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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 1 [...***...] 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. |
R ESEARCH P ROGRAM G
OVERNANCE |
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.
| 3. |
C ONDUCT OF THE
R ESEARCH P ROGRAM |
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 Notice, Sepracor shall send ACADIA a written notice
providing a list designating all compounds from the list provided
pursuant to Section 4.1(b)(ii) of [...***...] for each of
the Chosen Compounds that Sepracor belie
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