration Lead Compound [***] either itself, or through a Third Party.
Allergan shall give written notice to ACADIA no later than the time that
Allergan begins Phase III trials of such Collaboration Lead Compound in a
Major Market specifying whether Allergan intends to develop such
Collaboration Lead Compound [***] either by itself or in collaboration with a
Third Party. In the event that Allergan provides ACADIA with written notice
that Allergan will develop such Collaboration Lead Compound itself, Allergan
will deliver to ACADIA a development plan within [***] of such notice. Such
[***] development plan shall comply with the provisions of Section 5.1. In
the event that Allergan provides ACADIA with written notice that Allergan
will develop such Collaboration Lead Compound through a Third Party, Allergan
will use reasonable efforts to select and complete an Agreement with such
Third Party to develop said Collaboration Lead Compound and commercialize the
resulting Allergan Product in [***] within [***] of such notice.
6.5 FAILURE TO PURSUE DEVELOPMENT IN [***]. If Allergan fails to
diligently begin the development of a Collaboration Lead Compound in [***] as
required in Section 6.4, Allergan will grant to ACADIA an exclusive (even as
to Allergan), perpetual and royalty-free right, with the right to sublicense,
under the Allergan Technology and Allergan's interest in the Collaboration
Technology to make, have made, use and sell Active Compounds, including
Allergan Designated Compounds, Allergan Pool Compounds and Collaboration Lead
Compounds, in the Field in [***] itself, or with any Third Party. Allergan
will release ACADIA from ACADIA's ophthalmology exclusivity requirement
pursuant to the September 24, 1997 Collaboration
13
*CONFIDENTIAL TREATMENT REQUESTED
Agreement as it relates to ACADIA's right to make, have made, use and sell
Active Compounds, including Allergan Designated Compounds, Allergan Pool
Compounds and Collaboration Lead Compounds, in the Field in [***] itself or
with a Third Party. ACADIA will also have the royalty-free right to use all
Allergan Know-How and Collaboration Know-How to (a) make, have made, use and
sell Active Compounds, including Allergan Designated Compounds, Allergan Pool
Compounds and Collaboration Lead Compounds, in the Field in [***] and (b)
pursue regulatory approval to make, have made, use and sell Active Compounds,
including Allergan Designated Compounds, Allergan Pool Compounds and
Collaboration Lead Compounds, in the Field in [***].
7. FEES AND PAYMENTS.
7.1 UP-FRONT FEE. On the date of execution of this Agreement
Allergan shall pay ACADIA a one-time, non-refundable fee of [***].
7.2 RESEARCH FUNDING. During the [***] of the Research Term,
Allergan agrees to pay ACADIA, on a quarterly basis in advance, payable no
later than the [***] of the quarter, research funding payments at an
annualized rate of [***] per ACADIA FTE devoted to the Research Program
during the [***] of the Research Term. Thereafter, such rate per ACADIA FTE
will be increased, if applicable, for the [***] of the Research Term by a
multiplier factor which reflects changes in the Pharmaceutical Manufacturers'
Producer Price Index for the United States (or its successor Index) as
reported as of the date that is [***] prior to the anniversary of the
Effective Date when compared to the comparable statistic as of the date that
is [***] prior to the Effective Date, subject to a cap of [***] per ACADIA
FTE. Such funding shall be in such amounts as are set forth in the Research
Plan, provided that the Research Plan shall initially provide for at least a
total of [***] ACADIA FTEs for the longer of the first [***] of the Research
Term or until a Collaboration Lead Compound is designated by Allergan. Once a
Collaboration Lead Compound is designated by Allergan, the RMC will amend the
Research Plan and agree upon the amount of research funding to be paid by
Allergan to ACADIA during the final [***] or fraction thereof remaining
before the first anniversary date of this Agreement. Such research funding
shall support a minimum of [***] ACADIA FTEs. If the Research Term is
extended beyond the first anniversary of this Agreement the actual funding
level for such extension shall be agreed upon by the RMC; provided, however,
if such funding does not support a minimum of [***] ACADIA FTEs, then
Allergan shall not be able to select as an Allergan Designated Compound or a
Collaboration Lead Compound any compound that was not an Allergan Pool
Compound on the [***] anniversary date of this Agreement.
It is intended that, as determined by the RMC, Allergan will provide
sufficient research funding to ACADIA during the Research Term (and any
renewal or extension thereof) to support the number of FTEs required to
pursue the activities set forth in the Research Plan in accordance with
Exhibit B hereto, as the Research Plan is developed and approved by the RMC,
in accordance with the research budget developed and approved by the RMC as
described in Section 2.5, and subject to the limitations, including the
minimum funding levels, set forth above. The first and last quarter payments
shall be prorated, with the first quarter payment due
14
*CONFIDENTIAL TREATMENT REQUESTED
[***] after the Effective Date. ACADIA shall give notice to Allergan in the
event that the total FTEs for its muscarinic program drop below [***] FTEs.
7.3 MILESTONE PAYMENTS.
(a) Within [***] after achievement by Allergan, its Affiliates,
sublicensees, partners, collaborators or other Third Parties designated by
Allergan, of each of the following milestones with respect to each
Collaboration Lead Compound Allergan shall pay ACADIA the following
non-refundable milestones (provided, however, that if Allergan abandons
development of a Collaboration Lead Compound and replaces it with development
of another Collaboration Lead Compound, no duplicate milestone payments shall
be due for the replacement compound if such milestone payment was made with
respect to the compound it replaced):
-------------------------------------------------------------------------------------------------------------------
MILESTONE EVENT AMOUNT OF PAYMENT
-------------------------------------------------------------------------------------------------------------------
[***] [***]
-------------------------------------------------------------------------------------------------------------------
[***] [***]
-------------------------------------------------------------------------------------------------------------------
[***] [***]
-------------------------------------------------------------------------------------------------------------------
[***] [***]
-------------------------------------------------------------------------------------------------------------------
[***] [***]
-------------------------------------------------------------------------------------------------------------------
[***] [***]
-------------------------------------------------------------------------------------------------------------------
[***] [***]
-------------------------------------------------------------------------------------------------------------------
[***] [***]
-------------------------------------------------------------------------------------------------------------------
(b) [***] of each milestone payment made by Allergan for Milestone
Events 5, 6, and 8 above shall be creditable against royalties owed on Net
Sales of Allergan Products, pursuant to Section 7.4, provided that in no
event shall ACADIA receive less than [***] of the royalties otherwise due to
it for such Collaboration Lead Compound in any given quarter.
15
*CONFIDENTIAL TREATMENT REQUESTED
7.4 ROYALTIES.
(a) ALLERGAN ROYALTY PAYMENTS TO ACADIA. Allergan shall pay to
ACADIA the following royalties on annual Net Sales: (a) [***] of Net Sales of
Allergan Products on all annual Net Sales up to [***]; and (b) [***] of
incremental annual Net Sales of Allergan Products in excess of [***] up to
[***] and (c) [***] of incremental annual Net Sales of Allergan Products in
excess of [***]; subject to any adjustment pursuant to Section 7.4 (c). For
purposes of the foregoing, annual Net Sales shall be determined on a calendar
year basis.
(b) ACADIA ROYALTY PAYMENTS TO ALLERGAN. If Allergan files an IND
which is accepted by the FDA on a Collaboration Lead Compound, and this
Agreement is later terminated by Allergan (other than for breach by ACADIA),
and ACADIA, in collaboration with a Third Party licensee, uses Allergan
Technology and/or Collaboration Technology in connection with the development
or commercialization of such Collaboration Lead Compound for use in the Field
then ACADIA shall pay to Allergan, as applicable, an up-front fee and
milestone payment(s) (excluding equity investments) and a royalty equal to
the percentage appropriately applied from the following table multiplied by
the up-front fee and milestone payment(s) (excluding equity investments)
received by ACADIA and royalty payments received by ACADIA from such Third
Party licensee on Net Sales of ACADIA Products containing such Collaboration
Lead Compound, subject to any adjustment pursuant to Section 7.4 (c).
-----------------------------------------------------------------------------------------------
Percentage of ACADIA
Last Event Completed Prior to Termination by Allergan royalty, upfront fee
and milestones
-----------------------------------------------------------------------------------------------
[***] [***]
-----------------------------------------------------------------------------------------------
[***] [***]
-----------------------------------------------------------------------------------------------
[***] [***]
-----------------------------------------------------------------------------------------------
[***] [***]
-----------------------------------------------------------------------------------------------
In the event that ACADIA uses Allergan Technology and/or
Collaboration Technology in connection with the development or
commercialization of such Collaboration Lead Compound for use in the Field
and ACADIA commercializes such Collaboration Lead Compound itself, rather
than outlicensing rights to such Collaboration Lead Compound to a Third
Party, then ACADIA shall pay to Allergan, as applicable, an upfront fee and
milestone payment(s) (excluding equity investments) and a royalty on Net
Sales of ACADIA Products containing such Collaboration Lead Compound (which
royalty shall not be less than [***] of Net Sales) which shall be negotiated
in good faith by the parties in light of the industry standards at that time
for deals executed at the stage of development last completed by Allergan
each multiplied by the applicable percentage from the table above subject to
any adjustment pursuant to Section 7.4 (c).
Notwithstanding the foregoing, in the event that the total of all
upfront fee and milestone payments paid to Allergan by ACADIA pursuant to this
Section 7.4 (b) are less than the total
16
*CONFIDENTIAL TREATMENT REQUESTED
upfront fee and milestones paid to ACADIA by Allergan prior to the
termination of this Agreement by Allergan, then ACADIA shall make a final
milestone payment to Allergan upon NDA Approval of an ACADIA Product
containing such Collaboration Lead Compound in a Major Market, the amount of
such final payment equal to the difference between the total of the upfront
fee and milestone payments paid by ACADIA to Allergan pursuant to this
Section 7.4 (b) and the actual total amount of the upfront fee and milestones
paid to ACADIA by Allergan prior to termination of this Agreement by Allergan.
(c) ROYALTY RATE IN THE EVENT OF NO MARKET EXCLUSIVITY. In the event
that Allergan Products or ACADIA Products are sold in a Major Market, [***]
(hereinafter each of which individually is defined as a "Key Commercial
Country") in which (i) no Valid Claim exists, and (ii) unit sales of such
Allergan Product or ACADIA Product as measured by IMS, or its successor
database, in a calendar quarter in a Key Commercial Country are less than
[***] of the Total Market Units in such Key Commercial Country, in such
calendar quarter, then the royalty payment due to ACADIA or to Allergan, as
the case may be, for Net Sales of such Allergan Product or ACADIA Product in
such Key Commercial Country, as the case may be, [***]. For the purpose of
this Section 7.4(c), Total Market Units shall mean the sum of (i) the units
of the Allergan Product or ACADIA Product sold and (ii) the total number of
units sold of all generic products which contain the same active ingredient
as the Collaboration Lead Compound contained in such Allergan Product or
ACADIA Product and are approved for a similar therapeutic use as such
Allergan Product or ACADIA Product, each as measured by IMS or its successor
database. In the event that (x) a Valid Claim covering the Allergan Product
or ACADIA Product is established or re-established in such Key Commercial
Country, or (y) unit sales of such Allergan Product or ACADIA Product as
measured by IMS, or its successor database in such Key Commercial Country
become greater than [***] of the Total Market Units in such Key Commercial
Country, then the royalty payment due to ACADIA or to Allergan, as the case
may be, with respect to Net Sales of such Allergan Product or ACADIA Product
in such Key Commercial Country, as the case may be, after such date shall
revert to [***].
In the event that Allergan Products or ACADIA Products are sold in a
country which is not a Key Commercial Country (hereinafter each such country
is individually defined as a "Non-Key Commercial Country") in which (i) no
Valid Claim exists, and (ii) there are commercial sales by a Third Party of a
generic product(s) which contains the same active ingredient as the
Collaboration Lead Compound contained in such Allergan Product or ACADIA
Product and which generic product(s) is approved for a similar therapeutic
use as such Allergan Product or ACADIA Product, then the royalty payment due
to ACADIA or to Allergan, as the case may be, for Net Sales of such Allergan
Product or ACADIA Product in such Non-Key Commercial Country, as the case may
be, shall be [***]. In the event that (x) a Valid Claim covering the Allergan
Product or ACADIA Product is established or re-established in such Non-Key
Commercial Country, or (y) all such Third Parties shall cease sale of such
generic product(s) in such Non-Key Commercial Country, then the royalty
payment due to ACADIA or to Allergan, as the case may be, with respect to Net
Sales of such Allergan Product or ACADIA Product in such non-Key Commercial
Country, as the case may be, after such date shall [***].
17
*CONFIDENTIAL TREATMENT REQUESTED
(d) ROYALTY TERM. Royalties for sales of each Allergan Product or
ACADIA Product in a given country shall be paid for a period equal to the
Royalty Term for such Allergan Product or ACADIA Product in such country.
(e) CREDIT FOR THIRD PARTY ROYALTIES. In the event that a party
obligated to pay royalties under this Agreement must make royalty payments
under a license from a Third Party in respect of any patents that are
necessary to develop, make, have made, use, sell, have sold or import a
Collaboration Lead Compound, an Allergan Product or an ACADIA Product then
such party may reduce the royalty otherwise owing on Net Sales of such
product [***] of the royalty payments made under such Third Party license;
provided, however, that the royalty otherwise payable under the applicable
provision of this Agreement during any quarter shall not be reduced by more
than [***].
8. PAYMENTS; RECORDS; AUDITS.
8.1 PAYMENT; REPORTS. Royalty payments and reports for the sale of
Allergan Products or ACADIA Products shall be calculated and reported for
each calendar quarter. All royalty payments due to a party under this
Agreement shall be paid within [***] of the end of each calendar
quarter. Each payment of royalties shall be accompanied by a report of Net
Sales of Allergan Products or ACADIA Products, in sufficient detail to permit
confirmation of the accuracy of the royalty payment made, including, without
limitation, the number of each Allergan Product or ACADIA Product sold, the
gross sales and Net Sales of each Allergan Product or ACADIA Product, the
royalties, in U.S. dollars, payable, the exchange rates used and any other
information necessary to determine the appropriate amount of royalties due.
8.2 EXCHANGE RATE; MANNER AND PLACE OF PAYMENT. All payments
hereunder shall be payable in U.S. dollars. With respect to each quarter, for
countries other than the United States, whenever conversion of payments from
any foreign currency shall be required, such conversion shall be calculated
using the same exchange rate(s) that the payor uses for its own U.S. dollar
financial statement reporting purposes prepared in accordance with GAAP. All
payments owed under this Agreement shall be made by wire transfer to a bank
and account designated in writing by the payee, unless otherwise specified by
such payee.
8.3 LATE PAYMENTS. In the event that any payment, including royalty,
milestone and research payments, due hereunder is not made when due, the
payment shall accrue interest from the date due at the rate of [***];
provided, however, that in no event shall such rate exceed the maximum legal
annual interest rate, The payment of such interest shall not limit a party
from exercising any other rights it may have as a consequence of the lateness
of any payment.
8.4 RECORDS AND AUDITS. During the Royalty Term and for a period of
[***] thereafter, each party shall keep complete and accurate records
pertaining to the development and sale or other disposition of Allergan
Products or ACADIA Products, in sufficient detail to permit the other party
to confirm the accuracy of all payments due hereunder. Each party shall have
the right to cause an independent, certified public accountant reasonably
acceptable to the other to audit such records to confirm Net Sales and
royalty and other payments for a period covering not more than the preceding
[***]. Such audits may be exercised during
18
*CONFIDENTIAL TREATMENT REQUESTED
normal business hours [***] upon at least [***] prior written notice to the
other party. Prompt adjustments shall be made by the parties to reflect the
results of such audit. The party causing such audit shall bear the full cost
of such audit unless such audit discloses an underpayment of more than [***]
from the amount of royalties or other payments due under this Agreement. In
such case, the audited party shall bear the full cost of such audit.
8.5 WITHHOLDING OF TAXES. Any withholding of taxes levied by tax
authorities outside the United States on the payments hereunder shall be
borne by the party receiving such payment and deducted by the party making
such payment from the sums otherwise payable by it hereunder for payment to
the proper tax authorities. The parties agree to cooperate with each other,
in the event a party claims exemption from such withholding or seeks
deductions under any double taxation or other similar treaty or agreement
from time to time in force, such cooperation to consist of providing receipts
of payment of such withheld tax or other documents reasonably available.
8.6 EXCHANGE AND ROYALTY RATE CONTROLS. If at any time legal
restrictions prevent the prompt remittance of part or all royalties with
respect to any country where any Allergan Product or ACADIA Product is sold,
payment shall be made through such lawful means or methods as the party
making such payment may determine. When in any country the law or regulations
prohibit both the transmittal and deposit of royalties on sales in such a
country, royalty payments shall be suspended for as long as such prohibition
is in effect, and as soon as such prohibition ceases to be in effect, all
royalties that would have been obligated to be transmitted or deposited, but
for the prohibition, shall forthwith be deposited or transmitted promptly to
the extent allowable, as the case may be. If any royalty rate specified in
this Agreement should exceed the permissible rate established in any country,
the royalty rate for sales in such country shall be adjusted to the highest
legally permissible or government-approved rate.
9. INTELLECTUAL PROPERTY.
9.1 OWNERSHIP OF TECHNOLOGY. Inventorship with respect to inventions
made pursuant to work carried out under the Collaboration shall be determined
in accordance with United States rules of inventorship. Except as provided
below, each party shall own solely all inventions made solely by its
employees and agents, and the parties shall own jointly all inventions
jointly made hereunder.
9.2 PATENT PROSECUTION. It is the intention of the parties to secure
broad patent protection for discoveries and inventions made in connection
with the Collaboration. Allergan shall be responsible for the filing,
prosecution and maintenance at Allergan's sole cost of all Allergan Patents,
and all Collaboration Patents or ACADIA Patents to the extent the claims
filed in the Collaboration Patents or ACADIA Patents are limited to the Field
or Collaboration Lead Compounds. Except for those patents or patent
applications described above, ACADIA shall be responsible for the filing,
prosecution and maintenance of all ACADIA Patents and all Collaboration
Patents. Allergan shall reimburse ACADIA for [***] of all reasonable out of
pocket legal expenses incurred by ACADIA that are associated with the filing
and prosecuting of (i) all Collaboration Patent(s) and (ii) any ACADIA
Patents having claims covering [***] Muscarinics that are useful in the
Field. In the event that ACADIA elects to
19
*CONFIDENTIAL TREATMENT REQUESTED
assign, including an assignment pursuant to the provisions of Section 15.7,
its right to file, prosecute and maintain Collaboration Patents or ACADIA
Patents having claims covering Collaboration Lead Compounds or their use
thereof in the Field, then Allergan may, except in the case of an assignment
by ACADIA to any Affiliate, to a special purpose corporation or similar
entity which assignment is permitted under Section 15.7, assume
responsibility for the filing, prosecution and maintenance of such
Collaboration Patents and/or ACADIA Patents at Allergan's own expense,
provided, however, that if Allergan's assumption of such responsibilities
would impair a transaction permitted under Section 15.7 then Allergan shall
negotiate in good faith to remedy such impairment. Each party shall consider
in good faith the requests and suggestions of the other party with respect to
strategies for filing and prosecuting patent applications, and, in
particular, ACADIA agrees that, at Allergan's request, and to the extent
practicable and that such activities do not materially diminish ACADIA's
overall patent estate, patent applications for Collaboration Patents or
ACADIA Patents will be filed with claims limited to the Field or
Collaboration Lead Compounds, provided however, that in the event that
Allergan designates a Collaboration Lead Compound and provides notice to
ACADIA that Allergan desires to file a patent application for Collaboration
Patents or ACADIA Patents covering such Collaboration Lead Compound, Allergan
shall not make such filing for a period of [***] following such notice to
ACADIA, without prior written consent by ACADIA. Each party shall keep the
other party informed of progress with regard to the filing, prosecution and
maintenance of patent applications and patents subject to this Section 9.2.
In the event a party is responsible for the filing, prosecution and
maintenance of patent applications or patents hereunder, and elects, other
than as provided above, not to do so, it shall inform the other party at
least [***] before any relevant deadline for filing or other action and
transmit all information reasonable and appropriate relating to such patent
or patent application, and such other party shall then have the right to
file, prosecute and maintain such patent applications and patents at its own
expense, in which case the party declining to continue such patent
applications and patents shall assign its rights in such patent applications
and patents to the other party.
9.3 COOPERATION OF THE PARTIES. Each party agrees to cooperate fully
in the preparation, filing, and prosecution of any patent rights under this
Agreement. Such cooperation includes, but is not limited to:
(a) executing all papers and instruments, or requiring its employees
or agents, to execute such papers and instruments, so as to effectuate the
ownership of patent rights set forth in Section 9.1 above and to enable the
other party to apply for and to prosecute patent applications in any country;
and
(b) promptly informing the other party of any matters coming to such
party's attention that may affect the preparation, filing, or prosecution of
any such patent applications.
9.4 INFRINGEMENT BY THIRD PARTIES. ACADIA and Allergan shall
promptly notify the other in writing of any alleged or threatened
infringement of any patent included in the Allergan Patents, ACADIA Patents
or Collaboration Patents of which they become aware. Both parties shall use
their best efforts in cooperating with each other to terminate such
infringement without litigation with each party being responsible for its own
out-of-pocket costs, including legal costs. In the event any alleged or
threatened infringement by a Third Party in the Field cannot be terminated
without litigation, Allergan shall have the first right, but not the
obligation, to bring
20
*CONFIDENTIAL TREATMENT REQUESTED
and control any action or proceeding with respect to infringement of a patent
included in the Allergan Patents or Collaboration Patents and ACADIA Patents
having claims limited to the Field or Collaboration Lead Compounds, at its
own expense and by counsel of its own choice. ACADIA shall have the first
right to bring and control any action or proceeding with respect to
infringements of a patent in the ACADIA Patents or Collaboration Patents not
referred to in the preceding sentence. The party not bringing the action
shall have the right, at its own expense, to be represented in any action
involving any patent covering inventions owned jointly by the parties by
counsel of its own choice. If either party fails to bring an action or
proceeding with respect to a patent covering inventions licensed hereunder
within: (a) [***] following the notice of alleged infringement or (b) [***]
before the time limit, if any, set forth in the appropriate laws and
regulations for the filing of such actions, whichever comes first, the other
party shall have the right to bring and control any such action at its own
expense and by counsel of its own choice, and the party initially declining
to bring such action shall have the right, at its own expense, to be
represented in any such action by counsel of its own choice. In the event a
party brings an infringement action, the other party shall cooperate fully,
including if required to bring such action, the furnishing of a power of
attorney. Neither party shall have the right to settle any patent
infringement litigation under this Section 9.4 in a manner that diminishes
the rights or interests of the other party without the consent of such other
party. Except as otherwise agreed to by the parties as part of a cost sharing
arrangement, any recovery realized as a result of such litigation, after
reimbursement of any litigation expenses of Allergan and ACADIA, shall be
divided between the parties in accordance with their relative economic
interests as directly related to the royalty payments described in Section
7.4 hereof.
9.5 INFRINGEMENT OF THIRD PARTY RIGHTS. Each party shall promptly
notify the other in writing of any allegation by a Third Party that the
activity of either of the parties hereunder infringes or may infringe the
intellectual property rights of such Third Party.
Allergan shall have the first right but not the obligation to control
any defense of any such claim involving alleged infringement of Third Party
rights by Allergan's activities under this Agreement at its own expense and
by counsel of its own choice, and ACADIA shall have the right but not the
obligation, at its own expense, to be represented in any such action by
counsel of its own choice. If Allergan fails to proceed in a timely fashion
with regard to such defense, ACADIA shall have the right but not the
obligation to control any such defense of such claim at its own expense and
by counsel of its own choice, and Allergan shall have the right but not the
obligation, at its own expense, to be represented in any such action by
counsel of its own choice.
ACADIA shall have the first right but not the obligation to control
any defense of any such claim involving alleged infringement of Third Party
rights by ACADIA's activities under this Agreement at its own expense and by
counsel of its own choice, and Allergan shall have the right but not the
obligation, at its own expense, to be represented in any such action by
counsel of its own choice. If ACADIA fails to proceed in a timely fashion
with regard to such defense, Allergan shall have the right but not the
obligation to control any such defense of such claim at its own expense and
by counsel of its own choice, and ACADIA shall have the right but not the
obligation, at its own expense, to be represented in any such action by
counsel of its own choice.
21
*CONFIDENTIAL TREATMENT REQUESTED
Neither party shall have the right to settle any patent infringement
litigation under this Section 9.5 in a manner that diminishes the rights or
interests of the other party without the consent of such party.
9.6 TRADEMARKS. Allergan and ACADIA shall each obtain, own and
enforce its own trademarks with respect to Allergan Products or ACADIA
Products that each commercializes hereunder.
9.7 PATENT LABELING. Allergan shall xxxx all Allergan Products or
their containers that are manufactured used or sold under the terms of this
Agreement in accordance with the appropriate patent markings laws.
10. REPRESENTATIONS AND WARRANTIES.
10.1 REPRESENTATIONS AND WARRANTIES. Each party represents to the
other that as of the Effective Date:
(a) CORPORATE POWER. It is duly organized and validly existing under
the laws of its state of incorporation or formation, and has full corporate
power and authority to enter into this Agreement and to carry out the
provisions hereof
(b) DUE AUTHORIZATION. It is duly authorized to execute and deliver
this Agreement and to perform its obligations hereunder, and the person or
persons executing this Agreement on its behalf has been duly authorized to do
so by all requisite corporate action.
(c) BINDING AGREEMENT. This Agreement is legally binding upon it,
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by it does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by
which it may be bound, nor violate any material law or regulation of any
court, governmental body or administrative or other agency having
jurisdiction over it.
(d) GRANT OF RIGHTS; MAINTENANCE OF AGREEMENTS. It has not, and will
not during the term of this Agreement, grant any right to any third party
which would conflict with the rights granted to the other party hereunder. It
has (or will have at the time performance is due) maintained and will
maintain and keep in full force and effect all agreements (including license
agreements) and filings (including patent filings) necessary to perform its
obligations hereunder,
(e) VALIDITY. It is aware of no action, suit or inquiry or
investigation instituted by or before any court or governmental agency which
questions or threatens the validity of this Agreement or of any Allergan
Patents and ACADIA Patents.
10.2 ACADIA REPRESENTATIONS AND WARRANTIES. ACADIA represents and
warrants that as of the Effective Date:
(a) it is the sole and exclusive owner of the ACADIA Patents and
ACADIA Know-How and has sufficient rights and power to grant the licenses to
Allergan which it purports to grant herein, and no such rights granted to
Allergan hereunder are licensed by ACADIA from any Third Party;
22
(b) the ACADIA Know-How and the ACADIA Patents are free of any
encumbrances, liens, judgments and/or security interests that would affect
the exercise by Allergan of its rights in the Field; provided, however, that
the Fund for Industrial Growth has a security interest in certain of the
ACADIA Technology, and, in ACADIA's rights under this Agreement, including
any moneys paid to ACADIA under this Agreement, and that, should the Fund for
Industrial Growth be assigned or assume ACADIA's rights under this Agreement
pursuant to such security interest rights, Allergan shall make all payments
otherwise due to ACADIA under this Agreement to the Fund for Industrial
Growth, in which case this Agreement and all of Allergan's rights hereunder
shall continue without interruption or impairment;
(c) and to its actual knowledge there are no outstanding and
unresolved claims or accusations that any compounds or products manufactured,
used or sold by ACADIA and licensed hereunder or any methods or process
practiced by ACADIA infringe or may infringe any Third Party patent(s) or
other intellectual property rights and it has disclosed to Allergan any Third
Party patent(s) which it is aware that might be infringed by the manufacture,
use or sale of Allergan Products or the practice of any methods or processes
covered by the ACADIA Patents or included in the ACADIA Know-How by Allergan
its Affiliates or sublicensees;
(d) all patents and patent applications included in the ACADIA
Patents are valid and in full force and effect, and are not the current
subject of any interference or opposition proceeding; and
(e) and to its actual knowledge it is unaware of any publications or
activities including without limitation, patents, articles and public uses or
sales, by it or others which would or might invalidate any claim(s) of any
patent or patent application included in the ACADIA Patents.
(f) it has not conducted, nor has it commissioned the conducting of,
any formal or informal infringement or validity studies regarding any patent
or patent application included in the ACADIA Patents listed on Exhibit C that
it has not disclosed in writing to Allergan prior to the Effective Date.
10.3 ALLERGAN REPRESENTATIONS AND WARRANTIES. Allergan represents
and warrants that as of the Effective Date:
(a) Allergan owns the Allergan Know-How and has sufficient rights
and power to grant the licenses to ACADIA which it purports to grant herein;
and
(b) and to its actual knowledge there are no outstanding and
unresolved claims or accusations that any methods or process practiced by
Allergan as part of the Allergan Know-How infringe or may infringe any third
party patent(s).
10.4 DISCLAIMER CONCERNING TECHNOLOGY. EXCEPT AS SPECIFICALLY SET
FORTH HEREIN, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY
EACH PARTY HEREUNDER IS PROVIDED "AS IS" AND EACH PARTY EXPRESSLY DISCLAIMS
ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES, OR ARISING FROM
23
A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT
THERETO. Without limiting the generality of the foregoing, each party
expressly does not warrant (a) the success of any study or test commenced
under the Collaboration or (b) the safety or usefulness for any purpose of
the technology it provides hereunder.
11. CONFIDENTIALITY; PUBLICATION.
11.1 CONFIDENTIALITY. Except to the extent expressly authorized by
this Agreement or otherwise agreed in writing by the parties, the parties
agree that, hereinafter and until the [***] anniversary of the completion of
the Royalty Term, the receiving party shall keep confidential and shall not
publish or otherwise disclose and shall not use for any purpose other than as
expressly provided for in this Agreement any Confidential Information
furnished to it by the other party pursuant to this Agreement. Each party may
use such Confidential Information only to the extent required to accomplish
the purposes of this Agreement. Each party will use at least the same
standard of care as it uses to protect proprietary or confidential
information of its own to ensure that its employees, agents, consultants and
other representatives do not disclose or make any unauthorized use of the
Confidential Information. Each party will promptly notify the other upon
discovery of any unauthorized use or disclosure of the Confidential
Information.
11.2 EXCEPTIONS. Confidential Information shall not include any
information which the receiving party can prove by competent evidence:
(a) is now, or hereafter becomes, through no act or failure to act
on the part of the receiving party, generally known or available;
(b) is known by the receiving party at the time of receiving such
information, as evidenced by its records;
(c) is hereafter furnished to the receiving party by a Third Party,
as a matter of right and without restriction on disclosure;
(d) is independently developed by the receiving party without the
aid, application or use of Confidential Information of the disclosing party;
or
(e) is the subject of a written permission to disclose provided by
the disclosing party.
11.3 TERMS OF AGREEMENT. The parties agree that this Agreement and
the terms hereof will be considered Confidential Information of both parties.
Notwithstanding the foregoing, either party may disclose such terms as are
required to be disclosed under strictures of confidentiality to bona fide
potential sublicensees or for fund raising efforts to investors and potential
investors or as otherwise required pursuant to applicable law.
11.4 AUTHORIZED DISCLOSURE. Each party may disclose Confidential
Information belonging to the other party to the extent such disclosure is
reasonably necessary in the following instances:
(a) filing or prosecuting patents relating to the Collaboration;
24
*CONFIDENTIAL TREATMENT REQUESTED
(b) regulatory filings;
(c) prosecuting or defending litigation;
(d) complying with applicable court orders or governmental regulations;
(e) conducting pre-clinical or clinical trials of Collaboration Lead
Compounds; and
(f) disclosure to Affiliates, sublicensees, employees, consultants,
agents or other Third Parties in connection with due diligence or similar
investigations by such Third Parties, in each case who agree to be bound by
similar terms of confidentiality and non-use at least equivalent in scope to
those set forth in this ARTICLE 11.
Notwithstanding the foregoing, in the event a party is required to
make a disclosure of the other party's Confidential Information pursuant to
this Section 11.4, it will seek to secure confidential treatment of such
information at least as diligently as such party would use to protect its own
confidential information. In addition, ACADIA shall not be entitled to
disclose Confidential Information related to Allergan Designated Compounds or
Collaboration Lead Compounds to Third Parties, without the prior written
approval of Allergan, such approval not to be unreasonably withheld; however,
ACADIA shall be entitled to disclose all data and information related to that
certain compound covered under the Confidential Disclosure Agreement dated
March 1, 1998 described in Section 3.2. The parties will consult with each
other on the provisions of this Agreement to be redacted in any filings made
by the parties with the Securities and Exchange Commission or as otherwise
required by law.
Nothing in this Agreement shall prevent ACADIA from disclosing
Confidential Information on [***] Muscarinics (but not Allergan Designated
Compounds, Allergan Pool Compounds or Collaboration Lead Compounds) to any
Third Party with which ACADIA has entered into an agreement for [***]
muscarinics outside the Field.
11.5 PUBLICATIONS. Each party to this Agreement recognizes that the
publication of papers regarding results of and other information regarding
the Collaboration, including oral presentations and abstracts, may be
beneficial to both parties provided such publications are subject to
reasonable controls to protect Confidential Information. Accordingly, each
party shall have the right to review and approve any paper proposed for
publication by the other party, including oral presentations and abstracts,
which utilizes data generated from the Collaboration and/or includes
Confidential Information of the other party. Before any such paper is
submitted for publication, the party proposing publication shall deliver a
complete copy to the other party at least [***] prior to submitting the paper
to a publisher. Such other party shall review any such paper and give its
comments to the publishing party within [***] of its receipt of such paper.
With respect to oral presentation materials and abstracts, the reviewing
party shall make reasonable efforts to expedite review of such materials and
abstracts, and shall return such items as soon as practicable to the
publishing party with appropriate comments, if any, but in no event later
than [***] from the date of receipt by the reviewing party. The publishing
party shall comply with the reviewing party's request to delete references to
the other party's Confidential Information in any such paper and agrees to
withhold publication of
25
*CONFIDENTIAL TREATMENT REQUESTED
same for an additional [***] in order to permit the parties to obtain patent
protection, if either of the parties deems it necessary, in accordance with
the terms of this Agreement.
12. TERM AND TERMINATION.
12.1 TERM OF THE AGREEMENT. The term of the collaborative activities
of the parties pursuant to the Research Program shall commence on the
Effective Date and continue until expiration of the Research Term, unless
earlier terminated pursuant to Section 12.2, 12.3 or 12.4, or extended by
mutual agreement of the parties. The term of this Agreement (the "Term of the
Agreement") shall commence on the Effective Date and continue until six (6)
months after the expiration of the last Royalty Term for any Allergan Product
or ACADIA Product, unless earlier terminated pursuant to Section 12.2, 12.3
or 12.4 or extended upon terms mutually agreeable to both parties.
Notwithstanding the foregoing, this Agreement will expire upon the [***]
anniversary of the expiration of the Research Term if Allergan has not
designated a Collaboration Lead Compound.
12.2 TERMINATION BY MUTUAL AGREEMENT. The parties may at any time
terminate this Agreement by written agreement executed by both Allergan and
ACADIA.
12.3 TERMINATION BY ALLERGAN. Allergan may terminate this Agreement
by giving ninety (90) days prior written notice to ACADIA, but in no event
may Allergan terminate this Agreement pursuant to this Section 12.3 prior to
the first anniversary of the Effective Date hereof.
12.4 TERMINATION FOR CAUSE. Each party shall have the right to
terminate this Agreement upon [***] prior written notice to the other upon
the occurrence of any of the following:
(a) Upon or after the bankruptcy, insolvency, dissolution or winding
up of the other party (other than a dissolution or winding up for the purpose
of reconstruction or amalgamation); or
(b) Upon or after the breach of any material provision of this
Agreement by the other party if the breaching party has not cured such breach
within the [***] period following written notice of termination by the
non-breaching party.
All licenses granted to the non-breaching party under Sections 6.1
and 6.2 of this Agreement shall survive such termination for so long as such
non-breaching party is not in breach of its obligations to the other party
under this Agreement.
12.5 ACCRUED RIGHTS, SURVIVING OBLIGATIONS.
(a) Expiration or termination of this Agreement shall not affect any
rights or obligations of either party accruing prior to such expiration or
termination. The terms of this Section 12.5 and Sections 7.4, 8, 9.1, 9.3,
10, 11.1, 11.2, 11.3, 11.4, 12.4, 13, 14 and 15 (except for Section 15.7) of
this Agreement shall survive expiration or termination of this Agreement.
Promptly after termination of this Agreement each party (other than a
non-breaching party that retains a license as described in Section 12.4)
shall return or dispose of any technology or know-
26
*CONFIDENTIAL TREATMENT REQUESTED
how of the other in the accordance with the instructions of the other,
including without limitation any compounds, assays or other biological or
chemical materials.
(b) Upon termination of the Agreement by Allergan for any reason,
other than breach by ACADIA, all rights to [***] Muscarinics hereunder will
revert to ACADIA and Allergan will release ACADIA from ACADIA's ophthalmology
exclusivity requirement pursuant to the September 24, 1997 Collaboration
Agreement as it relates to ACADIA's right to make, have made, use and sell
products that act by means of the [***] muscarinic receptor in the Field
itself or with a Third Party. Thereafter, Allergan will grant ACADIA a
royalty-free right under the Allergan Technology and Allergan's interest in
the Collaboration Technology to make, have made, use and sell jointly owned
compounds developed during the Collaboration that act at the [***] muscarinic
receptor, including, but not limited to Active Compounds, Allergan Designated
Compounds and Collaboration Lead Compounds in or outside of the Field itself
or with a Third Party of ACADIA's sole choice. ACADIA will also have the
exclusive, perpetual and royalty-free right to use all data and information
generated by Allergan as a result of the Collaboration that is related to the
[***] muscarinic receptor or compounds that act at the [***] muscarinic
receptor (but excluding proprietary data and information relating to the
scale up of the synthesis of Allergan Designated Compounds and Collaboration
Lead Compounds), by ACADIA or jointly by Allergan and ACADIA during the term
of this Agreement for any purpose. Notwithstanding the foregoing, in the
event that Allergan terminates the Agreement after successfully filing an IND
on a Collaboration Lead Compound in a Major Market, ACADIA's rights upon
termination, as set forth above relating to the use of all data and
information generated by Allergan on such Collaboration Lead Compound for use
in the Field, shall be royalty-bearing as set forth in Section 7.4(b).
(c) Upon expiration of this Agreement at or after the end of the
Research Term, if Allergan has not selected a Collaboration Lead Compound,
all rights to [***] Muscarinics will [***]. Thereafter, Allergan will grant
ACADIA the right under the Allergan Technology and Allergan's interest in the
Collaboration Technology to make, have made, use and sell jointly owned
compounds that act by way of the [***] muscarinic receptor, including, but
not limited to, Active Compounds, Allergan Designated Compounds and
Collaboration Lead Compounds in the Field itself or with a Third Party of
ACADIA's sole choice. ACADIA will also have the exclusive and perpetual right
to use all data and information generated by Allergan as a result of the
Collaboration that is related to the [***] muscarinic receptor or compounds
that act at the [***] muscarinic receptor (but excluding proprietary data and
information relating to the scale up of the synthesis of Allergan Designated
Compounds and Collaboration Lead Compounds), by ACADIA or jointly by Allergan
and ACADIA during the Term of the Agreement for any purpose. In consideration
for Allergan granting such rights to ACADIA, ACADIA agrees to pay Allergan a
one-time fee in an amount equal to the total amount paid by Allergan to
ACADIA for research support (FTE support) during the Research Term provided,
however, that such payment shall only be due upon first Regulatory Approval
in a Major Market of an [***] Muscarinic in the Field and only if such [***]
Muscarinic was an Allergan Designated Compound or a Collaboration Lead
Compound at the time of expiration of this Agreement and ACADIA utilizes data
or information
27
*CONFIDENTIAL TREATMENT REQUESTED
generated by Allergan on such Allergan Designated Compound or such
Collaboration Lead Compound to obtain such Regulatory Approval.
(d) ALLERGAN FULLY PAID UP LICENSE. Upon expiration of the last
Royalty Term for any Allergan Product, Allergan shall have a fully-paid,
royalty free, non-exclusive perpetual license to use the ACADIA Know-How to
manufacture, use and sell such Allergan Product; provided however, that
Allergan shall have no right to sublicense outside the Field any ACADIA
Know-How which is Confidential Information.
(e) ACADIA FULLY PAID UP LICENSE. Upon expiration of the last
Royalty Term for any ACADIA Product, ACADIA shall have a fully-paid, royalty
free, non-exclusive perpetual license to use the Allergan Know-How to
manufacture, use and sell such ACADIA Product; provided however, that ACADIA
shall have no right to sublicense any Allergan Know-How which is Confidential
Information.
13. INDEMNITY.
13.1 INDEMNIFICATION. Each party hereby agrees to save, defend and
hold the other party and its directors, officers, employees, and agents
harmless from and against any and all claims, suits, actions, demands,
liabilities, expenses and/or loss, including reasonable legal expense and
attorneys' fees (collectively, "Claims") for damage to persons or property
resulting directly or indirectly from actions in connection with the
Collaboration by the indemnifying party, its Affiliates, agents or
sublicensees, but only to the extent such Claims result from the gross
negligence or willful misconduct of the indemnifying party or its Affiliates,
agents or sublicensees and do not result from the negligence of the party
seeking indemnification.
13.2 CONTROL OF DEFENSE. Any entity entitled to indemnification
under this Section 13 shall give notice to the indemnifying party of any
Claims that may be subject to indemnification, promptly after learning of
such Claim, and the indemnifying party shall assume the defense of such
Claims with counsel reasonably satisfactory to the indemnified party. If such
defense is assumed by the indemnifying party with counsel so selected, the
indemnifying party will not be subject to any liability for any settlement of
such Claims made by the indemnified party without its consent (but such
consent will not be unreasonably withheld or delayed), and will not be
obligated to pay the fees and expenses of any separate counsel retained by
the indemnified party with respect to such Claims.
13.3 INSURANCE. Allergan, at its own expense, shall maintain product
liability insurance (or self-insure), in amounts consistent with industry
standards for other such pharmaceutical companies during the Term of the
Agreement and shall name ACADIA as an additional insured with respect to such
insurance. Allergan shall provide a certificate of insurance (or evidence of
self-insurance) evidencing such coverage.
ACADIA, at its own expense, shall maintain liability insurance (or
self-insure) in amounts consistent with industry standards for other such
biotechnology companies during the Term of the Agreement. ACADIA shall
provide a certificate of insurance (or evidence of self-insurance) evidencing
such coverage.
28
14. GOVERNING LAW; DISPUTE RESOLUTION.
14.1 GOVERNING LAW. This Agreement shall be governed by the laws of
the State of California as such laws are applied to contracts entered into or
to be performed entirely within such state.
14.2 DISPUTE RESOLUTION. Except as provided in Section 2.6, and
except with respect to matters pertaining to injunctive relief, in the event
of any dispute, the parties shall refer such dispute to the Chief Executive
Officer of ACADIA and a Senior Executive of Allergan appointed by Allergan's
Chief Executive Officer for attempted resolution by good faith negotiations
within [***] after such referral is made. During such period of good faith
negotiations, any applicable time periods under this Agreement shall be
tolled. In the event such executives are unable to resolve such dispute
within such [***] period, the parties shall submit their dispute to binding
arbitration before a retired California Superior Court Judge at
J.A.M.S./Endispute located in Orange County, California, such arbitration to
be conducted pursuant to the J.A.M.S./Endispute procedure rules for
commercial disputes then in effect. The award of the arbitrator shall include
an award of reasonable attorneys' fees and costs to the prevailing party.
14.3 JURISDICTION AND VENUE. Except as provided in Section 2.7 or
14.3 above, any claim or controversy arising out of or related to this
Agreement or any breach hereof (including claims for injunctive relief) shall
be adjudicated in the state and federal courts in Orange County having
jurisdiction over disputes arising in the State of California, and the
parties hereby consent to the jurisdiction and venue of such courts.
15. GENERAL PROVISIONS.
15.1 NOTICES. All notices required or permitted to be given under
this Agreement shall be in writing and shall be mailed by registered or
certified mail, Federal Express or other nationally recognized overnight
delivery service, addressed to the signatory to whom such notice is required
or permitted to be given and transmitted by facsimile to the number indicated
below. All notices shall be deemed to have been given when mailed, as
evidenced by the postmark at the point of mailing, or faxed.
All notices to Allergan shall be Allergan, Inc.
addressed as follows: 0000 Xxxxxx Xxxxx
Xxxxxx, XX 00000
Attn: President, Research and Development
Fax: (000) 000-0000
with a copy to: Allergan, Inc.
0000 Xxxxxx Xxxxx Xxxxxx, XX 00000
Attn: Allergan General Counsel
Fax: (000) 000-0000
29
*CONFIDENTIAL TREATMENT REQUESTED
All notices to ACADIA shall be ACADIA Pharmaceuticals Inc.
addressed as follows: 0000 Xxxxxxxx Xxxxxx Xxxx.
Xxx Xxxxx, XX 00000
Attn: Chief Executive Officer
Fax: (000) 000-0000
with a copy to: Pillsbury Madison & Sutro LLP
0000 Xxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000-0000
Attn: Xxxx X. Xxxxxxx
Fax: (000) 000-0000
Any party may, by written notice to the other, designate a new
address or fax number to which notices to the party giving the notice shall
thereafter be mailed or fixed.
15.2 FORCE MAJEURE. No party shall be liable for any delay or
failure of performance (other than payment obligations) to the extent such
delay or failure is caused by circumstances beyond its reasonable control and
that by the exercise of due diligence it is unable to prevent, provided that
the party claiming excuse uses its best efforts to overcome the same.
15.3 ENTIRETY OF AGREEMENT. This Agreement embodies the entire,
final and complete agreement and understanding between the parties and
replaces and supersedes all prior discussions and agreements between them
with respect to its subject matter, except for the September 24, 1997
Collaboration Agreement and the Confidential Disclosure Agreement dated as of
March 1, 1998, which shall continue in accordance with its terms, except to
the extent specifically modified hereby. No modification or waiver of any
terms or conditions hereof shall be effective unless made in writing and
signed by a duly authorized officer of each party.
15.4 NON-WAIVER. The failure of a party in any one or more instances
to insist upon strict performance of any of the terms and conditions of this
Agreement shall not constitute a waiver or relinquishment, to any extent, of
the right to assert or rely upon any such terms or conditions on any future
occasion.
15.5 DISCLAIMER OF AGENCY. Neither party is, or will be deemed to
be, the legal representative or agent of the other, nor shall either party
have the right or authority to assume, create, or incur any third party
liability or obligation of any kind, express or implied, against or in the
name of or on behalf of another except as expressly set forth in this
Agreement.
15.6 SEVERABILITY. If a court of competent jurisdiction declares any
provision of this Agreement invalid or unenforceable, or if any government or
other agency having jurisdiction over either ACADIA or Allergan deems any
provision to be contrary to any laws, then that provision shall be severed
and the remainder of the Agreement shall continue in full force and effect.
To the extent possible, the parties shall revise such invalidated provision
in a manner that will render such provision valid without impairing the
parties' original intent.
15.7 AFFILIATES; ASSIGNMENT. Except as otherwise provided herein,
neither party may assign its rights or delegate its duties under this
Agreement without the prior written consent of
30
the other party, not to be unreasonably withheld. Notwithstanding the
foregoing, each party may assign this Agreement to any of its Affiliates, to
a special purpose corporation or similar entity at least fifty percent (50%)
of the outstanding shares of any class or series of stock of which is owned
by such party in a manner such that the assignor will remain liable and
responsible for the performance and observance of all its duties and
obligations hereunder without the consent of the other party. In addition,
the consent of the other party will not be required in connection with a
merger involving either party or with respect to an assignment of this
Agreement in connection with, as the case may be, the acquisition, sale of
all or substantially all of the assets of either party, or a change of
control or similar transaction. This Agreement shall be binding upon the
successors and permitted assigns of the parties. Any attempted delegation or
assignment not in accordance with this Section 15.7 shall be of no force or
effect. Notwithstanding the foregoing provisions of this Section 15.7, or any
other provision of this Agreement, ACADIA may not assign or otherwise
transfer its rights hereunder, whether by merger, acquisition, sale of
assets, operation of law or otherwise, to Alcon, Bausch & Lomb, Ciba Vision
or Santen.
15.8 HEADINGS. The headings contained in this Agreement are inserted
for reference only and shall not be deemed a part of the text hereof.
15.9 LIMITATION OF LIABILITY. NO PARTY SHALL BE LIABLE TO ANOTHER
FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES,
INCLUDING BUT NOT LIMITED TO LOST PROFITS, ARISING FROM OR RELATING TO ANY
BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH
DAMAGES. Nothing in this Section is intended to limit or restrict the
indemnification rights or obligations of any party.
15.10 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document.
15.11 BANKRUPTCY. All rights and licenses granted under this
Agreement will be considered for purposes of Section 365(n) of the Bankruptcy
Code, licenses of rights to "intellectual property" as defined under Section
101(56) of the Bankruptcy Code. The parties agree that a licensee of such
rights under this Agreement will retain and may fully exercise all of its
rights and elections under the Bankruptcy Code. In the event that a licensor
seeks or is involuntarily placed under the protection of the Bankruptcy Code,
and the trustee in bankruptcy rejects this Agreement, the licensee hereby
elects, pursuant to Section 365(n), to retain all rights granted to it under
this Agreement to the extent permitted by law.
31
15.12 PUBLIC DISCLOSURE. Except for such disclosure as is deemed
necessary, in the reasonable judgment of a party, to comply with applicable
laws or regulations, no public announcement, news release, public statement
or publication relating to the existence of this Agreement, or the terms
hereof, will be made without the other party's prior written approval, which
approval shall not be unreasonably withheld. The parties agree that they will
use reasonable efforts to coordinate the initial announcement or press
release relating to the existence of this Agreement in the form attached as
Exhibit E, so that such initial announcement or press release by each is made
contemporaneously.
IN WITNESS WHEREOF, the parties hereto have duly executed this
Agreement.
ACADIA PHARMACEUTICALS INC.
By /s/ Xxxxxxx X. Xxxxxxxx
-----------------------------------------------------------
Xxxxxxx X. Xxxxxxxx, Pharm.D.,
Chief Executive Officer
ALLERGAN, INC.
By /s/ Xxxxxx Panglay
-----------------------------------------------------------
Title Corporate Vice President, Corporate Development
--------------------------------------------------------
ALLERGAN PHARMACEUTICALS (IRELAND) LIMITED, INC.
BY /s/ Xxxxxxxxx Xxxxxx
--------------------------------------------------------------
Title Vice President
--------------------------------------------------------
ALLERGAN SALES, INC.
By /s/ Xxxxxx Panglay
-----------------------------------------------------------
Title Vice President
--------------------------------------------------------
32
EXHIBIT A
DEFINITION OF PROOF OF CONCEPT IN GLAUCOMA PATIENTS
A-1
PROOF OF CONCEPT IN GLAUCOMA PATIENTS
Proof of Concept in Glaucoma Patients shall be considered met if [***]:
[***]
A-2
*CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT B
RESEARCH PLAN
B-1
[***]
B-2
*CONFIDENTIAL TREATMENT REQUESTED
[***]
B-3
*CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT C
ACADIA PATENTS
[***]
C-1
*CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT D
FORM OF MATERIALS TRANSFER AGREEMENT
D-1
MATERIALS TRANSFER AGREEMENT
This Agreement is made as of ___________, 199_, by and between
ACADIA PHARMACEUTICALS INC., a Delaware corporation (ACADIA) and ALLERGAN,
INC., a Delaware corporation ("Allergan").
[ACADIA/Allergan] (hereinafter, the Recipient") desires to receive
the materials described on Exhibit A attached hereto (the "Materials") from
[Allergan/ACADIA] (hereinafter, the "Provider") for the purpose of performing
certain studies pursuant to the Collaborative Research Development and
License Agreement by and between ACADIA and Allergan dated July _, 1999 (the
"Research Agreement") as described in detail in Exhibit B to the Research
Agreement (the "Project').
The Recipient and the Provider hereby agree as follows:
1. USE OF MATERIALS.
The Recipient will utilize its expertise and facilities to undertake
the Project and will use the Materials solely for the Project. The Recipient
shall not sell, transfer, disclose or otherwise provide access to the
Materials, any method or process relating thereto or any material that could
not have been made but for foregoing to any person or entity without the
prior written consent of the Provider, except that the Recipient may allow
access to the Materials to its employees or agents or permitted
subcontractors for purposes consistent with this Agreement. The Recipient
will take reasonable steps to ensure that such employees and agents or
permitted subcontractors will use the materials in a manner that is
consistent with the terms of this Agreement. The Recipient will destroy the
Materials or otherwise dispose of the Materials as mutually agreed by the
Provider and the Recipient upon expiration or termination of this Agreement.
2. PRECAUTIONS.
The Recipient understands that the Materials may have unpredictable
and unknown biological and/or chemical properties, that they are to be used
with caution, and that they are not to be used for testing in or treatment of
humans. The Recipient will use the Materials in compliance with all
applicable laws and regulation, including those applicable to research
involving recombinant DNA and isotopes.
3. INTELLECTUAL PROPERTY.
In performing the Projects, the Recipient may develop ideas,
inventions, techniques and other technology and associated intellectual
property (collectively "Inventions"). The parties agree that ownership of all
Inventions, including without limitation Inventions relating to the
Materials, their preparation or use, shall be governed by the provisions of
the Research Agreement relating to ownership of intellectual property.
D-2
4. REPORTS AND PUBLICATIONS.
The Recipient shall keep accurate records of the results of the
Project and will promptly and fully disclose to the Provider such results in
such manner and at such time as determined by the Research Management
Committee under the Research Agreement. Publication of the Projects results
shall be governed by the provisions of the Research Agreement relating to
publication.
5. CONFIDENTIALITY.
The parties agree that the terms of the Research Agreement relating
to Confidential Information shall apply to all information that one party
receives from the other party pursuant to this Agreement.
6. NO LICENSE.
Nothing in this Agreement shall be construed as conferring on either
party any implied license or implied option to license any disclosed
Confidential Information, technology, or any patent or patent application
owned by the other party.
7. WARRANTY DISCLAIMER.
THE MATERIALS ARE SUPPLIED TO THE RECIPIENT WITH NO WARRANTIES OF
ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OR THAT THEY ARE FREE FROM THE RIGHTFUL
CLAIM OR ANY THIRD PARTY BY WAY OF INFRINGEMENT OR THE LIKE.
8. TERM AND TERMINATION.
This Agreement will be effective as of the date first written above
and will continue until the Research Agreement terminates. The parties may
terminate this Agreement prior to such time or extend the term of this
Agreement by mutual written agreement as provided herein. Either party will
have the right to terminate this Agreement on [***] written notice for
material breach of this Agreement, which breach is not cured within such [***]
period. Promptly upon any termination, the Recipient will deliver to the
Provider any remaining Materials, and any modifications, replications or
derivatives thereof and copies of all results of the Projects. Section 3, 4,
5, 6, 7 and 8 will survive the termination or expiration of this Agreement.
9. ENTIRE AGREEMENT, GOVERNING LAW.
This Agreement sets forth complete and final agreements of the
parties with respect to the subject matter of this Agreement and supersedes
all prior agreements and understandings, written or oral, between the parties
hereto which relate to the subject matter of this Agreement, other than the
Research Agreement. This Agreement may be amended only by a writing signed by
the parties. This Agreement shall be governed by the laws of the State of
California without regard to choice of law provisions.
D-3
*CONFIDENTIAL TREATMENT REQUESTED
IN WITNESS WHEREOF, the parties have by duly authorized persons,
executed this Agreement as of the date first above written.
ALLERGAN, INC. ACADIA PHARMACEUTICALS INC.
By: By:
------------------------------ ------------------------------
Title: Title:
--------------------------- --------------------------
D-4
EXHIBIT E
FORM OF PRESS RELEASE
E-1
FOR IMMEDIATE RELEASE CONTACTS: ACADIA PHARMACEUTICALS
XXXXXX X. XXXXX, VP AND CFO
(000) 000-0000
XXXXXXX X. XXXXXXXX, PHARM.D., CEO
(000) 000-0000
ALLERGAN INVESTOR RELATIONS
XXXXX XXXXXXX, (000) 000-0000
ALLERGAN MEDIA RELATIONS
XXX XXXXXXX, (000) 000-0000
ACADIA OUT-LICENSES NOVEL LEAD COMPOUNDS FOR
TREATMENT OF GLAUCOMA TO ALLERGAN
(SAN DIEGO, CALIFORNIA, COPENHAGEN, DENMARK AND IRVINE, CALIFORNIA JULY 27,
1999)--ACADIA Pharmaceuticals and Allergan (NYSE: AGN) announced today that
they have entered into a license and research collaboration agreement to
discover, develop and commercialize compounds for glaucoma, based on ACADIA's
proprietary and highly receptor subtype-selective muscarinic lead compounds.
Under the terms of the agreement, ACADIA will grant Allergan worldwide rights
to products based on these novel lead compounds for the treatment of ocular
disease. ACADIA will provide its expertise in medicinal chemistry and
high-throughput pharmacology to enable the final selection of up to two
development candidates for clinical development and commercialization by
Allergan. In exchange, ACADIA may receive up to nearly $19 million for the
first development candidate, in the form of up-front fees, research support,
and traditional milestone payments. ACADIA will also receive substantial
royalties on future product sales worldwide. Pursuant to the agreement,
Allergan also has the right to select a second development candidate, subject
to similar milestone and royalty payments to ACADIA.
Discovered in one of ACADIA's internal drug discovery programs, these new
lead compounds are highly selective for a specific subtype of the muscarinic
receptor. Compounds with unprecedented receptor subtype selectivity were
initially identified from ACADIA's diverse chemical library using the
Company's patented Receptor Selection and Amplification Technology
(R-SAT-TM-). ACADIA scientists have synthesized numerous analogs and
performed precise pharmacological analysis using R-SAT-TM- to derive a
detailed Structure-Activity Relationship for this family of molecules.
Through these efforts, ACADIA has successfully discovered molecules that
selectively target the subtype of the muscarinic receptor responsible for the
lowering of intraocular pressure, while avoiding interaction with other
receptor subtypes believed to cause side effects commonly associated with
certain existing glaucoma therapies. In animal models of glaucoma, Allergan
has shown that ACADIA's initial chemical lead produces a sustainable
reduction of intraocular pressure, when applied topically, without the dose
limiting side effects of these traditional anti-glaucoma therapies.
"ACADIA's lead compounds provide the potential for an important new
breakthrough in glaucoma therapy," said Xxxxx Xxxxx, Allergan's President and
Chief Executive Officer. "This latest collaboration between Allergan and
ACADIA is consistent with Allergan's objective to continue to expand our
growing glaucoma franchise through the discovery and development of new and
complimentary therapeutic approaches to the disorder that have the potential
to significantly improve patient care."
In addition to this new license and collaboration agreement concerning
ACADIA's muscarinic compounds, ACADIA and Allergan have another pre-existing
collaboration directed at the discovery of other therapeutics for ocular
disease. In November 1998, just one year into that collaboration, Allergan
nominated a subtype-selective alpha-adrenergic agonist as a clinical
candidate for glaucoma. Alpha-adrenergic agents lower introcular pressure,
in part, by decreasing inflow of ocular fluid, while ACADIA's new
receptor-selective muscarinic lead compounds are designed to increase the
outflow of fluid from the eye. Both inflow and outflow agents are used as
initial therapy and in combination to lower intraocular pressure associated
with glaucoma.
"Given the outstanding success of our existing discovery collaboration with
Allergan, they were the obvious preferred partner for our internal glaucoma
program," added Xxxxxxx X. Xxxxxxxx, Pharm.D., ACADIA's Chief Executive
Officer. "The successful discovery of our second clinical lead compound in
less than one year further validates ACADIA's unique ability to rapidly
identify novel receptor-selective compounds with the potential for improved
clinical utility over existing therapies."
Forward Looking Statements
Any of the above statements that refer to Allergan's estimated or anticipated
future results are forward-looking and reflect Allergan's current analysis of
existing trends and information. Actual results may differ based on a number
of factors including timing and uncertainty of the results of both research
and regulatory processes and including the research, development, regulatory
approval, introduction and consumer acceptance of new products. The reader is
cautioned not to rely on these forward-looking statements. Allergan
disclaims any intent or obligation to update these statements. Additional
information concerning these factors can be found in press releases as well
as in Allergan's public periodic filings with the Securities and Exchange
Commission, including the discussion under the heading "Certain Factors and
Trends Affecting Business" in Allergan's 1998 Form 10-K. Copies of Allergan
press releases and additional information about Allergan are available on the
World Wide Web at XXX.XXXXXXXX.XXX, or you can contact the Allergan Investor
Relations Department by calling 000-000-0000.
ACADIA is a privately held drug discovery company focused on the
identification of novel lead compounds for the treatment of Central Nervous
System disorders. ACADIA uses its integrated discovery platform to identify
and validate the molecular targets relevant to a disease and to discover
highly selective compounds that specifically regulate these targets. ACADIA
has a portfolio of internal drug discovery programs and is commercializing
this pipeline through licensing and discovery collaborations with
pharmaceutical partners. The Company's corporate headquarters and biological
research are located in San Diego, California; chemistry research facilities
are located in Copenhagen, Denmark. Additional information can be found on the
Company's website at XXX.XXXXXX-XXXXX.XXX.
Allergan, headquartered in Irvine, California, is a technology-driven, global
healthcare company, providing eye care and specialty pharmaceutical products
worldwide. Allergan develops and commercializes products in the eye care
pharmaceutical, ophthalmic surgical device, over-the-counter contact lens
care, movement disorder and dermatological markets that deliver value to our
customers, satisfy unmet medical needs and improve patients' lives.
