Exhibit 99.1
Certain confidential information contained in
this document, marked by brackets and asterisks, has been omitted
pursuant to a request for confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended, and has
been filed separately with the Securities and Exchange
Commission.
LICENSE, OPTION AND COLLABORATION
AGREEMENT
by and between
ACADIA PHARMACEUTICALS INC.
and
SEPRACOR INC.
This document is the confidential information of
both parties hereto.
It should be distributed on a need-to-know basis
and kept in a secure area.
LICENSE, OPTION AND COLLABORATION
AGREEMENT
T HIS L ICENSE , O PTION AND C OLLABORATION A GREEMENT ( “Agreement” ) is by
and between ACADIA P HARMACEUTICALS I NC . , a
Delaware corporation ( “ACADIA” ), having
an address of 3911 Sorrento Valley Boulevard, San Diego, CA 92121,
and S EPRACOR I NC . , a
Delaware corporation ( “Sepracor” ),
having an address of 84 Waterford Drive, Marlborough, MA
01752.
R ECITALS
W HEREAS , ACADIA has developed expertise and acquired
proprietary rights related to [...***...] , as more fully
described below;
W HEREAS , Sepracor is engaged in the research, development
and commercialization of pharmaceutical products;
W HEREAS , Sepracor and ACADIA desire to enter into a
collaborative relationship to identify and develop Muscarinic
Compounds (as defined below) for clinical development and
commercialization by Sepracor, subject to the terms and conditions
set forth herein;
W HEREAS , Sepracor and ACADIA also desire to enter into
a collaborative relationship to evaluate Option Compounds (as
defined below), and Sepracor wishes to obtain, and ACADIA is
willing to grant to Sepracor, a time-limited option to obtain an
exclusive license with respect to an Option Compound, subject to
the terms and conditions set forth herein; and
W HEREAS , concurrently with this Agreement, Sepracor and
ACADIA will enter into a separate common stock purchase agreement
pursuant to which Sepracor will purchase and commit to purchase
shares of ACADIA’s common stock on the terms provided
therein.
A GREEMENT
N OW ,
T HEREFORE
, in consideration of the foregoing
premises and the mutual promises, terms, conditions, and covenants
contained herein and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, ACADIA
and Sepracor hereby agree as follows:
For purposes of this Agreement,
initially capitalized terms used in this Agreement, whether used in
the singular or plural, shall have the following meanings, unless
the context clearly requires otherwise:
1.1 “ACADIA
Inventions” shall
mean all Inventions conceived, or simultaneously conceived and
reduced to practice, solely by ACADIA employees, consultants, or
contractors in the course and as part of the Research
Program.
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1.2 “ACADIA
Know-How” shall
mean Information not included in the ACADIA Patents or Joint
Patents that ACADIA or any of its Affiliates Controls on the
Effective Date or during the Research Term that pertains to or
arises from the Research Program or the Evaluation or that is
necessary for the development, manufacture, use, offer for sale, or
sale of any Product, including, without limitation, all such
Information that is conceived or developed by ACADIA or any of its
Affiliates in the course and as part of the Research Program, and,
in each case, any replication or any part of such Information;
provided, however, that ACADIA Know-How excludes any such
Information relating to ACADIA’s compounds known as ACP-103
and ACP-104, ACP-104 Analogs and/or [...***...] Eyecare
Compounds, which is Confidential Information of ACADIA.
1.3 “ACADIA Muscarinic
Compounds” shall
mean any compound Controlled by ACADIA on the Effective Date, the
primary mode of action of which is [...***...] , including,
without limitation, ACADIA’s proprietary [...***...] ,
but subject to exclusion of [...***...] Agonists under the
circumstances described in Section 2.3(b). Notwithstanding the
foregoing or any other provision of this Agreement to the contrary,
neither ACADIA’s compound known as ACP-104
(N-desmethylclozapine) nor any ACP-104 Analogs shall be considered
ACADIA Muscarinic Compounds for purposes of this
Agreement.
1.4 “ACADIA
Patents” shall mean
all Patents that ACADIA or any of its Affiliates Controls as of the
Effective Date or during the Research Term that are necessary or
useful for (a) performance of the Research Program or the
Evaluation, or (b) for the development, manufacture, use, import,
offer for sale, or sale of any Selected Muscarinic Compound,
Licensed Compound or Product, but excluding the Joint Patents, and
shall include without limitation the Patents listed in Schedule 1.4
of this Agreement.
1.5 “ACADIA
Technology” shall
mean the ACADIA Patents, ACADIA Inventions, and ACADIA
Know-How.
1.6 “ACP-104
Analogs” shall mean
compounds described on Schedule 1.6.
1.7
“Affiliate” shall mean, with respect to either party hereto,
any corporation, company, partnership, joint venture, or any other
entity controlled by, controlling, or under common control with
such party, and shall include any corporation, company,
partnership, joint venture, or other entity at least fifty percent
(50%) of whose voting stock or participating profit interest is
owned or controlled, directly or indirectly, by such party, and any
corporation, company, partnership, joint venture, or other entity
which owns or controls, directly or indirectly, at least fifty
percent (50%) of the voting stock of such party.
1.8 “Back-Up Selected
Muscarinic Compound” shall mean any Muscarinic Compound that is
designated by Sepracor as a back-up compound for a Primary Selected
Muscarinic Compound and any Other Forms of any such Muscarinic
Compound.
1.9 “Business
Day” shall mean a
day on which banks are open for business in both Marlborough,
Massachusetts and San Diego, California, excluding Saturdays and
Sundays.
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1.10 “Calendar
Quarter” shall mean
each respective period of three (3) consecutive months ending on
March 31, June 30, September 30, and December 31.
1.11 “Chosen
Compound” shall
mean any Evaluation Compound designated by Sepracor for
investigation during the Final Evaluation Period. For the avoidance
of doubt, any Option Compound that is an Evaluation Compound
designated as a Chosen Compound shall include Other Forms of such
Option Compound.
1.12 “Combination
Product” shall mean
a Product which comprises two (2) or more active pharmaceutical
ingredients at least one (1) of which is a Selected Muscarinic
Compound.
1.13
“Committee” shall mean the JRC or JDC, as
applicable.
1.14 “Confidential
Information” shall
mean any Information possessed, obtained, developed, or created by
or on behalf of a party that is identified by the party as
confidential or proprietary, or that a receiving party knows is
confidential or proprietary or has a reasonable basis to believe is
confidential or proprietary.
1.15 “Control” or
“Controlled” shall mean, with respect to any Information,
Patent or other intellectual property right, the legal authority or
right (whether by ownership, license or otherwise) of a party
hereto to grant access, a license or a sublicense of or under
Information, Patents, or intellectual property rights to another
party hereto, or to otherwise disclose proprietary or trade secret
information to such other party, without breaching the terms of any
agreement with a Third Party, or misappropriating the proprietary
or trade secret information of a Third Party.
1.16 “Effective
Date” shall mean
the later of (a) the date on which Sepracor executes this
Agreement, and (b) the date on which ACADIA executes this
Agreement.
1.17 “Eszopiclone
Compounds” shall
mean: a)
6–(5–chloro–2–pyridinyl)-6,7–dihydro-7–oxo–5H–pyrrolo[3,4b]pyrazin–5–y–l4–
methylpiperazine–1–carboxylate or
6–(5-chloropyri-2-dyl)-5–(4-methylpiperazin–1–yl)carbonyloxy–7–oxo–6,7–dihydro–5H–
pyrrolo[3,4b]pyrazine, also
known as zopiclone; b) racemic zopiclone; c) (+)-zopiclone or
eszopiclone; d) (-)-zopiclone; e) metabolites of any of a) through
d); f) all salts, solvates, or clathrates of any of a) through e);
and g) all polymorphs, crystals forms, amorphorous forms, or
co-crystals of any of the foregoing.
1.18
“Evaluation” shall mean Sepracor’s assessment of Option
Compounds to determine Sepracor’s interest in obtaining a
license to make, develop, use, promote, and commercialize Fixed
Co-Formulation Products.
1.19 “Evaluation
Compound” shall
mean an Option Compound selected by Sepracor for Preliminary
Evaluation Work during the Preliminary Evaluation Period, and Other
Forms of any such Option Compound.
1.20 “Evaluation
Results” shall mean
the results of the Preliminary Evaluation Work and Evaluation
Studies.
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1.21 “Evaluation
Studies” shall mean
studies or work conducted by or on behalf of Sepracor using Chosen
Compounds during the Final Evaluation Period, including without
limitation, synthesis of Chosen Compounds, GLP and GMP drug supply
manufacturing, in vivo or in vitro genotoxicity,
safety pharmacology, toxicology, pharmacokinetics, metabolism,
toxicology, formulation, stability, and proof-of-principle studies
involving any Chosen Compound, but excluding any studies in
humans.
1.22 “Exercise
Notice” shall mean
Sepracor’s written notice to ACADIA identifying the Chosen
Compound for which Sepracor desires to exercise the Option granted
in Section 4.3 of this Agreement.
1.23 “Eyecare
Indications” shall
mean diseases, disorders, or conditions involving the eye
[...***...] .
1.24 “FDA”
shall mean the United States Food
and Drug Administration, or any successor agency thereto having the
administrative authority to regulate the marketing of human
pharmaceutical products or biological therapeutic products,
delivery systems and devices in the United States of
America.
1.25 “Filing
Party” shall mean
the party to this Agreement responsible for the preparation,
filing, prosecution, and maintenance of an ACADIA Patent, a Product
Patent or a Joint Patent.
1.26 “Final Evaluation
Period” shall mean
the period beginning on the date of Sepracor’s written notice
to ACADIA identifying Chosen Compounds and continuing until the
earlier of (a) [...***...] such written notice or a later or
earlier date as may be agreed upon by the parties in writing, or
(b) Sepracor’s exercise of the Option.
1.27 “First Commercial
Sale” shall mean,
with respect to any Product, the first sale by Sepracor, or any of
its Affiliates or Sublicensees, to a Third Party for end use or
consumption of such Product in a country after the governing health
regulatory authority of such country has granted Regulatory
Approval. Sale to an Affiliate or Sublicensee shall not constitute
a First Commercial Sale.
1.28 “Fixed Co-Formulation
Product” shall mean
a pharmaceutical product containing a fixed co-formulation of
Licensed Compound and at least one other active ingredient,
including all formulations, line extensions and modes of
administration thereof.
1.29 “FTE”
shall mean the equivalent of a
full-time scientist’s work time over a 12-month period
(including normal vacations, sick days and holidays). The portion
of an FTE year devoted by an employee or consultant to the Research
Program shall be determined by dividing the number of full working
days during any 12-month period devoted by such employee or
consultant to the Research Program by the total number of working
days in such 12-month period. Subject to the provisions of Section
3.4(a) of this Agreement, each party understands and agrees that
the other party retains complete discretion to change the identity
of any individual employee or consultant devoted to the Research
Program and/or the frequency and the time
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during which such individual employee’s or
consultant’s efforts are devoted to the Research
Program.
1.30 “Generic
Version” shall mean
any pharmaceutical product that is introduced in a country, by an
entity other than Sepracor, or its Affiliates or Sublicensees,
containing the same or equivalent (by FDA or other regulatory
authority standards, on a country-by-country basis) active
pharmaceutical ingredient(s) as contained in a Product, including,
without limitation, any such pharmaceutical product that is
AB-rated or determined to be bioequivalent to a Product by the FDA,
or similarly rated by other regulatory authorities outside the
United States, on a country-by-country basis.
1.31 “IND”
shall mean an Investigational New
Drug Application filed with the FDA, or the equivalent application
or filing filed with any equivalent agency or governmental
authority outside the United States of America (including any
supra-national agency such as in the European Union) necessary to
commence human clinical trials in such jurisdiction.
1.32 “IND
Plan” shall mean a
written development plan for the conduct of preclinical toxicology
and pharmacokinetic studies of a Product Candidate to support
filing of an IND for such Product Candidate.
1.33
“Information” shall mean all tangible and intangible
scientific, technical, trade, financial, or business information
including, without limitation: a) cells, cell lines, organisms,
animal models, genes, gene fragments, gene sequences and loci,
probes, DNA, RNA, cDNA libraries, plasmids, vectors, expression
systems, antibodies, proteins, and biological substances, and any
constituents, progeny, mutants, derivatives or replications thereof
or therefrom; b) compounds, solid state forms, compositions of
matter, formulations, techniques, processes, methods, trade
secrets, formulae, procedures, tests, apparatus, equipment,
drawings, schemes, informatics, computer software, source code,
computer hardware, data, results, analyses, documentation, reports,
testing information (including without limitation, pharmacological,
toxicological, preclinical, and clinical test design, methods,
protocols, data, results, analyses, and conclusions), quality
assurance and quality control information, knowledge, know-how,
skill, and experience; c) inventions (whether patentable or not),
patent applications, and patent positioning; d) sources of supply,
relationships with consultants and employees, finances, financial
plans, information relating to investors or potential investors,
strategies, tactics, business plans, business developments; e)
information concerning the existence, scope, or activities of any
research, development, manufacturing, marketing, or other projects,
and f) any other information about or belonging to a party, or its
suppliers, licensors, licensees, partners, affiliates, customers,
or potential suppliers, licensors, licensees, partners, or
customers whether communicated in writing, verbally, or
electronically, which is provided by one party to the other party
or otherwise generated by a party in connection with this
Agreement.
1.34
“Inventions” shall mean all inventions conceived, or
simultaneously conceived and reduced to practice, in the course and
as part of the Research Program.
1.35 “Joint Development
Committee” or
“JDC” shall mean a committee composed of three
(3) representatives from Sepracor and three (3) representatives
from ACADIA.
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1.36 “Joint
Inventions” shall
mean all Inventions conceived, or simultaneously conceived and
reduced to practice, jointly by Sepracor employees, consultants, or
contractors and ACADIA employees, consultants, or contractors in
the course and as part of the Research Program.
1.37 “Joint Muscarinic
Compounds” shall
mean any compounds, other than ACADIA Muscarinic Compounds or
ACADIA’s compound known as ACP-104 (N-desmethylclozapine) or
ACP-104 Analogs, the primary mode of action of which is activity as
a [...***...] of any one (1) or more of the muscarinic
receptor subtypes, including, without limitation, m
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[...***...]
receptor subtypes, that is identified or developed during the
course of the Research Program, but subject to exclusion of
[...***...] Agonists under the circumstances described in
Section 2.3(b).
1.38 “Joint
Patents” shall mean
all Patents that claim or disclose a Joint Invention.
1.39 “Joint Research
Committee” or
“JRC” shall mean a committee composed of three
(3) representatives from Sepracor and three (3) representatives
from ACADIA that is responsible for overseeing, monitoring, and
making decisions relating to scientific aspects of the Research
Program and compounds being investigated thereunder until such time
as a compound is designated as a Product Candidate.
1.40 “Licensed
Compound” shall
mean the Chosen Compound that is identified by Sepracor in the
Exercise Notice. For the avoidance of doubt, any Option Compound
that is a Chosen Compound designated as Licensed Compound shall
include Other Forms of such Option Compound.
1.41 “Limited ACADIA
Patents” shall mean
those ACADIA Patents listed on Schedule 1.41, as may be amended
from time to time pursuant to Section 9.2(a)(iv), to which a Third
Party has rights to file, prosecute, maintain, defend, or enforce
for so long as such Third Party has any such right.
1.42 “[...***...]
Agonist” shall mean
any compound Controlled by ACADIA on the Effective Date or during
the Research Term, the primary mode of action of which is activity
as a selective agonist of the [...***...] muscarinic
receptor subtype.
1.43 “Major
Market” shall mean
the [...***...] .
1.44
“Materials” shall have the meaning provided in Section
3.7.
1.45 “Muscarinic
Compound” shall
mean any ACADIA Muscarinic Compound or Joint Muscarinic Compound,
but excluding any [...***...] Eyecare Compound and excluding
any [...***...] Agonists under the circumstances described
in Section 2.3(b). Notwithstanding the foregoing or any other
provision of this Agreement to the contrary, neither ACADIA’s
compound known as ACP-104 (N-desmethylclozapine) nor any ACP-104
Analogs shall be considered Muscarinic Compounds for purposes of
this Agreement.
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1.46 “Muscarinic
Field” shall mean
the treatment, prevention, or both, of any disease or disorder in
humans, but excluding the prevention or treatment of ocular
disease.
1.47 “Muscarinic
Product” shall mean
a pharmaceutical product containing any Selected Muscarinic
Compound (or any Other Forms of the Muscarinic Compound that is a
Selected Muscarinic Compound) including, in each case, all
formulations, line extensions and modes of administration
thereof.
1.48 “NDA”
shall mean a New Drug Application
(as more fully defined in 21 C.F.R. 314.5 et seq. ) and all
amendments and supplements thereto filed with the FDA, or the
equivalent application filed with any equivalent agency or
governmental authority outside the United States of America
(including any supra-national agency such as in the European
Union), including all documents, data, and other information
concerning a pharmaceutical product which are necessary for gaining
Regulatory Approval to market and sell such pharmaceutical
product.
1.49 “ [...***...] ” shall mean
any [...***...] of Licensed Compound that arise from
[...***...] , if any, of Licensed Compound where the product
of such [...***...] .
1.50 “Net
Sales” shall mean,
with respect to a Product, the gross amounts invoiced by Sepracor
and its Affiliates and any of their Sublicensees in the United
States (but not their respective Sublicensees outside the United
States) for sales of Products to Third Parties that are not
Affiliates or Sublicensees of the selling party (unless such
Affiliate or Sublicensee is the end user of such Product, in which
case the amount billed therefor shall be deemed to be the amount
that would be billed to a Third Party end user in an
arm’s-length transaction), less the following items, as
allocable to such Product (if not previously deducted from the
amount invoiced): (a) trade, quantity or cash discounts actually
allowed (provided that such discounts are not applied
disproportionately to Product when compared to the other products
of Sepracor, its Affiliates and Sublicensees in the United States,
as applicable) including, charge back payments, administrative
fees, and rebates granted to managed care organizations, purchasers
and reimbursers or to trade customers, including but not limited
to, wholesalers and chain and pharmacy buying groups, (b) credits
actually allowed for claims, allowances for damaged goods,
retroactive price reductions or returned goods, (c) prepaid
freight, postage, shipping, customs duties and insurance charges
and (d) sales taxes, value added taxes, duties and other
governmental charges, rebates or charge backs actually paid in
connection with the sale, to the extent not reimbursed (but
excluding what are commonly known as income taxes).
In the event that Product is sold in
the form of a Combination Product, Net Sales will be calculated by
multiplying actual Net Sales (determined in accordance with the
first paragraph of this Section 1.50) by the fraction A/(A+B)
where: i) A is the invoice price of the Muscarinic Compound(s)
contained in the Combination Product if sold separately by
Sepracor, or its Affiliates or Sublicensees, during the applicable
Calendar Quarter, and ii) B is the invoice price of any other
active pharmaceutical component or components in the Combination
Product if sold separately by Sepracor, or its Affiliates or
Sublicensees, during the applicable Calendar Quarter. If Product is
sold in the form of a Combination Product and one (1) or more of
the active
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pharmaceutical ingredients of the Combination
Product is not sold separately, then Net Sales will instead be
calculated as follows:
1) if the Muscarinic Compound(s)
contained in the Combination Product is sold separately by
Sepracor, or its Affiliates or Sublicensees, but the other active
pharmaceutical component(s) contained in the Combination Product is
not sold separately by Sepracor, or its Affiliates or Sublicensees,
Net Sales (determined in accordance with the first paragraph of
this Section 1.50) will be multiplied by the fraction C/D where: a)
C is the invoice price of the Muscarinic Compound(s) contained in
the Combination Product sold separately during the applicable
Calendar Quarter, and b) D is the invoice price of the Combination
Product sold separately during the applicable Calendar
Quarter;
2) if the Muscarinic Compound(s)
contained in the Combination Product is not sold separately by
Sepracor, or its Affiliates or Sublicensees, but the other active
pharmaceutical component(s) contained in the Combination Product is
sold separately by Sepracor, or its Affiliates or Sublicensees, Net
Sales (determined in accordance with the first paragraph of this
Section 1.50) will be multiplied by the fraction 1-(E/F) where: a)
E is the invoice price of the other active pharmaceutical
component(s) contained in the Combination Product sold separately
during the applicable Calendar Quarter, and b) F is the invoice
price of the Combination Product sold separately during the
applicable Calendar Quarter; and
3) if neither the Muscarinic
Compound(s) contained in the Combination Product nor the other
active pharmaceutical component(s) contained in the Combination
Product is sold separately by Sepracor, or its Affiliates or
Sublicensees, Net Sales (determined in accordance with the first
paragraph of this Section 1.50) will be multiplied by the fraction
one-half (1/2).
1.51 “Option
Compounds” shall
mean any compound Controlled by ACADIA as of the Effective Date the
primary mode of action of which is activity as a selective inverse
agonist of 5HT 2A [...***...] . Notwithstanding the foregoing or
any other provision of this Agreement to the contrary,
ACADIA’s compound known as ACP-103 shall not be considered an
Option Compound for purposes of this Agreement.
1.52 “Option Compound
Information” shall
mean Information in ACADIA’s Control that (a) is readily
available to ACADIA, its Affiliates, or any of their employees,
consultants, or contractors at the time such Information is to be
provided, and (b) addresses any of the characteristics or
properties of Option Compounds, Evaluation Compounds, Chosen
Compounds, or Licensed Compound, as applicable, including, without
limitation, Information relating to structure, methods or process
for synthesis, metabolism, bioavailability, binding assays,
functional assays, and any in vivo studies. If such Option
Compound Information (i) relates to Option Compounds, it shall
include such Information that exists as of the Effective Date, (ii)
relates to Evaluation Compounds, it shall include such Information
that exists as of the Effective Date and during the Preliminary
Evaluation Period, (iii) relates to Chosen Compounds it shall
include such Information that exists as of the Effective Date and
during the Option Period, or (iv) relates to Licensed Compound it
shall include Information that exists as of the Effective Date and
during the Option Period.
1.53 “Option Exercise
Fee” shall mean
[...***...] dollars ($[...***...]) .
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1.54 “Option
Period” shall mean,
cumulatively, the Preliminary Evaluation Period and the Final
Evaluation Period, unless earlier terminated in accordance with
Article 12.
1.55 “Other
Form” shall mean,
with regard to a particular compound, any and all: 1)
[...***...] ; 2) [...***...] ; 3) [...***...]
; 4) [...***...] of any of 1), 2), and (if applicable) 3)
above; and 5) [...***...] of any of 1), 2), (if applicable)
3), and 4) above; provided, however , with regard to
Licensed Compound, the term “Other Form” shall not
include [...***...] , and further provided that with regard
to Chosen Compounds (including Licensed Compound) the inclusion in
the term “Other Form” of [...***...] pursuant
clause 3) of this Section 1.55 shall be subject to the provisions
of Sections 4.1(b)(ii) and 4.4(b).
1.56
“Patents” shall mean all issued or granted patents and all
patent applications worldwide, including without limitation, any
and all provisional applications, substitutions, inventor’s
certificate, divisions, RCEs, continuations, continuations-in-part,
re-examinations, reissues, renewals, registrations, confirmations,
extensions, term restorations, supplementary protection
certificates, and any other filings thereof.
1.57 “Percentage-Based
Payments” shall
have the meaning provided in Section 7.7.
1.58 “Phase I Clinical
Trial” shall mean a
human clinical study conducted in accordance with good clinical
practice in a small number of healthy volunteers or patients
designed or intended to establish an initial safety profile,
pharmacodynamics, or pharmacokinetics of a Product.
1.59 “Phase II Clinical
Trial” shall mean a
human clinical trial that satisfies the requirements for a Phase II
study as defined in 21 C.F.R. 312.21(b) (or its successor
regulation).
1.60 “Phase III Clinical
Trials” shall mean
a human clinical trial that satisfies the requirements for a Phase
III study as defined in 21 C.F.R. 312.21(c) (or its successor
regulation).
1.61 “Preclinical
Development Costs” shall mean actual external costs incurred by
ACADIA before the Effective Date, or at Sepracor’s written
request after the Effective Date, for conduct of any of the
following types of studies using a compound that is at any time
designated as a Licensed Compound specifically intended to support
the filing of an IND: in vivo and in vitro
genotoxicity; safety pharmacology; drug metabolism;
pharmacokinetics; general toxicology studies; GLP and GMP drug
supply manufacturing; or stability.
1.62 “Preliminary
Evaluation Period” shall mean the period beginning upon
Sepracor’s receipt of Option Compound Information relating to
all Evaluation Compounds pursuant to Section 4.1(a) and continuing
until the earlier of (a) the [...***...] anniversary of
Sepracor’s receipt of such Information, or a later or earlier
date as may be agreed upon by the parties in writing, or (b) the
date of Sepracor’s written notice to ACADIA identifying any
Chosen Compound.
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1.63 “Preliminary
Evaluation Work” shall mean studies or work conducted by or on
behalf of Sepracor, at Sepracor’s cost and expense, using
Evaluation Compounds that in Sepracor’s sole determination
are desirable for selecting Chosen Compounds, including without
limitation, synthesis of Evaluation Compounds, binding assays,
functional assays, metabolism, bioavailability, stability, and
toxicology, but excluding any studies in humans.
1.64 “Primary Selected
Muscarinic Compound” shall mean any Muscarinic Compound that, on or
before the expiration or termination (other than termination by
ACADIA in accordance with Section 12.2 or 12.4) of the Research
Term, was designated a Product Candidate, and any Other Forms of
any such Muscarinic Compound.
1.65
“Product” shall mean a Muscarinic Product or a Fixed
Co-Formulation Product.
1.66 “Product
Candidate” shall
mean a Selected Muscarinic Compound approved by the JRC as a
candidate for further research and development to support
Regulatory Approval.
1.67 “Product Candidate
Criteria ” shall
mean the information, evaluation parameters, and criteria
established by the JRC.
1.68 “Product
Patents” shall mean
a) any and all ACADIA Patents (excluding Limited ACADIA Patents)
that contain claims limited to Selected Muscarinic Compounds or
Products under development or commercialization by or on behalf of
Sepracor or its Affiliates or Sublicensees, including, without
limitation, claims directed to an active pharmaceutical ingredient
(“API”), Other Forms of an API, compositions comprising
an API, formulations, delivery systems, processes for making any of
the foregoing, and methods of using such API, Other Forms thereof,
Selected Muscarinic Compounds or Products, and b) any and all Joint
Patents that contain at least one (1) claim directed to one (1) or
more Selected Muscarinic Compounds or Products under development or
commercialization by or on behalf of Sepracor or its Affiliates or
Sublicensees, including, without limitation, claims directed to an
API, Other Forms of an API, compositions comprising an API,
formulations, delivery systems, processes for making any of the
foregoing, and methods of using such API, Other Forms thereof,
Selected Muscarinic Compounds, or Products. For clarification,
Product Patents shall not include any ACADIA Patent that contains
one (1) or more claims directed to ACP-103, ACP-104, ACP-104
Analogs, [...***...] Eyecare Compounds, any Muscarinic
Compound that is not a Selected Muscarinic Compound, or any Option
Compound, including, without limitation, claims directed to an API,
Other Forms of an API, compositions comprising an API,
formulations, delivery systems, processes for making any of the
foregoing, and methods of using such API, Other Forms thereof, such
compounds, or products based on such compounds.
1.69 “Regulatory
Approval” shall
mean any and all approvals (including price and reimbursement
approvals, if required), licenses, registrations, or authorizations
of any country, federal, supranational, state or local regulatory
agency, department, bureau or other government entity that are
necessary for the manufacture, use, storage, import, transport
and/or sale of a Product in such jurisdiction.
1.70 “Research
Plan” shall mean
the written plan for conducting the Research Program, as amended
from time to time by the JRC.
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1.71 “Research
Program” shall mean
a research program carried out by the parties during the Research
Term for the identification and development of one or more
Muscarinic Compounds with potential utility for the treatment or
prevention of any indication in the Muscarinic Field, including
without limitation [...***...] , as more fully described in
Articles 2 and 3 of this Agreement and in the Research Plan. For
purposes of clarification, the Research Program excludes the
Evaluation.
1.72 “Research
Term” shall mean
the period beginning on the Effective Date and ending on the third
anniversary of the Effective Date, subject to termination in
accordance with Article 12 and extension for additional,
consecutive [...***...] periods by written agreement of the
parties.
1.73 “Returned
Products” shall
mean any Muscarinic Products based on Primary Selected Muscarinic
Compounds and their respective Back-Up Selected Muscarinic
Compounds, rights to which revert to ACADIA pursuant to Section
6.2(a)(i).
1.74 “Royalty
Term” shall mean,
in the case of any Product, in any country, the period of time
commencing on the First Commercial Sale of such Product in such
country and ending upon the later of either (a) [...***...]
years after the date of First Commercial Sale of such Product in
such country, or such earlier time as a Generic Version of such
Product is launched in such country and (b) the expiration of the
last to expire of any issued patent within the ACADIA Patents,
Joint Patents, or Sepracor Patents arising from Sepracor
Inventions, containing a claim directed to such Product or use
thereof in such country.
1.75 “Selected
Indications” shall
mean, for each Primary Selected Muscarinic Compound and any Back-Up
Selected Muscarinic Compounds thereof, one or more specific
indications in the Muscarinic Field for which, on or before
expiration or termination of the Research Term, Sepracor has the
then-current good faith intention of pursuing clinical
development.
1.76 “Selected Muscarinic
Compound” shall
mean a Primary Selected Muscarinic Compound or a Back-Up Selected
Muscarinic Compound, as applicable.
1.77 “Sepracor
Inventions” shall
mean all Inventions conceived, or simultaneously conceived and
reduced to practice, solely by Sepracor employees, consultants, or
contractors in the course and as part of the Research
Program.
1.78 “Sepracor
Know-How” shall
mean Information not included in the Sepracor Patents or Joint
Patents that Sepracor or any of its Affiliates Controls on the
Effective Date or during the Research Term that pertains to or
arises from the Research Program or the Evaluation, or that is
necessary for the development, manufacture, use, offer for sale, or
sale of any Product, including, without limitation, all such
Information that is conceived or developed by Sepracor or any of
its Affiliates in the course and as part of the Research Program or
the Evaluation, and, in each case, any replication or any part of
such Information; provided, however, that Sepracor Know-How
excludes any such Information relating to Eszopiclone Compounds,
which is Confidential Information of Sepracor.
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1.79 “Sepracor
Patents” shall mean
all Patents that Sepracor or any of its Affiliates Controls on the
Effective Date or during the Research Term that are necessary or
useful for (a) performance of the Research Program or the
Evaluation, or (b) the development, manufacture, use, import, offer
for sale, or sale of any Selected Muscarinic Compound, Licensed
Compound or Product, but excluding Joint Patents, and also
excluding any Patents directed to Eszopiclone Compounds or the use
of Eszopiclone Compounds.
1.80 “Sepracor
Technology” shall
mean the Sepracor Patents, Sepracor Inventions, and Sepracor
Know-How.
1.81 “Sleep
Field” shall mean
the treatment, prevention, or management, or any combination
thereof, as a primary objective, of any condition, disturbance,
disease, or disorder in humans the principal effect(s) of which are
(i) on [...***...] , or (ii) to [...***...] , and
also including, without limitation, any such condition,
disturbance, disease, or disorder where the treatment, prevention,
or management, or any combination thereof, of any such condition,
disturbance, disease, or disorder may result, as a secondary
objective, in [...***...] associated with or arising from
any of the foregoing conditions, disturbances, diseases, or
disorders. For clarification, the Sleep Field excludes
[...***...] (including, without limitation, where the
treatment, prevention, or management, or any combination thereof,
of any of the foregoing conditions, disturbances, diseases,
disorders, or psychoses may result, as a secondary objective, in
[...***...] (excluding anything recited in the first
sentence of this Section 1.81) associated with or arising from any
of the foregoing conditions, disturbances, diseases, disorders or
psychoses).
1.82 “Stock Purchase
Agreement” shall
mean the agreement discussed in more detail in Section
7.1.
1.83
“Sublicensee” shall mean a Third Party to whom Sepracor or any
of its Affiliates has granted a license or sublicense to develop,
make, have made, use, distribute for sale, promote, market, offer
for sale, sell, have sold, import, or export Products, beyond the
mere right to purchase Products from Sepracor or its Affiliates.
For the avoidance of doubt, the parties agree that a Third Party
acquiring all or substantially all of the business of Sepracor or
its
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Affiliates, whether by merger, sale of stock,
sale of assets, or otherwise, shall not be a
Sublicensee.
1.84 “Sublicensing
Revenues” shall
mean the amount actually received by Sepracor or an Affiliate of
Sepracor from any and all Sublicensees (excluding any amounts
described in the proviso below) arising from the license or
sublicense of the right, [...***...] , to develop, make,
have made, use, distribute for sale, promote, market, offer for
sale, sell, have sold, import or export Products. Sublicensing
Revenues shall include up-front or license fees, milestone
payments, royalties paid to Sepracor or any of its Affiliates by a
Sublicensee based on such Sublicensee’s sale of Products,
premiums above the fair market value on sales of securities, annual
maintenance fees and any other payments in respect of the grant to
such Sublicensee of a license or sublicense of the right,
[...***...] , to develop, make, have made, use, distribute
for sale, promote, market, offer for sale, sell, have sold, import
or export Products (with any of the foregoing consideration
received by Sepracor or its Affiliate other than in the form of
cash to be valued at its fair market value as of the date of
receipt); provided, however, that Sublicensing Revenues
shall not include any payments tied directly to the provision of
goods and services by Sepracor or its Affiliate to such Sublicensee
(including, without limitation, any amounts received as
reimbursement of costs or expenses actually incurred by Sepracor or
its Affiliate for research, development, manufacturing (including,
without limitation, packaging, samples, storage, and shipping),
marketing, and payment of government fees) to compensate Sepracor
or its Affiliate for the fair market value of the provision of such
goods and services, or payments for securities (other than premiums
above the fair market value of such securities).
1.85 “Successful
Completion” shall
mean, with respect to a Phase II Clinical Trial of a Product, that
Sepracor has received the final report of the results of such Phase
II Clinical Trial and Sepracor has not terminated all development
of such Product within [...***...] of receipt of such final
report and provided ACADIA with written notice thereof.
1.86
“Term” shall
have the meaning provided in Section 12.1.
1.87 “Third
Party” shall mean
any entity other than ACADIA or Sepracor or an Affiliate of ACADIA
or Sepracor.
1.88 “Third Party
Compound” shall
mean certain of the [...***...] Eyecare Compounds listed in
Schedule 1.89 as of the Effective Date, which are licensed to a
Third Party [...***...] .
1.89 “[...***...] Eyecare
Compounds” shall
mean specific Muscarinic Compounds and Other Forms thereof
(excluding [...***...] as set forth in clause 3) of Section
1.55) that the parties agree are [...***...] , as listed in
Schedule 1.89, as may be updated pursuant to Section
3.10(b).
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2.
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R
ESEARCH P ROGRAM G OVERNANCE
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2.1 Joint Research
Committee.
(a) Formation &
Chairperson. Promptly
after the Effective Date, the parties will form a Joint Research
Committee. Each party may change the identity of any or all of its
members on the JRC at any time in its sole discretion. One member
of the JRC shall be selected to act as the chairperson of the JRC,
with each chairperson acting for a term of [...***...] . The
chairperson shall be selected [...***...] by ACADIA and
Sepracor, and [...***...] shall designate the first
chairperson.
(b) JRC Meetings.
The JRC shall meet at least four (4)
times per calendar year during the Research Term or at such greater
frequency as the JRC agrees. Such meetings may be conducted by
videoconference, teleconference or in person, as agreed by the
parties (except that at least two (2) of such meetings per year
shall be conducted in person), and the parties shall agree upon the
time of meetings. A reasonable number of additional representatives
of a party may attend meetings of the JRC in a non-voting
capacity.
(c) Reports.
Within [...***...] after each
meeting, the JRC chairperson will provide the parties with a
written report describing, in reasonable detail, the status of the
Research Program, a summary of the results and progress to date,
the issues requiring resolution, and the agreed resolution of
previously reported issues.
(d) Period.
The JRC shall remain in place until
the expiration or termination of the Research Term.
2.2 Joint Research Committee
Functions and Powers. The
responsibilities of the JRC shall be as follows:
(a) reviewing scientific information and data for
Muscarinic Compounds, and for Muscarinic Compounds that satisfy
Product Candidate Criteria, voting on approval of such Muscarinic
Compounds as Product Candidates;
(b) developing and approving the Research Plan
within [...***...] of the Effective Date;
(c) overseeing and monitoring the progress of the
Research Program;
(d) determining the total number (which shall not be
less than [...***...] nor more than [...***...] at
any given time, and shall be subject to the provisions of Section
3.4) and functional mix of ACADIA chemistry, in vitro
biology and in vivo biology FTEs to be devoted to the
Research Program; and
(e) sharing information generated in the course of
the Preliminary Evaluation Work and the Evaluation
Studies.
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2.3 Joint Research Committee
Decision-Making.
(a) Voting.
Decisions of the JRC shall be made
by unanimous vote, with each member present at or participating in
such meeting having one vote; provided, however, that
present or participating members of a party shall have the right to
vote by proxy for members of that party who do not attend or
participate. No vote of the JRC may be taken unless at least two
(2) of each party’s representatives are present for the JRC
vote.
(i) If the JRC is unable to reach a unanimous vote
on any matter, then the matter shall be referred to the Chief
Scientific Officer of ACADIA and the Executive Vice President,
Research and Development, of Sepracor for further discussion and
resolution. These officers shall have [...***...] to attempt
in good faith to resolve the matter and thereby make the decision
on behalf of the JRC.
(ii) If the officers referred to in Section 2.3(a)(i)
above are unable to reach an agreement at the end of the
[...***...] period, then the matter shall be referred to the
Chief Executive Officer of ACADIA and the Chief Executive Officer
of Sepracor. The CEOs shall have [...***...] to attempt in
good faith to resolve the matter and thereby make the decision on
behalf of the JRC.
(iii) If the CEOs are unable to reach an agreement on
such matters at the end of the [...***...] period referred
to in Section 2.3(a)(ii) above, then Sepracor shall have the right
to make the final decision on behalf of the JRC, but in no event
will Sepracor have the right to increase the number of ACADIA FTEs
beyond [...***...] FTEs in any year of the Research Term
without ACADIA’s written consent.
(b) Reversion of [...***...]
Agonists. If (i) the JRC
determines, in accordance with Section 2.3(a) above, at any time
during the Research Term, that research and development of
[...***...] Agonists is not being currently pursued under
the Research Program or in good faith planned to be pursued under
the Research Program during the Research Term as reflected in the
Research Plan, or (ii) at the end of the Research Term, there is
not at least one (1) [...***...] Agonist that has been
designated as a Primary Selected Muscarinic Compound, then,
effective upon the date of such determination under subsection (i)
or the end of the Research Term under the circumstances described
in subsection (ii), as applicable, all [...***...] Agonists
shall be excluded from the definition of Muscarinic Compounds for
purposes of this Agreement (including, without limitation, the
license granted to Sepracor under Section 6.1(a)) and shall no
longer be subject to this Agreement, and ACADIA shall be free to
pursue research, development and commercialization of
[...***...] Agonists for any indication, itself or with its
Affiliates and Third Parties.
2.4 Joint Development
Committee.
(a) Formation &
Chairperson. Promptly
after the selection of the first Product Candidate, the parties
will form a Joint Development Committee. Each party may change the
identity of any or all of its members on the JDC at any time in its
sole discretion. One (1) member of the JDC shall be selected to act
as the chairperson of the JDC, with each chairperson acting for a
term of [...***...]. The chairperson shall be selected
[...***...] by ACADIA and Sepracor, and [...***...]
shall designate the first chairperson.
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(b) JDC Meetings.
The JDC shall meet at least four (4)
times per year during the Research Term and for so long thereafter
as any Product Candidate is in preclinical studies conducted prior
to filing of an IND for the Product Candidate, or at such greater
frequency as the JDC agrees. Such meetings may be conducted by
videoconference, teleconference or in person, as agreed by the
parties (except that at least two (2) of such meetings per year
shall be conducted in person), and the parties shall agree upon the
time of meetings. A reasonable number of additional representatives
of a party may attend meetings of the JDC in a non-voting
capacity.
(c) Reports.
Within [...***...] after each
meeting, the JDC chairperson will provide the parties with a
written report describing, in reasonable detail, the status of
development efforts with respect to each Product Candidate, a
summary of the results and progress to date, the issues requiring
resolution, and the agreed resolution of previously reported
issues.
(d) Period.
The JDC shall remain in place for so
long as any Product Candidate (including any Other Forms of such
Product Candidate) remains in preclinical studies conducted prior
to IND filing and has not been entered into clinical
trials.
2.5 Joint Development Committee
Functions and Powers. The
responsibilities of the JDC shall be as follows:
(a) developing and approving an IND Plan for each
Product Candidate, within [...***...] of the JRC’s
selection of such Product Candidate;
(b) overseeing development and regulatory strategies
for Product Candidates prior to acceptance of an IND for a Product
Candidate;
(c) carrying out the other duties and
responsibilities described for it in this Agreement; and
(d) so long as a JDC remains in effect, act as a
mechanism for Sepracor to provide updates to ACADIA related to work
with Product Candidates following acceptance of an IND for the
same.
For purposes of clarification, the JDC’s
authority shall be Product-specific (i.e., the JDC shall exercise
its rights under this Article 2 on a Product-by-Product basis,
commencing as of designation of a Product Candidate and ending at
such time as an IND is accepted for a Muscarinic Product based on
such Product Candidate (or Other Forms of such Product
Candidate)).
2.6 Joint Development Committee
Decision-Making. Decisions of the JDC shall be made by unanimous
vote, with each member present at or participating in such meeting
having one vote; provided, however, that present or
participating members of a party shall have the right to vote by
proxy for members of that party who do not attend or participate.
No vote of the JDC may be taken unless at least two (2) of each
party’s representatives on the JDC are present to
vote.
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(a) If the JDC is unable to reach a unanimous vote
on any matter, then the matter shall be referred to the Chief
Scientific Officer of ACADIA and the Executive Vice President,
Research and Development, of Sepracor for further discussion and
resolution. These officers shall have [...***...] to attempt
in good faith to resolve the matter and thereby make the decision
on behalf of the JDC.
(b) If the officers referred to in Section 2.6(a)
above are unable to reach an agreement by the end of the
[...***...] period, then the matter shall be referred to the
Chief Executive Officer of ACADIA and the Chief Executive Officer
of Sepracor. The CEOs shall have [...***...] to attempt in
good faith to resolve the matter and thereby make the decision on
behalf of the JDC.
(c) If the CEOs fail to reach an agreement by the
end of the [...***...] period referred to in Section 2.6(b)
above, then Sepracor shall have the right to make the final
decision on behalf of the JDC.
2.7 Product Business
Decisions. All business
decisions relating to development, promotion, or commercialization
of any Product in any country, including, but not limited to,
decisions concerning commercial activities, labeling, pricing,
reimbursement, trademarks, brand names, logos, packing, package
design, sales, package inserts, promotional materials, and
promotional activities, and the decision to launch or continue to
market any Product in any country, shall be within the sole
discretion of Sepracor.
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3.
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C
ONDUCT OF THE R ESEARCH P ROGRAM
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3.1 Objectives;
Responsibilities. The
parties hereby agree to establish the Research Program, to be
conducted by the parties during the Research Term in accordance
with the Research Plan, any IND Plan and the terms of this
Agreement, with the goal of identifying [...***...]
Muscarinic Compounds with potential utility in the Muscarinic Field
and developing [...***...] Muscarinic Products for further
development and commercialization by Sepracor in the Muscarinic
Field, including, without limitation, the treatment or prevention
of [...***...] . The initial Research Plan shall be mutually
agreed upon in writing by the parties as promptly as practicable
(but in any event within [...***...] following the Effective
Date). Any amendments or revisions to the Research Plan shall be in
writing and shall require unanimous approval of the JRC. During the
Research Program, there shall be no limit on the number of
Muscarinic Compounds or Product Candidates that are worked on or
evaluated.
3.2 Technology
Transfer. Commencing
immediately after the Effective Date and from time to time
thereafter during the Research Term, ACADIA shall disclose to
Sepracor such ACADIA Technology as is reasonably necessary to
enable Sepracor to carry out its obligations under the Research
Program and to exercise fully the licenses granted to Sepracor
under this Agreement, and Sepracor shall disclose to ACADIA such
Sepracor Technology as is reasonably necessary to enable ACADIA to
carry out its obligations under the Research Program and to
exercise fully the licenses granted to ACADIA under this
Agreement.
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3.3 Performance
Standards. Each party
shall conduct its activities under the Research Program and any IND
Plan in good scientific manner, and in compliance in all material
respects with the requirements of applicable laws and regulations
and with applicable good laboratory practices, to attempt to
achieve its objectives efficiently and expeditiously. Each party
shall maintain laboratories, offices and all other facilities
reasonably necessary to carry out the activities to be performed by
it pursuant to the Research Plan or any IND Plan. In conformity
with standard pharmaceutical and biotechnology industry practices
and the terms and conditions of this Agreement, each party shall
prepare and maintain, or shall cause to be prepared and maintained,
complete and accurate written records, accounts, notes, reports,
and data with respect to activities conducted pursuant to the
Research Plan or any IND Plan and, upon the other party’s
written request, shall send legible copies of the aforesaid to the
other party, all of which shall be subject to the confidentiality
and other obligations of Article 11. Upon reasonable advance
notice, each party agrees to make its employees and non-employee
consultants reasonably available at their respective places of
employment to consult with the other party on issues arising under
the Research Program during the Research Term or relating to
development or commercialization of Products (provided that, if
consultation by employees or consultants of ACADIA relating to
development or commercialization of Products requested by Sepracor
after the Research Term involves additional laboratory services or
performance of preclinical or clinical studies, Sepracor shall
reimburse ACADIA for such employees’ or consultants’
time spent carrying out such services or studies in accordance with
the terms of a separately negotiated agreement).
3.4 Research
Commitment.
(a) Commitment/FTEs.
During the Research Term, each party
shall use its commercially reasonable efforts to perform its
responsibilities under the Research Plan and any IND Plan in
accordance with such plan and the terms and conditions of this
Agreement. Without limiting the generality of the foregoing, ACADIA
shall devote to the performance of its responsibilities under the
Research Plan and any IND Plan such number of FTEs as is determined
by the JRC in accordance with Article 2, provided that in no event
shall ACADIA be obligated to devote more than an aggregate of
[...***...] FTEs to all Research Plan and IND Plan
activities at any given time, and further provided that, in the
event that ACADIA is obligated to devote more than
[...***...] FTEs in any year, for that year, Sepracor will
increase the research funding described in Section 7.3 of this
Agreement by an incremental rate of [...***...] per FTE,
subject to Section 3.4(b) below; and further provided that, with
respect to staffing of FTEs for the Research Program, ACADIA shall
[...***...] .
(b) No Express or Implied
Employment. Nothing in
this Agreement creates or intends to create, any express or implied
employment by Sepracor or its Affiliates of any ACADIA FTE, and no
FTE funded by Sepracor in accordance with this Agreement shall be
entitled to any Sepracor, or its Affiliates, benefits, including
without limitation, employee stock options, employee stock purchase
plans, 401(k) programs, health insurance, or workers compensation.
ACADIA is responsible for all employee withholding taxes or other
taxes owed with regard to any FTE in any country, and shall
indemnify and hold Sepracor harmless for any claims, suits, or
causes of action relating thereto.
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(c) FTE Reports.
At or before each JRC meeting,
ACADIA shall provide Sepracor with a quarterly FTE allocation
report for the Research Program and a list of the FTEs staffing the
Research Program. In addition, Sepracor may request an interim FTE
allocation report at any time by providing written notice to
ACADIA, and ACADIA shall provide such interim report to Sepracor
within [...***...] thereafter; provided ,
however , that Sepracor may not request an interim report
more than one (1) time per Calendar Quarter. The format and content
of the FTE allocation report shall be decided by the JRC at its
first meeting after the Effective Date.
3.5 Research Reports.
Each party shall keep the other
party fully informed as to all discoveries and technical
developments (including, without limitation, any Inventions) made
in the course of performing activities under the Research Plan or
any IND Plan. In particular, each party shall prepare, and
distribute to all members of the applicable Committee no later than
[...***...] prior to the next Committee meeting, a
reasonably detailed written summary report, in such form and format
and setting forth such information regarding the results and
progress of performance of the Research Plan or IND Plan
activities, as applicable, as determined from time to time by such
Committee. Nothing herein shall require ACADIA or Sepracor to
disclose to the other information received from or generated for a
Third Party that remains subject to bona fide
confidentiality obligations to such Third Party.
3.6 Subcontracts.
A party may perform some of its
obligations under the Evaluation, the Research Plan, or any IND
Plan through one (1) or more subcontractors, provided that (a) none
of the other party’s rights hereunder are diminished or
otherwise adversely affected as a result of such subcontracting,
(b) the subcontractor undertakes in writing obligations of
confidentiality and non-use regarding Confidential Information
which are substantially the same as those undertaken by the parties
pursuant to Article 11 hereof, and (c) the subcontractor is
approved by the JRC, provided that Sepracor shall not require
approval by the JRC, JDC, or ACADIA with regard to any work
performed by subcontractors or on behalf of Sepracor or its
Affiliates relating to Product Candidates or development or
commercialization of Products. In the event a party performs any of
its obligations under the Research Plan or any IND Plan through a
subcontractor, then such party will at all times be responsible for
the performance and payment of such subcontractor.
3.7 Materials
Transfer. In order to
facilitate the Research Program and the Evaluation, either party
may provide to the other party certain biological materials or
chemical compounds Controlled by the supplying party, including,
but not limited to, Muscarinic Compounds, Option Compounds or Other
Forms of any of the foregoing (collectively,
“Materials” ) for use by the other party
in furtherance of the Research Program, any IND Plan or the
Evaluation, as applicable. Except as otherwise provided under this
Agreement, all such Materials delivered to the other party will
remain the sole property of the supplying party, will be used only
in furtherance of the Research Program or Evaluation in accordance
with this Agreement, will not be used or delivered to or for the
benefit of any Third Party, except for subcontractors pursuant to
Section 3.6, without the prior written consent of the supplying
party, and will be used in compliance with all applicable laws,
rules and regulations. The Materials supplied under this Agreement
must be used with prudence and appropriate caution in any
experimental work because not all of their characteristics may be
known. Except as expressly set forth herein, THE MATERIALS ARE
PROVIDED “AS IS” AND WITHOUT ANY
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REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY
WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE
ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD
PARTY.
3.8 Selected Muscarinic
Compounds.
(a) Back-Up Selected Muscarinic
Compounds. Upon
expiration or termination of the Research Term (other than
termination by ACADIA in accordance with Section 12.2 or 12.4),
Sepracor shall have the right to designate up to [...***...]
Back-Up Selected Muscarinic Compounds for each Primary Selected
Muscarinic Compound by providing written notice to ACADIA for each
such designation within [...***...] of such expiration or
termination.
(b) Selected
Indications. With respect
to each Primary Selected Muscarinic Compound and Back-Up Selected
Muscarinic Compounds thereof, Sepracor shall, by no later than
[...***...] following expiration or termination of the
Research Term (other than termination by ACADIA in accordance with
Section 12.2 or 12.4), provide ACADIA with written notice
identifying Selected Indications for the same.
(c) Post-Research Term
Rights.
(i) Upon expiration or termination of the Research
Term (other than termination by ACADIA in accordance with Section
12.2 or 12.4), all rights (excluding any rights under Sepracor
Technology or Sepracor’s interest as an owner of Joint
Patents) to any Muscarinic Compound that is not designated as a
Selected Muscarinic Compound within [...***...] after the
effective date of such expiration or termination shall revert to
ACADIA. From and after such time, Sepracor shall not develop, or
attempt to develop, any Muscarinic Compound Controlled by ACADIA
(excluding Joint Muscarinic Compounds Controlled by both parties),
or Other Forms of any such Muscarinic Compound, that is not a
Selected Muscarinic Compound, and Sepracor’s license under
Section 6.1(a)(iii) shall only apply to Selected Muscarinic
Compounds (including Back-Up Selected Muscarinic Compounds
designated in accordance with this Section 3.8). For purposes of
clarification, and notwithstanding any of the foregoing provisions
of this Section 3.8 regarding designation of Selected Indication(s)
to the contrary, for so long as Sepracor’s license under
Section 6.1(a)(iii) remains in effect with respect to a Selected
Muscarinic Compound, Sepracor shall have the exclusive right to
develop and commercialize such Selected Muscarinic Compound for any
indications in the Muscarinic Field, and ACADIA and its Affiliates
shall not have any right to develop, commercialize, or sell (alone
or through a Third Party) any Selected Muscarinic Compound outside
the Muscarinic Field.
(ii) Upon expiration or termination of the Research
Term, except as otherwise specifically provided in Section
6.1(b)(ii), ACADIA shall not have any rights or licenses in, to, or
under any Sepracor Technology, or other Patents (excluding Joint
Patents) or Information belonging to or provided by Sepracor or its
Affiliates, and ACADIA shall not use the same or share it with any
Third Party. Upon expiration or termination of the Research
Term,
***Confidential Treatment
Requested
20
except as otherwise specifically
provided in Section 6.1(a)(iii) and (iv), Sepracor shall not have
any rights or licenses in, to, or under any ACADIA Technology, or
other Patents (excluding Joint Patents) or Information belonging to
or provided by ACADIA or its Affiliates, and Sepracor shall not use
the same or share it with any Third Party.
3.9 Exclusivity.
Until [...***...] of the
expiration or termination of the Research Term (other than
termination by ACADIA in accordance Section 12.2 or 12.4), ACADIA
shall not develop or commercialize (either directly or through any
Third Party) any Muscarinic Compound for use in the Selected
Indications. However, if, at any time prior to [...***...]
of the expiration or termination of the Research Term (other than
termination by ACADIA in accordance with Section 12.2 or 12.4),
Sepracor is not engaged in any development or commercialization
efforts whatsoever with respect to at least one (1) Selected
Muscarinic Compound or Muscarinic Product for any given Selected
Indication, or either (i) Sepracor in good faith notifies ACADIA in
writing that it intends to abandon research and development of all
Selected Muscarinic Compounds or Muscarinic Products for such
Selected Indication or (ii) the minutes of any board or committee
meeting of Sepracor reflect Sepracor’s abandonment of
research and development of all Selected Muscarinic Compounds and
Muscarinic Products for such Selected Indication, then the
restriction set forth in the first sentence of this Section 3.9
shall terminate with respect to such Selected
Indication.
3.10 ACADIA Development of
[...***...] Eyecare Compounds.
(a) Original [...***...] Eyecare
Compounds. Sepracor
agrees that ACADIA shall retain all rights (excluding any rights
under Sepracor Technology or Sepracor’s interest as an owner
of Joint Patents) to pursue, itself or with any Affiliate or Third
Party, one (1) or more [...***...] Eyecare Compounds subject
to the terms and provisions of this Agreement.
(b) Designation of New
[...***...] Eyecare Compounds. From time to time during the Research Term,
ACADIA may provide Sepracor written notice identifying one (1) or
more Muscarinic Compounds that ACADIA in good faith believes are
[...***...] due to one or more factors (such as
[...***...] ), and such written notice will provide Sepracor
with data to evidence such unsuitability and shall include a
request to designate the identified Muscarinic Compounds as
[...***...] Eyecare Compounds. Should Sepracor believe, in
good faith, that any of such Muscarinic Compounds identified by
ACADIA in its written notice are suitable or potentially suitable
for [...***...] Sepracor shall provide ACADIA with written
notice identifying the Muscarinic Compound(s) described in
ACADIA’s notice that Sepracor believes are suitable for
[...***...] or that Sepracor believes inadequate information
exists at the time to determine whether any such Muscarinic
Compound is suitable for [...***...] , and explaining its
rationale for such belief, within [...***...] of receipt of
such notice from ACADIA, and such Muscarinic Compound(s) shall not
be considered [...***...] Eyecare Compounds. If Sepracor
notifies ACADIA that Sepracor agrees with ACADIA’s
determination of such Muscarinic Compound(s)’ unsuitability
for [...***...] , or if Sepracor does not respond to
ACADIA’s written notice regarding the unsuitability of such
Muscarinic Compound(s) for [...***...] within
[...***...] after receipt of such notice, such Muscarinic
Compound(s) shall be deemed [...***...] Eyecare Compound(s)
and shall cease to be considered Muscarinic Compound(s) for
purposes of this Agreement.
***Confidential Treatment
Requested
21
(c) Other Requests.
From time to time during the
Research Term, ACADIA may, by written notice to Sepracor, request
Sepracor’s written consent that ACADIA may pursue research,
development and commercialization (either directly or through its
Affiliates or any Third Party) for Eyecare Indications of one or
more specific Muscarinic Compounds (excluding any Selected
Muscarinic Compounds) that are potentially suitable for systemic
administration. Sepracor agrees to consider in good faith any such
request, and provide ACADIA with written notice of its
determination.
|
4.
|
E
VALUATION
; L ICENSE O PTION
|
4.1 Option Period.
(a) Preliminary Evaluation
Period. Within
[...***...] of the Effective Date, ACADIA will send Sepracor
all then existing Option Compound Information, and a written notice
confirming that all then existing Option Compound Information was
sent to Sepracor. Within [...***...] of Sepracor’s
receipt of all Option Compound Information, Sepracor shall identify
to ACADIA, by written notice, [...***...] Evaluation
Compounds for the purpose of conducting Preliminary Evaluation
Work. Within [...***...] of receipt of Sepracor’s
notice identifying Evaluation Compounds, ACADIA will provide
Sepracor with Option Compound Information not previously provided
to Sepracor relating to Evaluation Compounds, including without
limitation methods and processes for synthesizing the same, and to
the extent available, reasonable quantities of each Evaluation
Compound for purposes of conducting Preliminary Evaluation Work
during the Preliminary Evaluation Period.
(b) Selection of Chosen
Compounds.
(i) Selection.
Sepracor shall have the right,
exercisable by written notice to ACADIA from the Effective Date and
throughout the Preliminary Evaluation Period, to designate up to
[...***...] Chosen Compounds for purposes of conducting
Evaluation Studies during the Final Evaluation Period. Sepracor
will use good faith efforts to make the designation of the Chosen
Compounds as promptly as possible within the Preliminary Evaluation
Period. Within [...***...] of ACADIA’s receipt of
Sepracor’s notice designating Chosen Compounds, ACADIA shall
deliver to Sepracor a reasonably detailed written summary of
existing Preclinical Development Costs for each Chosen
Compound.
(ii) Identification of Other
Forms. By no later than
[...***...] from the date of its written notice designating
Chosen Compounds pursuant to Section 4.1(b)(i) above, Sepacor shall
send ACADIA a written notice providing a cumulative list
designating all compounds that Sepracor believes in good faith may
be Chosen Compound [...***...] based on scientifically
acceptable principles and methods, and the compounds on such list
shall thereafter be the only [...***...] for Chosen
Compounds included in the term “Other Form” pursuant to
clause 3) of Section 1.55.
(c) Evaluation Reports
. On a [...***...] during the
Option Period, Sepracor will provide to ACADIA the Evaluation
Results and a summary of other Sepracor
***Confidential Treatment
Requested
22
Know-How generated in the course of
the Preliminary Evaluation Work or Evaluation Studies, which may be
provided through the JRC.
(d) Use of Evaluation
Results. Except as
otherwise provided in this Agreement, Sepracor shall use Option
Compound Information, Option Compounds, and Evaluation Results
solely for the purpose of carrying out the Evaluation. Without
limiting the generality of the foregoing, except as otherwise
provided in this Agreement, Sepracor agrees that after the
Effective Date it shall not (i) use Option Compounds, Option
Compound Information, or Evaluation Results received or generated
by Sepracor pursuant to this Agreement in research that is subject
to licensing, or similar obligations to any Third Party, (ii)
disclose or transfer Option Compounds, Option Compound Information,
or Evaluation Results to any Third Party without ACADIA’s
prior written consent except as otherwise provided in Section 3.6
of this Agreement, (iii) develop, or attempt to develop, any Other
Forms of any Option Compound; or (iv) except as otherwise provided
in Section 9.3, file (or cause to be filed) any patent application
anywhere in the world containing any Option Compound Information or
any results of the Evaluation Studies, or that contains compound
claims directed to any Option Compound or Other Forms thereof, or
any method of use of any Option Compound or Other Forms thereof,
without ACADIA’s prior written consent.
4.2 Extension of Option Period
for ACADIA Delay. The
Option Period may be extended by the parties if ACADIA does not
timely provide the Option Compound Information or the required
quantities of Evaluation Compounds in accordance with Section 4.1.
If Sepracor in good faith believes that ACADIA has not timely
provided such Option Compound Information or Evaluation Compounds,
Sepracor shall provide ACADIA with written notice thereof, and the
parties shall negotiate in good faith and mutually agree in writing
upon an extension of the Option Period that is commensurate with
the duration of any delay in the Evaluation caused by
ACADIA’s failure to comply with its obligations under Section
4.1.
4.3 Grant of Option.
Subject to the terms and conditions
of this Agreement, ACADIA hereby grants to Sepracor an option (the
“Option” ), exercisable during the Final
Evaluation Period with respect to one (1) Chosen Compound, to
obtain an exclusive, worldwide, royalty-bearing license, with the
right to sublicense, under the ACADIA Technology to develop, make,
have made, use, distribute, distribute for sale, promote, sell,
offer for sale, have sold, or import Fixed Co-Formulation Products
in the Sleep Field.
4.4 Exercise of Option &
Licensed Compound Other Forms.
(a) Option Exercise.
Subject to the terms and conditions
of this Agreement, Sepracor may exercise the Option granted under
Section 4.3 at any time during the Final Evaluation Period by
sending the Exercise Notice to ACADIA and by paying the Option
Exercise Fee to ACADIA in accordance with the terms of Section 7.2
of this Agreement. Sepracor will use commercially reasonable
efforts to exercise the Option as promptly as possible within the
Final Evaluation Period.
23
(b) Licensed Compound Other
Forms.
(i) Initial
Identification. By no
later [...***...] from the date of the Exercise N
